Inventiva (IVA) investor relations material

Strategic direction and future plans

• Transitioning from a development-stage to a commercial-stage company, leveraging new management and leadership to prepare for the 2028 launch of lanifibranor, an oral therapy for MASH.

• Emphasizing a holistic approach to MASH, integrating liver-directed and cardiometabolic therapies, and anticipating a future with more combination treatments and broader physician involvement.

• Preparing for a market where most patients may already be on GLP-1 agonists, with lanifibranor positioned as an add-on or alternative for those needing additional liver-directed efficacy.

• Anticipating increased disease awareness, earlier diagnosis, and a shift toward prevention and integrated metabolic health services by 2028.

• Organization reinforced with experienced executives and new CEO to support leadership in MASH and commercial launch.

Financial guidance and market outlook

• Raised over $411 million in PIPE financing, ensuring strong financial positioning to support clinical development and commercialization.

• The addressable U.S. market for MASH is rapidly expanding, with diagnosed and under-treatment patients up 70% in four years, now at 367,000, and expected to grow further as awareness and screening improve.

• MASH affects approximately 1.9 million diagnosed patients in the US, with significant unmet need for effective, liver-directed therapies.

• Real-world practice is shifting toward non-invasive diagnostics and broader use of GLP-1s, with payers and guidelines expected to adapt as new therapies like lanifibranor become available.

• The company is preparing for reimbursement and adoption challenges, emphasizing the simplicity, tolerability, and broad metabolic benefits of lanifibranor.

Lanifibranor: Mechanism, efficacy, and differentiation

• Lanifibranor is a once-daily, oral, pan-PPAR agonist designed to address intrahepatic fibrosis and extrahepatic metabolic dysfunction.

• Demonstrated both MASH resolution and direct fibrosis regression at 24 weeks in Phase 2b, with additional cardiometabolic benefits.

• Intellectual property protection extends through 2041, supporting durable market exclusivity.

• Differentiation centers on dual intrahepatic and extrahepatic benefits, oral administration, and potential to address high-risk MASH patients.

• Favorable safety profile with manageable side effects; most common AEs include diarrhea, nausea, and peripheral edema.