Core Viewpoint - Inventiva, a clinical-stage biopharmaceutical company, has filed its 2024 Universal Registration Document and Annual Report for the year ended December 31, 2024, with relevant regulatory authorities in France and the United States, highlighting its focus on developing therapies for metabolic dysfunction-associated steatohepatitis (MASH) and other unmet medical needs [1][9]. Company Overview - Inventiva specializes in the development of oral small molecule therapies targeting MASH and other diseases with significant unmet medical needs [3]. - The company is currently conducting the NATiV3 pivotal Phase 3 clinical trial for lanifibranor, a novel pan-PPAR agonist aimed at treating adult patients with MASH [3]. - Inventiva has a scientific team of approximately 90 professionals with expertise in various fields, including biology, medicinal chemistry, and clinical development [4]. Financial Reporting - The 2024 Universal Registration Document and the 2024 Annual Report on Form 20-F are accessible on the company's website and the websites of the French Autorité des Marchés Financiers and the U.S. Securities and Exchange Commission [2][9]. - The filings include management reports and annual financial reports, which provide insights into the company's performance and future outlook [1].

Core Insights - Inventiva has completed patient enrollment in its NATiV3 Phase 3 clinical trial, exceeding initial targets with 1009 patients in the main cohort and 410 in the exploratory cohort [1][6][4] - Topline results from the NATiV3 trial are expected in the second half of 2026, which could lead to the approval of lanifibranor as a new oral therapy for MASH [2][6] - The completion of enrollment supports the conditions for the second tranche of structured financing amounting to approximately €116 million [3] Company Overview - Inventiva is a clinical-stage biopharmaceutical company focused on developing oral small molecule therapies for metabolic dysfunction-associated steatohepatitis (MASH) and other diseases with significant unmet medical needs [8][10] - The company is evaluating lanifibranor, a novel pan-PPAR agonist, in the NATiV3 pivotal Phase 3 clinical trial for adult patients with MASH [8][7] Clinical Trial Details - The NATiV3 trial is a randomized, double-blind, placebo-controlled study assessing the long-term efficacy and safety of lanifibranor in patients with biopsy-proven non-cirrhotic MASH and F2/F3 stage liver fibrosis [4][6] - The trial aims to evaluate several histological endpoints, including MASH resolution and improvement of fibrosis after 72 weeks of treatment [4] Product Information - Lanifibranor is designed to induce antifibrotic, anti-inflammatory, and beneficial vascular and metabolic changes by activating all three PPAR isoforms [5][7] - It is the only pan-PPAR agonist in clinical development for the treatment of MASH, with a favorable tolerability profile observed in clinical trials [7][5]

Financial Data and Key Metrics Changes - The company reported a cash position of €96.6 million at the end of 2024, up from €36 million at the end of December 2023, representing a net positive variance of approximately €61 million [21] - Revenues for 2024 were €9.2 million, down from €17.5 million in 2023, primarily due to milestone payments from CTTQ [25] - The net loss for the full year was €184.2 million, compared to €110.4 million in 2023, reflecting an increase in financial losses [28] Business Line Data and Key Metrics Changes - R&D expenses decreased by 17% to €19.9 million in 2024 from €110 million in 2023, attributed to operational delays [26] - General and administrative expenses increased to €15.8 million in 2024 from €13.8 million in 2023, a rise of 14% [27] Market Data and Key Metrics Changes - The company is positioned to potentially become a leading oral drug for MASH in Japan, South Korea, and China through partnerships with Hepalys and CTTQ [13] - The demand for MASH treatment is increasing, with limited current treatment options available [31] Company Strategy and Development Direction - The company is focusing all resources on the development of lanifibranor, leading to a reduction of approximately 50% of its workforce [14] - A strategic review led to the reinforcement of the Board of Directors with three new members to support the company's mission [16] Management's Comments on Operating Environment and Future Outlook - Management expressed high confidence in completing patient enrollment by the end of April 2025, which is crucial for securing additional financing [42] - The company anticipates a strong commercial opportunity for lanifibranor, especially given the recent approval of competing treatments in the MASH market [44][56] Other Important Information - The company raised approximately $184 million in gross proceeds through various financing operations in 2024 [18] - The company confirmed a cash runway until September 2025 without additional financing, extending to September 2026 with the anticipated second tranche [24] Q&A Session Summary Question: Are the background doses for patients on GLP1 low-dose diabetic doses or high-dose for weight loss? - Management confirmed that GLP1 is mostly anti-diabetic dosing, including various GLP1 agonists [36] Question: What is the level of confidence in randomizing the last patient to secure capital increase? - Management expressed high confidence in completing recruitment by the end of April 2025, with sufficient patients already in the screening process [42] Question: What are the plans for additional financing post-data readout in 2H 2026? - Management indicated that there is significant interest in the MASH market and they are actively evaluating options to secure necessary funding [46] Question: Is there any specific rate in the screening that could derail the last person from becoming randomized? - Management explained that the screening process has a defined timeline, and any delays in patient appointments could affect randomization [52] Question: How are R&D expenses expected to change considering workforce reduction and NATiV3? - Management expects a slight increase in R&D expenses by 10% to 20% as they prepare for NDA filing and commercialization [64] Question: What is the design and timing of an outcome study required by the FDA? - Management stated that the outcome study needs to be underway at the time of NDA filing, which is planned for the first half of 2027 [77]

