Annual Report • Apr 7, 2022
Annual Report
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Universal Registration Document 2021 Including the Annual Financial Report

1.1 16 Selected financial data
| 2.1 | Risks related to partnerships | 50 |
|---|---|---|
| 2.2 | Financial risks | 51 |
| 2.3 | Risks in relation to the portfolio | 54 |
| 2.4 | Risks related to clinical development | 55 |
| 2.5 | Industrial business risks | 58 |
| 2.6 | Risks related to intellectual property | 60 |

| 4.1 | General framework | 104 |
|---|---|---|
| 4.2 | Respect for ethical values | 106 |
| 4.3 | Commitment to patients | 108 |
| 4.4 | Commitment to our partners | 110 |
| 4.5 | Commitment to our employees | 112 |
| 4.6 | Commitment to our shareholders and investors | 120 |
| 4.7 | Commitment to society and THE REGIONS | 121 |
| 4.8 | Commitment to the planet | 122 |
4.9 126 Methodological note
| 6.1 | Share capital | 202 |
|---|---|---|
| 6.2 | Principal shareholders | 205 |
| 6.3 | Articles of incorporation and articles of association |
207 |
| 6.4 | History and information about the Company during the fiscal year |
210 |
| 6.5 | Information on investments in affiliates | 210 |
| 6.6 | Share buyback program | 211 |
| 6.7 | Statutory auditors' report on related party agreements |
213 |
| 6.8 | Employees | 216 |
73
7.1 218 Person responsible 7.2 Persons responsible for auditing the financial statements 219 7.3 Information from third parties, expert statements and declarations of interest 220 7.4 221 Documents available to the public 7.5 222 Cross-reference tables 7.6 227 Glossary 7.7 Appendix: management report for THE management report for the period ended December 31, 2021 229
3

Transgene is a biotechnology company focused on designing and developing therapeutic vaccines and oncolytic viruses for the treatment of cancer. Our immunotherapies stimulate immune responses and specifically target cancer cells. To achieve this, we integrate a therapeutic arsenal in viral vectors, each component of which plays a role in the fight against tumors.
Transgene has several products in clinical development (Phase I and II trials): TG4050, an individualized therapeutic vaccine from the myvac® platform, TG4001, a therapeutic vaccine against HPV-positive cancers, and two oncolytic viruses, TG6002, which enables a chemotherapy to be produced directly in the tumor, and BT-001, the first candidate from the Invir.IO™ platform, armed with an anti-CTLA-4 antibody.
Transgene has two next-generation platforms that are based on its viral vector expertise.
Transgene also relies on strategy collaborations with recognized players, such as AstraZeneca and Merck KGaA/Pfizer, the leader in Information Technology (IT) NEC, and BioInvent.
The Company is based in Strasbourg, France, and has additional operations in Lyon. Transgene is listed on the regulated stock market in Paris (Euronext compartment B).


This Universal Registration Document was filed on April 6, 2022, with the AMF, as competent authority under regulation (EU) 2017/1129, without prior approval pursuant to Article 9 of the said regulation.
The Universal Registration Document may be used for the purposes of an offer to the public of securities or admission of securities to trading on a regulated market if completed by a security note and, if applicable, a summary and any amendments to the Universal Registration Document. The whole is approved by the AMF in accordance with regulation (EU) 2017/1129.
This is a translation into English of the (universal) registration document of the Company issued in French, which is available on the website of the Issuer.
| Abbreviation | Meaning |
|---|---|
| AACR | American Association for Cancer Research |
| AML | Approval for market launch |
| ANSM | Agence nationale de sécurité du médicament et des produits de santé (French medicines agency) |
| CAR-T | Chimeric Antigen Receptor T, chimeric antigen receptor (T-cell) |
| CRO | Contract Research Organization |
| CTLA-4 | Cytotoxic T-lymphocyte-associated protein 4 |
| DNA | Deoxyribonucleic Acid |
| EMA | European Medicines Agency |
| EPO | European Patent Office |
| ESMO | European Society for Medical Oncology |
| FDA | Food and Drug Administration |
| GM-CSF | Granulocyte-macrophage colony-stimulating factor |
| GMP | Good manufacturing practice |
| HBsAg | HBV surface antigen |
| HCC | Hepatocellular carcinoma |
| HPV | Human Papilloma Virus |
| ICI | Immune checkpoint inhibitor |
| IL-2 | Interleukin 2 |
| IT | Intratumoral |
| IV | Intravenous |
| MHRA | Medicines and Healthcare Products Regulatory Agency |
| MVA | Modified Vaccinia Ankara |
| OV | Oncolytic virus |
| PD-L1or PD-1 | Programmed death-ligand 1, Programmed cell death 1 |
| RR | Ribonucleotide reductase |
| RTC | Research tax credit (RTC) |
| SC | Subcutaneous |
| SCCHN | Squamous cell carcinoma of the head and neck |
| SdAbs | Single-domain antibody |
| SITC | Society for Immunotherapy of Cancer |
| SPA | Special protocol assessment |
| TAA | Tumor associated antigen |
| TK | Thymidine kinase |
| VV | Vaccinia virus |
Transgene is focused on developing highly innovative immunotherapies for the treatment of cancer.
The principle: to stimulate and to educate the immune system with the goal of enabling it to recognize and destroy cancer cells.
To achieve this goal, Transgene has developed two technological approaches: therapeutic vaccines and oncolytic viruses. We design these drug candidates by integrating a comprehensive therapeutic arsenal within the genome of optimized viruses (also known as viral vectors). These viral vectors use highly attenuated viral strains with an established safety profile; they cannot replicate within healthy cells.
Our immunotherapies can either be used as single agent or in combination with other cancer treatments.

Key achievements in 2021 have confirmed the relevance and value of our two cancer therapeutic approaches. The expected newsflow for 2022 should reinforce the potential and value of our products in development."

H. Ben Brahim Chairman and Chief Executive Officer
04 - TRANSGENE - DOCUMENT D'ENREGISTREMENT UNIVERSEL 2020
It has been more than a year since I joined Transgene as Chairman and Chief Executive Officer and I am pleased and proud to have experienced such a successful year in 2021 for the Company. Through our capacity for scientific and technological innovation, and by leveraging our strong clinical expertise, we have continued, and will continue, to develop our cancer immunotherapeutics with agility and conviction.
"
Thanks to the commitment of all our employees, Transgene has achieved many important milestones in 2021. We shared the first positive data from two Phase I trials with TG4050, our proprietary therapeutic vaccine based on our myvac® platform. These results demonstrate the significant potential of this breakthrough therapy. The immunogenicity of the vaccine and first signs of clinical activity have been observed. We should be able to confirm these results in the coming months and provide more in-depth data at major scientific congresses, including the AACR, in 2022.
The Phase II trial with TG4001, our therapeutic vaccine against HPV16-positive anogenital cancers, has been launched in 2021, with the first patient enrolled in June, and is continuing at a steady pace. First data from an interim analysis, including up to 50 patients, will be reported in the fourth quarter of 2022.
With our oncolytic viruses, acceleration also continued with the first patient included in the Phase I/IIa study evaluating BT-001, our first candidate from our Invir.IO™ platform.
We also presented the first Phase I data with TG6002 at two major conferences in 2021: AACR and ESMO. These results confirm the feasibility of intravenous administration of this oncolytic virus, based on our proprietary viral vector behind the Invir.IO™ platform. These observations suggest an extended use of these therapies in oncology, significantly expanding the market opportunity of our oncolytic viruses.
In addition, our knowledge and expertise on our Invir.IO™ platform was recognized with the first license option exercised in late 2021 by AstraZeneca for an oncolytic virus, resulting in an upfront payment of \$8 million. The collaboration with AstraZeneca continues under the agreement for the development of 5 oncolytic immunotherapies by Transgene.
While we achieved significant milestones in 2021, we expect important readouts with our entire product portfolio in 2022.
Following the successful completion of a €34.1 million private placement in June 2021 and the additional sale of Tasly BioPharmaceuticals shares in September 2021 for €17.4 million, Transgene has financial visibility until the end of 2023.
We are then in position to pursue Transgene's mission: create value by developing new innovative cancer therapies to complete the therapeutic arsenal available to clinicians and patients. "

| Product | Target/transgene | Indication | Collaboration | Preclinical | Phase I | Phase II |
|---|---|---|---|---|---|---|
| THERAPEUTIC VACCINE | ||||||
| TG4050 | 30 neoantigens | Ovarian cancer Head and neck cancers |
||||
| TG4001 | HPV16 E6 – E7 | Anogenital HPV+ cancers |
||||
| ONCOLYTIC VIRUS (OV) | ||||||
| 5-FU | Gastro-intestinal cancers (IV*) |
|||||
| TG6002 | chemotherapy | Colorectal cancer (IHA*) |
||||
| BT-001 | Anti-CTLA4 + GM-CSF |
Tumeurs solides | ||||
| OVs | Undisclosed | Solid tumors | ||||
| 5 OVs | Undisclosed (1 option exercised) |
Solid tumors | ||||
| OV | Undisclosed (CAR-T combination) |
Solid tumors | ||||
| * IV: intravenous administration, IHA: intrahepatic artery administration | ||||||

To develop innovative treatments of cancers for which there is no satisfactory treatment.

Our mission carries the values of ESG in itself. Transgene has always paid particular attention to ESG and has always promoted the values of humanism, citizenship and respect for the environment.
An ESG report is presented in chapter 4 of this document.
OUR INNOVATIVE IMMUNOTHERAPIES

Therapeutic vaccines aim at inducing a cascade of immune reactions that lead to the production of cytotoxic T cells (effective T cells) that will be able to recognize and destroy cancer cells.

By integrating cancer cell-specific gene sequences into the genome of a viral vector, we direct the immune response against the tumor cells that carry these same sequences.
Transgene developed myvac®, an immunotherapy platform, which leverages cutting-edge Artificial Intelligence (AI) capabilities to customize the treatment for each patient.
Transgene's highly innovative technology platform, myvac®, enables the generation of a virus-based immunotherapy, which encodes patient-specific cancer cell mutations (neoantigens) identified and selected by NEC's Neoantigen Prediction System, an advanced AI technology approach. The company has also set up a unique in-house Good Manufacturing Practices (GMP) unit.


Watch our video on myvac®
First promising results with this innovative individualized therapy
It is being evaluated in two clinical trials in Europe and in the United States.
The first positive results obtained in the first 6 patients were announced in November 2021. Further detailed data will be presented at major scientific conferences in oncology in 2022.


This therapeutic vaccine provided particularly promising results in a Phase Ib/II clinical trial in 2020. These were presented at the SITC 2020 and ESMO IO 2020 congresses by Professor Christophe Le Tourneau of the Institut Curie.
The pooled analysis of this Phase Ib/II trial demonstrated pronounced anti-tumor activity of the combination of TG4001 and avelumab. Transgene observed that the presence of liver metastases had a significant impact on the results: in patients without liver metastases, the response rate was 34.8% and a median progression-free survival of 5.6 months was achieved.
These promising data compare favorably with standards of care. They allow Transgene and Merck KGaA to expand clinical development in a randomized, controlled Phase II trial. The first patient of this study was included in June 2021. An interim analysis will be performed after the inclusion of approximately 50 patients; data are expected in Q4-2022.
Interview of Prof. Le Tourneau and of our Chief medical officer on the recent Phase Ib/II data:

OUR INNOVATIVE IMMUNOTHERAPIES
Oncolytic viruses are designed to selectively multiply in cancer cells and induce their breakdown (a process called cell lysis). This process is also involved in activating the patient's immune system. Oncolytic viruses also have the ability to carry therapeutic payloads in their genome, which are expressed during replication in the tumor, and allow to attack the tumor microenvironment on several fronts.
Discover the mechanism of action of oncolytic viruses

is an oncolytic virus that allows the production of a chemotherapy agent directly in the tumor.

This drug candidate is being investigated in two clinical trials, evaluating intravenous and intra-arterial hepatic routes of administration, in patients with gastrointestinal cancers. Initial Phase I clinical data with TG6002 were presented at two major congresses in 2021: AACR and ESMO.
These results confirm the feasibility of intravenous administration of this oncolytic virus, based on our proprietary viral vector behind the Invir.IO™ platform.
Discover the mechanism of action of TG6002

Transgene's proprietary platform, Invir.IO™ , is dedicated to the design and development of a new generation of oncolytic viruses.
Invir.IO™-based oncolytic viruses are optimized to act as a Trojan horse; they are called 'armed' or multifunctional viruses.
To design these therapies, Transgene integrates into the genome of a patented virus the genetic sequences encoding the therapies that will be produced during viral replication, directly in the tumor. The objective is to improve therapeutic efficacy while limiting side effects for the patient.
It is armed with an anti-CTLA4 antibody from our partner BioInvent. BT-001 is currently being evaluated in a Phase I/IIa trial; the first patient was treated in February 2021.

Transgene and AstraZeneca have entered into a collaboration agreement under which Transgene designs five innovative oncolytic viruses based on the Invir.IO™ platform.
AstraZeneca has exercised a first license option for an oncolytic virus in December 2021.
More information on Invir.IO™


| 1.2.1 | General business overview | 17 |
|---|---|---|
| 1.2.2 | Overview of platforms and main products | 21 |
| 1.2.3 | Strategic collaboration agreements | 30 |
| 1.2.4 | Other products and collaborations | 31 |
| 1.2.5 | Competitive advantages | 35 |
| 1.2.6 | Principal markets and competition | 36 |
| 1.2.7 | Organizational chart | 38 |
| 1.3 | BUSINESS OVERVIEW | 39 |
| 1.3.1 | Principal activities of the fiscal year | 39 |
|---|---|---|
| 1.3.2 | Presentation of the financial statements | 39 |
| 1.3.3 | Financial position and appropriation of income | 42 |
| 1.3.4 | Cash flow, financing and capital resources | 44 |
| 1.3.5 | Investments | 45 |
| 1.3.6 | Foreseeable changes, future prospects and significant |
events subsequent to the end of the financial year 45
1


| (in € thousands, except for shares and per share data) (Consolidated financial statements, IAS/IFRS) |
Dec. 31, 2021 IAS/IFRS |
Dec. 31, 2020 IAS/IFRS |
Dec. 31, 2019 IAS/IFRS |
|---|---|---|---|
| INCOME STATEMENT DATA | |||
| Operating income | 17,413 | 9,915 | 13,733 |
| Research and development expenses | (32,883) | (27,346) | (31,385) |
| General and administrative expenses | (7,369) | (6,547) | (7,134) |
| Other expenses | (686) | (15) | (668) |
| Operating expenses | (40,938) | (33,908) | (39,187) |
| Operating income/(loss) | (23,525) | (23,993) | (25,454) |
| Financial income/(loss) | 3,989 | 6,762 | 6,650 |
| Share of profit/(loss) and disposal of investments in associates | - | - | - |
| Income/(loss) before tax | (19,536) | (17,231) | (18,804) |
| Income tax expense | - | - | - |
| Net income/(loss) | (19,536) | (17,231) | (18,804) |
| Basic earnings per share | (0.21) | (0.21) | (0.23) |
| Diluted earnings per share | (0.20) | (0.21) | (0.23) |
| Number of shares outstanding | 97,771,334 | 83,841,334 | 83,265,464 |
| Cash, cash equivalents and other current financial assets | 49,569 | 26,354 | 43,371 |
| Total assets | 101,838 | 85,453 | 115,477 |
| Equity | 67,209 | 50,716 | 65,697 |
| Net cash flow generated by/ (used in) operational activities | (31,943) | (28,742) | (22,413) |
Presentation of the Company and its business
Transgene is a biotechnology company that designs and develops immunotherapy products against cancer. These therapies stimulate the immune defenses of patients in order to specifically target cancer cells.
To achieve this goal, Transgene integrates a comprehensive therapeutic arsenal within optimized viruses (also called viral vectors). Each part of these constructs plays a role in eliminating the tumor. This arsenal consists of genetic sequences called transgenes.
The Company has two technology platforms utilizing viral vector engineering: therapeutic vaccines and oncolytic viruses.
Transgene has four products in clinical development which are therefore being evaluated in patients:
With myvac® , Transgene has developed an innovative platform to create individualized immunotherapies based on neoantigens, which are specific mutations that are found in the tumors of each patient. To select these neoantigens and personalize TG4050 for each patient, Transgene relies on the artificial intelligence (AI) capabilities of its partner NEC, a world leader in information technologies. TG4001 is Transgene's most advanced drug candidate. On the basis of promising results obtained in a Phase Ib/II trial, TG4001 is currently being evaluated in a Phase II, controlled and randomized trial, launched in March 2021. This study compares TG4001 in combination with avelumab with avelumab monotherapy in HPV16-positive anogenital cancers.
With its proprietary Invir.IO™ platform, Transgene builds on its expertise in viral vectors engineering to design a new generation of multi-functional oncolytic viruses. In collaboration with BioInvent, Transgene is developing BT-001, an oncolytic virus armed with an anti-CTLA-4 antibody and the cytokine GM-CSF.
Transgene and AstraZeneca have been working together since 2019 to co-develop five multi-armed oncolytic viruses from this platform. This research agreement includes a license option, which may be exercised by the pharmaceutical company for each of these drug candidates. In December 2021, AstraZeneca exercised an option to license a first oncolytic virus.
Transgene also conducts other research programs based on its viral vector technology and aimed at supporting the development of its candidates.
The Company is based in Strasbourg, France, and has additional operations in Lyon, France.
Transgene is listed on the regulated stock market (Euronext compartment B) in Paris, France.
As a biotechnology company, Transgene designs and develops immunotherapy products (drug candidates or investigational drugs) against cancer. The Company has several drug candidates and two technological platforms (myvac® and Invir.IO™) deriving from its know-how in bioengineering.
The Company's business model consists of obtaining the proof of concept for the clinical efficacy or for the potential of its products, primarily in order to license or sell the candidates' rights to pharmaceutical partners able to add value to them and handle their clinical development up to and through the marketing phase.
This search for a partner can be done either on the basis of clinical results (Phase I/II), or on a preclinical proof of concept, as part of global or regional agreements. In exceptional cases, Transgene may be required to conduct Phase III clinical trials or carry out the clinical development of a drug candidate up to the application for approval for market launch (AML).
Cancer treatment has improved greatly in the recent years, with the approval of immunotherapy products. One of the approaches has been to improve the targeting of these tumors by taking into account their specific characteristics, such as type of tissue affected, genetic and immunological profiles, stage of growth, etc.
The myvac® and Invir.IO™ platforms meet this challenge with novel approaches, respectively by attacking the tumor on several fronts and by training patients' immune system to recognize their own tumor. The personalized immunotherapies of myvac® and the multi-armed oncolytic viruses of Invir.IO™ were designed to be part of the therapeutic arsenal of tomorrow.

PRESENTATION OF TRANSGENE AND ITS BUSINESS
Presentation of the Company and its business
All of the Company's activities relate to the research and development of innovative therapies.
Transgene owns an extensive intellectual property portfolio, that protects research and development activities.
Transgene utilizes viral vectors in which tailored gene sequences have been inserted. The virus acts as a vector to bring these sequences into the tissues where the immune response is triggered and where the desired therapeutic modalities will be expressed. Transgene uses highly attenuated viral strains, optimized to target tumor cells and whose safety profile is recognized.
Transgene's viral vector technology and know-how are the result of several decades of research. Today, we have an in-depth and extensive understanding of them. They are key proprietary competitive advantages for Transgene through the Invir.IO™ and myvac® technology platforms. This R&D process notably allows the design of new drug candidates that have the potential to enter preclinical and clinical development.
Genes are sequences of DNA and can be found in every cell. They supply the information necessary to produce proteins. The production of proteins starts in the cell's nucleus when the gene is copied. This process called gene expression results in the cells producing the protein.
The most used approach to date for delivering genes has involved transferring the genes with viral vectors. These are used to transfer the genetic material into the patient's cells.
The development of gene transfer methods that are reliable and adaptable is a key element in the development of effective therapies. A therapeutic gene must be included in a vector that, associated with the gene, transports it into the patient's cells. Gene transfer therapies are currently divided into two distinct approaches:
● the in vivo (inside the body) approach consists of directly administering to the patient a pharmaceutical compound containing the therapeutic gene and a "vector" responsible for conveying the gene to the patient's target cells, either for gene therapy purposes or to induce an immune response. Transgene products fall into this category;
● cell therapy, or ex vivo (outside the body) therapy, consists of removing cells from a patient, cultivating them in a laboratory using a vector to introduce the functional gene into the cells, then re-implanting the modified cells into the patient. At present, Transgene does not develop cell therapy products. It does have the required know-how and may contemplate developments in this field at some point in the future.
To be effective, a vector must be able to:
The selected type of vector must also be safe.
Transgene's research in molecular biology techniques for gene transfer has led to the development of various vector technologies. Transgene's research programs on vector technology aim to provide vectors with features that will optimize their performance and safety through:
The poxvirus family of viruses includes the Vaccinia virus, a non-human virus, which has been attenuated and used in "preventive" smallpox vaccination. They meet the aforementioned criteria in a very satisfactory manner.
The large capacity of the genome of the Vaccinia virus makes it an especially interesting platform, since it is possible to insert many transgenes into it while ensuring the stability of its genome.
Transgene's lead drug candidates depend on various strains of poxviruses, including MVA (Modified Vaccinia Ankara) for the therapeutic vaccines and the Vaccinia Viruses, in particular the Copenhagen strain, for the oncolytic viruses.
1
For its therapeutic vaccines, Transgene has developed vectors based on the MVA strain, which does not spread in human cells. This strain is thus particularly safe, as demonstrated by its intensive use as a human smallpox vaccine. The MVA vector was tested in Phase II clinical trials of anti-cancer vaccines. It showed high tolerability and an ability to induce a strong and broad immune response (see Section 1.2.2.1).
Transgene launched myvac® in 2018 and treated the first patient in 2020 with the individualized product TG4050. With the myvac® platform, the Company enters the field of individualized immunotherapy. Our approach is based on the clinically validated MVA viral vector. The myvac® products are designed to stimulate and educate the immune system against a patient's cancer by using the genetic mutations specific to his or her tumor (referred to as neoantigens). Once they have been identified through sequencing and selected using artificial intelligence technology, several neoantigens are then incorporated into the genome of the viral vector. Two Phase I clinical trials of TG4050, the first candidate product derived from myvac® , started in early 2020 and the first positive data were released in 2021.
Transgene is also developing TG4001, a therapeutic vaccine targeting cancers caused by the human papilloma virus. It is undergoing a Phase II clinical trial.
The Company developed a Vaccinia virus that carries a gene of the rabies virus capable of vaccinating wild animals, particularly foxes, against rabies by scattering vaccine-impregnated bait. This product is marketed today by Boehringer Ingelheim under the name Raboral V-RG®.
Oncolytic immunotherapy is a new class of anti-cancer treatments. Transgene was one of the pioneers in the development of these replicative viruses.
Oncolytic viruses replicate in cancer cells, leading to the destruction of these cells. They do not replicate in healthy cells. This mechanism differs from conventional treatments such as chemotherapy, antibodies and radiation therapy. Oncolytic products should therefore be used in combination with these treatments or in monotherapy.
Transgene's oncolytic virus program focuses on new generations of Vaccinia viruses, some of whose genes have been suppressed ("deleted") to increase tolerance while maintaining effectiveness and their capacity to stimulate the immune system. In addition, these viruses can be armed with multiple features whereby they might alter the immune response in the tumor microenvironment.
Launched in 2017, the Invir.IO™ platform (see Section 1.2.2.2) is part of this research. This technology platform makes it possible to develop a new generation of multifunctional oncolytic viruses targeting the tumor microenvironment. This platform relies on a patented strain of Vaccinia virus (VVCOP TK-RR-) into which a wide variety of transgenes (such as enzymes, antibodies and cytokines) can be integrated.
A number of projects are based on the Invir.IO™ platform, including:
Transgene owns an extensive intellectual property portfolio, that protects research and development activities.
Transgene's portfolio consists of several products in preclinical and clinical development. They are being evaluated for the treatment of cancers in various stages of the disease for which there is an important medical need.
Transgene has all the capabilities needed to conduct the different steps of preclinical and clinical development of its drug candidates and respects regulation.
Preclinical tests aim at evaluating, in vitro and in vivo, the safety and the efficacy potential of the products. They are undertaken by Transgene or in collaboration with partners or subcontractors. The purpose of clinical trials is to assess the safety and efficacy of the product in patients (so-called Phase I, Phase II and Phase III trials).
In oncology, clinical trials are conducted on patients. They are always volunteers, duly informed, who can leave the trial if they wish. For several years in oncology, the boundaries between the different phases of clinical trials have become increasingly fuzzy. Trials may thus combine several phases, for example Phase I/II trials. The descriptions below cover the general scope of clinical trials and do not strictly apply to all Transgene clinical trials.
Phase I: first stage of testing a drug in humans. The Phase I study tests treatment on a small number of patients in order to evaluate safety and the dose to use in Phase II.
Phase II: Phase II clinical studies include a larger number of patients than Phase I and are designed to assess the safety, dose effect and sometimes the efficacy of new treatments. Some immuno-oncology treatments have at times been authorized after extremely positive Phase II results in an indication of high medical need, subject to launching a Phase III trial.

PRESENTATION OF TRANSGENE AND ITS BUSINESS
Presentation of the Company and its business
Phase III: Phase III clinical studies can involve hundreds or thousands of patients, depending on the disease, and are designed to evaluate the safety and efficacy of a drug in a controlled setting. The success of a Phase III trial generally leads to the filing of an approval for market launch (AML), required to bring the drug to market.
Our immunotherapies can be used as single agents or in combination with other approved or investigational treatments such as Immune checkpoint inhibitors (ICIs) or chemotherapy.
Transgene has a new production unit called PilotClin. This pilot facility can manufacture small clinical batches that comply with GMP standards, in particular for Phase I clinical trials. It was also designed to meet the tailored or specific production needs of myvac® or Invir.IO™ projects.
Transgene participates in collaborative programs with public and private partners, in France and internationally. The aim of these collaborations between our staff and the scientific and medical community is to develop our R&D expertise and our portfolio of products and processes, while increasing their visibility, and if possible, to generate revenue or share costs. These collaboration agreements also serve as ways to validate our approaches and as such are crucial to increasing the attractiveness of the products to potential commercial partners.
Several collaborations continued in 2021, including in particular:
Both preclinical and clinical pharmaceutical development as well as pharmaceutical manufacturing, including plant and equipment, and marketing are all subject to very thorough regulations developed by many governmental authorities at the national and at the European level, and in the United States. The European Medicines Agency (EMA), the French Agence nationale de sécurité du médicament et des produits de santé (ANSM), the US Food and Drug Administration (FDA) and other regulators require compliance with strict conditions for the manufacturing, development and marketing of products such as those developed by Transgene, especially at the preclinical and clinical stages.
The degree of reporting required for the authorization of a clinical trial or for marketing has been standardized for all medications. The information must meet quality, safety and efficacy requirements.
Requests for authorization of clinical trials are carried out at the national level and can require several approvals from clinical centers.
In the European Union, there is a "centralized" procedure for obtaining approval for market launch for biotechnology products, thereby avoiding a separate submission to each Member State. In the United States and the European Union, the average time required to obtain this authorization is approximately one year from the date the request is submitted.
Presentation of the Company and its business
1
Transgene's product portfolio includes therapeutic vaccines and oncolytic viruses. The following table summarizes the progress of Transgene's portfolio as of the date of this Registration Document:
| Product | Target/transgene | Indication | Collaboration | Preclinical | Phase I | Phase II | |
|---|---|---|---|---|---|---|---|
| THERAPEUTIC VACCINE | |||||||
| TG4050 | 30 neoantigens | Ovarian cancer | |||||
| Head and neck cancers |
|||||||
| TG4001 | HPV16 E6 – E7 | Anogenital HPV+ cancers |
|||||
| ONCOLYTIC VIRUS (OV) | |||||||
| TG6002 | 5-FU chemotherapy |
Gastro-intestinal cancers (IV*) |
|||||
| Colorectal cancer (IHA*) |
|||||||
| BT-001 | Anti-CTLA4 + GM-CSF |
Tumeurs solides | |||||
| OVs | Undisclosed | Solid tumors | |||||
| 5 OVs | Undisclosed (1 option exercised) |
Solid tumors | |||||
| OV | Undisclosed (CAR-T combination) |
Solid tumors |
* IV: intravenous administration, IHA: intrahepatic artery administration
The primary target markets of these candidate products are detailed in Section 1.2.6 of this document.
The purpose of therapeutic vaccines is to trigger a cascade of immune responses that result in the production of T-lymphocytes able to recognize and destroy cancer cells.
By integrating genetic sequences specific to cancer cells into the genome of a viral vector, we use the strong sensitivity of the immune system to viruses to induce a response against specific antigens of tumor cells. Transgene uses the viral vector MVA (Modified Vaccinia Ankara), a viral strain recognized for its good safety profile and its immunogenicity.
The main therapeutic vaccines currently in clinical development are TG4050, an individualized immunotherapy based on the myvac® platform and TG4001, which targets HPV-positive cancers.
myvac®: an innovative individualized immunotherapy that uses Artificial Intelligence technology to personalize each patients' treatment.

With the myvac® platform, Transgene is entering the field of individualized immunotherapy and precision medicine. Our approach is based on the MVA viral vector. The myvac® products format designed to stimulate and educate the immune system against a patient's cancer by targeting the genetic mutations specific to his or her tumor (referred to as neoantigens). This approach has the advantage of an optimized process allowing a production time compatible with the clinical care of patients. With myvac®, Transgene overcame several scientific and technical challenges. The Company set up an innovative workflow that combines bioengineering, digital transformation, established vectorization know-how and unique manufacturing capabilities.
The aim of this platform is to generate several drug candidates that can be administered alone or in combination with other approaches.

PRESENTATION OF TRANSGENE AND ITS BUSINESS
Presentation of the Company and its business
TG4050 is the first product from the myvac® platform. The first patients were treated in the two Phase I clinical trials which began in early 2020.
The myvac® platform is based on a MVA vector whose safety, biological activity and ability to induce an immune response against tumor antigens are established and recognized. The MVA can also induce a broadening of the anti-tumor immune repertoire, known as epitope spreading.
The design of the TG4050 vaccine is based on the integration, into a viral vector, of neoantigens (patient-specific tumor mutations) identified among hundreds of mutations present in the genome of tumor cells. Once identified by sequencing, the mutations of vaccine interest are selected using the power of NEC's artificial intelligence (AI) technologies, and several mutations (up to 30) are integrated into the genome of the viral vector. The prediction system is based on AI expertise that goes back more than 20 years, already used in oncology. The initial training of the system was made possible by the availability of a large public and proprietary database that allows it to prioritize and select with precision the most immunogenic sequences. The system is then constantly improved on the basis of the observations made in the patients treated.
Thus, when myvac® is administered to the patient, it triggers an immune cascade against these different targets present in the cancer cells.
Transgene and NEC presented data at the AACR 2020 meeting demonstrating that the prediction algorithm used to personalize TG4050 for each patient is able to accurately identify immunogenic tumoral mutations, even among a large number of tumoral mutations identified in the patient (1). These results demonstrate the superiority of our approach in terms of specificity compared to reference tools. Transgene believes that this advantage could result in increased activity in patients.
A production unit, PilotClin, dedicated in particular to individualized clinical batches of TG4050 was created on the Strasbourg (Illkirch) site. It complies with the pharmaceutical manufacturing standards and supplied the doses necessary to the clinical development.

The implementation of new-generation vaccines requires the existence of a technological ecosystem to allow clinicians to best select the patients most able to benefit from this type of approach and to implement the process enabling the characterization of the patient and the availability of the product. To prepare such an environment, Transgene has formed a collaborative network enabling the establishment of a technological ecosystem.
An innovative project, NEOVIVA, received certification from BioValley France, the Grand Est Region Healthcare Competitiveness Cluster, and Eurobiomed. Transgene holds the intellectual property for the myvac® viral platform and works actively on the translational development of this innovative technology, particularly as part of the project with French partners: the Institut Curie and HalioDx.
vector genome
(1) B. Mallone et al., "Performance of neoantigen prediction for the design of TG4050, a patient specific neoantigen cancer vaccine", AACR 2020, June 22-24, 2020, Poster presentation.
The NEOVIVA project will receive a €5.2 million grant from the PIA (Programme d'investissements d'avenir) run by Bpifrance, of which Transgene will receive €2.6 million. The payments are staggered over the 5-year duration of the program.
TG4050 is an individualized immunotherapy designed to stimulate the immune system of patients in order to induce a response that is able to recognize and destroy tumor cells in a specific manner. This individualized immunotherapy is designed and manufactured for each patient, on the basis of the mutations specific to his or her tumor. These mutations are identified by sequencing the tumor tissue and are prioritized using the NEC Antigen Prediction System, then integrated into the myvac® technology platform (see above). This individualized immunotherapy is produced for each patient in a timeframe compatible with the clinical trial requirements.
The development of TG4050 is based on a strategic partnership between NEC and Transgene. By providing its artificial intelligence and machine learning capabilities, its databases and its expertise in prioritizing neoantigens, NEC supplying Transgene with an essential component for TG4050. The quality and robustness of NEC's AI give Transgene a strong competitive advantage.
In addition, NEC is also funding 50% of the cost of the two Phase I clinical trials of TG4050.
The viral vector myvac® is based on an MVA, optimized to increase the expression of antigens and their presentation to the immune system. Transgene has also developed VacDesignR™, a tool for optimized insertion of neoantigen sequences into the vector genome.
TG4050 is a therapeutic vaccine "customized" for each patient, depending on the mutations identified in his or her tumor. These mutations may lead to the expression of tumor neoantigens that are especially useful targets for the tumor-fighting immune response. These neoantigens are known to stimulate a stronger immune response than the "classic" tumor antigens because their expression is limited to the tumor and therefore do not have tolerance issues.
Once identified by sequencing and selected using artificial intelligence algorithms, up to 30 neoantigens are integrated into the genome of the myvac® viral vector.
Thus, when TG4050 is administered to the patient, it triggers a cascade of immune responses against a range of targets present in cancer cells.
This approach differs from autologous treatments in that no biological material from the patient is used in manufacturing this pharmaceutical product, making it easier to manufacture and standardize. It is also individualized since it uses the information specific to the characteristics of the patient's tumor.
A first Phase I trial involves the administration of TG4050 to patients with ovarian cancer who have undergone surgery and (neo)adjuvant chemotherapy. A significant fraction of these patients will experience a return of the disease within one year of the initial treatment. TG4050 is administered at the first signs of asymptomatic recurrence in order to initiate a strong immune response in the patient against the cancer cells and potentially prevent progression to a more severe relapse.
A clinical trial began in January 2020 after being authorized by the FDA in May 2019 and by the ANSM in July 2019. A first patient was treated in 2020.
This multi-center, one-arm trial is taking place in the United States and France. The evaluation criteria for the trial include safety, feasibility and biological activity of the therapeutic vaccine.
Dr. Matthew Block, an immunologist and medical oncologist at the Mayo Clinic, is conducting the trial in the United States. In France, the trial is conducted by Dr. Martinez at the Oncopole de Toulouse and by Prof. Le Tourneau at the Institut Curie.
This clinical study is sponsored by Transgene, and is co-financed with NEC.
A second Phase I trial of TG4050 is being conducted among patients with locally advanced, newly diagnosed HPV-negative cancers of the head and neck after surgical resection and adjuvant treatment. To date, patients suffering from these cancers have no effective treatment to prevent disease recurrence. Patients with the most advanced stages of cancer will see a return of the disease within a year following the initial treatment. In this randomized trial, half of the participants receive the therapeutic vaccine immediately after completing the adjuvant treatment. The other half will receive it when the disease recurs, in addition to the standard treatment. In both cases, TG4050 is administered with the aim of initiating a strong immune response in the patient against the cancer cells.

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Presentation of the Company and its business
It began in January 2020 after being authorized by the MHRA and the ANSM in July 2019. A first patient was dosed in early 2021.
This two-arm, randomized, open, multi-center trial includes patients in the United Kingdom and France. The evaluation criteria for the trial include safety, feasibility and biological activity of the therapeutic vaccine.
In France, the trial is conducted by Prof. Delord at the Oncopole de Toulouse and by Prof. Le Tourneau at the Institut Curie. In the United Kingdom, the trial is coordinated by Prof. Ottensmeier of the Clatterbridge Cancer Center in Liverpool.
This clinical study is sponsored by Transgene, and is co-financed with NEC.
In November 2021, Transgene presented the first positive results from the Phase I trials of TG4050. These data were generated from the first six patients treated; they demonstrated the significant potential of this individualized immunotherapy against ovarian cancer and head and neck cancer.
The primary endpoints for these trials are safety and feasibility. Secondary endpoints include the biological activity of the TG4050 vaccine.
Main results of these two Phase I studies, as of November 22, 2021:
● In the early treatment arm of the head and neck trial (n = 2): as of November 22, 2021, the two patients had been treated for ten months and five months respectively and were stable.
In both clinical studies, patient recruitment and treatment are progressing in line with Transgene's expectations. In total, Transgene plans to treat 13 patients in the ovarian cancer trial and 30 patients in the head and neck trial. Additional data will be presented at major oncology conferences, including the AACR, in 2022.
The Company has not set a possible date for commercial launch.
TG4001 is a therapeutic vaccine targeting the human papilloma virus (HPV-16), including some cancers of the oropharynx and the majority of anogenital cancers. TG4001 has been administered to more than 300 subjects. It has demonstrated good tolerability, a significant HPV clearance rate and promising efficacy results in several clinical trials. TG4001's mechanism of action and safety profile make it very suitable for use in combination with other therapies.
TG4001 is a therapeutic vaccine designed from a highly attenuated, non-replicative Vaccinia virus (MVA). It expresses the E6 and E7 antigens of the HPV-16 virus and interleukin-2 (IL-2), which stimulates immune responses. TG4001 was designed to act against cells carrying the E6 and E7 antigens of HPV-16 in a twofold manner: training the immune system to recognise and kill specifically those cells and, due to IL-2, stimulating the immune system. Its good safety profile was observed in all clinical trials conducted to date.
TG4001 is being developed in recurrent or metastatic HPV-16 positive cancers. This development is currently being conducted in combination with an Immune checkpoint inhibitor, avelumab (an anti-PD-L1 monoclonal antibody).
Clinical collaboration with the Merck KGaA/EMD Serono and Pfizer alliance, which supplies avelumab, an Immune checkpoint inhibitor of the human anti-PD-L1 monoclonal antibody type, for the Phase Ib/II trial described below (see also Section 1.2.3).
In 2017, Transgene began a Phase Ib/II clinical trial to assess the potential of the therapeutic vaccine TG4001 in combination with avelumab in patients with recurrent or metastatic HPV-16 positive tumors.
Transgene is the trial sponsor. The principal investigator is Professor Le Tourneau of the Institut Curie (Paris).
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In 2020, Transgene presented at two scientific and medical congresses (1) results showing a pronounced clinical antitumor activity of the combination of TG4001 and avelumab. These results are based on a pooled analysis of data from 34 evaluable Phase Ib/II patients with oropharyngeal, anal, cervix or other HPV-16 positive cancers.
The objective of this exploratory study was to evaluate the safety and efficacy of the combination of TG4001 and an Immune checkpoint inhibitor in a heterogeneous group of patients treated for their recurrent/metastatic disease with aggressive HPV-16 positive cancers, at an advanced stage.
Main results of the Phase Ib/II trial of TG4001 and avelumab:
An overall response rate of 23.5% was achieved in the 34 evaluable patients. Eight patients responded positively: one complete response and seven partial responses were observed (according to RECIST 1.1 criteria). Responses were obtained for all types of primary tumors, regardless of the number of lines of previous treatments. These results compare favorably with checkpoint inhibitors administered alone.
In patients without liver metastases (n = 23), the objective response rate (ORR) was 34.8%, and the median progression-free survival (PFS) was 5.6 months compared with an ORR of 0% and a PFS of 1.4 months for patients with hepatic metastases (n = 11). The presence of liver metastases was, therefore, identified, during the analysis of the trial data, as having a significant negative impact on the clinical results (the p-values are 0.012 and 0.001 for the ORR and median PFS respectively). The presence of liver metastases is generally associated with an unfavorable prognosis even when these patients are treated with an anti-PD-1/PD-L1.
The disease control rate (DCR) at 12 weeks was 56.6% in patients without hepatic metastases, compared with 9.1% in patients with liver metastases. 60% of patients without liver metastases did not see their disease progress to the fourth month; at the sixth month, this rate was still 40%. At the fourth month, all patients with liver metastases had seen a progress of their disease.
The treatment is able to modulate the tumor microenvironment and induce a "warming" of the tumor phenotype. Seven out of the eleven patients that could be evaluated developed a vaccine-induced T-cell response against the E6 and/or E7 antigens. This response, noted from the 43rd day, was still present six months after the start of treatment. These results support previous findings on long-term control of the disease. An increase in CD3 and CD8 T-cell infiltrates, as well as in PD-L1 expression, was observed in most patients after 43 days of treatment with TG4001 and avelumab. In the overall patient population, these three parameters were higher after treatment. Moreover, analysis of the gene expression profile within the tumor revealed an increase in the expression of immune genes between the beginning and the 43rd treatment day. These genes are involved in immune system activities such as antigen processing and the effector and cytotoxic functions of T cells.
In line with previous data from Phase Ib, the safety of the combination of TG4001 and avelumab was confirmed. The most common treatment-related adverse reactions (TRAE) were general disorders (fever) and injection site reactions (rash). 9.5% of patients reported grade 3, 4 or 5 TRAE.
Initial promising efficacy data were obtained in the Phase Ib part of the trial. These data have been presented in a poster at the European Society for Medical Oncology (ESMO) 2019 Congress.
All of this data supports the continued clinical development of TG4001.
Transgene has amended the protocol of the Phase Ib/II trial in order to accelerate the launch of a randomized Phase II trial based on the promising Phase Ib/II results. This trial, called Phase II part 2, is supported by Merck KGaA and Pfizer, which provide avelumab; Transgene retains all rights to TG4001.
The Phase II part 2 study aims to compare the combination of TG4001 with avelumab versus avelumab alone in HPV-16 positives anogenital cancers. This trial focuses on patients without liver metastases, as this population has previously been identified as responding better to treatment than patients with liver metastases.
(1) Le Tourneau et al. "TG4001 (Tipapkinogene sovacivec) and avelumab for recurrent/metastatic (R/M) Human Papilloma Virus (HPV) – 16+ cancers: clinical efficacy and immunogenicity". 2020 SITC Annual Meeting, November 9-11, 2020, Poster presentation – Le Tourneau et al. "TG4001 therapeutic vaccination combined with PD-L1 blocker avelumab remodels the tumor microenvironment (TME) and drives antitumor responses in Human PapillomaVirus (HPV)+ malignancies". 2020 ESMO IO meeting, December 12, 2020, mini oral presentation.

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The first patient was included in June 2021. The trial is actively recruiting patients in Europe (France and Spain) and was recently initiated in the United States.
The main objective of the trial is progression-free survival (PFS) according to RECIST 1.1 criteria. Secondary endpoints include objective response rate (ORR), disease control rate (DCR), overall survival (OS) and other immunological parameters. The trial may include around 150 patients in the final analysis.
An interim analysis will be performed after the inclusion of approximately 50 patients. Transgene expects to report the results of this analysis in the fourth quarter of 2022.
Solid proof of concept was obtained in a Phase IIb study among patients with precancerous lesions of the cervix (intra-epithelial neoplasia CIN 2/3).
This randomized trial, which included 192 patients, compared the administration of TG4001 in monotherapy with a placebo. 129 women had received TG4001, and 63 the placebo.
These results were published in 2019 in Gynecologic Oncology by Dr D.M. Harper of the University of Michigan.
They provided solid proof of concept of the activity of the product in an HPV-positive pathology and, in this respect, are extremely encouraging for TG4001 and the entire MVA platform.
Transgene plans to release the first data from the interim analysis of Phase II part 2 in the fourth quarter 2022.
The Company has not set a possible date for commercial launch.
Oncolytic viruses are a particularly innovative therapeutic class that offers promise in the fight against cancer.
They replicate in a targeted manner in the tumor where they destroy the cancer cells by cell lysis (or oncolysis) causing the release of tumor antigens thus inducing a specific activation of the immune system against the tumor cells.
Oncolytic viruses can be armed with a comprehensive therapeutic arsenal comprising complementary anti-cancer weapons embedded in their genome: in this case, we refer to multifunction or "armed" viruses.
By attacking the tumor with several mechanisms of action, Transgene develops therapeutic approaches that can lead to an effective therapy against cancer.
Transgene's two oncolytic viruses currently in clinical development are based on a patented strain: VVcop TK-RRwhich is also the foundation of the Invir.IO™ platform. It is a poxvirus, optimized to be able to replicate selectively in tumor cells. This selectivity for cancer cells was obtained by removing two genes from it: the genes coding for thymidine kinase (TK) and ribonucleotide reductase (RR). TK and RR are present in great quantity in cancer cells and are necessary for viral replication, but are present in small quantity in healthy cells, making viral replication impossible.
A new generation of multifunctional oncolytic virus, TG6002 has been designed to combine the mechanism of oncolysis (targeted destruction of the cancer cell) with the targeted production of chemotherapy (5-FU), directly in the tumor. In addition, the destruction of tumor cells results in the release of tumor antigens, which cause an increase in the immune response. These approaches can attack solid tumors on multiple fronts while avoiding the side effects of chemotherapy.
TG6002 is based on the VVcop TK-RR- strain described above. It has been optimized to selectively replicate in tumor cells and attract immune defenses into the tumor. TG6002 also expresses the patented gene FCU1, for which expression in the tumor cell leads to the local conversion of the pro-drug 5-FC (flucytosine) in 5-FU (fluouracile), a commonly used chemotherapy. As such, when TG6002 is administered in combination with 5-FC, it allows the production of chemotherapy in the tumor.
TG6002 combines several mechanisms of action to:
(1) Resolution: total disappearance of CIN lesions.
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TG6002 is able to strengthen conventional treatments and could be used in combination (with chemotherapy, monoclonal antibodies or radiation and Immune checkpoint inhibitors) or as monotherapy with cancers that resist these treatments.
Transgene is developing TG6002 for the treatment of several solid tumors, such as gastrointestinal adenocarcinoma (stomach, pancreas and colon), for which 5-FU is a common treatment.
The objective of this study is to confirm the tolerance of TG6002 administered intravenously in increasing doses and to provide the first translational data relating to this administration route.
In September 2021, the dose escalation was completed in the absence of dose-limiting toxicity of TG6002 at a dose of 3x109 pfu thus validating the safety profile. In parallel with the dose escalation, since September 2021, a dose intensification schedule has been evaluated for the last two dose levels (109 pfu and 3x109 pfu).
In addition, the first translational data show that after its intravenous administration, TG6002 is able to selectively replicate and persist in tumor cells leading to the local expression of its functional payload.
This multi-center trial is active in France, Belgium and Spain. It will include up to 59 patients with advanced gastrointestinal tumors such as colon cancers.
Transgene also started a Phase I/IIa clinical trial of TG6002 administered through the intrahepatic artery (IHA) in patients with CRC with inoperable liver metastases.
By administering TG6002 via hepatic artery, Transgene offers an additional therapeutic option for these hard-to-treat patients. IHA administration should guide TG6002 into the tumor at a higher concentration, thereby augmenting the efficacy while limiting patients' systemic exposure.
Dr. Adel Samson, MB ChB PhD, a medical oncologist at St James University Hospital of Leeds, is the principal investigator of the trial, and Transgene is the sponsor.
This one-arm, multicenter, open trial evaluates the safety, pharmacokinetics and efficacy of repeated, increasing doses of TG6002 administered through the intrahepatic artery in combination with 5-FC administered orally. It is ongoing in the United Kingdom and France. Part 1 of this trial could include up to 20 patients.
The dose escalation of part 1 of the trial began in 2020, inclusions were suspended from April to September 2020 due to the Covid-19 pandemic. The last cohort of patients (dose of 109 pfu) are currently being included.
Transgene relies on a set of robust preclinical data, having demonstrated the good tolerance and efficacy profile of the TG6002 viral vector in several preclinical models in vitro (cell lines) and in vivo (xenografts on immunodeficient mice). In some models, partial responses and even complete ones were observed, as well as a "remote" effectiveness of the oncolytic virus on the metastases. Preclinical results obtained on models of colorectal cancer were published in Molecular Therapy Oncolytics in 2019.
First translational results were presented at AACR 2021 and ESMO 2021 and constitute the clinical proof of concept of the intravenous administration of the viral strain VVCOPTK-RRpatented by Transgene. They show that after being administered intravenously, TG6002 reaches the tumor, selectively replicates within tumor cells and induces the localized expression of its functional transgene (the FCU1 gene). The analyzes carried out enable Transgene to document the pharmacokinetic properties (PK), the biodistribution of TG6002, and the activity of the FCU1 gene, as part of an IV administration.
Main results obtained providing the clinical proof of concept of the feasibility of the IV administration of TG6002:
These results confirm the relevance of intravenous administration of oncolytic viruses from the viral strain VVCOPTK-RR behind the Invir.IO™ platform,
To date, the only oncolytic virus approved by regulatory agencies is administered directly into the tumor (intratumoral administration), which limits its use to superficial tumors. Intravenous administration would extend the use of oncolytic viruses, derived from Transgene's Invir.IO™ platform, to many solid tumors.
The end of the Phase I trial evaluating TG6002 administered intravenously is expected by mid-2022. All translational data will be presented in the fourth quarter of 2022. The first data from the Phase I trial evaluating TG6002 administered by the intrahepatic artery route are expected in mid-2022.

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T601 is an immunotherapy derived from TG6002 technology. It is currently being developed in China by Tasly BioPharmaceuticals Group Co, Ltd., which holds all rights to research, development and commercialization of T601 for Greater China, following an agreement reached in July 2018. A Phase I clinical trial evaluating T601 administered intravenously to patients with gastrointestinal tumors is underway.
The Company has not set a possible date for commercial launch.

The Invir.IO™ platform is based on a patented strain of the vaccine virus (VVCOPTK-RR- ) the origin of a new generation of multifunctional oncolytic viruses able to modulate the tumor microenvironment and thus show improved anti-tumor activity.
The oncolytic viruses generated using the Invir.IO™ platform can be administered by different routes, including intravenous, locoregional or intratumoral routes. They are able to integrate large quantities of genetic material and thus produce, within the tumor, anti-tumor molecules that amplify the anti-tumor activity specific to the virus. Transgene's integrated expertise in design, preclinical characterization and clinical evaluation make Invir.IO™ the ideal platform for developing a portfolio of multifunctional oncolytic viruses.
The Invir.IO™ platform allows the design of product candidates integrating a wide range of weapons (immune checkpoint inhibitors, cytokines, enzymes, etc.).
BT-001 is the first drug candidate from Invir.IO™. It received the necessary authorizations to launch a clinical trial at the end of 2020.
Since 2019, Transgene and AstraZeneca have been working together to generate new oncolytic viruses from the Invir.IO™ platform. In December 2021, the first licensing option was exercised by AstraZeneca. Collaboration continues for the development of other candidates.
Transgene is also designing other proprietary oncolytic viruses that are currently at the preclinical stage.
Thanks to Transgene's unique know-how and expertise, the Invir.IO™ platform can generate, produce and characterize numerous candidate products in a highly efficient way.
Our oncolytic viruses are designed to directly and selectively destroy the cancer cells by using an oncolysis mechanism, while also inducing immune responses against tumor cells. In addition, during replication, the virus expresses the weapons integrated in its genome and therefore allows the expression of immunomodulators and/or therapeutic agents specifically in the tumor.
The purpose of these viruses is to counter the mechanisms of immunosuppression linked to the aberrant proliferation of cancer cells which allow the tumor to escape the immune system. These complex cellular and metabolic mechanisms develop in the tumor microenvironment.
Many therapies are very effective locally but can be toxic when administered systemically. By introducing genetic sequences coding for such therapies into its viruses, Transgene aims to allow the production of these molecules directly in the tumor at therapeutic doses, during the replication of the virus, without exposing the patient to the side effects traditionally associated with the systemic administration of these therapies.
This effect is in addition to the oncolysis activity. This enables the effective modulation of the tumor microenvironment and an increase in the immuno-sensitivity of the tumor while limiting systemic exposure.
Transgene has already demonstrated preclinically that the oncolytic viruses from the Invir.IO™ platform attack tumors on several fronts. In addition to the remarkable lytic properties of the Vaccinia viruses, our oncolytic viruses:
In addition to its proprietary development work, Transgene has signed collaborative research agreements (see Section 1.2.3 and 1.2.4.2). For example, they plan to vectorize the sequences of molecules of interest developed by the partners in an oncolytic virus from the Invir.IO™ platform:
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BT-001 is an innovative oncolytic virus derived from the Invir.IO™ platform. It expresses an anti-CTLA-4 antibody and the cytokine GM-CSF. It is co-developed by Transgene and BioInvent.
BT-001 was designed to produce an anti-CTLA-4 antibody within the tumor in order to minimize the systemic adverse effects associated with this class of immune checkpoint inhibitor and ensure significant therapeutic activity.
BT-001 is co-developed by Transgene and BioInvent on a 50/50 basis.
BT-001 is a multifunctional oncolytic virus. It is based on Transgene's Invir.IO™ platform and its patented oncolytic virus VVcopTK-RR-. BT-001 encodes an anti-CTLA-4 antibody derived from BioInvent's n-CoDeR® /F.I.R.S.T™ technology, depleting Tregs and a human cytokine (GM-CSF).
BT-001 combines an action of destroying tumor cells (oncolysis), the activation of anti-tumor immune defenses and the production, in the tumor, of an anti-CTLA-4 antibody and the cytokine GM-CSF, an immunomodulatory cytokine. In particular, the anti-CTLA-4 antibody has shown, in preclinical studies, an activity of modulation of the tumor microenvironment, by causing a depletion of T-reg, lymphocytes that can reduce the action of effector T cells in the tumor.
Transgene and BioInvent are developing BT-001 for the treatment of solid cancers.
An open-label, multi-center Phase I/IIa study is evaluating increasing doses of BT-001 alone and in combination with pembrolizumab.
This trial, ongoing in Europe (France and Belgium), was authorized by the FDA in the United States in May 2021. The first patient was included in February 2021.
Phase I of the trial is organized in two parts. Part A can include up to 36 patients with advanced/metastatic solid tumors who have already received multiple lines of treatment, including other immunotherapies. In this part, BT-001 is administered as a monotherapy by IT injections into palpable skin or subcutaneous lesions, or into easily injectable lymph nodes. It aims to establish the tolerance of BT-001 and to determine the dose and administration schedule for further development. Part B explores the tolerance and synergistic activity of the combination of IT injections of BT-001 with the anti-PD1 monoclonal antibody pembrolizumab in 12 patients. Phase IIa is dedicated to the evaluation of this combination regimen in several patient cohorts with different types of solid tumors. The potential of this approach could be extended to cohorts of patients with cancers that are not traditionally treated with this type of treatment
BT-001 was evaluated in several preclinical models, in vitro and in vivo. The results were published in the Journal for ImmunoTherapy of Cancer in 2022, presented at SITC 2021 and will be presented at AACR 2022.
In several preclinical models, the murine form of BT-001 (mBT-001) shows exceptional anti-tumor activity, which causes the disappearance of tumors in a majority of mice (> 70% in all the models tested). mBT-001 is effective against both injected and distant tumors.
The preclinical trials also confirmed that the anti-CTLA-4 and GM-CSF antibody expressed by mBT-001 in the tumor cells of mice retains its biochemical integrity and folding, functionality and biological activity.
The results also show that BT-001 can be used in many indications as monotherapy and in combination with anti-PD-1/PD-L1 therapies, including in tumors resistant to treatments due to their low immune capacity.
Finally, they show that the production of anti-CTLA-4 antibodies specifically in the tumor should improve tolerance by reducing the systemic exposure of this class of immune checkpoint inhibitor.
In January 2022, preclinical proof of concept data were published in the Journal for ImmunoTherapy of Cancer (JITC). The results published in this article entitled "Vectorized Treg-depleting aCTLA-4 elicits antigen cross-presentation and CD8+ T cell immunity to reject "cold" tumors", demonstrate the potential of the virus to provide therapeutic benefit beyond anti-PD1/anti-CTLA-4 immune checkpoint inhibitors.
Systemically administered anti-CTLA-4 antibodies such as ipilimumab, an approved treatment, have demonstrated significant efficacy but also a toxicity that limits their clinical use. The JITC article shows that, in vivo, the anti-CTLA-4 antibody vectorized and administered by the intratumoral route improves the safety profile of the antibody by reducing systemic exposure. Efficacy is also improved: data from the immunocompetent mouse model show that the vectorized antibody has anti-tumor activity in "cold tumors" that are usually resistant to systemically administered immune checkpoint inhibitors. In addition, they show that better efficacy of BT-001 involves an increase and stimulation of tumor-specific T cells
The next clinical update on the Phase I trial is expected in the second quarter of 2022.
The Company has not set a possible date for commercial launch.

In October 2016, Transgene, Merck KGaA and Pfizer entered avelumab and certain technical services to the collaboration, into a collaboration agreement to evaluate the potential of with Transgene contributing TG4001 and playing the role of the therapeutic vaccine candidate TG4001 in combination trial sponsor. On the basis of the Phase Ib/II results presented with avelumab for the treatment of human papilloma virus at SITC 2020, Transgene, Merck KGaA and Pfizer have (HPV) positive cancers, after failure of standard therapy in the decided to extend their collaboration to part 2 of Phase II framework of a Phase I/II trial. Avelumab is a fully human evaluating TG4001 + avelumab versus avelumab alone. anti-PD-L1 IgG1 monoclonal antibody that is jointly owned by Merck KGaA and Pfizer. Merck KGaA and Pfizer are providing
In December 2017, Transgene and BioInvent announced a co-development agreement to develop viral vectors from Transgene's Invir.IO™ platform, armed with an anti-CTLA-4 monoclonal antibody developed by BioInvent. The immunotherapies resulting from these collaborations will combine the effects of oncolytic viruses with the properties of the vectorized antibodies, which will be expressed directly in the tumor microenvironment, so as to remove immunosuppression in solid tumors.
The terms of each agreement provide for development conducted by the two companies with an equal share of the costs and revenues and royalties that result, with the possibility for each party to opt out of the ensuing steps of the collaboration in exchange for granting a license and an adjustment of the financial terms.
On March 4, 2019, Transgene and NEC Corporation signed a TG4050 with the goal of obtaining a first proof of concept of collaboration agreement for the design of a personalized the myvac® vaccine that combines Transgene's myvac® neoantigen prediction technologies created by NEC. NEC also development, registration and use of this candidate. co-finances up to 50% of the costs of the two Phase I trials of
In May 2019, the Company announced the signing with US \$10 million at signature (2019), and US \$8 million following AstraZeneca of a collaborative research agreement with the exercise of a first option on an oncolytic virus (2021), to exclusive licensing options to co-develop five multi-armed which payments could be added upon completion of oncolytic viruses derived from Invir.IO™. The agreement calls preclinical stages and the exercise of options for each other for the Company to bring its expertise in the area of oncolytic candidate selected by AstraZeneca, as well as milestone viruses, including viral design and viral engineering, based on payments related to development and marketing, and its optimized Vaccinia virus integrating the double TK-RR- royalties. deletion. Transgene will undertake the preclinical development in vitro of the candidates. Transgene received
technology. The companies are in discussions technology with regarding the extension of their collaboration to support the
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TG1050 is a therapeutic vaccine for the treatment of chronic hepatitis B. This product went into clinical development in 2015 in patients with a chronic HBV (hepatitis B virus) infection being treated by standard antiviral. This product has shown a good safety profile and after administration of a single or multiple doses of TG1050.
TG1050 is an immunotherapy based on the human adenovirus serotype 5. This non-replicating virus expresses several HBV antigens: the DNA polymerase enzyme responsible for the replication of the virus, the surface protein located on the outside of the virus and which allows the HBV to enter the cells it infects, and lastly the HBV capsid protein, i.e. the protein that makes up the structure surrounding the viral genome. Once produced in the body via the adenovirus vector, these HBV proteins activate the patient's immune system and induce HBV-specific T lymphocytes that can recognize infected cells and eliminate them.
TG1050 is for treatment of chronic hepatitis B.
Transgene in 2015 initiated a Phase I/Ib clinical study aimed at evaluating TG1050 in patients with chronic hepatitis B treated with standard antivirals. This randomized, double-blind, placebo-controlled, multi-center trial (Europe and North America) assessed the safety profile and tolerability of single and repeated administration of three doses of TG1050, and helped improve understanding of antiviral activity and immune system responses induced by TG1050.
In November 2018, Transgene presented the results of this clinical trial to the AASLD Liver Meeting, showing the achievement of the following objectives:
As Transgene does not wish to continue developing this product on its own, it is stopped until the partner is identified.
The Company has not set a possible date for commercial launch.
T101 is an immunotherapy derived from TG1050 technology. It is being developed in China by Tasly BioPharmaceuticals Group Co, Ltd., which holds all rights to research, development and commercialization of T101 for Greater China, following an agreement reached in July 2018.
Following a Phase II trial of T101 in China, Tasly BioPharmaceuticals announced its intention to stop clinical development of this drug candidate.
Pexa-Vec (JX594/TG6006 – pexastimogene devacirepvec) is an oncolytic virus designed to selectively target and destroy cancer cells by intracellular replication of the virus cells (oncolysis) and stimulate the anti-tumor immune response. Its mechanism of action and safety profile make it an ideal candidate for combination with other therapies, including Immune checkpoint inhibitors (ICIs).
The modified Vaccinia virus from which Pexa-Vec is derived can selectively replicate in tumor cells. The safety profile and cancer cell selectivity were obtained by the deletion of the thymidine kinase (TK) gene, thus making the virus dependent on the constant high-level expression of the TK gene in cancer cells. Pexa-Vec was also modified to express the immunostimulating protein GM-CSF, Pexa-Vec uses three mechanisms of action to "attack" tumors: cell lysis via the selective replication of the virus in tumor cells, blocking of tumor vascularization and stimulation of the immune response against the tumor (active immunotherapy).
Transgene acquired Pexa-Vec's development and commercial rights for Europe (see Section 1.2.4.2).
A translational study with administration of Pexa-Vex intravenously before surgical intervention (a neo-adjuvant indication) made it possible to document Pexa-Vec's mechanism of action in the tumor microenvironment. The University of Leeds is the sponsor of this trial. Eight patients were treated. Transgene presented early positive findings at ASCO in June 2018, showing that Pexa-Vec stimulates anti-tumor immunity after intravenous administration. A complete pathological response was observed at surgical resection in one of the four patients. The complete results were presented at ESMO in September 2019.
Clinical trials in different types of tumors showed that Pexa-Vec is well tolerated by patients and has a biological activity when injected directly into tumors or administered by IV infusion. Pexa-Vec has an acceptable tolerability profile with known and tolerable secondary effects.

