Core Viewpoint - Inventiva announced the publication of preclinical study results indicating that lanifibranor may reduce Portal Hypertension (PH), a significant complication of chronic liver diseases, including MASH and cirrhosis [1][5][6]. Group 1: Study Overview - The study was a collaboration with Ghent University Hospital and evaluated lanifibranor's effects on PH independent of hepatic conditions [2]. - Two distinct mouse models were used: Partial Portal Vein Ligation (PPVL) and common Bile Duct Ligation (cBDL) [3]. Group 2: Results from PPVL Model - In the PPVL model, lanifibranor reduced portal pressure by 28% at 10 mg/kg (p=0.03) and 39% at 30 mg/kg (p=0.001) in a dose-dependent manner [3]. - Improvements were linked to vascular changes in the splanchnic compartment, including reduced blood flow in the superior mesenteric artery (p=0.07) and decreased endothelial cell staining [3]. Group 3: Results from cBDL Model - In the cBDL model, lanifibranor also reduced portal pressure and spleen weight while improving fibrosis [4]. - The treatment decreased dysfunction in Liver Sinusoidal Endothelial Cells (LSEC) and hepatic angiogenesis associated with fibrotic PH [4]. Group 4: Implications for Treatment - The study suggests that lanifibranor could be a therapeutic option for patients with clinically significant PH, addressing both intra-hepatic and extra-hepatic conditions [5][6]. - Prof. Sven Francque highlighted the potential of lanifibranor in managing complications related to portal hypertension in chronic liver diseases [6]. Group 5: About Lanifibranor - Lanifibranor is an orally available small molecule that activates all three PPAR isoforms, designed to induce anti-fibrotic, anti-inflammatory, and beneficial vascular changes [8]. - It is the only pan-PPAR agonist in clinical development for MASH, with Breakthrough Therapy and Fast Track designations from the FDA [8]. Group 6: About Inventiva - Inventiva is focused on developing oral small molecule therapies for MASH and other diseases with significant unmet medical needs [9]. - The company is currently evaluating lanifibranor in the NATiV3 pivotal Phase 3 clinical trial for MASH treatment [9].

Core Viewpoint - The initiation of the clinical development program for lanifibranor in Japan marks a significant step for Inventiva and Hepalys in addressing metabolic dysfunction-associated steatohepatitis (MASH) in a market where approximately 2.7% of the population is affected by this condition [4][9]. Company Overview - Inventiva is a clinical-stage biopharmaceutical company focused on developing oral small molecule therapies for MASH and other diseases with unmet medical needs. The company is currently evaluating lanifibranor in a pivotal Phase 3 clinical trial [11]. - Hepalys Pharma, Inc. is a private biopharmaceutical company dedicated to developing novel therapeutics for liver disease, with a focus on lanifibranor and other compounds for Asian markets [6]. Clinical Development - The Phase 1 clinical trial for lanifibranor in Japan involves 32 subjects who will be randomly assigned to four cohorts, receiving the drug once daily for 14 days [2]. - The trial is part of an exclusive licensing agreement between Inventiva and Hepalys, which outlines that Hepalys will conduct and finance all necessary trials in Japan and South Korea for new drug applications [3]. Market Potential - The partnership aims to introduce lanifibranor to the Japanese market, where there is a significant patient population suffering from MASH, thus presenting a potential opportunity for the companies if the drug is approved [4][5]. Product Information - Lanifibranor is a pan-PPAR agonist designed to induce antifibrotic, anti-inflammatory, and beneficial metabolic changes by activating all three PPAR isoforms. It is the only pan-PPAR agonist in clinical development for MASH [10]. - The FDA has granted Breakthrough Therapy and Fast Track designations to lanifibranor, indicating its potential therapeutic benefits for MASH [10].

Core Viewpoint - Inventiva reported preliminary unaudited financial results for the year ended December 31, 2024, highlighting significant changes in cash position, revenues, and operational activities related to its clinical development of lanifibranor for MASH [1][6]. Financial Results - As of December 31, 2024, the company's cash and cash equivalents were €96.6 million, a substantial increase from €26.9 million in 2023 [2]. - Net cash used in operating activities was (€85.9) million in 2024, up 5.3% from (€81.6) million in 2023 [3]. - R&D expenses decreased by 17% to €90.9 million in 2024 from €110.0 million in 2023, primarily due to a temporary pause in patient recruitment for the NATiV3 trial [3]. - Revenues for 2024 were €9.2 million, down from €17.5 million in 2023, mainly due to milestone payments from CTTQ [11][12]. Business Update - The NATiV3 Phase 3 clinical trial screening was completed in early January 2025, with over 95% of the target patients randomized [13]. - The company plans to focus exclusively on the development of lanifibranor, halting all preclinical research activities and reducing its workforce by approximately 50% [14][15]. Financing Activities - The company generated €145.6 million from financing activities in 2024, a significant increase from €29.1 million in 2023, due to various financing agreements [5]. - The first tranche of structured financing closed with gross proceeds of €116 million, with expectations for additional funding in 2025 [9]. Future Outlook - The company estimates that its current cash position and expected funding will allow it to finance operations until the end of the third quarter of 2026 [9]. - Key upcoming milestones include the randomization of the last patient in the NATiV3 trial and participation in several investor and scientific conferences [17].

