Inventiva, a clinical-stage biopharmaceutical company, has announced a new financing agreement to support its ongoing research and development efforts. The company has secured €94.1 million as an immediate investment, with the potential to raise up to €348 million in multiple tranches, contingent upon fulfilling certain conditions. This substantial funding will be primarily directed towards advancing the Phase 3 NATiV3 clinical trial of
lanifibranor, intended for the treatment of
metabolic dysfunction-associated steatohepatitis (MASH) in noncirrhotic patients.
The financing transaction has attracted participation from a mix of new and existing investors, notably
New Enterprise Associates, BVF Partners LP, and Samsara BioCapital. Additional funds will come from investors such as Andera Partners, Deep Track Capital, Eventide Asset Management, Great Point Partners, LLC, Invus, Perceptive Advisors, Schonfeld Strategic Advisors, and Sofinnova Crossover I SLP. The funds are expected to facilitate not only the clinical trials but also the potential filing for marketing authorization and commercialization of lanifibranor.
In conjunction with this financing effort, Inventiva is set to see some changes in its Board of Directors. Mark Pruzanski, MD, has been nominated as the new Chairman, and Srinivas Akkaraju, MD, PhD, is proposed as a new director, pending approval at the upcoming General Meeting of Shareholders. The company has also indicated that up to four additional directors may be appointed by the top four investors, provided they meet independence criteria and replace existing board members, excluding Frederic Cren, Mark Pruzanski, and Srini Akkaraju.
Mark Pruzanski expressed optimism about lanifibranor’s potential, highlighting its benefits for patients with
Type 2 diabetes and
advanced fibrosis due to MASH. He noted that the drug's dual action as an insulin sensitizer and antifibrotic agent could position it as a leading oral treatment option. With the new funding, he looks forward to working with the board to maximize the potential of lanifibranor.
Frederic Cren, CEO of Inventiva, emphasized the significance of this financing at a pivotal moment for the company. He reiterated the confidence shown by investors and the company's partner, CTTQ, in the therapeutic value of lanifibranor. The proceeds will support the MASH program, regulatory filings, and potential market rollout of the drug. Cren also welcomed Pruzanski's extensive expertise in the MASH field, anticipating his valuable contributions to bringing lanifibranor to market.
Additionally, Dr. Nezam (“Nid”) Afdhal, Chief of Gastroenterology at Beth Israel Deaconess Medical Center and Professor at Harvard Medical School, underscored the medical community’s excitement about lanifibranor. He highlighted its dual benefit in improving fibrosis and resolving MASH, along with enhancing metabolic and cardiovascular profiles in patients.
The financing will be executed in several phases, with the first phase involving the issuance of new ordinary shares and prefunded warrants worth €94.1 million, subject to customary closing conditions. Subsequent phases, contingent on meeting specific preconditions, may raise an additional €21.4 million and €116 million respectively. The total funding could reach up to €232 million if all conditions are satisfied and tranches are issued.
Inventiva plans to allocate the proceeds from the initial €94.1 million financing, along with available cash, primarily towards the clinical program for lanifibranor, accounting for approximately 85% of the funds. The remaining 15% will cover general corporate expenses. The company has committed not to use these funds for early debt redemption or securities repurchase prior to scheduled maturity.
As of June 30, 2024, the company had €10.1 million in cash and cash equivalents, with additional cash preservation measures in place. However, without the new financing, Inventiva estimated it would only be able to sustain operations until mid-October 2024. The successful completion of this financing will extend the company’s financial runway to the end of the second quarter of 2025, with further potential extensions dependent on the issuance of additional tranches.
In summary, this new financing round significantly strengthens Inventiva’s financial position, enabling continued progress in the development and potential commercialization of lanifibranor, a promising therapy for MASH. The company’s leadership and board appointments further bolster its strategic direction and operational focus.
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