Inventiva obtains up to $380m for MASH treatment lanifibranor

Inventiva has successfully secured up to €348 million ($380 million) in funding to complete a Phase III trial for its primary clinical asset, lanifibranor, which is being developed to treat metabolic dysfunction-associated steatohepatitis (MASH). The financing will primarily be used to finalize the Phase III trial (NCT04849728) for lanifibranor. Additionally, the funds will aid in the preparation for marketing approval submissions and the eventual commercialization of the drug, as announced in a press release on October 14.

The French biopharmaceutical company is set to immediately receive $103.4 million from the multi-tranche equity financing, with the remaining funds to be provided through future issuance phases. Inventiva also disclosed that an additional $30 million had been secured through milestone payments under an existing licensing and collaboration agreement with Chinese pharmaceutical company CTTQ.

Following the announcement, shares of Inventiva, which is listed on Nasdaq, increased by 27% at the market opening on October 14 compared to the market close on October 11. The company currently has a market capitalization of $98.6 million.

The financing transaction was spearheaded by New Enterprise Associates, BVF Partners LP, and Samsara BioCapital, with participation from other existing and new investors. Dr. Mark Pruzanski, the current chairman of Corteria Pharmaceuticals and biotech company Abcuro, will assume the role of chairman at Inventiva. Srinivas Akkaraju, the founder of Samsara BioCapital, will join as a director following the deal. Additionally, four directors from the four largest investors will be added to the board, with at least two replacing existing directors.

Lanifibranor is Inventiva’s only clinical candidate, and the company had estimated it would need approximately €250 million to finance its operations until the Phase III topline results in MASH patients are achieved. The ongoing study, named NATiV3, is anticipated to reach this milestone in the latter half of 2026.

The randomized, double-blind, placebo-controlled trial aims to evaluate the long-term efficacy and safety of lanifibranor in adults with biopsy-confirmed non-cirrhotic MASH and F2/F3 stage liver fibrosis. Approximately 1,000 patients are expected to participate in the study across 494 study locations, according to an entry on ClinicalTrials.gov. The trial has resumed after a temporary halt in recruitment earlier this year due to a potential treatment-related serious adverse event.

Interest in the MASH treatment space has grown this year, especially after Madrigal Pharmaceuticals received the first approval from the US Food and Drug Administration (FDA) for a MASH treatment, Rezdiffra (resmetirom). According to GlobalData, the MASH market is projected to reach $25.7 billion in sales by 2032 across the seven major markets: the US, France, Germany, Italy, Spain, the UK, and Japan.

Lanifibranor is an orally administered small molecule that activates three peroxisome proliferator-activated receptor (PPAR) isoforms. These ligand-activated transcription factors are known to regulate four components of MASH: inflammation, fibrosis, steatosis, and metabolism. Inventiva’s pan-PPAR agonist demonstrated positive outcomes in a Phase IIb trial, achieving both primary and key secondary endpoints.

Inventiva’s CEO, Frederic Cren, stated, “This financing reflects the confidence of the participating investors and our partner CTTQ in the value of lanifibranor as a breakthrough therapy for patients suffering from MASH. The total proceeds from the financing will support the MASH program and subsequent filing for marketing approval, along with preparations for the potential commercialization of lanifibranor.”