Daix (France), Long Island City (New York, United States), April 3, 2024
– Inventiva (Euronext Paris and Nasdaq: IVA) (the “Company”), a biopharmaceutical company specializing in the clinical development of orally administered small molecules for the treatment of steatohepatitis associated with metabolic dysfunction (MASH), or NASH, and other diseases with an unmet medical need, today announces that it has filed its 2023 Universal Registration Document for the financial year ending December 31, 2023, including the management report and the annual financial report, with the Financial Markets Authority (the AMF) as well as its 2023 Annual Report (“Form 20-F”) for the financial year ended December 31, 2023 with the “
Securities and Exchange Commission
» (SEC) in the United States.
These documents can be consulted on the Company’s website (
www.inventivapharma.com
), “Investors” section. In addition, the 2023 Universal Registration Document is available on the AMF website (
www.amf-france.org
) and the 2023 Annual Report (“Form 20-F”) is also available on the SEC website (
www.sec.gov
).
About Inventiva
Inventiva is a biopharmaceutical company focused on the research and development of orally administered small molecules for the treatment of patients with MASH/NASH, mucopolysaccharidoses (“MPS”) and other diseases with significant unmet medical needs. The Company has significant experience and expertise in the development of compounds targeting nuclear receptors, transcription factors and epigenetic modulation. Inventiva is currently developing a clinical candidate, has a pipeline of two preclinical programs and continues to explore additional development opportunities to expand its portfolio.
Lanifibranor, Inventiva’s most advanced drug candidate, is currently being evaluated in the pivotal Phase III NATiV3 clinical study for the treatment of adult patients with MASH/NASH, a common and progressive chronic liver disease, for for which there is currently no approved treatment.
Inventiva’s portfolio also includes odiparcil, a drug candidate for the treatment of adult patients suffering from MPS type VI. As part of its decision to focus its clinical efforts on the development of lanifibranor, Inventiva has suspended its clinical efforts relating to odiparcil and is reviewing all available options to optimize its development. Inventiva is also in the process of selecting a drug candidate as part of its program dedicated to the Hippo signaling pathway.
The Company has a scientific team of approximately 90 people with strong expertise in biology, medicinal and computational chemistry, pharmacokinetics and pharmacology as well as clinical development. Inventiva has a chemical library of approximately 240,000 molecules, approximately 60% of which are exclusive to the Company, as well as its own laboratories and equipment.
Inventiva is a company listed on compartment B of the regulated market of Euronext Paris (symbol: IVA – ISIN: FR0013233012) and on the Nasdaq Global Market in the United States (symbol: IVA). www.inventivapharma.com
Contacts
Warning
This press release contains forward-looking statements. All statements, other than statements of historical facts, contained in this press release are forward-looking statements. These statements include, without limitation, forecasts regarding Inventiva’s preclinical programs and clinical trials, including the design, duration, timing, recruitment costs, selection and recruitment for such trials, do not are not limited to these statements, including the ongoing phase III trial with lanifibranor in patients with MASH/NASH, releases and publications on clinical trial data, information, ideas and impacts that may be gathered from the clinical trials, the potential therapeutic benefits of Inventiva’s product candidates, including lanifibranor, the potential of lanifibranor to meet patient needs, the estimated size of the market and patient population, regulatory submissions potential, approvals and commercialization, Inventiva’s pipeline and preclinical and clinical development plans, potential development and regulatory pathway for odiparcil, and future activities, expectations, plans, growth and prospects from Inventiva. Some of these statements, forecasts and estimates may be identified by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “projects”, “plans”, “seeks”, “estimates”, “may”, “will”, “could”, “should”, “designed”, “hopes”, “target”, “aims” and “continue” and other similar expressions. These statements are not historical facts but rather statements of future expectations and other forward-looking statements based on management’s beliefs. These statements reflect the opinions and assumptions held on the date on which they were made and are subject to known or unknown risks and uncertainties from which future results, performance or future events may differ materially from those which are stated. indicated or implied in these statements. Future events are difficult to predict and may depend on factors that are beyond Inventiva’s control. With regard to the portfolio of product candidates, it