In a significant strategic shift, French biotech Inventiva announced plans to reduce its workforce by half and narrow its focus exclusively to developing lanifibranor for metabolic dysfunction-associated steatohepatitis (MASH). The restructuring, scheduled for implementation in the second quarter, marks a crucial pivot for the company's future direction.
Strategic Pipeline Consolidation
The company will discontinue all preclinical research activities except those supporting the lanifibranor program. This decision includes terminating its oncology program, which had been investigating the disruption of YAP-TEAD interaction in the Hippo signaling pathway.
MASH Program Progress and Challenges
Inventiva's Phase III clinical trial for lanifibranor has made substantial progress, with patient screening completed in early January and over 95% of participants randomized. The company expects to complete enrollment in the first half of 2024, with top-line results anticipated in the second half of 2026.
However, the development program has faced challenges. In February 2024, the company voluntarily paused patient recruitment following a case of severe liver enzyme elevations. This pause came shortly before the FDA's March 2024 approval of Madrigal Pharmaceuticals' Rezdiffra (resmetirom), which became the first approved therapy for MASH.
Financial Position and Future Outlook
The company's financial performance shows a decline in revenue from 17.5 million euros in 2023 to 9.2 million euros in 2024. As of December 31, Inventiva maintained cash and cash equivalents of 96.6 million euros.
Looking ahead, Inventiva expects to strengthen its financial position in the second quarter through multiple sources:
- Anticipated gross proceeds of approximately 116 million euros from a second tranche of structured financing
- A 10 million dollar milestone payment from Chia Tai Tianqing Pharmaceutical Group, tied to their licensing agreement for lanifibranor development in China
These financial arrangements, combined with the workforce reduction and pipeline restructuring, are projected to sustain the company's operations through the end of the third quarter of 2026, aligning with the timeline for lanifibranor's Phase III results.