Interim / Quarterly Report • Sep 28, 2023
Interim / Quarterly Report
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Société anonyme with a capital of 38 591 068.25 euros Headquarters: 49, boulevard du général Martial Valin - 75015 Paris 410 910 095 R.C.S. Paris
| 1. | PREAMBLE |
4 |
|---|---|---|
| 2. | BUSINESS ACTIVITY AND SIGNIFICANT EVENTS DURING THE HALF YEAR | 4 |
| 2.1. Research and development4 |
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| 2.2. Governance 7 |
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| 2.3. Financing 7 |
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| 3. | IMPACT ON FINANCIAL POSITION AND EARNINGS | 8 |
| 3.1. Review of accounts and earnings8 |
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| 3.2. Available cash8 |
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| 4. | MAIN RISKS AND UNCERTAINTIES FOR THE NEXT SIX MONTHS |
8 |
| 4.1. Financial risks 8 |
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| 4.2. Risks related to the Company's business9 |
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| 4.3. Legal and regulatory risks9 |
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| 4.4. Insurance and risk coverage9 |
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| 4.5. Litigation9 |
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| 5. | FORESEEABLE DEVELOPMENT OF THE GROUP'S SITUATION AND FUTURE PROSPECTS | 9 |
| 5.1. Major investments for the future, future financing policy 10 |
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| 5.2. Significant events since the end of the period10 |
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| 5.3. Main communications from the Company during the first half of the year and after the closing date10 |
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| 6. | MAJOR RELATED PARTY TRANSACTIONS | 11 |
| 7. | CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS AT JUNE 30, 2023 | 12 |
| CONSOLIDATED BALANCE SHEET 12 |
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| CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME 13 |
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| CONSOLIDATED STATEMENT OF CHANGES IN EQUITY14 | ||
| CONSOLIDATED STATEMENT OF NET CASH FLOWS16 | ||
| NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS17 | ||
| NOTE 1: BASIS OF PREPARATION OF FINANCIAL STATEMENTS17 | ||
| NOTE 2: SCOPE OF CONSOLIDATION17 | ||
| NOTE 3: OPERATING SEGMENT REPORTING (IFRS 8)18 | ||
| NOTE 4: INTANGIBLE ASSETS18 | ||
| NOTE 5: RIGHTS OF USE 18 |
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| NOTE 6: CURRENT ASSETS19 | ||
| NOTE 7: CASH AND CASH EQUIVALENTS20 | ||
| NOTE 8: SHAREHOLDERS' EQUITY 20 |
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| NOTE 9: NON-CURRENT LIABILITIES 26 |
| NOTE 10: CURRENT LIABILITIES 28 |
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|---|---|
| NOTE 11: OPERATING INCOME AND EXPENSES29 | |
| NOTE 12: FINANCIAL INCOME30 | |
| NOTE 13: EARNINGS PER SHARE 30 |
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| NOTE 14: RELATED PARTIES 30 |
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| NOTE 15: POST-CLOSING EVENTS 30 |
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| CERTIFICATION OF THE PERSON RESPONSIBLE FOR THE SEMI-ANNUAL FINANCIAL REPORT |
31 |
This report is prepared in accordance with Article L. 451-1-2 of the French Monetary and Financial Code and Articles 222-4 to 222-6 of the General Regulations of the Autorité des marchés financiers (AMF) and the provisions of Articles L.232-7 par. 3 and R 232-13 of the French Commercial Code.
Valerio Therapeutics (formerly Onxeo) is a French clinical-stage biotechnology company developing innovative oncology drugs targeting tumor DNA-binding functions through unique mechanisms of action in the sought-after field of DNA Damage Response (DDR).
DNA damage response consists of a network of cellular pathways that detect, report and repair DNA damage. Proteins monitor DNA integrity and can activate cell cycle checkpoints and repair pathways in response to damage to prevent the generation of potentially deleterious mutations. Applied to oncology, this new field of research aims to weaken or block the ability of tumor cells to repair damage to their DNA, either naturally or under the effect of cytotoxic treatments. Tumor cells are much more dependent on DNA repair mechanisms than healthy cells, due to their uncontrolled proliferation.
The Company is focused on bringing early-stage first-in-class or disruptive compounds from translational research to clinical proof-of-concept, a value-creating inflection point appealing to potential partners.
Valerio Therapeutics is listed on Euronext Growth in Paris.
The Company's portfolio is based on platON™, Valerio Therapeutics's DNA decoy platform.
PlatON™ is the Company's proprietary chemistry platform of DNA decoy therapeutics, which generates new innovative compounds and broaden the Company's product pipeline.
The Company's portfolio includes:
The Company is convinced of the significant therapeutic potential of its DNA decoy technology and the disruptive innovation it represents, which could pave the way for a new paradigm in cancer treatment.
AsiDNA™ is a first-in-class product in the DDR field. It interferes with tumor DNA repair by a very original decoy agonist mechanism, resulting in particular from research at the Institut Curie.
The product is composed of a double-stranded DNA fragment that behaves like a damaged tumor DNA fragment. It hijacks and sequesters key proteins for tumor DNA repair (decoy mechanism), then hyperactivates them (agonist mechanism). AsiDNA™ thus induces inhibition of DNA repair and depletion of the repair pathways of the tumor cell, which nevertheless continues its replication cycle, but with damaged DNA, leading to cell death. AsiDNA™ specifically targets tumor cells and has a very favorable safety profile in humans observed in three Phase 1/1b clinical studies.
Unlike so-called "targeted" therapies that inhibit a specific protein or pathway, such as PARP inhibitors (PARPi), AsiDNA™ does not inhibit one or more repair proteins but instead hyperactivates them, thereby disrupting the entire repair cascade. Thus, it does not induce resistance mechanisms, which all targeted therapies used in oncology today face. This resistance leads to a loss of efficacy and therefore to therapeutic failures after several cycles of treatment.
It is a very strong differentiating factor that allows its use in combination with other tumor DNA damaging agents such as radiotherapy and chemotherapy, or in combination with inhibitors of a specific repair pathway such as PARPi or other
targeted therapies, to increase their efficacy, notably by abrogating resistance to these treatments, without increasing toxicity.
In the first half of 2023, the Company continued the clinical development of AsiDNA™.
Valerio Therapeutics presented new preclinical data confirming the relevance of combining AsiDNA™ with PARP inhibitors (PARPi) in tumor models with an active homologous recombination repair proficient (HRP) pathway on March 9, 2022, at the ESMO Targeted Anticancer Therapies Congress. Although PARP inhibitors have shown significant benefit in cancer patients with homologous recombination repair deficiency (HRD), they show no or very limited efficacy in tumors with active homologous recombination repair proficiency (HRP). The data presented by Valerio Therapeutics highlight the therapeutic advisability of combining AsiDNA™ with PARPi in HRP tumors to overcome intrinsic or acquired resistance in the clinical setting.
At the American Association for Cancer Research (AACR) Annual Meeting held April 8-13, 2022, the Company presented new preclinical data confirming AsiDNA™'s capabilities to protect against cancer treatment toxicity and combat tumor resistance:
On June 30, 2022, the Company announced that the Food and Drug Administration (FDA) approved the initial Investigational New Drug (IND) application for AsiDNA, its first-in-class drug candidate. This is the first IND filed by Valerio Therapeutics in the United States since the initiation of the operation in the United States (April 2022).
This decision allowed the Company to initiate a multi-center Phase 1b/2 trial to evaluate the safety and efficacy of AsiDNA in combination with the PARP inhibitor Olaparib in patients with epithelial ovarian cancer, breast cancer and metastatic castration-resistant prostate cancer who have progressed despite initial treatment with PARP inhibitors. The Company initiated the clinical trial in December 2022 at three clinical sites in the United States.
The Phase 1b/2 study in the US is currently ongoing, 1 patient enrolled in the study. The plan is to continue enrollment in the dose escalation phase until Q3 2023, convene a Safety Monitoring Committee (SMC) to review the data, identify dose for expansion.