PRESENTATION OF TRANSGENE AND ITS BUSINESS
Presentation of the Company and its business
Pexa-Vec has also been evaluated in "investigator-sponsored" studies, which Transgene is coordinating. These Phase I/II studies combined Pexa-Vec with other therapies.
In parallel, SillaJen and Lee's Pharma are conducting Phase I and II clinical trials in their respective geographic regions (North America and Asia/China). These tests principally combine Pexa-Vec with ICIs for the treatment of various solid tumors.
Transgene does not plan to launch a new clinical trial of Pexa-Vec. The Company retains the European rights for this candidate product.
The Company has not set a possible date for commercial launch.
Transgene conducts other research programs, capitalizing on its recognized expertise in the engineering of viral vectors, and aimed in the long term at extending the Company's portfolio of preclinical and clinical drug candidates.
In October 2017, Transgene and Randox announced a co-development agreement to develop viral vectors from Transgene's Invir.IO™ platform, armed with single-domain monoclonal antibodies (SdAb) generated by Randox. The immunotherapies resulting from these collaborations will combine the effects of oncolytic viruses with the properties of the vectorized antibodies, which will be expressed directly in the tumor microenvironment, so as to remove immunosuppression in solid tumors. The terms of each agreement provide for development conducted by the two companies with an equal share of the costs and revenues and royalties that result, with the possibility for each party to opt out of the ensuing steps of the collaboration in exchange for granting a license and an adjustment of the financial terms.
In May 2019, the Company implemented a new framework agreement drawing up the conditions applicable to the production services provided by ABL Europe for the clinical batches of drug candidates. This agreement succeeded the agreement of February 1, 2016, and eliminated the business volume guarantee previously granted by Transgene as consideration for a priority right for its orders.
In April 2019 the Company signed a contract with Natixis for a revolving credit agreement capped at €20 million, available in one or more drawdowns. As part of this credit agreement, Transgene must pledge its shares in Tasly BioPharmaceuticals prior to the first draw. The outstanding amount (excluding interest) may not exceed the equivalent of 60% of the value of the pledged Tasly BioPharmaceuticals shares or a ceiling of €20 million. If the value of its shares declines, for example in the event of a decline in the market price of Tasly BioPharmaceuticals on the STAR market in Shanghai after its listing, Transgene may be forced to repay part or all of the amounts borrowed. The agreement with Natixis contains a number of standard provisions, including an early repayment clause in the event of a change of control or certain adverse events, plus restrictions placed on Transgene's debt. If the outstanding amount drawn exceeds 60% of the value of the shares, the Company must immediately repay the difference. The interest on the outstanding amounts drawn as well as an availability commission for the undrawn part are payable on a quarterly basis. In accordance with the principles of revolving loans, the amounts drawn must be repaid in full by the end of the program at the latest. This loan agreement initially ran until October 2021. In March 2020, an amendment extended the availability of this credit facility until June 30, 2022. An additional amendment has been signed in September 2020 resizing this credit line to €15 million, following the sale of 10.3 million Tasly BioPharmaceuticals shares in July 2020. Following the sale of 8.4 million Tasly BioPharmaceuticals shares in September 2021, Transgene and Natixis terminated this credit agreement.
In 2013, Transgene signed a collaboration agreement for the creation of a new advanced platform dedicated to the manufacturing of immunotherapy products, including Transgene therapeutic products. The platform was built on the Genzyme Polyclonals site in Lyon, and remains the exclusive property of Sanofi.
Sanofi and Genzyme will act as a bioproduction services company (Contract Manufacturing Organization – CMO) for Transgene and will manufacture clinical and commercial batches for Transgene's immunotherapy products based on MVA technology. Transgene will be a preferred customer of the commercial manufacturing platform for 15 years.
Construction of the viral vector production platform at Sanofi Genzyme Lyon was completed in June 2015. Certification by all health authorities of this platform for the production of large batches of "off-the-shelf", MVA-based therapeutic vaccines was first sought in 2016. Approval of the French health authority was obtained in May 2017 and final approval in the United States was obtained in January 2019.
In July 2018, Transgene subscribed for 27.4 million newly issued shares of Tasly BioPharmaceuticals, i.e. 2.53% of its share capital, through a contribution in kind of the intellectual property in China necessary for the development and exploitation of a therapeutic vaccine against hepatitis B as well as Transgene's stake in the joint venture Transgene Tasly (Tianjin) BioPharmaceutical Co. Ltd. The assets contributed by Transgene were valued at US \$48 million between the parties, and the unit value of the shares received is that negotiated by the institutional funds.
Presentation of the Company and its business
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In July 2020, Transgene sold 10.3 million shares of Tasly BioPharmaceuticals to a Chinese institutional fund, and collected US \$22.2 million (€19 million). Following this share sale, Transgene holds 17.1 million shares in Tasly BioPharmaceuticals, equivalent to 1.58% of the Chinese company's capital. In September 2021, Transgene sold 8.4 million shares of Tasly BioPharmaceuticals to a related company, and received US \$20.2 million (€17.4 million). Following this transaction, Transgene holds 8.7 million shares in Tasly BioPharmaceuticals, i.e. 0.8% of the Chinese company's capital. Transgene's remaining shareholding in Tasly BioPharmaceuticals is valued at approximately €18.9 million based on the price as at December 31, 2021.
At the time of the capital increase in 2018, Tasly BioPharmaceuticals and its parent company Tasly Holding Group signed a shareholders' agreement to define their relationships prior to the initial public offering. Besides the normal clauses such as a right of first refusal in the event a shareholder wishes to sell, Tasly Holding Group agrees to buy out the shares subscribed by Transgene. Tasly BioPharmaceuticals is currently pursuing an IPO on the STAR Market in Shanghai, China, after a first unsuccessful attempt at an IPO on the Hong Kong Stock Exchange in 2019-2020. In the event that Tasly BioPharmaceuticals is not listed on the STAR Market before December 31, 2021, and no application is being assessed by the market authorities, Transgene will benefit from a put option that can be exercised from December 2021, requiring Tasly Holding Group to enter into (or have a third party enter into) a sale agreement for Transgene's stake in Tasly BioPharmaceuticals within three months at the initial subscription price plus a contractual annual rate. In December 2021, the shareholders' agreement was amended in order to postpone the date of exercise of the put option until September 30, 2022 and to provide for the effective termination of the shareholders' agreement as soon as Tasly BioPharmaceuticals submitted an initial public offering on the STAR Market in Shanghai.
Transgene is a partner in and coordinator of a research program with, among others, Traaser, HalioDx and the Institut Curie. This program aims to develop an industrial ecosystem able to produce and develop personalized vaccines to treat cancer. That program is known as "NEOVIVA" and is supported by Bpifrance. The members of the consortium signed their agreement with Bpifrance in March 2019.
Under the NEOVIVA program, Transgene could receive grants and conditional advances of up to €0.2 million and €2.37 million, respectively, over the duration of the program. If the project is a success, defined in consultation with Bpifrance, Transgene shall be required, under certain conditions, to repay the advances in installments and then, if applicable, make additional repayments until 2040 or up to a cap of €3.35 million. These obligations relate to the candidate in development, TG4050. Transgene is not liable for any potential repayments by other members of the consortium.
Transgene was a partner in a research program coordinated by Institut Mérieux, which brings together, among others, bioMérieux, Transgene, Genosafe and the Genethon Association. The program's goal was to develop a new generation of diagnostics and therapies focusing on cancers and infectious and genetic diseases. This program, called "ADNA" ("Advanced Diagnostics for New Therapeutic Approaches"), supported by Bpifrance, began in 2007 and ended in 2016.
Under the ADNA program, Transgene received a total of €8.3 million in grants and €15.9 million, in conditional advances. If the project is a success, defined as the marketing of a product for which a grant has been awarded and attaining a minimum revenue level, Transgene must, under certain conditions, repay the advances in installments and then, if applicable, make additional repayments until 2035 or up to a defined minimum. These obligations relate to the drug candidate TG4001.
In July 2013, Transgene granted Ascend BioPharmaceutical, which became Stamford Pharmaceutical ("Stamford"), a biotechnology company based in the United States and Australia, a license for the immunotherapy product TG1042 to treat a common form of cancer of the skin, nodular basal cell carcinoma (or "BCC" for basal cell carcinoma), as well as two other oncology indications, with Transgene retaining rights to other potential indications. Stamford is currently pursuing a clinical trial of TG1042 in Phase II.
Transgene and Valneva (formerly Vivalis) have signed two agreements enabling Transgene to use the EB66® cell line in its production processes for certain Transgene products. The first agreement, signed in July 2011, covers the production of Transgene therapeutic MVA vaccines and the second, signed in December 2020, covers the production of Transgene oncolytic products derived from a Vaccinia virus.
Under these agreements, Transgene may be required to pay milestone payments or annuities depending on the stage of development of the drug candidates as well as royalties associated with the sales of Transgene products made from Valneva's EB66® cell line. Valneva will also receive revenue from manufacturing under GMP conditions the initial clinical batches of MVA therapeutic vaccine.
In August 2010, Transgene and Jennerex Inc. (acquired by the South Korean-based company SillaJen in 2014) signed an exclusive partnership agreement for the development and commercialization in Europe, the Commonwealth of Independent States (CIS) and the Middle East of the oncolytic virus Pexa-Vec for the treatment of solid tumors. In 2015, SillaJen and Transgene amended the partnership agreement to streamline the conduct of clinical studies reflecting the areas of interest of each partner and to redefine the territories. Transgene returned rights to SillaJen for all Middle Eastern countries, Russia, Ukraine, Belarus and Turkey. SillaJen assumed the responsibility of conducting the Phase III

PRESENTATION OF TRANSGENE AND ITS BUSINESS
Presentation of the Company and its business
trial in hepatocellular carcinoma. Transgene remains responsible for submitting requests for marketing approval and retains commercialization rights in its territories.
As part of the development activities, Transgene may have to Transgene. pay SillaJen up to \$116.25 million (including \$15.25 million already paid) in milestone and approval for market launch
payments for several indications, as well as royalties from the sale of Pexa-Vec by Transgene and its sub-licensees. SillaJen also has an option to co-promote the product in the five major European countries in the exclusive territory of
Presentation of the Company and its business
Transgene believes that its therapeutic approaches and its technologies differ from current treatments in immuno-oncology and that they have the potential to deliver significant improvement to the clinical results of cancer patients.
The Company's main competitive advantages are described below.
The MVA platform is one of Transgene's technology platforms and is designed to allow a maximum number of gene transfer applications. It makes available delivery techniques for differentiated genes, suited to distinct clinical situations, specifically in the field of cancer. It has been put into use for several therapeutic vaccines currently under development and for the new myvac® personalized vaccine program.
This technology platform has the following potential advantages:
Transgene has an innovative platform to develop a new generation of multifunctional oncolytic viruses, armed with several "anti-cancer weapons" (see Section 1.2.2.2). Multifunctional oncolytic viruses are particularly promising therapies, with the potential to significantly improve the treatment of patients. Study TG6002.02 demonstrated the feasibility of intravenous administration of the VVcopTK-RRvector behind the Invir.IO™ platform. Transgene believes that this intravenous administration capacity constitutes a competitive advantage over other oncolytic viruses.
This platform leverages Transgene's historical know-how in engineering viral vectors. It is intended to generate, including through collaboration agreements, a portfolio of particularly innovative drug candidates able to modulate the tumor microenvironment.
With myvac® , Transgene has a state-of-the-art platform for innovation in cancer-fighting immunotherapies. The Company's know-how in virotherapy enables it to incorporate coding sequences for antigens into our individualized immunotherapy. By incorporating sequencing and artificial intelligence into the design of the virus, myvac® signals the entry of viral vector-based approaches into the era of digital transformation and precision oncology.
Transgene has created an organization able to design and manufacture this product, which is individualized for each patient, on a competitive basis in terms of turnaround time and cost. This new therapeutic option could represent a major improvement over existing therapies. myvac® is also the result of a policy of opening up to partners developing technologies that complement our expertise, in order to develop a multidisciplinary approach.
Transgene capitalizes on four decades of recognized scientific expertise. The Company has been active in the field of gene transfer therapy and immunotherapy since 1992, and has gained extensive know-how in key fields for its development: virology, the conduct of clinical trials, and regulatory matters.
Transgene has applied for patents and will continue to do so to protect its products, vector technologies and related processes and other technologies. As of the date of this Registration Document, Transgene holds around 130 patents granted in several countries and territories (including Europe and the United States). More than 100 patent applications are currently pending. In addition to its patent portfolio, Transgene has licenses for third-party patents and the use of third-party processes and technologies.
2021 Universal Registration Document 35
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Transgene is an oncology (cancer treatment) R&D focused biotechnology company. It does not market any products.
In 2020, nearly 10.0 million deaths were caused by cancer worldwide. This disease is the leading cause of death in developed countries. It affected 19.3 million new patients in 2020. The new version of the IARC (International Agency for Research on Cancer) online database, GLOBOCAN 2020, gives the most recent estimates for 36 types of cancer in 185 countries and provides a thorough overview of the global burden of cancer. By 2040, new cancer cases are expected to reach 29.5 million with cancer deaths increasing to 16.4 million, as a result of population growth and aging (sources: Sung, H et al, CA Cancer J Clin. 2021; National Cancer Institute 2020).
Surgery and radiotherapy are currently considered the best treatments available for many cancers. However, patients' survival rate is reduced when the tumors are invasive and metastases appear. Chemotherapy and hormone therapy are the main treatments for cancers at these advanced stages. Nevertheless, except in the case of certain less common types of cancer such as acute childhood leukemia, Hodgkin's disease and testicular cancer, few patients are cured by these treatments and improving their chances of survival remains challenging.
New anti-cancer treatments – called targeted therapies, which include ICIs – have emerged in recent years and several of them are on the market. These therapies use agents that can specifically target and attack cancer cells without seriously harming healthy cells.
Immunotherapy, which also includes ICIs, is another new field in oncology. It uses the patients' immune system by either activating it against the cancer cells or by giving it additional protection, such as proteins produced by bio-molecular engineering. Transgene's cancer treatment programs mainly seek to stimulate and educate the immune system to induce tumor rejection or to directly destroy cancer cells.
The economic impact of cancer is considerable. Its estimated total cost amounted to \$97 billion for 2017. The market is expected to reach \$274 billion in 2030, assuming an annual average growth rate of 7.5% between 2021 and 2030. The growth of the market is due to the increase in the number of cases as well as by access to new therapies (Allied Market Research).
Several types of cancers are linked with HPVs and known as "HPV-positive". These notably include head and neck cancers and anogenital cancers:
The current treatment options are surgical resection with either radiotherapy, radio-chemotherapy and/or Immune checkpoint inhibitors (ICIs). More efficient treatments need to be developed to treat these diseases, especially for advanced metastatic cancers. Combining immunotherapy with ICIs could be a promising therapeutic option to meet this major medical need. In some indications, with the ICIs, the median overall survival remains less than 11 months, with a median progression-free survival in the order of 2 to 4 months. The overall response rates fall between 10% and 15% depending on the indication.
The randomized Phase II part 2 trial with TG4001, alone or in combination with avelumab, focuses on anogenital cancers.
Gastrointestinal cancers include several forms of cancer of the digestive system. They include cancers of the esophagus, gallbladder, liver, pancreas, stomach, small intestine, colon, rectum and anus.
Colorectal cancer (CRC) is the third most frequently diagnosed cancer and the second leading cause of cancer death in the world. In 2020, almost 325,000 new cases of CRC were reported in Europe, with 159,000 deaths. Worldwide, this represents 1.15 million new cases and 577,000 deaths (Globocan 2020). Around half of patients develop liver metastasis, of which only a small proportion are eligible for surgical resection. In the last decade, the prognosis for patients with metastatic CRC has improved, with an average median survival of 30 months.
Presentation of the Company and its business
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Ovarian cancer is generally aggressive and detected at an advanced stage. Worldwide, it is the eighth leading cause of cancer deaths in women, but the fifth leading cause of cancer death in Western Europe and North America (Globocan 2018). In 2020, the number of cases worldwide was 314,000 with 207,000 deaths (Globocan 2020).
Treatment of ovarian cancers is mainly based on surgery, which aims to remove the entire tumor and its extensions outside of the ovaries. Chemotherapy is often prescribed after this operation to eliminate any remaining cancer cells and reduce the risk of recurrence. Whilst over 70% of patients have a positive clinical response to this treatment, half of women will have a recurrence (source : Burger et al, New End J Med, 2011). New treatments have been authorized that enable improved progression-free survival but without significant improvements to overall survival. The aggressive and advanced ovarian cancer forms continue to represent a significant medical need.
Squamous cell carcinoma of the head and neck bring together different cancers that affect the mouth cavity, pharynx and larynx. When they are not linked to an HPV infection (see above), they are generally due to excessive alcohol or tobacco consumption and have a more unfavorable prognosis. With the exception of cancers such as oropharyngeal cancers, which are mainly due to HPV, most head and neck cancers are HPV-negative. We estimate the number of new HPV-negative cases at just over 747,000 worldwide per year, with around 367,000 deaths. There are strong regional disparities in terms of incidence. (Globocan 2020)
For patients diagnosed at a locoregional stage, surgical treatment must be combined with a therapy such as adjuvant radiation therapy or chemo-radio therapy. These different adjuvant treatments aim to reduce the risk of recurrence. However, disease recurrence is observed during the first year after treatment in 60% of patients (Bernier and Cooper, Oncologist, 2005).
The Company is operating in a competitive environment in which many of the other companies have more substantial financial and human resources than it does. These competitors could roll out technologies similar to the Company's viral platforms or develop and market therapies for the same indications as the Company.
For example Bavarian Nordic AS, BioNtech, Gritstone, Vaccibody and Moderna, with respect to therapeutic vaccines (notably personalized), and Amgen, Replimune, Oncorus, with respect to oncolytic viruses, are all trying to develop viral immunotherapies.
Although there is currently no effective treatment to cure all cancers or solid tumors in particular, some treatments able to prolong survival, such as chemotherapy, are recognized. The outlook for patients has improved over recent years with targeted therapeutic approaches and immunotherapies (including ICIs). These medications are therefore competing or complementary products, depending on their mechanism of action. Transgene's immunotherapies (therapeutic vaccines and oncolytic viruses) act to stimulate the patient's immune response and can be combined with ICIs or chemotherapies.
In the treatment of chronic hepatitis B (indication for TG1050), the standard treatment is a class of antivirals, the nucleosides. One of the treatments, Entecavir, is now available as a generic medication and the other treatment, Tenofovir (Viread® ), is commercialized by Gilead. Other products at varying stages of development exist, including the Gilead, Arbutus Biopharma and Alnylam Pharmaceuticals programs.
However, despite the advances made in cancer treatments, innovative therapies still need to be developed to extend patients' lives and improve their quality of life.

Transgene is 61.9% owned by TSGH, a financial holding company, which in turn is 99.5% owned by Institut Mérieux itself 99.8% owned by Compagnie Mérieux Alliance, which is 68% owned by the Mérieux family and 32% owned by Fondation Christophe and Rodolphe Mérieux.
Within this group, bioMérieux works on clinical diagnostics, Mérieux NutriSciences provides services in food security and health, and Transgene focuses on immunotherapy research and development.

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The Company has a subsidiary in the United States, Transgene, Inc., based in Boston, Massachusetts, in which it holds 100% of its capital and voting rights. This subsidiary represents Transgene before various organizations, regulatory authorities and study centers for its clinical trials in the United States. In this context, it comes under the operational control of Transgene, charges its costs to Transgene and has no significant assets. Jean-Philippe Del, Chief Financial Officer, and Hedi Ben Brahim, Chairman and Chief Executive Officer of Transgene, are directors of Transgene, Inc.
Transgene created a new subsidiary in China in February 2020, Transgene BioPharmaceutical Technology (Shanghai) Co. Ltd., based in Shanghai, in which it holds 100% of the capital and voting rights. This company was established to support Transgene's business with Chinese partners. In this context, it comes under the operational control of Transgene and has no significant assets. Éric Quéméneur, Maud Brandely and John Felitti, are directors of this company. Hedi Ben Brahim, Chairman and Chief Executive Officer of Transgene, is its supervisor.
In 2021, Transgene confirmed the potential of its two innovative platforms. The Company has an ambitious portfolio of product candidates.
In 2021, the first positive findings were announced from Phase I trials of TG4050, an individualized immunotherapy based on myvac® technology. These positive data were obtained in the first six patients treated; they demonstrate the significant potential of this individualized approach against cancer, based on Transgene's viral engineering expertise combined with the artificial intelligence technologies of its partner NEC.
Based on positive results obtained in 2020, a new randomized Phase II trial of TG4001, in combination with avelumab, was initiated in 2021 in Europe and the United States.
Initial data from Phase I of TG6002 were communicated at major conferences in 2021 and provided the clinical proof of concept for the intravenous administration of the oncolytic viruses developed by Transgene.
BT-001, the first oncolytic virus in our Invir.IO™ platform, co-developed with BioInvent, continues its clinical development in Europe. Promising preclinical data were presented at a major congress and published in a prestigious journal.
In December 2021, Astrazeneca exercised a first license option on an oncolytic virus developed by Transgene, as part of the collaboration agreement under which Transgene is to supply five candidates derived from the Invir.IO™ platform.
The Company completed a capital increase through a private placement in June 2021, allowing it to raise €34.1 million. Transgene also received €17.4 million net in September 2021 from the sale of part of its Tasly BioPharmaceuticals shareholding.
The products developed by Transgene are immunotherapies based on viral vectors. Potential peak sales could exceed a billion euros per year, in cancers such as colorectal cancer. Immunotherapy, including Immune checkpoint inhibitors (ICIs), has been an area of significant clinical progress for the past several years. Transgene focuses on severe diseases for which better treatments will increase life expectancy. The viral approaches used by Transgene have a favorable tolerability profile.
Transgene designs and develops drug candidates at preclinical and clinical development stages. The Company intends to obtain proof of concept of the medical efficacy of its immunotherapies in humans, used as a monotherapy and/or in combination, in particular with ICIs. Once proof of concept is established, Transgene intends to license its products to pharmaceutical industry players.

Business overview
In order to better valuate its technology platform based on viral vectors, and with the aim of subsequently signing licensing contracts, Transgene also plans to sign collaborative development agreements with pharmaceutical industry and/or biotechnology companies. Transgene does not plan to produce or market its products on a large scale.
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At the date of this Registration Document, with no products on the market, Transgene generates revenue from (i) collaboration and licensing agreements signed with other companies in its sector (see Section 1.2.3 and 1.2.4) and (ii) public funding of research expenses (grants and research tax credits).
Some collaboration and licensing agreements provide for research or manufacturing services by the Company, with obligations to customers. The Company invoices its services at a contractually defined price that is generally based on time spent, and billings are recorded in operating income as and when the services are performed. Some of these contracts provide for manufacturing services with a performance obligation. In these cases, the services are recorded in operating income in the income statement after satisfactory quality control and customer acceptance. Revenue received but not yet recognized in the income statement based on the above principles is recorded as a liability under Deferred income until it meets the criteria for recognition as operating income. Income from patent licenses generally consists of fees for access to technology paid and non-refundable on the signing of the agreement, and financing by milestone payments and other payments such as royalties on sales.
The Company may be required to grant an option right for a license. Income associated with the concession is recorded as Deferred income on the balance sheet and recognized as income on a straight-line basis until the estimated date of exercise of the option by the beneficiary. The expected date of exercise of the option is reviewed periodically.
In the event that the Company is not committed to perform work for the development of technology after signature, the non-refundable fees for technology usage rights paid when the license is signed are recognized as Operating income upon the fulfillment of the contractual obligations. In the event that the Company should continue some development work in the technology after signature, or if it has a higher obligation to deliver the product, these rights are recognized in deferred operating income over the period of development or delivery of the product.
Milestone payments received under collaboration and licensing agreements are recognized as income when the operative event has occurred and there are no longer any conditions precedent to the payment by the third party. Operative events are usually the scientific or clinical results obtained by Transgene, the commencement of studies or external factors such as regulatory approvals.
Royalties on sales received under collaboration and licensing agreements are based on sales by licensees of products or technologies. They are recognized on the basis of the license terms, when the sales can be reliably measured and recovery of the related receivables is reasonably assured.
Certain research and development expenses in France are entitled to a research tax credit recognized at the end of the year in which the expense was recorded and the tax credit claimed. If it has not been used by allocation to a tax charge, the tax credit may be redeemed in accordance with the tax provisions. Research tax credits are recognized in the income statement under Public funding for research expenses in accordance with IAS 20.
Research and development expenses are recognized on the income statement in the period in which they are incurred. Development expenses are capitalized only when IAS 38 requirements are met. At the current development stage of its products, the Company believes that, at the date of this Registration Document, these conditions were not met, and therefore, it did not capitalize its development expenses.
The Company distributes stock options and bonus shares to its officers and employees. The charge for these distributions is evaluated and spread over time, according to the principles of IFRS 2.
In accordance with the prevailing laws and practices in France, Transgene offers certain benefits to ensure eligible employees receive a lump sum payment at the time of retirement (lump-sum retirement benefits). In accordance with the obligations and regulations, these defined benefit plans may be funded by investments in various instruments. The rights acquired by active staff are estimated using actuarial valuations based on the probability of death and continued employment by the Company, as well as expected future salaries. The benefit obligation is measured by the projected unit credit method. The value of the obligations was calculated according to the new valuation method recommended by the IFRIC in its decision of April 2021 relating to the allocation of the cost of services associated with a benefits plan. This provision does not apply to employees of entities located abroad.
Business overview
Financial assets consist of deposits and guarantees for leased assets or debt from a financial institution, equity securities, earn-outs due on the sale of interests, and cash advances made to non-consolidated equity investments.
The valuation of non-consolidated investments without significant influence is based on an analysis using the fair value method. This valuation is periodically reviewed at each reporting date.
Earn-outs due are valued at amortized cost and revalued each year based on expected changes in cash flow. Future cash flows are re-estimated and discounted each year-end based on the progress of the programs concerned and estimated success rates for each clinical phase. The impact of this re-estimate is recognized in financial income/loss.
Other financial assets are recorded at cost and depreciated, as needed, if their carrying value exceeds their recoverable amount as estimated by the Company.
As of December 31, 2021, the Company no longer had any investments in affiliates accounted for using the equity method.
Conditional advances are only reimbursed if the research and development projects that they finance are successful, according to criteria set out in advance with the funding body.
Conditional advances received as part of the ADNA program are recorded according to IRFS 9, based on discounted expected future reimbursements. The reimbursement of advances is subject to the fulfillment of a revenue threshold on the TG4001 product predetermined for the following five years, and in proportion to the revenue from these products until a reimbursement ceiling is reached, or up until 2035. Future cash flows are re-estimated and discounted each year-end based on the update on the revenue prospects of the two products. The impact of this re-estimate is recognized in financial income/loss.

The Company has historically incurred losses and expects to should be limited to payments related to existing and future continue to incur more losses over the next few years, due to strategic partnerships with pharmaceutical companies, third costs incurred by its research and development programs and party research contracts, current or future license preclinical and clinical trials. In previous years, the main agreements, financial income from cash investment and sources of Transgene revenue were the remuneration of public funding. service contracts for third parties, research and development collaboration and government subsidies. Future revenue
| (in € thousands, except for per-share data) | Dec. 31, 2021 | Dec. 31, 2020 |
|---|---|---|
| Revenue from collaborative and licensing agreements | 9,993 | 2,981 |
| Government financing for research expenditure | 7,021 | 6,362 |
| Other income | 399 | 572 |
| Operating income | 17,413 | 9,915 |
| Research and development expenses | (32,883) | (27,346) |
| General and administrative expenses | (7,369) | (6,547) |
| Other expenses | (686) | (15) |
| Operating expenses | (40,938) | (33,908) |
| Operating income/(loss) | (23,525) | (23,993) |
| Financial income/(loss) | 3,989 | 6,762 |
| Share of profit/(loss) and disposal of investments in associates | - | - |
| Income/(loss) before tax | (19,536) | (17,231) |
| Income tax expense | - | |
| Net income/(loss) | (19,536) | (17,231) |
| NET INCOME/(LOSS) | (19,536) | (17,231) |
| Basic earnings per share (€) | (0.21) | (0.21) |
| Diluted earnings per share (€) | (0.20) | (0.21) |
Revenues from collaboration and licensing agreements amounted to €10 million in 2021 compared to €3 million in 2020. These are mainly revenues recognized over the period as part of the collaboration with AstraZeneca for €9.9 million (compared to €2.9 million in 2020); This increase is linked to the exercise of the license option made by AstraZeneca for an oncolytic virus from the Invir.IOTM platform for €7.1 million in 2021.
Public funding for research expenses accounted for €7 million in 2021 versus €6.4 million in 2020, relating to the research tax credit of €7 million in 2021 (€6.3 million in 2020).
Other income stood at €0.4 million in 2021, versus 0.6 million in 2020. It corresponds to the €0.2 million in NEOVIVA conditional advances granted at a preferential rate, as in 2020. These advances have been restated in accordance with IAS 20, with the subsidy portion recognized in Other income.
R&D expenses amounted to €32.9 million in 2021, versus €27.3 million in 2020.
Business overview
The following table details R&D expenses by type:
| (in € millions) | Dec. 31, 2021 | Dec. 31, 2020 |
|---|---|---|
| Payroll costs | 12.4 | 11.5 |
| Share-based payments | 1.7 | 0.8 |
| Intellectual property expenses and licensing costs | 1.1 | 0.9 |
| External expenses for clinical projects | 6.3 | 5.4 |
| External expenses for other projects | 4.5 | 2.4 |
| Operating expenses | 5.1 | 4.6 |
| Depreciation and provisions | 1.8 | 1.7 |
| RESEARCH AND DEVELOPMENT EXPENSES | 32.9 | 27.3 |
R&D payroll costs (salaries, charges and related expenses) amounted to €12.4 million in 2021, compared to €11.5 million in 2020, due to the increase in headcount linked to the increase in production activities.
The cost of share-based payments amounted to €1.7 million at December 31, 2021, compared to €0.8 million for the same period in 2020, notably following the granting of a new free shares plan in 2021.
Intellectual property and licensing expenses amounted to €1.1 million in 2021 versus €0.9 million in 2020.
External expenses on clinical projects were up to €6.3 million at December 31, 2021, compared with €5.4 at December 31, 2020 following the launch of several studies, notably for the TG4001 and BT-001 projects as well as for the accelerated spending for the TG4050 project.
External expenses on other projects (research or industrial) amounted to €4.5 million in December 31, 2021, compared to €2.4 million in December 31, 2020. This increase is mainly due to the start in 2021 of a project to improve manufacturing processes.
Operating expenses also increased to €5.1 million at December 31, 2021, compared to €4.6 million over the same period last year due to the internal production of clinical batches for the various studies.
General and administrative expenses amounted to €7.4 million at December 31, 2021, compared to €6.5 million at December 31, 2020
The following table details G&A (general and administrative) expenses by type:
| (in € millions) | Dec. 31, 2021 | Dec. 31, 2020 |
|---|---|---|
| Payroll costs | 3.4 | 3.2 |
| Share-based payments | 1.3 | 0.9 |
| Fees and administrative expenses | 1.9 | 1.8 |
| Other general and administrative expenses | 0.7 | 0.5 |
| Depreciation and provisions | 0.1 | 0.1 |
| GENERAL AND ADMINISTRATIVE EXPENSES | 7.4 | 6.5 |
Payroll expenses at December 31, 2021 were €3.4 million, compared to €3.2 million at December 31, 2020. The cost of share-based payments amounted to €1.3 million at December 31, 2021, compared to €0.9 million for the same period in 2020, notably following the granting of a new free shares plan in 2021. Management fees and expenses amounted to €1.9 million in 2021, compared to €1.8 million in 2020.
Other general and administrative expenses amounted to €0.7 million at December 31, 2021, compared with €0.5 million at December 31, 2020.
1


Net financial income resulted in a net income of €4 million in 2021 versus a net income of €6.8 million in 2020.
In September 2021, the Company sold 49% of the equity securities of Tasly BioPharmaceuticals for €17.4 million. The sale of the Tasly BioPharmaceuticals shares generated a net gain on the disposal of assets of €1.3 million. The shares still held by the Company as of December 31, 2021, were revalued at €2.4 million. This revaluation corresponds to the difference between the fair value in euros (sale price in September) and the fair value at December 31, 2020. In 2020, the first partial sale of shares Tasly BioPharmaceuticals and the revaluation of the remaining shares generated income of €9.1 million.
At December 31, 2021, the discounting of the debt on ADNA's conditional advances generated financial income of €0.7 million, compared with a financial expense of €0.6 million at December 31, 2020.
As of December 31, 2020, the Company had recognized income of €1.3 million following the agreement reached with the former shareholders of ElsaLys Biotech SA for the acquisition of the latter by Mediolanum Farmaceutici.
As of December 31, 2020, the Company recognized a financial expense of €1.8 million corresponding to the waiver of the receivable on the sale of SillaJen investments. The representative of the former shareholders had entered into an agreement with SillaJen terminating the earn-out commitments
Net income before tax was a net loss of €19.5 million in 2021 versus a net loss of €17.2 million in 2020.
Net income before tax was a loss of €19.5 million in 2021 versus a net loss of €17.2 million in 2020.
Net loss per share was therefore €0.21 in 2021, as in 2020.
The Company has not distributed a dividend since its formation. In the coming years, it plans to use all available funds to finance the business and future growth.
None.
To date, the Company has been funded by capital increases. Historically, the Company has mainly been financed by its majority shareholder, due to that shareholder's wish to maintain control and the level of equity interest.
Investments in property, plant and equipment and intangible assets amounted to €1.0 million in 2021 (€2.4 million in 2020).
Since 2019, Transgene has acted as lead company in a new research program, NEOVIVA, supported by Bpifrance. The Company could receive up to €2.6 million (€0.2 million in subsidies, €2.4 million in conditional advances) over five years. Transgene received €0.6 million of conditional advances under this program in 2021.
In April 2019 the Company signed a revolving credit agreement with Natixis, capped at €20 million, which can be drawn down once or on several occasions. Transgene was to pledge the shares held in Tasly BioPharmaceuticals. An amendment was signed in September 2020 bringing this credit line to a maximum of €15 million, following a first sale of Tasly BioPharmaceuticals shares in July 2020. Following the second sale of Tasly BioPharmaceuticals shares in September 2021, the credit line was canceled completely, in accordance with the terms of the agreement. The Company had not drawn on this credit facility
The Company's cash is invested in short-term money-market mutual funds or placed, at market conditions, in a cash pool managed by the majority shareholder of Transgene, Institut Mérieux.
As of December 31, 2021, the Company's available cash amounted to €49.6 million versus €26.3 million on December 31, 2020. The Company held a capital increase in June 2021 raising gross proceeds of €34.1 million.
The Company's net cash burn amounted to €10 million in 2021, excluding capital increases, versus €17 million in 2020, excluding capital increase.
Business overview
The main investments in tangible and intangible assets made by the Company during the past two years are as follows:
| 2021 | Thousand euros | Principal investments |
|---|---|---|
| Tangible | 660 | Maintenance and laboratory equipment |
| Intangible | 28 | Software |
| 2020 | Thousand euros | Principal investments |
| Tangible | 850 | Maintenance and laboratory equipment |
| Intangible | 25 | Software |
None of these investments had a unit value higher than €0.5 million.
The forecast budget for tangible and intangible investments in 2022 amounts to around €1.0 million. This budget includes current operating investments for the replacement and improvement of equipment and facilities.
Investment in financial assets over the last three years evolved as follows:
● in September 2021, the Company sold 49% of its stake in Tasly BioPharmaceuticals for €17.4 million. The Company now holds 8.7 million shares of Tasly BioPharmaceuticals, i.e. 0.8% of this company's share capital. During a first sale, in July 2020, the Company sold 38% of the Tasly BioPharmaceuticals shares it held for US \$22 million. At the time, the Company held 1.58% of Tasly BioPharmaceuticals;
● in April 2020, the Company acquired a stake in Vaxxel SAS for €118 thousand, in return for the transfer of rights to the DuckCelt® -T17 cell line. This amount corresponded to 10% of the share capital of Vaxxel SAS at the date of the transaction;
The Company has financial visibility through the end of 2023. Because of the difficult-to-predict effects of the Covid-19 pandemic on the expense and revenue assumptions on which this financial forecast is based (see 2.4.8), the Company cannot accurately estimate at this stage the impact of this pandemic on its cash consumption, but considers that this impact would be moderate.
None.
None.

| 2.1 | RISKS RELATED TO PARTNERSHIPS | |
|---|---|---|
| 2.1.1 | Our candidate portfolio may not meet the needs of partners | |
| 2.1.2 | Dependence on partners | |
| 2.1.3 | Transgene may not be sufficiently visible to potential partners |
|
| 2.2 | FINANCIAL RISKS | |
| 2.2.1 | Available funds may be exhausted | |
| 2.2.2 | Capital requirements may persist and even increase | |
| 2.2.3 | Revenues from partnerships may not materialize | |
| 2.2.4 | License revenue is volatile | |
| 2.2.5 | Partnership structures may not immediately increase liquidity |
|
| 2.2.6 | Financing efforts may have an adverse effect on existing shareholders |
|
| 2.2.7 | Uncertain value of equity securities in other companies | |
| 2.2.8 | Exposure to loans and factoring | |
| 2.2.9 | The French tax regime could change unfavorably | |
| 2.2.10 | High foreign exchange risk | |
| 2.3 | RISKS IN RELATION TO THE PORTFOLIO | |
| 2.3.1 | Poor market acceptance may limit the value of our products | |
| 2.3.2 | Our technological and competitive environment is rapidly evolving |
|
| 2.3.3 | Combining therapies carry additional risks | |
| 2.3.4 | Transgene may not identify emerging technologies or fail to successfully integrate them |
|
| 2.4 | RISKS RELATED TO CLINICAL | |
| DEVELOPMENT | ||
| 2.4.1 | One or more of our clinical trials could fail; the marketing of our products may not be approved for marketing |
|
| 2.4.2 | Opportunities may be lost due to long and costly regulatory process. |
|
| 2.4.3 | Difficulties in determining the parameters necessary for the success of our drug candidates |
|
| 2.4.4 | We may be involved in trial protocols that turn out to no longer be feasible or relevant for authorization, reimbursement or partnership opportunities |
|
| 2.4.5 | The complex regulatory environment of clinical trials may impose significant costs |
|
| 2.4.6 | Product liability claims could harm our business | |
| 2.4.7 | Uncertainties created by Brexit | |
| 2.4.8 | Impact of the Covid-19 pandemic | |
| 2.5 | INDUSTRIAL BUSINESS RISKS | |
| 2.5.1 | Transgene's ability to produce clinical batches and to fulfill its contractual obligations towards AstraZeneca depends on the performance of its internal production tool |
|
| 2.5.2 | Dependence on subcontractors | |
| 2.5.3 | Dependence on critical suppliers for the procurement of raw materials and consumables |
|
| 2.5.4 | Environmental risks related to the manufacture and use of our products |
|
| 2.6 | RISKS RELATED TO INTELLECTUAL | |
| PROPERTY | ||
| 2.6.1 | The Company may fail to patent its products | |
| 2.6.2 | The Company may not have the freedom to operate | |
| 2.6.3 | Intellectual property rights other than patents may be |
| 2.6.3 | Intellectual property rights other than patents may be |
|---|---|
2


The Company conducted a review of the risks that could have a material adverse effect on its activity, financial position, earnings or its ability to achieve its goals. In this section, in application of Article 16 of the Prospectus regulation we present the categories of risk that we consider to be the most relevant to investors as of the date of this Universal Registration Document. Investors should note that the selection of risks presented below is based on the criteria set out under Article 16 of the Prospectus regulation and the recommendations of ESMA, and that an investment in the Company remains subject to additional risks which are either (i) unforeseen as of the date of this Universal Registration Document, (ii) the realization of which is not considered, as of the date of this Universal Registration Document, to be as likely to have a material negative effect on its activity, financial position, earnings or its ability to achieve its goals, or (iii) which are generic to its industry, to listed companies or to any company generally, even if such risks are substantial. For example, a category of risks related to commercialized products has not been included because the Company currently has no registered products and does not under our current business model intend to directly commercialize our products, but changes in the product liability regime or the marketing environment can be expected to have some effect on the value of our investigational drugs to partners and therefore on the value of our business.
Investors should carefully consider the following risk factors. They must also take note of the other information provided in this Universal Registration Document, in particular information related to the financial statements and notes thereto.
The table set out below summarizes the principal risk factors identified by the Company as of the date of this Universal Registration Document and indicates for each risk factor the likelihood of occurrence and the possible negative effect on the Company, in each case taking into account corrective actions and risk management measures that have been put in place. Based on the Company's evaluation, the likelihood of occurrence has been classified as "low", "medium" or "high" and the potential negative effect has been classified as "low", "moderate" or "critical". For each of the seven risk categories below, the order of the risks takes into account this classification with the risk having the highest likelihood of occurrence and most critical potential negative effect appearing first in the list.
| Ref. | Category | Risk | Probability | Potential impact |
|---|---|---|---|---|
| 2.1.1 | Our portfolio of candidates may not meet our partners' requirements. | medium | critical | |
| 2.1.2 | Partnership | Dependence on partners. | medium | critical |
| 2.1.3 | Transgene may not be sufficiently visible to potential partners. | low | moderate | |
| 2.2.1 | Available funds might be exhausted. | high | critical | |
| 2.2.2 | Capital needs might persist and even increase. | high | critical | |
| 2.2.3 | Revenues from partnerships might not materialize. | medium | critical | |
| 2.2.4 | Licensing revenue is volatile. | high | moderate | |
| 2.2.5 | Partnership structures may not immediately increase liquidity | medium | moderate | |
| 2.2.6 | Finance | Financing efforts may have an adverse effect on existing shareholders. |
medium | moderate |
| 2.2.7 | Uncertain value of equity securities in other companies. | high | critical | |
| 2.2.8 | Exposure to loans and factoring. | low | low | |
| 2.2.9 | French income tax laws could change unfavorably. | low | moderate | |
| 2.2.10 | High foreign exchange risk. | medium | moderate |
| Ref. | Category | Risk | Probability | Potential impact |
|---|---|---|---|---|
| 2.3.1 | Portfolio | Poor market acceptance may limit the value of our products. | medium | critical |
| 2.3.2 | Our technological and competitive environment changes rapidly. | high | critical | |
| 2.3.3 | Combining therapies carries additional risks. | medium | moderate | |
| 2.3.4 | Transgene could be unable to identify emerging technologies or integrate them successfully. |
medium | moderate | |
| 2.4.1 | One or more of our clinical trials might fail/Our products might not be authorized for sale. |
high | critical | |
| 2.4.2 | Opportunities might be lost due to long and costly regulatory process. |
medium | critical | |
| 2.4.3 | Difficulties in determining the necessary parameters for the success of our candidate drugs. |
medium | critical | |
| 2.4.4 | Clinical development |
We may be involved in trial protocols that turn out to no longer be feasible or suitable for authorization, repayment or partnership opportunities. |
low | critical |
| 2.4.5 | The complex regulatory environment for clinical trials may impose heavy costs. |
medium | moderate | |
| 2.4.6 | Liability claims regarding products could harm our business. | low | low | |
| 2.4.7 | Uncertainties created by Brexit. | medium | low | |
| 2.4.8 | Impact of the Covid-19 pandemic. | high | moderate | |
| 2.5.1 | Transgene's ability to produce clinical batches and fulfill its contractual obligations to AstraZeneca depends on the performance of its internal production tool. |
low | critical | |
| 2.5.2 | Manufacturing | Dependence on outsourcers. | low | critical |
| 2.5.3 | issues | Reliance on critical suppliers for the procurement of raw materials and consumables |
low | moderate |
| 2.5.4 | Environmental risks related to the manufacture and use of our products. |
low | low | |
| 2.6.1 | The Company might fail to patent its products. | low | critical | |
| 2.6.2 | Intellectual | The Company may not be free to operate. | medium | moderate |
| 2.6.3 | property | Unpatented intellectual property may be difficult to enforce legally. | medium | moderate |
| 2.6.4 | Intellectual property disputes are risky and costly | low | low |

The Company's business model (see Section 1.2.1.1) entails out-licensing of our drug candidates and technologies to third-party partners for the completion of clinical trials, product registration and, ultimately, commercialization. Multiple risks affect such partnerships.
The pharmaceutical companies that make up the largest part partners for a given candidate. As a result, even a Phase I or II of Transgene's partnering opportunities typically in-license candidate which has the potential ultimately to be developed product candidates to reinforce their own product pipelines into a successful commercial product may not necessarily for reasons which may be driven by their own technological meet partner demand at the time when Transgene would capacities, perceived pipeline gaps including those caused by ordinarily seek to license it. In addition to the opportunity internal program failures, changes to strategy, competitive cost, failure to out-license a candidate at such a juncture may considerations or other fluctuating criteria and are not require Transgene to continue costly development into the possible for Transgene to predict when they will make critical subsequent clinical stage, to accept lower value opportunities, decisions in relation to their portfolio. While the or even to shelve the candidate. pharmaceutical market overall is highly competitive, there are in reality typically a relatively small number of potential
Transgene depends on a limited number of potential partners for the development and marketing of its candidates. Depending on the agreement, Partners may either decide or co-decide the development and commercialization paths for a candidate and may impose choices which Transgene considers sub-optimal for the candidate or for Transgene's overall product platform. In developments which provide for co-decision, there may also be cases in which development is blocked by failure to reach an agreement. In the event of disagreement, it may be difficult for Transgene to successfully assert its rights because of the difficulty inherent to litigating in a foreign court against a well-funded party. Even where there is no fundamental disagreement on the strategy of development or breach of contractual obligations, the results obtained by the partnered product in clinical studies or commercially or changes in a partners' business strategy may cause the partner to terminate our partnership. The failure or termination of a partnership could have a significant negative impact on Transgene's financial prospects or on investor sentiment concerning the Company. In cases where Transgene recovers the rights to the terminated product, there can be no assurance that a new partner can be found even after substantial additional investment by Transgene in the further development of the drug candidate. As of the date of this Universal Registration Document, the Company has signed the following agreements with partners for products it is developing:
● AstraZeneca: research and license option agreement on five oncolytic virus candidates from the Invir.IO™ platform (see Section 1.2.3);
Because of Transgene's relatively small size and its location in Transgene risks being unable to convince a major partner and Strasbourg, France, outside of the principal establish a partnership in timely fashion. The candidate drug bio-pharmaceutical centers, the Company competes with proposed to potential partner has to fit with the partner's other medical research companies with greater resources for strategic objectives and be more attractive than competing generating publications, participating in key industry events candidate drugs. and conducting business development. Consequently,
The Company's development requires significant capital. Multiple risks affect our ability to continue to fund our activities.
monetize the equity securities in Tasly BioPharmaceuticals by altogether. the end of 2023 is dependent on the success of its IPO project in 2022. Transgene's financial position means that in
Based on current financial resources available to Transgene the medium and long term, additional cash resources will be (cash, cash equivalents, other financial assets and equity required. If Transgene is unable to generate additional cash investment in Tasly) and projected operating expenses, resources during that time frame, the Company may be Transgene estimates that it has the financial capacity to required to significantly curtail one or more of its research finance its activities through 2023. The Company's ability to and development programs or to cease operations
While Transgene's long-term business plan aims for stable operational sources of funds—such as royalties from out-licensed products—to reliably cover operating expenses, today Transgene's operations consume more cash than they generate. For example, in 2021, operational expenditures for the year were in excess of €40 million, whereas sources of funds from operations were significantly less than this at nearly €17 million. Moreover, our funds received from operations are not recurrent and may vary greatly from year to year. Potential increases in operating expenditures, whether unexpected expenses or the naturally increasing costs of clinical trials (as development products pass from small early stage trials to larger later stage trials), may increase the net cash burn. Increased net cash burn could cause our projected cash resources for a given period to be inadequate, and require non-dilutive or dilutive funding more rapidly than anticipated.
The Company's future capital requirements will depend on many factors, including the following:
● the continued development of research & development programs and the extension of such programs;

In the medium term, Transgene's strategy is to generate be no guarantee that Transgene will succeed in partnering its additional cash resources through the out-licensing of products, or that the cash payments that Transgene is able to product candidates or other partnering structures. generate through its partnering activities will be sufficient to Out-licensing and other partnering structures are typically, offset its cash burn over the medium term, whether because although not always, remunerated by an up-front cash of the size or the timing of payments received. payment which can be applied to compensate net cash burn, followed by any milestone payments and royalties. There can
Over the longer term, even so-called "recurrent" sources of especially true if, as we expect will be Transgene's case for licensing revenues are subject to significant contingencies, the foreseeable future, such revenues derive from a small such as development failures or lower than expected product number of products and do not benefit from the portfolio sales. The fact that revenues in one year are sufficient to effect. cover operational expenditures is not a guarantee that they will continue to be sufficient the following year. This is
Even successful partnering may take a form which, while buy-out of Transgene's interest in its former joint venture with value enhancing for shareholders, does not reduce net cash Tasly BioPharmaceuticals in China, Transgene may receive burn or increase liquidity in the short- or even medium-term. assets which cannot be immediately converted into cash. Or For example, an initial upfront payment may be tied to an the partnering structure may back load at the end of the obligation to conduct a clinical trial the cost of which absorbs period, with only small short-term payments. some or all of the cash received. Or as in the case of the
If Transgene is unable to generate sufficient funds through capital market conditions. Historically, the financing of the partnering activities, alternative sources of funding, if Company was provided, for the most part, by its majority available, may reduce the value of existing shareholdings. shareholder, due in particular to the shareholder's interest in Sales of assets of a company in financial distress may not maintaining its level of investment and control. This interest extract full value. Credit may be available only on financially could be a brake, if the majority shareholder does not have burdensome terms, and creates the future risk of default. the means to pursue a capital increase and thereby imposes a Raising funds through the issuance of new shares is dilutive to limit on its amount. existing shareholders and could be complicated by poor
The 8.7 million shares Transgene owns in Tasly on another market, Chinese corporation law will block the sale BioPharmaceuticals represent a significant potential source of by Transgene of its shares for the first 12 months after listing, future funding; but Transgene's ability to liquidate this asset during which time the value of this asset will be exposed to depends on a Tasly BioPharmaceuticals listing or, in the market volatility. In the event that Tasly BioPharmaceuticals absence of one, on Transgene's exercising an option on the does not submit a new application for listing on the STAR holding company for Tasly Group. Tasly BioPharmaceuticals is Market before September 30, 2022 for assessment by the currently pursuing an IPO on the STAR Market in Shanghai, market authorities, Transgene will benefit from a put option China, after a first unsuccessful attempt at an IPO on the requiring a holding company for the Tasly Group to enter into Hong Kong Stock Exchange in 2019-2020, followed by a (or have a third party enter into) a sale agreement for failed listing on the STAR Market in 2021. The success and Transgene's stake in Tasly BioPharmaceuticals within three timing of this planned IPO are not certain at this point and are months at the initial subscription price plus a contractual subject to current market conditions and the uncertainty annual rate. This option was granted by Tasly Holding Group inherent in all financial markets. If Tasly BioPharmaceuticals to protect Transgene and other pre-listing investors against succeeds in being listed on the STAR Market or alternatively the risk of Tasly BioPharmaceuticals not being listed. In the
event that Tasly BioPharmaceuticals submits a new option and the completion of the sale are subject to risks such application for listing on the STAR Market before as counterparty risk. September 30, 2022, the option expires. The exercise of this
A significant portion of Transgene's current cash comes from past with the early repayment of a €10 million loan from the conditional advances from Bpifrance (see Section 5.1.2, European Investment Bank. In the event that Transgene does Note 9), and the factoring of annual research tax credits (see not have sufficient funding, the repayment would reduce Section 5.1.2, Note 9). Transgene must reimburse these Transgene's available funds for its future activities and amounts either at their maturities or upon the occurrence of potentially exhaust its financial resources. contractually defined events. Since 2020, Transgene's exposure to loans decreased significantly compared to the
Transgene benefits materially from two features of the French corporate tax regime: the research tax credit (RTC) and the ability to carry forward cumulated losses. Over the last three fiscal years, the Company has recorded €7,027 thousand (2021), €6,352 thousand (2020), and €6,619 thousand (2019) under the RTC. Given the importance of the RTC in the financing of the Company's activities, if the RTC were to be modified or eliminated by a change in French tax policy, this would impact the Company's financing capacities. Moreover, as with any tax benefit, the amounts received or claimed by the Company may be contested by the tax authorities, for example based on an assessment of eligibility of expenditure, sufficient supporting documents, or the calculation method.
Accumulated tax loss carry forwards stood at €755 million as of December 31, 2021. Applicable French law provides that tax loss carry forwards can be used to offset up to 50% of net income, with the first €1.0 million of net income capable of being entirely offset. Under current French tax law the unused balance of the tax losses in application of such rule can be carried forward to future fiscal years, under the same conditions and without time restriction. The ability to offset a substantial part of future taxable gains increases the value to shareholders of revenues that Transgene may generate in the future. Changes to French tax rules limiting or eliminating Transgene's ability to apply the carry forward would therefore negatively impact the value of anticipated future cash flows and therefore the value of our shares.
While Transgene's shares are quoted in euro and most of debt. In addition, Transgene's 8.7 million shares in Tasly Transgene's expenditures and indebtedness is in euro, BioPharmaceuticals will be listed in Chinese yuan, which contracts in our industry (including our recent contract with means that a change in the value of the yuan against the euro AstraZeneca) frequently provide for payment of amounts or a restriction on the convertibility of the yuan may have a defined in U.S. dollars, meaning that variations in the value of negative impact on one of Transgene's most important assets the dollar relative to the euro can cause a material change in and on future sources of liquidity. our net cash burn for a given period or our ability to service

Because of the long development times of the portfolio of drug candidates generated by Transgene, decisions regarding the composition of that portfolio including the focus of exploratory research and regarding substantial expenditures on development must be made years before a partnering event or other opportunity to extract value from the candidate will occur. Multiple risks are related to our decisions regarding the composition of our drug candidate portfolio.
The portfolio of immunotherapy products currently under depend in part on the setting by public authorities, private development by the Company consist primarily of therapeutic health insurers and other organizations in Europe and the vaccines and oncolytic viral vectors. These are novel medical United States of reimbursement rates sufficient for its technologies for which clinical data on safety and efficacy medications as well as the volume of prescriptions filled by remain limited and for which direct pricing benchmarks are patients. Expectations regarding marketing will drive our virtually non-existent. Moreover, notwithstanding ability to out-license our products at an acceptable price, and demonstrations of safety and efficacy through clinical trials, actual future market adoption will drive the amount of patients and care providers may be slow to adopt treatments revenues ultimately generated for Transgene through royalty based on genetically modified viruses. The ability of the payments. Company's partners to successfully market its products will
One of the key criteria upon which Transgene selects the competitors. This risk could also have an impact on our ability focus of its portfolio of drug candidates, both in terms of the to include patients in clinical studies and on the scientific or entities under development and the indications being commercial usefulness of the protocols of the studies under pursued, is the existence of an unmet medical need and our way. If the medical need originally targeted by our drug technological and competitive advantages in satisfying it. candidate is met by a competitor, whether through a product Because of the long development times of these drug similar to ours or through a different therapeutic approach, candidates, in addition to the risks of clinical failure disclosed the ability of our drug candidate to be approved, reimbursed elsewhere (see Section 2.4), this requires us to make at a satisfactory price and widely prescribed is diminished and judgments about what developments are likely to be made in its value as an out-licensed product is reduced. Assessing the the future by other companies and their impact on medical technological and competitive environment of our drug need. Although the Company endeavors to increase its candidates is reiterated over their entire development. To the technological capacities to remain competitive, the research extent that such a change to the environment materializes but and development activities conducted by its competitors is not timely recognized by the Company, we may continue to could make the Company's products obsolete or not make investment decisions based on erroneous estimations of competitive, or they could offer better treatments. Moreover, future returns. patients and healthcare providers could prefer other existing therapies or therapies recently developed by the Company's
The Company's candidate drugs are increasingly being investigational product carries the risk that the side effects of administered in combination with other treatments such as the other product may be mistakenly attributed to a chemotherapy or other immunotherapies. The choice of Transgene candidate or that the clinical trial will fail for therapeutic classes and specific products that will be reasons beyond the control of the Transgene candidate. Even associated with our drug candidates is playing an increasing obtaining a marketing authorization in combination with a part in our development strategy, because the marketing marketed product exposes Transgene to the risk that its sales authorization resulting from such studies will go to the will be limited if the combined product is not as well accepted specific combinations tested. The combination with another on the market as competing drugs.
Transgene's current portfolio has been selected and better understanding of the mode of action of our products. developed to take advantage of the Company's leading Thus, technology survey and assessment are essential expertise in a number of fields such as viral genome activities within the Company, both for the choice of engineering, translational immunology, biomanufacturing, and candidates in our portfolio and their successful design and bioinformatics. Exploitation of Transgene's areas of expertise development. Transgene must additionally determine in each is largely dependent on a key enabling technologies that case whether the technology is to be fully integrated through Transgene must carefully identify and master to maintain its recruitments, licensing and/or acquisitions, or managed competitive edge. Recent programs have been designed by through service providers or co-development partners. A taking advantage of emerging methods, such as machine failure on the part of Transgene to successfully identify its learning and artificial intelligence for the myvac® "tumor on a chip" for its Invir.IO™ platform. Advanced immune limit its medium- and long-term development capabilities. phenotyping technologies have been largely used in our clinical trials, for the monitoring of patient responses and for a
platform, or technological needs and integrate adequate capacity may
There are numerous uncertainties until the clinical development is completed.
The Company's products may only be marketed pursuant to a valid approval for market launch (AML) for launch obtained through the conduct of successful clinical trials. In order to obtain an AML, the Company, or its licensee, must demonstrate to the competent regulatory authorities, in particular the EMA and the FDA, the pharmaceutical quality of the products, their safety and their effectiveness for the targeted indications. Each agency has its own AML requirements, and approval in one geographical zone does not necessarily guarantee it will be obtained for other geographical zones. In particular, without FDA approval, it would be impossible for the Company to access the US market, which is the largest pharmaceutical market in the world in value.
Each stage of the clinical trials carries a significant risk of failure, which could prevent further development of the drug candidate. The latter may be poorly tolerated, not effective enough or may have no therapeutic benefit. For example, in December 2019, the Company announced that it had stopped developing TG4010 because the main assessment criterion of a Phase II study in combination with nivolumab and chemotherapy had not been met. In vivo preclinical trials do not necessarily predict the results that will be obtained in humans. Likewise, positive results in early clinical phases obtained on a small number of patients may not be borne out in later phases on more patients. Drug candidates in an early stage of development, such as those from Transgene, face a higher degree of uncertainty than more mature candidates and make it difficult to assess our activities and prospects, which could increase the risk of an investment in Transgene.

