Inventiva (IVA) investor relations material

Company transformation and leadership

• Underwent significant transformation in the past 18 months, including a $411M raise in October 2024 and an additional $172M, ensuring full capitalization for lead asset development.

• Strengthened management team with experienced leaders from Intercept and Ipsen, focusing on medical, regulatory, and commercial expertise.

• Remains France-based but plans to build a transatlantic presence, expanding U.S. commercial infrastructure while maintaining French headquarters.

Market landscape and opportunity

• MASH market projected to exceed $15B by 2035, with over 60% of patients having T2D and current U.S. diagnosed patients at 2 million, up 25% since 2024.

• Targeting F2 and F3 patient populations, about 375,000 in the U.S., which has grown 20% since 2024.

• Only about 1.9 million are diagnosed in the US, with a significant portion underdiagnosed and undertreated, highlighting unmet need.

• Recent approvals of GLP-1 and THR beta therapies have increased diagnosis rates and market awareness.

Product positioning and clinical data

• Lanifibranor is a pan-PPAR agonist, designed for balanced, low-potency binding to minimize adverse events and address both liver and systemic metabolic issues.

• Phase 2b trial demonstrated significant improvements in fibrosis and MASH resolution, with favorable cardiometabolic and glycemic markers at 24 weeks.

• Statistically significant results were achieved on key FDA and EMA endpoints, with greater effect sizes in patients with T2D.

• Biomarker analysis showed rapid, sustained intra-hepatic and extra-hepatic benefits, including improved liver enzymes, HDL, triglycerides, insulin sensitivity, and blood pressure.

• Safety profile shows low peripheral edema (2%) and milder weight gain compared to previous PPAR agonists; most frequent adverse events were mild and consistent with improved insulin sensitivity.