Lanifibranor

Inventiva secures €21.4 million, completing the first tranche of a €348 million financing. Funds will advance the Phase III NATiV3 trial for lanifibranor in MASH. Mark Pruzanski and Srinivas Akkaraju join the Board of Directors.

Inventiva secures €21.4M, completing the first tranche of a €348M multi-tranche equity financing. Funds will advance the Phase III NATiV3 trial of lanifibranor for MASH. Mark Pruzanski and Srinivas Akkaraju join the Board of Directors.

Inventiva reported €13.9 million in cash and cash equivalents as of September 30, 2024, and €1.3 million in revenues for the first nine months of 2024. The company issued royalty certificates worth €20.1 million on July 18, 2024, and received €94.1 million in gross proceeds from an equity raise on October 14, 2024. Including a $10 million milestone payment from CTTQ on November 18, 2024, Inventiva estimates it can finance operations until the end of Q2 2025.

Inventiva reports cash and cash equivalents of €13.9 million as of September 30, 2024, and revenues of €1.3 million for the first nine months of 2024. The company issued royalty certificates for €20.1 million in July 2024 and received €94.1 million from an equity raise in October 2024, plus a $10 million milestone payment in November 2024, enabling operations until Q2 2025.

Madrigal Pharmaceuticals' Rezdiffra leads MASH treatment market, but opens opportunities for competitors like Inventiva Pharma's lanifibranor. GLP-1s, including Novo Nordisk's semaglutide and Eli Lilly's tirzepatide, show promise but face adherence issues. Inventiva sees potential in lanifibranor's anti-fibrotic and metabolic effects, aiming for market differentiation.

Boston Pharmaceuticals unveiled Phase II data for efimosfermin alfa, showing significant fibrosis improvements in MASH patients, with 45.2% achieving at least a one-stage improvement in fibrosis without MASH worsening. Efimosfermin alfa, a once-monthly FGF21 analog, also resolved MASH without fibrosis worsening in 67.7% of treated patients, compared to 29.4% in the placebo group. The drug demonstrated good tolerability and will continue Phase II development.

LEGEND study results show lanifibranor significantly lowers HbA1c in MASH and T2D patients, with 50% achieving HbA1c <6.5% at week 24. Combination with empagliflozin improves outcomes and avoids weight gain.

Inventiva, a Dijon biotech company, raised nearly €348 million in an exceptional fundraising, surpassing the 2023 record of €130 million set by Amolyt Pharma. The funds will support Inventiva's phase III trial for lanifibranor against MASH, with results expected in H2 2026. The financing includes immediate and future tranches, with additional potential investment from CCTQ.

The Data Monitoring Committee recommended continuing the NATiV3 Phase 3 clinical trial of lanifibranor in MASH patients without protocol modification, based on a review of safety data from over 1000 patients, confirming lanifibranor's good safety profile.