If the clinical trial process cannot be managed to obtain results quickly and in a cost-effective way, Transgene may miss approval, partnering or marketing opportunities to faster competitors or be unable to complete the clinical trials resulting in higher costs and lower probability of success. Multiple factors contribute to this risk:
The success of a product generally depends on the identification of the regimen and route of administration, selection of patients, other products with which it is combined, or other factors extrinsic to our drug candidate. In this case, clinical trials of a drug candidate, even if they are positive, may not reach the statistical thresholds required to provide clinical proof of concept for further development and to obtain marketing authorization. If these parameters are not successfully defined, a product which, in a better-targeted context, could have obtained regulatory authorization and commercial success, can therefore be excluded.
To select patients that are most likely to benefit from a market adoption of our product even if obtains AML. treatment, it has become almost indispensable to find biomarkers (particular biological characteristics) in them. It
allows principally to predict or demonstrate their response to treatment. It cannot be guaranteed that the Company will succeed in identifying the relevant biomarkers for its products, even where a responsive sub-population of patients exist. Where biomarkers have been successfully identified, they must be incorporated into diagnostic tests, called companion diagnostics, which will then accompany the treatment so that it can be administered to those most likely to benefit. Validation of companion diagnostic tests is an entirely separate clinical development process that happens concurrently with the clinical trials for a treatment and adds a level of complexity and additional costs which may limit
The rapid changes in medical research and treatments the patient populations and the inclusion criteria are no available that have been seen in oncology, and longer relevant, which can make it unfeasible to include immunotherapy in particular, present a major risk that a patients in the clinical trial. In 2018, for instance, the sponsor clinical trial protocol which once appeared well adapted to of an independent clinical study dealing with TG4010 chose providing clinical proof of concept, obtaining marketing to stop its study largely for these reasons. Clinical results from approval, negotiating satisfactory reimbursement and other competing products may also cause the competent attracting partnering opportunities has become outdated. regulatory authorities to modify their evaluation criteria. As a Once a clinical trial is initiated, changing its parameters is result, the protocol may not provide for the collection of data, difficult and as a practical matter often impossible. If the which are now required by health authorities. Finally, the standard treatments change during a clinical study, the level choice of biomarkers or combination products made on best of results hoped for when the study was originally designed information at the inception of the trial may tie its results to may turn out to be inadequate as compared to the technologies that are no longer favored several years later. therapeutic options that might have become available during the study. Changes in standards of care may also mean that
In recent years, laws related to the pharmaceutical industry's those of the French CNIL) have become increasingly interactions with healthcare professionals (typically referred stringent. Failure to comply with these rules could expose the to as "sunshine" and "transparency" acts) and handling of Company to reputational damage, penalties and legal costs. sensitive patient data (most notably the European Data Protection regulation and national implementing rules such as
Since Transgene tests its drug candidates on humans, the risk party using or marketing the Transgene's products, could of being sued for product liability is inherent in its activities. bring criminal or civil proceedings against it. Such allegations, Side effects or manufacturing defects in products developed even if they are unfounded, may make it impossible to and administered in clinical trials could lead to deterioration continue developing the drug candidate and may damage the of the patient's condition, injury or even death. For example, Company's reputation. These lawsuits could divert the Company's liability could be called into question by management from implementing its business strategy and patients participating in clinical trials in the context of the could be costly to defend. In addition, if the Company is held development of tested candidates and unexpected side liable in any of these possible lawsuits, it may incur significant effects resulting from their administration. Patients, regulatory penalties and suffer other damage to its reputation. bodies, biopharmaceutical companies and any other third
Our clinical trials in the United Kingdom are subject to the conducting clinical trials with TG6002 and TG4050 in the U.K. Medicines and Healthcare Products Regulatory Agency, United Kingdom and cannot be certain that these trials will or MHRA. Following the departure of the United Kingdom not be affected. From January 1, 2021, our research activities from the European Union at the end of 2020, there is in the United Kingdom are no longer eligible for the research considerable uncertainty about the rules applicable to the tax credit (RTC). United Kingdom in a number of areas. We are currently

The Covid-19 pandemic, which has lasted since March 2020, has had and continues to have an impact on Transgene's activities. As of the date of this document, this has mainly impacted clinical studies that have either been, or are still being, delayed due to the slowdown in patient inclusion or the length of time taken by the regulatory authorities to authorize the launch or the amendment of clinical studies. For example, a clinical study conducted in the United Kingdom (for TG6002) was the most impacted due to the temporary closure of the clinical center, preventing the recruitment of patients. The launch of the clinical study with BT-001 was impacted by an extended delay of several months for the review of the French authorization request by the ANSM.
If containment and global spread were to continue, the impact of the disease and the containment measures adopted by governments and the civil society could cause dysfunction in the supply and shipping chain on which the Company depends, lack of visibility in the scientific community due to the cancelation of international conferences, disorganization of the clinical sites participating in its clinical studies, delay or inability to produce its drug candidates, or even temporary closure of our establishments. As of today, the Company cannot be assured that it would be possible to implement its clinical study program under the conditions and within the time frame initially planned, if one or more of these risks should materialize. The occurrence of these risks would also have a downward impact on the Company's anticipated level of expenses, as well as on expected revenues from collaborations. This financial impact is difficult to quantify precisely at the date of this document.
The viruses on which Transgene's immunotherapies are based require highly specialized manufacturing, which expose an investment in the Company's shares to a number of specific risks.
The timelines and size of the batches (and therefore the cost) production method for initial testing of the option products. produced by Transgene's current manufacturing Two production lines have been installed, tested and subcontractors are not compatible with the rapid turn-around approved by the ANSM, and Transgene is studying an times required to produce the small patient-specific batches additional capacity increase for this tool. If production of TG4050, for which we target a delivery of the patient capacity fails to keep pace with the growth of demand by specific drug so that they can be administered in the time Transgene and its customers, Transgene's clinical trials and required by the trial protocols. To overcome these production relationships with partners could be negatively impacted. If issues, the Company has acquired the means to produce this new production equipment does not maintain its internally and to GMP standards small batches of approval by the ANSM or if it proves to be less reliable than poxvirus-based products for purposes of research and expected by the Company, the Company risks finding some small-scale clinical studies. This production line can also of its activities disrupted and delayed, with consequences on manufacture small batches of our Invir.IO™ products. The the costs and even the feasibility of some of its projects. contract with AstraZeneca intends to benefit from the competitive advantage provided by this faster, less costly
The Company has also subcontracted the manufacturing of clinical studies due to the specificities linked to certain batches required for its clinical studies. The bioproduction. Therefore, while neither contract is exclusive, manufacturing unit of the sub-contractor, ABL Europe, does the Company's ability to voluntarily switch sub-contractors not have sufficient capacity to guarantee the within a reasonable time frame is limited, meaning that the commercial-scale production of these products beyond the Company is dependent on the availability of product slots and initial launch phase. The Company secured its ability to the pricing practices of its sub-contractors. The Company subcontract commercial-scale manufacturing of some of its may not be able to negotiate competitive production costs or products by entering into a partnership with Sanofi Genzyme. delivery times for its products, which would have a material The Company would need to make substantial additional adverse effect on its business, earnings, financial position and investment to have its products manufactured on a development. Should the production capacity of existing commercial scale by other third parties or to manufacture the sub-contractors no longer be available to Transgene, for products internally again on a large scale, and the technology example due to a business interruption or a loss of regulatory transfer and production validation process could be expected approvals, transferring production to a back-up site would to entail a lead time of well over a year before production for entail significant delays and costs. use in patients could commence. In the event of such a transfer, the regulatory authorities may also require new
The Company uses raw materials from different suppliers in certification is complete. Moreover, the current volumes its manufacturing processes of its drug candidates; some of ordered by the Company do not allow it to negotiate the suppliers are the sole source of the material in question. agreements guaranteeing a supply of certain key raw The Company certifies its suppliers pursuant to materials from qualified critical suppliers. The Company pharmaceutical best manufacturing practices. If one of the therefore cannot ensure that it could be supplied by certain sole-source suppliers should default, the Company must find critical suppliers, that it could secure a second supplier or that and certify another source. However, identifying and it could do so in a timely manner. certifying such a supplier could take several months and their products could not be used in the Company's processes until
The Company's manufacturing, research and development completely ruled out. In the event of an accident, it could be activities, preclinical studies and clinical trials require the held liable for all consequent harm, and its liability could controlled storage, use and disposal of hazardous materials, exceed the limits of its insurance policies or not be covered. It both chemical and biological. The Company is subject to laws might be unable to maintain its insurance coverage on and regulations relating to the use, manufacture, storage, acceptable terms or possibly at all. It might have to bear handling and disposal of materials and waste. Even though it significant expenditures in order to comply with present or believes that its safety procedures for the handling and future provisions of environmental law. As of the date of this disposal of these hazardous materials comply with legal and Universal Registration Document, the Company has made no regulatory standards, the risk of contamination or accidental specific provision for industrial and environmental risks. injury caused by these hazardous materials cannot be

The Company's business model (see Section 1.2.1.1) consists of selling licenses of drug candidates and technologies to third parties. The Company relies on its ability to grant rights under its intellectual property which do not conflict with the intellectual property rights of third parties. The Company is exposed to multiple risks related to intellectual property.
Transgene's ability to partner out a product or technology, and the value obtained by Transgene, will depend largely on its ability to obtain patents covering its products and processes allowing it to benefit from the exclusive use of inventions for the period prior to patent expiration. Transgene has filed and plans to continue to file numerous patent applications for various aspects of its operations (such as viral vectors and methods for preparing and administering them, genes and gene combinations, monoclonal antibodies, biomarkers, etc.) in the United States, Europe and selected other countries. However, we may not be able to obtain, maintain or enforce our patents and other intellectual property rights which could affect our ability to compete effectively. For example, we cannot guarantee:
● that we will be able to develop new patentable drug candidates or technologies or obtain patents to protect such new candidates or technologies;
The conduct of the Company's business or administration of its products may fall under the intellectual property rights of others. The existence of such third-party rights could obligate the Company or its partners to:
Its business would be affected if it or its partners were unable to invalidate these rights or obtain a license, or if it could only obtain a license under conditions deemed unacceptable. The same would hold if it were unable to redesign the products or processes so as to avoid being sued for infringement.
The Company seeks to take into account third-party rights when making its product portfolio and clinical development decisions. The identification of such intellectual property rights and the evaluation of whether the Company's activities in fact fall within their scope is subject to interpretation, and frequently litigated. For example, a family of patents from the company Replimune claims product characteristics that would include the BT-001 drug candidate. Opposition proceedings against the granting of titles are underway in the United States and Europe to challenge the validity of these patents on the grounds, in particular, of insufficient description and lack of inventive step. Transgene believes that the broad claims of this family are ill-founded in law, and is confident in a positive outcome for BT-001. Notwithstanding this confidence, there can be no guarantee regarding the success of these procedures, and even in the event of success, pending the decision of the competent bodies, the freedom to operate risk that weighs on BT-001 could make the candidate-drug less attractive to potential partners.
The monitoring implemented by the Company to prevent brought by the Company limit or invalidate some of the freedom to operate risk may be insufficient due to (i) delays patent's claims. in publishing patent applications (18 months after the filing or priority date), (ii) failure to publish certain patent applications in the United States, (iii) the changing scope of patent claims between the application and the granted patent, and (iv) uncertainty as to whether the patent will ultimately be allowed in any form or if post-patent opposition procedures
Even when the Company makes its own patent application, it cannot be sure that certain third parties have not been the first to invent products or to file patent applications relating to inventions also covered by their own patent applications or those of their partners.
Transgene believes that several elements of its program Transgene has chosen to protect its interests by relying on involve technology, processes, know-how, data, including non-disclosure agreements with its employees, consultants culturing and production processes, as well as purification and certain contractors. All of its employment contracts technology, which cannot be patented. Because it is generally include confidentiality clauses. These confidentiality clauses impossible to establish an exclusive right-of-use over most do not provide sufficient protection and may be terminated. non-patented intellectual property, the Company may also In that event, the Company believes that there is no not be able to determine the correct value of these resources satisfactory remedy possible. Its product design and from its partners. With regard to technologies, know-how and manufacturing secrets could be revealed and used data that are not patentable or are only potentially independently by its competitors. patentable, and to processes, other than production processes, for which patents would be difficult to enforce,
Transgene's success will also depend upon its ability to financial costs and result in decisions unfavorable to prevent other parties from using its intellectual property and Transgene's interests. Competitors with greater resources its ability to defend itself against claims that Transgene could better withstand the costs of a complex proceeding. products infringe third party rights. Such disputes involve Any litigation of this type could seriously affect the complex legal and factual questions and are frequently Company's ability to continue its business. resolved in litigation, which could generate in substantial
2

| 3.2.1 | Governance principles adopted by the Company | 73 |
|---|---|---|
| 3.2.2 | Composition, conditions related to the preparation and organization of the tasks of the Board of Directors |
75 |
| 3.2.3 | Related-party agreements | 77 |
| 3.2.4 | Compensation | 78 |
| 3.2.5 | Additional information | 79 |
3.3.1 Compensation for 2022 – Compensation policy – Principles and criteria for determining the compensation of corporate officers 80 3.3.2 Compensation for 2021 – Corporate officers' compensation 86 3.3.3 Individual compensation for 2021 – Executive corporate officers' compensation 92
3.4.1 95 Stock options 3.4.2 96 Free share awards
3


CORPORATE GOVERNANCE Administrative and management bodies

Administrative and management bodies
The following table gives the names of those on the Transgene Executive Committee, their current positions in the Company and the date they assumed those duties.
| Name | Age Current position | Committee member since |
|---|---|---|
| Hedi Ben Brahim | 41 Chairman and Chief Executive Officer | 2021 |
| Christophe Ancel | 58 Director of Pharmaceutical Operations and Chief Pharmacist – Deputy CEO | 2014 |
| Steven Bloom | 61 Chief Business Officer (CBO) | 2022 |
| Maud Brandely | 68 Director of Medical Affairs (CMO) | 2016 |
| Jean-Philippe Del | 42 Chief Financial Officer (CFO) | 2014 |
| John Felitti | 52 Corporate Secretary – General Counsel | 2016 |
| Éric Quéméneur | 58 Executive Vice-President – Scientific Director (CSO) | 2014 |
| Gaëlle Stadtler | 39 Human Resources Director | 2021 |
Hedi Ben Brahim joined Transgene on January 1, 2021, as Chairman and Chief Executive Officer. He has also been Operational Director of the Immunotherapy division at Institut Mérieux since September 2018, a position he retains. He is also Chairman of the Board of Directors of ABL Inc., a contract research and development and bioproduction company (CRO/CMO). Before joining Institut Mérieux, Hedi Ben Brahim managed a subsidiary of Vallourec. He began his career in the French public sector at the Ministry of the Economy, Action and Public Accounts, then at the Ministry of Social Affairs and Health. He is a graduate of École Polytechnique and École Nationale Supérieure des Mines de Paris.
Christophe Ancel joined Transgene in 2008 as Head of Quality Assurance, and then as Director of Operational Quality. He is Responsible Pharmacist and in this respect, he is Deputy CEO since 2014. Previously he worked as a quality consultant to a variety of international pharmaceutical laboratories. From 2001 to 2005 he was Quality Manager, Deputy Pharmacist and acting Responsible Pharmacist at the French production plant of E. Lilly. In 2001 he was Quality Manager and acting Responsible Pharmacist at a Cardinal Health plant. From 1992 to 2000, he worked at Alcon Laboratories in the quality area and was Deputy Pharmacist at their production site. His various professional experiences have led him to work in an international setting of sterile product manufacturing and marketing. Christophe Ancel has a PhD in pharmacology.
Steven Bloom joined Transgene in February 2022 as Director of Business Development. Previously, he held senior management positions in large multinational and biotechnology companies, and during the course of his duties concluded major transactions in the field of oncology. Before joining Transgene, he also held the following positions: Senior Vice-President at Boston Pharmaceuticals; Sales Director at Vavotar Life Sciences (formerly known as NantiBodyFc), Verastem Oncology and Ziopharm Oncology. Earlier in his career, Steve spent 18 years at Eli Lilly, where he held key positions in sales, marketing and corporate affairs at several locations in the United States. Steve holds a Bachelor of Science degree in Pharmacy from Northeastern University in Boston.
Maud Brandely joined Transgene in 2016 as Director of Medical Affairs (CMO). She was the Director of the Clinical Oncology Development at Pierre Fabre until February 2016. She was responsible for all Phase I to Phase III clinical trials. She played a role in the registration of oral Navelbine products for the treatment of both breast and lung cancer and for vinflunine in bladder cancer. Prior to Pierre Fabre, she was Director of Taxotere Clinical Development at Rhône Poulenc (RPR, now Sanofi), where she was responsible for setting up clinical studies with the aim of registration in the United States and Europe. As such, she divided her time between Collegeville and Paris to oversee her US and European teams. Prior to RPR, she worked for Hoechst-Roussel-Uclaf (now Sanofi) and was involved in the development of cytokines (IL-2, IFN) and cytotoxins. She is an MD and has a PhD in immunology.
Jean-Philippe Del became Transgene's Chief Financial Officer and a member of the Executive Committee in 2014. Before that, he had been Director of Administration and Finance. He joined the Company in 2005 and oversaw the management control system, accounting and purchasing. Before joining Transgene, he was a financial auditor at Mazars and began his career in 2001 as a financial controller at Brasseries Kronenbourg. Jean-Philippe Del holds a DESCF degree and is a finance and accounting graduate of Université de Strasbourg.

CORPORATE GOVERNANCE Administrative and management bodies
John Felitti joined Transgene in 2016 as General Counsel and Corporate Secretary. Prior to his appointment, he was Associate Vice-President, Corporate law, Finance and Securities law at Sanofi and previously held other positions in the Sanofi and Aventis legal departments. From 1996 to 2003, he was an associate attorney at the Paris offices of the US law firm Shearman & Sterling. He is admitted to practice in New York and is a former member of the Paris Bar. After majoring in economics at Harvard University (AB 1991) and the College of Europe (MA 1993), John Felitti studied law at the University of Michigan (JD 1996) and the University of Paris II – Panthéon (LLM 1997). He also holds a business degree from INSEAD (GEMBA 2015).
Éric Quéméneur joined Transgene in 2014 as Executive Vice-President, in charge of Research and Development. Before joining Transgene, he served as Director of Programs and Reclamation in the Life Sciences Department of the CEA, after a 20 year career in that organization. His responsibilities included managing the Research and Development programs and transferring them into applications, leading multi-disciplinary teams and developing national and international alliances. He is a biochemical engineer, INSA Lyon (1986), with a PhD in science, a D.U. degree in Industrial Pharmaceuticals from Université Claude Bernard Lyon 1 and a Certificate in Research Management from Université Pierre et Marie Curie – Paris VI. He is the author of some 80 publications in international scientific journals.
Gaëlle Stadtler was appointed Head of Human Resources and made a member of the Executive Committee on January 4, 2021. She joined Transgene in 2018 as Human Resources and Internal Communication Manager. Between 2011 and 2017, she held the positions of Head of Human Resources at Sensient Flavors and Human Resources Generalist at L&L Products. Gaëlle Stadtler began her career within the Mars Inc. as a Talent and Training Coordinator. She holds a Master's degree in Management from Skema Business School Lille and a Master's degree in HR from EM Strasbourg.
Transgene is governed by a Board of Directors composed of ten members as of the date of this Registration Document, six of whom qualify as independent directors. The directors' term of office is three years.
Alain Mérieux, who was a Director of the Company until May 22, 2019, is now Honorary Chairman of the Board of Directors.
Chairman and Chief Executive Officer – Director Member of the Strategy Committee Age: 41 First appointment: 2019 Term expires: 2022
Number of Company shares held: 450 Number of Company stock options held: 0 The tables below summarize the mandates and roles of the members of the Board of Directors. The Board assessed the status of independent director in accordance with the criteria of the MiddleNext Corporate Governance Code. The directors' terms expire on the date of the Ordinary General Meeting held in the year indicated to approve the financial statements for the year ended on December 31 preceding the meeting.
Operational Director of the Immunotherapy Division at Institut Mérieux (1)
Graduate of Polytechnique
Graduate of the École Nationale Supérieure des Mines de Paris Vice-President of Commercial Operations then Chief Executive Officer of Vallourec Drilling Products – Europe Africa
General Manager Production – VAM U.S. – Vallourec Group
Vice President Corporate Planning – Vallourec Group
Head of the Health Products Office at the Social Security Directorate of the Ministry of Labor, Social Relations, the Family, Solidarity and the City
Other offices held:
Chairman of the Board of ABL Inc. (1)
Director: Geneuro (2)
Offices expired during the last five years:
Chairman of the Supervisory Board of Fab' Entech
(1) Institut Mérieux group company.
(2) Listed company.
Member of the Strategy Committee and Member of the Clinical Development Committee Age: 62
First appointment: 2004 Term expires: 2023 Number of Company shares held: 564,661 Number of Company options held: 0
Deputy CEO of Institut Mérieux – Technological Innovation and Scientific Partnerships (1)
Chairman of the Technological Research Institute BIOASTER (2)
Graduated from the Management Program at Harvard Business School
Chairman of bioMérieuxInc. (United States) (1)
Executive Vice-President of bioMérieux SA (1)(3)
Chief Executive Officer of Innogenetics BV
Chief Executive Officer: TSGH (1), Permanent representative of TSGH on the Board of ABL, Inc. (1)
Director: bioMérieux SA (1)(3); ERYtech Pharma (3); NH TherAguix Offices expired during the last five years:
Chairman and Chief Executive Officer of Transgene (end: 2020); Representative of the FPUL on the Board of Directors of CPE Lyon (end: 2020);
Chairman of the Lyonbiopôle competitiveness cluster (end: 2017); Representative of Lyonbiopôle on the Board of Directors of the Synergie Lyon Cancer Foundation (end: 2017)
Director Chairman of the Strategy Committee Age: 73 First appointment: 2013 Term expires: 2022 Number of Company shares held: 0 Number of Company options held: 0
Principal role outside of the Company:
Vice-President Institut Mérieux (1)
HEC Paris and MBA Cornell University (United States)
Chairman and Chief Executive Officer of IPSEN (2001-2010) Chairman and Chief Executive Officer of bioMérieux (2011-2017) Other offices held:
Director of bioMérieux SA (1)(3); LabCorp of America (U.S.) (3); Lupine (India) (3); PierreFabreSA
Offices expired during the last five years:
Chairman of the Supervisory Board: Biolog ID SAS (2021) Chairman of BioMérieux (end: 2017)
Independent director Member of the Audit and Compensation Committees and Member of the Clinical Development Committee Age: 77 First appointment: 2016
Term expires: 2022 Number of Company shares held: 1,000 Number of Company stock options held: 0
Co-founder of several biotechs (Trophos, Immunotech…)
Business Director at Crédit National, responsible for corporate finance of industrial sector companies
independent director
Chief Executive Officer of Genoscience Pharma SAS (end: 2020); Chairman of Axenis (end: 2020)
(2) Association, foundation or other.
(3) Listed company.

Principal role outside of the Company: independent director
Management experience and expertise:
Doctor of medicine
30 years clinical experience in oncology (held clinical development management positions)
Halozyme Therapeutics (1), Oxford BioTherapeutics (1), Nordic Nanovectors ASA (1),
IDDI – International Drug Development Institute (2)
Member of the international scientific committee of the National Cancer Institute (1) and of Netris Pharma
Chairman: Fondation Synergie Lyon Cancer (2)
Offices expired during the last five years:
Director: ONXEO (end: 2021); ITEOS Therapeutics (end: 2017)
Independent director Chairman of the Compensation Committee and Member of the Audit Committee Age: 57
First appointment: 2000 Term expires: 2023 Number of Company shares held: 74,403 Number of Company stock options held: 0
Chief Executive Officer: Habert Dassault Finance (SAS)*
Deputy CEO and permanent representative of Groupe Industriel Marcel Dassault (GIMD) (SAS)
Management experience and expertise:
Holds an MBA from INSEAD and a master's degree in business law from Panthéon-Assas Paris II University
Directorships within GIMD including the Figaro Group*, Dassault Médias*, and Figaro classifieds*; CCM Benchmark
Other directorships: Mérieux NutriSciences (2) (as permanent representative of GIMD); Colombus Family Holding; Dargaud (SA); Éditions Dupuis (Belgium); Éclosion (Switzerland); ITEN (SA); SITC (SAS) KTO TV (Association) and Fondation KTO
Member of the Governance Board of Odyssey intl (SAS) - HDF
Member of the Supervisory Board of the companies: Marco Vasco (SAS); Les Maisons du Voyage; Futurae (SAS) - HDF; Medoucine (SAS) HDF
As permanent representative of GIMD: bioMérieux SA; Silliker; Sport 24 (SA), Intigold
Chairman of Dassault Développement (SAS) (2020)
* Controlled by GIMD.
(1) Association, foundation or other.
(2) Institut Mérieux group company
Independent director Chairwoman of the Audit Committee Age: 69 First appointment: 2017 Term expires: 2023 Number of Company shares held: 0 Number of Company stock options held: 0
Chartered accountant; holds an MBA from the European Business School (Paris, Frankfurt and London)
Consultant supporting the installation of French and European biotechnology companies in the United States; Founder and Chief Executive Officer of Axelia Partners (formerly Marie Landel & Associates)
Director: Genethon
Director: Member of the of the consultative strategic committee of Coretec Industry Group (end: 2021); Safe Orthopedics (end: 2019); Cellnovo Group SA (end: 2019); TxCell (end: 2018)
Member of the Compensation Committee, Member of the Strategy Committee and Member of the Clinical Development Committee Age: 45 First appointment: 2017 Term expires: 2023 Number of Company shares held: 0 Number of Company stock options held: 0
Founder and Chief Executive Officer: Outcomes4me Inc. (U.S.)
Senior Vice-President Global Head of Oncology Policy and Market Access at Novartis, and
Vice-President, R&D Global, Strategy, External Scientific and Innovation Policy at Sanofi
Certificate in finance and health systems organization from Harvard Business School
Chief Executive Officer: Outcomes4me Inc. (U.S.)
Director: Pieris Pharmaceuticals (U.S.) (1)
Offices expired during the last five years: None
Member of the Audit Committee and Member of the Compensation Committee 17, rue Bourgelat 69002 Lyon
First appointment: 2002
Term expires: 2023
Number of Company shares held: 50,323,665 Number of Company stock options held: 0
Principal role outside of the Company: None

Number of Company stock options held: 0
Principal role outside of the Company:
Chief Financial Officer of Institut Mérieux (1) (since 2020) Management experience and expertise:
Chief Financial Officer EMEA of BioMérieux (2014-2020) preceded by several management control positions PWC 1993-2002 in financial audit
Certified Chartered Accountant in Accounting and Finance
Other offices held:
None Offices expired during the last five years:
None
Independent director Member of the Clinical Development Committee Age: 58 First appointment: 2013 Term expires: 2022 Number of Company shares held: 469 Number of Company stock options held: 0
Professor at the University of Paris Sud in Immunology and Biology and Oncologist-researcher-immunotherapist at the Institut Gustave Roussy
Director of Research at INSERM (U1015)
Co-director of IGR/Curie/INSERM Clinical Investigations Center
Doctor of medicine
Director of Research and INSERM Unit (jointly approved by the Ligue contre le cancer) and Co-director of the IGR/Curie/INSERM Biotherapy Clinical Investigations Center
Member of the Scientific Advisory Board of Lytix Biopharma, Epivax and NeoVax Cofounder of EverImmune
Based on current legislation, there are no directors elected by the employees within the Board of Directors. Moreover, as the capital share held by the employees is less than 3%, there are no directors representing employee shareholders within the Board of Directors.
However, two employees represent the Social and Economic Committee and participate in the meetings of the Board of Directors, without voting rights.
(1) Institut Mérieux group company.
The Board of Directors meets at least four times per year. At least one executive session (a meeting without the attendance of the Chairman and Chief Executive Officer or another member of the Executive Committee) per year is proposed to directors. The Board's functioning is governed by internal rules that are regularly updated and published on the Company's website. The Board's work is prepared by four special committees responsible for assisting the Board in its discussions and decisions (see paragraph 3.1.3, next section).
There are no service contracts linking any member of the Board of Directors to the Company or to any of its subsidiaries and providing benefits. One corporate officer, the Deputy CEO, Christophe Ancel, has both an employment contract and a corporate mandate.
To the best of the Company's knowledge, there is no arrangement or agreement entered into with the major shareholders or with customers, suppliers or others, such as a shareholder agreement or engagement letter, under which any member of the Board of Directors or the Chairman and Chief Executive Officer or the Deputy CEO has been selected.
As of the date of this Registration Document, and to the Company's best knowledge, there is no current or potential conflict between the private interests of the members of the Board of Directors or of the Company's management and the interests of the Company. The agreements involving certain directors are subject to the related-party agreement procedure and are presented in paragraph 3.2.3.
The main point of vigilance regarding potential conflicts of interest within the Board results from certain directors' connections with the Company's main shareholders. Institut Mérieux holds 99.5% of the capital and voting rights of TSGH SAS, which itself owns, as of the date of this Registration Document, 61.9% of the capital and 71.7% of the voting rights of the Company. Mr. Hedi Ben Brahim, the Chairman and Chief Executive Officer holds other offices within the Insititut Mérieux. Philippe Archinard and Mr. Jean-Luc Bellingard, directors of the Company, are also directors of bioMérieux SA. Mr. Philippe Archinard is the permanent representative of TSGH on the Board of ABL, Inc. and Mr. Hedi Ben Brahim is Chairman of the Board of the same company.
In order to protect against conflicts of interest or the appearance of a conflict of interest, the Company has set up a Board comprising a majority of independent directors and has set up diligent monitoring of related-party agreements in order to ensure that decision-making is separate from all private interests. The Company also proposes a separation of duties in order to entrust the Chairmanship of the Board to an independent director following the General Meeting of 2022.
During the capital increase in 2021, the Company managed the potential conflict of interest related to the subscription of a significant share of the transaction by TSGH by organizing a meeting of independent directors that did not take part in the transaction, to validate the principle of the transaction and examine its terms and conditions, in particular its price, which was set with a discount comparable to the average of recent transactions.
To the Company's knowledge as of the date of this Registration Document, there is no family connection between the members of the Board of Directors and the Company's senior management.
3
Moreover, to the Company's knowledge as of the date of this Registration Document, no member of the Board of Directors has been:
Finally, to the Company's knowledge as of the date of this Registration Document, no members of the Board of Directors have been disqualified by a court from acting as a member of an administrative, management or Supervisory Board of an issuer or from acting in the management or conduct of the affairs of any issuer within at least the past five years.

The Audit Committee, composed of Ms. Landel (Chairman of the Committee), Mr. Habert and Mr. Béret, independent directors, and TSGH (represented by Ms. Sandrine Flory), and whose working methods are described in Section 3.2.2, examined the following points during the fiscal year 2021:
The Compensation Committee, consisting of Mr. Béret, Mr. Habert (Chairman of the committee) and Ms. Saïd, all independent directors, as well as TSGH, and whose working methods are described in Section 3.2.2, examined, in 2021, among other subjects, the compensation of the Board of Directors, executive management and the Executive Committee during 2021 and 2020; reviewed the Company's overall compensation policy, including annual bonuses, advised on the collective objectives and their weighting as well as the design and implementation of an annual and exceptional employee share grant program. The Compensation Committee also reviewed the equity and gender equality indices for FY 2016-2020, the parts of the Corporate Governance report and the 2020 Universal Registration Document containing the compensation developments and the draft resolutions to be presented to shareholders in relation to compensation at the AGM of May 26, 2021. The Compensation Committee discussed a succession plan for Company managers in the event of unplanned or early departure and approved the addition of provisions into the Board's internal rules to ensure continuity of the Company's operations in the event of an unplanned or precipitated departure.
The Strategy Committee, comprising Mr. Archinard, Mr. Bélingard (Chairman of the committee), Mr. Ben Brahim and Ms. Saïd, independent director, was consulted from time to time in 2021. The Committee's work notably concerned external growth opportunities, partnership opportunities and strategic reviews.
The Clinical Development Committee, composed of the independent directors Mr. Béret and Mr. Bizzari, Ms. Saïd and Ms. Zitvogel and Mr. Archinard met four times throughout the year to prepare the main regular meetings of the Board of Directors to support the decision making on research and development investments, in line with the strategy defined by the Board. In 2021, this Committee formulated opinions for the Board on the review of the protocol for part 2 of Phase II of study TG4001.12 (TG4001 + avelumab) and advised the Board on studies under preparation.
The Corporate Social Responsibility (CSR) Committee was established by the Board of Directors at its meeting of December 15, 2021. The CSR Committee is responsible for advising the Board on issues relating to the Company's social and environmental responsibility and for making recommendations to the Board of Directors in this area. Since March 16, 2022, the CSR Committee has had a charter approved by the Board of Directors and published on the Company's website. The composition of the committee will be determined by the Board of Directors following the 2022 Combined General Meeting. Due to the date of its establishment, this committee did not meet in 2021.
This paragraph restates in its entirety the report required by Article L. 225-37 of the French Commercial Code, relating to the manner in which the Company's Board of Directors prepares and organizes its work in accordance with Articles L. 225-37-4 and L. 22-10-10 of the French Commercial Code.
This report was adopted by the Board of Directors at its meeting of March 16, 2022. In accordance with Article L. 225-235 of the French Commercial Code, the Board of Directors' report on Corporate Governance was submitted in full to the Statutory Auditors.
The Company refers to the Corporate Governance recommendations contained in the MiddleNext Code of Corporate Governance for mid- and small-cap companies of September 2021 ("MiddleNext Code"). The MiddleNext Code can be consulted on the MiddleNext website or on that of the Company. The Board regularly reviews the points of vigilance in the MiddleNext Code, including as part of its self-assessment of Board functioning, and prepares an annual report on its compliance with the 22 recommendations of the MiddleNext Code.
| MiddleNext Code recommendations | Adoption |
|---|---|
| "Supervisory" power | |
| R1: Board members' ethics | Yes |
| R2: Conflicts of interest | Yes |
| R3: Composition of the Board of Directors – Presence of independent members | Yes |
| R4: Information for Board members | Yes |
| R5: Training for Board members | Yes; see comment |
| R6: Organization of Board and Committee meetings | Yes |
| R7: Implementation of committees | Yes |
| R8: Establishment of a specialist committee on Corporate Social/Societal and Environmental Responsibility (CSR) |
Yes; see comment |
| R9: Implementation of internal Board rules | Yes |
| R10: Choice of each "Board member" | Yes |
| R11: Duration of terms for Board members | Yes |
| R12: Compensation of a "member of the Board" in respect of his or her office | Yes |
| R13: Implementation of an assessment of the Board's work | Yes |
| R14: "Shareholder" relations | Yes |
| Executive power | |
| R15: Diversity and equity policy within the company | Yes |
| R16: Definition and transparency of compensation for executive corporate officers | Yes |
| R17: Preparation of Management succession | Yes |
| R18: Concurrent holding of an employment contract and corporate office | Yes; see comment |
| R19: Departure benefits | Yes; see comment |
| R20: Additional pension plan | Yes |
| R21: Stock options and free share grants | Yes, partially |
| R22: Review of points of vigilance | Yes |

CORPORATE GOVERNANCE Report on Corporate Governance – Governance
Based on the report, the Board considers that Transgene's Corporate Governance complies with the 22 recommendations of the MiddleNext Code, with the exception of the partial discrepancy for one item in recommendation R21.
With regard to recommendations R5 and R8, at the meeting of December 15, 2021, the Board updated its Internal regulations to implement a policy for training directors and to establish a CSR Committee in accordance with the new provisions of the MiddleNext Code published in September 2021. The concrete implementation of these new recommendations begins in 2022.
With regard to the recommendation R21 of the MiddleNext Code (stock options and free share grants), the Company regularly grants free shares to all of its employees, without excessively focusing on executive managers. In accordance with recommendation R21 to make all or part of the grants for the benefit of executive managers subject to conditions, half of each grant to executive managers is subject to performance conditions reflecting the medium to long term interest of the Company. However, for certain grants, the assessment period is one year, which leads the Board to consider that the "significant time period" recommended by recommendation R21 is only partially applied. In the context of Transgene, the Board considers that this one-year assessment period is appropriate for the conditions concerned, which are aimed at the actions required to be carried out in the coming year to achieve the Company's long-term objectives. The Company has not granted stock options since 2012.
The Board considers that the concurrent holding of the position of Deputy CEO and an employment contract is consistent with the letter and spirit of the MiddleNext Code's recommendations. For transparency with the Company's shareholders, this analysis is presented in more detail below for the two recommendations covering the implementation of this concurrent holding of offices.
With regard to recommendation R18 of the MiddleNext Code (concurrent holding of an employment contract and corporate office), an employment contract remains in force for the Deputy CEO. Before his appointment as Deputy CEO, Christophe Ancel was an employee of Transgene. His employment contract has remained in force since his appointment due to the continuation of his previous salaried activity. The Board is of the opinion that maintaining this employment contract is justified in this case given that the Responsible Pharmacist's corporate office is a regulatory requirement. It should be noted that recommendation R18 does not specifically target the corporate office of a Deputy CEO, and even for corporate offices targeted by this recommendation, concurrent holding is managed but not prohibited. There is no employment contract between Transgene and its Chairman and Chief Executive Officer or between Transgene and the other corporate officers targeted by the recommendation.
With regard to recommendation R19 of the MiddleNext Code (departure benefits), the Deputy CEO does not receive any departure benefits other than those provided by the collective bargaining agreement that governs his employment contract. These benefits are granted only in the event of the termination of the employment contract under the conditions provided by the collective bargaining agreement and are not paid for the expiry of the corporate office. The amount and conditions of these benefits are in accordance with recommendation R19 (See paragraph 3.3.1). The Company has not granted departure benefits in the event of the termination of his functions to the Chairman and Chief Executive Officer.
Report on Corporate Governance – Governance
The Company is governed by a Board of Directors currently consisting of ten members, of whom nine are individuals and the tenth is the majority shareholder, TSGH. Four women sit on the Board: Ms. Sandrine Flory, as permanent representative of TSGH and Ms. Marie-Yvonne Landel, Ms. Maya Saïd and Ms. Laurence Zitvogel, independent directors.
The term of the directors' mandates is three years. The table below indicates the number of shares or options providing future rights to shares (stock options) held by each individual director:
| Director | Number of shares held | Number of options |
|---|---|---|
| Philippe Archinard | 564,661* | None |
| Jean-Luc Bélingard | - | None |
| Hedi Ben Brahim | 450 | None |
| Antoine Béret (I) | 1,000 | None |
| Jean-Pierre Bizzari (I) | 5,000 | None |
| Benoit Habert (I) | 74,403 | None |
| Marie-Yvonne Landel (I) | - | None |
| Maya Saïd (I) | - | None |
| Sandrine Flory (TSGH representative) | - | None |
| Laurence Zitvogel (I) | 469 | None |
* Excluding the shares held by TSGH. TSGH is a 99.5%-owned subsidiary of Institut Mérieux, which is itself 99.8%-owned by Compagnie Mérieux Alliance, controlled by the family of Mr. Alain Mérieux. Mr. Philippe Archinard holds 0.5% of the share capital of TSGH.
(I) Independent director.
In its current composition, the Board of Directors has six independent directors as defined by recommendation R3 of the MiddleNext Corporate Governance Code. According to the MiddleNext Code, five criteria are used to determine the independence of Board members, characterized by the absence of any significant financial, contractual or family relationship likely to affect their independence of judgment:
It should be noted that neither the MiddleNext Code nor the Board's rules of procedure include seniority as a director as a criterion for independence or lack of independence. Moreover, MiddleNext Code does not define the percentage that would constitute a "significant percentage of voting rights" for the independence analysis, and the Board's rules of procedure set this percentage at 10% in line with the AFEP-MEDEF Code and stock market practices. By applying this threshold to the Company's current shareholder structure, the directors related to the Institut Mérieux group cannot be considered to be independent whilst this criterion is not a determining factor for directors such as Mr. Habert who are related to other shareholders.
The full list of directors, the dates of their first appointment and the expiry of their terms of office, is provided in Section 3.1.1.2 of the Company's registration document.
No member of the Board of Directors was elected by the employees. Two employees, one of whom represents managers, represent the Works Council and participate in the Board of Directors' meetings. Representatives of the Social and Economic Committee participate in the deliberations of the Board in an advisory capacity.
In addition to the Statutory Auditors, who participate in most Board meetings, the representatives of the Works Council are also in attendance at the meetings, as is the Chief Financial Officer, the Executive Vice-President and the Corporate Secretary, who acts as secretary to the Board. The Directors of the Board with scientific and medical backgrounds will from time to time hold ad hoc scientific or medical meetings with the Company's scientists and its medical, clinical and regulatory staff to discuss issues related to the products under development.

CORPORATE GOVERNANCE Report on Corporate Governance – Governance
The Board of Directors met five times in 2021, with an average attendance rate by the directors of 100% (1). At each of these meetings, the Board was informed in detail of the Company's situation in terms of the development of its business, the progress of its research projects, clinical programs and its financial position. In addition to performing its legal duties to approve the annual and interim financial statements and to arrange and convene General Shareholders' Meetings, the Board discussed the Company's strategic issues. The Board regularly speaks with the special committees and deliberates on recommendations they make.
The duties of the Chairmanship of the Board and the senior management of the Company are performed by the same individual. The Company proposes a separation of duties in order to entrust the Chairmanship of the Board to an independent director following the Combined General Meeting of 2022. Mr. Hedi Ben Brahim would remain Chief Executive Officer and director. The separation of duties would strengthen the control of independent directors and mobilize complementary skills at the top of the Company.
In accordance with recommendation R9 of the MiddleNext Code, the Board of Directors has adopted internal rules (available on the Company's website: www.transgene.fr).
The Company also complies with recommendation R13 of the MiddleNext Code dealing with the yearly assessment by Board members of the Board's operations and preparation of its work. In accordance with recommendation R22 of the MiddleNext Code, the Board of Directors reviewed the points of vigilance according to the MiddleNext Code.
The Board of Directors is assisted by four committees:
● the Audit Committee, consisting of four directors, three of whom are independent. It is chaired by an independent director and the Chairman and Chief Executive Officer is not a member. The Chief Financial Officer is invited to each meeting to present the Company's financial data and answer questions from the committee. The Statutory Auditors attend all committee meetings. The committee is responsible for preparing the work of the Board of Directors on financial and accounting issues and advising it, in particular, regarding financial statements, their audit and internal control and their compliance with accounting standards. It monitors the independence of the Statutory Auditors and, more generally, ensures that the choices, renewal methods and fees for the Statutory Auditors are monitored, along with the completion of their mission. It approves the internal audit and monitors its progress. Furthermore, the Audit Committee monitors the cash investment policy and the terms and conditions for certain investments. As a result of the reinforcement of its risk monitoring tasks, at least once a year, it carries out a review of all of the main risks to which Transgene may be exposed. The four committee members have financial accounting expertise by training or experience. In addition, Benoît Habert, Marie-Yvonne Landel and Sandrine Flory are deemed to be financial experts within the meaning of Article L. 823-19 of the French Commercial Code. The Audit Committee members acquired relevant expertise during their academic training and professional experience, as can be seen in their biographies.
Transgene does not entrust any assignments other than statutory audits to its Statutory Auditors with the exception of a few consultations previously approved by the Audit Committee (see Note 29 to the corporate financial statements); the Audit Committee has received the assurance from the Finance Department that the latter has submitted all requests for services other than the certification of financial statements to it.
The Audit Committee met four times in fiscal year 2021. The work of the Audit Committee is governed by a charter that is reviewed and adapted as necessary to changes in Corporate Governance best practices. In 2021, the committee regularly reported on its work and recommendations to the Board of Directors after each of its meetings.
(1) This calculation takes into account the decision of Ms. Flory and Mr. Habert to recuse themselves at the meeting of June 14, 2021 concerning the refinancing of the Company with the participation of TSGH and Sitam Belgium.
Report on Corporate Governance – Governance
● the Corporate Social Responsibility Committee (CSR), responsibility, and for making recommendations to the established, by a decision of December 15, 2021, in Board of Directors in this area. The composition of the CSR accordance with recommendation R8 of the MiddleNext Committee will be determined by the Board following the Code, is responsible for advising the Board on issues Combined General Meeting of 2022. relating to the Company's social and environmental
| Director | Audit Committee | Compensation Committee |
Clinical Development Committee* |
Strategic Committee |
CSR Committee |
|---|---|---|---|---|---|
| Hedi Ben Brahim | -- | -- | -- | Member | -- |
| Philippe Archinard | -- | -- | Member | Member | -- |
| Jean-Luc Bélingard | -- | -- | -- | Chairman | -- |
| Antoine Béret | |||||
| (independent) | Member | Member | -- | -- | -- |
| Jean-Pierre Bizzari | |||||
| (independent) | -- | -- | Member | -- | -- |
| Benoît Habert | |||||
| (independent) | Member | Chairman | -- | -- | -- |
| Marie Landel | |||||
| (independent) | Chairwoman | -- | -- | -- | -- |
| Maya Saïd | |||||
| (independent) | -- | Member | Member | Member | -- |
| TSGH | Member | Member | -- | -- | -- |
| Laurence Zitvogel | |||||
| (independent) | -- | -- | Member | -- | -- |
* The Chair of the Development Committee rotates among the members.
French Commercial Code, on September 18, 2019, the Board and indirectly, to the related-party agreements submitted for of Directors approved an internal Charter, amended on prior approval take part in the Board's discussions and vote. December 15, 2021, on the identification procedure for The Board also entrusts the Audit Committee with reviewing regulated and current agreements (the "Charter"). It is the agreements qualified as current and signed under normal stipulated that this Charter formalizes the identification conditions and the criteria used for their qualification at least procedure for related-party agreements that applies prior to once a year. The Charter on related party agreements and the signature of an agreement that may be qualified as a commitments can be found on the Company's website. related-party agreement, and also to any amendments, renewals or cancellations of agreements, including for agreements considered to be "free" (or "current and signed under normal conditions") at the time of their signature. Pursuant to the Charter, in addition to the declaration by the direct and/or indirect parties provided by the law, the Board entrusts the Company's legal department with ensuring that agreement projects that may be qualified as related-party agreements or free agreements are identified. The Board
entrusts disinterested members of the Audit Committee with analyzing the related-party agreement projects submitted to the Board for prior approval and to formulate In accordance with Articles L. 225-37-4 and L. 22-10-12 of the recommendations. Only disinterested members, both directly
In 2021, the Company neither authorized nor entered into any new related-party agreements.

CORPORATE GOVERNANCE Report on Corporate Governance – Governance
The following agreements and commitments previously approved by the General Shareholders' Meeting pursuant to Article L. 225-38 of the French Commercial Code continued during 2021:
The position of the executive corporate officers is subject to specific regulations which are presented below in Sections 3.3.1 (compensation policy applicable in 2022) and 3.3.2 and 3.3.3 (compensation for 2021). The Chairman and Chief Executive Officer does not have an employment contract with the Company. He is compensated by the Company for his position as a corporate officer. The Chairman and Chief Executive Officer receives compensation from Institut Mérieux for his duties within this company.
The Responsible Pharmacist, appointed Deputy CEO in application of the provisions of the Public Health Code holds an employment contract as Director of Quality Assurance. The Board is of the opinion that maintaining this employment contract is justified in this case given that the Responsible Pharmacist's corporate office is a regulatory requirement. The Responsible Pharmacist receives a salary under his employment contract. Any changes are based entirely on the achievement of individual and collective objectives.
The salary and bonuses paid to the members of the Executive Committee, including those of the Deputy CEO, are determined based on a proposal from the Chairman and Chief Executive Officer and submitted for review to the Compensation Committee which also approves proposals for deferred remuneration in the form of share or subscription option allocations. The Company has not granted departure benefits in the event of the termination of his functions to the Chairman and Chief Executive Officer. The Deputy CEO does not receive benefits in the event of the termination of his agreement enabled Transgene to sell part of its business under attractive conditions;
Further details on the related-party agreements can be found in the Statutory Auditors' special report in Chapter 6 under the heading 6.7.
corporate office. However, under his employment contract, the national pharmaceutical industry collective bargaining agreement provides for an indemnity calculated based on seniority and without performance conditions in certain cases.
Only independent directors receive compensation. These consist of a yearly fixed fee of €4,000 to which is added an amount related to the director's actual attendance at Board meetings of €3,000 per meeting, in accordance with recommendation R12 of the MiddleNext Code. Additional compensation of independent members of the special committees is €2,000 per committee meeting. These variable amounts are doubled for the physical participation of independent directors residing outside Europe. No other form of compensation, including deferred compensation, such as warrants or stock options, was paid by the Company to non-executive corporate officers. The maximum amount that may be allocated to all directors (excluding the Chairman or Chief Executive Officer) in a calendar year is capped at €250,000 following a decision by the General Shareholders' Meeting in 2017. A draft resolution submitted to the General Meeting in May 2022 will increase this amount to €300,000 euros per year if it is adopted.
The gross amount of directors' fees paid over the last two years to directors in office as of December 31, 2021, is shown in Section 3.3.2 of the Company's Registration Document. As the scale has not changed since March 2017, the differences are attributable to the number of meetings of the Board and its committees as well as each director's attendance.
Report on Corporate Governance – Governance
No special limits have been set on the powers of the Chief Executive Officer, with the exception of the following points that require the CEO to refer the following matters to the Board:
The Company has not established any special rules as to shareholder participation in General Meetings; its articles of association in this regard refer to the provisions of law in the French Commercial Code. In 2021, due to the health crisis, the Annual General Meeting was held behind closed doors as permitted by the regulations in force. In accordance with the recommendations of the French Financial Markets Authority (Autorité des Marchés Financiers), the meeting was teletransmitted.
This information is presented and discussed in the Board's management report and in Chapter 6 of the Company's Universal Registration Document.
The Company has not identified any material financial risks related to climate change. The Company's main industrial activities were outsourced in February 2016. The low-carbon strategy for the remaining aspects of its business is focused on reducing energy consumption at its Illkirch and Lyon sites.

CORPORATE GOVERNANCE Report on Corporate Governance – Say on Pay
Pursuant to Ruling no. 2019-1234 of November 27, 2019, on the compensation of corporate officers of listed companies and decree no. 2019-1235 of November 27, 2019, transposing Directive (EU) 2017/828 of May 17, 2017, amending Directive 2007/36/EC for the purpose of promoting the long-term commitment of shareholders, this Section 3.3.1 constitutes a report to shareholders, presenting the policy on the principles and criteria for setting, distributing and allocating the fixed, variable and exceptional items that comprise the total compensation and benefits of any kind of Transgene's corporate officers. It was prepared by the Board of Directors of March 16, 2022, upon proposal by the Compensation Committee. This policy will be submitted to the General Meeting of May 25, 2022, for all corporate officers.
This report contains the information specified in Article L. 22-10-8 of the French Commercial Code as well as the additional information that the Board of Directors considers useful for an overview of the compensation of corporate officers, and is attached to the report mentioned in Articles L. 225-100 and L. 225-102 that presents the income statement and business of Transgene.
This report concerns the corporate officers of the Company, i.e. (i) the Chairman and Chief Executive Officer, (ii) the Deputy CEO and (iii) the directors.
The current term of office of the Chairman and Chief Executive Officer is a renewable 3-year period, corresponding to his term as director. The terms of the current directors' mandates are also all three years. The Company's articles of association provide that the term of a director's mandate, and by extension, the Chairman and Chief Executive Officer's mandate, may be set at between one and four years at the time of appointment, with three years being the default term. As Mr. Hedi Ben Brahim was appointed Chairman and Chief Executive Officer during an existing term of office, his first term of office as Chairman and Chief Executive Officer is shorter than three years and ends in 2022 at the end of his term as director. A proposal is submitted to the General Meeting of May 25, 2022 to renew his term of office as director for a period of three years. In addition, the Company proposes a separation of duties in order to entrust the Chairmanship of the Board to an independent director following the Combined General Meeting of 2022. Mr. Hedi Ben Brahim would resign as Chief Executive Officer and Director. The Deputy CEO's corporate office and his employment contract are for an indefinite period. All corporate mandates can be terminated ad nutum by the Company's shareholders, and by the Board of Directors in the case of the Deputy CEO. Christophe Ancel's employment contract may be terminated by the Chairman and Chief Executive Officer under the conditions of the pharmaceutical industry collective bargaining agreement, which provides for three months' notice.
This report contains the specific information required by Article L. 22-10-8 of the French Commercial Code as well as the additional information that the Board of Directors considers useful for an overview of corporate officers' compensation.
The implementation of the compensation policy for corporate officers (Chairman and Chief Executive Officer, Deputy CEO and Directors) for 2022 described below is subject to the adoption of a resolution concerning the overall compensation policy at the General Meeting.
To establish the compensation policy for corporate officers, the Compensation Committee analyzes the compensation in its totality taking all of the components into account. On the recommendation of this committee, based on the general principles described below, the Board of Directors approved the compensation policy for its executive corporate officers, while ensuring for the Chairman and Chief Executive Officer and the Deputy CEO that the rules to determine this compensation are coherent with the annual assessment of the individual performance which it compares to Transgene's performance.
Periodic reviews are made on the same basis, depending on feedback and the observation of practices in other comparable companies. These reviews also take into account the change in compensation conditions for Transgene's employees, and notably, although not a determining factor, the increases granted as part of the mandatory annual negotiations. The Compensation Committee consults the Strategic Review Committee on the Company's annual and medium-long-term objectives, before recommending performance conditions for the variable compensation and for the allocation of free shares to executive corporate officers to the Board of Directors. These performance conditions are based partly on collective targets and partly on individual targets. Once approved by the Board and by the General Shareholders' Meeting, the implementation of the policy is monitored by the Compensation Committee, which reports at least annually to the Board and formulates recommendations on the decisions that the Board makes.
After the assessment period applicable to a performance condition, the Compensation Committee assesses the level of achievement and formulates a recommendation to the Board. The Compensation Committee or the Board may consult the Chairman and Chief Executive Officer during the formulation and the periodic review of the compensation policy, but, to avoid conflicts of interest, the latter does not take part in decisions concerning him. The Deputy CEO does not take part in the sessions of the Compensation Committee or the Board of Directors. To assess Transgene's policy compared to practices in other companies, the committee may use market studies or external experts. The Compensation Committee also plays a central role in the compensation allocated to directors, by recommending allocation rules to the Board, monitoring their implementation and by recommending, if required, that the Board propose a revised budget to the General Shareholders' Meeting.
The Chairman and Chief Executive Officer does not hold an employment contract. Hedi Ben Brahim has never been an employee of Transgene or its subsidiaries. The Chairman and Chief Executive Officer receives compensation from Institut Mérieux for his duties at Institut Mérieux, it being specified that this compensation does not fall within the scope of Transgene's compensation policy and is not subject to Transgene shareholders.
Before his appointment as Deputy CEO, Christophe Ancel was an employee of Transgene. His employment contract has remained in force since his appointment. The Board considers that the maintaining of this employment contract is justified in this particular case, given that the Responsible Pharmacist's corporate office is a regulatory obligation in France for a pharmaceutical establishment.
For the Chairman and Chief Executive Officer, the Board of Directors approved the following general principles that form the basis for determining his compensation and benefits:
For the Deputy CEO, an executive corporate officer due to his regulatory status as Responsible Pharmacist of Transgene, the Board of Directors decided to follow the same compensation and benefits structure as that applied to Transgene's Executive Committee. The result is:

The Board is of the opinion that the procedures for setting the compensation of these two corporate officers comply with the principles defined in recommendations R16 and R21 of the MiddleNext Corporate Governance Code. The proportion of free shares awarded to the two corporate officers in 2021 compared to the full award is 32.9%, a level that the Board does not consider to be an excessive concentration. The Board decided to subject a portion only of the free shares granted to the corporate officers to performance conditions.
An analysis by the Compensation Committee, followed by the Board, concluded that application of the rules to all of the free Company shares granted was not appropriate given that their evolution, in the absence of recurring revenue generated by business activity remains subject to a high technological risk whose hazards are already taken into account in the vesting period and the holding period of the shares, the volatility of their value, and in the presence condition. The multi-year vesting and lock-up periods after the award is a medium-term horizon and, in itself, sufficient to provide an incentive for long-term collective performance, and is reinforced for the Chairman and Chief Executive Officer, who has an obligation to retain 10% of the grant until the end of his duties. The performance assessment period varies according to the award from one to three years.
For the directors, the Board of Directors approved the following general principles on which directors' compensation is based:
The Board of Directors considers that the general principles enable the alignment of the compensation policy with the Company's fundamental interests.
| Fundamental interest | Chairman and Chief Executive Officer |
Deputy CEO | Directors |
|---|---|---|---|
| Respect for corporate interests | Sufficient to attract/retain a qualified candidate |
Sufficient to attract/retain a qualified candidate |
Sufficient to attract/retain a qualified candidate Not excessive; no |
| Not excessive; performance conditions |
Not excessive; performance conditions |
compensation required for non-independents |
|
| Contribution to Transgene's strategy |
Variable compensation conditional on achievement of results and free share grants partly subject to achievement of results and for which the value, in any case, depends on Transgene's performance |
Variable compensation conditional on achievement of results and free share grants partly subject to achievement of results and for which the value, in any case, depends on Transgene's performance |
Helps attract relevant skills and coordinate specialist committees |
| Contribution to Transgene's long-term success |
Sufficient to attract/retain a qualified candidate |
Sufficient to attract/retain a qualified candidate |
Sufficient to attract/retain a qualified candidate |
Since the last ex-ante compensation policy submitted to shareholders during the General Meeting of May 26, 2021, the substantial amendments are:
The Board listens to the opinions expressed by shareholders on the issue of compensation. During the 2020 and 2021 General Meetings, no questions concerning compensation were submitted before or during the discussions. The resolutions concerning compensation were all adopted by a large majority of shareholders, including shareholders not related to the reference shareholder.
Once approved by the shareholders, the policy is expected to be applied to the Company's current corporate officers, including in the event that the term of office of these individuals is renewed during the fiscal year. In the event of a change in individuals or the addition of new mandates during the year, the following rules shall be applied:
The Board of Directors reserves the right to temporarily derogate from this policy in exceptional circumstances, but only after a majority of directors, in which takes part a majority of independent directors, determines that this exemption from the compensation policy is necessary to serve the interests and long-term success of the whole Company or to guarantee its viability. The Board of Directors' exemptions and grounds shall be published on the Company's website without waiting for the publication of the following year's Corporate Governance report. The exceptional conditions justifying a temporary exemption may include, for example, the impossibility of recruiting a new qualified corporate officer with the resources provided by the current policy, or the need to retain key individuals in the event of a possible takeover or restructuring.
Fixed compensation, paid in 12 monthly installments, reviewed and adjusted annually by the Board of Directors on the recommendation of the Compensation Committee taking into account in particular the best practices in the Company's industry. It is proposed to set this fixed compensation at a gross amount of €240,000 for the fiscal year 2022.
3
A maximum of 40% of fixed compensation. The variable compensation is determined according to the level of achievement of the collective objectives (weight: 80%) and individual criteria (weight: 20%), as noted by the Board of Directors on the advice of the Compensation Committee. These targets are both quantitative and qualitative, based on the achievement of the Company's strategic objectives.
The Company's collective objectives for 2022: The Board of Directors has set the performance criteria applicable to all employees:

Individual targets for 2022: The Board of Directors set the following individual performance criteria for the Chairman and Chief Executive Officer:
At the Board's discretion, an outperformance of one criterion could compensate for a partial achievement of another criterion, without the overall assessment exceeding 100%.
It is noted that these objectives are partly financial in nature and partly non-financial in nature, but always aligned with the corporate interest. They are expected to change from year to year according to the Board of Directors' assessment of the priority actions to achieve the Company's medium and long-term objectives. The Board's practice is to set the same collective targets for all employees in order to align the Company on a shared course.
In the event of exceptional circumstances, the Board of Directors, on the advice of the Compensation Committee, could propose an exceptional bonus. This is paid during the fiscal year after the one in which the performance was noted.
Pursuant to Article L. 22-10-8 of the French Commercial Code, the payment of the annual or exceptional variable compensation is subject to approval by an Ordinary General Meeting of the items of compensation of the Chairman and Chief Executive Officer under the conditions stipulated in Article L. 22-10-34 of the French Commercial Code. Once paid, the compensation is not subject to a restitution obligation.
The resulting cash compensation (excluding any exceptional bonus) may reach a total of €336,000 in respect of the 2022 fiscal year, of which 71.4% fixed and 28.6% variable.
The Board of Directors allocates free shares subject to a presence condition within the limits of the envelope authorized by the General Shareholders' Meeting. Half of the shares are subject to performance conditions based on the Company performance criteria used for setting annual variable compensation. The minimum vesting and lock-up periods are those provided for by law, and at least 10% of the shares definitively vested must be retained until the end of a corporate mandate at Transgene. Share-based compensation aims to increase the portion of "risky" compensation due to performance conditions and the connection to the share price. No more than a quarter of the share allocations could be allocated to the Chairman and Chief Executive Officer.
Fixed compensation, paid in 12 monthly installments, reviewed and adjusted annually by the Board of Directors on the recommendation of the Compensation Committee and the Chairman and Chief Executive Officer, taking into account in particular the best practices in the Company's industry. The gross fixed compensation proposed for the 2022 fiscal year is €143,028, an increase of 2.8% compared to 2021. In addition, as Responsible Pharmacist, Christophe Ancel receives a fixed annual service bonus of €1,800 per year.
A target variable portion of 30% of fixed compensation rising to a maximum of 40% in the event of exceptional outperformance. The variable compensation is determined according to the level of achievement of the collective (weight: 40%) and individual (weight: 60%) objectives, as noted by the Board of Directors on the advice of the Compensation Committee. These targets are both quantitative and qualitative, based on the achievement of the Company's strategic objectives.
Under his employment contract, Christophe Ancel may benefit from incentive or profit-sharing plans as well as contributions and other benefits set up by the Company for all French employees.
Ensure the production of batches for clinical trials and the supply of new products (weighting: 1/3);
Contribute to the improvement of production and continuous control while preparing for the future (weighting: 1/3);
Ensure the implementation and improvement of the quality policy (weighting: 1/6); and
ESG: energy cost reduction plan (weighting: 1/6).
It is noted that these objectives are partly financial in nature and partly non-financial in nature, but always aligned with the corporate interest. They are expected to change from year to year according to the Board of Directors' assessment of the priority actions to achieve the Company's medium and long-term objectives. The Board's practice is to set the same collective targets for all employees in order to align the Company on a shared course. In the event of extraordinary circumstances, the Board of Directors, on the proposal of the Chairman and Chief Executive Officer and on the advice of the Compensation Committee, could propose an extraordinary bonus.
Christophe Ancel's compensation is entirely paid in respect of his employment contract and no additional compensation is paid or allocated in respect of his corporate office. Once paid, the compensation is not subject to a restitution obligation.
The resulting cash compensation (excluding any exceptional bonus) may reach a total of €200,239 in respect of fiscal year 2022, of which 71.4% fixed and 28.6% variable.
A Company car is allocated to the Deputy CEO. The value for 2022 is estimated at approximately €5,000.
The Board of Directors allocates free shares subject to a presence condition within the limits of the envelope authorized by the General Shareholders' Meeting. Half of the shares are subject to performance conditions based on the Company performance criteria used for setting annual variable compensation. The minimum vesting and lock-up periods shall be those provided for by law. Share-based compensation aims to increase the portion of "risky" compensation due to performance conditions and the connection to the share price. The allocation to the Deputy CEO shall not exceed the allocation to other members of the Executive Committee.
As compensation for their Board activity, the directors benefit collectively from a fixed annual amount known as "allocated compensation" for which the amount is recorded in operating expenses. The Board breaks down the compensation that is allocated and determined by the General Shareholders' Meeting. The directors' compensation must be distinguished from the amounts allocated for particular activities associated with employment contracts, compensation for the Chairman, Chief Executive Officer and Deputy CEOs, exceptional compensation for specific missions or mandates, refund of expenses.
The independent directors have the right to a fixed portion as consideration for their position as directors and, if applicable, as members, or Chairman, of one or several committees, and to a variable portion according to their effective and regular attendance at Board meetings, and if applicable, at the meetings of the committees in which they are members. The variable portion is the main portion of the compensation. The maximum amount that can be allocated to all directors (excluding the Chairman or Chief Executive Officer) in a calendar year is capped at €250,000 following a decision by the General Shareholders' Meeting in 2017. A draft resolution submitted to the General Meeting in May 2022 will increase this amount to €300,000 euros per year if it is adopted.
The Board has adopted the following scale:

Pursuant to Ruling no. 2019-1234 of November 27, 2019, on the compensation of corporate officers of listed companies and decree no. 2019-1235 of November 27, 2019, transposing Directive (EU) 2017/828 of May 17, 2017, amending Directive 2007/36/EC for the purpose of promoting the long-term commitment of shareholders, this Section 3.3.2 constitutes a report to shareholders on the compensation paid or awarded to corporate officers of the Company during fiscal year 2021 in respect of their office. This report contains the specific information required by Article L. 22-10-9 of the French Commercial Code as well as the additional information that the Board of Directors considers useful for an overview of corporate officers' compensation.
This report concerns the corporate officers of the Company, i.e. (i) the Chairman and Chief Executive Officer, (ii) the Deputy CEO and (iii) the directors.
Following a proposal by the Compensation Committee, at its meeting on March 10, 2021, the Board of Directors agreed the compensation package for Hedi Ben Brahim and Christophe Ancel for 2021. This package was proposed to the General Shareholders' Meeting on May 26, 2021, as a compensation policy as stipulated under Article L. 22-10-8 of the French Commercial Code in force at that date. Following a proposal by the Compensation Committee, at its meeting on March 16, 2022, the Board of Directors approved the level of achievement of the performance conditions for the variable compensation as well as the free share awards, and consequently, the amount of variable compensation and the number of free shares vested.
With regard to the other corporate officers, i.e. Company directors other than the Chairman and Chief Executive Officer, the shareholders during the Combined Shareholders' Meeting of June 8, 2017, authorized a maximum annual compensation budget of €250,000 and delegated the Board of Directors to set up the rules for allocation between the directors in accordance with the law. (A draft resolution submitted to the General Meeting in May 2022 will increase this amount to €300,000 euros per year if it is adopted.) Following the proposal by the Compensation Committee, at its meeting of March 17, 2017, the Board of Directors established the rules for allocating this compensation to directors and this scale was included in the Board of Directors' internal rules during its meeting of December 18, 2019, and reconfirmed by the Board on December 15, 2021.
The following table presents the average and median compensation based on a full-time equivalent of Company employees other than corporate officers (the guideline) as well as the so-called "equity" ratios between these guidelines, the minimum annual wage, in France (SMIC), on the one hand, and on the other hand, the compensation paid to each of the executive corporate officers over the last five fiscal years.
| Guidelines | Chairman and Chief Executive Officer |
Deputy CEO | Transgene | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Fiscal year |
Compensation | Equity ratios | Equity ratios | Financial Performance |
|||||||||
| Average = A |
Median = B |
Minimum wage = C |
Compensation CEO portion |
vs. A |
vs. B |
vs. C |
Compensation Deputy CEO portion |
vs. A |
vs. B |
vs. C |
Revenues | Net income/ (loss) |
|
| 2021 | 55,935 | 44,574 | 18,753 | 224,414 | 4.2 | 5.03 | 11.96 | 185,614 | 3.3 | 4.16 | 9.89 | 17,413 | (19,536) |
| 2020 | 56,445 | 47,188 | 18,655 | 746,276 | 13.2 | 15.8 | 40.0 | 152,222 | 2.7 | 3.2 | 8.2 | 9,915 | (17,231) |
| 2019 | 57,374 | 48,391 | 18,255 | 752,351 | 13.1 | 15.6 | 41.2 | 143,809 | 2.5 | 3.0 | 7.9 | 13,733 | (18,804) |
| 2018 | 58,839 | 49,441 | 17,982 | 743,511 | 12.6 | 15.0 | 41.3 | 141,601 | 2.4 | 2.9 | 7.9 | 42,919 | 8,029 |
| 2017 | 55,483 | 46,753 | 17,763 | 731,732 | 13.2 | 15.7 | 41.2 | 139,710 | 2.5 | 3.0 | 7.9 | 8,144 | (32,275) |
Report on Corporate Governance – Say on Pay
Transgene is a biotechnology company in a research and development phase and, in its business model, financial performance, excluding fund-raising, is not the most relevant indicator.
The Board listens to the opinions expressed by shareholders on the issue of compensation. During the 2020 and 2021 Annual General Meetings, no questions concerning compensation were submitted before or during the discussions. The resolutions concerning compensation were all adopted by a large majority of shareholders, including shareholders not related to the reference shareholder.
There are no discrepancies or deviations to report for the fiscal year 2021. The compensation paid or awarded to corporate officers in respect of fiscal year 2021 complies with the conditions of resolution 9 and resolution 10 approved by the Company's shareholders during the Combined General Meeting of May 26, 2021.
The compensation allocated to directors complies with the conditions of resolution 5 approved by the Company's shareholders during the Combined Shareholders' Meeting of June 8, 2017.
In accordance with the Compensation Policy for the Chairman and Chief Executive Officer approved by the General Shareholders' Meeting on May 26, 2021, his annual compensation for 2021 was made up of annual fixed gross compensation of €220,000 and variable compensation of between 0 and 40% of his annual fixed compensation, conditional on both the Company's collective objectives for 2021 and certain other individual objectives related to his duties being met.
The Deputy CEO's annual compensation for 2021 was made up of annual fixed gross compensation of €139,118 and variable compensation of between 0% and 25% of his annual fixed compensation, conditional on both the Company's collective objectives for 2021 and certain other individual objectives related to his duties as Quality Manager being met. In addition, as Responsible Pharmacist, Christophe Ancel receives a service bonus of €1,800 per year. It should be noted that Christophe Ancel's compensation results from his employment contract and that no additional compensation is paid in respect of his corporate office.
For Hedi Ben Brahim, the level of achievement of Company collective and his individual objectives gives rise to variable compensation of 40% of his fixed annual compensation for 2021. For Christophe Ancel, the level of achievement of Company collective objectives and individual performance conditions, increased by an exceptional bonus of €1,800, results in variable compensation of 25% of his annual fixed compensation in respect of 2021, increased to 30% once exceptional compensation is included.
It should be recalled that the performance conditions are partly financial and partly non-financial, but always aligned with the corporate interest by combining a significant share of the executive corporate officer's variable compensation with priorities such as research, continued technological advantages, clinical development programs, CSR or the completion of major partnerships or financing operations. The non-financial components consist of priority actions to achieve the Company's medium and long term objectives. For example, the development of the Company's reputation through publications, obtaining clinical results or establishing partnerships with public or university research centers. For 2021, the Board of Directors has determined that the criterias of the collective objectives were fully met. The demanding criteria chosen by the Board of Directors resulted in only partial achievement and the loss of part of the variable and share-based compensation between 2016 and 2020. See "Performance Conditions" in Section 3.4.2.
Following a proposal by the Compensation Committee, on March 16, 2022, the Board of Directors reviewed the extent to which the collective criteria from the 2021 objectives had been met. The collective objectives for 2021: prepare the 2022 business development plan by maintaining the 2021 clinical plan (weighting: 6/10); mobilize research for value creation (weighting: 2/10); and develop the financial outlook (weighting: 2/10). Given the relative weighting of the various performance criteria, the Board of Directors observed a 100% level of achievement of the Company's collective objectives for 2021.
See Section 3.3.3.
As part of a multi-year free share allocation plan voted at the General Meeting of 2018 and on the proposal of the Compensation Committee, the Board of Directors imposed a requirement for the Management Committee and in particular for the Chairman and Chief Executive Officer that half of the free shares awarded in September 2019 be vested in proportion to the achievement of the medium-to-long-term objectives to be assessed in March 2022. These medium and long-term objectives are: (I) obtaining clinical results for TG4050, TG6002 and at least one Invir.IO™ product with at least a second Invir.IO™ product in clinical trials (25%), (II) the exercise by AstraZeneca of a minimum number of options as part of the collaboration agreement signed in 2019 (25%), (III) significant partnerships for TG4001 and TG4010 (25%), and (IV) two years of financial visibility thanks to non-dilutive source (25%). The conditions may also be validated by the achievement of a minimum level of share price. Due to the partial achievement of several criteria, the Board, on the recommendation of the Compensation Committee, has retained an overall achievement level of 60%. The specific thresholds for the performance conditions and level of achievement are not disclosed for reasons of confidentiality.

