This Annual Report on Form 20-F, or annual report, contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, that are based on our management’s beliefs and assumptions and on information currently available to our management. All statements other than present and historical facts and conditions contained in this annual report, including statements regarding our future results of operations and financial positions, business strategy, plans and our objectives for future operations, are forward-looking statements. When used in this annual report, the words “anticipate,” “seek,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “goal,” “intend,” “is designed to,” “may,” “might,” “plan,” “will,” “would,” “potential,” “predict,” “objective,” “should,” “target,” “hopefully,” or the negative of these and similar expressions identify forward-looking statements. Forward-looking statements include, but are not limited to, statements about:
| ● | our plans to research, develop and commercialize our current and future product candidates; |
| ● | the timing, design, duration, recruitment, costs, screening, enrollment and randomization of our planned and ongoing clinical trials; |
| ● | clinical trial data releases and publications and the information and insights that may be gathered from our planned and ongoing clinical trials; |
| ● | the timing of any planned investigational new drug, or IND, application or new drug application, or NDA, and comparable foreign submissions; |
| ● | expectations with respect to the benefits of our existing and future collaborations, including our license agreements with Chia Tai Tianqing Pharmaceutical Group, Co., LTD., or CTTQ, and with Hepalys Pharma, Inc., or Hepalys, on the clinical development, regulatory approvals and, if approved, commercialization of lanifibranor, and the achievement of milestones thereunder and the timing thereof; |
| ● | our ability to successfully cooperate with existing licensees or enter into new collaborations, and to fulfill our obligations under any agreements entered into in connection with such collaborations; |
| ● | potential milestone payments and royalties we may receive under our agreement with Biossil Inc., or Biossil, with respect to the development of odiparcil; |
| ● | the clinical utility, potential benefits and market acceptance of lanifibranor; |
| ● | our ability to identify additional products or product candidates with significant commercial potential; |
| ● | our expectations related to the sufficiency of our capital resources and our ability to continue as a going concern, including our expectations with respect to raising additional funds, executing any potential transactions and achievement of milestones and operating targets; |
| ● | our ability to satisfy in part or full the conditions precedent to closing the third tranche of the structured equity financing of up to €348 million announced on October 14, 2024, or the Structured Financing, and the timing thereof; |
| ● | the potential exercise by the investors of our warrants and pre-funded warrants, including the securities issued or to be issued in connection with the Structured Financing and the warrants issued to the European Investment Bank, or EIB; |
| ● | the expected use of proceeds from any financing transactions, including capital increases, royalty certificates, warrants and debt financing, and our ability to fulfill our obligations under any agreements entered into in connection with such transactions, including our ability to repay debt in a timely manner, or at all; |
| ● | our ability to attract, retain and motivate key personnel and to manage executive succession and organizational changes; |
| ● | the impact of government laws and regulations; |
| ● | the effects of epidemics or pandemics on our business, operations and development timelines and plans; |
| ● | our expectations regarding our ability to obtain, maintain and enforce intellectual property protection for our lanifibranor and our ability to operate our business without infringing, misappropriating or otherwise violating the intellectual property rights of others; |
| ● | our estimates regarding future revenue, expenses, capital requirements and need for additional financing; |
| ● | unfavorable conditions in our industry, the global economy or global supply chain, including financial and credit market fluctuations, tariffs and other trade barriers, international trade relations, political turmoil, natural catastrophes, warfare (such as the conflict involving Russia and Ukraine, the conflict in the Middle East and the related risk of a larger conflict), and terrorist attacks; and |
| ● | other risks and uncertainties, including those listed in this annual report under the caption “Risk Factors.” |
You should refer to the section of this annual report titled “Item 3.D Risk Factors” for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking statements in this annual report will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame or at all. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
You should read this annual report and the documents that we reference in this annual report and have filed as exhibits to this annual report completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements.
This annual report contains market data and industry forecasts that were obtained from industry publications. These data involve a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. We have not independently verified any third-party information. While we believe the market position, market opportunity and market size information included in this annual report is generally reliable, such information is inherently imprecise.
Summary Risk Factors
| ● | We require substantial additional funding, which may not be available to us on acceptable terms, or at all, and failure to obtain this necessary capital when needed may force us to curtail, delay or discontinue our product candidate development efforts or other operations. These factors raise substantial doubt regarding our ability to continue as a going concern. |
| ● | We are a clinical-stage company with no approved products and no historical product revenues, which makes it difficult to assess our future prospects and financial results. |
| ● | We have incurred significant losses since our inception and anticipate that we will continue to incur significant losses for the foreseeable future. We have never generated any revenue from product sales and may never achieve or maintain profitability. |
| ● | We are heavily dependent on the success of our product candidate lanifibranor. We cannot give any assurance that any product candidate will successfully complete clinical trials, receive regulatory approval or be commercialized. |
| ● | The regulatory approval processes of the U.S. Food and Drug Administration, or FDA, the European Commission including the opinion from the European Medicines Agency, or EMA, the Chinese National Medical Products Administration, or NMPA, and other comparable regulatory authorities are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for lanifibranor, our business will be substantially harmed. |
| ● | Clinical development is a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials as well as data from any interim analysis of ongoing clinical trials may not be predictive of future trial results. Clinical failure can occur at any stage of clinical development. |
| ● | We may not realize the benefits expected through the license agreements with CTTQ and Hepalys, and the license agreements could have adverse effects on our business. |
| ● | We currently have no marketing and sales organization. To the extent lanifibranor is approved for marketing, if we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our product candidate, we may not be able to effectively market and sell our product candidate or generate product revenues. |
| ● | We face significant competition for our development efforts, and if we do not compete effectively, our commercial opportunities will be reduced or eliminated. |
| ● | We may encounter substantial delays in our clinical trials or we may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities. |
| ● | We rely completely on third parties to manufacture our pre-clinical and clinical drug supplies and we intend to rely on third parties to produce commercial supplies of any approved product candidate. Manufacturers are subject to significant regulation with respect to manufacturing our products. The manufacturing facilities on which we rely may not continue to meet regulatory requirements and may have limited capacity. |
| ● | The rights of shareholders in companies subject to French corporate law differ in material respects from the rights of shareholders of corporations incorporated in the United States. |
