To the Board of Directors of GeNeuro SA
Chemin du Pré-Fleuri 3 1228 Plan-les-Ouates Switzerland
28 April 2023
Dear Sirs,
We hereby give our consent to the inclusion or, as applicable, incorporation by reference in the Universal Registration Document (Document d'Enregistrement Universel) dated 28 April 2023 and filed by GeNeuro SA with the Autorité des Marchés Financiers ("AMF") of:
- our auditors' report dated 28 April 2023 on the consolidated financial statements of GeNeuro SA as of and for the year ended 31 December 2022 included in section 18.3.1 of the Universal Registration Document, in the form and context in which it is included, as shown in the enclosed proof of the Universal Registration Document which we have signed for identification;
- our auditors' report dated 28 April 2023 on the financial statements of GeNeuro SA as of and for the year ended 31 December 2022 included in section 23 of the Universal Registration Document, in the form and context in which itis included, as shown in the enclosed proof of the Registration Document which we have signed for identification;
- our auditors' report dated 28 April 2023 on the remuneration report of GeNeuro SA for the year ended 31 December 2022 included in section 13.5 of the Universal Registration Document, in the form and context in which it is included, as shown in the enclosed proof of the Registration Document which we have signed for identification;
This letter is provided solely for the use of GeNeuro SA for the purpose of enabling the Chief Executive Officer and Chief Financial Officer of GeNeuro SA to comply with article 212-15 of the Règlement général of the AMF in connection with the Universal Registration Document of GeNeuro SA approved by the AMF and may not be provided to any third party without our written consent. In this respect however, we consent that this letter be provided to the AMF in accordance with article 212-15 of the Règlement général, on the understanding that we accept no additional or new responsibility or liability toward sthe AMF or towards any other third party to whom this letter may be provided or into whose hands it may come.
In giving this consent we have performed the procedures required by ISA 720 - The Auditor's Responsibility Relating to Other Information in Documents Containing Audited Financial Statements, issued by the International Auditing and Assurance Standards Board in connection with the Universal Registration Document.
Yours faithfully,
PricewaterhouseCoopers SA
Luc Schulthess | Adelina Todorova |
Licensed audit expert | |
Auditor in charge |
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A Swiss joint stock company (société anonyme) with share capital of 1,249,951.40 Swiss francs
Registered and principal office: 3 chemin du Pré-Fleuri - 1228 Plan-les-Ouates - Geneva - Switzerland
CHE-112.754.833Registre du commerce (commercial register) of Geneva
2022
UNIVERSAL REGISTRATION DOCUMENT
including the Annual Financial Report
This Universal Registration Document was filed on April 28, 2023 with the Autorité des marchés financiers ("AMF") as competent authority under Regulation (EU) 2017/1129, without prior approval in accordance with Article 9 of the said Regulation.
This Universal Registration Document may be used for the purpose of an offer to the public of securities or the admission of securities to trading on a regulated market if it is supplemented by a securities note and, if applicable, by a summary and any amendments made to the Universal Registration Document. These documents are being together approved by the AMF in accordance with Regulation (EU) 2017/1129.
Copies of this Universal Registration Document are available at no cost at the headquarters of GeNeuro SA (3 chemin du Pré-Fleuri - 1228 Plan-les-Ouates / Geneva - Switzerland), as well as electronically on the GeNeuro website (www.geneuro.com) or on the AMF website (www.amf-france.org).
Luc Schulthess | Adelina Todorova |
Licensed audit expert | |
Auditor in charge | |
Geneva, Switzerland, April 28 2023 |
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GeNeuro SA - 2022 Universal Registration Document
GENERAL OBSERVATIONS
Unless otherwise indicated, in this universal registration document (the "Universal Registration Document") the terms "Company" or "GeNeuro" mean GeNeuro SA and the term "Group" means the Company and its subsidiaries GeNeuro Innovation SAS ("GeNeuro Innovation"), in France.
This Universal Registration Document was prepared pursuant to Annex 1 and Annex 2 of the delegated regulation (EU) 2019/980 of the Commission of 14 March 2019 which complements Regulation (EU) 2017/2019 of the European Parliament and Counsel and, pursuant to article 19 of the Regulation (EU) 2017/1129, incorporates by reference (i) the Company's consolidated financial statements for the year ended December 31, 2021, prepared in accordance with IFRS, and the auditors' report related thereto presented in section 18.3 of the Universal Registration Document filed with the AMF on April 27, 2022 and (ii) the Company's consolidated financial statements for the year ended December 31, 2020, prepared in accordance with IFRS, and the auditors' report related thereto presented in section 18.3 of the Universal Registration Document filed with the AMF on April 30, 2021.
This Universal Registration Document contains statements about the Group's objectives. These statements are sometimes identified by the use of the future tense, the conditional tense, and expressions with forward-looking character, such as "think," "has as an objective," "expects," "intends," "should," "with the ambition of," "consider," "believe," "wish," "could," etc. This information is based on data, assumptions, and estimates considered reasonable by the Company. They may change or be changed because of uncertainties related to any business as well as to the economic, financial, competitive and regulatory environment.
