Inventiva Announces Major Restructuring, Focuses on MASH Candidate Lanifibranor

French biotech company Inventiva has unveiled a significant restructuring plan, including substantial workforce reductions and a strategic shift in its pipeline focus. The move comes as the company aims to extend its operational runway and prioritize the development of its lead candidate for metabolic dysfunction-associated steatohepatitis (MASH).

Workforce Reduction and Pipeline Shift

Inventiva announced plans to lay off approximately half of its employees in the second quarter of 2025. This drastic measure is part of a broader strategy to streamline operations and concentrate resources on its most promising asset, lanifibranor, for the treatment of MASH.

The company will discontinue all preclinical research activities unrelated to the lanifibranor program. This includes terminating its primary oncology program, which focused on disrupting the interaction between YAP and TEAD in the Hippo signaling pathway.

Lanifibranor Phase III Trial Progress

Despite the restructuring, Inventiva reported progress in its Phase III clinical trial for lanifibranor in MASH patients. The company has completed patient screening, with over 95% of participants randomized. Enrollment is expected to conclude within the first half of 2025, and top-line results are anticipated in the second half of 2026.

It's worth noting that Inventiva voluntarily paused patient recruitment for this trial in February 2024 following a case of severe liver enzyme elevations. This pause came shortly before the FDA's approval of Madrigal Pharmaceuticals' Rezdiffra (resmetirom) in March 2024, marking the first-ever approved therapy for MASH.

Financial Outlook and Funding

Inventiva's 2024 revenue decreased to 9.2 million euros ($9.5 million) from 17.5 million euros ($18.1 million) in 2023. As of December 31, 2024, the company reported cash and cash equivalents of 96.6 million euros ($99.8 million).

To bolster its financial position, Inventiva expects to receive gross proceeds of approximately 116 million euros ($119.8 million) in the second quarter of 2025. This funding will come from a second tranche of structured financing and a 10 million dollar milestone payment from Chia Tai Tianqing Pharmaceutical Group, related to a licensing agreement for lanifibranor's clinical development in China.

The combination of these financial measures, along with the restructuring efforts, is projected to extend Inventiva's operational runway until the end of the third quarter of 2026, aligning with the expected timeline for lanifibranor's Phase III trial results.