- Inventiva secures €94.1 million of a multi-tranche equity financing of up to €348 million, subject to satisfaction of specified conditions, from both new and existing investors, and up to $30 million in milestone payments relating to equity financing pursuant to amendment to license and collaboration agreement with CTTQ.
- Proceeds from financing to be primarily used to advance Inventiva’s Phase 3, NATiV3 clinical trial evaluating lanifibranor in patients with MASH.
- More than 1,100 patients randomized in the NATiV3 study evaluating lanifibranor for the treatment of noncirrhotic MASH, with completion of enrollment projected in 1H 2025.
- Appointment to the Board of Directors of Mark Pruzanski, MD, as Chairman and Srinivas Akkaraju, MD, PhD, as director, subject to the next General Meeting of Shareholders’ approval.
Inventiva (Euronext Paris and Nasdaq: IVA) (“Inventiva” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”) and other diseases with significant unmet medical needs, today announced financing of immediately €94.1 million and up to €348 million (the “Transaction”), subject to satisfaction of specified conditions, to fund the completion of the Phase 3 NATiV3 MASH trial and preparation for the potential filing for marketing approval and commercialization of lanifibranor.
The Transaction was led by New Enterprise Associates, BVF Partners LP and Samsara BioCapital, with the participation of additional existing and new investors including Andera Partners, Deep Track Capital, Eventide Asset Management, Great Point Partners, LLC, Invus, Perceptive Advisors, Schonfeld Strategic Advisors and Sofinnova Crossover I SLP.
Pursuant to the Transaction and subject to shareholder approval at the next general meeting to be convened by December 16, 2024, the Company appointed Mark Pruzanski, MD, as Company Chairman, and Srinivas Akkaraju, MD, PhD, as a director. Up to four additional directors are to be named by each of the other four largest investors, of whom at least two will qualify as independent and would replace existing directors (excluding Frederic Cren, Mark Pruzanski and Srini Akkaraju).
Dr. Mark Pruzanski said: “I have long believed in the therapeutic potential of lanifibranor in MASH and am honored at the prospect of joining Inventiva as Chairman. Based on the previously published Phase 2b NATIVE study results, lanifibranor has a profile that positions it as a possible ‘best in category’ oral drug: its insulin sensitizing and direct antifibrotic benefits make it an ideal therapy for the large population of Type 2 diabetic patients with advanced fibrosis due to MASH who are at the greatest risk of progressing to liver failure. With the support of the equivalent of up to $410 million in funding announced today, I look forward to working with Frederic and the rest of the Board to help transition the Company to maximize its ability to deliver on lanifibranor’s promise.”
J.P. Morgan, TD Cowen, Guggenheim Securities, and LifeSci Capital are acting as placement agents for the financing, and Namsen Capital is acting as Equity Capital Markets Advisor.
Frederic Cren, Chief Executive Officer of Inventiva, stated: “I am very pleased to announce this important financing at a critical juncture for the Company. This 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. I would also like to highlight the benefit Mark’s deep expertise in the MASH field brings and look forward to working with him to ensure the best chance of getting lanifibranor to patients.”
Dr. Nezam (“Nid”) Afdhal, Chief of Gastroenterology, Beth Israel Deaconess Medical Center, Professor of Medicine, Harvard Medical School, said: “Investigators and clinicians remain excited about the prospect of lanifibranor in MASH due to its effect on improving both fibrosis and resolution of MASH. PPAR agonism with lanifibranor has also been demonstrated to improve the metabolic profile and cardiovascular risk factors in our patients with MASH. This dual benefit has the potential to identify lanifibranor as an optimal choice for patients with MASH, significant fibrosis, and diabetes.”