Furthermore, the achievement of the Group's objectives assumes the success of its strategy, which is set forth in Section 5.1.2 of the Universal Registration Document. The Company can make no commitment or give any assurance that the objectives set forth in this Universal Registration Document will be achieved.
Investors are urged to give consideration to the risk factors set forth in Chapter 3 "Risk Factors" of this Universal Registration Document before making their investment decision. The occurrence of such risks could have a negative effect on the Group's business, financial condition, results of operations, or prospects. Furthermore, other risks, not presently identified or not considered material by the Company, could have the same negative effect, and investors could lose all or part of their investment.
This Universal Registration Document also contains information about the markets in which the Group competes, some of which information was obtained from sources external to the Company. Unless otherwise indicated, the information relating to the markets in which the Group competes or its competitive position contained in this Universal Registration Document comes from the Company's internal estimates. These internal estimates are based on reports of analysts, specialized studies, industry publications, any and all information published by market survey companies, and public and governmental sources, as well as internal knowledge of the market by the Company. Even though such information is considered reliable, it has not been independently verified by the Company. Furthermore, in light of the very rapid changes occurring in France, in the world, and in the industry in which the Group competes, it is possible that such information may prove erroneous or not be up to date. The Group's business, accordingly, could evolve in a different way from the one described in this Universal Registration Document. The Company has not committed or agreed to publish any update of the information contained herein, except in connection with any legal or regulatory obligation that may apply to it.
A glossary that contains definitions of certain technical terms used in this Universal Registration Document, as well as an index of abbreviations used, are set forth in Appendix of this Universal Registration Document.
A reconciliation table with the Annual Financial Report is located at the end of this Universal Registration Document.
This Universal Registration Document has been prepared on the basis of the Company's annual consolidated financial statements for the financial years ending December 31, 2021 and 2022.
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GeNeuro SA - 2022 Universal Registration Document
TABLE OF CONTENTS | |||
CHAPTER 1. | PERSONS RESPONSIBLE FOR THIS UNIVERSAL REGISTRATION DOCUMENT | 6 | |
1.1 | Person Responsible For The Universal Registration Document | 6 | |
1.2 | Certificate Of The Person Responsible For The Universal Registration Document | 6 | |
1.3 | Information From Third Parties, Experts' Statements or Reports | 6 | |
1.4 | Declaration relating to the registration document | 6 | |
1.5 | Person Responsible For The Financial Information | 6 | |
1.6 | Indicative Timetable for Financial Communication | 6 | |
CHAPTER 2. | STATUTORY AUDITORS OF THE FINANCIAL STATEMENTS | 7 | |
2.1 | Principal Statutory Auditor | 7 | |
2.2 | Subsidiary Statutory Auditor | 7 | |
CHAPTER 3. | RISK FACTORS | 8 |
3.1 Risks Related To The Development and Potential Future Commercialization of The Group's Product
Candidates | 9 | |
3.2 | Risks Related To The Company's Financial Situation and Capital Needs | 16 |
3.3 | Risks Related To The Company, Its Operations and Organization | 20 |
3.4 | Risks Related To The Company's Dependency on Third Parties | 21 |
3.5 | Risks Relating To The Company's Intellectual Property Rights | 23 |
CHAPTER 4. INFORMATION ABOUT THE COMPANY AND THE GROUP | 25 | |
4.1 | History And Development Of The Company And The Group | 25 |
CHAPTER 5. DESCRIPTION OF THE GROUP'S BUSINESS | 30 | |
5.1 | General Presentation | 30 |
5.2 | Temelimab: Clinical Development as of the Date Hereof | 37 |
5.3 | Continued Clinical Development in MS | 50 |
5.4 | Long-COVID | 50 |
5.5 | The HERV Platform in other indications | 52 |
5.6 | Research And Development and Intellectual Property | 58 |
5.7 | Organization of the Company | 76 |
5.8 | Material Events having an Impact on the Information set forth in Sections 5.1 to 5.3 | 78 |
5.9 Degree of the Company's Dependence on Patents, Licenses, Manufacturing and Commercial or Financial
Agreements or new Manufacturing Processes | 78 | |
5.10 | Factual Basis for any Statement by the Company about its Competitive Position | 78 |
