Earnings Release • Mar 30, 2022
Earnings Release
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Nantes, France – March 30, 2022, 6:00 p.m. CET – OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) reported its consolidated annual financial results for 2021 and provided an update on key achievements, as well as the Company's outlook for 2022 for its immunotherapies in immuno-oncology and immuno-inflammation.
Dominique Costantini, Chief Executive Officer of OSE Immunotherapeutics, comments: "The company has a diversified product portfolio and relies on several partnership agreements, which are a very important assets providing a foundation for our planned clinical advances in multiple indications. We are very proud of the progress achieved by OSE with, first of all, the results of the Phase 3 Tedopi® trial which showed significant survival benefits versus chemotherapy treatment. Importantly, the non-small cell lung cancer patientsincluded in thistrial had failed second-line checkpoint inhibitor treatments and represent a hard-to-treat patient population with high medical need. Based on these results, we are preparing an early access dossier to be proposed to regulatory Agencies in 2022. We will also present a project of additional Phase 3 trial in patients with secondary resistance after failure with a checkpoint

inhibitor, this one in first line treatment, as this is also an indication that has become the most frequent and with high medical need.
We also announced the clinical advancements, funded by our partner Boehringer Ingelheim, of the anti-SIRPα product BI765063 in an ongoing expansion trial in solid tumors. This follows promising results from the Phase 1 study conducted with BI 765063 as monotherapy and in combination with our partner's anti-PD1 product.
The Phase 2 of anti-IL-7R OSE-127 in Sjögren's disease is also advancing, via our partner Servier, being made in parallel to the Phase 2 trial being conducted by OSE in ulcerative colitis.
We also received a €5 million milestone payment triggered by an IND authorization allowing our recent partner Veloxis to initiate the U.S. clinical development of anti-CD28 FR104 in transplantation.
With regards to our epitope platform, we have shared data verifying that CoVepiT, a multi-target COVID vaccine candidate, induced positive long-term memory T response in a clinical study, and we plan to optimize the most relevant peptidesto be ready for any new pandemic crisis with a novel variant of concern.
The combination of these clinical development advances and financial results strengthens our confidence for the future. We have new "First-in-Class" innovation projects in R&D and we will pursue our licensing agreement strategy which ensures broad development and recurring revenue."
As of December 31, 2021, the turnover amounted to €26 million mainly due to the license agreements and associated milestone payments.
R&D expenses represent 75% of the Company's total expenses.
Available cash amounted to €33.6 million (versus €29.4 million as of December 31, 2020). Considering its current clinical development and R&D programs, this cash should give a financial visibility until Q1 2023 to finance the Company's activities, without including additional revenues from new license agreements and the research tax credit.
Tedopi®, a 10 neoepitope combination to induce specific T-lymphocyte activation: Shared positive final results for Phase 3 clinical trial in non-small cell lung cancer (NSCLC) in secondary resistance, after failure with secondline treatment with checkpoint inhibitors;
Initiated two Phase 2 clinical trials in combination with an immune checkpoint inhibitor, sponsored by investigator groups.
• Positive final results from the 'Atalante-1' Phase 3 study of Tedopi® presented at the 2021 ESMO (European Society for Medical Oncology) conference. The secondary resistance data have shown a significant improvement in overall survival versus a chemotherapy (docetaxel /pemetrexed), a favorable

risk/benefit ratio and a good quality of life in NSCLC patients after secondary resistance to second-line immune checkpoint inhibitors.


New data reflecting expansion and progress on three early-stage programs developed in Immuno-Oncology and Immuno-Inflammation presented at the 2021 AACR (American Association of Cancer Research) and SITC (Society for Immunotherapy of Cancer) annual meetings
*Center for Research in Transplantation and Immunology, UMR1064, INSERM, Nantes University at Nantes University Hospital (CHU).
• An article published in Science Advances is the first peer-reviewed publication to describe an agonist monoclonal antibody (OSE-230) that triggers pro-resolutive mechanisms in macrophages and neutrophils in chronic inflammatory condition. This breakthrough discovery opens the development pathway of OSE-230 in various chronic inflammations such as inflammatory bowel diseases, lung or kidney inflammatory diseases, arthritis and type 1 diabetes. Moreover, the data presented at the AACR meeting revealed for the first time a therapeutic potential of triggering the pro-resolutive pathways using anti-ChemR23 agonistic monoclonal antibodies to limit chronic inflammation in the tumor microenvironment and inhibit metastasis development.

