INVENTIVA

Inventiva received a $10 million milestone payment from CTTQ following successful completion of the second tranche of its €348 million structured financing program.

Inventiva published results in Journal of Hepatology Reports showing lanifibranor reduced liver sinusoidal endothelial cell capillarization in MASH patients during the Phase 2b NATIVE trial.

Over 80 companies are actively developing treatments for Non-Alcoholic Steatohepatitis (NASH), with Inventiva Pharma and Cirius Therapeutics leading with Phase III candidates lanifibranor and MSDC-0602K respectively.

• Inventiva and Hepalys Pharma have initiated the clinical development of lanifibranor in Japan, dosing the first participant in a Phase 1 trial to evaluate safety, tolerability, and pharmacokinetics. • The study will involve 32 subjects across four cohorts receiving daily lanifibranor doses for 14 days, marking a crucial step toward potential MASH treatment in the Japanese market. • Positive results could lead to a pivotal Phase 3 trial in Japan, where approximately 2.7% of the population suffers from MASH, representing a significant market opportunity.

• Inventiva announces major restructuring, including significant workforce reduction and termination of preclinical programs, to extend financial runway through critical Phase III trial completion. • The company's strategic realignment focuses resources on lanifibranor, their lead candidate for Metabolic Dysfunction-Associated Steatohepatitis (MASH), with pivotal data expected in H2 2026. • This cost-cutting initiative aims to ensure the company can reach the crucial Phase III data readout milestone for lanifibranor without compromising the trial's execution.

• French biotech Inventiva announces major restructuring, planning to lay off 50% of employees and discontinue all preclinical research except for its lead MASH candidate lanifibranor. • Company's Phase III trial for lanifibranor in MASH has achieved over 95% patient randomization, with top-line results expected in second half of 2026. • Strategic financial moves, including structured financing and milestone payments, combined with cost-cutting measures, expected to extend operations through Q3 2026.

Inventiva announces strategic pipeline prioritization, halting all preclinical research to focus exclusively on lanifibranor development for MASH treatment, with planned 50% workforce reduction.

• Recent proof-of-concept study demonstrates Lanifibranor's significant efficacy in improving insulin sensitivity and reducing hepatic fat in MASLD patients with type 2 diabetes. • H.C. Wainwright maintains Buy rating for Inventiva with $13 price target, citing strong potential for Lanifibranor in treating MASH fibrosis. • Pivotal NATiV3 trial results anticipated in 2026, potentially leading to accelerated approval for MASH fibrosis treatment by end of 2027.

• Inventiva has secured €21.4 million, completing the first tranche of a financing plan aimed at raising up to €348 million. • The funds will primarily support the Phase III NATiV3 clinical trial of lanifibranor for treating metabolic dysfunction-associated steatohepatitis (MASH). • Mark Pruzanski has been appointed as the new Chairman, and Srinivas Akkaraju joins as a new board member, strengthening Inventiva's leadership. • The company anticipates completing recruitment for the pivotal Phase III trial in the first half of 2025, marking a significant milestone.

• The non-alcoholic steatohepatitis (NASH) market is poised for substantial growth, projected to expand significantly by 2032 across the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan. • This growth is fueled by the introduction of novel therapies targeting NASH, with several drugs in Phase II and Phase III clinical trials showing promise for improving treatment outcomes. • Key players such as Madrigal Pharmaceuticals, Intercept Pharmaceuticals, and Novo Nordisk are actively developing innovative treatments, contributing to a dynamic and competitive market landscape. • The increasing prevalence of NASH and the growing understanding of its pathophysiology are driving the demand for effective therapies, creating opportunities for pharmaceutical companies.