5.11 | Investments | 78 |
CHAPTER 6. ORGANIZATION CHART | 79 | |
6.1 | Organization | 79 |
6.2 | Subsidiaries And Equity Stakes | 79 |
6.3 | Restructurings | 79 |
CHAPTER 7. ANALYSIS OF FINANCIAL CONDITION AND RESULTS | 80 | |
7.1 | Financial Condition | 80 |
7.2 | Comparison Of The Financial Statements For The Two Years Ended December 31, 2022 and 2021 | 84 |
7.3 | Group's Market Risks | 89 |
CHAPTER 8. CASH AND EQUITY | 90 | |
8.1 | Information About Equity, Liquidity, And Sources Of Funds | 90 |
8.2 | Description Of The Group's Cash Flows | 92 |
8.3 | Borrowing Conditions And Financing Structure | 93 |
8.4 Information About Any Restriction On The Use Of Funds Significantly Influencing, Or Potentially Influencing,
The Group's Business, Directly Or Indirectly | 93 | |
8.5 | Sources Of Funds Expected For Future Investments | 93 |
8.6 | Off-Balance Sheet Commitments | 94 |
CHAPTER 9. REGULATORY ENVIRONMENT | 95 | |
9.1 | In the United States | 95 |
9.2 | In the European Union | 101 |
9.3 | Registration procedures outside of Europe and the United States | 102 |
9.4 | Reimbursement | 102 |
9.5 | Other Healthcare Laws and Compliance Requirements in the United States | 104 |
9.6 | Data protection Rules in Europe | 105 |
CHAPTER 10. INFORMATION ON TRENDS | 106 |
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GeNeuro SA - 2022 Universal Registration Document
10.1 | Recent Changes Since The End Of Financial Year 2022 | 106 |
10.2 Known Trends, Uncertainties, Requests For Commitment Or Event Reasonably Likely To Influence The
Company's Prospects | 106 | |
CHAPTER 11. | FORECASTS OR ESTIMATES OF PROFIT OR LOSS | 107 |
CHAPTER 12. | ADMINISTRATIVE, MANAGEMENT, SUPERVISORY, AND SENIOR MANAGEMENT BODIES | 108 |
12.1 | Members Of The Administration, Management, And Supervisory Bodies | 108 |
12.2 | Conflicts Of Interest In The Administration, Management, And Supervisory Bodies | 114 |
CHAPTER 13. | COMPENSATION AND BENEFITS | 115 |
13.1 Compensation And Benefits Of Any Kind Granted To Executive Officers And Members Of The
Administrative, Management, And Supervisory Bodies | 115 |
13.2 Amounts Provisioned By The Company And Its Subsidiary For Payment Of Pensions, Retirement, Or Other
Benefits To Executives | 119 | |
13.3 | Loans And Guarantees Granted To Executives | 119 |
13.4 | Legal Framework Relating To Compensation | 120 |
13.5 | 2022 Remuneration Report | 124 |
CHAPTER 14. OPERATION OF ADMINISTRATION AND MANAGEMENT BODIES OF THE COMPANY | 133 | |
14.1 | Organization And Operation Of The Company's Management And Administrative Bodies | 133 |
14.2 Agreements Between Members Of Administration Or Management Bodies And The Company Or Any Of
Its Subsidiaries | 135 | ||
14.3 | Operation Of Committees | 135 | |
14.4 | Statement Regarding Company Governance | 138 | |
14.5 | Internal Control And Company Governance | 140 | |
CHAPTER 15. EMPLOYEES | 142 | ||
15.1 | Human Resources | 142 | |
15.2 | Profit Sharing And Participation Of Employees | 142 | |
CHAPTER 16. PRINCIPAL SHAREHOLDERS | 143 | ||
16.1 | Identification Of Shareholders | 143 | |
16.2 | Shareholder Voting Rights | 144 | |
16.3 | Shareholders' Agreements, Lock-Up Obligations, And Concerted Action | 144 | |
16.4 | Control Of The Company | 144 | |
16.5 | Agreements That Could Cause A Change Of The Company's Control | 144 | |
CHAPTER 17. TRANSACTIONS WITH RELATED PARTIES | 145 | ||
17.1 | Intragroup Agreements | 145 | |
17.2 | Transactions With Related Parties | 145 | |
17.3 | Special Reports Of Auditors | 145 | |
CHAPTER 18. INFORMATION REGARDING THE COMPANY'S | ASSETS, | FINANCIAL SITUATION AND | |
RESULTS | 146 | ||
18.1 | Historical Financial Information | 146 | |
18.2 | Pro Forma Financial Information | 146 | |
18.3 | Financial Statements | 146 | |
CHAPTER 19. ADDITIONAL INFORMATION | 187 | ||
19.1 | Equity Capital | 187 | |
19.2 | Articles Of Association | 189 | |
CHAPTER 20. MATERIAL AGREEMENTS | 195 | ||
CHAPTER 21. DOCUMENTS AVAILABLE TO THE PUBLIC | 196 | ||
CHAPTER 22. INFORMATION ON INVESTMENTS | 196 | ||
CHAPTER 23. ANNUAL ACCOUNTS FOR THE YEAR ENDED DECEMBER 31, 2022 | 197 | ||
CHAPTER 24. RESOLUTIONS TO BE SUBMITTED TO THE | JUNE 14, | 2023, | ANNUAL GENERAL |
SHAREHOLDERS' MEETING | 214 | ||
Appendix | ................................................................................................................................................................. | 215 | |
Annual Financial Report Cross-reference Table | 217 |
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GeNeuro SA - 2022 Universal Registration Document
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GeNeuro SA published this content on 28 April 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 01 May 2023 08:47:07 UTC.