In addition, during the first half of the year, Valerio Therapeutics continued supporting two investigator induced studies conducted in collaboration with two academic research centers of excellence in oncology:
PlatON® is a chemistry platform for building new molecules using three components: the oligonucleotide (a double-stranded DNA fragment), a linker between the two strands to ensure the stability of the fragment, and a vector to promote cell penetration (a cholesterol molecule in the case of AsiDNA®). With platON®, Valerio Therapeutics has the means to enrich its portfolio of highly innovative drug candidates while capitalizing on the expertise and knowledge it has accumulated in the field of DNA repair mechanisms in recent years.
After AsiDNA®, the first compound derived from platON®, the company has designed a family of new compounds called OX400 based on its DNA decoy platform. Based on Valerio Therapeutics's proprietary decoy agonist technology, the OX400 family is positioned both in the field of DNA damage response (DDR) by acting as apan-DDR DNA decoy, and in immunooncology by stimulating the anti-tumor innate immunity.
Endowed with an original decoy agonist mechanism of action like all platON® compounds, OX400 family does not induce tumor resistance to treatment, which represents a clear distinction from targeted therapies such as PARP inhibitors. Finally, like AsiDNA®, OX400 family has no activity on healthy cells, which should give it a favorable safety profile in the clinic.
During the first half of 2023, the Company continued to optimize the OX400 pan-DDR DNA decoy family to improve its action on repair proteins, involved in the tumor DNA repair cascade, and its activation of the antitumor immune response via the cGAS-STING pathway.
VIO-01 is A Pan-DDR DNA Decoy Targeting Multiple Proteins & Repair Pathways. VIO-01 is a member of the OX400 family and represents the most optimal drug candidate selected to enter into preclinical development. VIO-01 traps several DDR Proteins Inhibiting Different DNA Repair Pathways. VIO-01 reaches the nucleus and acts as a decoy for several DNA repair enzymes. It has an increased resistance to nucleases and plasmatic stability.
Valerio Therapeutics presented new preclinical data confirming the pan-DDR DNA decoy effect of VIO-01 and the high antitumor activity in tumor models independently from the homologous recombination repair status on April 19, 2023, at the prestigious American Association for Cancer Research (AACR) Annual Meeting. Although PARP inhibitors have shown significant benefit in cancer patients with homologous recombination repair deficiency (HRD), they show no or very limited efficacy in tumors with active homologous recombination repair proficiency (HRP). The data presented by Valerio Therapeutics highlight the therapeutic advisability of VIO-10 in HRP and HRD tumors to overcome intrinsic or acquired resistance in the clinical setting.
The Company presented new preclinical data confirming VIO-01's capability to abrogate several DNA repair pathways and induce a drug-driven synthetic lethality, without the need of a combined treatment:
In parallel to these studies, IND-enabling toxicology studies have been performed to identify the highest non severely toxic dose allowing to identify the starting dose for the future VIO-01 clinical trial.
Based on the emerging pre-clinical evidence regarding VIO-01, as more data became available related to the proposed mechanisms of the drug, the Company reassessed the potential indications, reviewed the emerging treatment landscape and most conducive regulatory strategy. The outcome of the exercise was an update to the clinical development plan and potential indications.
With the current understanding that VIO-01 is an agonist of the HRR pathway, specifically trapping PARP 1 proteins resulting in the hyperactivation of PARP; the Company plans to file an IND to the US FDA in the second semester 2023. Once the IND has been approved by the FDA, the Company plans to initiate the clinical development of VIO-01 in the US. The IND opening trial will evaluate the safety, tolerability and determine the recommended Phase 2 dose (RP2D) of VIO-01 in participants with recurrent mutated HRR solid tumors in the phase 1 study and evaluate the anti-tumor activity of VIO-01 as a monotherapy.
Valerio Therapeutics continued to optimize the PlatON platform to develop more potent assets coupled to innovative technologies. The objective of this optimization wasto combine our PlaTON platform's DNA decoys with the targeted protein degradation strategy offered by PROTACs (PROteolysis-TArgeting Chimeras) technology. PROTACs technology and other tumor specific targeting options may be a novel class of heterobifunctional molecules that can selectively degrade target proteins within cells. This approach offers, several advantages over the other molecules involved in modulating the DNA damage response, such as increased selectivity and reduced toxicity. Our specific strategy involves generating DecoyTAC combining our vectorized DNA decoy molecules capable of efficient cell penetration with a linker+E3 ligand promoting the complete degradation of the DDR target proteins, thereby presenting a novel mechanism of action.
Our exploration of the convergence of PROTACs and DNA Decoys aims to not only propose new therapeutic modalities against DDR proteins but also against transcription factor proteins that are challenging to target. Through these efforts, we strive to advance the field of oncology drug development and contribute to the treatment of cancer patients globally.
The Combined General Shareholders' Meeting on June 6, 2023 renewed the term of office of Financière de la Montagne (represented by Mr. Nicolas Trebouta) and Robert Coleman as directors for three years.
As of the date of this report, the Board of Directors is composed of 7 members, 6 men and 1 woman, including 3 independent members.
| First name, Last name, Title | Independent Director |
Year of first appointment |
End of term | Audit Committee |
Compensation and Nomination Committee |
Scientific Committee |
|---|---|---|---|---|---|---|
| Ms. Shefali Agarwal, chairwoman and CEO | No | 2021 | 2024 | Member | ||
| Mr. Khalil Barrage, director representing Invus |
No | 2022 | 2025 | |||
| Mr. Julien Miara, director representing Invus |
No | 2022 | 2025 | Member | Member | |
| Financière de la Montagne, director represented by Mr. Nicolas Trebouta |
No | 2011 | 2026 | Member | ||
| Mr. Robert Coleman, director | Yes | 2021 | 2026 | Chair | ||
| Mr. Bryan Giraudo, director | Yes | 2021 | 2024 | Chair | Member | |
| GammaX Corporate Advisory, director represented by Mr. Jacques Mallet |
Yes | 2021 | 2025 | Chair | Member |
On June 9, 2023, Valerio Therapeutics (formerly Onxeo) completed a new €12 million round of financing from its historical shareholders Invus and Financière de la Montagne and a new investor, Agenus Inc. This financing, structured in the form of a capital increase, was announced in April 2023 as being part of the financing structure enabling the Company to finance its activities at least until the second quarter of 2024.
The net proceeds of the issue are intended (i) for the development of VIO-01 (formerly OX425), both clinically and industrially, (ii) for ongoing and future clinical trials and (iii) more generally, to finance the Company's current expenses.
The capital increase was carried out by issuing ordinary shares with cancellation of the shareholders' preferential subscription rights, in favor of a category of persons, on the basis of the 6 th and 7th resolutions of the Extraordinary Shareholders' Meeting of February 6th, 2023, in accordance with the provisions of Articles L. 225-129 et seq. of the French Commercial Code.
A total of 42,857,143 new ordinary shares, with a par value of €0.25 each, were issued to Invus Public Equities LP, Financière de la Montagne and Agenus. The new shares represent approximately 38% of the Company's share capital before the completion of the private placement. The subscription price has been set at €0.28 per new share, corresponding to the weighted average of the prices of the last three trading sessions (i.e. from May 12 to 16, 2023 inclusive) without discount, representing net proceeds of the issue of €12 million.
The issue has not given rise to a prospectus submitted to the AMF for approval.
The new shares were admitted to trading on the Euronext Growth market in Paris on June 9, 2023. They are listed on the same quotation line as the Company's existing shares (ISIN: FR0010095596), carry current dividend rights and were immediately assimilated to the Company's existing shares.