Core Insights - Inventiva reported significant progress in its clinical trials and secured substantial financing to support its operations and research initiatives [2][4][7] Financial Performance - As of December 31, 2024, the company's cash and cash equivalents increased to €96.6 million from €26.9 million in 2023 [3] - Net cash used in operating activities rose to (€85.9) million in 2024, a 5.3% increase from (€81.6) million in 2023 [4] - R&D expenses decreased by 17% to €90.9 million in 2024, down from €110.0 million in 2023, primarily due to a temporary pause in patient recruitment for the NATiV3 trial [4][14] - Revenues for 2024 were €9.2 million, a decline from €17.5 million in 2023, mainly due to changes in licensing agreements [12][19] - The net loss for 2024 was (€184.2) million, compared to (€110.4) million in 2023, largely due to non-cash accounting treatments [18][20] Clinical Development - The NATiV3 Phase 3 trial for lanifibranor is nearing completion of patient enrollment, with the last patient screened in January 2025 [7][32] - Positive results were published from the LEGEND Phase 2 trial, indicating lanifibranor's potential in treating MASH and Type 2 diabetes [2][22] - A strategic pipeline prioritization plan was presented, focusing exclusively on lanifibranor and resulting in a 50% workforce reduction [7][23] Financing Activities - The company secured a structured multi-tranche equity financing of up to €348 million, with gross proceeds of €116 million from the first tranche [5][6][7] - Expected proceeds from the second tranche of the financing are approximately €116 million, along with a milestone payment of $10 million from CTTQ [9] Future Outlook - The company estimates its current cash position will support operations until the middle of the third quarter of 2025, with potential additional funding extending this to the end of the third quarter of 2026 [8][9] - Upcoming milestones include the completion of the NATiV3 trial and participation in various investor and scientific conferences [33][28]

Core Viewpoint - Inventiva, a clinical-stage biopharmaceutical company, is set to present its 2024 full-year financial results on March 27, 2025, highlighting its focus on developing therapies for metabolic dysfunction-associated steatohepatitis (MASH) and other unmet medical needs [1][2]. Company Overview - Inventiva specializes in oral small molecule therapies aimed at treating MASH and other diseases with significant unmet medical needs [4]. - The company is currently conducting the NATiV3 pivotal Phase 3 clinical trial for lanifibranor, a novel pan-PPAR agonist targeting adult patients with MASH [4]. - Inventiva has a scientific team of approximately 90 experts in various fields, including biology, medicinal chemistry, and clinical development [5]. - The company possesses a library of around 240,000 pharmacologically relevant molecules, with about 60% being proprietary [5]. - Inventiva is publicly listed on Euronext Paris and NASDAQ under the ticker IVA [6].

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]