Inventiva Secures €21.4 Million to Advance Lanifibranor in MASH Phase III Trial
Key Insights
Inventiva has secured €21.4 million, completing the first tranche of a financing plan aimed at raising up to €348 million.
The funds will primarily support the Phase III NATiV3 clinical trial of lanifibranor for treating metabolic dysfunction-associated steatohepatitis (search) (MASH (search)).
Mark Pruzanski has been appointed as the new Chairman, and Srinivas Akkaraju joins as a new board member, strengthening Inventiva's leadership.
Inventiva, a biopharmaceutical company focused on developing oral small molecule therapies, announced the successful completion of the first tranche of its multi-tranche equity financing, securing €21.4 million. This funding is part of a larger initiative to raise up to €348 million, initially announced on October 14, 2024. The primary application of these funds will be to advance Inventiva's Phase III NATiV3 clinical trial, which is evaluating lanifibranor in patients with metabolic dysfunction-associated steatohepatitis (search) (MASH (search)).
Frédéric Cren, CEO of Inventiva, expressed enthusiasm about the financing, stating, "The multi-tranche equity raise of up to €348 million has been instrumental to keep Inventiva on track with recruitment for our pivotal Phase III clinical trial of our asset lanifibranor. We believe that lanifibranor holds significant potential to address unmet medical needs, and we are encouraged by the intensification of trial activities, with a completion of our recruitment expected in the first half of 2025."
Use of Proceeds
The net proceeds from this transaction, amounting to €20.1 million, will be allocated with approximately 85% dedicated to the NATiV3 clinical program for lanifibranor in MASH (search). The remaining 15% will be used for general corporate purposes. Inventiva has committed not to use these funds for early debt redemption or to repurchase securities issued as part of this transaction.
Financial Position and Outlook
As of September 30, 2024, Inventiva reported cash and cash equivalents of €13.9 million, alongside a long-term deposit of €9.0 million as of December 31, 2023. Factoring in the proceeds from the initial capital increase of €94.1 million and a $10 million milestone payment from Chia Tai Tianqing Pharmaceutical (CTTQ), the company estimates its current resources will sustain operations until mid-Q3 2025.
To cover obligations until mid-December 2025, Inventiva estimates additional cash requirements of between €120 million and €130 million. The completion of the second tranche of the Multi-Tranche Financing, anticipated to yield gross proceeds of €116 million, could extend the company's financial visibility beyond 12 months.
Governance Changes
In addition to the financial news, Inventiva announced the appointment of Mark Pruzanski as the new Chairman of the Board of Directors and Srinivas Akkaraju as a new member of the Board. These appointments, effective following the shareholders' general meeting on December 11, 2024, replace Pierre Broqua and Sofia BVBA, represented by Chris Buyse. Frédéric Cren will continue to serve as Chief Executive Officer.
About Lanifibranor and NATiV3 Trial
Lanifibranor is Inventiva's lead product candidate, currently undergoing evaluation in the pivotal Phase III NATiV3 clinical trial for the treatment of MASH (search). MASH is a prevalent and progressive chronic liver disease characterized by inflammation and liver cell damage, often associated with metabolic dysfunction. There is a significant unmet need for effective therapies to treat MASH, as it can lead to cirrhosis, liver failure, and hepatocellular carcinoma.
The NATiV3 trial is a global, randomized, placebo-controlled study designed to assess the efficacy and safety of lanifibranor in adult patients with MASH (search). The primary endpoints include resolution of steatohepatitis without worsening of fibrosis and improvement in fibrosis by at least one stage without worsening of steatohepatitis. The trial aims to enroll a diverse patient population to ensure the results are broadly applicable.
About Inventiva
Inventiva is focused on developing oral small molecule therapies for MASH (search) and other diseases with unmet medical needs. The company leverages its expertise in nuclear receptors, transcription factors, and epigenetic modulation to advance its pipeline. In addition to lanifibranor, Inventiva has preclinical programs and continues to explore new development opportunities.