Summary of Inventiva's Presentation at JPMorgan Healthcare Conference Company Overview - **Company**: Inventiva - **CEO**: Andrew Openshin - **Lead Asset**: Lanifibranor, an oral therapy for MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease) - **Recent Transformation**: The company has undergone significant changes in the last 18 months, including a fully enrolled phase three trial and substantial funding [2][3] Financial Highlights - **Funding**: - $411 million raised in October 2024 - Additional $172 million raised in October [3] - **Cash Balance**: Expected to last until Q3 2027, assuming positive data from trials [21] Clinical Development - **Phase 3 Trial**: - Fully recruited with over 1,000 patients enrolled - Anticipated readout in the second half of the year - Focus on F2 and F3 patient populations, excluding F1 patients [3][17] - **Phase 2b Results**: - 18% effect size on fibrosis and 24% on MASH resolution - Significant improvements in cardiometabolic markers [11][12] Market Opportunity - **MASH Market Size**: Expected to grow to $15 billion by 2035 - **Current Diagnosis Rate**: Approximately 2 million diagnosed MASH patients in the U.S., representing a 25% increase since 2024 [5][6] - **Target Patient Population**: F2 and F3 patients, approximately 375,000 in the U.S. [6] Competitive Landscape - **Treatment Evolution**: - GLP-1 therapies are expected to be the backbone for F1, F2, and F3 patients - Lanifibranor positioned as a complementary oral therapy [7][8] - **Safety Profile**: - Low rates of peripheral edema (2%) and milder weight gain compared to previous PPAR agonists [15][16] Future Plans - **Outcomes Trial**: Planned for patients with compensated cirrhosis MASH to confirm clinical benefits [18] - **Market Launch**: Anticipated for 2028, with strategic preparations ongoing for commercialization in 2026 [20][21] Management and Strategy - **Management Team**: Strengthened with experienced professionals from Intercept and Ipsen [4] - **Strategic Preparation**: Focus on market research and building medical affairs presence in 2026 [24] Additional Insights - **Patient Impact**: Emphasis on the potential to reverse stages of fibrosis and improve patient outcomes [22] - **Company Positioning**: Plans to remain France-based while expanding U.S. commercial infrastructure [23] This summary encapsulates the key points from Inventiva's presentation, highlighting the company's strategic direction, clinical developments, market opportunities, and future plans.