Inventiva announces filing of its 2022 Universal Registration
Document and 2022 Annual Report on Form 20-F
Daix (France),
Long Island City (New York, United
States), March
30, 2023 Inventiva (Euronext Paris and Nasdaq:
IVA), a clinical-stage biopharmaceutical company focused on the
development of oral small molecule therapies for the treatment of
non-alcoholic steatohepatitis (NASH) and other diseases with
significant unmet medical needs, today announced that it had filed
its 2022 Universal Registration Document for the year ended
December 31, 2022, including the management report and the annual
financial report, with the French “Autorité des Marchés Financiers”
(AMF) and its 2022 Annual Report on Form 20-F for the year ended
December 31, 2022 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 2022 Universal
Registration Document is available on the website of the AMF
(www.amf-france.org) and the 2022 Annual Report on Form 20-F is
also available on the website of the 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 NASH, mucopolysaccharidoses
(“MPS”) 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 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 an oncology development 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
InventivaPascaline ClercVP of Global External
Affairsmedia@inventivapharma.com+1 240 620 9175 |
Brunswick GroupTristan Roquet Montegon / Aude
Lepreux /Matthieu BenoistMedia
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
enrolment for those trials, including the ongoing NATiV3 Phase III
clinical trial with lanifibranor in NASH and the LEGEND Phase IIa
combination trial with lanifibranor and empagliflozin in patients
with NASH and type 2 diabetes, potential development of and
regulatory pathway for odiparcil, 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 and approvals, and Inventiva’s
pipeline and preclinical and clinical development plans, future
activities, expectations, plans, growth and prospects. 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”, 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. Actual 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 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 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 clinical trials may not support Inventiva's product
candidate claims, Inventiva’s expectations with respect to the
changes to the clinical development plan for lanifibranor for the
treatment of NASH may not be realized and may not support the
approval of a New Drug Application, Inventiva may encounter
substantial delays in its clinical trials or Inventiva may fail to
demonstrate safety and efficacy to the satisfaction of applicable
regulatory authorities, the ability of Inventiva to recruit and
retain patients in clinical studies, enrolment 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 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 business, and preclinical studies and
clinical development programs and timelines, its financial
condition and results of operations could be materially and
adversely affected by the current COVID-19 pandemic and
geopolitical events, such as the conflict between Russia and
Ukraine, related sanctions and related impacts and potential
impacts on the initiation, enrolment and completion of Inventiva’s
clinical trials on anticipated timelines, and macroeconomic
conditions, including global inflation, 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, 2022 filed with the Autorité des Marchés
Financiers on March 30, 2023, and the Annual Report on Form 20-F
for the year ended December 31, 2022 filed with the Securities and
Exchange Commission on March 30, 2023.
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 - 30.03.2022
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