The application of this 60% achievement level to the allocation of free shares in September 2019 results in a 40% reduction in the conditional portion of the allocation to the Deputy CEO and other members of the Management Committee. The current Chairman and Chief Executive Officer is not the beneficiary of this award.
Under a free share allocation plan in three equal annual remaining tranches have definitive vesting dates of May 26, tranches adopted at the 2021 General Meeting following a 2023 and May 26, 2024. Half of the free shares in this second proposal by the Compensation Committee, the Board of and third tranche will vest in proportion to the achievement Directors placed a requirement on the Executive Committee, of the collective objectives for 2022 and 2023, respectively. and in particular on the Chairman and Chief Executive Officer that half of the free shares in the first tranche would de facto vest on a proportionate basis according to the achievement of the Company's collective objectives for 2021 as described in the 2020 Universal Registration Document. Applying this
100% level of achievement of the 2021 collective objectives to the first tranche of free shares results in no reduction of the conditional portion of the allocation. Assuming that the condition of presence is met at the date of delivery of this tranche on May 26, 2022, all free shares will be vested definitively by the beneficiaries, including the Chairman and Chief Executive Officer and the Deputy CEO. The two
An overview of the compensation packages of executive corporate officers for fiscal year 2021 is presented below.
| (in € thousands) | FY 2020 | FY 2021 |
|---|---|---|
| Hedi Ben Brahim, Chairman and Chief Executive Officer | ||
| Compensation payable for the fiscal year (detailed in Table 2) | N/A | 312 |
| Valuation of multi-year compensation | N/A | None |
| Valuation of options awarded during the year (detailed in Table 4) | N/A | None |
| Valuation of performance shares assigned during the fiscal year – no allocation in 2020, 642,652 shares in 2021 |
N/A | 1,896 |
| TOTAL | N/A | 2,208 |
| Christophe Ancel, Responsible Pharmacist, Deputy CEO | ||
| Compensation payable for the fiscal year (detailed in Table 2) | 152 | 174 |
| Valuation of multi-year compensation | None | None |
| Valuation of options awarded during the year (detailed in Table 4) | None | None |
| Valuation of performance shares assigned during the fiscal year – 30,000 shares in 2020, 114,287 shares in 2021 |
40 | 337 |
| TOTAL | 192 | 511 |
NB: The allocations of shares are presented on the date of allocation without taking into account subsequent reductions, for example due to the application of performance conditions. The valuation is at the stock market price on the grant date and the value on the vesting date may vary significantly.
The shares awarded in May 2021 remain partly subject to performance conditions which will be assessed in March 2023 and March 2024.
Report on Corporate Governance – Say on Pay
| FY 2020 | FY 2021 | |||
|---|---|---|---|---|
| (in € thousands) | Amount due | Amount paid | Amount due | Amount paid |
| Hedi Ben Brahim, Chairman and Chief Executive Officer |
||||
| Fixed compensation | N/A | N/A | 220 | 220 |
| Variable compensation | N/A | N/A | 88(1) | -(2) |
| Exceptional compensation | - | - | - | - |
| Director's compensation | - | - | - | - |
| Payments in kind | - | - | 4 | 4 |
| TOTAL | N/A | N/A | 312 | 224 |
| Christophe Ancel, Responsible Pharmacist, Deputy CEO |
||||
| Fixed compensation(A) | 116 | 115 | 125 | 125 |
| Variable compensation | 29 | 28 | 35(1) | 29(2) |
| Director's compensation | - | - | - | |
| Service bonus | 2 | 2 | 2 | 2 |
| Exceptional compensation | 11 | 2 | 7 | 11 |
| Payments in kind | 5 | 5 | 5 | 5 |
| TOTAL | 163 | 152 | 174 | 172 |
| Philippe Archinard, former Chairman and Chief Executive Officer (for comparison) |
||||
| Fixed compensation | 403 | 403 | N/A | N/A |
| Variable compensation | 351 | 343 | N/A | 351 |
| TOTAL | 754 | 746 | N/A | 351 |
(1) For variable remuneration in respect of financial year N, paid or to be paid during financial year N+1.
(2) For the variable compensation for the year N-1, paid during the year N.
(A)Pro rata fixed compensation in the amount of €139,118 authorized for full-time employment.
Table 10
See Section 3.4.2.

| Employment Executive corporate officers contract |
Additional pension |
Compensation due or that may become due as a result of termination or plan change in positions |
Compensation related to a non-compete clause |
|||||
|---|---|---|---|---|---|---|---|---|
| YES | NO | YES | NO | YES | NO | YES | NO | |
| Hedi Ben Brahim, Chairman and Chief Executive Officer Term of office: 2021-present |
X | X | X | X | ||||
| Philippe Archinard, Chief Executive Officer Term of office: 2004-2020 |
X | X | X | X | ||||
| Christophe Ancel, Deputy CEO Terms of office: 2015-present |
X | X | X (1) | X |
(1) Due in respect of the employment contract and not the maintenance of the corporate office.
As far as the Company is aware:
At December 31, 2021, retirement provisions set up by the Company for the corporate officers totaled €2 thousand for Hedi Ben Brahim and €93 thousand for Christophe Ancel. The Chairman and Chief Executive Officer and the Deputy CEO do not benefit from supplementary pension schemes in addition to those provided by law and the pharmaceutical industry collective bargaining agreement.
The following table presents the total compensation allocated to each director in respect of the 2021 fiscal year compared to the 2020 fiscal year. The maximum aggregate budget and the breakdown rules did not change in 2020 or 2021, and the differences between the two fiscal years are attributable only to the number of meetings of the Board and special committees convened and the attendance of each director.
Report on Corporate Governance – Say on Pay
| Non-executive corporate officers Amount paid in 2020 (in € thousands) |
Amount paid in 2021 |
|---|---|
| PHILIPPE ARCHINARD (1) | |
| Directors' compensation None |
None |
| None Other compensation |
None |
| JEAN-PIERRE BIZZARI | |
| Directors' compensation 31 |
48 |
| Other compensation None |
None |
| JEAN-LUC BÉLINGARD (1) | |
| None Directors' compensation |
None |
| None Other compensation |
None |
| ANTOINE BÉRET | |
| Directors' compensation 38 |
41 |
| Other compensation None |
None |
| BENOÎT HABERT | |
| 30 Directors' compensation |
25 |
| None Other compensation |
None |
| MARIE-YVONNE LANDEL | |
| Directors' compensation 34 |
42 |
| Other compensation None |
None |
| TSGH (SANDRINE FLORY) (2) | |
| None Directors' compensation |
None |
| Other compensation None |
None |
| MAYA SAÏD | |
| Directors' compensation 43 |
49 |
| None Other compensation |
None |
| LAURENCE ZITVOGEL | |
| 24 Directors' compensation |
27 |
| Other compensation None |
None |
| TOTAL 200 |
232 |
(1) Non-independent director.
(2) In 2020, TSGH was represented by Ms. Dominique TAKIZAWA.
It should be noted that the rules for allocating compensation are set in the Board of Directors' Internal Rules and are presented in Section 3.3.1.4 of this document under the heading "Criteria and methods selected by the Board of Directors to determine, allocate and award directors' compensation".
As far as the Company is aware:
● none of the directors benefit from an undertaking on the part of the Company or its subsidiaries in terms of elements related to compensation, indemnities or benefits of any kind which are or may be due in light of the employment, termination of employment or change in position, or afterwards;
● none of the directors received compensation from TSGH, which directly controls Transgene, during the fiscal year. It should be noted that in 2020 and 2021, the Company did not pay any compensation to Mr. Archinard, Mr. Bélingard and Mr. Ben Brahim, nor TSGH and its permanent representative (Dominique Takizawa, replaced by Sandrine Flory as from January 1, 2021).

Pursuant to Ruling no. 2019-1234 of November 27, 2019, on the compensation of corporate officers of listed companies and decree no. 2019-1235 of November 27, 2019, transposing Directive (EU) 2017/828 of May 17, 2017, amending Directive 2007/36/EC for the purpose of promoting the long-term commitment of shareholders, this Section 3.3.3 constitutes a report to shareholders on the compensation paid or awarded to each executive corporate officer of the Company during fiscal year 2021 in respect of their office. This report contains the specific information required by Article L. 22-10-9 of the French Commercial Code as well as the additional information that the Board of Directors considers useful for an overview of executive corporate officers' compensation.
This report concerns the executive corporate officers of the Company, i.e. (i) the Chairman and Chief Executive Officer and (ii) the Deputy CEO. The overall compensation paid or awarded in respect of 2021 is presented individually for the Chairman and Chief Executive Officer and for the Deputy CEO in Section 3.3.2, above. The variable and exceptional compensation package for the Chairman and Chief Executive Officer and Deputy CEO are subject to the approval by the Ordinary General Meeting of such a package for the person in question under the conditions set out in Article L. 22-10-34. The following sub-sections "A" and "B" present for the Chairman and Chief Executive Officer and the Deputy CEO, respectively, the information requested by law for this approval.
The total compensation for the Chairman and Chief Executive Officer paid or awarded in 2021 amounts to €308,011 in cash, and is valued at €2,208,417 including the share-based compensation awarded by the Board in 2021 as well as benefits in kind (see Tables 1 and 2). Fixed compensation represents 71.4% of compensation in cash, with variable compensation representing the remaining 28.6%. This proportion complies with the ex-ante compensation policy adopted in 2021, which provided for variable compensation of up to 100% of the fixed compensation.
The Chairman and Chief Executive Officer's performance criteria for 2021 consist of the following financial and extra-financial objectives: prepare the 2022 business development plan by maintaining the clinical plan in 2021 (weighting: 6/10); mobilize research for value creation (weighting: 2/10); and develop the financial outlook (weighting: 2/10). (these three objectives represent the collective performance conditions applicable to all staff for annual variable compensation) and individual performance criteria made up of elements linked to the progress of clinical projects and product candidates in order to prepare tomorrow's deals (weighting: 25%); the Company's financial visibility (weighting: 25%); the development of the company's human capital (weighting: 20%); the implementation of a renewed Business Development approach (weighting: 20%); and the acceleration of CSR initiatives (weighting: 10%).
The Board considered that the individual criteria for 2021 had been met, in particular due to compliance with the clinical plan set out, the extension of financial visibility through a successful private placement and the monetization of part of Transgene's stake in the capital of Tasly Biopharmaceuticals, the renewal of part of the Executive Committee, the implementation of a new Business Development structure reporting to a Chief Business Officer, and the organization of ESG initiatives and a dedicated working group within the company. The Chairman and Chief Executive Officer did not take part in this deliberation.
The variable compensation awarded in respect of 2021 is paid in 2022 in order to assess the performance after the end of the fiscal year. In 2021, the Chairman and Chief Executive Officer was not paid any variable compensation in respect of the 2020 fiscal year, since he only took office on January 1, 2021.
During the fiscal year 2021, the Chairman and Chief Executive Officer benefited from the annual free allocation in May of 642,852 shares, consisting of a welcome allocation of 300,000 shares and a triennial allocation of 342,852 shares. These shares are entirely subject to a presence condition and half of the three-year allocation is subject to the same collective performance conditions as the annual variable compensation. The specific thresholds for the performance conditions are not communicated for reasons of confidentiality. 100% of the welcome award and 10% of the three-year award remain subject to a holding obligation until departure from his functions.
The absence of a certain number of elements is recalled:
More generally, no differences or exemptions should be noted with respect to fiscal year 2021. The compensation paid or awarded to the Chairman and Chief Executive Officer in respect of the 2021 fiscal year complies with the conditions of resolution 8 approved by the Company's shareholders during the Combined General Meeting of May 26, 2021.
Report on Corporate Governance – Say on Pay
These components are summarized in the table below with a comparison with the 2021 fiscal year.
| (in thousands of euros or number of shares) | FY 2020 | FY 2021 |
|---|---|---|
| Hedi Ben Brahim, Chairman and Chief Executive Officer | ||
| Compensation payable with respect to the fiscal year | N/A | 312 |
| of which fixed compensation paid during the fiscal year | N/A | 220 |
| of which variable compensation in respect of the fiscal year but paid during the following fiscal year after shareholder approval |
N/A | 88 |
| of which exceptional compensation due in respect of the fiscal year but paid during the following fiscal year after shareholder approval |
N/A | None |
| of which directors' compensation | N/A | None |
| of which benefits in kind | N/A | 4 |
| Valuation of multi-year compensation | N/A | None |
| Valuation of options awarded during the fiscal year | N/A | None |
| Valuation of performance shares during the year – 642,852 shares in 2021 | N/A | 1,896 |
| Number of performance shares vested during the fiscal year | N/A | - |
| TOTAL | N/A | 2,208 |
The total compensation for the Deputy CEO paid or awarded in 2021 amounts to €173,701 in cash, and is valued at €510,711, including the share-based compensation and benefit in kind awarded by the Board in 2021 (see Tables 1 and 2). The fixed compensation represents 80% of the cash compensation, the variable compensation represents the remaining 20%. Excluding the exceptional bonus, this proportion complies with the ex-ante remuneration policy adopted in 2021, which provides for variable compensation of up to a target bonus of 25%).
The Deputy CEO's performance criteria for 2021 consisted of the following financial and extra-financial objectives: prepare the 2022 business development plan by maintaining the clinical plan in 2021 (weighting: 6/10); mobilize research to create value (weighting: 2/10); and develop the financial outlook (weighting: 2/10) (these three objectives represent the collective performance conditions applicable to all staff for the annual variable compensation) and individual objectives consisting of: management of production and pharmaceutical quality staff (weighting: 22%); the smooth running of production commitments (weighting: 22%) regulatory approval of the pharmaceutical laboratory and the PilotClin production tool (weighting: 22%); compliance with the quality requirements of the Company and its partners (weighting: 22%); and corporate social responsibility initiatives (weighting: 12%). On March 16, 2022, the Board, deliberating on the recommendation of the Compensation Committee, retained an overall level of achievement of 2020 objectives of 100%, including an achievement rate of 100% for collective objectives and 100% for individual objectives. The overall variable portion of €42,000 or 30% based on a fixed compensation of €139,118 consists of the realization of the variable portion of 25% (€34,780 thousand) plus an exceptional service bonus of €7,220 euros. The Deputy CEO did not take part in this discussion. It is recalled that the variable compensation for the Deputy CEO is granted in respect of his employment contract.
The variable compensation awarded in respect of 2021 is paid in 2022 in order to assess the performance after the end of the fiscal year. In 2021, the Deputy CEO was paid his variable compensation in respect of the 2020 fiscal year of €40,000, approved by the General Shareholders' Meeting of May 26, 2021 (resolution 7).
During the fiscal year 2020, the Deputy CEO benefited from the annual free award in March of 114,287 shares, all of which are subject to a presence condition and half of which to the same collective performance conditions as the annual variable compensation. The specific thresholds for the performance conditions are not communicated for reasons of confidentiality.
In 2021, the Deputy CEO benefited from a company car, valued at approximately €5,000. Under his employment contract, he benefits from the legal severance provided by the national pharmaceutical industry collective bargaining agreement that currently opens the rights to just under nine months' salary if the conditions are met.

The absence of a certain number of elements is recalled:
| (in thousands of euros or number of shares) | FY 2020 | FY 2021 |
|---|---|---|
| Christophe Ancel, Deputy CEO | ||
| Compensation payable with respect to the fiscal year (1) | 158 | 174 |
| of which fixed compensation paid during the fiscal year | 116 | 125 |
| of which variable compensation in respect of the fiscal year but paid during the following fiscal year after shareholder approval |
29 | 35 |
| of which exceptional compensation due in respect of the fiscal year but paid during the following fiscal year after shareholder approval |
11 | 7 |
| of which directors' compensation | None | None |
| of which benefits in kind | 5 | 5 |
| of which service bonus | 2 | 2 |
| Valuation of multi-year compensation | None | None |
| Valuation of options awarded during the fiscal year | None | None |
| Valuation of performance shares during the year – 30,000 shares in 2020, 114,287 shares in 2021 |
40 | 337 |
| Number of performance shares vested during the fiscal year | 21,653 | - |
| TOTAL | 203 | 511 |
(1) Annual Service bonus of € 1,800
Corporate Governance report – Information on stock option and free share plans
As of the date of this Registration Document, a stock option plan was authorized by the General Shareholders' Meeting in 2010 and implemented by the Board of Directors. No stock options have been awarded since 2012. The status of these plans at December 31, 2021, is summarized in the following table.
| Grant date | Exercise start date |
Expiration date |
Exercise price |
Number of options granted |
Number of options exercised in 2020 |
Number of options remaining to be exercised at Dec. 31, 2021* |
|---|---|---|---|---|---|---|
| Dec. 13, 2012 | Dec. 14,2017 | Dec. 14, 2022 | 7,859 | 92,578 | - | 41,532 |
| TOTAL | N/A | N/A | N/A | N/A | - | 41,532 |
* This amount includes adjustments, in terms of the number of options and the exercise price, in accordance with regulations, following the capital increases maintaining preferential subscription rights of shareholders conducted in November 2016 and July 2019.
Pursuant to Article L. 225-185, paragraph 4 of the French Commercial Code, the Board set at 10% the quantity of shares issued from the exercise of options granted that the Chairman and Chief Executive Officer will be obliged to hold as registered shares until he leaves his position. As of the date of this Document, no Executive Corporate Officer is a beneficiary of Transgene options.
None.
| Name of executive corporate officer |
Plan No. and date |
Type of options | Valuation (in euros per option) |
Number of options granted |
Exercise price (in euros) |
Exercise period |
|---|---|---|---|---|---|---|
| Hedi Ben Brahim | - | - | - | None | - | - |
| Christophe Ancel | - | - | - | None | - | - |
| TOTAL | N/A | N/A | N/A | NONE | N/A | N/A |

Corporate Governance report – Information on stock option and free share plans
| Name of executive corporate officer | Plan No. and date | Number of options exercised during the year | Exercise price |
|---|---|---|---|
| Hedi Ben Brahim | - | None | - |
| Christophe Ancel | - | None | - |
| TOTAL | N/A | NONE | N/A |
Summary information on stock options granted to the ten non-corporate officer employees who received the highest number of options and options they exercised during 2021: None.
| Stock options granted to the ten non-corporate officer employees who received the highest number of options and options they exercised |
Total number of options granted or exercised |
Weighted average price (in euros) |
Plan number |
|---|---|---|---|
| Options granted during the year by the issuer and by any company within the option plan scope, to the ten non-corporate officer employees of the issuer and of any company within this scope, who received the highest number of options. |
None | - | - |
| Options held on the issuer and the previously mentioned companies exercised during the year by the tenemployees of the issuer and these companies, who subscribed in this way the highest number of options. |
None | - | - |
Individual information on the options granted by the issuer and by any company within the option plan scope, to the ten non-corporate officer employees of the issuer and of any company within this scope, who received the highest number of options and the number of shares subscribed by the ten people subscribing to the most shares during the fiscal year: there were no option awards in 2021. No options were exercised during the fiscal year.
Five free share awards are outstanding as of December 31, 2021, adopted by the Board of Directors in 2019, 2020 and 2021 for all employees and executive corporate officers under a delegation granted by the General Shareholders' Meeting of May 22, 2019 and May 26, 2021.
Corporate Governance report – Information on stock option and free share plans
The status of these unvested awards at December 31, 2021, is summarized in the following table:
| 2021 PLAN | ||||
|---|---|---|---|---|
| General Meeting date | May 26, 2021 | |||
| Total number of shares authorized by the meeting | 2,500,000 | |||
| Grants 2021 |
||||
| Board of Directors meeting date | May 26, 2021 | |||
| Total number of free shares awarded | 1,999,556 | 300,000 | ||
| Of which allocations granted, during the year, by the issuer and by any company included in the scope of the allocation to corporate officers |
457,139 | 300,000 | ||
| Of which the Chairman and Chief Executive Officer | 342,852 | 300,000 | ||
| Of which the Deputy CEO | 114,287 | - | ||
| Of which the number of shares awarded to members of the Executive Committee |
1,200,000 | 300,000 | ||
| Of which, grants made during the fiscal year by the issuer and by any company in the scope of awards, to the ten non-corporate officer employees of the issuer and of any company within this scope, whose number of free shares awarded is greatest |
802,117 | - | ||
| Of which the balance not yet vested at Dec. 31, 2021 | 1,975,266 | 300,000 | ||
| Of which vested at Dec. 31, 2021 | - | |||
| Cumulative number of shares canceled or void at Dec. 31, 2021 |
24,690 | - | ||
| Vesting date | May 26, 2022 | May 26, 2023 | May 26, 2024 | Jan. 1, 2024 |
| Expiration date of the lock-up period | May 26, 2023 | May 26, 2023 | May 26, 2024 | End of contract |
| Share value on the date of allocation (closing price on the date of allocation) |
€2.95 | €2.95 |
| 2016 Plan | 2018 Plan | 2019 Plan | ||||
|---|---|---|---|---|---|---|
| General Meeting date | May 24, 2016 | May 23, 2018 | May 22, 2019 | |||
| Total number of shares authorized by the meeting |
600,000 | 1,200,000 | 2,000,000 | |||
| 2017 Grant | 2018 Grant | 2019 Grant | 2019 Grant 2019 Catch-up | 2020 Grant | ||
| Board of Directors meeting date | Mar. 17, 2017 | Mar. 21, 2018 | Mar. 20, 2019 | Sept. 18, 2019 |
May 27, 2020 | Sept. 16, 2020 |
| Total number of free shares awarded | 183,000 | 220,600 | 414,800 | 1,399,774 | 5,934 | 601,682 |
| Of which allocations granted, during the year, by the issuer and by any company included in the scope of the allocation to corporate officers |
31,000 | 34,600 | 77,500 | 350,000 | 0 | 150,000 |
| Of which the Chairman and Chief Executive Officer |
24,000 | 26,000 | 60,000 | 280,000 | 0 | 120,000 |
| Of which the Deputy CEO | 7,000 | 8,600 | 17,500 | 70,000 | 0 | 30,000 |
| Of which the number of shares awarded to members of the Executive Committee |
72,000 | 104,600 | 192,000 | 840,000 | 0 | 360,000 |
| Of which, grants made during the fiscal year by the issuer and by any company in the scope of awards, to the ten non-corporate officer employees of the issuer and of any company within this scope, whose number of free shares awarded is greatest |
49,400 | 85,000 | 628,236 | 223,620 | ||
| Of which the balance not yet vested at Dec. 31, 2021 |
0 | 0 | 0 | 1,309,994 | 5,934 | 565,704 |

Corporate Governance report – Information on stock option and free share plans
| 2016 Plan | 2018 Plan | 2019 Plan | ||||
|---|---|---|---|---|---|---|
| Of which the balance not yet vested at Dec.31,2021 |
0 | 0 | 0 | 1,309,994 | 5,934 | 565,704 |
| Of which vested at Dec. 31, 2021 | 173,175 | 200,750 | 375,120 | 0 | 0 | 0 |
| Cumulative number of shares canceled or void at Dec. 31, 2021 |
9,825 | 19,850 | 39,680 | 89,780 | 0 | 35,978 |
| Vesting date | Mar. 17, 2019 |
Mar. 21, | 2020 Apr. 20, 2020 | Mar. 30, 2022 |
Apr. 30, 2022 | Mar. 30, 2022 |
| Expiration date of the lock-up period | Mar. 17, 2021 |
Mar. 21, 2022 |
Apr. 20, 2021 | Mar. 30, 2022 |
May 27, 2022 | Sept. 16, 2022 |
| Share value on the date of allocation (closing price on the date of allocation) |
€2.63 | €3.15 | €2.98 | €1.78 | €1.47 | €1.35 |
Since December 31, 2021, the Board of Directors has made a grant of 140,336 shares targeted at employees recruited since the grant of May 26, 2021. No corporate officer benefited from this grant.
Pursuant to Article L. 225-185 paragraph 4 of the French Commercial Code, the Board set at 10% the quantity of shares granted under free share plans that the Chairman and Chief Executive Officer will be required to hold in registered form until their appointments end. For specific grants, the Board may increase this amount to 100%
The award of May 26, 2021: half of the grant to the members of the Executive Committee, including 171,426 of the 342,852 shares granted to the Chairman and Chief Executive Officer and 57,143 of the 114,287 shares granted to the Deputy CEO were subject to performance conditions. A quarter of the awards to employees is subject to the same performance conditions. The performance criterion will be the level of achievement of the Company's collective annual objectives for the fiscal year ending prior to the final allocation date of each tranche (e.g. fiscal year 2021 for the 2022 tranche), which will be assessed by the Board approving the closing of the annual financial statements for the fiscal year 2021, 2022 or 2023 as the case may be.
Grant of March 16, 2022: this targeted grant of 140,336 shares aims to integrate, a posteriori, people recruited since the grant of May 26, 2021 into the two residual tranches of this grant. The performance conditions are the same.
Welcome award of May 26, 2021: the 300,000 free shares granted to the Chairman and Chief Executive Officer are not subject to performance conditions. However, they are subject to a presence condition recorded on January 1, 2024, and subject to a holding obligation until the end of the CEO's term of appointment.
The award of September 16, 2020: Half of the awards to the members of the Management Committee, including 60,000 of the 120,000 shares awarded to the Chairman and Chief Executive Officer and 15,000 of the 30,000 shares granted to the Deputy CEO, are subject to the following performance conditions: preparing for business development for 2022 by maintaining the clinical plan in 2021 (weighting: 6/10); mobilizing research for value creation (weighting of 2/10); and developing the financial outlook (weighting: 2/10). The specific thresholds for the performance conditions are not communicated for reasons of confidentiality. These performance conditions will be assessed in March 2022. The Board of Directors noted an overall achievement of 100% of the Company's collective objectives for 2021.
The award of September 18, 2019: Half of the grant to members of the Executive Committee, including 140,000 of the 280,000 shares allocated to the Chairman and Chief Executive Officer and 35,000 of the 70,000 shares allocated to the Deputy CEO, are subject to the following performance conditions: the obtaining of clinical results for TG4050, TG6002 and at least one Invir.IO™ product with at least a second Invir.IO™ product in clinical trials, the exercise by AstraZeneca of a minimum number of options as part of the collaboration contract signed in 2019, significant partnerships for TG4001 and TG4010, and two years of financial visibility thanks to non-dilutive sources. The conditions may also be validated by the achievement of a minimum level of share price. The specific thresholds for the performance conditions are not communicated for reasons of confidentiality. These performance conditions will be assessed in March 2022. Applying this 60% achievement level to the March 2019 allocation of free shares results in a 40% reduction of the conditional portion of the allocation to the Deputy CEO and other members of the Management Committee.
The award of March 20, 2019: Half of the grant to members of the Executive Committee, including 30,000 of the 60,000 shares granted to the Chairman and Chief Executive Officer and 8,750 of the 17,500 shares granted to the Deputy CEO, were subject to performance conditions. Due to the Company's performance criteria only being partially met for 2019, on March 11, 2020, the Board of Directors reduced the Chairman and Chief Executive Officer's award of performance shares by 12,000 shares and the Deputy CEO's award by 3,500 shares of those awarded in March 2019.
The award of March 21, 2018: Half of the grant to the members of the Executive Committee, including 13,000 of the 26,000 shares granted to the Chairman and Chief Executive Officer and 4,300 of the 8,600 shares granted to the Deputy CEO, were subject to performance conditions. Due to the Company's performance criteria only being partially met for 2018, on March 20, 2019, the Board of Directors reduced the Chairman and Chief Executive Officer's allocation of performance shares by 3,250 shares and the Deputy CEO's allocation by 1,075 shares allocated in March 2018. These reductions are effective as from January 1, 2020.
The award of March 17, 2017: Half of the grant to the members of the Executive Committee, including 12,000 of the 24,000 shares granted to the Chairman and Chief Executive Officer and 3,500 of the 7,000 shares granted to the Deputy CEO were subject to performance conditions. Due to the Company's performance criteria only being partially met for 2017, on March 21, 2018, the Board of Directors reduced the Chairman and Chief Executive Officer's allocation of performance shares by 3,000 shares and the Deputy CEO's allocation by 875 shares allocated in March 2017.
Following the termination of Philippe Archinard as Chairman and Chief Executive Officer, the Board of Directors of March 10, 2021, on the recommendation of the Remuneration Committee and in view of the relevant plan regulations, determined that Philippe Archinard's unvested free shares remain subject to the presence condition which could be satisfied by maintaining his current position, or another position, within the Institut Mérieux group and that the performance conditions would not be enforceable against him. The Board of Directors also noted that the obligation to hold shares until the end of the term of office as Chairman and Chief Executive Officer has now lapsed.
At the date of this report, the free shares awarded, but not issued, represent a potential dilution of 2,463,068 shares. For information, the options awarded, but not exercised, represent a potential dilution of 41,532 shares. The resulting potential dilution related to the share-based compensation amounts to 2,504,600 shares, approximately 2.5% of the Company's share capital.
In total, 2,919,364 shares in the share capital of Transgene were issued under free share awards.

In addition to the information required by the "say-on-pay" provisions of the French Commercial Code (Article L. 225-37), the tables required by appendix 2 of the AMF position-recommendation no. 2014-14 are presented below.
& SUMMARY OF THE COMPENSATION, STOCK OPTIONS AND SHARES GRANTED TO EACH CORPORATE OFFICER
See paragraph 3.3.2.
See paragraph 3.3.2.
& TABLE OF THE REMUNERATION ALLOCATED AS A DIRECTOR AND OTHER REMUNERATION RECEIVED BY NON-EXECUTIVE CORPORATE OFFICERS
See paragraph 3.3.2.
See paragraph 3.4.1.1.
Chairman and Chief Executive Officer: 642,852 shares.
Deputy CEO: 114,287 shares.
AMF position-recommendation no. 2014-14 – Tables in Appendix 2
Chairman and Chief Executive Officer: None
Deputy CEO: None
See paragraph 3.4.1.1.
See paragraph 3.4.2.
See paragraph 3.3.3.


| 4.1 | GENERAL FRAMEWORK | 104 |
|---|---|---|
| 4.1.1 | Transgene's ESG governance | 104 |
| 4.1.2 | Transgene values | 105 |
| 4.1.3 | Stakeholder dialogue | 105 |
| 4.2 | RESPECT FOR ETHICAL VALUES | 106 |
| 4.3 | COMMITMENT TO PATIENTS | 108 |
| 4.4 | COMMITMENT TO OUR PARTNERS | 110 |
| 4.4.1 | Subcontracting and suppliers | 110 |
| 4.4.2 4.4.3 |
Interaction with healthcare professionals Fair practices |
111 111 |
| 4.5 | COMMITMENT TO OUR EMPLOYEES | 112 |
| 4.5.1 | Social issues | 112 |
| 4.5.2 | Non-discrimination | 116 |
| 4.5.3 | Health and Safety | 118 |
| 4.6 | COMMITMENT TO OUR SHAREHOLDERS | |
| AND INVESTORS | 120 | |
| 4.7 | COMMITMENT TO SOCIETY AND THE | |
| REGIONS | 121 | |
| 4.7.1 | Local, economic and social impact of the business | 121 |
| 4.7.2 | Relationships with persons or organizations who have an interest in the Company's activities |
121 |
| 4.8 | COMMITMENT TO THE PLANET | 122 |
| 4.8.1 | Preventing pollution | 122 |
| 4.8.2 | Waste management | 123 |
| 4.8.3 | Sustainable use of resources and protection of biodiversity |
123 |
| 4.9 | METHODOLOGICAL NOTE | 126 |


General framework
Transgene is committed to a social responsibility policy guided by ethical behavior and values shared by the Institut Mérieux group and by all of the Company's employees.
This report presents an overview of Transgene's commitment regarding Environmental, Social, and Governance (ESG) criteria.
Transgene has not been required to publish a statement of non-financial performance (SNFP) since 2016 (the Company has fewer than 500 employees) but has voluntarily continued its reporting since then.
Bringing new therapeutic responses to cancer patients is Transgene's mission. Through scientific and technological innovation, Transgene is working to push back the limits of existing treatments. Beyond the positive contribution of its drug candidates, Transgene wants to ensure the Company's sustainability by creating value, strengthening its social contribution and minimizing its environmental impact.
The importance of the ESG policy is based on the commitment of each employee and manager to this vision, and the need for the Company to attract and retain talent, to meet the expectations of investors.
As a result, Transgene, with the contribution of its employees, is guided by the recommendations of the United Nations Global Compact and incorporates its ten principles into its strategy, practices and procedures.
In order to strengthen its ESG approach and develop its network at the regional level and share innovative best practices, Transgene joined the "Initiatives Durables" (sustainable initiatives) association. This association was created in 2004 and is run by responsible economy professionals who form a reference network in the Grand Est (more than 130 member companies). The association "Initiatives Durables" (sustainable initiatives) is committed to economic, societal and environmental responsibility.
ESG governance is ensured by a dedicated working group comprised of departmental representatives appointed by the Executive Committee, to which it reports at least annually.
The Executive Committee validates the priority missions and indicators proposed by the working group, decides on the main strategic guidelines in terms of ESG and ensures that the proposed projects make ESG a factor of progress. The working group monitors the implementation of priority missions and assesses the level of indicators achieved by the Company's actions.
This working group was set up in 2019 and initially identified the ESG initiatives already in place at Transgene, and initiated discussions on the formalization of the Company's ESG policy.
Transgene does not have any products on the market. By definition, the Company therefore focuses its internal ESG activities on its R&D activities, the production of small clinical batches for its trials and its support activities.
Transgene's first ESG review took place in September 2021. The ESG team presented to the Executive Committee the actions carried out in 2020 and 2021 to promote Transgene's ESG commitment and measure its effects on the Company. Target objectives and an action plan for the coming year were also proposed.
knowledge and method;
Create value
● Innovate in all areas;
continuity, loyalty, respect for people.
● Take risks and take responsibility for your actions;
From the 2021 fiscal year, following the recommendation of evaluation criterion has been included in the annual the ESG working group, an individual performance assessment of all employees.
● Train co-workers and coach them in their careers, transmit
● Perpetuate a heritage based on enduring values:
The working group ensures that stakeholders are involved or taken into account in Transgene's ESG thought process.
At the end of the working group's discussions with stakeholders, Transgene's Executive Committee defines the priority missions, establishes relevant indicators and ensures their monitoring.
These priority missions and their indicators will be communicated to the stakeholders and discussed with them in order to monitor and refine them over time.
The working group also ensures internal and external communication on Transgene's ESG commitment and the results obtained.
The working group ensures employee involvement through regular consultations, in particular on defining projects to achieve and maintain societal indicators validated by the Executive Committee.
● Advance scientific and technological frontiers: promote multidisciplinary approaches and partnerships; ● Give priority to long-term vision.
Through Investor Relations, the working group ensures the proper communication of non-financial indicators to investors in the Universal Registration Document and other media and dialogue with non-financial rating agencies.
Patients are taken into account particularly for ethical reasons by the strong involvement of the medical affairs department.
Partner involvement is managed by the Purchases and Program and Alliance Management Departments.
The working group, in consultation with the Executive Committee, takes into account the commitment to society, the regions and the planet.
4

Transgene is part of the Institut Mérieux, and in accordance with the principles of the Institut Mérieux, undertakes to act worldwide as part of its public health mission and in accordance with the laws that govern each of its activities. Transgene is committed to maintaining high ethical standards, to protecting patients participating in clinical trials through robust research and development (R&D) processes, and to constantly improving the integrity and transparency of its activities, in order to preserve the trust of patients and the medical community, employees and stakeholders.
Since 2021, a specific section of the website is dedicated to Ethics & Compliance.
The Rules established by Transgene are consistent with those of Institut Mérieux and are the foundation that each of its employees must respect.
Transgene's actions are consistent with Institut Mérieux's historical ethical values, which are reflected in specific behaviors. Transgene intends to perpetuate the values of Institut Mérieux with its employees.
Institut Mérieux's values are available on its website: www.institut-merieux.com > Social commitment.
In accordance with the rules described in its Code of Conduct, Transgene undertakes to conduct its activities in compliance with the national laws, rules and regulations of the countries in which it operates.
Transgene is committed to, and expects each employee to respect, the highest standards of integrity. The Code of Conduct applies to all employees of Transgene and its subsidiaries, to all members of the Executive Committee and the Board of Directors.
Since 2020, Transgene updated its Code of Conduct. This document is available on the Company's website.
Transgene practices zero tolerance for all forms of corruption. The Company has put in place an anti-corruption framework within the Company and its subsidiaries, in particular pursuant to the Sapin 2 law, the UK Bribery Act, or the U.S. Foreign Corrupt Practices Act (FCPA). In 2017, Transgene adopted an anti-corruption and influence peddling code based on the Code of Conduct, and a charter governing interactions with healthcare professionals. These codes prohibit any attempt, direct or indirect, at corruption or influence peddling towards anyone.
A whistleblowing system and a whistleblower protection system are in place.
Any involvement in money laundering operations is strictly prohibited. Transactions involving financial flows are recorded in accordance with international accounting standards and other local standards. Transgene has financial policies and procedures in accordance with these standards and ensures that each of its entities complies with these rules. The Company's financial statements are also reviewed on an annual basis by certified auditors. The terms of the contracts have been adapted, a risk mapping has been carried out and accounting controls are carried out.
Since 2020, Transgene updated its Anti-corruption Code. This document is available on the Company's website.
A questionnaire to validate the correct understanding of this text must have been successfully completed by all employees.
Transgene is committed to protecting personal data and respecting privacy. We ensure our compliance with the rules on the protection of personal data (in particular the GDPR) and have implemented a compliance program consisting of processes and measures to ensure optimal protection of personal data (privacy by design). A data protection officer has been appointed and each employee is involved in complying with data protection obligations.
Since 2021, Transgene has formalized a general personal data protection policy. This document is available on the Company's website.
The Company follows a responsible tax policy and respects the local and international rules that apply to it.
Respect for ethical values
In addition to the aforementioned codes, Transgene has defined Internal rules of procedures and a set of policies covering the following aspects:
Companies and institutions depend on information technology to conduct their business. The daily use of computers, mobile devices and web applications brings a risk of cybercrime. Transgene has assessed these risks and implemented measures to prevent them, as far as possible.
Transgene employees are the first line of defense against cybercrime. Training and awareness-raising actions take place regularly.
The following measures are in place:
Transgene relies on internal resources and on multidisciplinary initiatives developed by Institut Mérieux for all its companies operating in different businesses, in order to guarantee compliance with a common vision of ethics and compliance.
Internal control procedures are described in Chapter 7 of this document. They cover in particular legal and regulatory compliance, risk management, the pharmaceutical control environment and financial and accounting information.
For example, a risk mapping process was conducted in 2021. Action plans were implemented to optimize the coverage of the identified risks.

As a public health player, Transgene puts the patient, and more broadly public health, at the heart of its action.
Our commitments focus on the fight against cancer through research and development of innovative therapies. These therapies stimulate the immune defenses of patients in order to specifically target cancer cells.
Transgene is committed to the research and development process to enable the design of new drug candidates with the potential to be integrated into the therapeutic arsenal of tomorrow.
Transgene's drug candidates are developed to provide benefits to patients and to respect their safety and that of those around them (caregivers, families, etc.). The Company has no products on the market.
Transgene ensures that all of its activities comply with national, European and U.S. regulations and meet strict quality, safety and efficacy requirements.
Transgene is committed to protecting the health of all by taking into account upstream the bioethical implications of its biomedical research activities.
Transgene's drug candidates are based on innovative technologies and target complex areas for which there are significant medical needs. As a result, obtaining very promising preliminary results does not mean that subsequent clinical trials will confirm these encouraging results. The risk of project failure is inherent in the business of Transgene and companies in the sector.
Transgene coordinates and carries out several activities, including several clinical trials. These trials can take several years and require both careful planning and strategic direction. Transgene has teams and committees dedicated to the implementation, monitoring and evaluation of its preclinical and clinical developments.
In 2021, Transgene dedicated €32.9 million in R&D expenses compared to €27.3 million in 2019. 73% of the workforce was dedicated to R&D in 2021, as in 2020.
To effectively meet the therapeutic needs of cancer patients, Transgene conducts clinical trials of its drug candidates in Europe and the United States.
This research falls within a strict regulatory framework whose purpose is to ensure the efficacy of therapeutic products.
Clinical trials are defined in coordination with Key Opinion Leaders (KOLs): oncologists nationally and internationally recognized for their contribution to improving patient care. This dialogue allows us to initiate clinical trials as closely as possible to the expectations of clinicians and patients, while creating a network of KOLs, who can then be involved in the treatment of patients included in clinical trials and the presentation of clinical trial results. In addition, the stability of the teams working with the clinical sites is a key factor in the trust established between them and the Company.
Clinical trials must receive authorizations from national health authorities, as well as be validated by several entities ensuring compliance with patients' rights, according to procedures that vary depending on the country and clinical sites (Patient Protection Committee, Ethics Committee, etc.). In view of these approvals, Transgene complies with all regulations in force and with a high level of requirements, both for the design and conduct of clinical trials and for the production of doses of drug candidate intended for patients. For example, the European Medicines Agency (EMA), the French National Agency for the Safety of Medicines and Health Products (ANSM), the Food and Drug Administration (FDA) in the United States and other regulators enforce compliance with stringent conditions for clinical trials and for the manufacture, development and even transport of products.
The clinical trials being conducted for the Company's drug candidates are conducted in strict compliance with the informed consent of the persons participating in biological research trials. Patients included in Transgene trials do not receive any compensation for their participation. They are free to leave the clinical trial at any time and without justification.
In addition, Transgene has an internal team dedicated to pharmacovigilance, which processes safety information from clinical trials in compliance with regulations.
For the Company's products to be marketed, they must receive an approval for market launch (AML) issued by the health authorities of the various territories in which they will be distributed.
Transgene's products and services aim to offer significant benefits to its customers (particularly pharmaceutical companies) and patients. It is therefore essential to provide them with accurate, transparent and objective information on these products and services. This information is shared in accordance with applicable laws, regulations and industry codes.
Transgene regularly receives questions and requests from patients and their families, particularly by e-mail. Transgene undertakes to ensure that all such requests receive a response from the medical team, in compliance with confidentiality obligations.
The Company provides educational content about its drug candidates on its website.
Transgene is committed to providing clinicians and patients in its clinical trials with products that fully comply with pharmaceutical regulations.
At its Illkirch-Graffenstaden site (France), the Company has a pilot manufacturing area dedicated to the production of small clinical batches (for Phase I and II trials) in accordance with Good Manufacturing Practice (GMP). This site is in charge of producing doses for patients included in the two Phase I trials of TG4050 (myvac® ). It has also been designed to enable the production of small batches of drug candidates from the Invir.IO™ platform for its clinical trials or those that its partners may conduct.
These activities present risks inherent to the quality of the products but also to the impossibility of supplying a sufficient number of doses. These manufacturing risks are mainly prevented through Quality Control and Quality Assurance functions, which monitor and audit the Company's processes.
These two functions make it possible to check the quality of manufacturing and controls, avoid any interruption in the supply chain and deliver products on schedule.
Other measures are in place, including:
The pilot production site received an ANSM inspection in 2020 and was certified as compliant with current standards.
The measures in place create a solid infrastructure that meets the requirements of pharmaceutical companies. In particular, audits carried out in 2021 by our partners concluded that our practices complied with their specifications.
As a scientific research company, Transgene considers that it has a civic responsibility to limit animal experimentation as much as possible. As such, Transgene seeks alternative models that are more respectful and also more predictive of the results that will be observed in patients.
As part of this approach, Transgene has been involved for several years in researching new models, in particular organs-on-chip. Two employees are members of the Euro Organ-on-Chip Society and the Company is hosting a CIFRE PhD student on this topic. Transgene is also part of the European ImSavar consortium bringing together public and private players. It is a founding member of the working group coordinated by BioValley France, whose purpose is to structure the French participants in this field.
These new organ-on-chip models are part of the "reduce, refine, replace" approach and also aim to optimize the predictability of preclinical models in terms of toxicity and efficacy. By working on these innovative models, Transgene and its partners collectively aim to reduce the attrition inherent in the development of new drug candidates, to offer effective treatments more quickly to patients and to ultimately minimize the use of laboratory animals.
The Company has an internal Ethics Committee responsible for evaluating preclinical trials. For its animal models, it selects AAALAC accredited partners (Association for Assessment and Accreditation of Laboratory Animal Care International), who comply with ethics legislation, have an animal welfare structure, an independent Ethics Committee and have social and enrichment programs. These structures may also implement programs for the reclassification of animals when study conditions permit. Transgene regularly conducts on-site audits with the partners concerned.

ENVIRONMENTAL, SOCIAL AND GOVERNANCE RESPONSIBILITY (ESG)
Commitment to our partners
Transgene has customers, suppliers and partners all over the world. The Institut Mérieux group's global network of suppliers and partners is a major asset for Transgene and the Group. Transgene is keen to forge strong and mutually beneficial relationships with responsible suppliers and partners.
The purchasing policy ensures compliance with fair practices. It establishes long-term relationships of trust, monitoring and partnership with our suppliers and service providers. The strength of our collaborations also helps encourage our partners to adopt their own ESG approach.
All employees must familiarize themselves with and apply the Transgene Anti-corruption Code and undertake to report any fraudulent practices.
Transgene also has access to an online database to verify whether the third parties with which it works or wishes to engage are considered at risk in terms of corruption.
The Company has established a code of ethics that all suppliers must adhere to. This document is available on the Company's website, in the Contacts/Purchasing section.
According to these principles, suppliers and partners must, among other things:
Transgene seeks to collaborate with diversified firms that can present their products, services and expertise. They may be small firms, run by women, minorities, veterans or people with disabilities.
The selection of suppliers is based on price, quality, delivery conditions, diversity criteria and reputation. It must also take into account their respect for responsible business practices in terms of ethics and the environment.
The Company makes significant use of the services of companies specializing in the conduct of clinical trials and related services, known as CROs (Contract Research Organizations) for most of its clinical trials. The Department of Medical and Regulatory Affairs oversees that these subcontractors perform the services properly. Control management ensures that subcontractors are within budget and the Quality Assurance Department checks for quality.
These providers operate within a strictly regulated framework that aims to ensure the quality of the clinical trials conducted and are audited by the Company's Quality Assurance group.
The Company also uses subcontracting for the manufacturing of certain of its batches of drug candidates used for clinical trials. ABL Europe, the subcontractor, belongs to the Institut Mérieux. It operates in the Company's old manufacturing premises and has hired former Transgene employees. The Responsible Pharmacist, who is the Director of Quality Assurance, closely oversees the services provided by this subcontractor.
Compliance of subcontractors working for and/or in the Company in relation to their social obligations to personnel involved in the Company is part of their specifications.
As of December 31, 2021, 78% of unpaid invoices are due within 30 days (see Section 7).
Essential to Transgene's success, healthcare professionals play an important role in developing products and services, conducting clinical trials, and helping patients use their solutions.
Transgene and its employees and representatives must never offer or provide anything to a healthcare professional (gift, donation, remuneration, hospitality) that would improperly influence their prescriptions, recommendations, purchases or supplies of products or services. All interactions with healthcare professionals must be based on a legitimate professional motive, relate to the practice of the beneficiary's profession and comply with the amounts set by law. What may be accepted as commercial or civic practice in other fields may be inappropriate for a healthcare professional. Where required by law, any transfer of value from Transgene to a healthcare professional must be authorized and/or declared to the government and professional bodies (e.g., the Order of Physicians).
All of our links with healthcare professionals are available on the transparence.sante.gouv.fr website administered by the French General Health Directorate.
Transgene has a policy governing interactions with professionals, covering several aspects, of which:
An internal audit is conducted twice a year by the Corporate Secretary, in coordination with the medical affairs departments and the Finance Department, to randomly check that transactions requiring a transparency declaration are accessible on the Transparence Santé (Health Transparency) official website.
Transgene has every interest in promoting a business sector with trustworthy practices. Most national and regional economic systems advocate free competition as the most beneficial way for consumers. The fairness of Transgene's relations with its suppliers and competitors fosters the trust of its stakeholders and facilitates their work.
In line with its Code of Conduct and the regulations applicable in Europe and the United States, Transgene condemns anti-competitive practices, including industrial espionage, price agreements and non-compliance with confidentiality obligations. The Corporate Secretary coordinates employee awareness-raising on these issues and, in collaboration with the Institut Mérieux, conducts annual internal audits on these issues.

ENVIRONMENTAL, SOCIAL AND GOVERNANCE RESPONSIBILITY (ESG)
Commitment to our employees
Our employees are what drives Transgene. The Company believes that they are its main resource for achieving its objectives.
In addition to complying with legal and regulatory constraints, the Company wants to help improve working conditions and develop the skills of our employees, two important performance drivers. Our commitment is to serve everyone, to maintain a dynamic, open and friendly working environment.
Transgene's ESG approach is a participatory approach in which employees actively propose and carry out various actions. Transgene's ESG approach involves everyone.
Transgene ensures that human rights are respected in all of its activities.
Transgene employs 167 employees (105 women and 62 men) based in France as of December 31, 2021.
The Company had one employee in its entity based in the United States, which has not been included in this reporting.
Data specific to the Company: employees present at December 31, 2021 – France
| Dec. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2021 | |
|---|---|---|---|
| Under 25years old | 12 | 12 | 12 |
| 25 to 39 years old | 42 | 47 | 54 |
| 40 to 49 years old | 36 | 37 | 38 |
| Over 50years old | 69 | 68 | 63 |
| Total | 159 | 164 | 167 |
| Managers | 110 | 109 | 112 |
| Non-managers | 38 | 44 | 43 |
| Other statuses (CIFFRE, apprentices) | 11 | 11 | 12 |
| Total | 159 | 164 | 167 |
| Permanent contract | 136 | 139 | 143 |
| Fixed-term contract | 12 | 14 | 12 |
| Other (CIFFRE, apprentices) | 11 | 11 | 12 |
| Total | 159 | 164 | 167 |
| Men | 56 | 58 | 62 |
| Women | 103 | 106 | 105 |
| Total | 159 | 164 | 167 |
All employees located in France are covered by the National Collective Bargaining Agreement for the pharmaceutical industry.
Well-being at work is part of Transgene's DNA, and each year it leads numerous initiatives intended to create and maintain a pleasant, convivial and appealing working environment.
The size and mindset of Transgene's teams enable employees to contribute to the daily life of the Company. This participative commitment is reflected in the implementation of actions that promote both individual initiatives and a collective spirit. For example: volunteer employees were able to choose tree species following a storm and plant fruit trees; an employee upcycling coffee capsules decorated one of the living spaces with her creations.
The offices have been designed to combine the fluidity of exchanges within and between the teams.
Ergonomic equipment is available to employees and training/awareness-raising on the prevention of musculoskeletal disorders and working on a screen carried out during the year.
The Health, Safety and Environment (HSE) department and HR are the first contact point for any questions relating to working conditions.
Transgene encourages employees to comment on their working conditions, particularly during departmental, laboratory or team meetings, during the annual information meeting (collection of questions before the meeting), in the context of working groups or cross-functional meetings (in particular "Transcom" and "Transverse" meetings).
The Sharepoint internal network, the "Transcript" blog, or internal surveys can be used to collect information.
A particularly innovative company, Transgene has many experts among its employees. Since 2016, they have been invited to present their occupation, their missions and the progress of their projects to all employees. These "Transverse" meetings take place on a monthly basis on a voluntary basis.
Transgene also encourages researchers and medical teams to present the results of their research at local, national or international congresses, and to publish scientific articles whenever possible. Transgene also promotes membership in learned societies such as the American Society of Clinical Oncology (ASCO), the Society for ImmunoTherapy of Cancer (SITC), the European Society for Medical Oncology (ESMO), the American Society for Biochemistry and Molecular Biology (ASBMB), the Société de Biologie de Strasbourg (SBS) and the European Organ-on-Chip Society (EUROoCS).
Since 2020, Transgene has been taking part in the Women in Science Day alongside Institut Mérieux companies. In 2020, two Transgene researchers were honored; a CIFRE PhD student and a researcher from this visibility in 2021 and a research technician in 2022.
Transgene regularly organizes meetings and convivial activities allowing employees of the two sites to meet and discuss informally (shared buffet, annual party, internal competitions, "our employees have hidden talents", seniority anniversaries, theme days – safety, disability). Physical meetings were suspended due to the health situation in 2020 and 2021 and replaced, when possible, by virtual events.
The Illkirch premises are located near the Neuhof forest, which is a prime area for outdoor sports activities such as running and walking.
Since 2008, Transgene has had a bicycle shed to encourage employees to use this mode of transport. For several years now, the Company has been taking part in Strasbourg's Au Boulot à Vélo challenge. With nearly 40 participants in 2020, almost 450 journeys and 3,200 km traveled, Transgene ranked third among companies with 101 to 500 employees. The Company moved up the rankings to take the top spot among companies in its category in 2021 by mobilizing 40 participants and clocking up more than 10,000 km (917 trips and some challenges allowing for some additional kilometers to be obtained). It has participated for several years in the Strasbourgeoise and the Course des Lumières.
Showers and changing rooms are available for athletes.
The head office has a cafeteria, an ideal space for lunch, and several living and break areas. Transgene has developed green spaces to allow meals to be taken outside, on the outskirts of a grove left in its natural state.
Since it was founded, the Company has striven to adopt numerous measures that help balance its employees' work and private lives:
In order to promote work-life balance and following an employee survey (78% employee response rate), Transgene set up a pilot project on remote working in 2019. This project made it possible to set up the necessary tools and infrastructure and to adapt management practices.
4

ENVIRONMENTAL, SOCIAL AND GOVERNANCE RESPONSIBILITY (ESG)
Commitment to our employees
Thanks to this pilot project, Transgene was able to quickly adapt to the lockdown measures in 2020, without major IT issues.
On September 1, 2020, an agreement on regular and occasional remote working came into force. Transgene also has a practical guide for remote workers and managers. Training on remote working best practices was offered to employees.
The Company had 53 regular remote workers (a fixed 1-2 days per week) in 2021 (44 in 2020) and 55 occasional remote workers (31 in 2020).
Agreements on the organization of working time provide for non-managerial working hours of 37 hours and 40 minutes per week and nine days of reduced working hours and, for managers, an annual fixed rate of 215 days with 9 days of additional time off.
Several agreements are in force on the following subjects:
An additional agreement for non-managerial employees was signed in 2003 on working overtime and exceptional hours worked at night, on weekends and on public holidays. It is more favorable than the Collective Agreement.
The Company has signed additional agreements covering all employees (excluding senior executives):
In order to onboard new arrivals quickly and efficiently, Transgene has various measures in place, including a personalized induction program, complemented by internal training and follow-up meetings during the first months.
(Including apprenticeship and professional training contracts and CIFRE PhD student)
| Hires | 23 (including 10 temporary and 7 apprentices) |
|---|---|
| Departures | 20 (5 temporary, 1 CIFRE PhD student and 3 apprentices) |
NB: the following indicators were based on a full-year headcount (136 employees in 2021).
Transgene has a compensation program based on international standards.
Total payroll for 2021 was €15.1 million (€14.7 million in 2020; €13.9 million in 2019).
Employees benefit from collective guarantees that exceed legal and contractual provisions:
Commitment to our employees
The following table shows the breakdown of average gross annual compensation (wages/salary and bonuses) for men and women for 2019, 2020 and 2021, in euros (excluding Executive Committee and CIFRE):
| 3 | 4-5 | 6 non-managers | 6 managers** | 7 | 8 | 9*** | |
|---|---|---|---|---|---|---|---|
| Men | N/A | 34,103 | NC* | 41,729 | 51,308 | 79,015 | NC* |
| Women | NC* | 33,772 | 44,787 | 41,968 | 52,583 | 71,153 | NC* |
| Men | N/A | 33,513 | NC* | 42,456 | 51,956 | 77,729 | NC* |
| Women | N/A | 34,211 | 44,555 | 41,279 | 52,844 | 68,002 | N/A |
| Men | 0 | 34,984 | NC* | 41,360 | 53,089 | 73,069 | 97,566 |
| Women | NC* | 35,752 | 43,006 | 42,002 | 50,889 | 65,650 | NC* |
* NC: data not provided for confidentiality reasons; fewer than 3 employees are covered by this classification.
** Excluding CIFRE.
*** Excluding Senior Director (2019 and 2020)..
After an analysis of remuneration, there is no overall significant difference in salary between men and women. The differences observed, particularly in classification 8, can be explained by seniority in a small workforce or by specific occupations.
The level of initial training is high (approximately 60% of employees have a higher education of the type BAC +5 and above). Continually maintaining employees' knowledge and skills at the highest level of technology is a necessity to maintain the Company's competitiveness. To preserve and develop this human capital, the Company devotes considerable effort to continuing training (4.72% of payroll in 2019; 3.58% of payroll in 2020 and 3.72% in 2021) and to the development of knowledge and know-how, including through a policy of sending people to leading, internationally recognized conferences and seminars and through numerous collaborations within the scientific community, and an extensive and constantly updated document base.
The Company also pays special attention to safeguarding its competencies through the transmission of knowledge, such as through hosting work-study programs, offering internships and offering in-house training.
5 CIFRE PhDs, 7 work-study students, 11 end-of-study interns and 14 third-year interns were accepted in 2021 (4 CIFRE PhDs, 11 work-study students, 10 end-of-study interns and 6 third-year interns in 2020). In the event of a job opening corresponding to their profile, they will be given priority review.
2,268 hours were dedicated to occupational training in 2021 (2,378 in 2019 and 1,883 in 2020). 85% of employees took at least one training course in 2020 (67% in 2019 and 56% in 2020).
Transgene encourages professional mobility within occupations (skills development) and to new businesses (cross-functional development). An individual performance and development interview with the N+1 is held every year for all employees, followed by a professional interview with the manager every three years (or with HR after a long leave). An internal development committee meets every year to review and issue an opinion on individual professional development requests.
Employees moving to another Mérieux Group entity retain their seniority and the free shares from which they benefit.
4

Commitment to our employees
Social dialogue takes place in accordance with the French Labor Code. The members of the Social and Economic Committee (CSE) were elected in February 2018. The renewal of the bodies is planned for the year 2022, at the end of the terms of office of the current SEC.
In its rules, the CSE created three commissions with different responsibilities: The Committee for Health, Safety and Working Conditions (CSSCT), the Commission for Gender Equality and the Training Commission.
The economic and social database, now the Economic, Social and Environmental Database (BDESE) in 2021, includes all the data provided to employee representatives. It is accessible on the Company's intranet and is updated according to the schedule of deadlines defined by the parties.
The Company undertook a number of discussions with its social partners, resulting in the signature of six agreements in 2021, four in 2020 and five in 2019:
Each year, the Company undertakes mandatory annual negotiations (NAO) leading to the signature of an additional agreement.
Employees as of December 31, 2021 – France
| Men | Women | Total | |
|---|---|---|---|
| Under 25years old | 4 | 8 | 12 |
| 25 to 39years old | 24 | 30 | 54 |
| 40 to 49years old | 14 | 24 | 38 |
| Over 50years old | 20 | 43 | 63 |
| Total | 62 | 105 | 167 |
Transgene's overall score on the Professional Equality Index for 2021 was 92 out of 100 (91/100 in 2020 and 90/100 in 2019).
The average age of the workforce was 43.3 years at the end of December 2021 (44.2 years for women and 41.8 years for men). The average length of service is 12.5 years (13.9 years for women, 10.2 years for men). 38% of the workforce is over 50 years old.
Transgene has been committed to the issue of integrating and retaining disabled workers in employment for several years now. In 2021, the Company entered into a partnership with a specialist consultant to provide local support for employees on various topics: occupational health, disability, caregiver situation, etc. In 2020, an employee benefited from support measures (preparation of the RQTH file, adapted workstation) in order to return to work after a long-term sick leave.
In light of the analysis of the comparative situation between women and men at the end of 2018 and 2019, the parties recognized that the situation in terms of professional equality was satisfactory overall and signed a new agreement on March 1, 2021 for a 3-year term to make the actions already put in place permanent and implement new actions relating to:
Situation noted at Transgene:
The Company benefits from measures defined in the pharmaceutical companies' collective agreement (Leem) of September 25, 2008, to promote the employment and retention in employment of people with disabilities, as amended by the Protocols of September 24, 2009, and November 21, 2019, and support from the branch organization, HandiEM, for the deployment of its disability policy. Within this framework, it has appointed a disability correspondent, to be a relay for HandiEM and a pilot for Transgene's disability policy.
Transgene has seven employees declared RQTH in 2021 (six employees in 2020 and 5 employees in 2019). The Company also used several social-support-through-work centers for various services (Handirect, ESAT ESSOR, AVS, ESAT La Ganzau, etc.).
To encourage the hiring of disabled workers, the Company's application management software displays its non-discrimination policy and allows disabled workers to identify themselves. Their applications can be prioritized accordingly.
The Company forged ahead with communications efforts to combat stereotypes on disabilities:
● it continued to arrange in-house consultations for all employees on health matters, on how companies accommodate illness and disabilities in the workplace and support for the recognition of disabilities. This ongoing effort, provided by a company called Hanvolution, then Cap!,, makes it possible for any employee who so desires to broach freely and in confidence all questions about health at work. This consultation resulted in the Recognition of the Quality of Disabled Worker (RQTH) for four people in 2018/2021;
4
● Transgene has also continued its communication efforts by organizing its ninth consecutive annual disability day in November 2021, to raise awareness and counter prejudice, as part of the Disability Employment Week (Semaine pour l'Emploi des Personnes Handicapées). This awareness-raising took place in the form of "Handi'Feels" workshops with seven simulators (ageing, hemiplegia, back pain, tremors/Parkinson's, eye disease, hearing impairment, knee pain), information banners, the projection of a TEDx conference and discussion time with the speakers.