cannot under any circumstances be guaranteed that the results of clinical studies will be available within the planned timeframe, that future clinical studies will be launched as planned, that these candidates will receive the necessary regulatory approvals, or that any of the milestones anticipated by Inventiva or its partners will be achieved within the expected time frame, or will be achieved at all. Actual results achieved may differ materially from any anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates, due to a number of factors, including that Inventiva cannot provide any guarantee on the final impact of the Suspected Unexpected Serious Adverse Reaction (SUSAR) on the recruitment and on the results or schedule of the NATiV3 trial or on the regulatory issues relating thereto, that Inventiva is a company in phase clinical stage without approved products and without historical product revenues, Inventiva has suffered significant losses since its inception, including that Inventiva is a clinical stage company which has no approved products and which does not have a history of revenue generated from the sale of products. Inventiva has incurred significant losses since its inception, has a limited operating history and has never generated revenue from product sales. Inventiva will require additional capital to finance its operations, otherwise Inventiva may be required to significantly reduce, delay or discontinue one or more of its research or development programs, or be unable to expand its activities or take advantage of its business opportunities, and may be unable to continue its activities. Inventiva’s future success also depends on the successful completion of clinical development, receipt of regulatory approvals and subsequent commercialization of its current and future product candidates. Prior preclinical studies or clinical trials are not necessarily predictive of future results and the results of Inventiva’s and its partners’ clinical trials may not confirm the reported benefits of Inventiva’s product candidates. Inventiva’s expectations regarding its clinical trials may prove to be incorrect and regulatory authorities may require additional suspensions and/or additional modifications to Inventiva’s clinical trials, Inventiva’s expectations regarding anticipated changes to the clinical development plan of lanifibranor for the treatment of MASH/NASH may not come to fruition and may not support approval of a new drug application. Inventiva and its partners may experience significant delays that exceed its expectations in its clinical trials or may fail to demonstrate the safety and effectiveness of its products to relevant regulatory authorities. Recruiting and retaining patients in clinical trials is a lengthy and costly process that could be made more difficult or impossible by multiple factors beyond the control of Inventiva and its partners. Inventiva’s product candidates could cause adverse reactions or have other properties that could delay or prevent their regulatory approval, or limit their commercial potential, Inventiva and its partners face significant competition and the activities, preclinical studies and Inventiva’s clinical development programs and schedules, financial condition and results of operations could be materially affected by geopolitical events, such as the conflict between Russia and Ukraine, and the state of war between Israel and Hamas and the risk of a broader conflict, relating to sanctions and the impacts and potential impacts on the launch, recruitment and finalization of clinical trials of Inventiva and its partners on schedule, epidemics, crises health and macroeconomic conditions, including overall inflation, increasing interest rates, financial market uncertainty and disruptions in banking systems. Given these risks and uncertainties, no representation is made as to the accuracy or appropriateness of these forward-looking statements, forecasts and estimates.
Furthermore, forward-looking statements, forecasts and estimates speak only as of the date of this release. Readers are therefore cautioned not to place undue reliance on these forward-looking statements. We invite you to refer to the Universal Registration Document for the financial year ending December 31, 2023 filed with the Financial Markets Authority on April 3, 2024, and the Annual Report (“Form 20-F”) for financial year ended December 31, 2023 filed with the Securities and Exchange Commission on April 3, 2024. Other risks and uncertainties of which Inventiva is not currently aware may also affect its forward-looking statements and may cause actual results and the timing of events differ significantly from those anticipated. All information contained in this press release is as of the date of the release. Except as required by law, Inventiva does not intend and has no obligation to update or revise any forward-looking statements referred to above. Therefore, Inventiva accepts no liability for any consequences arising from the use of any of the above statements.
Attachment
Inventiva – CP – URD and 20-F – FR – 03 04 2024