Following the completion of the capital increase, Invus Public Equities LP and Financière de la Montagne held 28.5% and 19% of the Company's capital respectively, on the basis of a total of 154,364,273 shares. Agenus held 11.5% of the Company's capital. A shareholder owning 1% of the Company's capital saw its stake reduced to 0.72%. To the Company's knowledge, no other shareholder owns more than 5% of its capital.
The Group did not record any consolidated revenues for the period ended June 30, 2023.
Personnel expenses amounted to €5 million, compared with €4.3 million in the first half of 2022. This increase is related to a 5% variation of the headcount, due to the strengthening of the scientific teams.
External expenses amounted to €6.1 million at June 30, 2023, compared with €4.6 million at June 30, 2022. R&D expenses with third parties increased in the first half of the year, from €4.1 million in 2022 to €5.6 million in 2023, mainly due to industrial development and manufacturing of clinical batches for AsiDNATM.
The financial result as of June 30, 2023 is a loss of €50k compared to a loss of €2.4 million at June 30, 2022, mainly due to the cost of the bond issue with SWK Holdings.
As a result of the changes in business activity reflected in the income and expense items described above, net income for the six months ended June 30, 2023 is negative at €11.6 million, compared with a loss of €11.5 million for the first half of 2022.
TheGroup's cash balance at June 30, 2023 was €16.8 million, compared with €14.6 million at December 31, 2022. The change in cash is mainly due to the capital increase implemented during the first half of the year, which provided Valerio Therapeutics with net proceeds of €12 million.
The cash available at June 30, 2023 gives Valerio Therapeutics visibility until the second quarter of 2024.
As of the date of this Report, the Company considers that it has limited exposure to risks on its operations due to COVID-19 (or any other pandemic risk) and the Russian-Ukrainian conflict. However, it does not rule out the possibility that lockdowns imposed by states and governments could be put back in place, or a continuation or increase in the sanctions enacted against Russia could affect the smooth running of its subcontracted activities, particularly the conduct of clinical trials and production operations. In addition, the Company believes that the current inflation trend, if it were to remain durably high, could significantly increase its operating expenses and increase its financing needs.
The effect of these events on the world's financial markets could have a short-term impact on its ability to finance itself on the capital markets and, consequently, on the conduct of its business.
Excluding the specific risks mentioned above, no specific risk factors are anticipated in the second half of 2023, other than the risk factors inherent in the Company's business, structure, strategy and environment, as described in the 2022 Annual Financial Report published on April 28, 2023. These risks,summarized below, are inherent in the development of innovative medicines and depend on the success of preclinical and clinical trials as well as on regulatory requirements in terms of safety, tolerability and effectiveness.
Financial risks are essentially risks related to the Company's cash flow as long as it is not generating significant revenues in relation to its expenses, particularly in research and development. As of June 30, 2023, the Company has a cash balance of €16.8 million, which provides financial visibility until the second quarter of 2024. In the meantime, it remains possible that the Company will have recourse to non-dilutive financing or possibly fundraising in the near to medium term to secure its operations in the event that it does not manage to generate additional resources, in particular through new licensing agreements or partnerships.
Factors such as the inability to establish licensing agreements for the products in its portfolio within the expected timeframe, a delay or insufficient success in its clinical trials, opportunities for development or external growth, and higher costs of ongoing developments, in particular due to additional requirements from regulatory authorities or to defend its intellectual property rights, may influence the need for, and the terms and conditions of, such financing.
The Company's operational risks relate primarily to the development of its products until the first significant clinical results (proof of mechanism or proof of concept in humans) are obtained, allowing it to initiate partnership discussions.
The Company's development portfolio consists primarily of products at an early stage of development and there is a significant risk that some or all of its drug candidates may not be developed, formulated or produced on acceptable economic terms, may have their development interrupted, may not be the subject of partnership or licensing agreements, may not obtain regulatory approval or may never be commercialized.
The risk of failure or substantial delay in the development of a drug exists at all stages and particularly in clinical trials, even if the Company applies its expertise in translational research, which seeks to identify factors that predict the activity of the drug in humans.
In addition, the response time of regulatory authorities to clinical trial applications submitted to them is also variable, particularly if additional requests are made by the authorities. Moreover, there is a significant competitive risk for all products developed by the Company.
With respect to the Company's structure and strategy, the most significant risks stem from the resources and size of the Company, which must attract and retain key personnel while outsourcing and subcontracting its production.
Legal risks are mainly related to intellectual property, as well as to licensing agreements in place and infringement once products are on the market.
The Company believes that it has the appropriate insurance coverage for its activities, including the coverage required by law for clinical trials, in France and in the rest of the world. The Company does not foresee any particular difficulties in maintaining adequate insurance levels in the future.
On February 11, 2020, Valerio Therapeutics entered into an agreement for the out-of-court settlement of the remaining proceedings in the litigation between it and the companies SpePharm and SpeBio B.V. since 2009, including the immediate, complete and final renunciation of all pending actions, as well as of all future claims or causes of action between the parties related to their past disagreements. This agreement commits Valerio Therapeutics to pay SpePharm 15 to 20% of the net amounts to be received from commercial agreements relating to Valerio Therapeutics R&D assets, for a total cumulative amount of €6 million within a period of 4 years, i.e. by January 31, 2024 at the latest. As of June 30, 2023, the residual amount of this debt is €4.1 million.
As of the date of this report, there are no governmental, legal or arbitration proceedings, including any proceedings of which the Company is aware, which are pending or which the Group is threatened with, that are likely to have or have had in the past 12 months a significant effect on the financial situation or profitability of the Group.
In 2023, the Company will continue to pursue its value creation strategy based on the development of its therapeutic innovations up to proof-of-concept studies in humans, and then generate revenues through agreements with other pharmaceutical companies capable of pursuing their development.
The Company anticipates the following major events:
- Enrollment to continue in the U.S. phase 1b/2 trial in combination with Olaparib in ovarian, breast and prostate cancers to identify the RP2D in combination with Olaparib.
- Clinical updates expected in the second half of 2023 from phase 1b/2 trials conducted in France and European Union under the sponsorship of academic centers:
o REVOCAN trial with Gustave Roussy
o Pediatric trial in High-Grade Glioma with Institut Curie
- Submissions for publications in international scientific journals of the results of preclinical or clinical studies as part of the development plan to demonstrate the potential of AsiDNA.
- Finalization of the IND-enabling preclinical studies.
- Preparation of an IND application with the FDA in S2 2023.
- Continued evaluation and optimization of PlatON platform and potential new drug candidates.
Additionally, Valerio Therapeutics is continuing active evaluation of business partnerships that can be synergistic to its pipeline and the team.
Valerio Therapeutics believes that, given its current activities, it has no further comments to make on trends that would be likely to affect its recurring revenues and general operating conditions from the date of the last fiscal year ended December 31, 2022 until the date of publication of this report.
The Company's main investments will be in research and development.
With a cash balance of €16.8 million as of June 30, 2023, the Company has sufficient visibility to carry out its projects, including the development of VIO-01 (formerly OX425) and the continuation of the preclinical development of the OX400 compounds, until the second quarter of 2024.
In addition, the Company reserves the right to consolidate its financial resources through new non-dilutive financing or by raising funds, in parallel with an ongoing search for new licensing agreements and/or partnerships.
There are no events after June 30, 2023 that could have an impact on the financial statements.
| January 18, 2023 | Availability of preparatory documents of the Extraordinary General Meeting of February 6, 2023 |
|---|---|
| January 25, 2023 | Update on the Development Program for its first-in-class drug candidate AsiDNA |
| January 27, 2023 | Announcement of the Financial Agenda for 2023 |
| February 6, 2023 | Report on the Extraordinary General Meeting of February 6, 2023 |
| March 14, 2023 | Announcement of the publication of the full-year results on April 14, 2023 and |
| holding of the annual general meeting on June 6, 2023 | |
| April 14, 2023 | Announcement of the publication of the full-year results on April 21, 2023 |
| April 21, 2023 | Announcement of the publication of the full-year results on April 24, 2023 |
| April 24, 2023 | Report of the Full Year 2022 Financial Results and Clinical Development Updates |
| April 28, 2023 | Publication of the 2022 Annual Financial Report |
| May 16, 2023 | Announcement of the availability of the preparatory documents and the |
| participation and voting procedures for the Combined General Meeting of June 6, | |
| 2023 |
| June 6, 2023 | Results of the general meeting of June 6 and in particular change of the name to become Valerio Therapeutics |
|---|---|
| July 6, 2023 | Half-year liquidity contract statement |
The full text of the press releases can be found on the Company's website www.valeriotx.com.