Commitment to our employees
The Company has implemented HR processes enabling non-discriminatory and objective practices:
The Company declares that it strictly upholds the freedom of association of employees. The right to collective bargaining is exercised in its institutions within the framework defined by the French Labor Code.
The Company has no operations in countries where such practices occur.
The Company has no operations in countries where such practices occur.
Transgene strives to prevent occupational illnesses and accidents. The purpose of the Company's security policy is to ensure the safety of people working within the Company and the protection of the Company's tangible and intangible assets. It applies in particular to R&D and production activities in PilotClin.
To define, implement and improve this safety culture, the Company has a Health, Safety and Environment (HSE) department, comprising an HSE head and HSE technician. The HSE team ensures that the rules and procedures are followed and organizes additional training. It is responsible for monitoring key indicators and regularly report on near-misses, incidents and accidents.
The 2021 annual prevention program was established at the beginning of the year, presented to the CSSCT and attached to the minutes of the meeting. All regulatory and mandatory actions have been completed; additional improvement actions initiated by the Company were completed during the year. Partially completed or uncompleted actions have been carried over to the 2022 annual prevention program. An annual prevention report is prepared each year, detailing all the key events of the previous year.
The health and safety training plan for 2021 involved 669 hours of HSE training, which represents 28% of total training hours.
In October 2021, the third Transgene Safety Day took place. After a forced stop in 2020, this day could be renewed with a training on "first aid". Employees have been trained by Civil Protection on how to identify and act in a dangerous situation for themselves and others
The Company has made the mandatory declarations for its facilities. Technical checks and inspections of the facilities are carried out in accordance with the legislation in force.
The laboratories are designed and equipped both to protect the experiments being conducted from any outside contamination and to protect the employees from accidental exposure to potentially hazardous products.
The Company's operations are subject to pharmaceutical standards (Laboratory and Clinical Best Practices) and to the provisions of the French Environmental Code that refer to the confined use of genetically modified organisms. In this regard, it is subject to administrative authority approval, given upon recommendation of the French High Council for Biotechnologies, for its viral vector constructions. Authorization includes the classification of these constructs and the confinement conditions for their handling. The Company's investments in the quality of its products have a safety and protection dimension, but are not necessarily recorded as specific costs related to this issue.
Transgene is also committed to training its staff. Staff have the necessary authorizations and training for the various safety needs related to their workstation.
The Health, Safety and Working Conditions Committee, now the Health, Safety and Working Conditions Commission, operates within the Company pursuant to the regulations in force.
The CSSCT meets at least four times a year in ordinary session. Minutes are taken of each meeting and circulated to all employees, to the occupational physician and to the labor inspectorate. It makes periodic visits to the sites and facilities, and may choose to hold extraordinary meetings following a serious accident or incident, or in the case of specific relocations, or new organizational measures that impact on employee health and safety. The procedures for serious and imminent danger were not called upon in 2021, 2020 and 2019. or in 2018. An analysis was carried out in 2021 (two in 2020 and two in 2019) following a workplace accident and an incident.
| Number of accidents (including on-site aid in the infirmary) | 2019 | 2020 | 2021 |
|---|---|---|---|
| Total Company accidents resulting in an entry in the infirmary logs or a report | 13 | 22 | 18 |
| Number of accidents reported | 3 | 8 | 5 |
| of which, commuting accidents (home-workplace) |
1 | 4 | 3 |
| workplace accidents |
2 | 4 | 1 |
| travel accidents (away from the workplace) |
0 | 0 | 1 |
| Number of accidents with work stoppage | 0 | 3 | 0 |
| Number of travel accidents with work stoppage | 0 | 1 | 0 |
| Frequency rate (1) | 0.00 | 12.229 | 0.00 |
| Severity rate (2) | 0.000 | 0.375 | 0.00 |
(1) Number of workplace accidents with stoppage (excluding during travel) multiplied by 1,000,000 and divided by the number of hours worked.
(2) Number of days lost due to temporary disability (excluding during travel) multiplied by 1,000 and divided by the number of hours worked.
No occupational illnesses were recognized in 2021 (as in 2020 and 2019). The employer did not file any reports indicating any processes that could cause occupational illnesses in 2021, as in 2020 and 2019.
After the forced shutdown in 2020, the safety day took place in 2021 on the topic of "life-saving skills". A total of 93 employees were trained by French Civil Protection on how to act in a situation that is dangerous for oneself or others. The following day, employees were able to put their knowledge on cardiac massage into practice thanks to a virtual reality animation.

Commitment to our shareholders and investors
For many years, Transgene has been investing in actions to raise awareness of the risk of "commuting accidents" and has taken initiatives to reduce this risk, such as the road safety day in 2019, various awareness-raising sessions on road safety in cars, by bicycle, etc.
In order to promote our prevention efforts and measures likely to reduce the frequency and severity of these accidents, the CARSAT Alsace-Moselle granted Transgene in 2021 a 25% reduction on the flat-rate premium for commuting accident coverage. This translates into a reduction of around €5,000 in the overall "workplace accident" premium.
In addition, Transgene was honored by this establishment at the 2019 Safety Competition.
The absenteeism rate was 3.92% in 2021 excluding partial activity related to Covid-19 (lockdown without the ability to work remotely or childcare duties), 7.29% in 2020, versus 2.76% in 2019. The high variation in the absenteeism rate between 2019 and 2020 is explained by three long-term illnesses (1,806 days) and one workplace accident (48 days off). Excluding these three long-term illnesses, the absenteeism rate stood at 2.16% in 2021 (2.03% in 2020), in line with previous years.
Through its various communication methods, Transgene provides a widely accessible documentary database that goes beyond regulatory requirements.
Its regular publications, as well as its participation in numerous events, ensure the greatest transparency of its activities and results.
In 2021, Transgene continued its efforts to raise its profile among French and international institutional investors.
Particular attention is paid to individual shareholders.
Transgene also ensures that its coverage is as broad and diversified as possible.
The Company is monitored by Oddo BHF, Bryan Garnier, Invest Securities, Kempen and Kepler Cheuvreux (whose research is available on a public website).
Since 2020, the British firm Intron Health initiated research coverage of Transgene.
Transgene is monitored by two ESG rating organizations: Gaïa Index Ethifinance and Vigeo Eiris. For the 2020 fiscal year, Vigeo Eiris assigned a score of 44/100 to Transgene, compared to 24/100 for the 2019 fiscal year. Gaïa EthiFinance awarded a score of 76/100 for the 2020 fiscal year, compared to 69/100 for the 2019 fiscal year.
The Company has been based in Strasbourg since its creation and has a site in Lyon. It strives to be active and present in its territories, promoting, whenever possible, suppliers and candidates from the Rhine valley (Alsace, Germany, Switzerland). Transgene's policy is to train young people and each year receives apprenticeship, professional training contracts, work-study and regularly CIFRE PhD candidates with the aim of training them.
Since its inception in 1979, the Company has located most of its activities in Strasbourg and in the suburbs of that city. As the French pioneer in genetic engineering, it has a strong local attraction, and provides professional opportunities for scientists, researchers and technicians in the life sciences.
The principal office of the Company is located in an area dedicated to scientific and technical activities, the Parc d'Innovation in Illkirch-Graffenstaden. There are therefore no immediate neighboring populations that its business could impact.
Neither the business, nor the facilities of the Company create noise pollution.
The Company is active locally, albeit on an informal basis and through some of its employees, with various associations, universities, institutions or collective groups, including Biovalley France (an association in favor of the development of activities related to life sciences in the Grand Est region) or Strasbourg Sud Développement, which carries out initiatives to promote employment in this sector.
Transgene is a member of professional associations such as France Biotech and Leem. It is also an SME member of Efpia. Transgene believes that it does not engage in lobbying activities.
Employees are encouraged to join learned societies (see 4.5.1.1 Sharing knowledge and bringing the Transgene culture to life).
To date, Transgene has not generated any profit. It therefore concentrates most of its financial resources on its research and development on innovative cancer therapies.
Whenever possible, and within its financial constraints, the Company supports initiatives related to its business and its regions.
Transgene donates functioning laboratory equipment that is no longer in use to associations or educational institutions. Three vortex mixers were donated to Biotech-Lab of the Strasbourg School of Biotechnology (ESBS) in 2020. In 2019, Transgene donated several pieces of equipment, including a laboratory automaton and an elispot reader (representing a total purchase value of nearly €200,000 before accounting depreciation), to the EASE school-plant located on the Illkirch Graffenstaden campus.
Faced with the shortage of equipment during the Covid-19 pandemic, Transgene donated masks (surgical and FFP2) and gowns to several health establishments in Strasbourg and Lyon.
Every year, Transgene takes part in two races whose profits go to the fight against cancer, the Strasbourgeoise and the Course des lumières in Lyon.
Likewise, Transgene supports the Les Petits Princes association, which enables children suffering from long-term illnesses to make their dreams come true, and la Ligue contre le Cancer.
Employees can participate, in a personal capacity, in local initiatives, publicized internally:
4

Commitment to the planet
By definition, research and innovation is linked to the academic world. Many employees have personal links with universities from which they are graduates or nearby universities. They are encouraged to participate in higher education, to present what they do or to give courses. As an example, Éric Quéméneur, Scientific Director of Transgene, is also Chairman (on a voluntary basis) of the École Supérieure de Biotechnologie de Strasbourg (ESBS).
Collective actions are also organized. Each year, Transgene works with the Faculty of Pharmacy in Strasbourg to present its activities to students. In 2020, Transgene was also asked to organize mock interviews at the ESBS to prepare students for their job search.
The Transgene Prize is awarded each year by the Société de Biologie de Strasbourg to a young doctor from the University of Strasbourg who has written an outstanding thesis in biology.
In 2021, Transgene took part in a Franco-German-Swiss exchange program co-organized by Alsace Tech allowing students of three nationalities to work on a professional project in order to improve their language and skills levels and develop their project management skills
Transgene has set up a proactive policy to welcome young people into companies (work-study/apprenticeship students, internships – including third-year internships -, CIFRE). Depending on the profile sought, Transgene makes intern and work-study offers to regional universities. Each year, the Company also welcomes about ten students from Alsatian secondary schools for a corporate discovery internship.
Our neighborhoods have talent: for several years, Transgene has enabled its employees to sponsor a young graduate having difficulties finding a job. This initiative was revitalized in 2021, with the participation of around fifteen mentors.
Controlling its environmental impact in response to the climate emergency is a major and growing challenge for civil society.
Transgene believes that its environmental footprint is reduced due to its R&D activity. Currently, Transgene's activities do not include any industrial production or distribution, which means that there is no significant consumption of raw materials, nor any significant release into the environment or of greenhouse gases. Transgene also operates within an extremely strict regulatory framework with which it complies.
Nevertheless, Transgene aims to further reduce its environmental impact and protect its natural resources. This involves sorting and recycling as much of its waste as possible or using green energy.
The drug candidates designed and developed by Transgene result from biological sciences (specifically, molecular and cellular biology) and use biotechnology processes (cell culture, purification processes, etc.) to enable a transition from laboratory work to the production of quantities of products controlled and approved for human clinical trials.
The processes to realize these products are extremely complex and require materials that present potential risks to individuals and the environment in the case of accidental exposure. These processes occur within several levels of containment.
Thus, the research laboratories are designed and equipped both to protect the product during its development from any outside contamination and to protect the employees as they do their work from accidental exposure to potentially hazardous products.
The Company believes that its research has very little impact on the environment, since operations relating to this activity take place in a confined environment. Transgene Laboratories are not affected by the regulations on Installations Classified for the Protection of the Environment.
The impact of this activity on the environment is controlled in two ways:
The Company regularly carries out actions to raise employee awareness of environmental issues, including waste sorting and digital pollution.
The Company has a Health, Safety and Environmental Officer. In addition, research takes place in a confined environment and related resources and equipment (air treatment filters, microbiological safety cabinets, autoclaves, etc.) help prevent environmental risks.
The Company has made no provisions or guarantees of this kind.
The Company's research and development activity is conducted in a confined environment. This confinement is obtained through several levels of air treatment and controls including microbiological safety cabinets, air depressurization to prevent its exit, absolute filters on ventilation ducts, etc. All of its equipment is regularly maintained and checked.
The airtightness of cooling production facilities (cooling units, heat pumps, cooling rooms) is checked and ensured regularly by service providers.
Refrigerants, potentially hazardous to the environment, were replaced in 2020. In 2021, no refrigerant leaks were recorded.
The Company's activity generates various types of waste that require sorting for special treatment. It ensures, as far as possible, that the quantity is reduced.
The Company has entered into agreements with qualified service providers for removal and treatment in accordance with the standards and rules that govern these various categories.
In addition, the Company conducts separate sorting and removal of non-hazardous waste, paper, cardboard, plastic and can, and special waste requiring special precautions.
The Company launched its onsite production of small clinical batches, which has been ramping up since 2018. This new activity and the work to commission and test the new production unit as well as the added workforce, has led to an increase in resource consumption since 2018.
The Company's activities involve the use of water. This use is directly related to changes in R&D projects and does not trigger relevant indicators.
The growth in water consumption between 2019 and 2020 is due to the ramp-up of the pilot production unit and the production of batches intended for clinical trials of TG4050.
The water used comes from the urban network; there are no specific supply constraints in the Grand Est Region.

| Year | Volume | Change |
|---|---|---|
| 2019 | 4,221 | +26% |
| 2020 | 4,881 | +16% |
| 2021 | 3,838 | -21% |
The equipment in the research laboratories and the facilities for producing clinical batches run exclusively on electricity. There is a very strict equipment maintenance plan to ensure optimal energy consumption.
The laboratory and office building, delivered in 2008, took into account the challenges of reducing energy costs within the scope of existing technologies at the time. It is equipped with heat pumps for heating and cooling and uses electricity for steam production.
Solar panels supply hot water to staff showers.
The Company decided to source 50% of its electricity from renewable energy sources, purchased from the local supplier Energies de Strasbourg.
| Year | Total | Change |
|---|---|---|
| 2019 | 3,740,072 | +12% |
| 2020 | 3,692,957 | -1.3% |
| 2021 | 3,556,466 | -9.1% |
For a more responsible use of natural resources, the site's printers are configured to use recycled paper as default setting.
Despite its activities, Transgene does not produce any direct greenhouse gas (GHG) emissions. Indirect GHG emissions are linked exclusively to electricity consumption and have generated 150 tonnes of CO2 equivalent in 2021.
The conversion of the above energy consumption into CO2 emission equivalents is done by applying the ADEME conversion factors.
The Company estimates that the direct or indirect generation of greenhouse gases from its activity is limited. Emissions mainly come from: business travel, commuting to and from work, sending our research or clinical samples, and delivery of research materials and consumables.
The Company has no activity requiring special measures to adapt to climate change impacts.
Transgene encourages its employees to use public transport and soft traffic modes.
Transgene also encourages the use of bicycles with the provision of a bicycle storage shed, showers and changing rooms.
Four electric charging stations have been made available to employees using an electric vehicle.
Whenever possible, Transgene recommends using environmentally-friendly modes of transport.
Due to the pandemic in 2021, the majority of events did not require travel, which is reflected in a significant drop in CO2 emissions.
CO2 equivalent – By calendar year, reservations made with the Egencia travel agency
| Plane | Train | |
|---|---|---|
| 2019 | 273.9 | 0.9 |
| 2020 | 82.0 | 0.5 |
| 2021 | 61.0 | 0.9 |
Neither the Company's activities nor its facilities have any impact on biodiversity.
The environment around Transgene is rich in meadows and flowering trees that offer a real potential of nectar and pollen for the development of an urban beekeeping. Aware of this situation and wanting to help protect bees, Transgene offered the ASAPISTRA beekeeping association a site on its land. This location currently hosts beehives, belonging to the ASAPISTRA association, for training purposes (for members of the association) and for educational purposes for Transgene employees.
Transgene has a grove on its site in Illkirch-Graffenstaden. It is left in a natural state to preserve the small fauna in this area. As part of the International Day for Biological Diversity, two lime trees and a local flowering species were planted there.


Transgene has not been required to publish a statement of non-financial performance (SNFP) since 2016 (the Company has fewer than 500 employees) but has voluntarily continued its reporting since then.
Methodological note
Methodologies for reporting social, safety and environmental indicators are likely to have certain limitations inherent in the practicalities of collecting and consolidating such information.
Unless otherwise indicated, the items in the following report concern the Company (Transgene), located in France, where its business is primarily conducted in two facilities located in Illkirch-Graffenstaden and Lyon. Its wholly-owned American and Chinese subsidiaries operate as representative offices (Transgene, Inc., based in the United States which has no employee at December 31, 2021 and Transgene BioPharmaceutical Technology (Shanghai) Co. Ltd., based in China, which has no employee at December 31, 2021) and no sales activity. They are therefore not included in this report's indicators.
Figures are provided for the fiscal years 2019, 2020 and 2021 only when such figures are relevant.
For the social indicators, the calculations were made using the headcount as at December 31, 2021, namely 167 employees (105 women and 62 men) of Transgene, based in France. The Group has one employee in its entity based in the United States, who has not been included in this reporting.
Employees on a permanent, temporary or work-study employment contract with Transgene at December 31, 2021, are counted in the total workforce. Trainees and temporary staff are excluded.
Temporary contracts are included in the reporting of this indicator. The following are excluded from the reporting for both hires and departures: the conversion of temporary employment contracts to permanent ones when the end of the prior contract coincides with the start of the new contract.
It refers to the ratio of the number of working hours missed (illness, workplace accidents and commuting accidents) to the number of hours worked.
This indicator covers only the activities located in France for the period from January 1 to December 31, 2021.
The number of hours worked is taken from the payroll summary and is used to calculate the rate of absenteeism.
The hours used to calculate the frequency and severity rates are taken from the annual declaration of social data (abbreviated to DSN), in the specific workplace accidents section.
The Commission on Professional Equality was involved in choosing the approach to categorizing the eligible workforce for calculating the first Professional Equality Index (by classification rather than socio-professional grouping).
The frequency rate of accidents with work stoppage equals the number of accidents with work stoppage of greater than or equal to one day occurring during a twelve-month period per million hours worked. The severity rate of workplace accidents is equal to the number of days lost due to temporary disability, excluding commuting accidents, occurring during a period of twelve months per thousand hours worked. Commuting accidents from the home to the workplace are excluded from the calculation of these indicators.
Unless otherwise indicated, the items in the following report concern the Company (Transgene), located in France, where its business is primarily conducted in two facilities located in Illkirch-Graffenstaden and Lyon. Its wholly-owned American and Chinese subsidiaries operate as representative offices (Transgene, Inc., based in the United States which has no employee at December 31, 2021 and Transgene BioPharmaceutical Technology (Shanghai) Co. Ltd., based in China, which has no employee at December 31, 2021) and no sales activity. They are therefore not included in this report's indicators. Figures are provided for the fiscal years 2019, 2021 and 2021 only when such figures are relevant.
The indicators on water consumption only cover the activities in the building housing the registered office, the administrative and regulatory activities and the R&D labs at the facility in Illkirch-Graffenstaden (France). The Company is not in a position to present environmental indicators for the laboratory in Lyon, since no information has been provided by the landlord.
The data comes from the Egencia Analytics Studio dashboard, provided by the travel agency Egencia. The CO2 Emissions Workspace uses a proprietary algorithm developed by Egencia's data scientists based on industry standards to track CO2 emissions. These standards were developed by the UK Department for the Environment, Food and Rural Affairs (DEFRA), and are considered by regulators as reference standards for estimating CO2 emissions.
ANNUAL
| 2021 Universal Registration Document | 127 | |
|---|---|---|
| AND NOTES | 128 | |
|---|---|---|
| 5.1.1 | Consolidated financial statements | 128 |
| 5.1.2 | Notes to the consolidated financial statements (in € thousands, unless otherwise indicated) |
133 |
| 5.1.3 | Date of latest financial information | 163 |
| 5.2 | STATUTORY AUDITOR'S REPORT ON THE CONSOLIDATED FINANCIAL STATEMENTS |
164 |
| 5.3 | ANNUAL FINANCIAL STATEMENTS AND NOTES |
170 |
| 5.3.1 | Annual financial statements | 170 |
| 5.3.2 | Notes to the annual financial statements | 172 |
5.1 CONSOLIDATED FINANCIAL STATEMENTS
| 5.4 | STATUTORY AUDITOR'S REPORT ON THE | |
|---|---|---|
| FINANCIAL STATEMENTS | 194 |
| 5.5 PRO FORMA FINANCIAL INFORMATION |
200 |
|---|---|
| ---------------------------------------- | ----- |

ANNUAL FINANCIAL STATEMENTS AT DECEMBER 31, 2021 Consolidated financial statements and notes
| (in € thousands) | Notes | Dec. 31, 2021 | Dec. 31, 2020 |
|---|---|---|---|
| CURRENT ASSETS | |||
| Cash and cash equivalents | 3 | 5,911 | 5,277 |
| Other current financial assets | 3 | 43,658 | 21,077 |
| Cash, cash equivalents and other current financial assets | 3 | 49,569 | 26,354 |
| Trade receivables | 4 | 10,133 | 1,667 |
| Other current assets | 5 | 2,543 | 2,666 |
| Total current assets | 62,245 | 30,687 | |
| NON-CURRENT ASSETS | |||
| Property, plant and equipment | 6 | 11,295 | 13,110 |
| Intangible assets | 7 | 92 | 141 |
| Non-current financial assets | 8 | 20,772 | 34,042 |
| Other non-current assets | 9 | 7,434 | 7,473 |
| Total non-current assets | 39,593 | 54,766 | |
| TOTAL ASSETS | 101,838 | 85,453 |
Consolidated financial statements and notes
| Notes (in € thousands) |
Dec. 31, 2021 | Dec. 31, 2020 |
|---|---|---|
| CURRENT LIABILITIES | ||
| Trade payables | 7,692 | 5,066 |
| 10 Current financial liabilities |
1,395 | 1,426 |
| 11 Provisions for risks and expenses |
48 | 511 |
| Other current liabilities 12 |
5,454 | 6,626 |
| Total current liabilities | 14,589 | 13,629 |
| NON-CURRENT LIABILITIES | ||
| 10 Non-current financial liabilities |
15,241 | 16,938 |
| 11 Employee benefits |
3,958 | 4,060 |
| 12 Other non-current liabilities |
841 | 110 |
| Total non-current liabilities | 20,040 | 21,108 |
| Total liabilities | 34,629 | 34,737 |
| EQUITY | ||
| 14 Share capital |
48,886 | 41,921 |
| Share premiums and reserves | 70,374 | 40,938 |
| 2 Retained earnings |
(31,092) | (13,861) |
| Profit/(loss) for the period | (19,536) | (17,231) |
| Other comprehensive income/(loss) | (1,423) | (1,051) |
| Total equity attributable to the Company's shareholders | 67,209 | 50,716 |
| TOTAL LIABILITIES AND EQUITY | 101,838 | 85,453 |

ANNUAL FINANCIAL STATEMENTS AT DECEMBER 31, 2021
Consolidated financial statements and notes
| (in € thousands, except for per-share data) | Notes | Dec. 31, 2021 | Dec. 31, 2020 |
|---|---|---|---|
| Revenue from collaborative and licensing agreements | 15 | 9,993 | 2,981 |
| Government financing for research expenditure | 15 | 7,021 | 6,362 |
| Other income | 15 | 399 | 572 |
| Operating income | 17,413 | 9,915 | |
| Research and development expenses | 16 | (32,883) | (27,346) |
| General and administrative expenses | 16 | (7,369) | (6,547) |
| Other expenses | 16 | (686) | (15) |
| Operating expenses | (40,938) | (33,908) | |
| Operating income/(loss) | (23,525) | (23,993) | |
| Financial income/(loss) | 17 | 3,989 | 6,762 |
| Income/(loss) before tax | (19,536) | (17,231) | |
| Income tax expense | 18 | - | - |
| NET INCOME/(LOSS) | (19,536) | (17,231) | |
| Basic earnings per share (in €) | 14 | (0.21) | (0.21) |
| Diluted earnings per share (in €) | 14 | (0.20) | (0.21) |
| (in € thousands) | Dec. 31, 2021 | Dec. 31, 2020 |
|---|---|---|
| Net income/(loss) | (19,536) | (17,231) |
| Foreign exchange gains/(losses) | 12 | (7) |
| Revaluation of hedging instruments | 61 | 70 |
| Other elements of comprehensive income/(loss) subsequently restated as income |
73 | 63 |
| Actuarial gains/(losses) on employee benefit provision | (445) | (56) |
| Other elements of comprehensive income/(loss) subsequently non-recyclable as income, net of deferred taxes |
(445) | (56) |
| Other comprehensive income/(loss) | (372) | 7 |
| NET COMPREHENSIVE INCOME/(LOSS) | (19,908) | (17,224) |
| Of which, attributable to parent company | (19,908) | (17,224) |
| Of which, non-controlling interests | - | - |
Consolidated financial statements and notes
| (in € thousands) | Notes | Dec. 31, 2021 | Dec. 31, 2020 |
|---|---|---|---|
| CASH FLOW FROM OPERATING ACTIVITIES | |||
| Net income/(loss) | (19,536) | (17,231) | |
| Cancellation of financial income/(loss) | (3,989) | (6,762) | |
| Elimination of non-cash items | |||
| Provisions | (1,031) | 722 | |
| Depreciation and amortization | 6, 7, 8 | 2,521 | 1,786 |
| Share-based payments | 16 | 3,002 | 1,744 |
| Others | (112) | (320) | |
| Net cash generated from/(used in) operating activities before change in working capital and other operating cash flow |
(19,145) | (20,061) | |
| CHANGE IN OPERATING WORKING CAPITAL REQUIREMENTS | |||
| Current receivables and prepaid expenses | 23 | (7,745) | 897 |
| Research tax credit (RTC)/CICE | 15 | (7,027) | (6,352) |
| Other current assets | 5 | (242) | 717 |
| Trade payables | 23 | 2,657 | (2,057) |
| Prepaid income | 12 | (1,124) | (2,015) |
| Other current liabilities | 12 | 683 | 129 |
| Net cash used in operating activities | (31,943) | (28,742) | |
| CASH FLOWS FROM INVESTING ACTIVITIES | |||
| (Acquisitions)/disposals of property, plant and equipment | 6 | (671) | (811) |
| (Acquisitions)/disposals of intangible assets | 7 | (15) | (41) |
| (Acquisitions)/disposals of non-consolidated equity securities | 8 | 17,193 | 18,224 |
| Other (acquisitions)/disposals | 8 | 286 | 370 |
| Net cash used in investing activities | 16,793 | 17,742 | |
| CASH FLOWS FROM FINANCING ACTIVITIES | |||
| Net financial income/(loss) proceeds | 17 | (167) | (123) |
| Gross proceeds from the issuance of shares | 14 | 34,129 | - |
| Share issue costs | (787) | - | |
| Conditional subsidies | 15 | 603 | 655 |
| (Acquisitions)/disposals of other financial assets | 3 | (22,582) | 21,041 |
| Net amounts received for financing of tax credits | 10 | 6,050 | 6,288 |
| Bank borrowing | 10 | (197) | (11,406) |
| Financial leases and change in lease obligations | 10 | (1,277) | (1,514) |
| Net cash generated from/(used in) financing activities | 15,772 | 14,941 | |
| Exchange rate differences on cash and cash equivalents | 12 | (7) | |
| Net increase/(decrease) in cash and cash equivalents | 634 | 3,934 | |
| Cash and cash equivalents at beginning of period | 5,277 | 1,343 | |
| Cash and cash equivalents at end of period | 5,911 | 5,277 | |
| Investments in other current financial assets | 43,658 | 21,077 | |
| CASH, CASH EQUIVALENTS AND OTHER CURRENT FINANCIAL ASSETS | 49,569 | 26,354 |

Consolidated financial statements and notes
| Common shares | Other | |||||||
|---|---|---|---|---|---|---|---|---|
| (in € thousands) | Number of shares |
Share capital |
Share premiums Reserves |
Retained earnings |
compre hensive income/ (loss) |
Net income/ (loss) |
Total attributable to the Company's shareholders |
|
| As of December 31, 2019 published | 83,265,464 | 83,265 | 37,712 | 2,026 | (37,444) | (1,058) | (18,804) | 65,697 |
| Change of accounting method on retirement benefits provision |
- | - | - | 466 | - | 466 | ||
| Adjusted position at January 1, 2020 | 83,265,464 | 83,265 | 37,712 | 2,026 | (36,978) | (1,058) | (18,804) | 66,163 |
| Increase of share capital | - | - | - | - | - | - | - | - |
| Free share awards | 575,870 | 576 | (244) | (332) | - | - | - | - |
| Share-based payments | - | - | 1,744 | - | - | - | - | 1,744 |
| Share capital reduction | - | (41,921) | - | - | 41,921 | - | - | - |
| Liquidity contract | - | - | - | 32 | - | - | - | 32 |
| Income/(loss) for the previous period | - | - | - | - | (18,804) | - | 18,804 | - |
| Allocation of net income/(loss) | - | - | - | - | - | - | (17,231) | (17,231) |
| Foreign exchange gains/(losses) | - | - | - | - | - | (7) | - | (7) |
| Actuarial gains/(losses) on employee benefit provision |
- | - | - | - | - | (56) | - | (56) |
| Interest rate swap | - | - | - | - | - | 70 | - | 70 |
| Net comprehensive income/(loss) | - | - | - | - | - | 7 | (17,231) | (17,224) |
| Adjusted position at December 31, 2020 | 83,841,334 | 41,921 | 39,212 | 1,726 | (13,861) | (1,051) | (17,231) | 50,716 |
| Increase of share capital | 13,930,000 | 6,965 | 26,377 | - | - | - | - | 33,342 |
| Free share awards | - | - | (1,150) | 1,150 | - | - | - | - |
| Share-based payments | - | - | 3,002 | - | - | - | - | 3,002 |
| Liquidity contract | - | - | - | 57 | - | - | - | 57 |
| Income/(loss) for the previous period | - | - | - | - | (17,231) | - | 17,231 | - |
| Allocation of net income/(loss) | - | - | - | - | - | - | (19,536) | (19,536) |
| Foreign exchange gains/(losses) | - | - | - | - | - | 12 | - | 12 |
| Actuarial gains/(losses) on employee benefit provision |
- | - | - | - | - | (445) | - | (445) |
| Interest rate swap | - | - | - | - | - | 61 | - | 61 |
| Net comprehensive income/(loss) | - | - | - | - | - | (372) | (19,536) | (19,908) |
| AS OF DECEMBER 31, 2021 | 97,771,334 | 48,886 | 67,441 | 2,933 | (31,092) | (1,423) | (19,536) | 67,209 |
Consolidated financial statements and notes
The consolidated financial statements of Transgene (the "Company") at December 31, 2021, were prepared in accordance with the principles and methods defined by IFRS (International Financial Reporting Standard) as adopted by the European Union. They were approved by the Board of Directors on March 16, 2022.
Transgene is a biotechnology company that designs and develops targeted immunotherapy products against cancers.
Transgene is fully consolidated in Compagnie Mérieux Alliance (17 rue Bourgelat, 69002 Lyon, France).
The consolidated financial statements include:
| NOTE 1 | ACCOUNTING PRINCIPLES | 134 | NOTE 14 | EQUITY | 151 |
|---|---|---|---|---|---|
| NOTE 2 | APPLICATION OF THE IFRIC POSITION OF MAY 2021 RELATING TO THE ALLOCATION OF THE COST OF SERVICES |
NOTE 15 | OPERATING INCOME | 154 | |
| NOTE 16 | OPERATING EXPENSES | 155 | |||
| ASSOCIATED WITH A DEFINED BENEFIT PLAN |
140 | NOTE 17 | FINANCIAL INCOME/(LOSS) | 156 | |
| NOTE 3 | CASH, CASH EQUIVALENTS AND OTHER | NOTE 18 | INCOME TAX EXPENSES | 157 | |
| CURRENT FINANCIAL ASSETS | 141 | NOTE 19 | PERSONNEL | 157 | |
| NOTE 4 | TRADE RECEIVABLES | 141 | NOTE 20 | AFFILIATED COMPANIES | 158 |
| NOTE 5 | OTHER CURRENT ASSETS | 141 | NOTE 21 | OFF-BALANCE SHEET COMMITMENTS | 159 |
| NOTE 6 | PROPERTY, PLANT AND EQUIPMENT | 142 | NOTE 22 | SEGMENT INFORMATION | 159 |
| NOTE 7 | INTANGIBLE ASSETS | 143 | NOTE 23 | BREAKDOWN OF ASSETS AND LIABILITIES | |
| NOTE 8 | NON-CURRENT FINANCIAL ASSETS | 144 | BY MATURITY | 159 | |
| NOTE 9 | OTHER NON-CURRENT ASSETS | 145 | NOTE 24 | FINANCIAL RISK MANAGEMENT OBJECTIVES AND POLICIES |
160 |
| NOTE 10 | FINANCIAL LIABILITIES | 146 | NOTE 25 | COMPENSATION PAID TO MEMBERS OF | |
| NOTE 11 | PROVISIONS FOR RISKS AND EXPENSES | 148 | ADMINISTRATIVE AND MANAGEMENT BODIES |
163 | |
| NOTE 12 | OTHER LIABILITIES | 149 | |||
| NOTE 13 | EMPLOYEE BENEFITS | 149 | NOTE 26 | STATUTORY AUDITORS' FEES | 163 |
| NOTE 27 | EVENTS AFTER THE REPORTING PERIOD | 163 |

The accounting principles used to prepare the consolidated financial statements are in accordance with IFRS standards and interpretations as adopted by the European Union as of December 31, 2021.
| Standard/Interpretation | Date of application per IASB (fiscal years beginning on or after) |
Date of expected European Union application (at the latest for the fiscal years beginning on or after) |
|---|---|---|
| Amendments to IFRS 4: Extension of the temporary exemption from the application of IFRS 9 |
01/01/2021 | 01/01/2021 |
| Amendments to IFRS 9, IAS 39, IFRS 37, IFRS 4 and IFRS 16 interest rate benchmark reform, phase 2 |
01/01/2021 | 01/01/2021 |
| Amendments to IFRS 16 on rent concessions applicable to rent concessions obtained after June 30 |
01/01/2021 | 01/01/2021 |
These amendments and decisions had no impact on the Company's financial statements as of December 31, 2021.
In addition, the decisions issued by IFRIC in 2021 had no impact on the Company's financial statements, with the exception of the decision relating to the allocation of benefits to periods of service rendered by the beneficiaries of post-employment benefit plans (Note 2).
| Standard/Interpretation | Date of application per IASB (fiscal years beginning on or after) |
Date of EU application (at the latest for the fiscal years beginning on or after) |
|---|---|---|
| Amendments to IAS 16: Revenue recognition prior to the | ||
| commencement of operations | 01/01/2022 | 01/01/2022 |
| Amendments to IAS 37: Loss-making contracts | 01/01/2022 | 01/01/2022 |
| Amendments to IFRS 3: Reference to the Conceptual Framework | 01/01/2022 | 01/01/2022 |
| Annual improvements to the standards 2018 - 2020 cycle | 01/01/2022 | 01/01/2022 |
| Amendments to IAS 1: Presentation of Financial Statements and | ||
| Disclosures on Accounting Principles and Methods | 01/01/2023 | 01/01/2023 |
| Amendment to IAS 8: Definition of an accounting estimate | 01/01/2023 | 01/01/2023 |
| Amendment to IFRS 10 and IAS 28 | 01/01/2023 | 01/01/2023 |
| Amendment to IAS 12: Deferred taxes related to assets and | ||
| liabilities arising from a single transaction | 01/01/2023 | 01/01/2023 |
| IFRS 14: Regulatory Deferral Accounts | 01/01/2023 | 01/01/2023 |
| IFRS 17: Insurance Contracts incorporating Amendments | 01/01/2023 | 01/01/2023 |
The Company does not expect the application of these standards to have a significant impact. There are no standards, amendments and interpretations published by the IASB whose application is mandatory for fiscal years beginning on or after January 1, 2021, that have not yet been approved at the European level (and whose early application is not possible at the European level) that would have a significant impact on the consolidated financial statements.
The consolidated financial statements were prepared in accordance with the general IFRS principles: fair presentation, going concern, accrual basis of accounting, consistency of presentation, and materiality.
In view of the capital increase carried out in June 2021, the Company's cash, cash equivalents and other current financial assets, the going concern principle was retained. The Company has financial visibility until the end of 2023.
Transgene's management made estimates and assumptions in preparing the financial statements in accordance with IFRS, which may have an impact on the assets and liabilities, and the reported amounts of income and expenses for the financial period. Actual results may be significantly different from these estimates.
The principal assumptions and estimates that could impact the Company's financial statements are:
In view of the Group's business, management considers that the fixed assets form part of a single cash-generating unit. At each reporting date, the Company assesses whether there is any indication that an asset may be impaired. In the presence of such a presumption, or when annual impairment testing is required for an asset, the Company makes an estimate of the recoverable amount of the asset. The recoverable amount of an asset or a cash-generating unit is the higher of its fair value less costs of disposal and its value in use. The recoverable amount is determined on an individual basis unless the asset generates cash inflows that are largely dependent on other assets or groups of assets. An impairment is recognized when the asset's carrying amount is higher than its recoverable amount. Its carrying amount is then written down to its recoverable amount. The value in use corresponds to the estimated future cash flows, discounted at a pre-tax rate that reflects current market assessments of the time value of money and the risks specific to the asset.
The Covid-19 pandemic has had a moderate impact on Transgene's activities in 2021. As of the date of this document, this has mainly impacted clinical studies that have been delayed due to the slowdown in patient recruitment or the length of time taken by the regulatory authorities to authorize the launch or the amendment of clinical studies, particularly in 2020.
If containment and global spread were to continue, the impact of the disease and the containment measures adopted by governments and the civil society could cause dysfunction in the supply and shipping chain on which the Company depends, lack of visibility in the scientific community due to the cancelation of international conferences, disorganization of the clinical sites participating in its clinical studies, delay or inability to produce its drug candidates, or even temporary closure of our establishments. As of today, the Company cannot be assured that it would be possible to implement its clinical study program under the conditions and within the time frame initially planned, if one or more of these risks should materialize. The occurrence of these risks would also have a downward impact on the Company's anticipated level of expenses, as well as on expected revenues from collaborations. This financial impact is difficult to quantify precisely at the date of this document.
The consolidated financial statements include the financial statements of Transgene, Transgene, Inc. and Transgene BioPharmaceutical Technology (Shanghai) Co. Ltd. ("Transgene Shanghai"), wholly owned subsidiaries whose registered offices are located in Boston, Massachusetts (United States) and Shanghai (China) respectively. These companies are fully consolidated. Intragroup balances and transactions are eliminated in consolidation, together with intragroup profits included in the carrying amount of assets.
The consolidated income statement is presented by function: research and development expenses and general and administrative expenses (Notes 15 to 17).
The currency used by the Company for the preparation of the consolidated financial statements is the euro.
The financial statements of Transgene, Inc. are prepared in US dollars.
The financial statements of Transgene Shanghai are prepared in yuan.
The balance sheets of Transgene, Inc. and Transgene Shanghai have been converted into euros using the exchange rate at the reporting date and in the income statement using the exchange rate of the month of accounting. Differences arising from conversion are recognized in equity.
In accordance with IAS 21 "Effects of changes in foreign exchange rates", transactions carried out in a foreign currency are translated at the exchange rate on the transaction date. Exchange rate differences resulting from differences between the transaction recording date and the payment date are recognized under the corresponding headings in the income statement (sales and purchases in the case of commercial transactions). Debts and receivables denominated in foreign currencies are translated at the closing rate of December 31, 2021, with the resulting translation difference recognized in profit or loss at the end of the fiscal year.

ANNUAL FINANCIAL STATEMENTS AT DECEMBER 31, 2021
Consolidated financial statements and notes
At the reporting date, foreign currency cash and cash equivalents, receivables and payables are converted into euros at the exchange rate on the reporting date. The resulting translation differences are recognized in the income statement.
Transgene did not use any currency hedging instruments in 2020 and 2021.
Transgene's cash reserves are invested mainly in low volatility and highly liquid, highly rated mutual funds (net asset value known daily). They are classified as available-for-sale financial assets and valued at their fair value under equity because these investments correspond either to bank accounts or to very short-term investments that do not present any risk of changes in value.
Trade receivables are recognized at amortized cost, which corresponds to their nominal value. All trade receivables are impaired when they are recorded, in the amount of losses expected at maturity.
These are cash investments with the Institut Mérieux, the principal shareholder of Transgene, under a "Group" cash management agreement. Contractually, investments made by the Company as part of the centralized cash management are liquid within a maximum period of four business days and bear interest based on a rate equal to Euribor +0.25% when Institut Mérieux is in a net borrowing position at the Group level and to Euribor when Institut Mérieux is in a net surplus at the Group level.
Prepaid expenses are measured at their nominal value, and the other current assets are initially recognized at cost and are subsequently measured at the lower of cost and net realizable value.
Property, plant and equipment are measured at cost less accumulated depreciation and any accumulated impairment losses, in accordance with the benchmark treatment under IAS 16.
Straight-line amortization is recognized based on the useful life of the asset by the Company, using the following periods:
| Type of asset | Period of depreciation |
|---|---|
| Buildings | 20-50 years |
| Fixtures and fittings | 10-20 years |
| Machinery and equipment (machinery and laboratory equipment) | 5-15 years |
| Office equipment and furniture | 5-10 years |
| IT equipment | 3-5 years |
Fixed asset elements and their residual value are accounted for in the depreciation if the value thereof is deemed significant.
Property, plant and equipment are tested for impairment whenever there is an indication that their recoverable amount may be less than their carrying amount.
Straight-line amortization is recognized based on the useful life of the asset by the Company, using the following periods:
| Type of intangible asset | Period of depreciation |
|---|---|
| Computer software and licenses | 1-5 years |
| Patents acquired | 5 years |
Intangible assets consist of the acquisition costs of software with IAS 38. and intellectual property licenses that are capitalized and amortized over their useful lives. The elements of intellectual
Purchased intangible assets property acquired are recognized as assets in accordance
Research expenses are expensed in the income statement in the period in which they are incurred.
Development costs incurred for the development of pharmaceutical products are capitalized when the requirements of IAS 38 are met. Given the nature of its products, the Company believes that the six criteria set out in IAS 38 "Intangible assets" are deemed to be met only at the time of the filing of an application for market authorization. The development expenses capitalized will be appropriately amortized over their useful life. No Company product received a marketing authorization in 2021.
Patents and licenses acquired in connection with internal R&D projects are also recognized according to an identical principle. They are recognized as an expense during the research phase and are capitalized during the development phase when IAS 38 criteria are met.
Financial assets consist of:
The valuation of non-consolidated investments without significant influence is based on an analysis using the fair value method. This valuation is periodically reviewed at each reporting date. Any impact resulting from this periodic valuation is recognized in the income statement.
Earn-outs due are valued at amortized cost and revalued each year based on expected changes in cash flow. Future cash flows are re-estimated and discounted each year-end based on the progress of the programs concerned and estimated success rates for each clinical phase. The impact of this re-estimate is recognized in financial income/loss.
Other financial assets are recorded at cost and depreciated, as needed, if their carrying value exceeds their recoverable amount as estimated by the Company.
Transgene uses the balance sheet method for recognizing deferred taxes. Using this method, deferred taxes are calculated on the basis of the temporary differences between the tax values and the carrying amount of assets and liabilities presented in the balance sheet.
Deferred taxes are evaluated using the liability method, on the basis of the tax provisions and tax rates applied when these differences invert.
Deferred tax assets are recognized for all deductible temporary differences, as well as for unused tax loss carry-forwards, carryback credits and other tax credits when it is probable that sufficient taxable profit shall be available against which the unused tax losses or unused tax credits can be used. Their posting is limited to the amount of deferred tax liabilities.
Deferred tax liabilities are recognized for all taxable temporary differences.
The carrying amount of deferred tax assets is reviewed at each period end and reduced to the extent that it is no longer probable that a taxable profit will be available to allow the deferred tax asset to be used. To assess the likelihood that taxable income will be available, consideration was given to the history of the results of previous years, forecasts of future results, non-recurring items not likely to recur in the future and the entity's fiscal policy. As a result, assessing the probability that unused tax losses or tax credits can be used involves a degree of judgment on the part of management.
Deferred taxes on items recognized directly in equity are also recorded in equity without affecting the income statement.
Provisions are recorded to cover contingencies and charges arising in the course of our business.
Conditional advances are only reimbursed if the research and development projects that they finance are successful, according to criteria set out in advance with the financing body. They are recognized under long-term financial debt in accordance with IAS20.
Conditional advances received as part of the ADNA program are recorded according to IRFS 9, based on discounted expected future reimbursements. The reimbursement of advances is subject to the fulfillment of a revenue threshold on TG4001 predetermined for the following five years, and in proportion to the revenue from this product until a reimbursement ceiling is reached, or up until 2035.
The Company evaluates at each closing date the direct and indirect revenue linked to the product to estimate future cash flows from the reimbursement of advances. These revenues are evaluated based on an updated business plan for this product and by a applying a comparable rate for this type of debt. The impact of this regular re-estimate is recorded in Net financial costs at the end of the fiscal year.

ANNUAL FINANCIAL STATEMENTS AT DECEMBER 31, 2021
Consolidated financial statements and notes
The main assumptions reviewed in the product business plan are as follows:
Conditional advances received as part of the NEOVIVA program are recognized according to IRFS 9, based on discounted expected future reimbursements.
In accordance with the prevailing laws and practices in France, Transgene offers certain benefits to ensure eligible employees receive a lump sum payment at the time of retirement (lump-sum retirement benefits). The Group's obligation under these defined benefit plans may be funded by plan assets consisting of various instruments, in line with the relevant government regulations.
The rights acquired by active staff are estimated using actuarial valuations based on the probability of death and continued employment by the Company, as well as expected future salaries. Commitments are valued using the projected credit unit method. The value of the commitments was calculated using the new valuation method recommended by the IFRIC in its April 2021 decision on the allocation of service costs associated with a defined benefit plan.
Capital increase expenses net of deferred tax where applicable are charged directly against the issuance premium, once the increase is completed.
The Company has access to a liquidity contract with a bank partner, making €500 thousand available. At closing date, treasury shares are restated as a deduction from equity. The profit/(loss) from the purchase and sale of treasury shares is transferred from income to equity, net of tax.
Revenue is recognized in accordance with IFRS 15. Under IFRS 15, revenue is recognized when the Company fulfills a performance obligation by supplying distinct goods or services (or a series of goods or services) to a client, i.e. when the client obtains control of these goods or these services. An asset is transferred when the client obtains control of this asset (or service).
Given the wide range of research and development opportunities in the therapeutic field, in addition to the fields in which the Company carries out research and development activities with its own scientific and financial resources, the Company concludes license and partnership agreements with third parties in certain specific fields that generate revenue. Consequently, each contract is analyzed, case by case, to determine whether it contains performance obligations towards the other party and, if so, to identify their nature in order to determine the appropriate accounting of the amounts that the Company received or is entitled to receive from the other party, according to the principles of IFRS 15. For example:
Potential revenue from attainment of project milestones or royalties on sales is not recognized prior to reaching the milestone or the completion of the sale.
Certain research and development expenses in France are entitled to a research tax credit recognized at the end of the year in which the expense was recorded and the tax credit claimed. If it has not been used by allocation to a tax charge, the tax credit may be redeemed in accordance with the tax provisions.
Research tax credits are recognized in the income statement under Government grants in accordance with IAS 20.
Consolidated financial statements and notes
Transgene receives government subsidies from local, national or regional bodies that cover all or part of the research and development on specific projects or topics. This assistance can take the form of subsidies or conditional advances.
Regarding subsidies, the Company recognizes on the income statement at the line Public financing of research expenses the portion of subsidies due under the agreements based on the percentage of expenses incurred as of the reporting date.
Research expenses are expensed in the income statement in the period in which they are incurred.
Development costs will be capitalized only when the requirements of IAS 38 are met.
The Company co-develops certain products with partners, including BioInvent and NEC. As such, the companies re-invoice their respective contributions to the project concerned, according to contractual terms. The Company recognizes these re-invoiced revenues/expenses as a reduction/increase in its research and development expenses, in accordance with IFRS 11.
The Company has share-based compensation plans giving rise to equity instruments (stock options or free share grants). The fair value of services provided by directors and employees in exchange for the grant of these instruments is recognized in expenses with an offsetting entry in equity. The total recognized in expenses for the vesting period is determined relative to the fair value of the stock options or the bonus shares on the allocation date. The amount of the expense is measured based on the estimated number of employees that will meet the vesting conditions under the terms of the plan.
Basic earnings per share are obtained by dividing the net income attributable to Company shareholders by the average weighted number of shares outstanding during the corresponding period (less shares intended to be awarded to employees as part of free share plans and treasury shares destined for stock market adjustment purposes).
Diluted earnings per share are obtained from the number of shares defined in basic earnings plus the weighted average number of potential shares to be issued and which would have a dilutive effect on earnings.
The CVAE is recorded, if any, in operating expenses under General and administrative expenses.

In May 2021, the IFRS Interpretation Committee (IRFS IC) published in the IFRIC Update a decision on the methods for distributing the cost of post-employment benefit plans over time, presenting the following features:
This decision is effective as of December 31, 2021. As this is a change in method to be applied retrospectively in accordance with IAS 8, the impact of first-time application must be recognized in equity at the beginning of the period, i.e. on January 1, 2020. This change in method had no impact on the income statement.
Financial information published on January 1 and December 31, 2020 are amended as follows:
| (in € thousands) | Dec. 31, 2019 | IFRIC impact | Jan. 1, 2020 IFRIC |
|---|---|---|---|
| NON-CURRENT LIABILITIES | |||
| Of which Employee benefits | 4,427 | (466) | 3,961 |
| Total non-current liabilities | 31,134 | (466) | 30,668 |
| Total liabilities | 49,780 | (466) | 49,314 |
| EQUITY | |||
| Of which Retained earnings | (37,444) | 466 | (36,978) |
| Total equity attributable to the Company's shareholders | 65,697 | 466 | 66,163 |
| TOTAL LIABILITIES AND EQUITY | 115,477 | - | 115,477 |
| (in € thousands) | Dec. 31, 2020 | IFRIC impact | Dec. 31, 2020 IFRIC |
|---|---|---|---|
| NON-CURRENT LIABILITIES | |||
| Of which Employee benefits | 4,526 | (466) | 4,060 |
| Total non-current liabilities | 21,574 | (466) | 21,108 |
| Total liabilities | 35,203 | (466) | 34,737 |
| EQUITY | |||
| Of which Retained earnings | (14,327) | 466 | (13,861) |
| Total equity attributable to the Company's shareholders | 50,250 | 466 | 50,716 |
| TOTAL LIABILITIES AND EQUITY | 85,453 | - | 85,453 |
Consolidated financial statements and notes
| (in € thousands) | Dec. 31, 2021 | Dec. 31, 2020 |
|---|---|---|
| Cash | 5,903 | 5,269 |
| Cash equivalents | 8 | 8 |
| Cash and cash equivalents | 5,911 | 5,277 |
| Other current financial assets | 43,658 | 21,077 |
| TOTAL CASH, CASH EQUIVALENTS AND OTHER CURRENT FINANCIAL ASSETS | 49,569 | 26,354 |
| Impact of applying the fair value recognized in financial income to the income statement |
- | - |
Cash equivalents consist of a time deposit account.
Other current financial assets consist of investments made through a cash pool set up by the Institut Mérieux group.
| (in € thousands) | Dec. 31, 2021 | Dec. 31, 2020 |
|---|---|---|
| Total gross | 10,133 | 1,667 |
| Provisions for impairment | - | - |
| NET TOTAL TRADE RECEIVABLES | 10,133 | 1,667 |
As of December 31, 2021, trade receivables mainly concern AstraZeneca receivables for an amount of €8,091 thousand, of which €7,063 thousand related to the exercise of the license option in December 2021 for an oncolytic virus developed by Transgene.
Trade receivables also include receivables from our co-development partners NEC for €1,322 thousand and BioInvent for €504 thousand at December 31, 2021.
| (in € thousands) | Dec. 31, 2021 | Dec. 31, 2020 |
|---|---|---|
| Research tax credits, current portion | 109 | 133 |
| State-recoverable VAT and tax receivables | 758 | 388 |
| Accrued credit notes | 48 | 14 |
| Employee benefits expense | 33 | 29 |
| Grant receivable | 24 | 49 |
| Prepaid expenses, current portion | 1,380 | 1,908 |
| Other current receivables | 191 | 145 |
| TOTAL OTHER CURRENT ASSETS | 2,543 | 2,666 |

ANNUAL FINANCIAL STATEMENTS AT DECEMBER 31, 2021
Consolidated financial statements and notes
Prepaid expenses are primarily related to manufacturing the Responsible Pharmacist some months after their contracts with ABL Europe. Contracts are signed several production following quality control. Transfer of property months prior to manufacturing in order to guarantee the takes place when the batch is released. production date. The batches produced are then released by
| (in € thousands) | Dec. 31, 2020 | Increase | Decrease | Dec. 31, 2021 |
|---|---|---|---|---|
| GROSS CARRYING AMOUNT | ||||
| Land | 1,771 | - | - | 1,771 |
| Buildings and fixtures | 17,285 | 187 | - | 17,472 |
| Right-of-use | 205 | - | - | 205 |
| Laboratory equipment | 11,997 | 340 | (211) | 12,126 |
| Office and computer equipment | 1,651 | 81 | (58) | 1,674 |
| Assets in progress | 65 | 405 | (368) | 102 |
| Total gross carrying amount of property, plant and equipment | 32,974 | 1,013 | (637) | 33,350 |
| DEPRECIATION, AMORTIZATION AND IMPAIRMENT | ||||
| Buildings and fixtures | (10,519) | (831) | - | (11,350) |
| Right-of-use | (124) | (68) | - | (192) |
| Laboratory equipment | (7,745) | (1,489) | 210 | (9,024) |
| Office and computer equipment | (1,476) | (70) | 57 | (1,489) |
| Total depreciation, amortization and impairment | (19,864) | (2,458) | 267 | (22,055) |
| NET BOOK VALUE OF PROPERTY, PLANT AND EQUIPMENT | 13,110 | (1,445) | (370) | 11,295 |
| (in € thousands) | Dec. 31, 2019 | Increase | Decrease | Dec. 31, 2020 |
|---|---|---|---|---|
| GROSS CARRYING AMOUNT | ||||
| Land | 1,771 | - | - | 1,771 |
| Buildings and fixtures | 16,385 | 900 | - | 17,285 |
| Right-of-use | 205 | - | - | 205 |
| Laboratory equipment | 10,856 | 1,318 | (177) | 11,997 |
| Office and computer equipment | 1,655 | 84 | (88) | 1,651 |
| Assets in progress | 793 | - | (728) | 65 |
| Total gross carrying amount of property, plant and equipment | 31,665 | 2,302 | (993) | 32,974 |
| DEPRECIATION, AMORTIZATION AND IMPAIRMENT | ||||
| Buildings and fixtures | (9,734) | (785) | - | (10,519) |
| Right-of-use | (55) | (69) | - | (124) |
| Laboratory equipment | (7,088) | (819) | 162 | (7,745) |
| Office and computer equipment | (1,505) | (59) | 88 | (1,476) |
| Total depreciation, amortization and impairment | (18,382) | (1,732) | 250 | (19,864) |
| NET BOOK VALUE OF PROPERTY, PLANT AND EQUIPMENT | 13,283 | 570 | (743) | 13,110 |
As of December 31, 2021, the Company has fully depreciated the equipment acquired in 2015 and on the Genzyme Polyclonals site for an amount of €682 thousand, given the prospects for using the equipment.
The depreciation expense for the property, plant and equipment reported in Transgene's income statement breaks down as follows:
| (in € thousands) | Dec. 31, 2021 | Dec. 31, 2020 |
|---|---|---|
| Research and development expenses | 1,726 | 1,687 |
| General and administrative expenses | 50 | 45 |
| Other Expenses | 682 | - |
| TOTAL DEPRECIATION EXPENSES FOR PROPERTY, PLANT AND EQUIPMENT | 2,458 | 1,732 |
| (in € thousands) | Dec. 31, 2020 | Increase | Decrease | Dec. 31, 2021 |
|---|---|---|---|---|
| GROSS CARRYING AMOUNT | ||||
| Intangible assets | 3,096 | 24 | (3) | 3,117 |
| Intangible assets in progress | 9 | 1 | (10) | - |
| Total gross carrying amount of intangible assets | 3,105 | 25 | (13) | 3,117 |
| DEPRECIATION, AMORTIZATION AND IMPAIRMENT | ||||
| Intangible assets | (2,964) | (66) | 5 | (3,025) |
| Total depreciation, amortization and impairment | (2,964) | (66) | 5 | (3,025) |
| NET BOOK VALUE OF INTANGIBLE ASSETS | 141 | (41) | (8) | 92 |
| (in € thousands) | Dec. 31, 2019 | Increase | Decrease | Dec. 31, 2020 |
|---|---|---|---|---|
| GROSS CARRYING AMOUNT | ||||
| Intangible assets | 4,277 | 32 | (1,213) | 3,096 |
| Intangible assets in progress | - | 9 | - | 9 |
| Total gross carrying amount of intangible assets | 4,277 | 41 | (1,213) | 3,105 |
| DEPRECIATION, AMORTIZATION AND IMPAIRMENT | ||||
| Intangible assets | (4,130) | (47) | 1,213 | (2,964) |
| Total depreciation, amortization and impairment | (4,130) | (47) | 1,213 | (2,964) |
| NET BOOK VALUE OF INTANGIBLE ASSETS | 147 | (6) | - | 141 |
The depreciation expense for the intangible assets reported in Transgene's income statement breaks down as follows:
| (in € thousands) | Dec. 31, 2021 | Dec. 31, 2020 |
|---|---|---|
| Research and development expenses | 12 | 23 |
| General and administrative expenses | 39 | 11 |
| TOTAL DEPRECIATION EXPENSES FOR INTANGIBLE ASSETS | 51 | 34 |

| (in € thousands) | Dec. 31, 2020 | Increase | Change in fair value through the income statement |
Decrease | Dec. 31, 2021 |
|---|---|---|---|---|---|
| FAIR VALUE | |||||
| Non-consolidated equity securities without significant influence: |
32,507 | - | 3,897 | (17,259) | 19,145 |
| Tasly BioPharmaceuticals |
32,339 | - | 3,855 | (17,259) | 18,935 |
| Vaxxel SAS |
168 | - | 42 | - | 210 |
| Other financial assets | 1,535 | 380 | - | (288) | 1,627 |
| FAIR VALUE | 34,042 | 380 | 3,897 | (17,547) | 20,772 |
| (in € thousands) | Dec. 31, 2019 | Increase | Change in fair value through the income statement |
Decrease | Dec. 31, 2020 |
|---|---|---|---|---|---|
| FAIR VALUE | |||||
| Non-consolidated equity securities without significant influence: |
41,458 | 118 | 10,005 | (19,074) | 32,507 |
| Tasly BioPharmaceuticals |
41,458 | - | 9,646 | (18,765) | 32,339 |
| Vaxxel SAS |
- | 118 | 50 | - | 168 |
| ElsaLys Biotech SA |
- | - | 309 | (309) | - |
| Other financial assets | 1,473 | 403 | - | (341) | 1,535 |
| FAIR VALUE | 42,931 | 521 | 10,005 | (19,415) | 34,042 |
The €18,935 thousand of non-consolidated equity securities without significant influence refer to the shares in Tasly BioPharmaceuticals obtained in July 2018 in exchange for the rights held in the Transgene Tasly (Tianjin) BioPharmaceutical Co. Ltd. joint venture and the rights to the product TG1050 for Greater China.
On September 22, 2021, the Company sold 49% of the shares it held, resulting in a reduction of €17,259 thousand. The remaining shares were valued at the price of this recent transaction, resulting in an increase of €2,442 thousand. Transgene holds 8.7 million shares of Tasly BioPharmaceuticals, i.e. 0.8% of its capital, valued at approximately ¥136 million or €18,935 thousand.
As a result of this transaction, the shareholders' agreement was amended in December 2021. This new agreement now provides that the commitment to buy back Transgene's shares by a holding company of the Tasly Group will be triggered in the absence of an IPO of Tasly Biopharmaceuticals by September 30, 2022.
These securities were valued at fair value with an offsetting entry in the income statement at the reporting date. As of December 31, 2021, the Company does not intend to dispose of Talsy BioPharmaceuticals shares in the short term, due to its ongoing IPO process. Once the IPO is completed, the Company will not be able to sell the shares held during a one-year post-IPO holding period.
In order to corroborate the fair value of the shares as of December 31, 2021 against the sale price recorded at the time of the September 2021 sale transaction and to ensure that this price remains representative of the fair value of the shares as of December 31, 2021, an independent consulting firm has reviewed and updated the model used, as well as the assumptions as of the closing date, on the basis of the elements related to the September 2021 transaction and the information provided by Tasly BioPharmaceuticals, including the financial statements as of December 31, 2020. This independent analysis confirms the appropriateness of the fair value retained at December 31, 2021.
The main assumptions used by management in measuring fair value as at December 31, 2021, were based on the assumptions obtained from Tasly BioPharmaceuticals and concern:
The valuation of these securities is directly impacted by the fluctuation of the euro/yuan parity. A 10% rise in the yuan would increase the value of the securities by 11%. A 10% fall in the yuan would decrease it by 9%.
In 2020, in exchange for the rights to the DuckCelt® -T17 cell line, the Company acquired 10% of the share capital of Vaxxel SAS at the time of the transaction. A refinancing transaction carried out by Vaxxel SAS in April 2021 led the Company to revalue its securities based on the valuation implied by this operation, leading to an increase in the equity investment valuation of €42 thousand. This price corresponds to the market price. The Company could also receive earn-outs of up to €4 million. As of December 31, 2021, the realization of the earn-outs is considered uncertain and distant. As a result, no earnout is recognized in the financial statements.
The increase in other financial assets in 2021 was primarily due to the holdback with respect to the use of the 2020 research tax credit in the amount of €318 thousand.
The decrease in other financial assets relates mainly to repayment of the holdback to guarantee the bank financing of the 2017 research tax credit in the amount of €270 thousand.
| (in € thousands) | Dec. 31, 2021 | Dec. 31, 2020 |
|---|---|---|
| RTC, non-current portion | 7,027 | 6,352 |
| Tax credit for Competitiveness and Employment (CICE), non-current portion | - | 109 |
| Other receivables, non-current portion | - | 276 |
| Prepaid expenses, non-current portion | 276 | 383 |
| Other non-current assets | 131 | 353 |
| TOTAL OTHER NON-CURRENT ASSETS | 7,434 | 7,473 |
€7,027 thousand for the 2021 Research tax credit (RTC) and a the French State. The Company has thus received €5,500, receivable of €109 thousand in respect of the competitiveness €6,288 and €6,034 thousand respectively for the 2018, 2019 and employment tax credit from 2018 (current portion). These and 2020 research tax credits (representing 95% financing). receivables can be used to offset income tax payments. If As this type of contract is deconsolidating, no liability is they are not used, they may be repaid in cash according to recognized in respect of this financing received. However, the the following schedule, in accordance with current tax rules Company remains liable for the amounts declared in the event (in € thousands). Given the absence of taxable income, these of a tax audit. Tax credit for CICE financing is not receivables are reimbursed after a period of three years by deconsolidating. The Company retains its receivable from the the French tax authorities. The Company has signed an State. agreement with a credit institution for the assignment of research tax credits for each of its 2018, 2019 and 2020
At December 31, 2021, the Company had a receivable of research tax credits, and no longer has any receivables from

Consolidated financial statements and notes
| Reference year | Year of expected reimbursement |
Bank financing |
Dec. 31, 2021 | Dec. 31, 2020 |
|---|---|---|---|---|
| RTC, NON-CURRENT PORTION | ||||
| 2020 | 2024 | Yes | - | 6,352 |
| 2021 | 2025 | No | 7,027 | - |
| Total non-current portion | 7,027 | 6,352 | ||
| TOTAL RTC | 7,027 | 6,352 | ||
| CICE, CURRENT PORTION | ||||
| 2017 | 2021 | Yes | - | 133 |
| 2018 | 2022 | Yes | 109 | - |
| Total current portion | 109 | 133 | ||
| CICE, NON-CURRENT PORTION | ||||
| 2018 | 2022 | Yes | - | 109 |
| Total non-current portion | - | 109 | ||
| TOTAL CICE | 109 | 242 |
In 2020, the sale agreement of ElsaLys Biotech SA shares, earnouts relating to future income from patent licenses and from a product for which the rights are held by ElsaLys Biotech SA were agreed upon.
As of December 31, 2021, ElsaLys has not sold the patent rights, and the revenue from the product concerned by the agreement does not generate a sufficient level of revenue for the Company to recognize an earn-out.
The following table breaks down financial liabilities by maturity:
| (in € thousands) | Dec. 31, 2021 | Dec. 31, 2020 |
|---|---|---|
| Financial liabilities, current portion | 1,395 | 1,426 |
| Financial liabilities, non-current portion | 15,241 | 16,938 |
| FINANCIAL LIABILITIES | 16,636 | 18,364 |
As of December 31, 2021, the main financial liabilities concern property financial lease (head office and main research and development laboratories) and conditional advances received by Bpifrance under the ADNA and NEOVIVA subsidized programs.
| (in € thousands) | Dec. 31, 2021 | Dec. 31, 2020 |
|---|---|---|
| Property leasing | 947 | 894 |
| Equipment leasing | 314 | 313 |
| Lease obligation | 20 | 56 |
| Financing of CICE | 114 | 118 |
| Interest on bank loan | - | 45 |
| FINANCIAL LIABILITIES, CURRENT PORTION | 1,395 | 1,426 |
Consolidated financial statements and notes
| (in € thousands) | Dec. 31, 2021 | Dec. 31, 2020 |
|---|---|---|
| Property leasing | 2,098 | 3,045 |
| Equipment leasing | 351 | 665 |
| Lease obligation | - | 33 |
| Interest rate swap | 51 | 112 |
| Conditional advances | 12,741 | 12,969 |
| Financing of CICE | - | 114 |
| FINANCIAL LIABILITIES, NON-CURRENT PORTION | 15,241 | 16,938 |
In April 2019, the Company signed a revolving credit agreement with Natixis, capped at €20 million, which can be drawn down on one or more occasions. Transgene was to pledge the shares held in Tasly BioPharmaceuticals. An amendment was signed in September 2020 bringing this credit line to a maximum of €15 million, following the partial disposal of Tasly BioPharmaceuticals shares in July 2020.
Following the second disposal of Tasly BioPharmaceuticals shares in September 2021, the credit facility was fully canceled, in accordance with the terms of the contract
The Company had not drawn down on this credit facility.
In December 2008, Transgene invested in a building housing labs and offices on the Illkirch-Graffenstaden site, in the suburbs of Strasbourg. Land and construction costs for the 6,900 sq.m. building totaled €15.6 million. This investment was financed by a 15-year finance lease, signed with a banking consortium in October 2007, with a residual value of €1.1 million. The first lease payment was made on January 1, 2009.
The balance of the principal amount at December 31, 2021, was €3,045 thousand, compared to €3,939 thousand at December 31, 2020. The following table shows the breakdown of this debt, based on the maturity, financial costs and present value of individual payments:
| Dec. 31, 2021 | Dec. 31, 2020 | |||
|---|---|---|---|---|
| Minimum payments |
Present value of the payments |
Minimum payments |
Present value of the payments |
|
| Due within one year | 978 | 967 | 935 | 930 |
| Due in one to five years | 2,116 | 2,072 | 3,095 | 3,039 |
| More than five years | - | - | - | - |
| Total future minimum lease payments | 3,094 | 3,039 | 4,030 | 3,969 |
| Finance costs included in the total | 48 | 48 | 90 | 89 |
| Outstanding principal: | 3,045 | 2,992 | 3,939 | 3,880 |
| of which current | 947 | 937 | 894 | 889 |
| of which non-current | 2,098 | 2,054 | 3,045 | 2,991 |
Transgene has acquired various pieces of laboratory totaled €665 thousand at December 31, 2021. equipment under financial leases. At December 31, 2021, the
Equipment leasing Company owned two pieces of leased equipment. The outstanding financial obligation under this financial lease

ANNUAL FINANCIAL STATEMENTS AT DECEMBER 31, 2021
Consolidated financial statements and notes
At December 31, 2021, conditional advances referred to repayable advances received under the ADNA program, which receives public financing from Bpifrance to develop the TG4010 and TG4001 products. This program ended on December 31, 2016. Transgene received a total of €15,942 thousand of conditional advances under this program.
As at December 31, 2021, the liability consisting of conditional advances in the Company's balance sheet amounts to €11,645 thousand. At each closing, the Company re-values its repayable advances received under the ADNA program based on the discounted expected future reimbursements as described in Note 1 to the Annual financial statements.
Repayment of these advances is conditional on reaching a certain revenue threshold with TG4001 and will be made in a fixed and predetermined amount during the following five years, then in proportion to the revenues of this product until a repayment ceiling is reached or in 2035. The expected future reimbursement flows are therefore estimated on the basis of an evaluation of the future direct and indirect revenues associated with TG4001 during its development. Other assumptions taken into account by Management in the valuation of the reimbursable advance liability include:
At December 31, 2021, the discount rate used was 7.5%.
A sensitivity analysis on:
Under the NEOVIVA program, signed in March 2019, Transgene could receive conditional advances of €2.4 million.
At December 31, 2021, the Company had received €1,495 thousand in conditional advances. The fair value of that liability at December 31, 2021, was calculated as €1,096 thousand and, the discount rate used was 7.5%.
| (in € thousands) | Dec. 31, 2020 | Provisions | Retained earnings |
Reversals not applicable |
Use of the provision |
Dec. 31, 2021 |
|---|---|---|---|---|---|---|
| Provisions for risks | 5 | 1 | - | - | - | 6 |
| Provisions for expenses | 506 | - | - | (360) | (104) | 42 |
| PROVISIONS FOR RISKS AND EXPENSES | 511 | 1 | - | (360) | (104) | 48 |
The provision for expenses corresponds to the costs remaining to be incurred for the ongoing clinical trial with TG4010, which was halted at the end of 2019. This provision was used in the amount of €104 thousand during the fiscal year 2021.
At December 31, 2021, the Company reviewed the remaining costs to be incurred on this project and has decided to write back €360 thousand.
| (in € thousands) | Dec. 31, 2021 | Dec. 31, 2020 |
|---|---|---|
| Tax and social liabilities | 4,472 | 3,791 |
| Prepaid income, of which: | 972 | 2,827 |
| Revenue from collaboration and licensing | 942 | 2,666 |
| Research and development grants | - | - |
| Others | 30 | 161 |
| Other short-term payables | 10 | 8 |
| TOTAL OTHER CURRENT LIABILITIES | 5,454 | 6,626 |
| (in € thousands) | Dec. 31, 2021 | Dec. 31, 2020 |
|---|---|---|
| Prepaid income, of which: | 841 | 110 |
| Revenue from collaboration and licensing | 836 | - |
| Research and development grants | - | - |
| Others | 5 | 110 |
| Other short-term payables | - | - |
| TOTAL OTHER NON-CURRENT LIABILITIES | 841 | 110 |
Prepaid income refers mainly to the staggered payments of recognized in 2022 and 2023 (€1,314 thousand related to the US\$10 million from the collaboration agreement with upfront payment and €464 thousand related to services AstraZeneca signed in April 2019. As of December 31, 2021, provided by the Company). €1,778 thousand remained in deferred revenue, which will be
In accordance with French law, Transgene participates in the financing of pensions for employees in France through the payment of contributions calculated on the basis of wages to bodies that manage retirement programs. For certain of its employees in France, Transgene also makes contributions, again based on wages, to private supplementary pension entities. There are no other obligations related to these contributions. At December 31, 2021, the Company applied the new valuation method recommended by the IFRIC.
Transgene is also liable for statutory length-of-service awards payable to employees in France upon retirement. The compensation benefits are due only to employees on the Company's payroll at the time of retirement. The assumptions used to calculate these provisions for retirement are as follows:
| Dec. 31, 2021 | Dec. 31, 2020 | |
|---|---|---|
| Discount rate | 0.90% | 0.60% |
| Expected long-term inflation rate | 1.90% | 1.70% |
| Rate of future salary increases | 3.00% | 1.50% |
| Retirement age: | ||
| managers |
65 years | 65 years |
| non-managers |
63 years | 63 years |
The duration of these commitments is 9.8 years.

