Daix (France), Long Island City (New York, United States), April 3, 2024 -
Inventiva (Euronext Paris and Nasdaq: IVA) (the "Company"), a clinical-stage
biopharmaceutical company focused on the development of oral small molecule
therapies for the treatment of metabolic dysfunction-associated steatohepatitis
("MASH"), also known as non-alcoholic steatohepatitis ("NASH"), and other
diseases with significant unmet medical needs, today announced that it had filed
its 2023 Universal Registration Document for the year ended December 31, 2023,
including the management report and the annual financial report, with the French
"Autorité des Marchés Financiers" ("AMF") and its 2023 Annual Report on Form 20-
F for the year ended December 31, 2023 with the U.S. Securities and Exchange
Commission ("SEC").
These documents can be accessed on the "Investors" section of the Company's
corporate website (www.inventivapharma.com (http://www.inventivapharma.com)). In
addition, the 2023 Universal Registration Document is available on the website
of the AMF (www.amf-france.org (http://www.amf-france.org)) and the 2023 Annual
Report on Form 20-F is also available on the website of
the SEC (www.sec.gov (http://www.sec.gov)).
About Inventiva
Inventiva is a clinical-stage biopharmaceutical company focused on the research
and development of oral small molecule therapies for the treatment of patients
with MASH/NASH, and other diseases with significant unmet medical need. The
Company benefits from a strong expertise and experience in the domain of
compounds targeting nuclear receptors, transcription factors and epigenetic
modulation. Inventiva is currently advancing one clinical candidate, has a
pipeline of two preclinical programs and continues to explore other development
opportunities to add to its pipeline.
Inventiva's lead product candidate, lanifibranor, is currently in a pivotal
Phase III clinical trial, NATiV3, for the treatment of adult patients with
MASH/NASH, a common and progressive chronic liver disease for which there are
currently no approved therapies.
Inventiva's pipeline also includes odiparcil, a drug candidate for the treatment
of adult MPS VI patients. As part of Inventiva's decision to focus clinical
efforts on the development of lanifibranor, it suspended its clinical efforts
relating to odiparcil and is reviewing available options with respect to its
potential further development. Inventiva is also in the process of selecting a
candidate for its Hippo signaling pathway program.
The Company has a scientific team of approximately 90 people with deep expertise
in the fields of biology, medicinal and computational chemistry,
pharmacokinetics and pharmacology, and clinical development. It owns an
extensive library of approximately 240,000 pharmacologically relevant molecules,
approximately 60% of which are proprietary, as well as a wholly-owned research
and development facility.
Inventiva is a public company listed on compartment B of the regulated market of
Euronext Paris (ticker: IVA, ISIN: FR0013233012) and on the Nasdaq Global Market
in the United States (ticker: IVA). www.inventivapharma.com
(http://www.inventivapharma.com/)
Contacts
Brunswick Group
Tristan Roquet Montegon Westwicke, an ICR
Inventiva / Company
Aude Lepreux / Patricia L. Bank
Pascaline Clerc Julia Cailleteau Investor relations
EVP, Strategy and Media relations patti.bank@westwicke.c
Corporate Affairs inventiva@brunswickgrou om
media@inventivaphar p.com (mailto:patti.bank@wes
ma.com (mailto:inventiva@bruns twicke.com)
(mailto:media@inven wickgroup.com)
tivapharma.com) +1
+1 202 499 8937 +33 1 53 96 83 83 415 513-1284
Important Notice
This press release contains "forward-looking statements" within the meaning of
the safe harbor provisions of the Private Securities Litigation Reform Act of
1995. All statements, other than statements of historical facts, included in
this press release are forward-looking statements.