Transactions with other related companies within the meaning of paragraph 9 of IAS 24 relate exclusively to companies included in the scope of consolidation and are not material to the financial statements as of June 30, 2023.
The half-year accounts as of June 30, 2023, drawn up according to IFRS standards and approved by the Board of Directors on September 28, 2023, have not been audited nor been the subject of a limited review; being remembered that a new auditor was appointed at the shareholders' meeting held on 6 June 2023.
| ASSETS (in thousands €) | June 30, 2023 | December 31, 2022 |
Note |
|---|---|---|---|
| Non-current assets | |||
| Intangible assets | 20,531 | 20,531 | 4 |
| Property, plant and equipment | 774 | 794 | |
| Rights of use | 872 | 1,093 | 5 |
| Other financial assets | 240 | 90 | |
| Total non-current assets | 22,417 | 22,507 | |
| Current assets | |||
| Trade receivables and related accounts | 1,473 | 6.1 | |
| Other current receivables | 4,777 | 4,521 | 6.2 |
| Cash and cash equivalents | 16,826 | 14,586 | 7 |
| Total current assets | 21,603 | 20,579 | |
| TOTAL ASSETS | 44,020 | 43,086 |
| LIABILITIES AND SHAREHOLDERS' EQUITY (in thousands of €) | June 30, 2023 | December 31, 2022 |
Note |
|---|---|---|---|
| Shareholders' equity | |||
| Capital | 38,591 | 27,877 | 8.1 |
| Less: Treasury shares | -97 | -81 | 8.2 |
| Additional paid-in capital | 28,991 | 27,705 | 8.3 |
| Retained earnings | -32,666 | -13,669 | |
| Result | -11,644 | -19,562 | |
| Total shareholders' equity | 23,176 | 22,270 | |
| Non-current liabilities | |||
| Non-current provisions | 764 | 869 | 9.1 |
| Deferred tax liability | |||
| Non-current financial debts | 7,547 | 8,104 | 9.2 |
| Non-current lease liabilities | 450 | 646 | 9.2 |
| Other non-current liabilities | 4,048 | ||
| Total non-current liabilities | 8,762 | 13,667 | |
| Current liabilities | |||
| Current provisions | 20 | ||
| Short-term borrowings and financial liabilities | 1,212 | 1,003 | 10.1 |
| Current lease liabilities | 327 | 335 | |
| Trade payables and related accounts | 4,388 | 3,449 | 10.2 |
| Other current liabilities | 6,155 | 2,342 | 10.3 |
| Total current liabilities | 12,082 | 7,149 | |
| TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | 44,020 | 43,086 |
| In thousands of € | June 30, 2023 | June 30, 2022 | Note |
|---|---|---|---|
| Recurring revenue from license agreements | |||
| Non-recurring revenue from license agreements | |||
| Total revenues | 0 | 0 | 11.1 |
| Purchases consumed | -219 | -242 | |
| Personnel expenses | -5,011 | -4,258 | 11.2 |
| External expenses | -6,128 | -4,652 | 11.3 |
| Taxes | -28 | -25 | |
| Net depreciation and provisions | -111 | -237 | |
| Other current operating expenses | -127 | -217 | |
| Operating expenses | -11,622 | -9,631 | |
| Other current operating income | 28 | 282 | |
| Recurring operating income | -11,594 | -9,348 | |
| Other operating income | 0 | 385 | |
| Other operating expenses | -417 | 0 | |
| Share of profit from equity affiliates | |||
| Operating income after share of profit from equity affiliates | -11,593 | -8,963 | |
| Cost of net financial debt | -14 | -2,154 | |
| Other financial income | 10 | 122 | |
| Other financial expenses | -46 | -416 | |
| Financial income | -50 | -2,448 | 12 |
| Income before tax | -11,644 | -11,412 | |
| Income tax expense | 0 | -59 | |
| - of which deferred tax | |||
| Net income of all consolidated accounts | -11,644 | -11,471 | |
| Earnings per share | -0.08 | -0.11 | 13 |
| In thousands of € | June 30, 2023 | June 30, 2022 | Note |
|---|---|---|---|
| Earnings for the period | -11,644 | -11,471 | |
| Translation differences | 133 | 113 | |
| Other items that can be reclassified to profit or loss | 133 | 113 | |
| Actuarial gains and losses | 93 | ||
| Other items that cannot be reclassified to profit or loss | 93 | ||
| Other comprehensive income for the period, net of tax | 133 | 207 | |
| Total comprehensive income for the period | -11,511 | -11,264 | |
| Total comprehensive income attributable to: | |||
| - owners of parent | -11,511 | -11,264 | |
| - non-controlling interests |
| Change in reserves and profit/loss | ||||||||
|---|---|---|---|---|---|---|---|---|
| In thousands of € | Capital | Own shares | Additional paid-in capital |
Conversion reserves |
Gains and losses recognized in equity |
Reserves and consolidated profit/loss |
Total Variations |
TOTAL |
| Shareholders' equity as of 1/01/2021 | 19,579 | -182 | 18,577 | -91 | -173 | -8,674 | -8,938 | 29,036 |
| Total comprehensive income for the period | 218 | 49 | -5,937 | -5,670 | -5,670 | |||
| Capital increase | 3,419 | 6,006 | 9,425 | |||||
| Own shares | 1 | -74 | -74 | -73 | ||||
| Other movements | 2 | -1 | -1 | 1 | ||||
| Share-based payments | 224 | 224 | 224 | |||||
| Shareholders' equity as of 12/31/2021 | 22,999 | -181 | 24,583 | 127 | -124 | -14,462 | -14,459 | 32,942 |
| Total comprehensive income for the period | 113 | 93 | -11,471 | -11,264 | -11,264 | |||
| Capital increase | 4,878 | 3,122 | 8,000 | |||||
| Own shares | 37 | -40 | -40 | -2 | ||||
| Other movements | ||||||||
| Share-based payments | 219 | 219 | 219 | |||||
| Shareholders' equity as of 6/30/2022 | 27,877 | -144 | 27,705 | 241 | -31 | -25,753 | -25,543 | 29,895 |
| Total comprehensive income for the period | -8 | -7 | -8,091 | -8,107 | -8,107 | |||
| Capital increase | ||||||||
| Own shares | 62 | -85 | -85 | -24 | ||||
| Other movements | 2 | 2 | ||||||
| Share-based payments | 505 | 505 | 505 | |||||
| Shareholders' equity as of 12/31/2022 | 27,878 | -82 | 27,706 | 232 | -38 | -33,426 | -33,231 | 22,270 |
| Total comprehensive income for the period | 133 | -11,644 | -11,510 | -11,510 | ||||
| Capital increase | 10,714 | 1,286 | 12,000 | |||||
| Own shares | -16 | 162 | 162 | 146 | ||||
| Other movements | ||||||||
| Share-based payments | 270 | 270 | 270 | |||||
| Shareholders' equity as of 6/30/2023 | 38,591 | -97 | 28,991 | 365 | -38 | -44,636 | -44,310 | 23,176 |
| In thousands of € | Note | June 30, 2023 | December 31, 2022 |
June 30, 2022 |
|---|---|---|---|---|
| Consolidated net income | -11,644 | -19,562 | -11,471 | |
| +/- Net depreciation and provisions (excluding those related to current assets) | 4, 5, 9.1 |
125 | -167 | 48 |
| -/+ Unrealized gains and losses related to changes in fair value | 174 | |||
| +/- Income and expenses calculated in relation to stock options and similar | 8.4 | 270 | 213 | 219 |
| instruments | ||||
| -/+ Other calculated income and expenses | 724 | |||
| -/+ Capital gains and losses on disposals | ||||
| -/+ Dilution gains and losses | ||||
| +/- Share of profit from equity affiliates | ||||
| +/- Other items with no impact on cash | ||||
| Cash flow from operations after cost of net financial debt and tax | -11,249 | -18,792 | -11,029 | |
| + Cost of gross financial debt | 12 | 42 | 2,189 | 2,157 |
| +/- Tax expense (including deferred taxes) | 285 | 59 | ||
| Cash flow from operations before cost of net financial debt and tax | -11,207 | -16,318 | -8,813 | |
| - Tax paid | ||||
| +/- Change in operating working capital requirements (including employee | 2,087 | -6,875 | 7,368 | |
| benefit liabilities) NET CASH FLOW PROVIDED BY OPERATING ACTIVITIES |
-9,120 | -9,443 | -1,446 | |
| - Disbursements related to acquisitions of property, plant and equipment and | ||||