ANNUAL FINANCIAL STATEMENTS AT DECEMBER 31, 2021
Consolidated financial statements and notes
The following table summarizes the conditions and amounts of actuarial pension obligations at December 31, 2021 and 2020, according to IAS 19 revised:
| (in € thousands) | Dec. 31, 2021 | Dec. 31, 2020 |
|---|---|---|
| CHANGE IN THE VALUE OF COMMITMENTS | ||
| Projected benefit obligation at beginning of year | 4,060 | 3,961 |
| Cost of services rendered for the year | 293 | 280 |
| Cost of discounting | 22 | 33 |
| Services paid | (863) | (270) |
| Change in assumptions | 434 | 105 |
| Reductions/terminations | - | - |
| Actuarial (gain)/loss | 12 | (49) |
| Total projected benefit obligation for retirement | 3,958 | 4,060 |
| DEFINED BENEFIT COST FOR THE YEAR | ||
| Cost of services rendered for the year | 293 | 280 |
| Cost of discounting | 23 | 33 |
| Reductions/terminations | - | - |
| Total cost of services and discounting | 316 | 313 |
| REVALUATIONS OF NET LIABILITIES/(ASSETS) | ||
| Actuarial losses (gains) related to changes in demographic assumptions | 4 | (34) |
| Actuarial losses (gains) related to changes in financial assumptions | 429 | 139 |
| Actuarial losses (gains) related to experience | 12 | (49) |
| Total revaluations of net liabilities/(assets) | 445 | 56 |
| CHANGES IN NET LIABILITIES/(ASSETS) | ||
| Liability/(asset) at beginning of year | 4,060 | 4,427 |
| Changes in scope | - | (466) |
| Amount recognized in the income statement | 316 | 313 |
| Disbursements | (863) | (270) |
| Amount recognized in other comprehensive income/(loss) | 445 | 56 |
| Total liability/(asset) at end of year | 3,958 | 4,060 |
| ACCUMULATED AMOUNTS RECOGNIZED IN OTHER COMPREHENSIVE INCOME | ||
| Accumulated amounts recognized at beginning of year | 529 | 473 |
| Revaluations of net liabilities/(assets) for the year | 417 | 56 |
| Accumulated amounts recognized at end of year | 946 | 529 |
| Deferred taxes | - | - |
| Net cumulative amounts recognized as income/(loss) at end of year | 946 | 529 |
A sensitivity test of the discount rate quantified the impact on the value of the obligation and the cost of services:
Consolidated financial statements and notes
Transgene completed a €34,128,500 capital increase in June 2021. This transaction resulted in the creation of 13,930,000 new shares at €0.50, i.e. an increase in share capital of €6,965,000. The balance of the capital increase was recorded as issuance premium for €27,163,500.
As of December 31, 2021, 97,771,334 shares of Transgene were outstanding, representing a share capital of €48,885,667.
During 2021, the Boards of Directors authorized the granting of 2,299,956 free shares.
The following table reconciles basic and diluted earnings per share. The number of shares is calculated on a prorata temporis basis.
| Dec. 31, 2021 | Dec. 31, 2020 | |
|---|---|---|
| BASIC EARNINGS PER SHARE | ||
| Available net profit (in € thousands) | (19,536) | (17,231) |
| Average number of shares outstanding | 91,111,649 | 83,841,334 |
| Basic earnings per share (in €) | (0.21) | (0.21) |
| Diluted earnings per share (in €) | (0.20) | (0.21) |
As of December 31, 2021, there was a potential dilution of 4,307,606 shares as a result of stock options that theoretically remain to be exercised or outstanding free shares.
As of the date of this Document, one stock option plan has been authorized by the General Shareholders' Meeting in 2010, and was implemented by the Board of Directors. No stock options have been awarded since 2012. The status of these plans at December 31, 2021, is summarized in the following table.
| Allocation date | Exercise start date |
Expiration date | Exercise price | Number of options granted |
Number of options exercised in 2021 |
Number of options remaining to be exercised at Dec. 31, 2021* |
|---|---|---|---|---|---|---|
| Dec. 13, 2012 | Dec. 14, 2017 | Dec. 14, 2022 | 7,859 | 92,578 | - | 41,532 |
| TOTAL | N/A | N/A | N/A | N/A | - | 41,532 |
* This amount includes adjustments, in terms of the number of options and the exercise price, in accordance with regulations, following the capital increases maintaining preferential subscription rights of shareholders completed in March 2014, November 2016 and in 2019.

Consolidated financial statements and notes
| Number of options remaining to be exercised |
Average exercise price per option |
|
|---|---|---|
| Outstanding options at December 31, 2019 | 256,992 | 13.17 |
| Options granted in 2020 | - | - |
| Options forfeited in 2020 | 215,460 | 14.20 |
| Options exercised in 2020 | - | - |
| Outstanding options at December 31, 2020 | 41,532 | 7.86 |
| Options granted in 2021 | - | - |
| Options forfeited in 2021 | - | - |
| Options exercised in 2021 | - | - |
| Outstanding options at December 31, 2021 | 41,532 | 7.86 |
| Options exercisable at December 31, 2021 | 41,532 | 7.86 |
The cost of services rendered is recognized as an expense over the vesting period. There was no expense in 2021, as in 2020.
Five free share awards are in the process of vesting as of December 31, 2021, adopted by the Board of Directors in 2019, 2020 and 2021 for the benefit of all employees and executive directors on the basis of a delegation granted by the General Meetings of May 22, 2019 and May 26, 2021.
The status of these unvested awards at December 31, 2021, is summarized in the following table:
| 2021 plan | ||||
|---|---|---|---|---|
| General Meeting date | May. 26, 2021 | |||
| Total number of shares authorized by the Meeting | 2,500,000 | |||
| Grants 2021 |
||||
| Board of Directors meeting date | May. 26, 2021 | |||
| Total number of free shares awarded | 1,999, 956 | 300,000 | ||
| Of which allocations granted, during the year, by the issuer and by any company included in the scope of the allocation to corporate officers |
457,139 | 300,000 | ||
| Of which the number of shares awarded to members of the Executive Committee |
1,200,000 | 300,000 | ||
| Of which awards granted, during the year by the issuer and by any company in the scope of the award, to the ten non-corporate officer employees of the issuer and of any company within this scope, whose number of free shares awarded is greatest |
802,117 | - | ||
| Of which the balance not yet vested at Dec. 31, 2021 | 1,975,266 | 300,000 | ||
| Vesting date | May. 26, 2022 May. 26, 2023 May. 26, 2024 |
Jan. 1, 2024 | ||
| Expiration date of the lock-up period | May. 26, 2022 May. 26, 2023 May. 26, 2024 |
End of contract | ||
| Value of the share on the award date | €2.95 | €2.95 |
| 2016 plan | 2018 plan | 2019 plan | ||||
|---|---|---|---|---|---|---|
| General Meeting date | May. 24, 2016 | May. 23, 2018 | May. 22, 2019 | |||
| Total number of shares authorized by the Meeting |
600,000 | 1,200,000 | 2,000,000 | |||
| 2017 Grant | 2018 Grant | 2019 Grant | 2019 Grant | 2019 Catch-up |
2020 Grant | |
| Board of Directors meeting date | Mar. 17, 2017 Mar. 21, 2018 | Mar. 20, 2019 | Sept. 18, 2019 |
May. 27, 2020 |
Sept. 16, 2020 |
|
| Total number of free shares awarded | 183,000 | 220,600 | 414,800 | 1,399,774 | 5,934 | 601,682 |
| Of which allocations granted, during the year, by the issuer and by any company included in the scope of the allocation to corporate officers |
31,000 | 34,600 | 77,500 | 350,000 | - | 150,000 |
| Of which the number of shares awarded to members of the Executive Committee |
72,000 | 104,600 | 192,000 | 840,000 | - | 360,000 |
| Of which awards granted, during the year by the issuer and by any company in the scope of the award, to the ten non-corporate officer employees of the issuer and of any company within this scope, whose number of free shares awarded is greatest |
49,400 | 85,000 | 628,236 | 223,620 | ||
| Of which the balance not yet vested at Dec. 31, 2021 |
- | - | - | 1,309,994 | 5,934 | 565,704 |
| Of which vested at Dec. 31, 2021 | 173,175 | 200,750 | 375,120 | - | - | - |
| Vesting date | Mar. 17, 2019 | Mar. 21, 2020 |
Apr. 20, 2020 |
Mar. 30, 2022 |
Apr. 30, 2022 |
Mar. 30, 2022 |
| Expiration date of the lock-up period | Mar. 17, 2021 | Mar. 21, 2022 |
Apr. 20, 2021 | Mar. 30, 2022 |
May. 27, 2022 |
Sept. 16, 2022 |
| Value of the share on the award date | €2.63 | €3.15 | €2.98 | €1.78 | €1.47 | €1.35 |
Company. The Executive Committee received 360,000 free shares during this grant. Performance conditions have been defined for half of these shares. These conditions will be assessed in March 2022.
● September 2019 grant: the shares are definitively granted 30 months after their allocation to employees who are still with the Company. The Executive Committee received 840,000 free shares during this grant. Performance conditions have been defined for half of these shares. These conditions will be assessed in March 2022.
The cost of services rendered is recognized as an expense over the vesting period. The expense amounted to €3,002 thousand in 2021 and €1,744 thousand in 2020.
The provision covering URSSAF contributions related to free shares amounted to €1,215 thousand at December 31, 2021 and was valued on the basis of the Transgene share price as at December 31, 2021.

| (in € thousands) | Dec. 31, 2021 | Dec. 31, 2020 |
|---|---|---|
| Revenue from research and development collaboration | 2,929 | 2,988 |
| License fees and royalties | 7,064 | (7) |
| TOTAL REVENUE FROM COLLABORATIVE AND LICENSING AGREEMENTS | 9,993 | 2,981 |
In 2019, the Company entered into a collaboration agreement with AstraZeneca with exclusive licensing options to co-develop oncolytic immunotherapies derived from the Invir.IO™ platform. In this regard, Transgene thus received €8.9 million (US\$10 million) in fees for access to its platform in the first half of 2019. Pursuant to IFRS 15.41 and inasmuch as Transgene has not transferred control of a pre-existing intellectual property and as AstraZeneca receives the benefits of the licensed rights as and when the research plan is carried out, this initial payment is recognized in income against the progress of the associated activities and measured against the costs incurred by Transgene to carry out its contractual obligations. This agreement provides for additional revenue as and when preclinical milestones are met. Transgene is eligible to receive an option exercise payment on each candidate in the event AstraZeneca exercises one or several license options, as well as development and commercial milestones and royalties.
The assumptions used by Management in the measurement of revenue related to the initial payment primarily concern:
At December 31, 2021, Transgene re-estimated the overall budget and its progress. The income related to the initial payment recognized at December 31, 2021 was assessed on the basis of this revised budget and program progress. The Company may receive up to US\$1.5 million for the delivery of these candidates.
Over the period, the income recognized under this collaboration agreement was €9,921 thousand. This amount includes the sum of €7,063 thousand relating to the exercise of the first license option by AstraZeneca in December 2021 for an oncolytic virus developed by Transgene. It also corresponds to the recognition of the initial payment for the activity €1,231 thousand carried out during the period. The balance of €1,778 thousand, not recognized at that date is recognized in deferred income at December 31, 2021 (Note 12). The Company also received €1,627 thousand for the production of batches and provision of various R&D services.
| (in € thousands) | Dec. 31, 2021 | Dec. 31, 2020 |
|---|---|---|
| Research subsidies | 34 | 50 |
| Research tax credit, net | 6,987 | 6,312 |
| TOTAL PUBLIC FINANCING FOR RESEARCH EXPENSES | 7,021 | 6,362 |
The net amount of the research tax credit was €6,987 thousand in 2021 compared to €6,312 thousand in 2020.
| Dec. 31, 2021 | Dec. 31, 2020 |
|---|---|
| 399 | 572 |
| 399 | 572 |
As of December 31, 2021, other income amounted to from this program recognized in Other income.At December €399 thousand, compared to €572 thousand at 31, 2020, the portion of repayable advances restated as December 2020. It corresponds in particular to €174 thousand subsidies during the year amounted to €224 thousand . for the conditional NEOVIVA program advances granted at a preferential rate. These advances have been restated in accordance with IAS 20, with the subsidy portion received
In 2020, the sale of the rights to the DuckCelt® -T17 cell line to the company Vaxxel SAS represents €118 thousand in Other income.
| (in € thousands) | Dec. 31, 2021 | Dec. 31, 2020 |
|---|---|---|
| Payroll costs (1) | 12,388 | 11,508 |
| Share-based payments (2) | 1,656 | 849 |
| Intellectual property expenses and licensing costs (3) | 1,124 | 889 |
| External expenses for clinical projects (4) | 6,256 | 5,378 |
| External expenses for other projects (5) | 4,546 | 2,381 |
| Operating expenses (6) | 5,148 | 4,631 |
| Depreciation and provisions (7) | 1,765 | 1,710 |
| TOTAL RESEARCH AND DEVELOPMENT EXPENSES | 32,883 | 27,346 |
(1) Represents wages and social security charges, taxes, retirement charges and other such costs.
(2) Represents expense for share-based payments offered to employees.
(3) Represents expenses for filing and maintaining patents as well as the costs of licenses acquired or granted.
(4) Represents expenses for services, subcontractors and consulting on clinical development projects.
(5) Represents expenses for services, subcontractors and consulting on other research or manufacturing projects.
(6) Represents operating expenses of research and production laboratories (energy, consumables and raw materials, maintenance, technical services, overheads, etc.).
(7) Represents the depreciation on the real estate and property allocated to R&D and to operating provisions.
As of December 31, 2021, research and development expenses increased to €32,883 thousand compared with €27,346 thousand as of December 31, 2020.
Payroll costs at December 31, 2021 amounted to €12,388 thousand, compared to €11,508 thousand at December 31, 2020, due to the increase in the workforce related to increased production activities. The cost of share-based payments amounted to €1,656 thousand at December 31, 2021, compared to €849 thousand over the same period in 2020, in particular following the granting of a new free share plan in 2021.
External expenses on clinical projects were up to €6,256 thousand at December 31, 2021, compared with €5,378 thousand at December 31, 2020 following the launch of several studies, notably for the TG4001 and BT-001 projects as well as for the accelerated spending on clinical trials for the TG4050 project.
External expenses on other projects amounted to €4,546 thousand at December 31, 2021, compared to €2,381 thousand at December 31, 2020. This increase is mainly due to the start in 2021 of a project to improve manufacturing processes.
Operating expenses were also up to €5,148 thousand at December 31, 2021, compared to €4,631 thousand over the same period last year due to the internal production of clinical batches for the various studies.
| (in € thousands) | Dec. 31, 2021 | Dec. 31, 2020 |
|---|---|---|
| Payroll costs (1) | 3,368 | 3,280 |
| Share-based payments (2) | 1,346 | 895 |
| Fees and administrative expenses (3) | 1,867 | 1,803 |
| Other general and administrative expenses (4) | 727 | 512 |
| Depreciation and provisions (5) | 61 | 57 |
| TOTAL GENERAL AND ADMINISTRATIVE EXPENSES | 7,369 | 6,547 |
(1) Represents wages and social security charges, taxes, retirement charges and other such costs.
(2) Represents expense for share-based payments offered to employees.
(3) Represents expenses for services, subcontracting and consulting for general and administrative departments.
(4) Represents operating expenses of general and administrative departments.
(5) Represents amortization and operating provisions allocated to general and administrative activities.
General and administrative expenses amounted to €7,369 thousand at December 31, 2021, compared to €6,547 thousand at December 31, 2020.
5

ANNUAL FINANCIAL STATEMENTS AT DECEMBER 31, 2021
Consolidated financial statements and notes
Payroll costs at December 31, 2021 stood at €3,368 thousand, compared with €3,280 thousand at December 31, 2020. The cost of share-based payments amounted to €1,346 thousand at December 31, 2021, compared to €895 thousand over the same period in 2020, in particular following the granting of a free shares plan in 2021.
Management fees and expenses amounted to €1,867 thousand at December 31, 2021 compared to €1,803 thousand for the same period in 2020.
Other general and administrative expenses amounted to €727 thousand at December 31, 2021 compared to €512 thousand at December 31, 2020.
| (in € thousands) | Dec. 31, 2021 | Dec. 31, 2020 |
|---|---|---|
| Net carrying value of disposals of fixed assets | 4 | - |
| Other expenses | 682 | 15 |
| TOTAL OTHER EXPENSES | 686 | 15 |
At December 31, 2021, other expenses were €686 thousand. They are mainly related to the depreciation of equipment stored at a third party for an amount of €682 thousand.
| (in € thousands) | Dec. 31, 2021 | Dec. 31, 2020 |
|---|---|---|
| Investment income | 82 | 92 |
| Cost of debt | (464) | (1,337) |
| COST OF DEBT NET OF INVESTMENT INCOME | (382) | (1,245) |
| Other financial income/(expenses) | 4,198 | 8,016 |
| Foreign exchange gains/(losses) | 173 | (9) |
| TOTAL OTHER FINANCIAL INCOME (EXPENSES) | 4,371 | 8,007 |
| TOTAL FINANCIAL INCOME/(LOSS) | 3,989 | 6,762 |
The cost of debt at December 31, 2021 corresponds to:
In July 2021, the Company sold 49% of the equity securities of Tasly BioPharmaceuticals. The sale of the shares generated a net gain on the disposal of assets of €1,347 thousand. The shares still held by the Company as of December 31, 2021, were revalued at €2,442 thousand. This revaluation of the shares corresponds to the difference between the fair value in euros (sale price in September) and the fair value at December 31, 2020 (Note 8). In 2020, a first sale of securities generated a net gain on the disposal of assets of €2,655 thousand and the revaluation of shares still held at December 31, 2020 generated a revaluation of €6,428 thousand.
At December 31, 2021, the discounting of the ADNA reimbursable advances generated financial income of €716 thousand, compared with a financial expense of €624 thousand at December 31, 2020.
As of December 31, 2020 the Company had also recognized income of €1,298 thousand following the agreement reached with the former shareholders of ElsaLys Biotech SA for the acquisition of the latter by the Italian company Mediolanum Farmaceutici.
As of December 31, 2020, the Company recognized a financial expense of €1,777 thousand corresponding to the waiver of the receivable on the sale of SillaJen investments. The representative of the former shareholders had entered into an agreement with SillaJen ending the earn-out commitments.
Consolidated financial statements and notes
Since the Company is in a tax loss position, its current tax charge is zero. The United States and Chinese subsidiaries did not recognize any current tax income or expense in 2020 and 2021.
| Basis | |
|---|---|
| IFRS earnings before taxes | (19,536) |
| Income tax rate | 26.50% |
| Theoretical income tax expense | 5,177 |
| Tax-exempt RTC | 1,862 |
| Uncapitalized tax losses | (7,637) |
| Other impacts | 598 |
| INCOME TAX RECOGNIZED | - |
At December 31, 2021, Transgene had tax loss carryforwards in France (indefinitely carryable) totaling €754,627 thousand. Transgene has no tax loss carryforwards from it's the United States and Chinese subsidiaries.
The Company had 167 employees at December 31, 2021. The Company had 165 employees as of December 31, 2020.
| As of December 31, 2021 | Men | Women | Total at Dec. 31, 2021* |
|---|---|---|---|
| Managers | 45 | 70 | 115 |
| Non-managers | 17 | 35 | 52 |
| TOTAL | 62 | 105 | 167 |
* Including 143 open-ended contracts at Dec. 31, 2021.
Payroll costs included in the Company's income statement (payroll taxes, pension costs, ancillary costs) were distributed as follows:
| (in € thousands) | Dec. 31, 2021 | Dec. 31, 2020 |
|---|---|---|
| Research and development expenses | 12,388 | 11,508 |
| General and administrative expenses | 3,368 | 3,280 |
| TOTAL PAYROLL COSTS | 15,756 | 14,788 |

ANNUAL FINANCIAL STATEMENTS AT DECEMBER 31, 2021
Consolidated financial statements and notes
Expenses relating to share-based payments (excluding social security contributions) amounted to:
| (in € thousands) | Dec. 31, 2021 | Dec. 31, 2020 |
|---|---|---|
| Research and development expenses | 1,656 | 849 |
| General and administrative expenses | 1,346 | 895 |
| TOTAL SHARE-BASED PAYMENTS | 3,002 | 1,744 |
Transgene signed a cash pooling agreement with Institut Mérieux. The cash and cash equivalents placed in the Institut Mérieux cash pool amounted to a receivable of €43.7 million at December 31, 2021; the resulting interest income was €68 thousand as of December 31, 2021.
The table below does not include these cash items.
| Dec. 31, 2021 | ||||
|---|---|---|---|---|
| (in € thousands) | Type of related party | Receivables | Payables | |
| ABL Europe SAS | Company in the Mérieux Group | - | 743 | |
| bioMérieux SA | Company in the Mérieux Group | - | - | |
| bioMérieux, Inc. | Company in the Mérieux Group | - | 30 | |
| Institut Mérieux | Company in the Mérieux Group | - | 9 | |
| Mérieux Université | Company in the Mérieux Group | - | 7 | |
| Thera Conseil | Company in the Mérieux Group | - | 6 | |
| TOTAL AFFILIATED COMPANIES | - | 796 |
| Dec. 31, 2021 | |||
|---|---|---|---|
| (in € thousands) | Type of related party | Revenue | Expenses |
| ABL Europe SAS (1) | Company in the Mérieux Group | 221 | 3,643 |
| bioMérieux SA | Company in the Mérieux Group | - | 1 |
| bioMérieux, Inc. (2) | Company in the Mérieux Group | - | 372 |
| Institut Mérieux (3) | Company in the Mérieux Group | - | 270 |
| Mérieux Université | Company in the Mérieux Group | - | 7 |
| Thera Conseil | Company in the Mérieux Group | - | 5 |
| TOTAL AFFILIATED COMPANIES | 221 | 4,298 |
(1) The revenue corresponding to the rent re-invoicing contract for hosting test labs. Expenses relate to the agreements for production services and audits provided by ABL Europe.
(2) Expenses related to the agreements for services and re-invoicing of staff, signed between Transgene, Inc. and bioMérieux, Inc.
(3) Expenses related to the agreements for services provided by Institut Mérieux.
As part of the agreements with Tasly BioPharmaceuticals in July 2018, Transgene had received 27.4 million shares in this company, i.e., 2.53% of its capital. At the time of the transaction, the assets contributed by Transgene were valued by the parties at US\$48 million, and the unit price of the shares received was that negotiated by the institutional funds during a capital increase. On this occasion, Transgene, the institutional funds, Tasly BioPharmaceuticals and its parent company Tasly Holding Group had signed a shareholders' agreement to frame their relations. In addition to the usual provisions such as a right of first refusal in the event of assignment by a shareholder, Tasly Holding Group undertook to repurchase the shares subscribed by Transgene in the event of no IPO within a predefined period, at the initial subscription price plus an annual contractual rate. In July 2020, the Company had sold 10.3 million Tasly BioPharmaceuticals shares. Following this transaction, Transgene held 17.1 million shares of Tasly BioPharmaceuticals, representing 1.58% of its share capital, valued at approximately US\$36.9 million. In September 2021, the Company sold 49% of its remaining shares (representing 8.4 million shares). Following this new sale, the Company now holds 8.7 million Tasly BioPharmaceuticals shares. As a result of this transaction in particular, the shareholder agreement was amended in December 2021. This new agreement now states that the undertaking to repurchase Transgene shares by a holding company of the Tasly Group will be triggered in the absence of an IPO on the Shanghai Stock Exchange of Tasly BioPharmaceuticals by September 30, 2022.
The Company has signed a research tax credit assignment agreement with a credit institution for each of its 2018, 2019 and 2020 research tax credits and no longer has any receivables from the French State. The Company therefore received, respectively, €5,500 thousand, €6,288 thousand and €6,034 thousand for the 2018, 2019 and 2020 research tax credits (representing 95% financing). As this type of contract is deconsolidating, no liability is recognized in respect of this financing received. However, the Company remains responsible for the amounts declared in the event of a tax audit.
Transgene is also bound by contracts with subcontractors. That could have an impact over several accounting periods. As of December 31, 2021, the Company estimated the current value of its financial commitments under these agreements to be approximately €29 million. These commitments equal in amount the cash still to be spent on contracts signed to date.
Under licensing or option agreements, third parties have promised to make milestone payments or pay royalties to the Company that are dependent upon future events whose probability remains uncertain as of the reporting date. The Company has promised, with respect to a number of third parties, to pay royalties or milestone payments under collaboration or licensing agreements that are dependent upon future events whose realization remains uncertain as of the reporting date.
The Company conducts its business exclusively in the clinical research and development of therapeutic vaccines and immunotherapeutic products, none of which are currently on the market. The majority of its operations is located in France. The Company therefore uses only one segment for the preparation and presentation of its financial statements.
| Assets (in € thousands) | Gross amount | One year or less | More than one year |
|---|---|---|---|
| Financial assets | 1,627 | 307 | 1,320 |
| Trade receivables | 10,133 | 10,133 | - |
| Research tax credits and CICE | 7,136 | 109 | 7,027 |
| Government, VAT and other local authorities | 758 | 758 | - |
| Personnel and related accounts | 33 | 33 | - |
| Prepaid expenses | 1,656 | 1,380 | 276 |
| Grant receivable | 24 | 24 | - |
| Other receivables | 370 | 239 | 131 |
| TOTAL ASSETS BY MATURITY | 21 ,737 | 12,983 | 8,754 |

Consolidated financial statements and notes
| Liabilities (in € thousands) | Gross amount | One year or less |
More than one year and less than or equal to five years |
More than five years |
|---|---|---|---|---|
| Trade payables | 7,692 | 7,692 | - | - |
| Property leasing | 3,045 | 947 | 2,098 | - |
| Equipment leasing | 665 | 314 | 351 | - |
| Lease obligation | 20 | 20 | - | - |
| Conditional advances | 12,741 | - | 1,096 | 11,645 |
| Financing of research tax credit and CICE | 114 | 114 | - | - |
| Provisions for risks and expenses | 48 | 48 | - | - |
| Provisions for retirement | 3,958 | 228 | 1,031 | 2,699 |
| Accrued employee benefits and tax expense | 4,472 | 4,472 | - | - |
| Prepaid income | 1,813 | 972 | 841 | - |
| Other liabilities | 61 | 10 | 51 | - |
| TOTAL LIABILITIES BY MATURITY | 34,629 | 14,817 | 5,468 | 14,344 |
The Company is not engaged in any foreign exchange hedges.
In 2009, the Company partially hedged the interest rate risk related to the financial leasing of its administrative and research building in Illkirch (Note 10), according to the following terms:
As the hedge is perfect, the variations in market value for the instrument are recognized at net value. At December 31, 2021, the market value of this hedging instrument was €51 thousand. The market value is the amount that the Company would have had to pay if it decided to liquidate the hedge at December 31, 2021.
The Company publishes its consolidated financial statements in euros. However, a portion of its revenue and expenses is recognized in US dollars. An increase or decrease in the euro exchange rate relative to the US dollar could impact operating results.
The Company has US dollar bank accounts. Net inflows in US dollars amounted to US\$19,828 thousand in 2021.
The following table shows the sensitivity of the Company's expenses to a 10% change in the US dollar rate during the years ended December 31, 2021, and 2020 (before tax and any hedging):
| Dec. 31, 2021 | Dec. 31, 2020 | |
|---|---|---|
| Flows denominated in US\$ | 19,828 | 22,169 |
| Equivalent in euros on the basis of an exchange rate of €1 = US\$1.1326 | 17,507 | 18,066 |
| Equivalent in euros in the event of an increase of 10% US\$ vs. € | 15,915 | 16,424 |
| Equivalent in euros in the event of a decrease of 10% US\$ vs. € | 19,452 | 20,074 |
The disposal of Tasly BioPharmaceuticals shares was completed in US dollars, which explains the net cash inflow at December 31, 2021.
The Company's foreign exchange position in US dollars as at December 31, 2021 is as follows:
| (in thousands) | US\$ |
|---|---|
| Assets | 11,221 |
| Liabilities | 883 |
| Net position | 10,338 |
| Adjusted | 10,338 |
| Off-balance sheet position | - |
As Tasly BioPharmaceuticals shares still held by the Company are denominated in yuan, the Company is also highly exposed to the risk of yuan exchange rate fluctuations.
The Company's foreign exchange position in yuan as at December 31, 2021 is as follows:
| (in thousands) | ¥ |
|---|---|
| Assets | 137,082 |
| Liabilities | 86 |
| Net position | 136,996 |
| Adjusted | 136,996 |
| Off-balance sheet position | - |
The Group controls the risks related to cash management through centralized tracking and approval procedures. Cash assets are invested in highly rated marketable securities.
Cash invested at December 31, 2021, in mutual funds, directly or through the centralized management of the Institut Mérieux group, amounted to €43.7 million. The Company has and will have significant capital requirements to finance its research and development, particularly preclinical and clinical trials of its products under development.
The Company has limited access to debt due to its losses and the high-risk nature of the business sector (pharmaceutical research and development) under which it operates. The Company plans to finance operations mainly by issuing new shares or through debt instruments when circumstances allow it.

ANNUAL FINANCIAL STATEMENTS AT DECEMBER 31, 2021
Consolidated financial statements and notes
| Assets and liabilities at fair value through |
Receivables, payables, borrowings, at |
Derivative | Carrying | ||
|---|---|---|---|---|---|
| Level | |||||
| 5,911 | - | - | 5,911 | 5,911 | 1 |
| 43,658 | - | - | 43,658 | 43,658 | 2 |
| - | 10,133 | - | 10,133 | 10,133 | - |
| 19,145 | 1,627 | - | 20,772 | 20,772 | 2-3 |
| - | 131 | - | 131 | 131 | 2 |
| 68,714 | 11,891 | - | 80,605 | 80,605 | |
| - | - | - | - | - | 2 |
| - | 2,449 | - | 2,449 | 2,449 | 2 |
| - | - | - | - | - | 2 |
| - | 12,741 | - | 12,741 | 12,741 | 3 |
| - | - | 51 | 51 | 51 | 2 |
| - | 15,190 | 51 | 15,241 | 15,241 | |
| - | 114 | - | 114 | 114 | 2 |
| - | 1,261 | - | 1,261 | 1,261 | 2 |
| - | 20 | - | 20 | 20 | 2 |
| - | 1,395 | - | 1,395 | 1,395 | - |
| - | 7,692 | - | 7,692 | 7,692 | - |
| - | 24,277 | 51 | 24,328 | 24,328 | - |
| income or loss | amortized cost | instruments | amount | Fair value |
In accordance with IFRS 13, financial instruments are categorized in three levels according to a hierarchy of methods that determine the fair value:
Consolidated financial statements and notes
The total expenses recorded for fiscal year 2021 in respect of compensation paid to members of the Board of Directors and the Executive Committee was €4,121 thousand.
| (in € thousands) | Dec. 31, 2021 | Dec. 31, 2020 |
|---|---|---|
| Base salaries | 1,372 | 1,825 |
| Variable compensation | 325 | 672 |
| Payments in kind | 44 | 33 |
| Free shares | 1,552 | 1,149 |
| Directors' compensation | 232 | 200 |
| Departure benefits | 596 | - |
| TOTAL | 4,121 | 3,879 |
| Ernst & Young et Autres | Grant Thornton | |||||||
|---|---|---|---|---|---|---|---|---|
| Amount (pre-tax) | % | Amount (pre-tax) | % | |||||
| (in € thousands) | 2021 | 2020 | 2021 | 2020 | 2021 | 2020 | 2021 | 2020 |
| Audit | - | - | - | - | - | - | ||
| STATUTORY AUDITORS, CERTIFICATION, EXAMINATION OF INDIVIDUAL AND CONSOLIDATED FINANCIAL STATEMENTS | ||||||||
| Issuer | 83 | 85 | 87% | 90% | 63 | 51 | 100% | 100% |
| Fully consolidated subsidiaries | - | - | - | - | - | - | - | |
| OTHER DUE DILIGENCE AND SERVICES DIRECTLY RELATED TO THE AUDIT | ||||||||
| Issuer | 12 | 9 | 13% | 10% | - | - | - | - |
| Fully consolidated subsidiaries | - | - | - | - | - | - | ||
| Sub-total | 95 | 94 | 100% | 100% | 63 | 51 | 100% | 100% |
| Other services provided by networks to fully consolidated subsidiaries |
- | - | - | - | - | - | - | |
| Legal, tax and social | - | - | - | - | - | - | - | |
| Other (specify if > 10% of the audit fees) | - | - | - | - | - | - | - | |
| Sub-total | - | - | - | - | - | - | - | |
| TOTAL | 95 | 94 | 100% | 100% | 63 | 51 | 100% | 100% |
None.
December 31, 2020, and June 30, 2021.

ANNUAL FINANCIAL STATEMENTS AT DECEMBER 31, 2021
Statutory auditor's report on the consolidated financial statements
Year ended December 31, 2021
This is a translation into English of the statutory auditors' report on the consolidated financial statements of the Company issued in French and it is provided solely for the convenience of English-speaking users. This statutory auditors' report includes information required by European regulations and French law, such as information about the appointment of the statutory auditors or verification of the information concerning the Group presented in the management report and other documents provided to shareholders. This report should be read in conjunction with, and construed in accordance with, French law and professional auditing standards applicable in France.
To the Annual General Meeting of Transgene S.A.,
In compliance with the engagement entrusted to us by your Annual General Meeting, we have audited the accompanying consolidated financial statements of Transgene S.A. for the year ended December 31, 2021.
In our opinion, the consolidated financial statements give a true and fair view of the assets and liabilities and of the financial position of the Group as at December 31, 2021 and of the results of its operations for the year then ended in accordance with International Financial Reporting Standards as adopted by the European Union.
The audit opinion expressed above is consistent with our report to the Audit Committee.
We conducted our audit in accordance with professional standards applicable in France. We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our opinion.
Our responsibilities under those standards are further described in the Statutory Auditor's Responsibilities for the Audit of the Consolidated Financial Statements section of our report.
We conducted our audit engagement in compliance with the independence requirements of the French Commercial Code (Code de commerce) and the French Code of Ethics for Statutory Auditors (Code de déontologie de la profession de commissaire aux comptes) for the period from January 1, 2021 to the date of our report and specifically we did not provide any prohibited non-audit services referred to in Article 5(1) of Regulation (EU) No. 537/2014.
Without qualifying the opinion expressed above, we draw your attention to Note 2 of the financial statements relating to the change in accounting method related to the valuation of employee benefits in accordance with the May 2021 IFRIC position.
Due to the global crisis related to the COVID-19 pandemic, the financial statements for this period have been prepared and audited under special circumstances. Indeed, this crisis and the exceptional measures taken in the context of the health emergency have had numerous consequences for companies, particularly on their operations and their financing, and have led to greater uncertainties regarding their future prospects. Some of these measures, such as travel restrictions and remote working, have also had an impact on companies' internal organization and on the performance of audits.
It is in this complex, evolving context that, in accordance with the requirements of Articles L. 823-9 and R. 823-7 of the French Commercial Code (Code de commerce) relating to the justification of our assessments, we inform you of the key audit matters relating to risks of material misstatement that, in our professional judgment, were of most significance in our audit of the consolidated financial statements of the current period, as well as how we addressed those risks.
These matters were addressed in the context of our audit of the consolidated financial statements as a whole and in forming our opinion thereon, and we do not provide a separate opinion on specific items of the consolidated financial statements.
| Risk identified | Our response |
|---|---|
| In July 2018, your Group received shares from Tasly Biopharmaceuticals amounting to USD 48m, in return, firstly, for the transfer of its investment in the joint venture which owned the T6002 rights, and secondly, for the transfer of the T1050 patent rights for Greater China. In July 2020, 38% of the shares held were sold. In September 2021, your Group signed an agreement with the |
Our work consisted in reviewing the methods and assumptions used by your Group to determine the fair value of the shares, in particular: reviewing the transaction of September 2021 to assess ● whether it was representative of the fair value of a transaction between two independent parties; comparing the valuation obtained based on the model and ● |
| Chinese company Tasly Pharmaceutical Group Co., Ltd. for the sale of 8,399,999 shares held in the company Tasly Biopharmaceuticals. This transaction represents a sale of 49% of the shares held by Transgene as of June 30, 2021. The remaining shares are still presented as non-consolidated investments without significant influence, given that: |
assumptions used as at December 31, 2021 with the value at the time of the sale in September 2021; including a specialist in our audit team to study the models ● and assumptions used by reviewing their consistency, first, with the budgets and forecasts used, and second, with our knowledge of the sector, acquired notably during interviews with Management and by comparison with similar projects |
| the Group does not intend to dispose of them in the near ● future due to the Tasly Biopharmaceuticals IPO process these shares may not be sold during a holding period of one ● year after the IPO. |
conducted by other companies in the same sector of activity; comparing the discount rate with our own estimate of this ● rate, established with the assistance of our valuation specialists and through the analysis of the various parameters. |
| The remaining shares held as at December 31, 2021 were valued at the price per share recorded when shares were sold in September 2021, based on Yuan exchange rate as of December 31, 2021. The fair value of the shares then held as of December 31, 2021 in the unlisted company Tasly Biopharmaceuticals appearing on your group's balance sheet amounts to MEUR 19. |
Lastly, we also assessed the appropriateness of the information disclosed in the notes to the financial statements, in particular the sensitivity analyses presented. |
| As stated in Notes 1 and 8 of the financial statements, the valuation of the capitalized shares is based on an analysis according to the fair value of the assets. |
|
| The valuation of these shares requires Management to exercise judgment in its choice of elements to be taken into account, corresponding to forecasts. |
|
| The main assumptions taken into account by Management in the measurement of fair value are based on assumptions obtained from Tasly Biopharmaceuticals and concern: |
|
| the estimate of the future cash flows that will be generated by ● the company held, notably by the products being developed; the probable technical success of the products being ● developed and their approval by the regulatory authorities; the market potential for these products being developed; ● the value of the shares according to the latest capital ● transactions; the discount rate used by Management. ● |
|
| Your Group had an independent advisory firm review and update the model used and the assumptions at year-end, based on the information provided by Tasly Biopharmaceuticals, with the aim of making sure that the price for the sale of part of the shares in September 2021 continued to be representative of the fair value of the shares still held as at December 31, 2021. |
|
| Any error in the assessment of the assumptions has an impact on the estimate of the fair value. We considered the determination of the fair value of the shares held to be a key audit matter as it |
5

ANNUAL FINANCIAL STATEMENTS AT DECEMBER 31, 2021
Statutory auditor's report on the consolidated financial statements
| Risk identified | Our response |
|---|---|
| In April 2019, your Group entered into a collaboration agreement with AstraZeneca with options for exclusive licenses to co-develop oncolytic immunotherapies using the Invir.IO™ platform. This agreement provides for the delivery of five candidates by your Group. Within this context, your Group received an initial payment of EUR 8.9m (USD10m) for access rights to its platform during the first half of 2019. In May 4, 2020, an amendment was signed with AstraZeneca defining two new candidates to be developed. Consequently, your Group re-estimated the program's overall budget and progress as at December 31, 2020. Your Group has also re-estimated the program's overall budget and progress as at December 31, 2021. As at December 31, 2021, the revenue in respect of the initial |
Our work consisted in reviewing the methods and assumptions used by Management to measure the revenue related to the initial payment. In particular, it consisted in: analyzing the methods used to measure the estimated overall ● costs related to the agreement, including the measurement of personnel costs, the hours necessary to perform the studies and the costs of consumables, by considering their consistency with, on the one hand, the budgets and forecasts drawn up by Management and presented to the Board of Directors, and on the other hand, our knowledge of the sector, acquired notably during interviews with Management; studying the valuation of the actual hours worked during ● financial year 2021 and the actual timesheets as at December 31, 2021; assessing the consistency of the schedule for the development ● |
| payment recognized under this collaboration represents EUR 1.2m. |
of candidates not yet performed in relation to the actual schedule for the first candidates, and on the basis of interviews with Management and the project manager. |
| As stated in Notes 1 and 15 to the consolidated statements, the recognition of the revenue related to the initial payment is based on the progress made in the associated activities and measured according to the costs incurred. |
Finally, we assessed the appropriateness of the information disclosed in the notes to the financial statements. |
| The measurement of the revenue requires Management to exercise judgment in its choice of the elements to be taken into account, corresponding to forecasts. |
|
| The main assumptions taken into account by Management in the measurement of the revenue related to the initial payment notably concern: |
|
| the number of candidates to be developed; ● the schedule for the development of the candidates; ● the estimated costs of the salaries and consumables related to ● the development of the candidates. |
|
| We considered the measurement of the revenue related to the collaboration agreement with AstraZeneca to be a key audit matter, as: |
|
| the measurement of the income recognized represents a ● material amount as at December 31, 2021; the determination of the revenue requires the use of estimates ● and assessments, notably to measure the estimated costs of the salaries and consumables related to the development of the candidates. the use of management judgement involved in its ● determination is significant. |
|
| Any error in the assessment of these assumptions would have an |
Statutory auditor's report on the consolidated financial statements
| Risk identified | Our response |
|---|---|
| As at December 31, 2021, the fair value of the liability consisting of repayable advances recorded in your Group's balance sheet amounts to MEUR 11.65. At year-end, your Group re-values its repayable advances liability under the ADNA program based on |
Our work consisted in reviewing the methods and assumptions used by your Group to measure the fair value of the ADNA repayable advances. In particular: |
| the amount of the expected repayments, as described in Notes 1 and 10 to the consolidated financial statements. |
we assessed the valuation model used and the assumptions ● adopted relating to the development of the TG4001 product, by considering their consistency with, on the one hand, the |
| The repayment of these advances is subject to the achievement of a certain threshold of revenue with the TG4001 product, and will be made based on a predetermined fixed amount over the following five years, and then in proportion to the revenue generated by this product until a repayment limit is reached or at the latest in 2035. The fair value of the repayments are thus estimated by Management based on the estimated future direct and indirect revenue generated solely by the TG4001 product being developed. |
budgets and forecasts drawn up by Management and presented to the Board of Directors, and on the other hand, our knowledge of the sector, acquired notably during interviews with Management; we compared the discount rate with our own estimate of this ● rate; we reviewed the US dollar to euro rate used within the ● context of the valuation performed. |
| The other assumptions used by Management to measure the fair value of the repayable advances liability notably concern; |
Finally, we assessed the appropriateness of the information disclosed in the notes to the financial statements. |
| the probabilities of success of the clinical phases; ● the timing and conditions of a partnership concerning the ● development and marketing of this product; |
● the discount rate used by Management.
The measurement of the repayable advances liability therefore requires Management to exercise judgment in its choice of the elements to be taken into account, in particular as regards forecasts.
Any error in the assessment of these assumptions would have an impact on the estimation of the debt to be repaid. We considered the measurement of the ADNA repayable advances to be a key audit matter as it involves significant exercise of judgment on the part of Management.

ANNUAL FINANCIAL STATEMENTS AT DECEMBER 31, 2021
Statutory auditor's report on the consolidated financial statements
We have also performed, in accordance with professional standards applicable in France, the specific verifications required by laws and regulations of the information relating to the Group given in the Board of Directors management report.
We have no matters to report as to its fair presentation and its consistency with the consolidated financial statements.
We have also verified, in accordance with the professional standard applicable in France relating to the procedures performed by statutory auditor regarding the annual and consolidated financial statements prepared in the European single electronic format, that the preparation of the consolidated financial statements included in the annual financial report mentioned in Article L. 451-1-2, I of the French Monetary and Financial Code (Code monétaire et financier), prepared under the Chairman and Chief Executive Officer's responsibility, complies with the single electronic format defined in Commission Delegated Regulation (EU) No. 2019/815 of 17 December 2018. Regarding consolidated financial statements, our work includes verifying that the tagging thereof complies with the format defined in the above-mentioned regulation.
On the basis of our work, we conclude that the preparation of the consolidated financial statements included in the annual financial report complies, in all material respects, with the European single electronic format.
We were appointed as statutory auditor of Transgene S.A. by your Annual General Meeting held on May 24, 2016 for GRANT THORNTON and on May 29, 1996 for ERNST & YOUNG et Autres.
As at December 31, 2021, GRANT THORNTON was in its 6th year and ERNST & YOUNG et Autres in its 26th year of total uninterrupted engagement (including 24 years since the securities of the company were admitted to trading on a regulated market).
Management is responsible for the preparation and fair presentation of the consolidated financial statements in accordance with International Financial Reporting Standards as adopted by the European Union and for such internal control as Management determines is necessary to enable the preparation of consolidated financial statements that are free from material misstatement, whether due to fraud or error.
In preparing the consolidated financial statements, Management is responsible for assessing the Company's ability to continue as a going concern, disclosing, as applicable, matters related to going concern and using the going concern basis of accounting unless it is expected to liquidate the Company or to cease operations.
The Audit Committee is responsible for monitoring the financial reporting process and the effectiveness of internal control and risk management systems and where applicable, its internal audit, regarding the accounting and financial reporting procedures.
The consolidated financial statements were approved by the Board of Directors.
Our role is to issue a report on the consolidated financial statements. Our objective is to obtain reasonable assurance about whether the consolidated financial statements as a whole are free from material misstatement. Reasonable assurance is a high level of assurance, but is not a guarantee that an audit conducted in accordance with professional standards will always detect a material misstatement when it exists. Misstatements can arise from fraud or error and are considered material if, individually or in the aggregate, they could reasonably be expected to influence the economic decisions of users made on the basis of these consolidated financial statements.
As specified in Article L. 823-10-1 of the French Commercial Code (Code de commerce), our statutory audit does not include assurance on the viability of the Company or the quality of management of the affairs of the Company.
As part of an audit conducted in accordance with professional standards applicable in France, the statutory auditor exercises professional judgment throughout the audit and furthermore:
We submit to the Audit Committee a report which includes in particular a description of the scope of the audit and the audit program implemented, as well as the results of our audit. We also report significant deficiencies, if any, in internal control regarding the accounting and financial reporting procedures that we have identified.
Our report to the Audit Committee includes the risks of material misstatement that, in our professional judgment, were of most significance in the audit of the consolidated financial statements of the current period and which are therefore the key audit matters that we are required to describe in this report.
We also provide the Audit Committee with the declaration provided for in Article 6 of Regulation (EU) No. 537/2014, confirming our independence within the meaning of the rules applicable in France as set out in particular in Articles L. 822-10 to L. 822-14 of the French Commercial Code (Code de commerce) and in the French Code of Ethics for Statutory Auditors (Code de déontologie de la profession de commissaire aux comptes). Where appropriate, we discuss with the Audit Committee the risks that may reasonably be thought to bear on our independence, and the related safeguards.
Lyon and Paris-La Défense, 6th April 2022
The Statutory Auditors
French original signed by
GRANT THORNTON French Member of Grant Thornton International Françoise Méchin
ERNST & YOUNG et Autres
Cédric Garcia Brigitte Barouky

ANNUAL FINANCIAL STATEMENTS AT DECEMBER 31, 2021 Annual financial statements and notes
| (in € thousands) | Notes | Dec. 31, 2021 | Dec. 31, 2020 |
|---|---|---|---|
| Intangible assets, at cost | 3,267 | 3,246 | |
| Intangible assets in progress | - | 9 | |
| (accumulated depreciation, amortization and provisions) | (3,175) | (3,114) | |
| Intangible assets - net | 11 | 92 | 141 |
| Property, plant and equipment: | |||
| Land | 584 | 584 | |
| Fixtures and fittings | 2,511 | 2,325 | |
| Laboratory equipment | 10,397 | 10,267 | |
| Office and computer equipment | 1,674 | 1,651 | |
| Assets in progress | 102 | 65 | |
| Total property, plant and equipment, at cost | 15,268 | 14,892 | |
| (accumulated depreciation, amortization and provisions) | (10,346) | (9,199) | |
| Property, plant and equipment - net | 10 | 4,922 | 5,693 |
| Financial assets - net | 12 | 15,529 | 27,983 |
| Total fixed assets | 20,543 | 33,817 | |
| Trade receivables | 7 | 10,133 | 1,667 |
| Research tax credit and competitiveness and employment tax credit due | 21 | 7,135 | 6,594 |
| Recoverable VAT and income tax receivables and other tax receivables | 8 | 758 | 388 |
| Other receivables, including centralized treasury | 8 | 44,127 | 22,013 |
| Available cash, cash equivalents | 6 | 5,854 | 5,218 |
| Total current assets | 68,007 | 35,880 | |
| Prepaid expenses | 20 | 1,652 | 2,092 |
| Currency translation difference | - | - | |
| TOTAL ASSETS | 90,202 | 71,789 |
Annual financial statements and notes
| (in € thousands) | Notes | Dec. 31, 2021 | Dec. 31, 2020 |
|---|---|---|---|
| Subscribed capital | 13 | 48,886 | 41,921 |
| Share premiums | 13 | 56,299 | 31,072 |
| Reserves | 13, 27 | 3,101 | 1,951 |
| Retained earnings | (36,700) | (16,972) | |
| Profit/(loss) for the period | (17,006) | (20,116) | |
| Statutory provisions | - | - | |
| Equity | 13 | 54,580 | 37,856 |
| Conditional advances | 14 | 17,437 | 16,834 |
| Financial Liabilities | 15 | 115 | 277 |
| Provisions for pensions | 16 | 3,958 | 4,448 |
| Other provisions for risks and expenses | 16 | 48 | 515 |
| Provisions for risks and expenses | 16 | 4,006 | 4,963 |
| Payables | 20 | 7,775 | 5,135 |
| Accrued employee benefits and tax expense | 20 | 4,466 | 3,785 |
| Other liabilities | 20 | 10 | 2 |
| Payables | 20 | 12,251 | 8,922 |
| Prepaid income | 20 | 1,813 | 2,937 |
| Currency translation difference | - | - | |
| Liabilities | 35,622 | 33,933 | |
| TOTAL EQUITY AND LIABILITIES | 90,202 | 71,789 |

ANNUAL FINANCIAL STATEMENTS AT DECEMBER 31, 2021
Annual financial statements and notes
| Notes (in € thousands) |
Dec. 31, 2021 | Dec. 31, 2020 |
|---|---|---|
| OPERATING INCOME | ||
| 3 Revenue from collaborative and licensing agreements |
13,555 | 5,523 |
| Research and development grants | 35 | 51 |
| Reversals of depreciation and provisions, transfers of expenses | 865 | 272 |
| Total operating income | 14,455 | 5,846 |
| OPERATING EXPENSE | ||
| Purchases of raw materials and other purchases | (2,445) | (1,979) |
| Other purchases and external expenses | (21,330) | (17,113) |
| Income tax, duties and other levies | (474) | (411) |
| Salaries and wages | (10,521) | (9,989) |
| Social security expenses | (5,857) | (4,788) |
| Depreciation, amortization and provisions | (2,240) | (1,095) |
| Other expenses | (718) | (617) |
| Total operating expenses | (43,585) | (35,992) |
| Operating income/(loss) | (29,130) | (30,146) |
| Net financial income/(loss) 4 |
(426) | (1,156) |
| Current income/(loss) before tax | (29,556) | (31,302) |
| 5 Net extraordinary income/(loss) |
5,493 | 4,799 |
| 21 Research tax credit (RTC) |
7,027 | 6,352 |
| 21 Income tax |
30 | 35 |
| PROFIT/(LOSS) FOR THE PERIOD | (17,006) | (20,116) |
The notes and tables presented below are an integral part of the annual financial statements. The annual financial statements at December 31, 2021, show a balance sheet total of €90,202 thousand and net loss of €17,006 thousand.
| NOTE 1 | NATURE OF THE BUSINESS ACTIVITY AND | NOTE 16 | PROVISIONS FOR RISKS AND EXPENSES | 186 | |
|---|---|---|---|---|---|
| SUMMARY OF ACCOUNTING PRINCIPLES | 173 | NOTE 17 | EXPENSES PAYABLE | 187 | |
| NOTE 2 | CHANGE IN ACCOUNTING METHODOLOGY |
176 | NOTE 18 | ACCRUED CHARGES AND DEFERRED INCOME |
187 |
| NOTE 3 | OPERATING INCOME | 176 | NOTE 19 | AFFILIATED COMPANIES | 188 |
| NOTE 4 | FINANCIAL INCOME/(LOSS) | 177 | |||
| NOTE 5 | EXTRAORDINARY INCOME/(LOSS) | 178 | NOTE 20 | MATURITIES OF RECEIVABLES AND PAYABLES |
189 |
| NOTE 6 | CASH AND MARKETABLE SECURITIES | 178 | NOTE 21 | INCOME TAX | 189 |
| NOTE 7 | TRADE RECEIVABLES | 179 | NOTE 22 | EXECUTIVE COMPENSATION AND | |
| NOTE 8 | OTHER RECEIVABLES | 179 | OBLIGATIONS | 190 | |
| NOTE 9 | ACCRUED INCOME | 179 | NOTE 23 | OFF-BALANCE SHEET COMMITMENTS | 190 |
| NOTE 10 | PROPERTY, PLANT AND EQUIPMENT | 180 | NOTE 24 | WORKFORCE | 191 |
| NOTE 11 | INTANGIBLE ASSETS | 180 | NOTE 25 | IDENTITY OF THE CONSOLIDATING ENTITY |
191 |
| NOTE 12 | FINANCIAL ASSETS | 181 | NOTE 26 | EVENTS AFTER THE REPORTING PERIOD | 192 |
| NOTE 13 | EQUITY | 182 | NOTE 27 | PREMIUMS AND RESERVES | 192 |
| NOTE 14 | CONDITIONAL ADVANCES | 185 | NOTE 28 | SUBSIDIARIES AND EQUITY INTERESTS | 192 |
| NOTE 15 | FINANCIAL LIABILITIES | 185 | NOTE 29 | STATUTORY AUDITORS' FEES | 193 |
Transgene ("the Company") is a French limited liability company (société anonyme) governed by the provisions of French law. It was created in 1979 to apply emerging techniques in genetic engineering in the context of contract research for industrial groups in the fields of molecular and cellular biology, virology, immunology and protein chemistry. The Company designs and develops immunotherapy products for treating cancer.
The annual financial statements for fiscal year 2021 are presented in accordance with the legal and regulatory requirements in effect in France as described in the national general chart of accounts (French GAAP), and in accordance with generally accepted principles which are the principles of prudence, continuity of operations, consistency in accounting methods, and independence of fiscal years.
Given the capital increase carried out in June 2021, the Company's cash, cash equivalents and other current financial assets, the going concern principle was retained. The Company has financial visibility until the end of 2023.
The Covid-19 pandemic, has had an impact on Transgene's activities in 2021.. As of the date of this document, this has mainly impacted clinical studies that have either been or are being delayed due to the slowdown in patient recruitment or the length of time taken by the regulatory authorities to authorize the launch or the amendment of clinical studies notably in 2020.
If containment and global spread were to continue, the impact of the disease and the containment measures adopted by governments and the civil society could cause dysfunction in the supply and shipping chain on which the Company depends, lack of visibility in the scientific community due to the cancelation of international conferences, disorganization of the clinical sites participating in its clinical studies, delay or inability to produce its drug candidates, or even temporary closure of our establishments. As of today, the Company cannot be assured that it would be possible to implement its clinical study program under the conditions and within the time frame initially planned, if one or more of these risks should materialize. The occurrence of these risks would also have a downward impact on the Company's anticipated level of expenses, as well as on expected revenues from collaborations. This financial impact is difficult to quantify precisely at the date of this document.
Transgene's revenue is comprised of revenues from patent licenses and collaborations in research (including the reimbursement of costs incurred by Transgene), development and production.
Revenue from patent licenses generally consists of rights to access technology, paid on signing of the agreement and which is not reimbursable, financing by milestone payments and other payments, such as royalties.
When Transgene is not committed to continuing to develop a technology after a license is signed, the fees are recognized as revenue when the Company's contractual obligations have been fulfilled.
When Transgene is committed to continuing to develop a technology after a license is signed or has a future obligation to deliver products, the fees are recognized as revenue over the development period or the product delivery period.
Milestone payments under collaboration agreements are recognized as revenue upon achievement of the incentive milestone events and when Transgene has no future performance obligations related to the payment. Milestone Payments are triggered either by the results of Transgene's research efforts or by events external to Transgene, such as regulatory approvals, the commencement of clinical trials or selection of candidates for drug development.
Royalties are based on the licensee's sales of products or technologies. They are recognized on the basis of the license terms, when the sales can be reliably measured and recovery of the related receivables is reasonably assured. Provisional estimates of royalties receivable are based on sales statistics and trends.
Transgene has entered into certain contracts for the provision of research or manufacturing services on a best-effort basis.
Transgene bills its services at a pre-agreed rate, generally on a time-spent basis, and billings are recorded as revenue as and when the work is done. Revenue from these contracts is recognized when the services are performed.

