* Hepalys Pharma, Inc. is a new company created by Catalys Pacific and in
which Inventiva has a 30% ownership position.
* Under the exclusive licensing agreement, Inventiva will receive a $10
million upfront payment, and is eligible to receive up to $ 231 million in
clinical, regulatory and commercial milestone payments in addition to tiered
royalties from mid double digits to low twenties based on net sales of
lanifibranor in Japan and South Korea.
* Pending regulatory approvals, Hepalys Pharma, Inc. is expected to initiate
Phase I PKPD studies in Japanese patients and healthy volunteers and will be
responsible for funding all studies of lanifibranor necessary to file for a
new drug application in Japan and South Korea.
* In addition to the 30% of shares of Hepalys Pharma, Inc., Inventiva already
owns, Inventiva has the option to acquire all outstanding shares of Hepalys
Pharma, Inc., at a pre-agreed multiple of post-money valuation.
* In the event Hepalys receives an offer to sell the license or rights related
to lanifibranor, Inventiva has a right of first refusal.
Daix (France), Long Island City (New York, United States), Tokyo (Japan),
September 20 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, and Hepalys Pharma, Inc., a
company incorporated in Japan and incubated by Catalys Pacific, have entered
into an exclusive licensing agreement (the "Agreement") to develop and
commercialize Inventiva's proprietary drug candidate lanifibranor for the
treatment of non-alcoholic steatohepatitis (NASH) in Japan and South Korea.
Hepalys Pharma is a new company founded by Catalys Pacific, an investment firm
specialized in creating and financing venture capital-backed biopharmaceutical
companies to develop pharmaceutical products in Asia. Hepalys Pharma is backed
by renowned investors including Catalys Pacific, Mitsubishi UFJ Capital, DBJ
Capital, and MEDIPAL Innovation Fund.
In parallel of the incorporation of Hepalys Pharma, Inventiva has exercised its
right to own 30% of the company.
Under the terms of this licensing agreement, Inventiva will receive a $10
million upfront payment from Hepalys Pharma and will be eligible to receive up
to $231 million in milestone payments if certain clinical, regulatory and
commercial conditions are met. Subject to regulatory approval, Inventiva has the
right to receive tiered royalties from mid double digits to low twenties based
on net sales of lanifibranor in Japan and South Korea.
In addition, under the terms of this agreement, Inventiva has the option to
acquire the outstanding shares of Hepalys Pharma at a pre-agreed multiple of
post-money valuation under certain conditions, and has a right of first refusal
if Hepalys Pharma, Inc. receives an offer to sell the license and rights related
to lanifibranor.
This agreement is expected to accelerate the time to market of lanifibranor in
Japan and South Korea if regulatory approvals are obtained. Both countries are
major markets, with up to 2.7%(1) of and up to 5.2%(2) of Japanese and South
Koreans, respectively, suffering from NASH, including about 15% of South Korean
patients with significant fibrosis. Hepalys Pharma, Inc. is expected to start
the clinical development of lanifibranor by conducting two phase I studies in
Japanese patients and healthy volunteers. It is anticipated that these studies
would support, if positive, the initiation of a dedicated pivotal trial in
Japanese and Korean patients with NASH, which is planned to start once the
results of NATiV3, the pivotal phase III trial currently conducted by Inventiva,
are available. Hepalys Pharma, Inc. will be responsible for conducting and
financing all development trials in Japan and South Korea needed to file for a
new drug application in these territories.
Frederic Cren, CEO and cofounder of Inventiva, stated: "We are thrilled to
further expand our global reach to Japan and South Korea through this exclusive
licensing agreement with Hepalys Pharma, Inc. We strongly believe that Hepalys
Pharma, Inc. with its experienced team is the right partner to start and fund
the clinical development of lanifibranor in Japan and South Korea. This
agreement is a great opportunity for Inventiva to speed up the potential
commercialization of its lead asset in these two major markets and diversify our
milestones and royalties' source of revenues if regulatory approvals are
achieved. With the ongoing partnership in Greater China and this new agreement
in Japan and Korea, Inventiva is eligible to receive up to an additional $519M
of clinical, regulatory and commercial milestones."
BT Slingsby, MD, PhD, MPH, Representative Director of Hepalys Pharma, Inc.,
stated: "We are delighted to enter into a licensing agreement with Inventiva. We
purposely founded Hepalys Pharma, Inc. to conduct the clinical development and
potential commercialization of lanifibranor, a drug candidate for the potential
treatment of NASH in Japan and Korea. We are confident that, if successful in
our clinical programs and if required regulatory approvals are obtained,
lanifibranor could potentially become an effective treatment for patients with
NASH in Japan and South Korea based on the efficacy demonstrated so far on
fibrosis and NASH resolution, and on the cardiometabolic components of the
disease. We are looking forward to starting the clinical development program of
lanifibranor in Japan and South Korea."
