OSE IMMUNOTHERAPEUTICS This is a translation into English of the Universal Registration Document of the Company issued in French and it is available on the website of the Issuer
OSE Immunotherapeutics
Limited Company (Société anonyme) with a Board of Directors with a capital of €3,780,220.20
Registered office: 22 Boulevard Benoni Goullin 44200 Nantes
479 457 715 Nantes Trade and Companies Register
2022 UNIVERSAL REGISTRATION DOCUMENT INCLUDING THE ANNUAL FINANCIAL REPORT
This Universal Registration Document has been filed on April 28, 2023, with the AMF, as the competent authority and without its
prior approval, in accordance with Article 9 of (EU) Regulation 2017/1129. The Universal Registration Document may be used for
the purposes of a public offer of securities or the admission of securities to trading on a regulated market if it is supplemented by
a securities note and, where applicable, a summary and its supplement (s). The whole is approved by the AMF in accordance with
EU Regulation 2017/1129.
Pursuant to Article 19 of Regulation (EU) No 2017/1129 of the European Parliament and of the Council, the following information is incorporated by reference in this registration document:
- The consolidated financial statements and the corresponding audit reports appearing on pages 190 - 265 of the universal registration document for fiscal year 2021 filed with the AMF on April 15, 22 under No. D22-0298 (https://www.ose-immuno/financial-statements)
- The consolidated financial statements and the corresponding audit reports appearing on pages 173 - 235 of the universal registration document for fiscal year 2020 filed with the AMF on April 15, 2021, under No. D21-0310 (https://www.ose-immuno/financial-statements)
Parts not included in such document(s) are either irrelevant to the investor or covered elsewhere in the registration document or universal registration document.
Copies of this Universal Registration Document are available, on request and free of charge, during normal business hours, at the registered office of OSE Immunotherapeutics, 22 Boulevard Benoni Goullin, 44200 Nantes, and on the Company's website www.ose-immuno.com), as well as on the AMF website (www.amf-france.org).
The information incorporated by reference should be read in accordance with the cross-reference table at the end of this universal registration document. Any information not indicated in this cross-reference table but forming part of the documents incorporated by reference is provided for information purposes only.
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This is a translation into English of the Universal Registration Document of the Company issued in French and it is available on the website of the Issuer
WARNING
This Universal Registration Document and the documents incorporated herein by reference, contain information about the Company's objectives and development areas. This information is sometimes identified by the use of the future or conditional tense and by forward-looking terms such as "consider", "envisage", "think", "aim", "expect", "intend", "should", "aspire", "estimate", "believe", "wish", "may", or, where applicable, the negative form of these same terms, or any other variant or similar terminology.
The reader's attention is drawn to the fact that these objectives and development areas depend on circumstances or events whose occurrence or outcome is uncertain.
These objectives and development areas are not historical data and should not be interpreted as guarantees that the facts and data referenced will occur, that assumptions will be correct or that objectives will be achieved. By their very nature, these objectives may not be achieved and the statements or information appearing in this Universal Registration Document may prove to be erroneous, without the Company in any way being obliged to update them, subject to applicable regulations and, in particular, the French Financial Markets Authority's General Regulation.
Investors are advised to give careful consideration to the risk factors described in section 3 of this Universal Registration Document, "Risk factors", before making any investment decisions. The occurrence of some, or all, of these risks is likely to have a negative impact on the Company's business, financial position, net financial income or its objectives. In addition, other risks that the Company has not yet identified or considers immaterial may have the same negative impact and investors may lose all, or part, of their investment.
This Universal Registration Document also contains information about the Company's business as well as the market and industry in which it operates. This information is primarily taken from studies carried out by internal and external sources (analysts' reports, expert studies, industry publications and any other information published by market research companies, public corporations and bodies). The Company believes that this information gives a true and fair picture of the market and the industry in which it operates and faithfully reflects its competitive position. Although this information is considered to be reliable, it has not been independently verified by the Company and the Company cannot guarantee that a third party using different methods to gather, analyze or calculate this market data would obtain the same results. The Company, the Company's direct or indirect shareholders and investment services providers cannot give any assurances or guarantees as to the accuracy of this information.