These statements include, but are not limited to, forecasts and estimates with
respect to Inventiva's pre-clinical programs and clinical trials, including
design, duration, timing, recruitment costs, screening and enrollment for those
trials, including the ongoing NATiV3 Phase III clinical trial with lanifibranor
in MASH/NASH, and clinical trial data releases and publications, the
information, insights and impacts that may be gathered from clinical trials, the
potential therapeutic benefits of Inventiva's product candidates, including
lanifibranor, potential regulatory submissions, approvals and commercialization,
Inventiva's pipeline and preclinical and clinical development plans, the
potential development of and regulatory pathway for odiparcil, and future
activities, expectations, plans, growth and prospects of Inventiva. Certain of
these statements, forecasts and estimates can be recognized by the use of words
such as, without limitation, "believes", "anticipates", "expects", "intends",
"plans", "seeks", "estimates", "may", "will", "would", "could", "might",
"should", "designed", "hopefully", "target", "potential", "opportunity",
"possible", "aim", and "continue" and similar expressions. Such statements are
not historical facts but rather are statements of future expectations and other
forward-looking statements that are based on management's beliefs. These
statements reflect such views and assumptions prevailing as of the date of the
statements and involve known and unknown risks and uncertainties that could
cause future results, performance, or future events to differ materially from
those expressed or implied in such statements. Actual events are difficult to
predict and may depend upon factors that are beyond Inventiva's control. There
can be no guarantees with respect to pipeline product candidates that the
clinical trial results will be available on their anticipated timeline, that
future clinical trials will be initiated as anticipated, that product candidates
will receive the necessary regulatory approvals, or that any of the anticipated
milestones by Inventiva or its partners will be reached on their expected
timeline, or at all. Future results may turn out to be materially different from
the 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 assurance on the impacts of the
Suspected Unexpected Serious Adverse Reaction (SUSAR) on enrollment or the
ultimate impact on the results or timing of the NATiV3 trial or regulatory
matters with respect thereto, that Inventiva is a clinical-stage company with no
approved products and no historical product revenues, Inventiva has incurred
significant losses since inception, Inventiva has a limited operating history
and has never generated any revenue from product sales, Inventiva will require
additional capital to finance its operations, in the absence of which, Inventiva
may be required to significantly curtail, delay or discontinue one or more of
its research or development programs or be unable to expand its operations or
otherwise capitalize on its business opportunities and may be unable to continue
as a going concern, Inventiva's ability to obtain financing and to enter into
potential transactions, Inventiva's future success is dependent on the
successful clinical development, regulatory approval and subsequent
commercialization of current and any future product candidates, preclinical
studies or earlier clinical trials are not necessarily predictive of future
results and the results of Inventiva's and its partners' clinical trials may not
support Inventiva's and its partners' product candidate claims, Inventiva's
expectations with respect to its clinical trials may prove to be wrong and
regulatory authorities may require holds and/or amendments to Inventiva's
clinical trials, Inventiva's expectations with respect to the clinical
development plan for lanifibranor for the treatment of MASH/NASH may not be
realized and may not support the approval of a New Drug Application, Inventiva
and its partners may encounter substantial delays beyond expectations in their
clinical trials or fail to demonstrate safety and efficacy to the satisfaction
of applicable regulatory authorities, the ability of Inventiva and its partners
to recruit and retain patients in clinical studies, enrollment and retention of
patients in clinical trials is an expensive and time-consuming process and could
be made more difficult or rendered impossible by multiple factors outside
Inventiva's and its partners' control, Inventiva's product candidates may cause
adverse drug reactions or have other properties that could delay or prevent
their regulatory approval, or limit their commercial potential, Inventiva faces
substantial competition and Inventiva's and its partners' business, and
preclinical studies and clinical development programs and timelines, its
financial condition and results of operations could be materially and adversely
affected by geopolitical events, such as the conflict between Russia and Ukraine
and related sanctions, impacts and potential impacts on the initiation,
enrollment and completion of Inventiva's and its partners' clinical trials on
anticipated timelines and the state of war between Israel and Hamas and the
related risk of a larger conflict, health epidemics, and macroeconomic
conditions, including global inflation, rising interest rates, uncertain
financial markets and disruptions in banking systems. Given these risks and
uncertainties, no representations are made as to the accuracy or fairness of
such forward-looking statements, forecasts, and estimates. Furthermore, forward-
looking statements, forecasts and estimates only speak as of the date of this
press release. Readers are cautioned not to place undue reliance on any of these
forward-looking statements.
Please refer to the Universal Registration Document for the year ended December
31, 2023, filed with the Autorité des Marchés Financiers on April 3, 2024, and
the Annual Report on Form 20-F for the 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
to differ materially from those anticipated. All information in this press
release is as of the date of the release. Except as required by law, Inventiva
has no intention and is under no obligation to update or review the forward-
looking statements referred to above. Consequently, Inventiva accepts no
liability for any consequences arising from the use of any of the above
statements.
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