ANNUAL FINANCIAL STATEMENTS AT DECEMBER 31, 2021
Annual financial statements and notes
Some of these contracts provide for manufacturing services with a performance obligation. In these cases, the services are recorded in operating income in the income statement after satisfactory quality control and customer acceptance.
Revenue received but not yet recognized in the income statement based on the above principles is recorded as a liability under "Deferred revenue" and is reclassified to the income statement when the revenue recognition criteria are met.
Research and development costs entitled the Company to a sold under receivables assignment contracts and the research tax credit, which is recognized at the end of the Company no longer has any receivables from the State. These fiscal year in which the costs are recognized and the credit is contracts are qualified as deconsolidating. The RTC 2021 will claimed. Unused research tax credits are refundable from the be reimbursed by the tax authorities in 2025. fourth year. The research tax credits for 2018 to 2020 that will be repaid by the tax authorities from 2022 to 2024 have been
The Company considers as cash and cash equivalents and of mutual funds mostly invested in underlying monetary marketable securities its liquid investments, which can be assets, bonds and long-term government bonds. Marketable bought or sold at any time based on prices that are securities are valued at a cost, which is the lower of the first determined on a daily basis, and which have no material in/first out method or market value. interest or risk. Marketable securities are comprised of shares
Property, plant and equipment are measured at cost. Depreciation is recognized in the income statement according to the probable useful lives, as follows:
| Type of asset | Depreciation method | Period |
|---|---|---|
| Buildings | Straight-line | 20-50 years |
| Fixtures and fittings | Straight-line | 10-20 years |
| Machinery and equipment (machinery and | ||
| laboratory equipment) | Straight-line | 5-15 years |
| Office equipment and furniture | Straight-line | 5-10 years |
| IT equipment | Straight-line | 3-5 years |
Share issue costs are charged to share premiums.
Expenses for applied research and development include the direct and indirect costs incurred on the projects, excluding any allocation of general and administrative expenses. The direct and indirect costs refer primarily to the salaries of researchers and research technicians, the depreciation expense on assets used and on the cost of materials and other services used.
Research costs are recognized as an expense on the income statement for the period in which they are incurred. Development costs are capitalized when the required conditions are met.
The Company believes that the costs incurred in developing its pharmaceutical products are equivalent to research costs until a marketing authorization request is filed with regulatory authorities. After that, they are considered to be development costs. No Company product received a marketing authorization in 2021.
Intangible assets mainly comprise licenses, acquired patents and computer software.
| Type of intangible asset | Depreciation method | Period of depreciation |
|---|---|---|
| Computer software and licenses | Straight-line | 1-5 years |
| Patents acquired | Straight-line | 5 years |
Investments in non-consolidated companies are recorded at cost and depreciated, as needed, if their carrying value exceeds their recoverable amount as estimated by the Company. At each closing date, the Company performs an impairment test.
Equity securities are recorded at cost and depreciated, as needed, if their carrying value exceeds their recoverable amount as estimated by the Company. At each closing date, the Company performs an impairment test.
Other financial assets are comprised of deposits and guarantees regarding property rentals and the holdback related to the assignment of debt under the research tax credit and the competitiveness and job creation tax credit. Deposits and guarantees are measured at cost and depreciated as needed to reflect their net realizable value. The Company uses a liquidity contract with a banking partner, Natixis Oddo BHF SCA, which makes €500 thousand available.
Prepaid expenses and the other current assets are measured at cost and may be impaired to reflect their net realizable value.
Provisions are recorded to cover contingencies and charges arising in the course of our business. With regard to provisions for pensions and other post-employment benefits, in particular, the rights acquired by serving employees are estimated according to actuarial evaluations, taking into account mortality rates, future salary levels and the probability of employees remaining with the Company until retirement.
Until 2020, the Company recognized actuarial gains and losses using the corridor method. In accordance with the new valuation method specified by the IFRIC with respect to calculating commitments relating to certain defined benefit plans, the Company has decided to align its commitments with those of the consolidated financial statements.
Conditional advances are only reimbursed if the research and development projects that they finance are successful, according to criteria set out in advance with the financing body. These advances are recognized in Financial liabilities.
Conditional advances received under the ADNA program are recorded based on the discounted expected future reimbursements. The reimbursement of advances is subject to the fulfillment of a revenue threshold on the product TG4001 predetermined for the following five years, and in proportion to the revenue from this product until a reimbursement ceiling is reached, or up until 2035.
The Company regularly evaluates direct and indirect revenue linked to the product to estimate future cash flows from the reimbursement of advances. This revenue is evaluated based on business plan that has been discounted for this product and by a applying a comparable rate for this type of debt. The impact of this regular re-estimate is recorded in Net financial costs at the end of the fiscal year.
The main assumptions reviewed in the product business plan are as follows:
If the valuation of the payable is less than the amounts actually collected, the recorded payable is equal to the amounts collected, as long as the Company has not obtained the agreement of the organization to forgive all or part of this payable.

ANNUAL FINANCIAL STATEMENTS AT DECEMBER 31, 2021
Annual financial statements and notes
Cash liquidity in foreign currencies is converted into euros at the exchange rate on the reporting date. The resulting conversion differences are recognized in the income statement.
Receivables and payables in foreign currencies are converted into euros at the exchange rate on the reporting date. The resulting conversion differences are recognized under "exchange rate gains/losses" on the balance sheet (under assets for unrealized losses, under liabilities for unrealized gains).
Unrealized losses are booked in a provision for risks under expenses for the year in provisions for risks and financial expenses.
The Company does not have a foreign currency hedging instrument.
Income tax expenses correspond to taxes due calculated at the standard rate in use at year-end, taking into account the research tax credit.
The underlying tax position is calculated on the basis of the differences between the tax values and carrying amount of assets and liabilities presented in the balance sheet. These differences are determined according to the tax provisions and discounted tax rates when these differences are inverted.
This tax arrangement was stopped in 2019.
Since the tax situation of the Company does not make it possible to deduct the tax credit from any taxable profits for the period, this CICE receivable will not be paid by the State until the end of the following three fiscal years.
Transgene received bank pre-financing for this receivable in 2018, and the proceeds on this asset were used to renew the Company's working capital.
When assessing employee benefits, the company took into represents a decrease in the benefit, recognized as retained account the impacts of the IFRIC agenda decision made in earnings. April 2021 and the amendment of the ANC recommendation on November 5, 2021. This involved taking the levels of vesting of rights and their ceilings into account in the rate of benefit recognition. The impact as at December 31, 2021
The impact of this method change was estimated at €388 thousand and was recognized as retained earnings at January 1, 2021
| (in € thousands) | Dec. 31, 2021 | Dec. 31, 2020 |
|---|---|---|
| Research and development services | 2,929 | 2,988 |
| Licenses | 7,064 | (7) |
| Other income from ancillary activities | 3,562 | 2,542 |
| TOTAL | 13,555 | 5,523 |
In April 2019, the Company entered into a collaboration pre-existing intellectual property and as AstraZeneca receives agreement with AstraZeneca with exclusive licensing options the benefits of the licensed rights as and when the Research to co-develop oncolytic immunotherapies derived from the Plan is carried out, this initial payment is recognized in income Invir.IO™ platform. In the first half of 2019, Transgene thus against the progress of the associated activities and received €8.9 million (US\$10 million) in fees for access to its measured against the costs incurred by Transgene to carry platform. Pursuant to French accounting principles and out its contractual obligations. This agreement provides for inasmuch as Transgene has not transferred control of a additional revenue as and when preclinical milestones are
met. Transgene is eligible to receive an option exercise payment on each candidate in the event AstraZeneca exercises one or several license options, as well as development and commercial milestones and royalties.
The assumptions used by Management in the measurement of revenue related to the initial payment primarily concern:
As at December 31, 2021, Transgene re-estimated the overall budget and its progress. The income related to the initial payment recognized at December 31, 2021 was assessed on the basis of this revised budget and program progress. The Company may receive up to US\$1.5 million for the delivery of these candidates.
Over the period, the income recognized under this collaboration agreement was €9,921 thousand. This amount corresponds for €7,063 thousand to the exercise of a first licensing option by AstraZeneca in December 2021 for an oncolytic virus developed by Transgene. It also corresponds to €1,231 thousand in recognition of the initial payment for the activity carried out during the period. The €1,778 thousand balance not recognized at this time was recorded in Prepaid income at December 31, 2021 (Note 20). The Company also received €1,627 thousand for the production of batches and R&D services
Other income from ancillary activities corresponds to development costs re-invoiced to BioInvent and NEC under the co-development agreements signed between Transgene and these partner companies.
| (in € thousands) | Dec. 31, 2021 | Dec. 31, 2020 |
|---|---|---|
| FINANCIAL INCOME | ||
| Income from other securities and fixed asset receivables | 4 | 3 |
| Interest and related income | 81 | 65 |
| Reversals of provisions and transfers of expenses | 7 | 212 |
| Positive exchange rate differences | 334 | 866 |
| Total financial income | 426 | 1,146 |
| FINANCIAL EXPENSE | ||
| Financial amortization and provisions | (3) | (105) |
| Interest and related expenses | (390) | (1,293) |
| Negative exchange rate differences | (459) | (904) |
| Total financial expenses | (852) | (2,302) |
| FINANCIAL INCOME/(LOSS) | (426) | (1,156) |
Interest and related expenses involved:
The positive and negative exchange rate differences are mainly related to the payment received on the disposal of Tasly BioPharmaceuticals shares in September 2021 upon the sale of 49% of these shares. The Company used a currency hedging instrument that hedged the impact of the change in the US dollar exchange rate.
As of December 31, 2021, ADNA payable has not changed as expected repayments remain lower than the amounts received.

| (in € thousands) | Dec. 31, 2021 | Dec. 31, 2020 |
|---|---|---|
| EXTRAORDINARY INCOME | ||
| Extraordinary income on management operations | 34 | 1,609 |
| Extraordinary income on equity operations | 17,695 | 19,965 |
| Reversals of provisions and transfers of expenses | 464 | 2,080 |
| Total extraordinary income | 18,193 | 23,654 |
| EXTRAORDINARY EXPENSES | ||
| Extraordinary expenses on management operations | - | (500) |
| Extraordinary expenses on equity operations | (12,700) | (18,355) |
| Provisions and transfers of expenses | - | - |
| Total extraordinary expenses | (12,700) | (18,855) |
| EXTRAORDINARY INCOME/(LOSS) | 5,493 | 4,799 |
In September 2021, the Company sold 49% of its shares in Tasly BioPharmaceuticals for €17,485 thousand. This disposal generated exceptional proceeds of €4,788 thousand.
In July 2020, the Company sold 38% of its shares in Tasly BioPharmaceuticals for €19,202 thousand. This sale generated exceptional proceeds of €3,655 thousand and exceptional expenses on transaction costs of €901 thousand.
In 2020, exceptional income on management transactions mainly corresponds to the reversal of a provision of €1 million on the ElsaLys Biotech SA receivable. During the first half of 2020, Transgene and all shareholders of ElsaLys Biotech SA reached an agreement on the acquisition of ElsaLys Biotech SA by the Italian company Mediolanum Farmaceutici. The deed of sale of ElsaLys Biotech SA shares to Mediolanum Farmaceutici stated that the Company would recover €599 thousand excluding tax, of which €500 thousand would be recovered over a period of 36 months, without interest, in 12 quarterly installments, and the Company had waived 50% of its claim for the TG3003 product (€500 thousand in exceptional expenses on management transactions). In return, the Company received compensation from former shareholders related to this debt waiver in the amount of €457 thousand, 75% of this amount being paid immediately and 25% payable by 2025.
During this transaction, the equity securities of ElsaLys Biotech SA held by Transgene were sold for €309 thousand and the provision of €1,694 thousand on the shares held was reversed.
In 2014, the Company sold the equity securities that it held in Jennerex, Inc. to SillaJen. This sale resulted in a sale price broken down into a fixed portion payable at the signing of the sale and a variable portion consisting of earn-outs. In the absence of payment by SillaJen of the earn-outs due since 2018, Fortis, which represents the former shareholders of Jennerex Inc., decided to institute legal proceedings in Delaware, USA. At the end of 2020, the representative of the former shareholders entered into an agreement with SillaJen, terminating SillaJen's commitments to pay additional earn-outs. This agreement enabled the Company to obtain compensation in the amount of €219 thousand and end the legal proceedings in the United States.
| (in € thousands) | Dec. 31, 2021 | Dec. 31, 2020 |
|---|---|---|
| Cash | 5,846 | 5,210 |
| Marketable securities | 8 | 8 |
| TOTAL | 5,854 | 5,218 |
| Unrecognized unrealized gains or losses | - | - |
In 2021, marketable securities were composed of short-term money market fund units.
| (in € thousands) | Dec. 31, 2021 | Dec. 31, 2020 |
|---|---|---|
| Invoices issued, gross | 7,988 | 422 |
| Invoices to be issued, gross | 2,145 | 1,245 |
| Provisions for impairment | - | - |
| NET TOTAL CUSTOMERS | 10,133 | 1,667 |
At December 31, 2021, trade receivables mainly concern AstraZeneca receivables for an amount of €8,091 thousand, of which €7,063 thousand related to the exercise of the license option in December 2021 for an oncolytic virus developed by Transgene.
Trade receivables also include receivables from our co-development partners NEC for €1,322 thousand and BioInvent for €504 thousand.
| (in € thousands) | Dec. 31, 2021 | Dec. 31, 2020 |
|---|---|---|
| Institut Mérieux centralized cash (cash pool) | 43,658 | 21,077 |
| Accrued credit notes (trade credit) | 48 | 14 |
| Employee benefits expense | 33 | 28 |
| Other receivables, non-current portion | 388 | 894 |
| VAT credit and tax credit | 571 | 337 |
| VAT on accrued invoices | 187 | 51 |
| TOTAL OTHER RECEIVABLES | 44,885 | 22,401 |
Contractually, investments made by the Company as part of the centralized cash management at Institut Mérieux are liquid within a maximum period of four business days and bear interest based on a rate equal to Euribor +0.25% when Institut Mérieux is in a net borrowing position at the Group level and to Euribor when Institut Mérieux is in a net surplus at the Group level.
| (in € thousands) | Dec. 31, 2021 | Dec. 31, 2020 |
|---|---|---|
| Accrued income - customers | 2,145 | 1,245 |
| VAT credit and tax credit | 571 | 337 |
| VAT on accrued invoices | 224 | 130 |
| Social organizations - income receivable | 5 | 1 |
| Other accrued income | 14 | 15 |
| TOTAL ACCRUED INCOME | 2,959 | 1,728 |

| (in € thousands) | Dec. 31, 2020 | Increase | Decrease | Dec. 31, 2021 |
|---|---|---|---|---|
| ACQUISITION COSTS | ||||
| Land | 584 | - | - | 584 |
| Buildings and fixtures | 2,324 | 188 | (1) | 2,511 |
| Laboratory equipment | 10,267 | 341 | (211) | 10,397 |
| Office and computer equipment | 1,652 | 81 | (59) | 1,674 |
| Assets in progress | 65 | 405 | (368) | 102 |
| Total | 14,892 | 1,015 | (639) | 15,268 |
| DEPRECIATION AND PROVISIONS | ||||
| Buildings and fixtures | (722) | (166) | 1 | (887) |
| Laboratory equipment | (7,000) | (1,179) | 210 | (7,969) |
| Office and computer equipment | (1,477) | (70) | 57 | (1,490) |
| Assets in progress | - | - | - | - |
| Total | (9,199) | (1,415) | 268 | (10,346) |
| NET TOTAL PROPERTY, PLANT AND EQUIPMENT | 5,693 | (400) | (371) | 4,922 |
At December 31, 2021, and taking into account its future use, the Company fully depreciated the equipment acquired in 2015 and stored on the Genzyme Polyclonals site for €682 thousand.
| (in € thousands) | Dec. 31, 2020 | Increase | Decrease | Dec. 31, 2021 |
|---|---|---|---|---|
| ACQUISITION COSTS | ||||
| Licenses and acquired patents | 1,788 | - | - | 1,788 |
| Other intangible assets | 1,458 | 24 | (3) | 1,479 |
| Assets in progress | 9 | 1 | (10) | - |
| Total | 3,255 | 25 | (13) | 3,267 |
| DEPRECIATION AND PROVISIONS | ||||
| Licenses and acquired patents | (1,752) | (17) | 2 | (1,767) |
| Other intangible assets | (1,362) | (49) | 3 | (1,408) |
| Total | (3,114) | (66) | 5 | (3,175) |
| NET TOTAL PROPERTY, PLANT AND EQUIPMENT | 141 | (41) | (8) | 92 |
Annual financial statements and notes
| (in € thousands) | Dec. 31, 2020 | Increase | Decrease | Dec. 31, 2021 |
|---|---|---|---|---|
| Equity securities | ||||
| Transgene BioPharmaceutical Technology (Shanghai) Co. Ltd. |
100 | - | - | 100 |
| Transgene, Inc. |
23 | - | - | 23 |
| Access Investment, Inc. |
29 | - | - | 29 |
| Total gross equity securities | 152 | - | - | 152 |
| Impairments on equity securities | (29) | - | - | (29) |
| Total net equity securities | 123 | - | - | 123 |
| Guarantees and deposits | 1,831 | 534 | (292) | 2,073 |
| Vaxxel SAS shares | 118 | - | - | 118 |
| Tasly BioPharmaceuticals securities | 25,911 | - | (12,696) | 13,215 |
| TOTAL FINANCIAL ASSETS | 27,983 | 534 | (12,988) | 15,529 |
In February 2020, the subsidiary Transgene BioPharmaceutical Technology (Shanghai) Co. Ltd was created with an investment of €100 thousand.
The Company has an investment in Transgene, Inc. in the amount of €23 thousand.
The Company has an investment in Access Investment, Inc. in the amount of €29 thousand. This investment is fully depreciated.
Guarantees and deposits consist largely of holdbacks related to the financing of the RTCs and the CICE. The increase of €534 thousand in 2021 mainly corresponds to the guarantee for the transfer of the 2020 RTC receivable (€318 thousand). The decrease of €292 thousand in 2021 mainly corresponds to the repayment of the guarantee for the assignment of the 2017 RTC receivable (€270 thousand).
The €13,215 thousand of non-consolidated equity securities without significant influence refer to the shares in Tasly BioPharmaceuticals obtained in July 2018 in exchange for the rights held in the Transgene Tasly (Tianjin) BioPharmaceutical Co. Ltd. joint venture and the rights to the product TG1050 for Greater China.
On September 22, 2021, the Company sold 49% of the shares it held, resulting in a decrease in net value of €12,696 thousand. Transgene holds 8.7 million shares of Tasly BioPharmaceuticals, i.e. 0.8% of its capital, for a carrying amount of €13,215 thousand at December 31, 2021. Based on the sale price of the shares in September 2021, these shares would have a value of €18,395 thousand. As a result of this transaction in particular, the shareholder agreement was amended in December 2021. This new agreement now states that the commitment to repurchase Transgene shares by a holding company of the Tasly Group will be triggered in the absence of an IPO on the Shanghai Stock Exchange on September 30, 2022. As of December 31, 2021, the Company does not intend to dispose of Talsy BioPharmaceuticals shares in the short term, due to its ongoing IPO process of Tasly Biopharmaceuticals. Once the IPO is completed, the Company will not be able to sell the shares held during a one-year post-IPO holding period.
In order to corroborate the fair value of the shares as of December 31, 2021 against the sale price recorded at the time of the September 2021 sale transaction and to ensure that this price remains representative of the fair value of the shares as of December 31, 2021, the Company has had the model used, as well as the assumptions as of the closing date, reviewed and updated by an independent consulting firm, on the basis of the elements related to the September 2021 transaction and the information provided by Tasly BioPharmaceuticals, including the annual financial statements as of December 31, 2020. This independent analysis confirms the appropriateness of the fair value retained at December 31, 2021.

ANNUAL FINANCIAL STATEMENTS AT DECEMBER 31, 2021
Annual financial statements and notes
The main assumptions taken into account by management in assessing value in use as of December 31, 2021 are based on assumptions obtained from Tasly BioPharmaceuticals and concern:
● the discount rate used by management.
This analysis confirms that there was no impairment of the shares at December 31, 2021 and therefore no impairment allowance. In the event of a 10% decline in the yuan, no impairment would be recognized.
In exchange for the rights to the DuckCelt® -T17 cell line, The Company acquired an equity investment in Vaxxel SAS for €118 thousand. A refinancing operation during the year 2021 and recent discussions with management confirms that no impairment loss is to be recognized.
Transgene completed a €34,128,500 capital increase in June 2021. This transaction resulted in the creation of 13,930,000 new shares at €0.50, i.e. an increase in share capital of €6,965,000. The balance of the capital increase was recorded as issuance premium for €27,163,500.
At December 31, 2021, the number of outstanding shares of Transgene was 97,771,334, representing a share capital of €48,885,667.
During 2021, the Boards of Directors authorized the allocation of 2,299,956 free shares.
As of the date of this Registration Document, a stock option plan was authorized by the General Shareholders' Meeting in 2010 and implemented by the Board of Directors. No stock options have been awarded since 2012. The status of these plans at December 31, 2021, is summarized in the following table.
| Allocation date | Exercise start date |
Expiration date |
Exercise price |
Number of options granted |
Number of options exercised in 2021 |
Number of options remaining to be exercised at Dec. 31, 2021* |
|---|---|---|---|---|---|---|
| Dec. 13, 2012 | Dec. 14, 2017 | Dec. 14, 2022 | 7,859 | 92,578 | - | 41,532 |
| TOTAL | N/A | N/A | N/A | N/A | - | 41,532 |
* This amount includes adjustments, in terms of the number of options and the exercise price, in accordance with regulations, following the capital increases maintaining preferential subscription rights of shareholders conducted in 2016 and 2019.
Five free share awards are outstanding as of December 31, 2021, adopted by the Board of Directors in 2019, 2020 and 2021 for all employees and executive corporate officers under a delegation granted by the General Meeting of May 22, 2019 and May 26, 2021.
The status of these unvested awards at December 31, 2021, is summarized in the following table:
| 2021 PLAN | |||||
|---|---|---|---|---|---|
| General Meeting date | May. 26, 2021 | ||||
| Total number of shares authorized by the Meeting | 2,500,000 | ||||
| Grants 2021 |
|||||
| Board of Directors meeting date | May. 26, 2021 | ||||
| Total number of free shares awarded | 1,999,956 | ||||
| Of which allocations granted, during the year, by the issuer and by any company included in the scope of the allocation to corporate officers |
300,000 | ||||
| Of which the number of shares awarded to members of the Executive Committee |
1,200,000 | 300,000 | |||
| Of which awards granted, during the year by the issuer and by any company in the scope of the award, to the ten non-corporate officer employees of the issuer and of any company within this scope, whose number of free shares awarded is greatest |
802,117 | - | |||
| Of which the balance not yet vested at Dec. 31, 2021 | 1,975,266 | 300,000 | |||
| Vesting date | May. 26, 2022 | May. 26, 2023 | May. 26, 2024 | Jan. 1, 2024 | |
| Expiration date of the lock-up period | May. 26, 2022 | May. 26, 2023 | May. 26, 2024 | End of contract | |
| Value of the share on the award date | €2.95 | €2.95 |
| 2016 PLAN | 2018 PLAN | 2019 PLAN | ||||
|---|---|---|---|---|---|---|
| General Meeting date | May. 24, 2016 | May. 23, 2018 | May. 22, 2019 | |||
| Total number of shares authorized by the Meeting |
600,000 | 1,200,000 | 2,000,000 | |||
| 2017 Grant |
2018 Grant |
2019 Grant |
2019 Grant |
2019 Catch-up |
2020 Grant |
|
| Board of Directors meeting date | Mar. 17, 2017 Mar. 21, 2018 | Mar. 20, 2019 | Sept. 18, 2019 |
May. 27, 2020 |
Sept. 16, 2020 |
|
| Total number of free shares awarded | 183,000 | 220,600 | 414,800 | 1,399,774 | 5,934 | 601,682 |
| Of which allocations granted, during the year, by the issuer and by any company included in the scope of the allocation to corporate officers |
31,000 | 34,600 | 77,500 | 350,000 | - | 150,000 |
| Of which the number of shares awarded to members of the Executive Committee |
72,000 | 104,600 | 192,000 | 840,000 | - | 360,000 |
| Of which awards granted, during the year by the issuer and by any company in the scope of the award, to the ten non-corporate officer employees of the issuer and of any company within this scope, whose number of free shares awarded is greatest |
49,400 | 85,000 | 628,236 | 223,620 |

Annual financial statements and notes
| 2016 PLAN | 2018 PLAN | 2019 PLAN | ||||
|---|---|---|---|---|---|---|
| Of which the balance not yet vested at Dec. 31, 2021 |
- | - | - | 1,309,994 | 5,934 | 565,704 |
| Of which vested at Dec. 31, 2021 | 173,175 | 200,750 | 375,120 | - | - | - |
| Vesting date | Mar. 17, 2019 | Mar. 21, 2020 |
Apr. 20, 2020 |
Mar. 30, 2022 |
Apr. 30, 2022 |
Mar. 30, 2022 |
| Expiration date of the lock-up period | Mar. 17, 2021 | Mar. 21, 2022 |
Apr. 20, 2021 | Mar. 30, 2022 |
May. 27, 2022 |
Sept. 16, 2022 |
| Value of the share on the award date | €2.63 | €3.15 | €2.98 | €1.78 | €1.47 | €1.35 |
5
As at December 31, 2021, the bonus shares awarded and not issued represent a potential dilution of 4,307,606 shares; the shares and options awarded and not exercised represent a potential dilution of 41,532 shares, giving a total of approximately 4.4% of the Company's share capital.
The provision covering URSSAF contributions related to free shares amounted to €1,215,000 as at December 31, 2021 and was valued on the basis of the Transgene share price as at December 31, 2021.
| (in € thousands) | Capital stock |
Premiums | Reserves | Retained earnings |
Result | Statutory provisions |
Equity |
|---|---|---|---|---|---|---|---|
| As of Dec. 31, 2020 published | 41,921 | 31,072 | 1,951 | (16,972) | (20,116) | - | 37,856 |
| Change in accounting method for retirement benefit provision |
- | - | - | 388 | - | - | 388 |
| Adjusted situation at January 1, 2021 | 41,921 | 31,072 | 1,951 | (16,584) | (20,116) | - | 38,244 |
| Increase of share capital | 6,965 | 26,377 | - | - | - | - | 33,342 |
| Free share awards | - | (1,150) | 1,150 | - | - | - | - |
| Share capital reduction | - | - | - | - | - | - | - |
| Net income/(loss) 2020 | - | - | - | (20,116) | 20,116 | - | - |
| Net income/(loss) 2021 | - | - | - | - | (17,006) | - | (17,006) |
| At Dec. 31, 2021 | 48,886 | 56,299 | 3,101 | (36,700) | (17,006) | - | 54,580 |
At December 31, 2021, conditional advances referred to conditional advances received under the ADNA ("Advanced Diagnostics for New therapeutic Approaches") program, which receives public financing from Bpifrance to develop the TG4001. This program ended on December 31, 2016. Transgene received a total of €15,942 thousand of conditional advances under this program.
As at December 31, 2021, the liability consisting of conditional advances in the Company's balance sheet amounts to €15,942 thousand. At closing, the Company re-values its conditional advances received under the ADNA program based on the discounted expected future reimbursements as described in Note 1 to the Annual financial statements. As of December 31, 2021, ADNA payable has not changed as expected repayments remain lower than the amounts received.
For the past three years, the Company has signed research tax credit assignment contracts for the 2018, 2019 and 2020 RTC with a credit institution and no longer has any receivables from the State. As this type of contract is deconsolidating, no liability is recognized for this financing received (up to 95%).
The Company has a debt to a credit institution for the financing of the CICE 2018, representing a debt of €114 thousand, compared to €225 thousand last year, the CICE 2017 having been repaid during 2021.
Under the NEOVIVA program, signed in March 2019, Transgene could receive conditional advances of €2.4 million.
At December 31, 2021, the Company had received €1,495 thousand conditional advances.
In April 2019, the Company signed a revolving credit agreement with Natixis, capped at €20 million, which can be drawn down on one or more occasions. Transgene was to pledge the shares held in Tasly BioPharmaceuticals. An amendment was signed in September 2020 bringing this credit line to a maximum of €15 million, following the sale of 38% of the Tasly BioPharmaceuticals shares in July 2020. Following the second sale of Tasly BioPharmaceuticals shares in September 2021, the credit facility was canceled completely, in accordance with the terms of the agreement. The Company had not drawn down on this credit facility.
| (in € thousands) | Dec. 31, 2021 | Dec. 31, 2020 |
|---|---|---|
| Financing of CICE | 114 | 232 |
| Interest on bank loan | - | 45 |
| Other | 1 | - |
| TOTAL FINANCIAL LIABILITIES | 115 | 277 |

| (in € thousands) | Dec. 31, 2020 |
Retained earnings |
Provisions | Reversals not applicable |
Use of the provision |
Dec. 31, 2021 |
|---|---|---|---|---|---|---|
| Exchange rate differences | 4 | - | - | (4) | - | - |
| Provision for expenses | 511 | - | 1 | (360) | (104) | 48 |
| Pension obligations | 4,448 | (388) | 761 | - | (863) | 3,958 |
| PROVISIONS FOR RISKS AND EXPENSES | 4,963 | (388) | 762 | (364) | (967) | 4,006 |
As of December 31, 2020, the provision for expenses corresponded to the costs remaining to be incurred for the ongoing clinical trial with TG4010, which was halted at the end of 2019. Of this provision, €104 thousand was used in fiscal year 2021.
The Company reviewed the remaining costs to be incurred on this project and has decided to write back €360 thousand.
The above provisions for retirement benefit obligations correspond to the estimated current value of the share capital equivalent to accrued future payments, depending on length of service and level of compensation when an employee retires, on the basis of the following actuarial calculation assumptions at December 31, 2021:
| Dec. 31, 2021 | Dec. 31, 2020 | |
|---|---|---|
| Discount rate | 0.90% | 0.60% |
| Rate of future salary increases | 3.00% | 1.50% |
| Retirement age: | ||
| managers |
65 years | 65 years |
| non-managers |
63 years | 63 years |
The provision entered on the balance sheet concerns only retirement payments for serving employees.
The following table summarizes the conditions and amounts of actuarial pension obligations at December 31, 2021:
| Dec. 31, 2021 | Dec. 31, 2020 | |
|---|---|---|
| CHANGE IN THE VALUE OF COMMITMENTS | ||
| Projected benefit obligation at January 1 | 4,448 | 4,427 |
| Impact of change in valuation method on provision for retirement benefits | (388) | - |
| Cost of services rendered for the year | 294 | 281 |
| Cost of discounting | 22 | 33 |
| Change in assumptions | 433 | 104 |
| Reductions/terminations | - | - |
| Actuarial (gain)/loss | 12 | (49) |
| Benefits paid during the year | (863) | (270) |
| Projected benefit obligation for retirement | 3,958 | 4,526 |
| Unrecognized actuarial losses | - | (78) |
| Unrecognized past service cost | - | - |
| Total unrecognized items | - | - |
| PROVISIONS FOR PENSIONS | 3,958 | 4,448 |
Annual financial statements and notes
| (in € thousands) | Dec. 31, 2021 | Dec. 31, 2020 |
|---|---|---|
| Suppliers-accrued invoices | 5,307 | 3,692 |
| Personnel and related accounts | 779 | 809 |
| Social security and other organizations | 814 | 855 |
| VAT collected and on invoices to be issued | 16 | 14 |
| Other expenses | - | 45 |
| TOTAL EXPENSES PAYABLE | 6,916 | 5,415 |
Deferred revenue and expenses relate exclusively to items recognized under operations.

Transgene signed a cash pooling agreement with Institut Mérieux. The cash and cash equivalents placed in the Institut Mérieux cash pool amounted to a receivable of €43.7 million at December 31, 2021; the resulting interest income was €68 thousand at December 31, 2021.
The table below does not include these cash items.
| 2021 | ||
|---|---|---|
| (in € thousands) | Receivables | Payables |
| ABL Europe SAS | - | 743 |
| bioMérieux SA | - | - |
| Institut Mérieux | - | 9 |
| Mérieux Université | - | 7 |
| Thera Conseil | - | 6 |
| Transgene, Inc. | - | 31 |
| Transgene Shanghai | - | 83 |
| TOTAL | - | 879 |
| 2021 | ||
|---|---|---|
| (in € thousands) | Revenue | Expenses |
| ABL Europe SAS (1) | 221 | 3,643 |
| bioMérieux SA | - | 1 |
| Institut Mérieux (2) | - | 270 |
| Mérieux Université | - | 7 |
| Thera Conseil | - | 5 |
| Transgene Inc. (3) | - | 377 |
| Transgene Shanghai (4) | - | 309 |
| TOTAL | 221 | 4,612 |
(1) The revenue corresponding to the rent re-invoicing contract for hosting test labs. Expenses related to the agreements for production services provided by ABL Europe and to leases of premises in Lyon.
(2) Expenses related to the agreements for services provided by Institut Mérieux.
(3) Expenses related to the re-invoicing of Transgene, Inc. services and staff.
(4) Expenses correspond to the re-invoicing of services of Transgene, Shanghai.
Annual financial statements and notes
| Receivables (in € thousands) | Gross amount | One year or less | More than one year |
|---|---|---|---|
| Other financial assets | 2,073 | 307 | 1,766 |
| Trade receivables | 10,133 | 10,133 | - |
| RTC and CICE | 7,136 | 109 | 7,027 |
| Government, VAT and other local authorities | 758 | 758 | - |
| Personnel and related accounts | 33 | 33 | - |
| Prepaid expenses | 1,652 | 1,376 | 276 |
| Research and development grants | 24 | 24 | - |
| Other receivables | 436 | 199 | 237 |
| TOTAL RECEIVABLES | 22,245 | 12,939 | 9,306 |
| Payables (in € thousands) | Gross amount | One year or less | More than one year and less than or equal to five years |
More than five years |
|---|---|---|---|---|
| Conditional advances | 17,437 | - | 1,495 | 15,942 |
| Financing of tax credits | 114 | 114 | - | - |
| Trade payables | 7,775 | 7,775 | - | - |
| Pension obligations | 3,958 | 228 | 1,031 | 2,699 |
| Accrued employee benefits and tax expense | 4,466 | 4,466 | - | - |
| Prepaid income | 1,813 | 972 | 841 | - |
| Other liabilities | 10 | 10 | - | - |
| TOTAL LIABILITIES | 35,573 | 13,565 | 3,367 | 18,641 |
In 2021 the RTC was €7,027 thousand (versus €6,352 thousand in 2020). This tax credit will be reimbursed by the tax authorities in 2025.
In June 2021, the Company signed an agreement to sell a research tax credit to a banking institution. The Company thereby received €6,034 thousand for the 2020 RTC (representing 95% financing) and no longer has a credit with the French government. This financing contract is classified as deconsolidating, and no debt is recognized for the financing received.
At December 31, 2021, Transgene had tax loss carryforwards in France (indefinitely carryable) totaling €754,627 thousand.

Directors' compensations amounted to €232 thousand. In 2021.
The Company paid no compensation to TSGH and its permanent representative.
Hedi Ben Brahim, Chairman and Chief Executive Officer of Transgene, has been mainly employed by the Company since January 1, 2021. As of December 31, 2021, he was also an employee of Institut Mérieux.
In 2021, the Company paid its Chairman and Chief Executive Officer, Hedi Ben Brahim, gross compensation of €224 thousand (no variable compensation).
Hedi Ben Brahim received gross compensation from Institut Mérieux of €161 thousand in 2021, of which €100 thousand was variable compensation and €4 thousand in benefits in kind – vehicle.
In 2021 the Company paid to the Responsible Pharmacist acting as Deputy CEO, Christophe Ancel, total compensation amounting to €172 thousand (versus €152 thousand in 2020), including €42 thousand in variable compensation (versus €32 thousand in 2020) and €5 thousand in benefits in kind – vehicle, as in 2020.
The Company paid a gross amount of €1,965 thousand in compensation to its Executive Committee in 2021.
No advances or credits were allocated to executives.
In December 2008, Transgene invested in a building housing by a 15-year finance lease, signed with a banking consortium labs and offices on the Illkirch site, in the suburbs of in October 2007, with a residual value of €1.1 million. The first Strasbourg. Land and construction costs for the 6,900 sq.m. lease payment was made on January 1, 2009. building totaled €15.6 million. This investment was financed
The table below summarizes the main residual obligations of the Company under this contract:
| (in € thousands) | 2021 | 2020 |
|---|---|---|
| Property leasing: | ||
| outstanding charges |
1,995 | 2,929 |
| residual purchase price |
1,094 | 1,094 |
Under the terms of the real estate financing lease for the acquisition of its administrative and research building in Illkirch, Transgene has a pledge granted by Banque Populaire to Alsabail, one of the lessors, for an amount of €1.6 million. In the first six months of 2009, the Company proceeded with partial coverage of the interest rate risk related to this financing, according to the following terms:
As the hedge is perfect, the variations in market value for the instrument are recognized at net value. At December 31, 2021, the market value of this hedging instrument was €51 thousand. The market value is the amount that the Company would have had to pay if it decided to liquidate the hedge at December 31, 2021.
Transgene has also been leasing premises from ABL Europe for its Lyon teams since 2019. The Company paid rent of €233 thousand to ABL Europe for the new premises.
The table below summarizes key financial commitments made by the Company:
| Payments due by period | |||||||
|---|---|---|---|---|---|---|---|
| (in € thousands) | Gross amount | One year or less |
From one to five years |
More than five years |
|||
| Finance lease obligation (real estate) | 3,045 | 947 | 2,098 | - | |||
| Finance lease obligation (non-real estate) | 665 | 314 | 351 | - | |||
| TOTAL | 3,710 | 1,261 | 2,449 | - |
Transgene is also bound by contracts with subcontractors. That could have an impact over several accounting periods. As of December 31, 2021, the Company estimated the current value of its financial commitments under these agreements to be approximately €29 million.
Under licensing or option agreements, third parties have promised to make milestone payments or pay royalties to the Company that are dependent upon future events whose probability remains uncertain as of the reporting date. The Company has promised, with respect to a number of third parties, to pay royalties or milestone payments under collaboration or licensing agreements that are dependent upon future events whose realization remains uncertain as of the reporting date.
As part of the agreements with Tasly BioPharmaceuticals in July 2018, Transgene had received 27.4 million shares in this company, i.e., 2.53% of its capital. At the time of the transaction, the assets contributed by Transgene were valued by the parties at US\$48 million, and the unit price of the shares received was that negotiated by the institutional funds during a capital increase. On this occasion, Transgene, the institutional funds, Tasly BioPharmaceuticals and its parent company Tasly Holding Group have signed a shareholders' agreement to frame their relations. In addition to the usual provisions such as a right of first refusal in the event of assignment by a shareholder, Tasly Holding Group undertook to repurchase the shares subscribed by Transgene in the event of no IPO within a predefined period, at the initial subscription price plus an annual contractual rate. In July 2020, the Company had sold 10.3 million Tasly BioPharmaceuticals shares. Following this transaction, Transgene held 17.1 million shares of Tasly BioPharmaceuticals, representing 1.58% of its share capital, valued at approximately US\$36.9 million. In September 2021, the Company sold 49% of its remaining shares (representing 8.4 million shares). Following this new sale, the Company now holds 8.7 million Tasly BioPharmaceuticals shares. As a result of this transaction in particular, the shareholder agreement was amended in December 2021. This new agreement now states that the undertaking to repurchase Transgene shares by a holding company of the Tasly Group will be triggered in the absence of an IPO on the Shanghai Stock Exchange of Tasly BioPharmaceuticals by September 30, 2022.
In addition to the usual provisions such as a right of first refusal in the event of assignment by a shareholder, Tasly Holding Group undertook to repurchase the shares subscribed by Transgene in the event of no IPO within a predefined period, at the initial subscription price plus an annual contractual rate. In July 2020, the Company had sold 10.3 million Tasly BioPharmaceuticals shares. Following this transaction, Transgene held 17.1 million shares of Tasly BioPharmaceuticals, representing 1.58% of its share capital, valued at approximately US\$36.9 million. In September 2021, the Company sold 49% of its remaining shares (representing 8.4 million shares). Following this new sale, the Company now holds 8.7 million Tasly BioPharmaceuticals shares. As a result of this transaction in particular, the shareholder agreement was amended in December 2021. This new agreement now states that the undertaking to repurchase Transgene shares by a holding company of the Tasly Group will be triggered in the absence of an IPO on the Shanghai Stock Exchange of Tasly BioPharmaceuticals by September 30, 2022
As at the date of this document, the Company has not made any material commitment (guarantees, collateral, etc.).
The Company had 167 employees at December 31, 2021, vs. 164 at December 31, 2020.
| Men | Women | Total * | |
|---|---|---|---|
| Managers | 45 | 70 | 115 |
| Non-managers | 17 | 35 | 52 |
| TOTAL | 62 | 105 | 167 |
* Including 143 open-ended contracts at Dec. 31, 2021.
The Company's financial statements were fully consolidated by Compagnie Mérieux Alliance, 17, rue Bourgelat, 69002 Lyon.

None.
The distribution options offered by the accumulated premiums and reserves were as follows:
| (in € thousands) | Total | Reimbursable or available for distribution |
Not available for distribution |
|---|---|---|---|
| Premiums | 56,299 | 56,299 | - |
| Legal reserve | 248 | - | 248 |
| Unavailable reserve | 2,853 | - | 2,853 |
| TOTAL | 59,400 | 56,299 | 3,101 |
| Financial information (in local currency) | Transgene, Inc. One Boston Place, Suite 4030 201 Washington Street BOSTON, MA 02108 USA |
Transgene BioPharmaceutical Technology (Shanghai) Co. Ltd. No. 4633, Pu San Road, Pudong District, Shanghai PR CHINA |
|
|---|---|---|---|
| Share capital | US\$30,000 | ¥768,630 | |
| Share capital other than capital | - | ||
| Proportion of capital held (in %) | 100% | 100% | |
| Gross | 23,114 | 100,000 | |
| Carrying value of securities held (in €) | Net | 23,114 | 100,000 |
| Loans and advances granted by the Company not yet reimbursed | None | None | |
| Amount of guarantee and undertakings given by the Company | None | None | |
| Revenues excl. tax of the previous fiscal year | US\$450,766 | ¥2,262,896 | |
| Income (profits or losses for the previous fiscal year) | - | - | |
| Dividends received during the year | None | None | |
| Comments | - | - |
Annual financial statements and notes
| Ernst & Young et Autres | Grant Thornton | |||||||
|---|---|---|---|---|---|---|---|---|
| Amount (pre-tax) | % | Amount (pre-tax) | % | |||||
| (in € thousands) | 2021 | 2020 | 2021 | 2020 | 2021 | 2020 | 2021 | 2020 |
| Audit | - | - | - | - | - | - | - | - |
| STATUTORY AUDITORS, CERTIFICATION, EXAMINATION OF INDIVIDUAL AND CONSOLIDATED FINANCIAL STATEMENTS | ||||||||
| Issuer | 83 | 85 | 87% | 90% | 63 | 51 | 100% | 100% |
| Fully consolidated subsidiaries | - | - | - | - | - | - | - | - |
| OTHER DUE DILIGENCE AND SERVICES DIRECTLY RELATED TO THE AUDIT | ||||||||
| Issuer | 12 | 9 | 13% | 10% | - | - | - | - |
| Fully consolidated subsidiaries | - | - | - | - | - | - | - | |
| Sub-total | 95 | 94 | 100% | 100% | 63 | 51 | 100% | 100% |
| Other services provided by networks to fully consolidated subsidiaries |
- | - | - | - | - | - | - | - |
| Legal, tax and social | - | - | - | - | - | - | - | - |
| Other (specify if > 10% of the audit fees) | - | - | - | - | - | - | - | - |
| Sub-total | - | - | - | - | - | - | - | - |
| TOTAL | 95 | 94 | 100% | 100% | 63 | 51 | 100% | 100% |
5

ANNUAL FINANCIAL STATEMENTS AT DECEMBER 31, 2021
Statutory auditor's report on the financial statements
Year ended December 31, 2021
This is a translation into English of the statutory auditors' report on the financial statements of the Company issued in French and it is provided solely for the convenience of English-speaking users. This statutory auditors' report includes information required by European regulations and French law, such as information about the appointment of the statutory auditors or verification of the management report and other documents provided to the shareholders. This report should be read in conjunction with, and construed in accordance with, French law and professional auditing standards applicable in France.
To the Annual General Meeting of Transgene S.A.,
In compliance with the engagement entrusted to us by your Annual General Meeting, we have audited the accompanying financial statements of Transgene S.A. for the year ended December 31, 2021.
In our opinion, the financial statements give a true and fair view of the assets and liabilities and of the financial position of the Company as at December 31, 2021 and of the results of its operations for the year then ended in accordance with French accounting principles.
The audit opinion expressed above is consistent with our report to the Audit Committee.
We conducted our audit in accordance with professional standards applicable in France. We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our opinion.
Our responsibilities under those standards are further described in the Statutory Auditor's Responsibilities for the Audit of the Financial Statements section of our report.
We conducted our audit engagement in compliance with the independence requirements of the French Commercial Code (Code de commerce) and the French Code of Ethics for Statutory Auditors (Code de déontologie de la profession de commissaire aux comptes) for the period from January 1, 2021 to the date of our report, and specifically we did not provide any prohibited non-audit services referred to in Article 5(1) of Regulation (EU) No. 537/2014.
Without qualifying the opinion expressed above, we draw your attention to Note 2 of the financial statements relating to the change in accounting method related to the valuation of employee benefits in accordance with ANC recommendation.
Due to the global crisis related to the COVID-19 pandemic, the financial statements for this period have been prepared and audited under special circumstances. Indeed, this crisis and the exceptional measures taken in the context of the health emergency have had numerous consequences for companies, particularly on their operations and their financing, and have led to greater uncertainties regarding their future prospects. Some of these measures, such as travel restrictions and remote working, have also had an impact on companies' internal organization and on the performance of audits.
It is in this complex, evolving context that, in accordance with the requirements of Articles L. 823-9 and R. 823-7 of the French Commercial Code (Code de commerce) relating to the justification of our assessments, we inform you of the key audit matters relating to risks of material misstatement that, in our professional judgment, were of most significance in our audit of the financial statements of the current period, as well as how we addressed those risks.
These matters were addressed in the context of our audit of the financial statements as a whole and in forming our opinion thereon, and we do not provide a separate opinion on specific items of the financial statements.

ANNUAL FINANCIAL STATEMENTS AT DECEMBER 31, 2021
Statutory auditor's report on the financial statements
| Risk identified | Our response |
|---|---|
| In April 2019, your Company entered into a collaboration agreement with AstraZeneca with options for exclusive licenses to co-develop oncolytic immunotherapies using the Invir.IO™ platform. This agreement provides for the delivery of five candidates by your Company. Within this context, your Company received an initial payment of EUR8.9m (USD10m) for access rights to its platform during the first half of 2019. In May 4, 2020, an amendment was signed with AstraZeneca defining two new candidates to be developed. Consequently, your Company re-estimated the program's overall budget and progress as at December 31, 2020. Your company has also re-estimated the program's overall budget and progress as at December 31, 2021. As at December 31, 2021, the revenue in respect of the initial payment recognized under this collaboration represents EUR 1.2m. As stated in Notes 1 and 3 to the financial statements, the recognition of the revenue related to the initial payment is based on the progress made in the associated activities and measured according to the costs incurred. The measurement of the revenue requires Management to exercise judgment in its choice of the elements to be taken into account, corresponding to forecasts. The main assumptions taken into account by Management in the measurement of the revenue related to the initial payment notably concern: the number of candidates to be developed; ● the schedule for the development of the candidates; ● the estimated costs of the salaries and consumables related to ● the development of the candidates. We considered the measurement of the revenue related to the collaboration agreement with AstraZeneca to be a key audit matter, as: the measurement of the income recognized represents a ● material amount as at December 31, 2021; the determination of the revenue requires the use of estimates ● and assessments, notably to measure the estimated costs of |
Our work consisted in reviewing the methods and assumptions used by Management to measure the revenue related to the initial payment. In particular, it consisted in: analyzing the methods used to measure the estimated overall ● costs related to the agreement, including the measurement of personnel costs, the hours necessary to perform the studies and the costs of consumables, by considering their consistency with, on the one hand, the budgets and forecasts drawn up by Management and presented to the Board of Directors, and on the other hand, our knowledge of the sector, acquired notably during interviews with Management; studying the valuation of the actual hours worked during ● financial year 2021 and the actual timesheets as at December 31, 2021; assessing the consistency of the schedule for the development ● of candidates not yet performed in relation to the actual schedule for the first candidates, and on the basis of interviews with Management and the project manager. Finally, we assessed the appropriateness of the information disclosed in the notes to the financial statements. |
| the salaries and consumables related to the development of the candidates. the use of management judgement involved in its ● determination is significant. |
|
| Any error in the assessment of these assumptions would have an impact on the estimation of the revenue to be recognized. |
|
Statutory auditor's report on the financial statements
| Risk identified | Our response | |||
|---|---|---|---|---|
| As at December 31, 2021, the value of the liability consisting of repayable advances recorded in your Company's balance sheet amounts to MEUR 15.94. At year-end, your Company re-values its repayable advances liability under the ADNA program based on |
Our work consisted in reviewing the methods and assumptions used by your Company to measure the ADNA repayable advances. In particular: |
|||
| the discounted flows of the expected repayments, as described in Notes 1 and 14 to the financial statements. |
we assessed the valuation model used and the assumptions ● adopted relating to the development of the TG4001 product, by considering their consistency with, on the one hand, the |
|||
| The repayment of these advances is subject to the achievement of a certain threshold of revenue with the TG4001 product, and will be made based on a predetermined fixed amount over the following five years, and then in proportion to the revenue generated by this product until a repayment limit is reached or at the latest in 2035. The expected future repayment flows are thus estimated by Management based on the estimated future direct and indirect revenue generated solely by the TG4001 product being developed. |
budgets and forecasts drawn up by Management and presented to the Board of Directors, and on the other hand, our knowledge of the sector, acquired notably during interviews with Management; we compared the discount rate with our own estimate of this ● rate; we reviewed the US dollar to euro rate used within the ● context of the valuation performed. |
|||
| The other assumptions used by Management to measure the repayable advances liability notably concern; |
Finally, we assessed the appropriateness of the information disclosed in the notes to the financial statements. |
|||
| the probabilities of success of the clinical phases; ● |
The measurement of the repayable advances liability therefore requires Management to exercise judgment in its choice of the elements to be taken into account, in particular as regards forecasts.
Any error in the assessment of these assumptions would have an impact on the estimation of the debt to be repaid. We considered the measurement of the ADNA repayable advances to be a key audit matter as it involves significant exercise of judgment on the part of Management.

ANNUAL FINANCIAL STATEMENTS AT DECEMBER 31, 2021
Statutory auditor's report on the financial statements
We have also performed, in accordance with professional standards applicable in France, the specific verifications required by laws and regulations.
We have no matters to report as to the fair presentation and the consistency with the financial statements of the information given in the Board of Directors' management report and in the other documents with respect to the financial position and the financial statements provided to the shareholders.
We attest the fair presentation and the consistency with the financial statements of the information relating to payment deadlines mentioned in Article D. 441-6 of the French Commercial Code (Code de commerce).
We attest that the Board of Directors' Report on Corporate Governance sets out the information required by Articles L. 225-37-4, L. 22-10-10 and L. 22-10-9 of the French Commercial Code (Code de commerce).
Concerning the information given in accordance with the requirements of Article L. 22-10-9 of the French Commercial Code (Code de commerce) relating to the remuneration and benefits received by, or allocated to the directors and any other commitments made in their favor, we have verified its consistency with the financial statements, or with the underlying information used to prepare these financial statements and, where applicable, with the information obtained by your Company from companies controlled thereby, included in the consolidation scope. Based on these procedures, we attest the accuracy and fair presentation of this information.
With respect to the information relating to items that your Company considered likely to have an impact in the event of a takeover bid or exchange offer, provided pursuant to Article L. 22-10-11 of the French Commercial Code (Code de commerce), we have agreed this information to the source documents communicated to us. Based on these procedures, we have no observations to make on this information.
In accordance with French law, we have verified that the required information concerning the purchase of investments and controlling interests and the identity of the shareholders and holders of voting rights has been properly disclosed in the management report.
We have also verified, in accordance with the professional standard applicable in France relating to the procedures performed by statutory auditor regarding the annual and consolidated financial statements prepared in the European single electronic format, that the preparation of the financial statements included in the annual financial report mentioned in Article L. 451-1-2, I of the French Monetary and Financial Code (Code monétaire et financier), prepared under the Chairman and Chief Executive Officer's responsibility, complies with the single electronic format defined in Commission Delegated Regulation (EU) No. 2019/815 of 17 December 2018.
On the basis of our work, we conclude that the preparation of the financial statements included in the annual financial report complies, in all material respects, with the European single electronic format.
We were appointed as statutory auditor of Transgene S.A. by your Annual General Meeting held on May 24, 2016 for GRANT THORNTON and on May 29, 1996 for ERNST & YOUNG et Autres.
As at December, 31 2021, GRANT THORNTON was in its sixth year and ERNST & YOUNG et Autres in its twenty-sixth year of total uninterrupted engagement (including twenty-four years since the securities of the Company were admitted to trading on a regulated market).
Management is responsible for the preparation and fair presentation of the financial statements in accordance with French accounting principles and for such internal control as Management determines is necessary to enable the preparation of financial statements that are free from material misstatement, whether due to fraud or error.
In preparing the financial statements, Management is responsible for assessing the Company's ability to continue as a going concern, disclosing, as applicable, matters related to going concern and using the going concern basis of accounting unless it is expected to liquidate the Company or to cease operations.
The Audit Committee is responsible for monitoring the financial reporting process and the effectiveness of internal control and risk management systems and where applicable, its internal audit, regarding the accounting and financial reporting procedures.
Statutory auditor's report on the financial statements
The financial statements were approved by the Board of Directors.
Our role is to issue a report on the financial statements. Our objective is to obtain reasonable assurance about whether the financial statements as a whole are free from material misstatement. Reasonable assurance is a high level of assurance, but is not a guarantee that an audit conducted in accordance with professional standards will always detect a material misstatement when it exists. Misstatements can arise from fraud or error and are considered material if, individually or in the aggregate, they could reasonably be expected to influence the economic decisions of users made on the basis of these financial statements.
As specified in Article L. 823-10-1 of the French Commercial Code (Code de commerce), our statutory audit does not include assurance on the viability of the Company or the quality of management of the affairs of the Company.
As part of an audit conducted in accordance with professional standards applicable in France, the statutory auditor exercises professional judgment throughout the audit and furthermore:
We submit to the Audit Committee a report which includes in particular a description of the scope of the audit and the audit program implemented, as well as the results of our audit. We also report significant deficiencies, if any, in internal control regarding the accounting and financial reporting procedures that we have identified.
Our report to the Audit Committee includes the risks of material misstatement that, in our professional judgment, were of most significance in the audit of the financial statements of the current period and which are therefore the key audit matters that we are required to describe in this report.
We also provide the Audit Committee with the declaration provided for in Article 6 of Regulation (EU) No. 537/2014, confirming our independence within the meaning of the rules applicable in France as set out in particular in Articles L. 822-10 to L. 822-14 of the French Commercial Code (Code de commerce) and in the French Code of Ethics for Statutory Auditors (Code de déontologie de la profession de commissaire aux comptes). Where appropriate, we discuss with the Audit Committee the risks that may reasonably be thought to bear on our independence, and the related safeguards.
Lyon and Paris-La Défense, 6th April 2022
The Statutory Auditors
French original signed by
GRANT THORNTON
French Member of Grant Thornton International Françoise Méchin
ERNST & YOUNG et Autres

None.
| 6.1 | SHARE CAPITAL | ||
|---|---|---|---|
| 6.1.1 | Amount of subscribed capital | ||
| 6.1.2 | Shares not representing capital | ||
| 6.1.3 | Shares held either by the Company itself, on its behalf or by its subsidiaries |
||
| 6.1.4 | Convertible securities, exchangeable securities, or securities with warrants |
||
| 6.1.5 | Conditions governing any right of acquisition and/or any obligation attached to the capital subscribed but not paid-up, or any undertaking to increase the share capital |
||
| 6.1.6 | Information on the stock of any member of the Group subject to an option or a conditional or unconditional agreement to place it under option |
||
| 6.1.7 | History of share capital | ||
| 6.2 | PRINCIPAL SHAREHOLDERS | ||
| 6.2.1 | Name of any person not a member of an administrative or management body directly or indirectly holding more than 5% (legal reporting threshold) of the Company's capital or voting rights |
||
| 6.2.2 | Special voting rights of major shareholders | ||
| 6.2.3 | Controlling shareholder | ||
| 6.2.4 | Agreement that may result in a subsequent change of control of the Company |
||
| 6.3 | ARTICLES OF INCORPORATION | ||
| AND ARTICLES OF ASSOCIATION |
|||
| 6.3.1 | Corporate purpose (Article 2 of the Articles of | ||
| Association) | |||
| 6.3.2 | Administration of the Company | ||
| 6.3.3 | Share classes | ||
| 6.3.4 | Shareholder rights | ||
| 6.3.5 | General Meetings (Article 21 of the articles of association) |
||
| 6.3.6 | Provisions having the effect of delaying, deferring, or preventing a change of control |
||
| 6.3.7 | Threshold crossings | ||
| 6.3.8 | Conditions imposed by the articles of incorporation and articles of association, a charter or regulation, that govern changes in capital when said conditions are stricter than legal provisions |
||
| 6.4 | HISTORY AND INFORMATION ABOUT THE COMPANY DURING THE FISCAL YEAR |
||
| 6.4.1 | Company name and commercial name | ||
| 6.4.2 | Place and registration number of the issuer | ||
| 6.4.3 | Date of incorporation and duration | ||
| 6.4.4 | Registered office, legal form, and applicable law | ||
| 6.5 | INFORMATION ON INVESTMENTS IN AFFILIATES |
||
| 6.6 | SHARE BUYBACK PROGRAM | ||
| 6.6.1 | Current situation 2021 | ||
| 6.6.2 | Description of the share buyback program pursuant to Articles 241-1 et seq. of the General regulation of the Autorité des marchés financiers (AMF) |
||
| 6.7 | STATUTORY AUDITORS' REPORT ON RELATED PARTY AGREEMENTS |
||
| 6.8 | EMPLOYEES | ||
| 6.8.1 | Workforce | ||
| 6.8.2 | Profit-sharing agreement |
6


€48,885,667 fully paid in at December 31, 2021, and €49,773,235 recognized as of the date of this Registration Document.
97 ,771, 334 shares at December 31, 2021, and 99 ,546,470 as of the date of this Registration Document, all of the same class and all fully paid up. No unpaid shares have been issued. The nominal value per share is €0.50.
None.
The Company has no knowledge of pledges or other security interests related to its existing shares at March 31, 2022.
In the framework of the liquidity contract, at December 31, 2021, 176,500 shares were held on behalf of the Company (see Section 6.6).
None.
At March 31, 2022, the number of shares that could be issued against outstanding stock options not yet exercised (41,532) and free share awards not yet vested (2 ,463 ,068) was 2 ,504 ,600 or around 5% of the Company's capital on a fully diluted basis (or 102,053,632 shares).
The following table shows the powers delegated to the Board of Directors by the Extraordinary General Meeting of May 26, 2021, and by the Extraordinary General Meeting of May 27, 2020, and the use the Board made of them as of the date of this Registration Document:
| Nature of the delegation granted | Maximum amount of delegation and effective date |
Amount used by the Board |
|---|---|---|
| Capital increase with preferential subscription rights for shareholders |
41 million shares in one or more tranches Expiration: July 27, 2022 |
None |
| Capital increase without preferential subscription rights for shareholders |
32 million shares in one or more tranches (included in the ceiling of 41 million shares) Expiration: July 27, 2022 |
None |
| Capital increase reserved for qualified investors or a restricted group of investors without preferential subscription rights in their favor |
20% of share capital with a price not less than the average of the price of three trading sessions with a maximum discount of 5% Expiration: July 27, 2022 |
6,965,000 |
| Setting the price of issuance of shares in the event of the waiver of preferential subscription rights in accordance with Article L. 225-136 1 paragraph 2 of the French Commercial Code |
10% of share capital per year Expiration: July 27, 2022 |
None |
| Capital increase with cancellation of pre-emptive subscription rights to compensate share tenders, in the case of an exchange offer or contribution in kind applicable to company securities on company securities |
10% of share capital Expiration: July 27, 2022 |
None |
| Capital increase with cancellation of pre-emptive subscription rights of shareholders for the benefit of categories of persons |
32 million shares in one or more tranches (included in the ceiling of 41 million shares) Expiration: November 27, 2021 |
None |
| Award of free shares in the Company to Company and Group employees without preferential subscription rights |
2.5 million existing or new shares Expiration: July 26, 2024 |
2 ,463 ,068 |
None.

| Fiscal year | Type of transaction |
Number of securities |
Capital increase (in euros) |
Share issuance premium (in euros) |
Total issue premiums (in euros) |
Amount of capital (in euros) |
|---|---|---|---|---|---|---|
| Increase of share | ||||||
| 2019 | capital (2) | 173,175 | 173,175 | - | - | 62,449,098 |
| 2019 | Increase of share capital (1) |
20,816,366 | 20,816,366 | 1.34 | 27,893,930 | 83,265,464 |
| 2020 | Increase of share capital (2) |
575,870 | 575,870 | - | - | 83,841,334 |
| 2020 | Capital reduction (3) |
83,841,334 | (41,920,667) | - | - | 41,920,667 |
| 2021 | Increase of share capital (1) |
13,930,000 | 6 965 000 | 1.95 | 27,163,500 | 48,885,667 |
| 2022 (1) | Increase of share capital (2) |
1 ,775, 136 | 887, 568 | - | - | 49,773,235 |
(1) Capital increase by issuing new shares.
(2) Capital increase by vesting free shares to Company employees.
(3) Capital reduction by €0.50 per share reduction in the nominal value of the shares.
Change in shareholder structure over the past three years (see Section 6.2.1 "Name of any person not a member of an administrative or management body directly or indirectly holding more than 5% (legal reporting threshold) of the Company's capital or voting rights").
(1) Until March 31, 2022.
The following table shows the breakdown of capital and voting rights of the Company at December 31, 2021, based on an analysis of bearer share ownership conducted at the Company's request following the capital increases carried out in January 2022 and the distribution as of the end of 2020 and 2019. There is no shareholder apart from the majority shareholder TSGH that owns more than 5% of share capital.
| As at Dec. 31, 2019 | As at Dec. 31, 2020 | As at Dec. 31, 2021 | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Shareholder | Number of shares |
% of capital |
% of voting rights (1) |
Number of shares |
% of capital |
% of voting rights (1) |
Number of shares |
% of capital |
% of voting rights (1) |
| TSGH (1) | 50,323,665 | 60.44 | 75.0 | 50,323,665 | 60.02 | 71.7 | 60,527,665 | 61.91 | 71.67 |
| SITAM Belgium* | 4,120,935 | 4.95 | 3.7 | 4,144,856 | 4.94 | 3.5 | 4,824,856 | 4.93 | 3.60 |
| Other shareholders (2) | 28,820,864 | 34.61 | 21.3 | 29,372,813 | 35.04 | 24.8 | 32,418,813 | 33.16 | 24.72 |
| Total | 83,265,464 | 100 | 100 | 83,841,334 | 100 | 100 | 97,771,334 | 100 | 100 |
| Dilutive impact stock options + free shares awarded (3) |
2,293,081 | 2.75 | 1.9 | 2,048,922 | 2.27 | 1.6 | 4,198,430 | 4.29 | 3.13 |
| TOTAL DILUTED | 85,558,545 | 85,890,256 | 101,969,606 |
(1) Article 8 of the articles of association grants double voting rights to all fully paid registered shares, registered in the name of the same shareholder for at least three years. In accordance with the provisions of Article L. 233-8 of the French Commercial Code, Transgene publishes monthly (if the information has changed since the last monthly publication) the total number of shares and voting rights on the AMF website and on its own site www.transgene.fr. At December 31, 2019, the total number of shares was 83,265,464; the total theoretical number of voting rights was 119,778,384 of which the number of exercisable voting rights was 119,593,384. At December 31, 2020, the total number of shares was 83,841,334; the total theoretical number of voting rights was 117,645,905 of which the number of exercisable voting rights was 117,481,722. At December 31, 2021, the total number of shares was 97,771,334; the total theoretical number of voting rights was 133,880,688 of which the number of exercisable voting rights was 133,704,188. No limitation has been placed on voting rights. The double voting rights attached to a share disappear the day the security is assigned or converted to the bearer.
(2) To the Company's knowledge, no other shareholders directly or indirectly own, alone or in concert, over 5% of the equity or voting rights. As of December 31, 2021, the Company held 176,500 of its own shares through a liquidity program. The total percentage of employee ownership is less than 1%. Since it is insignificant, the Company does not monitor employee shareholdings. There are not, to the knowledge of the Company, any concert parties, or agreements between shareholders.
(3) The stock options and free shares were granted exclusively to the employees of the Company and its subsidiary Transgene, Inc., including members of the Executive Committee and to the two executive corporate officers (Hedi Ben Brahim, Chairman and Chief Executive Officer, and Christophe Ancel, Responsible Pharmacist and Deputy Chief Executive Officer). At December 31, 2021, there were 41,532 options outstanding and 4,198,430 unvested free shares.
* Formerly "Dassault Belgique aviation".