| intangible assets | -97 | -488 | -71 | |
| + Cash receipts related to disposals of property, plant and equipment and | ||||
| intangible assets | ||||
| - Disbursements related to acquisitions of financial assets (non-consolidated | ||||
| shares) | ||||
| + Cash receipts related to disposals of financial assets (non-consolidated shares) | 80 | 3 | ||
| +/- Impact of changes in the scope of consolidation | ||||
| + Dividends received (equity affiliates, non-consolidated shares) | ||||
| +/- Change in loans and advances granted | ||||
| + Investment grants received | ||||
| +/- Other flows related to investment operations | ||||
| NET CASH FLOW USED IN INVESTING ACTIVITIES | -97 | -409 | -68 | |
| + Sums received from shareholders on capital increases | ||||
| . Paid by the shareholders of the parent company | 8.1 | 12,000 | 7,875 | 7,961 |
| . Paid by minority shareholders of consolidated companies | ||||
| + Amounts received on exercise of stock options | ||||
| -/+ Net repurchases and resales of own shares | 8.2 | 99 | 37 | |
| + Cash inflow from new loans | ||||
| - Loan repayments (including finance leases) | 9.2, 10.1 |
-550 | 1,513 | 2,343 |
| Of which reimbursement of rights of use (IFRS16) | -166 | -405 | -238 | |
| +/- Other flows related to financing operations | -7 | 1 | 3 | |
| NET CASH FLOW USED IN FINANCING ACTIVITIES | 11,443 | 6,463 | 10,343 | |
| +/- Impact of foreign exchange rate changes | 12 | 87 | 144 | |
| CHANGE IN NET CASH FLOW | 2,238 | -3,301 | 8,974 | |
| INITIAL CASH FLOW | 14,585 | 17,886 | 17,886 | |
| FINAL CASH FLOW | 16,823 | 14,585 | 26,861 |
Valero Therapeutics (formerly Onxeo) is a clinical-stage biotechnology company that develops new cancer drugs by targeting tumor DNA functions through unique mechanisms of action in the field of DNA Damage Response (DDR).
Valerio Therapeutics' interim consolidated financial statements at June 30, 2023 were approved by the Board of Directors on September 28, 2023. They have been prepared in accordance with International Financial Reporting Standards (IFRS) as applicable within the European Union for interim financial reporting (IAS 34), which allow the presentation of selected notes. The consolidated financial statements are therefore presented in condensed form and should be read in conjunction with the Group's annual financial statements for the year ended December 31, 2022, as included in the Annual Financial Report published on April 28, 2023.
The accounting policies applied as from January 1, 2023 are identical to those described in the notes to the consolidated financial statements published as of December 31, 2022.
In addition, the Group has chosen not to early adopt new standards, amendments and interpretations, when their application is mandatory after June 30, 2023, whether or not they have been adopted by the European Union. The impact of these standards and amendments is currently being analyzed.
As at December 31, 2022, the Group has used estimatesin preparing the financialstatementsforthe calculation of:
The financial statements have been prepared on a going concern basis. This basis wasretained by the Board of Directors in view of the fact that the Group had a consolidated net cash position of 16.8 million euros as of June 30, 2023, enabling it to finance its activities until the second quarter of 2024 based on its financing plan.
The Group includes Valerio Therapeutics SA, which concentrates most of its activitiesin Paris and in its Danish establishment in Copenhagen, and its subsidiaries listed below:
All subsidiaries are wholly owned and fully consolidated.
There were no changes in the scope of consolidation during the first half of 2023.
The Group as a whole constitutes a single operating segment. In accordance with IFRS 8.32 and 33, information on the breakdown of revenues by geographical area is provided in note 11.1. In accordance with this standard, the Group's non current assets are mainly located in France.
| In thousands of € | December 31, 2021 |
Increase | Decrease | December 31, 2022 |
Increase | Decrease | June 30, 2023 |
|---|---|---|---|---|---|---|---|
| AsiDNA™ R&D assets | 2,472 | 2,472 | 2,472 | ||||
| Goodwill | 20,059 | 20,059 | 20,059 | ||||
| Other intangible assets | 507 | 4 | 511 | 511 | |||
| Total gross values | 23,038 | 4 | 23,042 | 23,042 | |||
| Other depreciation | -507 | -4 | -511 | -511 | |||
| Total depreciation | -507 | -4 | -511 | -511 | |||
| Goodwill impairment | -2,000 | -2,000 | -2,000 | ||||
| Total impairment | -2,000 | -2,000 | -2,000 | ||||
| TOTAL | 20,531 | 0 | 0 | 20,531 | 0 | 0 | 20,531 |
The R&D assets acquired as part of the DNA Therapeutics acquisition, namely AsiDNA™, as well as goodwill are subject to impairment testing at least annually in accordance with IAS 36.
No indicator of impairment has been identified with respect to the R&D assetsrelated to AsiDNA, therefore no impairment test has been conducted and no impairment has been recognized as of June 30, 2023.
No indicator of impairment has been identified with respect to the goodwill and as the Company's market capitalization as of June 30, 2023, representative of the fair value of the goodwill, is higher than the consolidated net book value at that date, no impairment test has been performed and no impairment loss has been recognized.
Research and development costs incurred in the first half of 2023 have been expensed in the amount of 5.4 million euros, including 603 thousand euros for personnel expenses and 4.8 million euros for external expenses and regulatory fees and taxes.
| In thousands of € | December 31, 2021 |
Increase | Decrease | December 31, 2022 |
Increase | Decrease | June 30, 2023 |
|---|---|---|---|---|---|---|---|
| Rights of use | 3,681 | 107 | -867 | 2,921 | 0 | -64 | 2,857 |
| Depreciation of rights of use | -1,624 | -454 | 250 | -1,828 | -183 | 26 | -1,986 |
| Net value of rights of use | 2,057 | -347 | -617 | 1,093 | -183 | -38 | 872 |
The rights of use correspond mainly to the lease of the head office and to the rental of laboratory equipment and vehicles. These rights of use are amortized over the remaining term of the contracts.
| In thousands of € | June 30, 2023 | < 1 year | > 1 year | December 31, 2022 |
|---|---|---|---|---|
| Net trade receivables and related accounts | 0 | 1,473 |
Trade receivables at December 31, 2022 consisted exclusively of a receivable from the partner Biogen, corresponding to royaltiesto be received on sales and based off a license agreement. Thisreceivable was actually paid in the first half of 2023.
| In thousands of € | June 30, 2023 | < 1 year | > 1 year | December 31, 2022 |
|---|---|---|---|---|
| Advance payments | 425 | 425 | 455 | |
| Personnel and related accounts | 12 | 12 | 6 | |
| Research tax credit | 2,255 | 2,255 | 3,218 | |
| Other tax receivables | 316 | 316 | 553 | |
| Prepaid expenses | 1,768 | 1,768 | 289 | |
| Net value of Other receivables | 4,777 | 4,777 | 4,521 |
The "Research tax credit" item includes a French tax credit for 2022 in the amount of 1,474 thousand euros, which has not yet been reimbursed as of June 30, 2023, as well as the tax credit for the first half of 2023, in the amount of 750 thousand euros. It also includes a Danish Research tax credit from 2021, for 27 thousand euros.
