Inventiva announces filing of its 2023 Universal Registration
Document and 2023 Annual Report on Form 20-F
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). In addition, the 2023 Universal
Registration Document is available on the website of the AMF
(www.amf-france.org) and the 2023 Annual Report on Form 20-F is
also available on the website ofthe SEC (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
Contacts
Inventiva Pascaline ClercEVP, Strategy and Corporate
Affairsmedia@inventivapharma.com +1 202 499
8937 |
Brunswick GroupTristan Roquet Montegon /Aude Lepreux /Julia
CailleteauMedia relationsinventiva@brunswickgroup.com
+33 1 53 96 83 83 |
Westwicke, an ICR CompanyPatricia L. BankInvestor
relationspatti.bank@westwicke.com
+1 415 513-1284 |
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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.
- Inventiva - PR - URD and 20-F - EN - 04 03 2024
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