Inventiva(US:IVA)2025-10-08 17:02Summary of Inventiva Investor Day - October 08, 2025 Company Overview - Company: Inventiva (NasdaqGM:IVA) - Focus: Development of lanifibranor, an oral therapy for MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease) [1][2] Key Points and Arguments Management Changes - Recently raised over $400 million through a PIPE, enhancing the company's position for the global Phase 3 NATIVE 3 trial [2] - New Chief Medical Officer Jason Campagna and new CEO Andrew Ovenshain have joined the management team, bringing extensive experience in the biopharma sector [3][4] Market Opportunity - MASH is a progressive liver disease, underdiagnosed with only 10% of the 18 million patients in the U.S. diagnosed [9] - There are approximately 367,000 under-treated patients in the U.S., a 70% increase from four years ago, indicating a growing market [10] - Despite existing treatments, 90% of physicians believe there is a need for more effective products targeting liver diseases [10] Lanifibranor's Unique Positioning - Lanifibranor is a pan-PPAR agonist designed specifically for MASH, showing an 18% improvement in fibrosis in just six months during Phase 2b trials [11] - The therapy is an oral once-a-day monotherapy with a manageable safety profile, addressing both liver fibrosis and cardiovascular markers [11] Clinical Development and Future Milestones - The company aims to deliver top-line results from the NATIVE 3 trial in the second half of 2026 and plans to launch the therapy in 2028 [13] - The NATIVE 3 trial is fully enrolled, focusing on non-cirrhotic F2/F3 patients, with a primary endpoint of MASH resolution and fibrosis improvement [42] Additional Important Insights Mechanism of Action - Lanifibranor targets multiple pathways involved in MASH progression, including inflammation and fibrosis, through its action on PPAR receptors [20][21] - The drug has shown improvements in metabolic parameters, including reductions in fasting glucose and triglycerides, and increases in HDL cholesterol [24][25] Real-World Application and Treatment Landscape - The treatment landscape for MASH includes lifestyle modifications, GLP-1 agonists, and potential combination therapies with lanifibranor [55][63] - The real-world application of therapies is complex, with many patients already on GLP-1s and requiring careful management of their treatment regimens [62][64] Challenges and Considerations - The under-treatment and over-treatment of patients based on clinical risk factors highlight the need for better diagnostic and treatment strategies [65] - The integration of new therapies like lanifibranor into existing treatment protocols will require careful consideration of patient profiles and potential synergies with other medications [27][63] This summary encapsulates the key points discussed during the Inventiva Investor Day, focusing on the company's strategic direction, market potential, and the clinical development of lanifibranor as a treatment for MASH.