In accordance with IAS 20, that credit has been presented as a deduction from expense items according to their nature, as follows:
| In thousands of € | June 30, 2023 | December 31, 2022 |
June 30, 2022 |
|---|---|---|---|
| Personnel expenses | 112 | 326 | 192 |
| External expenses | 624 | 1,116 | 280 |
| Impairments and depreciation | 14 | 32 | 11 |
| Total | 750 | 1,474 | 483 |
The other tax receivables mainly relate to deductible VAT and to a VAT credit for which the Company has requested reimbursement.
The prepaid expenses amount to 1 768 thousand euros and are mostly related to third-party service providers, within the scientific field. Their proceedings are set out in milestones contracts, whose terms include advance billings. An estimate was computed as of June 30, 2023 to record all billings that did not correspond to a completed service at that date.
| In thousands of € | Net values as of 06/30/2023 |
Net values as of 12/31/2022 |
Changes in cash and cash equivalents |
|---|---|---|---|
| Cash position | 16,822 | 7,086 | 9,736 |
| Cash equivalents | 4 | 7,500 | -7,496 |
| Total Net Cash Position | 16,826 | 14,586 | 2,240 |
Cash equivalents include term accounts of 4 thousand euros that comply with the provisions of IAS 7.6 and IAS 7.7, i.e. short-term, highly liquid, readily convertible investments.
The change in net cash is mainly related to the company's operating expenses, notably in research and development, for a total amount of 5.4 million euros, offset by the receipt of 1.4 million euros in license revenues.
In terms of financing, the Group received in June 2023 a net amount of 12 million euros in the form of a capital increase.
As of June 30, 2023, the capital stock amounted to 38 591 thousand euros, divided into 154 364 273 ordinary shares with a par value of €0.25 each, all of the same class and fully paid up.
During the financial year, the share capital changed as follows:
| Par | # of shares | € | ||
|---|---|---|---|---|
| Fully paid-up shares as of 12/31/2022 | 0.25 | 111,507,13 | 27,876,782.50 | |
| Capital increase | (1) | 0.25 | 0 42,857,143 |
10,714,285.7 |
| Fully paid-up shares as of 06/30/2023 | 0.25 | 154,364,273 | 38,591,068.25 5 |
(1) A capital increase was carried out on June 2023, for a gross amount of 12 million euros, through the issuance of 42,857,143 new shares at a price of 0.28 euros each. The par value of each share is 0.25 euro, representing an increase in share capital of 10,714 thousand euro and additional paid-in capital of 1,286 thousand euro.
In accordance with IAS 32 §33, treasury shares acquired under the liquidity contract signed with Kepler Cheuvreux have been deducted from equity in the amount of 96,614 euros. Profits on share buybacks as of June 30, 2023, amounting to 162 thousand euros, have been added to reserves in accordance with the standard.
As a result of the capital increase described in 8.1 above, the additional paid-in capital account has increased by a total of 1,286 thousand euros.
Full details of stock options and share subscription warrants granted by the Group are given below.
During the first half of the year, the Board of Directors granted stock options to certain employees (the "SO 2022-5" and "SO 2023-1" plans) and to the Chief Executive Officer (the "SO 2023-2" plan). No new share subscription warrants have been granted.
These grants have the following characteristics:
| SO 2022-5 | SO 2023-1 | SO 2023-2 | |
|---|---|---|---|
| Date of grant | April 21, 2023 | June 29, 2023 | June 29, 2023 |
| Number of options granted | 720,000 | 645,000 | 1,714,500 |
| Strike price (€) | 0.32 | 0.26 | 0.26 |
| Vesting | Over 4 years, 25% per year | Over 4 years, 25% per year | Over 4 years, 25% per year |
The expense for the first half of 2023 relating to share-based payments amounts to 270 thousand euros, including 110 thousand euros in respect of instruments granted in 2023.
| Type | Date of authorization |
SSWs authorized | Date of grant | SSWs granted | SSWs subscribed | Beneficiaries | Outstanding SSWs as of 06/30/2023 adjusted (1) |
SSWs exercisable at 06/30/2023 adjusted (1) |
Adjusted subscription price per share in euros (1) |
Date of expiration |
|
|---|---|---|---|---|---|---|---|---|---|---|---|
| SSW 2013 | June 26, 2013 Resolution 17 |
100,000 | September 19, 2013 |
85,000 | 85,000 | 88,490 | 88,490 | 3.85 | September 19, 2023 |
||
| SSW 2014 | June 30, 2014 | September 22, 2014 |
107,500 | 82,500 | 85,886 | 85,886 | 6.17 | September 22, 2024 |
|||
| SSW 2014-2 | Resolution 19 | 314,800 | March 4, 2015 | 35,500 | 19,000 | Non-salaried and non-executive |
19,000 | 19,000 | 6.26 | March 4, 2025 | |
| SSW 2015 | May 20, 2015 | October 27, 2015 | 80,000 | 65,000 | members of the Board |
65,000 | 65,000 | 3.61 | October 27, 2025 | ||
| SSW 2015-2 | Resolution 18 | 405,000 | January 23, 2016 | 90,000 | 90,000 | 90,000 | 90,000 | 3.33 | January 23, 2026 | ||
| SSW 2016 | 405,520 | July 28, 2016 | 260,000 | 190,000 | 160,000 | 160,000 | 3.16 | July 28, 2026 | |||
| SSW 2016-2 | April 06, 2016 Resolution 23 |
October 25, 2016 | 30,000 | 30,000 | Key consultants of the company |
30,000 | 30,000 | 2.61 | October 25, 2026 | ||
| SSW 2016-3 | December 21, 2016 |
70,000 | 70,000 | 52,500 | 52,500 | 2.43 | December 21, 2026 |
||||
| SSW 2017 | May 24, 2017 Resolution 29 |
470,440 | July 28, 2017 | 340,000 | 300,000 | Non-salaried and | 300,000 | 300,000 | 4.00 | July 28, 2027 | |
| SSW 2018 | June 19, 2018 Resolution 28 |
360,000 | July 27, 2018 | 359,500 | 274,500 | non-executive members of the |
274,500 | 274,500 | 1.187 | July 27, 2028 | |
| SSW 2018-2 | October 25, 2018 | 85,000 | 85,000 | Board | 85,000 | 85,000 | 1.017 | October 25, 2028 | |||
| SSW 2020 | June 19, 2020 | September 17, 2020 |
500,000 | 350,000 | 350,000 | 350,000 | 0.684 | September 17, 2030 |
|||
| SSW 2021 | Resolution 31 | 500,000 | April 28, 2021 | 150,000 | 150,000 | Key consultants of the company (2) |
150,000 | 150,000 | 0.723 | April 28, 2031 |
(1) Adjustment of the number and subscription price of warrants following the capital increases of July 2011, July 2013 and December 2014, in accordance with Article L.228-99 of the French Commercial Code (Board of Directors' meetings of July 28, 2011, November 14, 2013 and January 22, 2015)
| Type | Date of authorization |
SSWs authorized | Date of grant | SSWs granted | SSWs subscribed | Beneficiaries | Outstanding SSWs as of 06/30/2023 |