About Hepalys Pharma, Inc.
Hepalys Pharma, Inc. is a private venture-backed biopharmaceutical company
focused on the development of novel therapeutics for liver disease, led by a
world-class team and a transpacific clinical advisory board, committed to
develop and commercialize lanifibranor and potentially other compounds for
patients in Asian countries. Hepalys is headquartered in Tokyo, Japan.
About Catalys Pacific
Catalys Pacific is a life sciences venture capital firm whose mission is to
provide healthcare solutions for patients worldwide through the creation of, and
investment in biotech companies. Catalys Pacific is led by a global team versed
in working closely with its partners in academia, biotech, venture capital and
the pharmaceutical industry worldwide with an emphasis in Japan. The firm
maintains offices in Tokyo, Japan and in San Francisco, California.
About lanifibranor
Lanifibranor, Inventiva's lead product candidate, is an orally-available small
molecule that acts to induce anti-fibrotic, anti-inflammatory and beneficial
vascular and metabolic changes in the body by activating all three peroxisome
proliferator-activated receptor (PPAR) isoforms, which are well-characterized
nuclear receptor proteins that regulate gene expression. Lanifibranor is a PPAR
agonist that is designed to target all three PPAR isoforms in a moderately
potent manner, with a well-balanced activation of PPAR? and PPAR?, and a partial
activation of PPAR?. While there are other PPAR agonists that target only one or
two PPAR isoforms for activation, lanifibranor is the only pan-PPAR agonist in
clinical development for the treatment of NASH. Inventiva believes that
lanifibranor's moderate and balanced pan-PPAR binding profile contributes to the
favorable tolerability profile that has been observed in clinical trials and
pre-clinical studies to date. The FDA has granted Breakthrough Therapy and Fast
Track designation to lanifibranor for the treatment of NASH.
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 (also known as metabolic dysfunction-associated
steatohepatitis (MASH)), 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
(http://www.inventivapharma.com/)
Contacts
Brunswick Group
Tristan Roquet Westwicke, an ICR
Inventiva Montegon / Company
Aude Lepreux / Patricia L. Bank
Pascaline Clerc Matthieu Benoist Investor relations
VP of Global External Media relations patti.bank@westwicke.
Affairs inventiva@brunswickgro com
media@inventivapharma up.com (mailto:patti.bank@we
.com (mailto:inventiva@brun stwicke.com)
(mailto:media@inventi swickgroup.com)
vapharma.com) +1
+1 240 620 9175 +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 enrolment for those trials, including the
ongoing NATiV3 Phase III clinical trial with lanifibranor in NASH, 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, expectations with
respect to clinical development and commercialization by Hepalys Pharma, Inc.,
including with respect to potential clinical trials and regulatory approvals,
expectations with respect to the benefits of the agreement with Hepalys Pharma,
Inc., including potential acceleration lanifibranor commercialization in the
event required regulatory approvals are obtained, potential regulatory
submissions and approvals, achievement of milestones, potential milestone
payments and potential royalties under the agreement with Hepalys Pharma, Inc.,
the rights and obligations under agreements with Hepalys Pharma Inc., including
Inventiva's right to purchase shares in the company and right of first refusal,
and Inventiva's pipeline and preclinical and clinical development plans, future
activities, expectations, plans, growth, potential revenues 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", "designed", "hopefully", "target", "potential', 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 and its
partners may encounter substantial delays 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, 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 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, related sanctions and
related impacts and potential impacts on the initiation, enrolment and
completion of Inventiva's and its partners' clinical trials on anticipated
timelines, health epidemics, 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 for other risks and
uncertainties affecting Inventiva, including those described from time to time
under the caption "Risk Factors". 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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1Eguchi Y, Wong G, Lee EI, Akhtar O, Lopes R, Sumida Y. Epidemiology of non-
alcoholic fatty liver disease and non-alcoholic steatohepatitis in Japan: A
focused literature review. JGH Open. 2020 May 5;4(5):808-817.
2Park J, Lee EY, Li J, Jun MJ, Yoon E, Ahn SB, Liu C, Yang H, Rui F, Zou B,
Henry L, Lee DH, Jun DW, Cheung RC, Nguyen MH. NASH/Liver Fibrosis Prevalence
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NAFLD by Metabolic Comorbidities: Lessons from South Korea. Dig Dis.
2021;39(6):634-645.
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