A meeting of the Board of Directors of OSE Immunotherapeutics was held on March 30, 2022. Following the Audit Committee opinion, the Board approved the annual and consolidated financial statements prepared under IFRS on 31 December 2021.
The key figures of the 2021 consolidated annual results are reported below (and presented in the attached tables):
| In K€ | December 31, 2021 | December 31, 2020 |
|---|---|---|
| Current operating result | (16,625) | (18,989) |
| Operating result | (16,625) | (18,989) |
| Net result | (16,850) | (16,555) |
| Available cash* | 33,579 | 29,368 |
| Consolidated balance sheet | 101,876 | 96,973 |
As of December 31, 2021, the Company's available cash* amounted to €33.6 million, versus €29.4 million as of December 31, 2020, providing financial visibility to Q1 2023.
In 2021, OSE secured:
This available cash will be reinforced in Q1 2022 by:
• €5 million milestone payment upon the U.S. IND obtained by Veloxis for FR104 in transplantation.
And in the coming months by:
This available cash will enable the Company to support clinical development and R&D costs for earlier stage products.
During 2021, the Company recorded a consolidated operating loss of - €16.6 million. Current operating expenses were €42.9 million (versus €29.4 million in 2020) of which 75% related to R&D. R&D expenses amounted to €30.6 million.
*Available cash and cash equivalents

OSE Immunotherapeutics is an integrated biotechnology company focused on developing and partnering therapies to control the immune system for Immuno-Oncology and Immuno-Inflammation. Its balanced first-in-class clinical and preclinical portfolio has a diversified risk profile:
Other ongoing combination trials sponsored by cooperative clinical research groups in oncology:
Phase 2 in pancreatic cancer (TEDOPaM), sponsor GERCOR.
Phase 2 in ovary cancer, in combination with pembrolizumab (TEDOVA), sponsor ARCAGY-GINECO.
CoVepiT: a prophylactic second-generation vaccine activating cytotoxic T lymphocytes against COVID-19, developed using optimized epitopes from SARS-CoV2 viral proteins, epitopes non impacted by multi-variants. Shows good tolerance and very good level of T cell immune response. In clinical testing, a long-term memory response was confirmed at 6 months. For more information: https://ose-immuno.com/en/
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| Contacts | |
|---|---|
| OSE Immunotherapeutics | Media |
| Sylvie Détry | U.S. Media: LifeSci Communications |
| [email protected] | Darren Opland, Ph.D. |
| +33 153 198 757 | [email protected] |
| +1 646 627 8387 | |
| Investor Relations | |
| Thomas Guillot | French Media: FP2COM |
| [email protected] | Florence Portejoie |
| +33 607 380 431 | [email protected] |
Guillaume van Renterghem – LifeSci Advisors [email protected] +41 76 735 01 31
This press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics' management in light of its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate.
+33 607 768 283
These forward-looking statements include statements typically using conditional and containing verbs such as "expect", "anticipate", "believe", "target", "plan", or "estimate", their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics' shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forwardlooking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Universal Registration Document filed with the AMF on 15 April 2021, including the annual financial report for the fiscal year 2020, available on the OSE Immunotherapeutics' website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forwardlooking information or statements.

| CONSOLIDATED PROFIT & LOSS | ||||
|---|---|---|---|---|
| P&L IN K€ | December 31, 2021 | December 31, 2020 | ||
| Turnover | 26,306 | 10,418 | ||
| Other operating income | 0 | 13 | ||
| Total Revenues | 26,306 | 10,432 | ||
| Research and development expenses | (30,550) | (22,355) | ||
| Overhead expenses | (8,608) | (4,783) | ||
| Expenses related to shares payments | (3,773) | (2,283) | ||
| OPERATING PROFIT/LOSS - CURRENT | (16,625) | (18,989) | ||
| Other operating products (badwill) | 0 | 0 | ||
| Other operating expenses | 0 | 0 | ||
| OPERATING PROFIT/LOSS | (16,625) | (18,989) | ||
| Financial products | 267 | 31 | ||
| Financial expenses | (856) | (288) | ||
| PROFIT/LOSS BEFORE TAX | (17,213) | (19,246) | ||
| Income Tax | 364 | 2,692 | ||
| NET PROFIT/LOSS | (16,850) | (16,555) | ||
| Of which consolidated net result attributable to shareholders | (16,850) | (16,555) | ||
| Net earnings attributable to shareholders | ||||
| Weighted average number of shares outstanding | 18,154,978 | 15,556,046 | ||
| Basic earnings per share | (0.93) | (1.06) | ||
| Diluted earnings per share | (0.93) | (1.06) |
| IN K€ | 2021 | 2020 |
|---|---|---|
| NET RESULT | (16,850) | (16,555) |
| Amounts to be recycled in the income statement: | ||
| Unrealized gains on securities available for sale, net of tax | ||
| Currency conversion difference | (55) | (4) |
| Amounts not to be recycled in the income statement: | 25 | (3) |
| Other comprehensive income in the period | (29) | (7) |
| GLOBAL PROFIT/LOSS | (16,879) | (16,561) |