SSWs exercisable as of 06/30/2023 |
Subscription price per share in euros |
Date of expiration |
|---|---|---|---|---|---|---|---|---|---|---|
| SSW 2021-2 | June 11, 2021 | 100,000 | 100,000 | Non-salaried and | 100,000 | 100,000 | 0.662 | June 11, 2031 | ||
| SSW 2021-3 | July 29, 2021 | 300,000 | 125,000 | non-executive members of the Board |
125,000 | 125,000 | 0.620 | July 29, 2031 | ||
| SSW 2021-4 | June 10, 2021 | 700,000 | October 6, 2021 | 150,000 | 75,000 | 75,000 | 75,000 | 0.560 | October 6, 2031 | |
| SSW 2022 | Resolution 19 | February 2, 2022 | 150,000 | 150,000 | Chair of the Board | 150,000 | 0 | 0.420 | February 2, 2032 | |
| SSW 2022-2 | February 2, 2022 | 75,000 | 75,000 | Non-salaried and non-executive members of the Board |
75,000 | 50,000 | 0.420 | February 2, 2032 | ||
| TOTAL SSWs | 2,275,376 | 2,100,376 |
| Plan designation | Date of authorization |
Number of options authorized |
Date of grant | Number of options granted |
Beneficiaries | Outstanding options as of 06/30/2023 adjusted (1) |
Options exercisable as of 06/30/2023 adjusted (1) |
Adjusted subscription price per share in euros (1) |
Date of expiration |
||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SO Employees 2013 | June 26, 2013 Resolution 15 |
283,000 | September 19, 2013 |
195,500 | Employees | 31,232 | 31,232 | 3.85 | September 19, 2023 |
||||||
| TOTAL SO 2013 | 283,000 | 195,500 | 31,232 | 31,232 | |||||||||||
| SO Employees 2014 | June 30, 2014 | September 22, | 138,700 | Employees | 9,587 | 9,587 | 6.17 | September 22, 2024 |
|||||||
| SO Executives 2014 | Resolution 17 | 314,800 | 2014 | 40,000 | Executives | 15,616 | 15,616 | 6.17 | September 22, 2024 |
||||||
| TOTAL SO 2014 | 314,800 | 178,700 | 25,203 | 25,203 | |||||||||||
| SO Employees 2017-2 | May 24, 2017 Resolution 26 |
470,440 | March 29, 2018 | 25,000 | Employees | 25,000 | 25,000 | 1.48 | March 29, 2028 | ||||||
| TOTAL SO 2017 | 470,440 | 25,000 | 25,000 | 25,000 | |||||||||||
| SO Employees 2018 | June 19, 2018 | 758,604 | Employees | 366,246 | 361,791 | 1.187 | July 27, 2028 | ||||||||
| SO Executives 2018 | Resolution 27 | 970,000 | July 27, 2018 | 150,723 | Executives | 108,723 | 98,223 | 1.187 | July 27, 2028 | ||||||
| TOTAL SO 2018 | 970,000 | 909,327 | 474,969 | 460,014 | |||||||||||
| SO Employees 2020 | June 19, 2020 | September 17, | 1,030,000 | Employees | 422,500 | 362,500 | 0.684 | September 17, 2030 |
|||||||
| SO Executives 2020 | Resolution 30 | 1,200,000 | 2020 | 170,000 | Executives | 170,000 | 170,000 | 0.684 | September 17, 2030 |
||||||
| TOTAL SO 2020 | 1,200,000 | 1,200,000 | 592,500 | 532,500 | |||||||||||
| SO Employees 2021 | July 29, 2021 | 281,000 | Employees | 87,750 | 53,250 | 0.62 | July 29, 2031 | ||||||||
| SO Executives 2021 | June 10, 2021 Resolution 30 |
1,500,000 | July 29, 2021 | 60,000 | Executives | 60,000 | 60,000 | 0.62 | July 29, 2031 | ||||||
| SO 2021-2 | July 29, 2021 | 429,194 | Employees & executives | 429,194 | 429,194 | 0.62 | July 29, 2031 | ||||||||
| TOTAL SO 2021 | 1,500,000 | 770,194 | 576,944 | 542,444 |
(1) Adjustment of the number and subscription price of options following the capital increases of July 2011, July 2013 and December 2014, in accordance with Article L.228-99 of the French Commercial Code (Board of Directors' meetings of July 28, 2011, November 14, 2013 and January 22, 2015)
| Plan designation | Date of authorization |
Number of options authorized |
Date of grant | Number of options granted |
Beneficiaries | Outstanding options as of 06/30/2023 |
Options exercisable as of 06/30/2023 |
Strike price per share in euros |
Date of expiration |
|---|---|---|---|---|---|---|---|---|---|
| SO 2022 | June 10, 2021 Resolution 18 |
1,500,000 | February 2, 2022 | 250,000 | Executives | 250,000 | 250,000 | 0.42 | February 2, 2032 |
| SO 2022 - 2 |
2,030,000 | Employees | 2,030,000 | 507,500 | 0.40 | May 4, 2032 | |||
| SO 2022 - 3 |
April 19, 2022 Resolution 4 |
May 4, 2022 | 3,810,285 | Executives | 3,810,285 | 2,323,523 | 0.40 | May 4, 2032 | |
| SO 2022 - 4 |
7,350,000 | September 13, 2022 |
240,000 | Employees | 240,000 | 0 | 0.33 | September 13, 2032 |
|
| SO 2022 - 5 |
April 21, 2023 | 720,000 | Employees | 720,000 | 0 | 0.32 | April 21, 2033 | ||
| TOTAL SO 2022 | 8,850,000 | 7,050,285 | 7,050,285 | 3,081,023 | |||||
| SO 2023 - 1 |
June 6, 2023 | 7,350,000 | June 29, 2023 | 645,000 | Employees | 645,000 | 0 | 0.26 | June 29, 2033 |
| SO 2023 - 2 |
Resolution 10 | June 29, 2023 | 1,714,500 | Executives | 1,714,500 | 0 | 0.26 | June 29, 2033 | |
| TOTAL SO 2023 | 7,350,000 | 2,359,500 | 2,359,500 | 0 | |||||
| TOTAL SO | 11, 135 ,633 |
4,697 ,416 |
| In thousands of € | December 31, 2022 |
Provision charges |
Reversals | June 30, 2023 |
|
|---|---|---|---|---|---|
| Used | Not used | ||||
| Pension obligations | 168 | -104 | 63 | ||
| Provisions | 701 | 701 | |||
| Total non-current provisions | 869 | -104 | 764 |
Pension provisions amounted to 63 thousand euros as of June 30, 2023, compared with 168 thousand euros at December 31, 2022. This decrease of 104 thousand euros, linked to the departure of employees, results in an impact on the income statement of 104 thousand euros(proceeds).
The actuarial assumptions used were as follows:
| June 30, 2023 | December 31, 2022 | |||
|---|---|---|---|---|
| Collective Agreement | National CBA of Pharmaceutical Companies | |||
| Retirement age | Between the ages of 65 and 67, in application of the law of November 10, 2010 on pension reform* |
|||
| Date of calculation | June 30, 2023 | December 31, 2022 | ||
| Mortality table | INSEE 2022 | INSEE 2022 | ||
| Discount rate | 3.75% | 3.74% | ||
| Salary increase rate | 3% | 3% | ||
| Turnover rate | By age bracket: - 0% 16 to 24 years old - 0% 25 to 34 years old - 5.75% 35 to 44 years old - 2.30% 45 to 54 years old - 1.15% over 55 years old |
By age bracket: - 0% 16 to 24 years old - 0% 25 to 34 years old - 5.75% 35 to 44 years old - 2.30% 45 to 54 years old - 1.15% over 55 years old |
||
| Social security rates | 46% |
*As of June 30, 2023, the retirement age is still between the ages of 65 and 67 but is based on the application of the implementation decree published on June 4, 2023. The implementation of this reform had not significant impact on the calculation of the pension obligations.