The global epidemic of the COVID-19 coronavirus continues to evolve rapidly. The extent to which the COVID-19 coronavirus is likely to affect the Company's business and clinical trials will depend on future developments, which cannot be predicted with certainty, such as the ultimate geographic distribution of the disease, its duration, travel restrictions and social distancing measures in the European Union, the United States and other countries, business closures or disruptions and the effectiveness of measures taken in these countries to contain and treat the disease. In addition, the extent of the adverse impact of this epidemic on the financial markets and on the Company's share price is unknown at this time. As of the date of the Universal Registration Document, the global economy is impacted by the epidemic.
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This is a translation into English of the Universal Registration Document of the Company issued in French and it is available on the website of the Issuer
Summary
1 RESPONSIBLE PERSONS, THIRD-PARTY INFORMATION, EXPERTS' REPORTS AND APPROVAL FROM THE COMPETENT
AUTHORITY | 10 | ||
1.1 | PERSON RESPONSIBLE FOR THE UNIVERSAL REGISTRATION DOCUMENT | 10 | |
1.2 | STATEMENT BY THE PERSON RESPONSIBLE FOR THE UNIVERSAL REGISTRATION DOCUMENT | 10 | |
1.3 | STATEMENT BY A PERSON ACTING AS AN EXPERT IN RESPECT OF THIS DOCUMENT | 10 | |
1.4 | THIRD-PARTYINFORMATION | 10 | |
1.5 | APPROVAL OF THE UNIVERSAL REGISTRATION DOCUMENT | 10 | |
2 | AUDITORS | 11 | |
2.1 | STATUTORY AUDITORS | 11 | |
2.2 | INFORMATION ON AUDITORS THAT HAVE RESIGNED, BEEN REMOVED OR NOT BEEN REAPPOINTED | 11 | |
3 | RISK FACTORS | 12 | |
3.1 | RISKS LINKED TO THE DEVELOPMENT OF OUR DRUG CANDIDATES | 14 | |
3.1.1 Risks linked to product development | 14 | ||
3.1.2 Risks linked to the completion of the clinical and preclinical phases of its products in development | 15 |
3.1.3 Risks of sub-contractor default (in particular those linked to clinical study outsourcing and product manufacturing) 17
3.1.4 Risk of dependency or operational delay in relation to programs under development | 19 | ||
3.1.5 Risks linked to the immuno-therapeutic approaches selected by the Company | 21 | ||
3.2 | RISKS LINKED TO THE PARTNERSHIP STRATEGY | 25 | |
3.2.1 Risks linked to research and dependency on current and future partnerships | 25 | ||
3.2.2 Risks linked to potential conflicts could affect the Company's relationship with its licensees | 29 | ||
3.3 | RISKS LINKED TO MARKETING | 29 | |
3.3.1 Risks linked to obtaining a Marketing Authorization (MA) | 29 | ||
3.3.2 Risks linked to the lack of commercial success of the products | 30 | ||
3.3.3 Risks linked to changes in drug reimbursement policies | 31 | ||
3.4 | RISKS LINKED TO INTELLECTUAL PROPERTY RIGHTS | 31 | |
3.4.1 Risks linked to uncertain protection of patents and other intellectual property rights | 31 | ||
3.4.2 Risks linked to legal liability, in particular product liability risks | 32 | ||
3.4.3 Risks linked to patents and intellectual property rights held by third parties | 33 | ||
3.5 | RISKS LINKED TO CAPITAL REQUIREMENTS | 33 | |