| ASSETS IN K€ | December 31, 2021 | December 31, 2020 |
|---|---|---|
| Acquired R&D costs | 51,122 | 52,600 |
| Tangible assets | 926 | 947 |
| Right-of-use assets | 4,513 | 2,848 |
| Financial assets | 936 | 581 |
| Differed tax assets | 173 | 165 |
| TOTAL NON CURRENT ASSETS | 57,670 | 57,141 |
| Trade receivables | 772 | 1,074 |
| Other current assets | 9,854 | 9,390 |
| Tax accounts receivables | 0 | 0 |
| Current financial assets | 0 | 0 |
| Cash and cash equivalents | 33,579 | 29,368 |
| TOTAL CURRENT ASSETS | 44,206 | 39,832 |
| TOTAL ASSETS | 101,876 | 96,973 |
| EQUITY & LIABILITIES IN K€ | December 31, 2021 | December 31, 2020 |
|---|---|---|
| SHAREHOLDERS' EQUITY | ||
| Stated capital | 3,705 | 3,597 |
| Share premium | 38,778 | 38,622 |
| Merger premium | 26,827 | 26,827 |
| Treasury stock | (160) | (93) |
| Reserves and retained earnings | (4,411) | 8,966 |
| Consolidated result | (16,850) | (16,555) |
| TOTAL SHAREHOLDERS' EQUITY | 47,890 | 61,364 |
| NON-CURRENT DEBTS | ||
| Non-current financial liabilities | 30,801 | 16,552 |
| Non-current lease liabilities | 3,965 | 2,318 |
| Non-current deferred tax liabilities | 1,748 | 2,080 |
| Non-current provisions | 710 | 531 |
| TOTAL NON-CURRENT DEBTS | 37,224 | 21,481 |
| CURRENT DEBTS | ||
| Current financial liabilities | 1,611 | 50 |
| Current lease liabilities | 756 | 594 |
| Trade payables | 9,607 | 10,286 |
| Corporate income tax liabilities | 14 | 2 |
| Social and tax payables | 3,724 | 2,108 |
| Other debts and accruals | 1,050 | 1,088 |
| TOTAL CURRENT DEBTS | 16,761 | 14,128 |
| TOTAL LIABILITIES | 101,876 | 96,973 |

| In K€ | December 31, 2021 | December 31, 2020 | |
|---|---|---|---|
| CONSOLIDATED RESULT | (16,850) | (16,555) | |
| +/- | Depreciation, amortization and provision expenses |
2,337 | 424 |
| + | Amortization on "right-of-use" | 687 | 457 |
| +/- | Shares based payments (1) | 2,944 | 1,787 |
| CASH FLOW BEFORE TAX | (10,881) | (13 888) | |
| + | Financial charges | 634 | 273 |
| - | Income tax expenses | (364) | (2,692) |
| - | Tax paid | (332) | (50) |
| +/- | Working capital variation (2) | 1,025 | (2,920) |
| CASH FLOW FROM OPERATING ACTIVITIES (A) | (9,919) | (19,277) | |
| - | Tangible assets increase | (472) | (210) |
| +/- | Financial assets variation | 0 | 0 |
| +/- | Mutual finds units accounted in current financial assets | 0 | 0 |
| +/- | Loans and advances variation | (355) | (294) |
| CASH FLOW FROM INVESTING ACTIVITIES (B) | (827) | (504) | |
| + | Capital increase (including share premium) | 265 | 17,427 |
| +/- | Own shares transactions | ||
| + | Warrant subscription | ||
| + | Loan subscription | 15,281 | 6,960 |
| - | Loan repayment | (40) | (325) |
| - | Lease debt repayment (3) | (549) | (482) |
| - | Financial charges | (273) | |
| CASH FLOW FROM FINANCING ACTIVITIES (C) | 14,957 | 23,306 | |
| +/- | Currency translation transactions (D) | 0 | |
| CASH VARIATION E = (A + B + C + D) | 4,211 | 3,526 | |
| CASH OPENING BALANCE (F) | 29,368 | 25,842 | |
| CASH CLOSING BALANCE (G) | 33,579 | 29,368 | |
| DIFFERENCE: E (G-F) | 0 | 0 |
(1) Warrants and free shares awards granted in 2021 and valuated for 2,944 K€
(2) Mainly explained by:
Decrease of trade receivable for 302 K€ Increase of other current assets for 464 K€
Decrease of trade accounts payable for 679 K€
(3) Explained by IFRS16 application, which corresponds to reimbursement of lease debt for 549 K€
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