Provisions are made for:
| In thousands of € | June 30, 2023 | December 31, 2022 |
Change | ||
|---|---|---|---|---|---|
| Total | Impact on cash flow |
No impact on cash flow |
|||
| Government-backed loans |
3,547 | 4,046 | -499 | -499 | |
| Convertible bond issue |
4,000 | 4,000 | |||
| Reimbursable advances |
58 | -58 | -58 | ||
| Subtotal | 7,547 | 8,104 | -557 | -557 | |
| Lease liabilities | 450 | 646 | -196 | -196 | |
| TOTAL | 7,997 | 8,750 | -753 | -753 |
The government-backed loans (GBLs) were granted in February 2021 by Bpifrance and the Group's commercial banks. Valerio Therapeutics has chosen to repay these loans over a period of 5 yearsstarting in February 2022, the first year being a grace period during which only interest will be paid. These loans bear interest at rates between 0.69% and 2.25% over the repayment period and these relatively low rates should lead to the recognition of a grant in accordance with IAS 20.
However, given the purpose and terms of the GBLs, the value of the grant is linked to the term of the loan and the grant should be considered a subsidy of the cost of financing the GBLs to be recognized in profit or loss on a symmetrical basis with the interest expense. The identification of a grant would therefore have no practical impact on the result for the period, nor on its presentation in relation to the recognition of the GBL at the contractual rate. For thisreason, the Group has chosen to record them at the value of the cash received net of transaction costs.
As a reminder, the convertible bonds were issued in April 2022 and subscribed by Invus Public Equities LP and Financière de la Montagne for €2.5 million and €1.5 million respectively. The maturity of thisloan isset for April 6, 2027. Convertible bonds do not bear interest. They may be converted into ordinary shares exclusively at the Company's initiative between the issue date and the maturity date; the CBs will entitle their holders, in the event of conversion, to a number N of new ordinary shares equal to the par value of one CB divided by X; X being the lesser of (a) 0.410 euros, and (b) the volumeweighted average of the prices of the three trading sessions preceding the date of the request for conversion, without any discount.
Repayable advances were granted by Bpifrance and the Ile-de-France region, notably under the Innov'Up Leader PIA program, to finance the Company's R&D programs AsiDNA™ and PlatON™. These advances do not bear interest. Reimbursable advances are due at the end of 2023 and are now considered current financial debt.
Lease liabilities are recognized in accordance with IFRS 16, in exchange for the recognition of rights of use for buildings and movable assets leased by the Group.
The table below shows a breakdown by maturity of non-current liabilities:
| In thousands of € | June 30, 2023 | 1 to 5 years | More than 5 years |
|---|---|---|---|
| Government-backed loans | 3,547 | 3,547 | |
| Convertible bond issue | 4,000 | 4,000 | |
| Lease liabilities | 450 | 450 | |
| TOTAL | 7,997 | 3,997 | 4,000 |
| June 30, December 31, 2023 2022 Total |
Change | ||||
|---|---|---|---|---|---|
| In thousands of € | Impact on cash flow |
No impact on cash flow |
|||
| Government-backed loans |
1,121 | 954 | 167 | -331 | 498 |
| Reimbursable advances | 83 | 52 | 58 | 58 | |
| Accrued interest | 6 | 16 | -10 | -10 | |
| Other | 3 | 8 | -5 | -5 | |
| Subtotal | 1,212 | 1,003 | 209 | -331 | 540 |
| Lease liabilities | 327 | 335 | -8 | -166 | 158 |
| TOTAL | 1,539 | 1,338 | 201 | -497 | 698 |
| In thousands of € | June 30, 2023 | December 31, 2022 |
|---|---|---|
| Trade payables and related accounts | 4,388 | 3,449 |
The change in trade payables is mainly due to the seasonal nature of R&D expenditure, particularly as a result of the industrial development operations associated with AsiDNA.
| In thousands of € | June 30, 2023 | December 31, 2022 |
|---|---|---|
| Social security and related liabilities | 1,554 | 1,812 |
| Tax liabilities | 547 | 484 |
| Other liabilities | 4,054 | 46 |
| Total | 6,155 | 2,342 |
Other current liabilities, in the amount of 4,054 thousand euros, correspond to the debt to SpePharm. The debt was recorded in other non-current liabilities as of December 2022.
This debt will be repaid in the form of a 20% share of the amounts received by Valerio Therapeuticso under existing or future license agreements. The residual amount of the debt at January 31, 2024 will be paid in full at that date.
| In thousands of € | June 30, 2023 | June 30, 2022 |
|---|---|---|
| Recurring revenue from license agreements | 0 | 0 |
| Non-recurring revenue from license agreements | 0 | 0 |
| Total revenues | 0 | 0 |
Personnel expenses are broken down as follows:
| In thousands of € | June 30, 2023 | June 30, 2022 |
|---|---|---|
| Salaries | 3,940 | 3,171 |
| Social security expenses | 893 | 1,033 |
| Employee benefits (IFRS 2) | 270 | 219 |
| Deduction of research tax credit | -112 | -192 |
| Other personnel expenses | 20 | 27 |
| Total | 5,011 | 4,258 |
The total workforce (employees and corporate officers) was 39 people as of June 30, 2023 compared to 36 as of June 30, 2022.
The increase in payrollrelative to the first half of 2023 is due to the reinforcement of the teams, and more specifically to the recruitment of highly qualified scientists.
External expenses are composed of the following items:
| In thousands of € | June 30, 2023 | June 30, 2022 |
|---|---|---|
| R&D costs | 5,643 | 4,107 |
| Deduction of research tax credit | -624 | -280 |
| General and administrative expenses | 1,109 | 824 |
| Total | 6,128 | 4,651 |
The increase in R&D expenses compared to 2022 is mainly related to the advancement of the preclinical and clinical projects.
| In thousands of € | June 30, 2023 | Impact on cash flow |
No impact on cash flow |
June 30, 2022 |
|---|---|---|---|---|
| Income in cash and cash equivalents | 28 | 28 | 3 | |
| Cost of financial debt | -42 | -42 | -2,157 | |
| Cost of net financial debt | -14 | -14 | -2,154 | |
| Other financial income | 10 | 10 | 122 | |
| Other financial expenses | -46 | -46 | -416 | |
| Financial income | -50 | -14 | -36 | -2,448 |
The cost of financial debt in 2022 mainly included the interest expense related to the bond issue with SWK Holdings Corporation.
| June 30, 2023 | June 30, 2022 | |
|---|---|---|
| Net income attributable to common shareholders (in €) | -11,643,553 | -11,470,752 |
| Number of shares issued | 154,364,273 | 111,507,130 |
| Number of treasury shares | 287,160 | 448,434 |
| Number of shares outstanding (excluding treasury shares) | 154,077,113 | 111,058,696 |
| Stock options | 11,135,633 | 8,573,978 |
| Share subscription warrants | 2,275,376 | 2,275,376 |
| Number of potential and issued shares (excluding treasury shares) | 167,488,122 | 121,908,050 |
| Weighted average number of shares outstanding (excluding treasury shares) |
116,192,346 | 101,050,318 |
| Net earnings per share in euros | -0.08 | -0.11 |
Related-party transactions within the meaning of paragraph 9 of IAS 24 did not have a material impact on the financial statements at June 30, 2023.
There are no events after June 30, 2023 that could have an impact on the financial statements
I hereby certify that, to the best of my knowledge, the condensed interim consolidated financial statements have been prepared in accordance with applicable accounting standards and give a true and fair view of the assets, financial position and results of the Company and all the companies included in the consolidation, and that the interim management report (presented in chapter 3 of this report) gives a true and fair view of the significant events of the first six months of the year, their impact on the financial statements, the main transactions between related parties and a description of the principal risks and uncertainties for the remaining six months of the year.
Paris, September 28, 2023
Ms. Shefali Agarwal Chairwoman and CEO
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