Daix (France), Long Island City (New York, USA)
March 11, 2022
– Inventiva (Euronext Paris and Nasdaq: IVA), a biopharmaceutical company specializing in the clinical development of orally administered small molecules for the treatment of non-alcoholic steatohepatitis (NASH) and other diseases with unmet medical need, announces today today have filed its 2021 Universal Registration Document for the financial year ended December 31, 2021, including the management report and the annual financial report, with the Autorité des marchés financiers (AMF) as well as its Annual Report 2021 (“Form 20-F”) for the year ended December 31, 2021 with the “
Securities and Exchange Commission
(SEC) in the United States.
These documents can be consulted on the Company’s website (
www.inventivapharma.com
), section
“Investors”. In addition, the 2021 Universal Registration Document is available on the AMF website (
www.amf-france.org
) and the 2021 Annual Report (“Form 20-F”) is also available on the SEC’s website (
www.sec.gov
).
About Inventiva
Inventiva is a biopharmaceutical company specializing in the research and development of orally administered small molecules for the treatment of NASH and other diseases with significant unmet medical need. The Company has significant experience and expertise in the development of compounds targeting nuclear receptors, transcription factors and epigenetic modulation. 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 NASH, a common and progressive chronic liver disease, for which it there is currently no approved treatment.
The Company entered into a strategic partnership with AbbVie in the field of autoimmune diseases which led to the discovery of the drug candidate cedirogant (ABBV-157), an orally administered RORγ inverse agonist whose efficacy in adult patients with moderate to severe plaque psoriasis is being evaluated in a Phase IIb clinical study conducted by AbbVie. Inventiva’s pipeline also includes odiparcil, a drug candidate for the treatment of adult patients with mucopolysaccharidosis (MPS) type 6. As part of its decision to focus its clinical efforts on the development of lanifibranor, Inventiva has suspended efforts related to odiparcil and is reviewing all possible options to optimize its development. Inventiva is in the process of selecting a drug candidate in oncology for its program in the Hippo signaling pathway.
The Company has a scientific team of approximately 70 people with strong expertise in biology, medicinal and computational chemistry, pharmacokinetics and pharmacology, as well as in clinical development. Inventiva has a chemical library of around 240,000 molecules, of which around 60% are exclusive to the Company, as well as its own laboratories and equipment.
Inventiva is listed on compartment C of the regulated market of Euronext Paris (Euronext Paris: 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, forecasts and estimates with respect to Inventiva’s clinical studies, clinical development plans, development stage, royalty payments and Inventiva’s future activities. Some of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “projects”, “plans”, “seeks”, “estimates”, “may”, “wants” and “continues” and other similar expressions. These statements do not relate to proven historical facts, but constitute projections, estimates and other forward-looking data based on management’s opinions, expectations regarding the potential commercial success and potential revenues of Inventiva’s drug candidates. These statements reflect the opinions and assumptions that were made on the date they were made. They are subject to known and unknown risks and uncertainties that could cause future results, performance or future events to differ materially from those indicated or implied by such statements. Actual events are difficult to predict and may depend on factors beyond Inventiva’s control. With respect to the pipeline of product candidates, there can be no assurance that the results of clinical studies will be available on schedule, that future clinical studies will be launched as planned, or that these candidates will receive the necessary regulatory approvals. .
Actual results may differ from future results described, implied or anticipated in such forward-looking statements due to a number of important factors, including that Inventiva is a clinical-stage company with no approved products and who does not have a history of revenue generated from the sale of products. These factors include, in particular, the significant losses generated since the creation of Inventiva, a limited operating history, the absence of income generated by the sale of Inventiva’s products, the need for additional funds to finance its operations.
Inventiva’s future success also depends on the successful clinical development, receipt of regulatory approvals and subsequent commercialization of its current and future product candidates.
Preclinical studies or prior clinical trials are not necessarily predictive of future results, and the results of Inventiva’s clinical trials may not support the reported benefits of Inventiva’s product candidates. Inventiva may experience significant delays in its clinical trials or Inventiva may fail to demonstrate the safety and efficacy of its products to the relevant regulatory authorities. Recruiting and retaining patients in clinical trials is a time-consuming and costly process that could be made more difficult or impossible by multiple factors beyond Inventiva’s control. Inventiva’s product candidates could cause adverse effects or have other properties that could delay or prevent their regulatory approval, or limit their commercial potential, Inventiva faces significant competition, and the activities, preclinical studies and development programs Inventiva’s clinical development as well as timelines, its financial condition and results of operations could be materially affected by the COVID-19 pandemic and geopolitical events, such as the conflict between Russia and Ukraine, which could delay the initiation, recruitment and completion of Inventiva’s clinical trials on schedule or delaying them. Given these uncertainties, no representation is made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. In addition, 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 ended December 31, 2020 filed with the Autorité des marchés financiers on March 15, 2021, the Annual Report (“Form 20-F”) for the financial year ended December 31, 2020 filed with the Securities and Exchange Commission on March 15, 2021 as well as the annual financial report for the year ended December 31, 2020 for additional information regarding these factors, risks and uncertainties, in addition to the Universal Registration Document for the financial year ended December 31, 2021 which should be filed with the Autorité des marchés financiers on March 11, 2021 and the Annual Report (“Form 20-F”) for the financial year ended December 31 2021 which is expected to be filed with the Securities and Exchange Commission on March 11, 2021.
Subject to applicable regulations, Inventiva makes no commitment to update or revise the information contained in this press release. Inventiva cannot therefore be held responsible for the consequences that may result from the use that would be made of these declarations.
Attachment
Inventiva – URD and 20-F CP – 11.03.2022