Inventiva (IVA) 43rd Annual J.P. Morgan Healthcare Conference 2025 summary

Key clinical and scientific updates

• Lanifibranor demonstrated best-in-class oral efficacy in Phase IIb, with 18% fibrosis improvement after six months and significant cardiometabolic benefits, especially for type 2 diabetes patients.

• The drug is well-tolerated, with a safety profile suitable for combination with GLP-1 therapies and no major class-related liabilities observed in toxicology studies.

• Phase III NATiV3 trial is over 95% enrolled, with screening stopped and last patient randomization targeted for the first half of 2025; data readout expected in the second half of 2026.

• Blinded analysis of Phase III interim data shows biomarker trends and patient characteristics consistent with Phase IIb, supporting confidence in replicating efficacy and safety.

• Lanifibranor is positioned as the only pan-PPAR in NASH, with IP protection through 2040 and a differentiated mechanism targeting all three PPAR isoforms.

Market positioning and competitive landscape

• Lanifibranor targets patients with advanced fibrosis and type 2 diabetes, a high-risk group with rapid disease progression and significant unmet need.

• Oral administration and direct antifibrotic activity after six months distinguish it from injectables and other mechanisms like FGF21 and Madrigal's Rezdiffra.

• Combination with GLP-1 or SGLT2 inhibitors can control weight gain and enhance metabolic benefits, with ongoing studies including these combinations.

• Recent industry moves, such as Gilead's $4B acquisition of CymaBay, highlight strategic value in the PPAR class.

• Market research and KOL feedback confirm a clear fit for lanifibranor in the advanced fibrosis/type 2 diabetes segment.

Financial and operational highlights

• Over $400 million raised, including $348 million in equity and $30 million in milestone payments, ensuring strong capitalization for trial completion and NDA preparation.

• Top-tier investors participated after extensive due diligence, reflecting confidence in the data and program.

• All preclinical and toxicology packages are finalized, with NDA filing preparation underway for a targeted 2027 submission and potential 2028 approval.

• The company aims to be the second oral drug approved for MASH, leveraging a robust clinical and financial position.

• Leadership changes include the appointment of an experienced chair with deep NASH/MASH expertise.