Core Insights - Inventiva announced the publication of a clinical study in the Journal of Hepatology, demonstrating the efficacy of lanifibranor in treating metabolic dysfunction-associated steatohepatitis (MASH) and type 2 diabetes (T2D) [1][2][3] Clinical Study Results - The proof-of-concept trial involved 38 patients with MASLD and T2D, showing a 44% reduction in intrahepatic triglycerides (IHTG) after 24 weeks of treatment with lanifibranor, compared to a 12% reduction in the placebo group [2][6] - A higher proportion of patients treated with lanifibranor achieved over 30% liver triglyceride reduction (65% vs. 22%) and MASLD resolution (25% vs. 0%) [2][6] - Secondary endpoints indicated improvements in glycemic control, lipid profiles, hepatic insulin sensitivity, muscle glucose disposal, and adipose tissue function, with no safety concerns reported [2][6] Mechanism of Action - Lanifibranor is a pan-PPAR agonist that activates all three PPAR isoforms, contributing to antifibrotic, anti-inflammatory, and beneficial metabolic changes [8] - The balanced activation of PPARα, PPARδ, and partial activation of PPARγ is believed to enhance the drug's tolerability profile [8] Company Overview - Inventiva is a clinical-stage biopharmaceutical company focused on developing oral small molecule therapies for MASH and other diseases with significant unmet medical needs [9] - The company is advancing lanifibranor through a pivotal Phase III clinical trial (NATiV3) for MASH treatment [10] - Inventiva has suspended clinical efforts related to odiparcil to concentrate on lanifibranor's development [11]

Core Points - Inventiva, a clinical-stage biopharmaceutical company, focuses on developing oral small molecule therapies for metabolic dysfunction-associated steatohepatitis (MASH) and other diseases with significant unmet medical needs [1][7] - The company has reported its half-year liquidity contract with Kepler Cheuvreux, detailing the resources available in its liquidity account as of December 31, 2024 [1][2] Financial Summary - As of December 31, 2024, the liquidity account had cash resources of €349,630.55 and 113,452 shares available [3] - The total number of buy-side executions for the semester was 1,281, with a traded volume of 215,444 shares amounting to €477,452.69 [3][6] - The total number of sell-side executions for the semester was 1,366, with a traded volume of 231,651 shares amounting to €538,913.35 [3][6] Clinical Development - Inventiva's lead product candidate, lanifibranor, is currently in a pivotal Phase III clinical trial (NATiV3) for treating adult patients with MASH [8] - The company has a pipeline that includes odiparcil, which is currently under review for further development after a decision to focus on lanifibranor [9] - Inventiva is also in the process of selecting a candidate for its Hippo signaling pathway program [9] Company Overview - Inventiva has a scientific team of approximately 90 people with expertise in various fields, including biology, medicinal chemistry, and clinical development [10] - The company owns a library of around 240,000 pharmacologically relevant molecules, with about 60% being proprietary [10] - Inventiva is publicly listed on Euronext Paris and Nasdaq, indicating its presence in both European and American markets [11]

Daix (France), New York City (New York, United States), January 22, 2025 – Inventiva (Euronext Paris and Nasdaq: IVA) (“Inventiva” or 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”) and other diseases with significant unmet medical needs, today announced that the results from its Proof-of-Concept trial evaluating lanifibranor in combination with empagliflozin ...

Daix (France), New York City (New York, United States), December 17, 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 Frédéric Cren, CEO and cofounder of Inventiva, has been invit ...

Inventiva secures €21.4 million leading to completion of the first tranche of the financing for c. €116 million, part of the multi-tranche equity financing of up to €348 million announced on October 14, 2024. Proceeds from the completed first tranche to be primarily used to advance Inventiva’s Phase III, NATiV3 clinical trial evaluating lanifibranor in patients with MASH. Appointment of Mark Pruzanski as new Chairman of the Board of Directors and Srinivas Akkaraju as new member of the Board of Directors ...

Daix (France), New York City (New York, United States), December 11, 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 the results of the votes of its Combined ShareholdersÂ' Meeting. ...

Cash and cash equivalents at €13.9 million, as of September 30, 2024.Revenues of €1.3 million for the first nine months of 2024.On July 18, 2024, Inventiva issued royalty certificates for an amount of €20.1 million.Considering the receipt of €94.1 million in gross proceeds from the closing of the first part of the first tranche of the equity raise announced on October 14, 20242 and the receipt of the $10 million milestone payment under the amended license and collaboration agreement with CTTQ on November 18 ...