3.5.1 Risks linked to uncertain additional funding | 33 | ||
3.5.2 Risks linked to the availability of public grants and research tax credits | 37 | ||
3.5.3 Valuation of intangible assets and impairment tests | 37 | ||
3.6 | RISK LINKED TO THE CONTROL SYSTEM FOR FOREIGN INVESTORS IN FRANCE | 37 | |
3.7 | INSURANCE AND RISK COVERAGE | 38 | |
3.8 | EXCEPTIONAL EVENTS AND LITIGATION | 39 | |
4 | INFORMATION ABOUT THE ISSUER | 40 | |
4.1 | COMPANY NAME | 40 | |
4.2 | PLACE OF REGISTRATION AND REGISTRATION NUMBER | 40 | |
4.3 | DATE AND TERM OF INCORPORATION | 40 | |
4.4 | REGISTERED OFFICE, LEGAL FORM AND LEGISLATION | 40 |
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This is a translation into English of the Universal Registration Document of the Company issued in French and it is available on the website of the Issuer
5 BUSINESS OVERVIEW | 41 | |
5.1 | PRINCIPAL ACTIVITIES | 41 |
5.1.1 Proprietary products in clinical development | 41 | |
5.1.2 Clinical products developed in partnership | 51 | |
5.1.3 Myeloid Platform | 61 | |
5.1.2 | Research and Development | 64 |
5.2 | PRINCIPAL MARKETS | 65 |
5.2.1 | Immuno-oncology market | 65 |
5.2.2 | Immuno-inflammatory disease market | 67 |
5.2.3 | Renal Transplant Market | 67 |
5.2.4 | Chronic Inflammation Market | 68 |
5.3 | IMPORTANT EVENTS IN THE DEVELOPMENT OF THE COMPANY'S BUSINESS | 68 |
5.4 | STRATEGY AND OBJECTIVES | 71 |
5.4.1 | A dynamic partnership development strategy based on a portfolio of innovative products | 72 |
5.4.2 | Clinical development of proprietary products | 73 |
5.4.3 Research & Development: active pursuit of new innovative research programs, proprietary research platforms,
evolution of the product portfolio to clinical phase | 74 | |
5.5 | RESEARCH & DEVELOPMENT, PATENTS AND LICENSES | 75 |
5.5.1 | Industrial property | 75 |
5.5.2 Brands and domain names | 94 | |
5.6 | COMPETITIVE POSITION | 94 |
5.6.1 Non-small cell lung cancer treatments | 94 | |
5.6.2 Existing second-line therapies for advanced lung cancer and choice of comparator for Phase 3 | 96 | |
5.6.3 | Immuno-Inflammation | 100 |
5.7 | INVESTMENTS | 108 |
5.7.1 Key investments made by the Company | 108 | |
5.7.2 | Future key investments | 109 |
5.7.3 Information on joint ventures or companies in which the Company holds a capital share likely to have a significant
impact on the valuation of its assets and liabilities, its financial position or results | 109 | ||
5.7.4 Environmental impacts of investments made by the Company | 109 | ||
6 | ORGANIZATIONAL STRUCTURE | 110 | |
6.1 | OVERVIEW OF THE COMPANY | 110 | |
6.2 | SUBSIDIARIES AND INVESTMENTS | 110 | |
7 | REVIEW OF THE FINANCIAL POSITION AND RESULTS | 112 | |
7.1 | FINANCIAL POSITION | 112 | |
7.2 | OPERATING PROFIT | 113 | |
7.2.1 Key factors affecting operating revenues | 113 | ||
7.2.2 Explanation of material changes in revenue or net income in the comparative annual financial statements | 114 | ||
8 | CAPITAL RESOURCES | 115 | |
8.1 | INFORMATION ON THE ISSUER'S CAPITAL | 115 | |
8.2 | CASH FLOWS | 116 | |
8.2.1 Statement of cash flows | 116 |
