Inventiva reports its 2022 Full-Year Results
Daix (France), Long Island City (New York, United States), March 29, 2023 – Inventiva (Euronext Paris and Nasdaq: IVA) (the “Company”), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of patients with non-alcoholic steatohepatitis (“NASH”) and other diseases with significant unmet medical needs, today reported its full-year results for 2022.
Frédéric Cren, Chairman, CEO and cofounder of Inventiva, stated: “2022 has been a successful year for Inventiva in many ways. On the clinical front, we achieved substantial progress in the development of lanifibranor starting with clearance by the FDA of our “Investigational New Drug” application for our Phase II clinical trial combining lanifibranor and empagliflozin in patients with NASH and type 2 diabetes. In China, we established a partnership with Sino Biopharm to develop and commercialize lanifibranor in Mainland China, Hong Kong Special Administrative Region, Macau Special Administrative Region and Taiwan. As part of this collaboration, we received an upfront payment of €12.8 million, including €1.3 million of withholding taxes for net proceeds of €11.5 million, in November 2022, and are eligible to receive up to $290 million in potential milestone payments and royalties on potential net sales of lanifibranor in China, subject to marketing approval in China.
Over the year, we also strengthened our financial position through a loan agreement of up to €50 million with the European Investment Bank, subject to completion of certain conditions2, of which we drew the first €25 million tranche in December 2022. In July 2022, we raised nearly €15 million, including more than €9 million gross proceeds through our “At-The-Market” program and loan agreements with a syndicate of French banks for a total amount of €5.3 million.
Looking forward, we are continuing our effort to implement the new design of NATiV3 which has been submitted in almost all countries involved in the study and has already been cleared in key countries including the United States. Enrollment in our investigator initiated study, led by Dr. Cusi, was completed in September and we expect the publication of this Phase II clinical study evaluating lanifibranor for the treatment of NAFLD in patients with T2D by the middle of the second quarter of 2023. Finally, both the results from our LEGEND Phase II study combining lanifibranor and empagliflozin in patients with NASH and T2D and the first visit of the last patient in our NATiV3 study, are expected in the second half of 2023.”
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