6IV Inventiva

• The first abstract demonstrates that the improvements of MACK-3, a diagnostic test for metabolic dysfunction-associated steatohepatitis, parallel the histological response to lanifibranor therapy in patients with MASH/NASH, in the NATIVE Phase IIb clinical trial.
• The second abstract brings additional evidence supporting the role of intrahepatic vascular alterations in the development of MASLD-related portal hypertension and the progression to MASH and highlights the potential of lanifibranor in addressing the different components of MASH disease including vascular alterations.

Daix (France), Long Island City (New York, United States), May 22, 2024 – Inventiva (Euronext Paris and Nasdaq: IVA), 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 two scientific abstracts have been selected for poster presentation at the upcoming International Liver Congress™ 2024 hosted by the European Association for the Study of the Liver (EASL) on June 5-8, 2024 in Milan, Italy.

The first abstract evaluates the correlation of the response of the biomarker algorithm MACK-3 with the improvement of liver histology as well as markers of cardiometabolic health with lanifibranor treatment. MACK-3 is composed of HOMA-IR, AST and CK-18 and has been validated against histology as a diagnostic marker for active MASH/NASH with fibrosis. The authors demonstrated that the decrease in MACK-3 value at the end of a 24 week-treatment period was significantly higher among the patients treated with lanifibranor which were qualified as responders for the histological endpoints of “MASH/NASH resolution and fibrosis improvement”, “Fibrosis improvement without worsening of MASH/NASH” and “MASH/NASH resolution without fibrosis worsening, compared to patients treated with lanifibranor but qualified as non-responders for the endpoints. Similar results were observed for improvement of NAS, SAF, and individual liver lesions: steatosis, lobular inflammation, and ballooning. MACK-3 improvement correlated as well as with increase of adiponectin levels and decrease of Pro-C3, a circulating marker of fibrogenesis, following therapy with lanifibranor. These results warrant additional study to evaluate MACK-3 as a potential marker for the evaluation of a treatment response to lanifibranor.

The second abstract evaluates the effect of the pan-PPAR agonist, lanifibranor, on the improvement of liver histology as well as vascular alterations in a model of early MASLD. An increase in intrahepatic vascular resistance related to endothelial dysfunction in MASLD can be a potential driver of disease progression. The authors demonstrated that in a model of early MASLD, lanifibranor improved steatosis, normalized the mean arterial blood pressure, strongly decreased the portal pressure in-vivo and normalized the transhepatic pressure gradient ex-vivo. Furthermore, lanifibranor also decreased the reactivity to the vasoconstrictor methoxamine and normalized the hyporeactivity to vasodilator acetylcholine. The results from the collaboration between the University of Antwerp and Inventiva support the role of intrahepatic vascular alterations in the development of MASLD-related portal hypertension as well as in the progression to MASH and highlight the potential of lanifibranor in addressing all the components of MASH disease.

The details of the presentations are as follows:

Abstracts :

Inventiva will also be present with a booth, and we are inviting you to visit us from Wednesday, June 5th until Saturday, June 8th at booth #N4 located in the exhibition hall 3 of the conference center.

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

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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, 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 expected benefit of having received Breakthrough Therapy Designation, including its impact on the development and review timeline of Inventiva’s product candidates, the potential development of and regulatory pathway for odiparcil, and future activities, expectations, plans, growth and prospects of Inventiva and its partners. 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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.

Attachment

• Inventiva - PR - EASL Abstracts - EN - 05 22 2024

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