There are no different voting rights for major shareholders. Pursuant to Article 8 of the articles of association, double voting rights are granted to all fully paid registered shares registered in the name of the same shareholder for at least three years, regardless of the number of shares held by the holder.
The Company's capital is 61.91% (71.67% of the voting rights) owned by TSGH SAS, which is in turn 99.5% owned by Institut Mérieux, which is owned by the Mérieux family. No specific measure limits the powers of the principal shareholder. The Company complies with the Code of Corporate Governance for small- and mid-cap companies. The Board of Directors includes a majority of directors who qualify as independent using the criteria defined in the Middle Next Corporate Governance Code. One independent director, Mr. Habert, is connected with the Dassault Group, which holds 4.93% of the Company's stock (3.60% of the voting rights) through a family relationship and in his capacity as Chairman and member of the Dassault Développement Strategy Committee. Moreover, a majority of the Audit Committee and Compensation Committee consists of independent directors (three out of four members).
To the Company's knowledge, at the date of this Document there is no agreement that could at a later date, if enforced, bring about a change in the controlling interest of the Company, nor pact outside the articles of association, or any anti-takeover measure, or specific powers of representation or appointment to executive bodies.
Articles of incorporation and articles of association
The purpose of the Company, both in France and abroad, on its own behalf and on behalf of third parties:
The Company is managed by a Board of Directors composed of at least three members and at most fifteen members who are elected by the General Meeting.
The directors are appointed for a period of three years. The renewal of the terms of office is carried out on a staggered basis, to ensure that the number of terms of Board members expiring is as regular as possible each year. Exceptionally, for the purpose of staggering, the Ordinary General Meeting may appoint a director for a duration of one, two or four years. Their directorship ends at the end of the Ordinary General Meeting approving the financial statements for the prior year, which is held during the year in which their term expires. The Board ensures that the number of terms expiring is as regular as possible each year.
The directors may be re-elected and may be recalled by the General Meeting at any time. In the event of a vacancy of one or more seats, the Board may, in the manner prescribed by law, make provisional appointments. The directors so appointed do not serve longer than the remainder of their predecessor's term, and their appointment must be ratified by the next following Ordinary General Meeting.
The Board of Directors elects from among its members who are individuals a Chairman and, possibly, one or more Vice-Chairmen, and sets their term of office that not exceed their term of office as a director, nor the time remaining from their appointment to the end of the Ordinary General Meeting called to approve the financial statements for the fiscal year in which the Chairman reaches 67 years of age.
However, the Board may under exceptional circumstances extend the period, fiscal year by fiscal year, as long as this extension does not exceed two fiscal years.
In the event of the absence or incapacity of the Chairman, the Board shall appoint a Chairman pro tempore from among the Vice-Chairs or, failing that, the directors.
The Board may also appoint a Secretary, who may or may not be a shareholder.
The Board of Directors proceeds with the controls and verifications it deems appropriate. Directors receive all of the information required to accomplish their mission and may request any document they consider useful.
The Chairman of the Board of Directors shall represent the Board of Directors. He organizes and directs its work and reports back to the General Meeting. He ensures the proper operations of the Company's bodies, and, specifically, that the directors are capable of fulfilling their duties.
Subject to the terms of the paragraphs above, the Board of Directors may delegate to one or more of its members or third parties, whether or not they are shareholders, any type of specific mandate for one or more specific objects, under conditions it defines, with or without potential substitution, to proceed with all studies and inquiries. When this occurs, the Board defines compensation, both fixed and proportional. If a director is given a paid term of office, then the provisions of Articles L. 225-38 et seq. of the French Commercial Code shall apply.

INFORMATION ABOUT THE COMPANY AND ITS CAPITAL
Articles of incorporation and articles of association
If the Board of Directors decides to separate the positions of Chairman and Chief Executive Officer, subject to the powers that the law confers expressly on Shareholders' Meetings as well as the powers that are specially reserved to the Board of Directors and within the limitations of the corporate purpose, the Chief Executive is invested with the broadest powers to act in the Company's name under all circumstances and represent it in relations with third parties.
On a recommendation from the Chief Executive Officer, the Board of Directors may appoint one or more persons to assist the Chief Executive Officer with the title of Deputy Chief Executive Officer.
The number of Chief Operating Officers may not exceed five.
If they are directors of the Company, the Chief Executive Officer and Chief Operating Officers may not be appointed for longer than their term as directors.
The Board of Directors sets the compensation of the Chairman of the Board, the Chief Executive Officer and, as applicable, the Deputy Chief Executive Officers. This compensation may be fixed or a combination of fixed and variable.
The directors are invited to the meetings of the Board by any means, including verbally. The internal rules of the Board of Directors may state that the directors who participate in the Board meeting by videoconference or telecommunication
enabling their identification and ensuring their effective participation are deemed to be present for the purposes of calculating the quorum and majority. Deliberations take place in quorum and majority conditions set out by law. In the event of a tie vote, the vote of the session's Chairman shall prevail.
A director may give his or her proxy to another director to represent him or her at a Board meeting.
Minutes are prepared and copies and excerpts of deliberations are issued and certified as defined by law.
The Responsible Pharmacist, who shall be licensed to practice in France (Table B of the Order) and shall file his license on behalf of the Company, will be responsible for the Company's compliance with the rules imposed by law and regulation governing the profession of pharmacist.
To this end, the Responsible Pharmacist has all the powers necessary to carry out, in the context of the Company's activities, all the missions provided for in Article R.5124-36 of the Public Health Code.
In the event of a conflict between the Chairman and the Responsible Pharmacist, the Board of Directors will arbitrate without ever imposing a decision that runs counter to the law or regulations that might incur the liability of the responsible Pharmacist.
Only one class of shares exists. Each share entitles the holder to one share proportional to the fraction of capital that it represents, in the Company's assets and earnings and in any liquidation surplus.
Shareholders' rights may only be changed, and in the manner prescribed by law, by an Extraordinary General Meeting that meets the conditions of quorum and majority set by the French Commercial Code. There is no more restrictive term in the articles of association. The Company capital may be changed pursuant to the terms of the law.
Articles of incorporation and articles of association
General Meetings are called and deliberate pursuant to the terms of the law. Meetings take place either at the corporate headquarters or at another place specified in the Notice of meeting.
The right to take part in General Meetings is defined and justified in accordance with the provisions of Article R. 22-10-28-85 of the French Commercial Code.
For the calculation of the quorum and majority, are deemed present, if applicable, shareholders taking part in the meeting by videoconference or by means of telecommunications under the applicable legal and regulatory conditions, and as stipulated below.
Each shareholder may vote by mail or give a letter of proxy subject to the conditions stipulated by current regulations, and notably using a form prepared and received by the Company under the conditions set by law and the regulations.
If the Board of Directors so decides at the time of the Notice to attend for the meeting, shareholders may also take part and vote in General Meetings by videoconference or by all means of telecommunications allowing his/her identification under the conditions and according to the modalities set by the current legal and regulatory provisions. The Board of Directors' decision to use telecommunications or videoconferencing technology will be published in the Notice to attend or the Notice of meeting.
The electronic form may be completed and signed directly on a site solely dedicated to this purpose using a code. The letter of proxy or vote expressed before the General Meeting by electronic means, as well as the acknowledgment given, will be considered as irrevocable written instructions enforceable on all parties, it being stated that if a transfer of ownership of the shares takes place before the deadline set in compliance with applicable regulations for the registration, the Company shall invalidate or amend, as the case may be, proxies or votes expressed before such date and time.
General Meetings are chaired by the Chairman of the Board of Directors or, in his absence, by a Vice-Chairman or by a director appointed for that purpose by the Board of Directors. Failing this, the assembly itself will elect a Chairman.
Minutes of General Meetings are prepared, and copies certified and delivered pursuant to the terms of the law. The Meeting Secretary is authorized to certify the copies and excerpts of General Meeting minutes.
A double voting right attached to registered shares recorded in the name of the same person for at least three years was established by the Extraordinary General Meeting of June 9, 2004, and incorporated into the articles of association (Article 8).
None.
None. The obligations prescribed by current laws and regulations apply.
None: no such terms exist for the Company.

INFORMATION ABOUT THE COMPANY AND ITS CAPITAL History and information about the Company during the fiscal year
Transgene
The Company is registered in the Strasbourg Trade and Company Registry under identification No. RCS B 317 540 581. Its economic activity Code (APE) is 7211Z (Biotechnology research and development).
The legal entity identifier (LEI) is 969500PDJW8N0FSGGK69.
The Company was founded in December 1979 in France for a period of 99 years that expires on December 31, 2078.
A French corporation (société anonyme) with a Board of Directors, governed by the French Commercial Code.
The table of subsidiaries and affiliates is presented in Note 28 to the Company's annual financial statements (Section 5.3.2).
The share buyback program authorization was renewed by the General Shareholders' Meeting of May 26, 2021.
In accordance with Articles L. 22-10-62 et seq. of the French Commercial Code, the Shareholders' Meeting of May 26, 2021, authorized the Board of Directors to trade Transgene stock for a period of 18 months, except during a public offering period for the Company's shares, for the purposes and in the manner prescribed by the share buyback program. The purchases must be made at a unit price no higher than €25 per share, with an overall purchase price of €20 million (or the foreign currency equivalent of these amounts on the same date) and in an amount no greater than 10% of the share capital at any one time.
In 2020, the Company made use of the authorizations to buy the Company's shares on the stock market in order to execute a liquidity contract with Natixis ODDO BHF SCA. The Company did not use any derivatives.
In 2021, under the liquidity contract, Natixis ODDO BHF:
At December 31, 2021, the Company directly held 176,500 shares for the purposes of creating liquidity under the liquidity contract (which represented around 0.36% of the capital), whose measured value at its price on December 31, 2021 (€2.54) (€1.648) was €448,310. At that same date, none of the treasury shares were allocated to covering stock option plans or held for cancellation.
Pursuant to Article 241-2 of the General regulation of the AMF, this paragraph constitutes the description of the buyback program that will be submitted to the General Meeting of May 25, 2022.
At December 31, 2021, the total number of shares held by Transgene was 176,500, representing 0.36% of Transgene's share capital. All of these shares were allocated with a view to liquidity under the liquidity contract.
At December 31, 2021, Transgene's treasury shares were allocated as follows:
● 176,500 shares allocated for liquidity purposes.
The liquidity contract with Natixis ODDO BHF started on January 2, 2020. The Company did not cancel or re-allocate any treasury shares. The Company did not use any derivatives and does not have any open positions.
Transgene intends to use its authorization to trade in its own shares under the share buyback program for the following purposes:
6

● to allocate shares to the employees or to the corporate officers of the Company and its subsidiaries according to the conditions and in the manner prescribed by law, notably in relation to the free allocation of shares, profit-sharing, stock option plans or Company savings plans.
This program is also intended to allow any market practice accepted by the Autorité des marchés financiers subsequently to this General Meeting and, more broadly, any transaction compliant with the regulations in force. In such a scenario, the Company will inform its shareholders by written communication.
The securities Transgene proposes to acquire are only shares.
Extract from the twenty-first resolution submitted to the General Meeting of May 25, 2022:
The General Meeting, acting under the conditions of quorum and majority required for Ordinary General Meetings, having reviewed the report of the Board of Directors, votes to adopt the share buyback program described hereinafter and to that end, in accordance with Articles L. 22-10-62 et seq. of the French Commercial Code, authorizes the Board of Directors, or any representative of the Board empowered to act on the Board's behalf, to purchase the Company's shares:
Taking into account:
The purchase, sale, exchange or transfer of shares may occur by any means, i.e., on a regulated market, on a multilateral trading facility, through systematic internalizers or over the counter, including by means of the acquisition or sale of blocks of shares, by using financial instruments, notably derivatives traded on a regulated market or multilateral trading facility, through systematic internalizers or over the counter, or by using warrants in the manner authorized by the laws and regulations in force at the time of the transactions in question and at such times as the Company's Board of Directors or a person acting on behalf of the Board shall choose; the maximum fraction of the share capital acquired or transferred in blocks may be the entire program.
Pursuant to Article L. 22-10-62 of the French Commercial Code and to the resolution that shall be submitted to the General Meeting of May 25, 2022, this buyback program may be carried out during an 18-month period starting on the date of the General Meeting of May 25, 2022, i.e., no later than November 26, 2023.
Pursuant to Article L. 22-10-62 of the French Commercial Code, the Company may not cancel shares thus repurchased beyond the limit of 10% (adjusted for any transactions affecting it subsequent to the closing of the Combined General Meeting of May 25, 2022) of the amount of the share capital in periods of twenty-four (24) months.
Annual General Meeting held to approve the financial statements for the year ended December 31, 2021
This is a translation into English of a report issued in French and it is provided solely for the convenience of English-speaking users. This report should be read in conjunction with, and construed in accordance with, French law and professional standards applicable in France.
To the Shareholders of Transgene S.A.,
In our capacity as statutory auditors of your Company, we hereby present to you our report on related party agreements.
We are required to inform you, on the basis of the information provided to us, of the terms and conditions of those agreements indicated to us, or that we may have identified in the performance of our engagement, as well as the reasons justifying why they benefit the Company. We are not required to give our opinion as to whether they are beneficial or appropriate or to ascertain the existence of other agreements. It is your responsibility, in accordance with Article R. 225-31 of the French Commercial Code (Code de commerce), to assess the relevance of these agreements prior to their approval.
We are also required, where applicable, to inform you in accordance with Article R. 225-31 of the French Commercial Code (Code de commerce) of the continuation of the implementation, during the year ended December 31, 2021, of the agreements previously approved by the Annual General Meeting.
We performed those procedures which we deemed necessary in compliance with professional guidance issued by the French Institute of Statutory Auditors (Compagnie nationale des commissaires aux comptes) relating to this type of engagement. These procedures consisted in verifying the consistency of the information provided to us with the relevant source documents.
We hereby inform you that we have not been notified of any agreements authorized and concluded during the year ended December 31, 2021 to be submitted to the Annual General Meeting for approval in accordance with Article R. 225-38 of the French Commercial Code (Code de commerce).
In accordance with Article R. 225-30 of the French Commercial Code (Code de commerce), we have been notified that the implementation of the following agreements, which were approved by the Annual General Meeting in prior years, continued during the year ended December 31, 2021.

Messrs Hedi Ben Brahim, Jean-Luc Bélingard, Philippe Archinard, and Ms Sandrine Flory.
Service agreement between Transgene and Institut Mérieux as modified in 2020 by an amendment.
The service contract provides for an allocation key for the cost of services rendered to all Institut Mérieux group companies based on three criteria: the payroll, revenue and fixed assets of each company. This allocation key remains applicable except for internal audit services, which will be invoiced as follows, pursuant to the amendment:
As at December 31, 2021, your Company has recorded an expense of € 288,726 under this agreement.
An adjustment in respect of the 2020 financial year was recorded for the 2021 financial year and your Company thus received a credit note in the amount of €26,303.
● With ABL Europe S.A.S. (a wholly owned subsidiary of ABL Inc., in turn wholly owned by TSGH S.A.S., in turn majority-owned by Institut Mérieux)
Messrs Alain Mérieux, Jean-Luc Bélingard, Philippe Archinard and Ms Sandrine Flory.
Within the scope of the sale of your Company's bioproduction asset to ABL Europe S.A.S., your Company signed a sublease agreement concerning a part of the quality control laboratory located at your Company's head office.
The sublease agreement stipulates the terms of use by ABL Europe S.A.S. of a part of your Company's quality control laboratory.
As at December 31, 2021, your Company recorded an income amounting to € 220,901 in respect of the sublease agreement concerning a part of the quality control laboratory located at your Company's head office.
Within the context of the sale of your Company's bioproduction asset to ABL Europe S.A.S., your Company signed a Social Agreement concerning the redeployment of employees.
This agreement sets forth the terms for the partial takeover of the employees assigned to bioproduction.
As at December 31, 2021, your Company recorded an expense amounting to € 6,106 in respect of a mutually agreed termination covered by this agreement.
This agreement, entered into on May 23, 2019 to replace the previous Exclusive Services Agreement, sets forth the terms for the sale of bioproduction services by ABL Europe S.A.S. to your Company. The new agreement no longer contains any condition of exclusivity or business volume guarantee.
As at 31 December 2021, your Company recorded an expense amounting to € 3,404,370 in respect of this agreement.
Messrs Alain Mérieux, Jean-Luc Bélingard, Philippe Archinard and Ms Sandrine Flory.
Agreement relating to the management of employee mobility within the Institut Mérieux group or Fondation Mérieux.
For employees who have worked in the Institut Mérieux group's companies and whose length of service in these companies has been taken into account without financial compensation, the costs relating to the termination of those employees' employment contracts and/or retirement will be allocated to the companies concerned according to an equitable economic allocation key. These costs will henceforth be allocated in proportion to the remuneration paid by each Institut Mérieux group company that has benefited from the employees' services, excluding remuneration having served as a base for the payment of a previous termination indemnity.
As at December 31, 2021, your Company was billed an amount of €149,296 by Institut Mérieux under this agreement.
In addition, we have been notified that the following agreements, which were approved by the Annual General Meeting in prior years, were not implemented during the year ended December 31, 2021.
● With the companies ElsaLys Biotech S.A.S. and TSGH S.A.S. (majority shareholder of your Company)
Messrs Hedi Ben Brahim, Jean-Luc Bélingard, Philippe Archinard, and Ms Sandrine Flory.
At the time of the execution of this agreement on April 9, 2020, your Company held an 8.25% stake in ElsaLys S.A.S., and TSGH S.A.S. held a 9% stake in ElsaLys S.A.S. These stakes were transferred on April 9, 2020 to the Mediolanum group. In the context of this transfer, an agreement was signed concerning the claim of € 1,000,000 excluding tax held by your Company over ElsaLys S.A.S.
This receivable of € 1,000,000 excluding tax, fully depreciated as at December 31, 2019, was recovered in the amount of € 957,494 following the agreements signed at the time of the sale of ElsaLys S.A.S. including:
As at December 31, 2021, the outstanding balance of TSGH amounts to €33,807, as no payments were received during the year 2021.
Lyon and Paris-La Défense, April 6th, 2022
The Statutory Auditors
French original signed by
GRANT THORTON Membre français de Grant Thornton International Françoise Méchin
ERNST & YOUNG et Autres
Cédric Garcia Brigitte Barouky

See the workforce table in Paragraph 4.5.1.
A profit-sharing agreement has existed since 1993, pursuant to the regulations in force. In light of the Company's loss-making position, no profit has been shared with employees under this agreement as of the date of this Registration Document.
| 7.1 | PERSON RESPONSIBLE | 218 |
|---|---|---|
| 7.1.1 | Person responsible for the information | 218 |
| 7.1.2 | Declaration by the person responsible | 218 |
| 7.2 | PERSONS RESPONSIBLE FOR AUDITING | |
| THE FINANCIAL STATEMENTS | 219 | |
| 7.2.1 | Statutory Auditors | 219 |
| 7.2.2 | Statutory Auditors 'fees | 220 |
| 7.3 | INFORMATION FROM THIRD PARTIES, EXPERT STATEMENTS AND DECLARATIONS |
|
| OF INTEREST | 220 | |
| 7.4 | DOCUMENTS AVAILABLE TO THE PUBLIC | 221 |
| 7.5 | CROSS-REFERENCE TABLES | 222 |
| 7.6 | GLOSSARY | 227 |
| 7.7 | APPENDIX: MANAGEMENT REPORT FOR THE MANAGEMENT REPORT FOR THE |
|
| PERIOD ENDED DECEMBER 31, 2021 |
229 | |
| Transgene confirms the potential of its two innovative platforms and expects significant clinical results in |
||
| 2022 | 229 | |
| Internal control procedures | 233 |
7


Hedi Ben Brahim Chairman and Chief Executive Officer
I, the undersigned, hereby certify that the information contained in this Universal Registration Document gives, to the best of my knowledge, a true and fair view of facts and is free from material misstatements.
I hereby certify that, to my knowledge, the financial statements have been drawn up in accordance with applicable accounting standards and give a true and fair view of the assets, financial position and profits and losses of the Company and of all the companies within the scope of consolidation, and that the management report on pages 229 to 237 presents a true and fair view of the business, profits and financial position of the Company and of all the companies within the scope of consolidation and a description of the principal risks and uncertainties they face.
Illkirch-Graffenstaden, 6 April 2022
Hedi Ben Brahim, Chairman and Chief Executive Officer
Persons responsible for auditing the financial statements
1/2, place des Saisons 92400 Courbevoie – Paris-La Défense represented by Cédric Garcia and Brigitte Barouky Grant Thornton 44 quai Charles de Gaulle 69006 Lyon represented by Françoise Méchin
ERNST & YOUNG et Autres is a member of the Compagnie régionale des commissaires aux Comptes de Versailles et du Centre and of the Ernst & Young network. Grant Thornton is a member of the Compagnie régionale des commissaires aux comptes de Versailles et du Centre and of the Grant Thornton International Ltd network.
Appointed May 29, 1996, and renewed February 16, 1998, and again on June 9, 2004, on June 17, 2010, and on May 24, 2016, until the General Meeting called to approve the 2021 financial statements.
Appointed May 24, 2016, until the General Meeting called to approve the 2021 financial statements.
| Auditex | |
|---|---|
| Tour Ernst & Young | |
| 1/2, place des Saisons | |
| 92400 Courbevoie – Paris – La Défense 1 |
IGEC 3, rue Léon-Jost 75017 Paris
Appointed June 17, 2010, and renewed May 24, 2016, until the General Meeting called to approve the 2021 financial statements. Appointed May 24, 2016, until the General Meeting called to approve the 2021 financial statements.

ADDITIONAL INFORMATION
Information from third parties, expert statements and declarations of interest
| Ernst & Young et Autres | Grant Thornton | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Amount (pre-tax) | % | Amount (pre-tax) | % | ||||||
| (in € thousands) | 2021 | 2020 | 2021 | 2020 | 2021 | 2020 | 2021 | 2020 | |
| Audit | - | - | - | - | - | - | - | - | |
| STATUTORY AUDITORS, CERTIFICATION, EXAMINATION OF INDIVIDUAL AND CONSOLIDATED FINANCIAL STATEMENTS | |||||||||
| Issuer | 83 | 85 | 87% | 90% | 63 | 51 | 100% | 100% | |
| Fully consolidated subsidiaries | - | - | - | - | - | - | - | - | |
| SERVICES OTHER THAN THE CERTIFICATION OF THE STATUTORY AUDITORS | |||||||||
| Issuer | 12 | 9 | 13% | 10% | - | - | - | - | |
| Fully consolidated subsidiaries | - | - | - | - | - | - | - | - | |
| Sub-total | 95 | 94 | 100% | 100% | 63 | 51 | 100% | 100% | |
| OTHER SERVICES PROVIDED BY NETWORKS TO FULLY CONSOLIDATED SUBSIDIARIES | |||||||||
| Legal, tax and social | - | - | - | - | - | - | - | - | |
| Other (specify if > 10% of the audit fees) | - | - | - | - | - | - | - | - | |
| Sub-total | - | - | - | - | - | - | - | - | |
| TOTAL | 95 | 94 | 100% | 100% | 63 | 51 | 100% | 100% |
7.3 INFORMATION FROM THIRD PARTIES, EXPERT STATEMENTS AND DECLARATIONS OF INTEREST
None.
In application of article 19 of 2017/1129 European regulation of the European Parliament and of the Council of June 14, 2017, the following information are incorporated by reference in this document:
of the 2020 Universal Registration Document filed with the AMF dated April 1, 2021, under the no. D.21-0248 (1).
of the 2019 reference document filed with the AMF dated April 2, 2020, under the no. D.20-0241 (2).
Throughout the validity period of this Registration Document, the following documents may be consulted:
These documents can be consulted on the website: www.transgene.fr or requested from Jean-Philippe Del, Chief Financial Officer.
(1) https://www.transgene.fr/wp-content/uploads/TRANSGENE_URD_2020-EN.pdf
(2) https://www.transgene.fr/wp-content/uploads/2019/05/doc-ref-2018-en.pdf
7

In order to facilitate the reading of the Universal Registration Document, the following table identifies the main information required by Annex 1 of European regulation No. 2019/980.
| Section of the Universal Registration Document |
||
|---|---|---|
| 1. | Persons responsible | 7 |
| 1.1 | Name and position | 7.1.1 |
| 1.2 | Declaration by the person responsible | 7.1.2 |
| 1.3 | Expert declaration and declaration of interests | N/A |
| 1.4 | Third-party information | 7.3 |
| 1.5 | Statement by the competent authority | N/A |
| 2. | Statutory Auditors | 7 |
| 2.1 | Statutory Auditors | 7.2.1 |
| 2.2 | Statutory Auditors who resigned, having been relieved of their engagement or not having been re-engaged during the period covered |
N/A |
| 3. | Risk factors | 2 |
| 4. | Information about the issuer | 6 |
| 4.1 | Legal and trade name of the Company | 6.4.1 |
| 4.2 | Place, registration number and LEI of the Company | 6.4.2 |
| 4.3 | Date of incorporation and term of the Company | 6.4.3 |
| 4.4 | Company registered office, legal form, governing law, and website | 6.4.4 |
| 5. | Business overview | 1,2,7 |
| 5.1 | Principal activities | 1.2.1 |
| 5.2 | Principal markets | 1.2.6 |
| 5.3 | Major events | 1.3.1 and 7.7 |
| 5.4 | Strategy and objectives | 1.2.1.1 |
| 5.5 | Dependence of the issuer on patents, licenses, contracts, and manufacturing processes | 2.6 |
| 5.6 | Issuer's competitive position | 1.2.6 |
| 5.7 | Investments | 1, 5 |
| 5.7.1 | Major investments | 1.3.5 |
| 5.7.2 | Major investments in progress or for which firm commitments have been made | 1.3.5 |
| 5.7.3 | Investments in businesses in which the issuer holds equity | 5.1.2 |
| 5.7.4 | Environmental issue that might influence the issuer's use of its property, plant, and equipment | N/A |
| 6. | Organizational structure | 1 |
| 6.1 | Summary description of the group | 1.2.7 |
| 6.2 | List of major subsidiaries | 1.2.7.2 |
| 7. | Review of financial position and results | 1,5,7 |
| 7.1 | Financial position | 5.1, 5.3 |
| 7.1.1 | Change in issuer's financial performance | 5.1, 5.3 |
| 7.1.2 | Probable change in issuer's business activities and R&D activities | 7.7 |
| 7.2 | Net operating income | 1.3.3, 5.1, 5.3 |
| 7.2.1 | Important factors, unusual or infrequent events or new developments | 1.3.3, 5.1, 5.3 |
| 7.2.2 | Reasons for significant changes in net sales or revenues | 1.3.3, 5.1, 5.3 |
| Section of the Universal Registration Document |
||
|---|---|---|
| 8. | Cash and equity | 1.3 |
| 8.1 | Information on the issuer's equity | 1.3.4 |
| 8.2 | Issuer's cash flow | 1.3.4 |
| 8.3 | Issuer's financing needs and financing structure | 1.3.6 |
| 8.4 | Restrictions on the use of the issuer's equity | N/A |
| 8.5 | Financing sources of expected cash flows | 1.3.4 |
| 9. | Regulatory environment | 2.4.5 |
| 10. | Information about trends | 1.3.6.1 |
| 10.1 | Main trends affecting production, sales and inventories, costs and selling prices and significant changes in the Group's financial performance since the end of the last financial year up to the date of registration of the Universal Registration Document |
1.3.6.1 |
| 10.2 | Known trend, uncertainty or demand or commitment or event reasonably likely to materially affect the outlook, at least for the current fiscal year |
1.3.6.1 |
| 11. | Profit forecasts or estimates | 1.3.6.2 |
| 12. | Administrative, management, oversight, and general management bodies | 3 |
| 12.1 | Composition of the administrative, management, oversight, and general management bodies | 3.1 |
| 12.2 | Conflicts of interest affecting the administrative, management, oversight, and general management bodies |
3.1.2.3 |
| 13. | Compensation and benefits | 3 |
| 13.1 | Compensation, benefits in kind, options and stock awards granted to the corporate officers | 3.3 |
| 13.2 | Total amount provisioned for the payment of pensions, retirement, and other benefits | 3.3.2 |
| 14. | Functioning of administrative and management bodies | 3 |
| 14.1 | Expiration date of corporate offices | 3.1.1.2 |
| 14.2 | Service contract linked to the Company's administrative, management or supervisory bodies | 3.1.2.2 |
| 14.3 | Audit Committee and Compensation Committee | 3.2.2 |
| 14.4 | Statement on Corporate Governance | 3.2.1 |
| 14.5 | Impact of future changes in the composition of boards and committees | 3.2.2 |
| 15. | Employees | 3.4, 4.5, 6.8 |
| 15.1 | Human resources | 4.5.1 |
| 15.2 | Equity investments and stock options | 3.4.1 |
| 15.3 | Employee share ownership agreement | 6.8.2 |
| 16. | Principal shareholders | 6.2 |
| 16.1 | Shareholders owning more than 5% of the share capital or voting rights | 6.2.1 |
| 16.2 | Existence of different voting rights | 6.2.2 |
| 16.3 | Control of the company by the principal shareholders | 6.2.3 |
| 16.4 | Shareholder agreements | 6.2.4 |
| 17. | Related-party transactions | 6.5, 6.7.5.3 Notes 19 and 28 |

| Section of the Universal Registration Document |
||
|---|---|---|
| 18. | Financial information concerning the assets, financial position, and results of the company | 1, 2, 5, 7.4 |
| 18.1 | Background financial information | 1.3, 5.1, 5.3 |
| 18.1.1 | Audited historical financial information for the last three years and the auditors' report prepared for each of those three periods |
5.1, 5.3, 7.4 |
| 18.1.2 | Change in accounting baseline date | N/A |
| 18.1.3 | Accounting standards | 5.1.2 Note 1 |
| 18.1.4 | Change in accounting standards | N/A |
| 18.1.5 | Financial statements (French GAAP) | 5.3 |
| 18.1.6 | Consolidated financial information | 5.1 |
| 18.1.7 | Date of latest financial information | 5.1.3 |
| 18.2 | Interim and other financial information | 5.1.3 |
| 18.3 | Audit of historical annual financial information | 5.2, 5.4, 7.4 |
| 18.4 | Pro forma financial information | 5.5 |
| 18.5 | Dividend policy | 1.3.3 |
| 18.6 | Legal and arbitration proceedings | 2.6.2 |
| 18.7 | Significant change in the issuer's financial position | 1.3.6.3 |
| 19. | Additional information | 6 |
| 19.1 | Capital stock | 6.1 |
| 19.1.1 | Amount of equity issued, total authorized capital stock, number of shares issued and fully paid in, number of shares issued but not fully paid in, par value per share and reconciliation of the number of shares outstanding on the opening date and on the closing date of the financial year |
6.1.1 |
| 19.1.2 | Number and main features of shares not representing capital | 6.1.2 |
| 19.1.3 | Number, carrying amount and par value of shares held by the Company itself or on its behalf by its subsidiaries |
6.1.3 |
| 19.1.4 | Convertible securities, exchangeable securities, or securities with warrants | 6.1.4 |
| 19.1.5 | Conditions governing any right of acquisition, or any obligation attached to the capital authorized but not issued, or any undertaking to increase the share capital |
6.1.5 |
| 19.1.6 | Equity of any member of the Group subject to an option or a conditional or unconditional agreement to place it under option |
6.1.6 |
| 19.1.7 | Changes to share capital | 6.1.7 |
| 19.2 | Articles of incorporation and articles of association | 6.3 |
| 20. | Material Contracts | 1.2.3, 1.2.4.2 |
| 21. | Documents available | 7.4 |
The cross-reference table below enables the main information stipulated in Article L. 451-1-2 of the French Monetary and Financial Code and Article 222-3 of the General regulation of the Autorité des Marchés Financiers to be identified.
| Headings | Sections |
|---|---|
| Transgene annual financial statements | 5.3, 7.4 |
| Transgene consolidated financial statements | 5.1, 7.4 |
| Management report (including at a minimum the information indicated in Articles L. 225-211, L. 22-10-35, and L. 225-211 paragraph 2 of the French Commercial Code) |
7.7 |
| Information contained in Articles L. 225-100 and L. 225-100-1 and L. 22-10-35 of the French Commercial Code | |
| Analysis and change in business, results, and debt situation |
1.3 |
| Key financial and extra-financial performance indicators |
1.1 |
| Use of financial instruments by the Company |
5.1 Note 24 |
| Main risks and uncertainties |
2 |
| Table of delegations on capital increases |
6.1.5 |
| Information contained in Articles L. 22-10-11 of the French Commercial Code: elements likely to have an impact in the event of a public offering |
6.2.4 |
| Information contained in Article L. 225-211 of the French Commercial Code: buyback by the Company of its own shares | 6.6 |
| Declaration by the person responsible for the Annual Financial Report | 7.1.2 |
| Statutory Auditors' report on the annual financial statements | 5.4, 7.4 |
| Statutory Auditors' report on the consolidated financial statements | 5.2, 7.4 |
| Statutory Auditors' fees | 7.2.2 |
| Report by the Chairman of the Board of Directors (Article L. 225-37 of the French Commercial Code) on Corporate Governance |
3.3 |
| Statutory Auditors' report on the report of the Board of Directors on Corporate Governance (L. 22-10-71) | 5.4 |
7

This Registration Document includes all of the items of the management report required by legal and regulatory provisions. The table below identifies the pages of this Registration Document that comprise the main items of the management report.
| Headings | Sections |
|---|---|
| Group business and change in business | 1.2, 1.3 |
| Group business results | 7.7 |
| Amendments to the presentation of the annual financial statements or to the assessment methods followed in previous years |
1.3.2 |
| Recent events | 1.3.1 |
| Foreseeable changes in the Company and outlook | 1.3.6 |
| Supplier payment terms | 7.7 |
| Amount of dividends distributed over the last three fiscal years | 1.3.3 |
| Table of results over the last five fiscal years | 7.7 |
| Main risks, management, and hedging | 2 |
| Research and development | 1.2 |
| Subsidiaries and investments | 1.2.7.2 |
| Social, environmental, and societal information | 4 |
| Corporate officers and executive directors (terms of office, compensation, transactions in Company securities) | 3 |
| Share capital and employee shareholders | 6 |
| Share buybacks | 6.6 |
| Factors that could have an impact in the event of a public offering | 6.2.4 |
| Delegations granted by the General Meeting | 6.1.5 |
| Report by the Chairman of the Board of Directors (Article L. 225-37 of the French Commercial Code) on Corporate Governance |
3.2 |
| Report on the compensation policy applicable to Executive corporate officers | 3.3 |
Adenovirus: a member of a family of DNA viruses responsible for diseases of the respiratory tract, eye, and gastrointestinal tract. The forms of adenovirus used in immunotherapy, particularly the type 5 adenovirus for Transgene, have a favorable tolerability profile.
Antibody: antibodies are proteins used by the immune system to identify and neutralize foreign bodies such as bacteria and viruses. The antibody binds itself to a specific location on its target, called the antigen. This binding activates several functions of the immune system, since antibodies have different modes of action depending on their type: some neutralize or disarm the antigens directly while others prepare them for destruction by white blood cells.
Cytokine: a large category of small proteins involved in the immune defense system. Some cytokines boost or inhibit the immune system, as needed.
Cytolysis – cytolytic: tending to dissolve (destroy) cells. The cytolysis may be caused by the T lymphocytes (a specific immune response) or by an oncolytic virus.
Gene: the functional and physical unit of heredity, transmitted from parent to child. Genes are components of DNA and most of them contain the information necessary to manufacture a specific protein.
GM-CSF (granulocyte-macrophage colony stimulating factor): a cytokine that acts as a growth factor on white corpuscles, especially granulocytes, macrophages and cells that become platelets. BT-001 contains a sequence that codes for GM-CSF.
ICI, Immune checkpoint inhibitor or blocker: new immunotherapy treatment based on monoclonal antibodies. Since 2015 several ICIs have been authorized. Their action mechanism primarily involves interactions between PD-1 and PD-L1 or CTLA4.
Interleukin 2 (IL-2): a cytokine that stimulates the growth of certain cells in the immune system involved in the defense of the organism.
Lymphocytes: immune cells (white corpuscles) produced by bone marrow and found in blood and lymph. The two principal types of lymphocytes are B cells and T cells. B lymphocytes produce antibodies and T lymphocytes help destroy tumor cells and control the immune response.
Metastasis: the spread of cancer cells from one part of the body to another.
MVA (Modified Vaccinia Ankara): a highly attenuated strain of the vaccine developed towards the end of the campaigns to eradicate smallpox. MVA is an attenuated virus often used to develop vaccines for antigen expression. MVA is a strain of choice for clinical studies due to its excellent safety profile and its ability to induce specific immune responses against vectorized antigens. TG4001 and TG4050 resulted from MVA.
Neoantigen: an antigen normally not expressed in the organism and induced by tumors. These are specific to the tumor. Several published papers attest to their strong immunogenic power. They are the cornerstone to the myvac® approach.
Objective tumor response: an objective tumor response is measurable. It is most often evaluated with medical imaging and is one of the major indicators in evaluating a cancer therapy.
Oncolytic virus: a virus that selectively infects cancer cells and destroys them. When the infected cancer cells are destroyed by lysis, they liberate new infectious viral particles that in turn help destroy the surrounding tumor cells. Besides directly destroying tumor cells, oncolytic viruses stimulate tumor-fighting immune responses in the patient. TG6002 and BT-001 are oncolytic viruses. A first oncolytic virus, Imlygic® , has been authorized for patients with metastatic melanomas.
PD-1, PD-L1: the PD-1 molecule, found on the surface of t-cells, binds to the PD-L1 molecule, on the surface of certain cancer cells. This interaction prevents the T-lymphocyte from acting on the abnormal cell and allows the tumor to grow. By inhibiting PD-1 or PD-L1, the ICIs help the immune system to once again be able to eliminate cancer cells. These markers, however, are expressed in patients to varying degrees. When patients have a high level of PD-L1s, ICIs have shown genuine effectiveness with certain diagnoses. When the PD-L1 level is low or undetectable ("negative PD-L1" patients), ICIs have not, to date, shown sufficient efficacy.
Phase I (clinical study): first trial stage of a medication in humans. The Phase I study tests treatment on a small number of people in order to evaluate safety and the maximum dose tolerated.
Phase II (clinical study): Phase II clinical studies include a greater number of patients than Phase 1 and are designed to evaluate the safety, dosage and sometimes the effectiveness of the new drug or treatment.
Phase III (clinical study): Phase III clinical studies can involve hundreds or thousands of patients depending on the disease, and are designed to evaluate the safety and effectiveness of a drug in a controlled setting.

Poxvirus: a large family of DNA viruses, the best known of which are the vaccine viruses that enabled the global eradication of smallpox in the late 1970s. Because it is so effective, this virus family is now used for other infectious diseases (HIV, tuberculosis, RSV) or in oncology (therapeutic vaccines, oncolytic virus).
Proof of concept: First demonstration of the mechanism of action or first sign of efficacy. It is obtained following preliminary and physical experiments, in preclinical and clinical trials (Phase I or II). This important stage is necessary to continue the development of a candidate medication. The proof of concept must be validated by larger studies such as Phase II or III clinical trials.
Protein: a molecule made up of chains of units called amino acids. There are 21 of these amino acids. These molecules play a number of roles: structural, as sensors, for repair, etc.
Protocol: the detailed plan of a scientific or medical experiment, a treatment or procedure. The protocol of a clinical study describes what is done, how and why.
Randomized: in a randomized clinical study the patients are assigned by chance to separate groups to compare different treatments.
Refractory: a disease is said to be refractory or resistant if it does not respond to a treatment.
Solid tumor: an abnormal mass of tissue that usually does not contain cysts or liquid areas. Solid tumors can be benign (non-cancerous) or malignant (cancerous).
Stage: the level of growth of a cancer. Stage is generally determined by the volume of the tumor, whether or not the lymph nodes have been affected and by the extent to which the cancer has spread from the original site to other areas of the body. Stages run from 0 to IV, with IV being the most advanced stage.
T cells or T lymphocytes: type of white blood cells belonging to the immune system and developing from stem cells in bone marrow. They help protect the body from infections and can help fight cancer. Transgene immunotherapies are designed to increase the immune response primarily by activating these T-lymphocytes.
Targeted therapy: a treatment that uses drugs to specifically identify, block or destroy cancer cells, with less damage to normal cells.
Therapeutic vaccines: their purpose is to induce innate and adaptive immune responses by triggering a cascade of immune reactions that result in the production of T-lymphocytes that specifically destroy the tumor/infected cells.
Tumor associated antigen: an antigen is a substance that causes the organism to mount an immune defence against it. Antigens can be produced by the organism itself (self-antigens) or come from the environment (non-self-antigens). The latter include toxins, chemicals, bacteria, viruses, parasites, and other substances from outside the body. The characteristic antigens of tumor cells or infected cells can be vectorized and integrated into our immunotherapies. Thus, the surface antigen of the hepatitis B virus was integrated into TG1050 and the HPV-16 E6 and E7 antigens into TG4001 to increase the immune response to the cells expressing these antigens. Certain tumor antigens are specific to each tumor or patient, in which case they are called neoantigens.
Viral vaccine vector: an attenuated form of a virus transporting one or several antigens. The vector is used to produce one or more antigens in the organism and stimulate the immune system, forcing it to mount an immune response against the targeted antigen(s).
Some definitions were adapted from the online dictionary of the National Cancer Institute at www.cancer.gov.
Appendix: management report for THE management report for the period ended December 31, 2021
We have called this Ordinary General Meeting to approve the financial statements for the fiscal year ended December 31, 2021, and to vote on several other resolutions.
This management report in addition to the topics it is legally obliged to cover, discusses the business and operations of our Company during the fiscal year ended, points out the key events, analyzes the financial statements and provides an outlook for 2022.
Transgene is developing TG4050, an individualized immunotherapy against cancer from its innovative myvac® platform. Transgene uses this "tailor-made" approach by combining its viral engineering expertise with the artificial intelligence technologies of its partner NEC. TG4050 is currently being evaluated in two Phase I clinical trials in Europe and the United States (ovarian cancer and HPV-negative head and neck cancers), which are 50% funded by NEC. The product is manufactured in a production unit that complies with GMP standards, within Transgene's premises. The first positive findings were announced in November 2021.
This positive data was obtained in the first six patients treated; it demonstrates the significant potential of this individualized immunotherapy. The specific immune responses measured show a robust T-cell response to several targeted mutations (neoantigens) with a median of ten positive responses per patient. The development of adaptive responses also suggests that the vaccine is able to effectively stimulate the immune system. The studies also provide preliminary data on the clinical activity of the product. Thus, among the four patients with ovarian cancer treated with TG4050, one patient had her CA-125 elevation resolved by vaccination for nine months before dying from an unrelated chronic disease, and one patient has remained stable nine months after the appearance of radiological lesions and the initiation of treatment. Head and neck cancer patients treated with TG4050 for ten and five months respectively were stable and without apparent disease as at November 22, 2021.
These results confirm the interest shown in using this prediction system for TG4050 and validate the myvac® platform as an effective approach for tumor vaccination. Additional data will be presented at the AACR congress on April 12, 2022 and at other scientific congresses in 2022.
TG4001 is a therapeutic vaccine targeting cancers caused by the human papilloma virus (HPV). It expresses the E6 and E7 antigens of the HPV-16 virus and interleukin-2 (IL-2), which stimulates immune responses. TG4001 is being developed in HPV-16 positive recurrent/metastatic cancers, without liver metastasis, with a clinical benefit having been observed for this population in the Phase Ib/II trial. TG4001 is currently being evaluated in a randomized Phase II trial, which can recruit up to 150 patients, comparing the efficacy of the combination of TG4001 with avelumab versus avelumab alone. The first patient was enrolled in June 2021. The trial is actively recruiting patients in Europe (France and Spain) and was recently initiated in the United States.
An interim analysis will be performed after the enrollment of approximately 50 patients. Transgene expects to release the results of this analysis in the fourth quarter of 2022

ADDITIONAL INFORMATION
Appendix: management report for THE management report for the period ended December 31, 2021
BT-001 is a patented oncolytic virus with strong antitumor potential (VVcopTK-RR-), from the Invir.IO™ platform and co-developed with BioInvent. It was designed to express the anti-CTLA-4 antibody and the GM-CSF cytokine directly in the tumor microenvironment. The production of antibodies in the tumor aims to cause a local decrease in immunosuppressive Treg cells and to ensure significant therapeutic activity by limiting systemic exposure.
Promising preclinical results of BT-001 were presented at the SITC 2021 annual congress. They show exceptional anti-tumor activity, which causes the disappearance of tumors in in vivo models. In January 2022, preclinical proof of concept data was published in theJournal for ImmunoTherapy of Cancer(JITC). The published results demonstrate the potential of the virus to provide therapeutic benefits that exceeds that of anti-PD1/anti-CTLA-4 immune checkpoint inhibitors. Further preclinical data will be presented at the AACR congress on April 12, 2022.
The open-label, multi-center Phase I/IIa study is evaluating increasing doses of BT-001 alone and in combination with pembrolizumab. The first patient of this trial, authorized in Europe (France and Belgium) and in the United States, was enrolled in February 2021. Patient recruitment is progressing in line with expectations.
The next update on the ongoing Phase I trial is expected in the second quarter of 2022
TG6002 is based on the patented Transgene strain VVcopTK-RR-. It was designed to express a chemotherapy agent, 5-FU, directly in the tumor. TG6002 is the subject of two Phase I/II clinical trials in gastrointestinal cancers for which 5-FU is a common treatment. Its administration is being evaluated by intravenous and intrahepatic artery routes.
The early Phase I data was presented at the AACR 2021 and ESMO 2021 congresses. This data constitutes the clinical proof of concept of the intravenous administration of Transgene's patented viral strain VVcopTK-RR. It shows that after being administered intravenously, TG6002 reaches the tumor, selectively replicates within tumor cells and induces localized expression of its functional transgene (the FCU1 gene). These results confirm the relevance of the intravenous administration of oncolytic viruses from the VVcopTK-RRviral strain, the origin of the Invir.IO™ platform, which could expand the potential use of Transgene's oncolytic therapies.
The Phase I trial evaluating TG6002 administered intravenously is expected to end by mid-2022. All translational data will be presented in the fourth quarter of 2022
| myvac® TG4050 |
Targets: tumor neoantigens |
|---|---|
| Co-developed with NEC ● First positive data on the first 6 patients treated demonstrating the immunogenicity of the ● vaccine as well as the first signs of clinical activity |
|
| Phase I | Ovarian cancer - after surgery and first-line chemotherapy (NCT03839524) |
| Active trial in the United States and France ● First patient treated in 2020 - Enrollments in line with expectations ● & Additional data expected in 2022, including at the AACR |
|
| Phase I | HPV-negative head and neck cancer – after surgery and adjuvant therapy (NCT04183166) |
| Active trial in the United Kingdom and France ● First patient treated in January 2021 - Enrollments in line with expectations ● & Additional data expected in 2022, including at the AACR |
|
| TG4001 | Targets: HPV-16 E6 and E7 oncoproteins |
| + avelumab Phase II |
Recurrent/metastatic HPV-positive anogenital cancers - first and second line (NCT03260023) |
Appendix: management report for THE management report for the period ended December 31, 2021
| TG4001 | Targets: HPV-16 E6 and E7 oncoproteins | ||||
|---|---|---|---|---|---|
| Randomized Phase II trial comparing the combination of TG4001 with avelumab versus ● avelumab alone First patient treated in June 2021. Active enrollment of patients in Europe (France and Spain) ● and initiation of the trial in the United States. |
|||||
| & Results of an interim analysis expected in Q4 2022 (No. 50) |
|||||
| Invir.IO™ BT-001 |
Payload: anti-CTLA-4 antibody and GM-CSF cytokine | ||||
| Phase I/IIa | Solid tumors (NCT04725331) | ||||
| Co-development with BioInvent ● Very encouraging preclinical results presented SITC 2021 and soon at AACR 2022 ● Trial active in France and Belgium and authorized in the United States ● First patient enrolled in February 2021 ● |
|||||
| & Next communication in Q2 2022 |
|||||
| TG6002 | Payload: FCU1 for the local production of 5-FU, a chemotherapy agent | ||||
| Phase I/IIa | Gastro-intestinal adenocarcinoma (colorectal cancer for Phase II) - Intravenous route (IV) (NCT03724071) |
||||
| Multicenter trial ongoing in Belgium, France and Spain ● Data constituting the clinical proof of concept of IV administration presented at the AACR 2021 ● and ESMO 2021 Escalation of the dose completed to the maximum planned dose (3109 pfu) validating the ● safety profile. Current dose intensification schedule (109 and 3109 pfu) & End of Phase I mid-2022 |
|||||
| Phase I/IIa | Colorectal cancer with liver metastases – Intrahepatic artery (IHA) route (NCT04194034) | ||||
| Active multicenter trial in the United Kingdom and France ● Inclusion of patients from the last cohort of the current dose escalation (109 pfu) in progress ● |
AstraZeneca exercised a first license option in December 2021 for an oncolytic virus from Transgene's Invir.IO™ platform. Transgene received an initial payment of US\$8 million for the exercise of this option and may also receive other payments upon achievement of milestones related to development, regulatory milestones and marketing, as well as royalties.
The collaboration with AstraZeneca, which provides for the co-development of other potential oncolytic immunotherapies, is ongoing. AstraZeneca has an option to acquire the rights to each of these innovative drug candidates for further clinical development.
In January 2022, Transgene announced the launch of a preclinical collaboration with PersonGen BioTherapeutics. This collaboration aims to assess the feasibility and efficacy of a combination regimen, combining the injection of PersonGen CAR-T cells with an oncolytic virus from the Invir.IO™ platform, against solid tumors.
At December 31, 2021, Transgene's available cash and available-for-sale financial assets totaled €49.6 million.
The Company has financial visibility until the end of 2023.
The 2021 separate financial statements, which will be submitted at the Ordinary General Meeting for approval, show a loss of €17 million and equity of €55 million.

Appendix: management report for THE management report for the period ended December 31, 2021
None.
Transactions by senior executives and corporate officers in the Company's securities None.
Employee interests in the Company's share capital are not significant. As of December 31, 2021, the number of shares resulting from the plans and held in registered form by employees is estimated at less than 1% of the share capital. A Company Savings Plan (PEE) also exists for employees.
Capital structure: the majority shareholder is TSGH. which holds 61.9% of Transgene. The Company is controlled in fine by Mr. Alain and Mr. Alexandre Mérieux via Compagnie Mérieux Alliance, which holds 99.8% of Institut Mérieux, which holds 99.5% of TSGH.
Under the share buyback program initially authorized by the General Meeting on June 8, 2017, and renewed by successive meetings, the Company has a liquidity contract. As of December 31, 2021, Transgene held 176,500 of its own shares under this contract.
Furthermore, the Company has not set up any measures, statutory or conventional, that may impact a public offering and has no knowledge of any agreements between shareholders likely to affect them.
Article L. 441-6 paragraph 9 of the French Commercial Code provides that the time agreed upon between the parties for the payment of sums due may not exceed 45 days from the last day of the month or 60 days from the invoice date. Absent an agreement, the maximum period is 30 days from the date of receipt of the merchandise or performance of service.
With regard to Transgene's trade payables invoices that were not paid at the end of the fiscal year, the breakdown by settlement date is as follows:
| At Dec. 31, 2021 | At Dec. 31, 2020 | |||
|---|---|---|---|---|
| Maturity | Euros | % of total | Euros | % of total |
| Past due | 493,025 | 21% | 57,031 | 4% |
| Between 1 and 30 days | 1,833,749 | 78% | 1,297,166 | 94% |
| Between 31 and 45 days | 22,467 | 1% | 24,728 | 2% |
| Between 46 and 60 days | 5,955 | - | 4,153 | - |
| Between 61 and 75 days | - | - | - | - |
| Between 76 and 90 days | - | - | - | - |
| Between 91 and 105 days | - | - | - | - |
| Between 106 and 120 days | - | - | - | - |
| More than 120 days | - | - | - | - |
| TOTAL | 2,355,195 | 100% | 1,383,078 | 100% |
Appendix: management report for THE management report for the period ended December 31, 2021
| SUPPLIERS: Unpaid invoices received at the closing date of the financial year which are due |
CLIENTS: Unpaid invoices issued at the closing date of the fiscal year which are due |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 1 to 30 days |
31 to 60 days |
61 to 90 days |
91 days and more |
Total (1 day and more) |
1 to 30 days |
31 to 60 days |
61 to 90 days |
91 days and more |
Total (1 day and more) |
|
| (A) LATE PAYMENT TRANCHES | ||||||||||
| Number of invoices | 50 | 6 | - | 1 | 57 | 7 | - | 1 | 3 | 11 |
| Total amount of invoices with tax |
331,034 | 157,419 | - | 4,573 | 493,025 | 551,088 | - | 3,500 | 10,500 | 565,088 |
| Percentage of the total amount of purchases for the financial year with tax |
1.01% | 0.48% | - | 0.01% | 1.51% | - | - | - | - | - |
| Percentage of financial year revenue specify with tax |
- | - | - | - | - | 3.99% | - | 0.03% | 0.08% | 4.10% |
| (B) INVOICES EXCLUDING (A) INVOLVING DISPUTED OR NON-RECOGNIZED LIABILITIES AND RECEIVABLES | ||||||||||
| Number of invoices | - | - | - | - | - | - | - | - | - | - |
| (C) REFERENCE PAYMENT PERIODS USED (CONTRACTUAL OR LEGAL PERIODS-ARTICLE L. 441-6 OR ARTICLE L. 443-1 OF THE FRENCH COMMERCIAL CODE) |
||||||||||
| Payment terms used to calculate the late payment |
Legal terms/sometimes contractual terms | Contractual terms |
The Company has implemented operating procedures, in particular related to the control of the commitment of financial and human resources, thereby creating a control environment. As it has evolved, the Company has adjusted its control objectives and methods, in particular to control its cash assets, which are its main financial resource, its key performance risks associated with the management of its projects and strategic partnerships, and, more generally, its compliance with regulatory duties applicable to biotechnology companies and to listed companies.
Internal control is a Company system, defined and implemented on its own responsibility, which aims to ensure:
Generally speaking, the Company's internal controls contribute to controlling its activities, the effectiveness of its operations and the efficient use of resources. By contributing to the prevention and control of risks of not achieving the Company's objectives, the internal control system plays a key role in the conduct and management of the Company's various activities. Accordingly, the Company introduced an enhanced control system on the key items of its main risks: liquidity risk and cash conservation, the risk of executing its clinical development plan through tight project management and quality risk through a quality assurance system. However, internal controls cannot provide an absolute guarantee that the Company's objectives will be achieved.
Transgene has adopted the internal control reference framework provided by the AMF for mid- and small-cap companies.
The first part of the report describes the conditions under which the Board of Directors contributes to the optimization of the Company's activities. The Audit Committee reviews the internal control process, specifically with respect to validation of the internal control action plan and the Company's financial communications. In that connection, it familiarizes itself before every interim and annual reporting with the Group's financial statements and the accompanying notes. The independent directors who are physicians or researchers (Drs. Bizzari, Saïd and Zitvogel) take part in special meetings to monitor the Company's clinical development policy. They act

Appendix: management report for THE management report for the period ended December 31, 2021
as advisers to the Company's Medical and Regulatory Affairs Department.
The Executive Committee, chaired by the Chairman and Chief Executive Officer, meets at least every two weeks by teleconference and every month in person. It comprises eight members representing each of the company's functional and operational departments. Other than tasks related to project management, it considers the Company's operations, monitors all aspects of management in terms of the operating plan and objectives assigned by the Board of Directors, and deliberates on all organizational and operational strategy items placed on the agenda by its members. It conducts quality management reviews twice a year and annually reviews the compliance systems (Sapin II, GDPR, Transparency) implemented by the Company and the mapping of operational and corruption risks.
Transgene's organization is based on functional departments, the coordination of which is ensured via a strong "project" strategy. Research programs, products under development and subcontracting are managed by project, headed by a project leader, and are the subject of reports. The project leader is responsible for coordinating, leading, and optimizing the various cross-functional tasks required to ensure the project's success. The project leader prepares a development plan and schedule and provides monthly reports on the milestones achieved and unforeseen difficulties. A specialized project management committee meets at least monthly to track project management. The committee comprises Executive Committee members and project managers. It provides an opportunity to track all the research and development projects, ensure correct allocation of resources and define priorities where necessary.
The Company uses collaborative project management software, which is shared by all departments and whose main functions are:
The Finance Department's role is to provide administrative and budgetary support to the line departments, to prepare management analyses for senior management, to enable effective financial decisions and the optimization of resources, and to ensure compliance with financial and accounting regulations, particularly for a publicly traded company. Within this department, the Head of Administration and Finance is charged with implementing and improving accounting and financial procedures, along with overseeing the action plan established after the annual audit.
The Corporate Secretary monitors the legality of the Company's and subsidiaries' activities and ensures compliance with the laws and regulations in effect and also supervises internal controls and risk management. He is the compliance and ethics officer of the organization and serves as the data protection officer.
Research and development, preclinical tests, clinical trials, facilities and equipment and the manufacture and marketing of therapeutic products are subject to very thorough regulations devised by numerous governmental authorities in France, Europe, the United States, and other countries. The European Medicines Agency (EMA), the French Agence nationale de sécurité du médicament et des produits de santé (ANSM), the Food and Drug Administration (FDA) in the United States and others, require compliance with stringent conditions for the manufacturing, development, and commercialization of products such as those developed by Transgene. Pharmaceutical companies are subject to regular visits by these bodies to identify deficiencies and appropriate remedies.
Such an environment of rigorous controls calls for an internal control system capable of ensuring compliance with standards. This is why the Company has set up, under the authority of the Responsible Pharmacist:
Appendix: management report for THE management report for the period ended December 31, 2021
Member companies of the Institut Mérieux group have been participating in a comprehensive internal control program coordinated by the Institut Mérieux. Each group company analyzes its risks and approves its own audit program. The audit itself is performed by a cross-functional team of internal auditors from group companies who are specially trained in internal audit techniques. The Company was audited in 2019 and action plans were monitored in 2020. A Sapin II audit was undertaken in 2021.
Procedures have been developed and implemented within the Company to ensure that the principal risks are managed internally in compliance with the policies and objectives set by management.
In 2021, the Company conducted an overall risk analysis to determine a new risk mapping. This mission involved all Company directors, and the final mapping was submitted to the Audit Committee and the Board of Directors. Action plans were implemented to optimize the hedging of the identified risks.
This approach led to the identification of the main risk factors that might significantly affect its operations and outlook, as described in Section 2 of its Registration Document. It has established a formal review that surveys the risks and the procedures to be put in place to manage them.
This risk analysis is updated annually and presented to the Audit Committee.
Transgene believes that certain operational and financial risks are significant either due to the probability of their occurrence or by their impact on the Company. They are subject to the following procedures:
Backup of the Company's strategic data takes place primarily through archiving, duplication, and separate storage procedures. The data is stored with a specialized operator offering a high level of data protection. However, the Company maintained equipment for local backups of the most critical data.
Cash and cash equivalents are the Transgene's main financial assets. The controls in place are intended to ensure the proper use and safety of the funds invested, in particular:
The Transgene's cash is currently invested in investment funds, either directly or in the Institut Mérieux group cash pool. This cash pool is placed under the supervision of a committee of Group liquidity managers (representing Transgene: the CFO), which meets once a month to study the cash position of the participants (both lenders and borrowers), the yields and the cash pool management decisions. The Audit Committee provides an update on the cash position at each of its meetings.
To ensure the quality and reliability of the financial and accounting information it prepares, the Company uses a framework of accounting principles and standards as well as a management reporting system that analyzes accounting data along the following lines: by cost center, type of income and expense, and project.
In order to outsource a portion of the financial expense of operational risks, the Company implements a policy of covering the main insurable risks, for itself and its subsidiaries, with coverage amounts that it believes are compatible with its cash usage requirements.
The Company has entered into licensing and development partnerships for the final development stages of its products, their manufacturing, and their commercialization. In order to maintain the highest level of collaboration with its partners and thus ensure optimum development of the product, a dedicated project leader ensures that the program is run properly, under the supervision of a monitoring committee that meets monthly. In addition, strategic partnerships are under special governance, usually in the form of a joint steering committee that meets regularly, or on an ad hoc basis to make key decisions (new strategic directions, new commitments, management of differences, etc.) throughout the life of the agreement.
The Company prepares the annual consolidated financial statements under IAS/IFRS, as well as the parent company financial statements for Transgene. The Company prepares interim consolidated financial statements under IAS/IFRS that are given a limited review by the Statutory Auditors. The consolidation process is not especially complex as the 2021 scope of consolidation included Transgene, its wholly owned subsidiaries, Transgene, Inc., whose purpose is representing Transgene before the U.S. health authorities (no employee in 2021), and Transgene BioPharmaceutical Technology (Shanghai) Co. Ltd. (no employee in 2021).
The Registration documents filed every year with the French Financial Markets Authority (AMF) are prepared jointly by the Finance Department and the Corporate Secretary. They are reviewed by the Group's legal counsel and auditors, under the responsibility of the Chairman and Chief Executive Officer.
The closing of the accounts is performed with the financial IT system ("ERP"). ERP manages procurement and supplies, warehouses, general and analytical accounting, as well as budgetary reporting. It allows for dividing up tasks by means of individual user profiles, while ensuring the integrity of the information. Computerized hierarchical approval procedures

Appendix: management report for THE management report for the period ended December 31, 2021
for purchases, travel authorizations and expense reports are in place.
ERP provides for the integration and traceability of restatement entries under IAS/IFRS standards, which limits the risk of error.
A list of tasks and controls to be effected by the Accounting Department for each closing ensures the appropriate rollout of closing procedures.
Quarterly reporting is prepared by the Finance Department and presented to the Executive Committee. This report is composed of the various Company and subsidiary activity financial and operational monitoring reports and notably analyzes actual and projected quantitative and qualitative accounting data.
The budgeting process is designed and coordinated during the fourth quarter by the Finance Department in close cooperation with the project managers and operating managers. A managing controller is fully dedicated to the collection and monitoring of financial information relating to projects.
The budget process is based on the validation of project priorities based on the annual portfolio review and on the project management software that ensures financial and human resources are adequate to meet project requirements and schedules. The budget is presented for validation by the Management Committee, which then submits it to the Board of Directors, after it has been reviewed by the Audit Committee. The budget is adjusted every half year and a re-estimate is presented to the Board of Directors during the third quarter.
| Other parts of the management report incorporated in this Registration Document | Please refer to the Registration Document |
|
|---|---|---|
| Annual financial | Corporate financial statements 2021 | Section 5.3 |
| statements | 2021 consolidated financial statements | Section 5.1 |
| List of corporate offices | Section 3.1.1 | |
| Corporate officers | Compensation | Section 3.2.4 |
| Subsidiaries and investments |
Section 5.3.2 Note 28 | |
| Risk factors | Chapter 2 | |
| Table of authorizations for the Board to increase the capital | Section 6.1.5 | |
| Shareholders structure | Section 6.2 | |
| Other information | Corporate Social Responsibility | Chapter 4 |
| Stock options report | Section 3.4.1 | |
| Special reports | Report on free shares awards | Section 3.4.2 |
Appendix: management report for THE management report for the period ended December 31, 2021
(Articles R. 225-81, R. 225-83, and R. 225-102 of the French Commercial Code) (in thousands of euros except number of shares and earnings per share)
| Category | 2017 | 2018 | 2019 | 2020 | 2021 |
|---|---|---|---|---|---|
| 1. FINANCIAL POSITION AT YEAR-END | |||||
| a) Share capital | 62,075 | 62,276 | 83,265 | 41,921 | 48,886 |
| b) Number of shares issued | 62,075,190 | 62,275,923 | 83,265,464 | 83,841,334 | 97,771,334 |
| 2. COMPREHENSIVE OPERATING NET INCOME/(LOSS) | |||||
| a) Revenue excl. VAT | 2,099 | 1,335 | 6,652 | 2,899 | 9 993 |
| b) Earnings before taxes, depreciation, and provisions | (35,004) | (2,647) | (27,762) | (27,868) | (23,155) |
| c) Income tax | 5,430 | 5,824 | 6,633 | 6,387 | 7,057 |
| d) Profit after taxes, depreciation, and provisions | (30,471) | 1,043 | (22,008) | (20,116) | (17,006) |
| e) Amount of profits distributed | - | - | - | - | - |
| 3. OPERATING INCOME REDUCED TO A SINGLE SHARE | |||||
| a) Profit after tax but before amortization, depreciation, and provisions |
(0.56) | 0.05 | (0.25) | (0.26) | (0.16) |
| b) Profit after taxes, depreciation, and provisions | (0.49) | 0.02 | (0.26) | (0.24) | (0.17) |
| c) Dividend paid per share | - | - | - | - | - |
| 4. STAFF | |||||
| a) Number of employees | 146 | 146 | 159 | 164 | 167 |
| b) Total payroll | 9,497 | 9,459 | 9,391 | 9,989 | 10,521 |
| c) Amount paid in social benefits (social security, welfare plans, etc.) |
4,550 | 4,607 | 4,857 | 4,788 | 5,857 |
7
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Graphic design : cgraphis Realization & execution : Agence Labrador Photos : cover © TRANSGENE

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