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This is a translation into English of the Universal Registration Document of the Company issued in French and it is available on the website of the Issuer
8.3 | FINANCING REQUIREMENTS AND STRUCTURE | 117 |
8.3.1 | Financing requirements | 117 |
8.3.2 | Financing structure | 117 |
8.4 RESTRICTIONS ON THE USE OF CAPITAL RESOURCES THAT HAVE MATERIALLY AFFECTED, OR COULD MATERIALLY AFFECT, DIRECTLY OR INDIRECTLY, THE
ISSUER'S OPERATIONS | 121 | |
8.5 | EXPECTED FINANCING SOURCES | 121 |
9 REGULATORY ENVIRONMENT | 122 | |
9.1 | INTRODUCTION | 122 |
9.2 | PRECLINICAL STUDIES | 122 |
9.3 | CONDUCT AND REGULATION OF CLINICAL TRIALS | 123 |
9.3.1 Clinical trial authorization in the European Union | 123 | |
9.3.2 Authorization of clinical trials in the United States | 125 | |
9.3.3 Publication of information on clinical trials | 125 | |
9.4 | REGULATION OF MARKETING AUTHORIZATIONS | 125 |
9.4.1 | Community procedures | 125 |
9.4.2 Registration procedures outside the EU | 126 | |
9.4.3 Exceptions to the usual registration procedures | 127 | |
9.4.4 | Orphan drugs | 128 |
9.5 | FRENCH SUNSHINE ACT - TRANSPARENCY OF INTERESTS | 128 |
10 | INFORMATION ON TRENDS | 130 |
10.1 | MAIN TRENDS SINCE THE END OF THE LAST FISCAL YEAR | 130 |
10.2 TRENDS, UNCERTAINTIES, DEMANDS, COMMITMENTS OR EVENTS THAT ARE REASONABLY LIKELY TO HAVE A MATERIAL EFFECT ON THE COMPANY'S
PROSPECTS | ....................................................................................................................................................................................... | 134 |
11 | PROFIT/(LOSS) FORECASTS OR ESTIMATES | 135 |
12 | ADMINISTRATIVE, MANAGEMENT AND SUPERVISORY BODIES, AND SENIOR MANAGEMENT | 136 |
12.1 | MANAGEMENT AND DIRECTORS | 136 |
12.1.1 | Composition of the Board of Directors | 136 |
12.1.2 | Composition of the operational management team | 139 |
12.1.3 | Disclosures about the Management team and directors | 140 |
12.2 | POTENTIAL CONFLICTS OF INTEREST OF THE MEMBERS OF THE BOARD OF DIRECTORS AND EXECUTIVE MANAGEMENT | 141 |
13 | COMPENSATION AND BENEFITS | 142 |
13.1 | TOTAL GROSS COMPENSATION FOR MEMBERS OF THE BOARD OF DIRECTORS AND EXECUTIVE MANAGEMENT | 142 |
13.2 | AMOUNTS PROVISIONED OR RECOGNIZED BY THE COMPANY FOR THE PURPOSE OF PAYING PENSIONS, RETIREMENT OR OTHER BENEFITS | 151 |
14 | OPERATING PROCEDURES OF THE ADMINISTRATIVE AND MANAGEMENT BODIES | 152 |
14.1 | OPERATING PROCEDURES AND TERMS OF OFFICE OF THE MEMBERS OF THE BOARD OF DIRECTORS AND EXECUTIVE MANAGEMENT | 152 |
14.1.1 | Board of Directors (Articles 19 to 22 of the bylaws) | 153 |
14.1.2 | Executive Management (Articles 23 to 26 of the bylaws) | 156 |
14.2 INFORMATION ON THE SERVICE CONTRACTS BETWEEN THE MEMBERS OF THE BOARD OF DIRECTORS AND THE EXECUTIVE MANAGEMENT AND THE
COMPANY OR ONE OF ITS SUBSIDIARIES | 157 |
14.2.1 Agreements between the Company, a director, the Chief Executive Officer or a Deputy Chief Executive Officer..157
14.3 COMMITTEES | 157 | |
14.3.1 | Audit Committee | 158 |
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Disclaimer
OSE Immunotherapeutics SA published this content on 25 July 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 25 July 2023 08:24:08 UTC.
