Inventiva ("Inventiva" or the "Company"), a clinical-focused biopharmaceutical company focused on the development of orally administered small molecule drugs for the treatment of metabolically dysfunction-associated steatohepatitis ("MASH") and other diseases with unmet medical need, announced that the Company has completed patient enrollment in the Phase 3 NATiV3 clinical trial, with the randomization of the last patient. Inventiva randomized 1,009 patients in the main cohort and 410 in the exploratory cohort, exceeding the initial targets of 969 and 350 patients respectively.

Frederic Cren, Chief Executive Officer and co-founder of Inventiva said: "The completion of enrollment in our Phase 3 study is an important milestone for the clinical development of lanifibranor. With preliminary results expected in the second half of 2026, lanifibranor could be the next oral drug approved for the treatment of patients with MASH. On behalf of the entire Inventiva team, I would like to extend my sincere thanks to the patients, our investigators and clinical center teams participating in the NATiV3 study worldwide, as well as to all our partners and collaborators whose unwavering commitment has made it possible to reach this important milestone. I would also like to thank the entire Inventiva team who have dedicated themselves to achieving this crucial milestone. »

Prof. Arun Sanyal, Director of the Stratvitz-Sanyal Institute for Liver Disease and Metabolic Health and Interim Chair of the Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University, and co-principal investigators of NATiV3 commented: "The promising data from the NATIVE Phase 2b study with lanifibranor after only six months of treatment, reinforce confidence in the potential of lanifibranor to become a gold standard therapy for patients with MASH, if approved. The unmet medical need for patients with NASH remains critical, and lanifibranor's unique mechanism of action would represent a targeted and potentially promising solution, particularly for patients with advanced fibrosis and type 2 diabetes. I look forward to seeing the key results and look forward to working closely with Inventiva to ensure the successful filing of the Marketing Authorization Application." »

The main results of NATiV3 are expected in the second half of 2026.

The completion of the NATiV3 enrollment contributes to the satisfaction of certain conditions related to the second tranche of approximately €116 million of the structured financing announced in October 2024 of up to €348 million, including: (i) the randomization of the last patient in the NATiV3 main cohort before April 30, 2025 and (ii) a discontinuation rate of less than 30% prior to week 72 at the time of the end of enrollment in NATiV3. The second tranche of the Structured Finance is subject to additional conditions as set out in the subscription agreements signed on October 11, 2024 and there can be no assurance that all conditions will be satisfied and that the second tranche or any other tranche of the Structured Finance will be completed within the expected timeframe or even that it will be completed.