Inventiva Secures Landmark Financing to Advance Lanifibranor in NASH

Inventiva, a clinical-stage biopharmaceutical company, has announced a transformative multi-tranche equity financing of up to €348 million to fund the completion of its pivotal Phase 3 NATiV3 trial for lanifibranor in non-cirrhotic NASH and prepare for potential regulatory approval and commercialization. The financing, led by a consortium of renowned healthcare investors, underscores the immense promise of lanifibranor as a breakthrough therapy for this devastating liver disease with significant unmet need.

Unlocking the Potential of Lanifibranor to Transform NASH Treatment

Securing Substantial Funding to Drive NATiV3 Trial and Regulatory Milestones

The €94.1 million initial tranche of the financing, with the potential for up to €348 million in total, will enable Inventiva to complete the pivotal NATiV3 study evaluating lanifibranor in patients with non-cirrhotic NASH. With over 1,100 patients already randomized, the trial is on track for enrollment completion in the first half of 2025, setting the stage for the highly anticipated topline data readout in the second half of 2026. This substantial funding will also support the initiation of a complementary study in NASH patients with compensated cirrhosis, further expanding lanifibranor's clinical development.

Strengthening Inventiva's Leadership with Renowned Industry Experts

Concurrent with the financing, Inventiva has appointed two esteemed industry leaders to its Board of Directors. Dr. Mark Pruzanski, a renowned expert in NASH and liver disease, will assume the role of Chairman, bringing his deep expertise and unwavering belief in lanifibranor's potential. Dr. Srinivas Akkaraju, a seasoned venture capitalist with an impressive track record of identifying and supporting transformative healthcare innovations, will also join the Board as a director. These strategic appointments underscore the confidence of Inventiva's investors in the company's ability to deliver on lanifibranor's promise.

Leveraging Collaborative Partnerships to Accelerate Commercialization

The financing also includes a milestone-based collaboration agreement with Inventiva's partner, CTTQ, a leading Chinese pharmaceutical company. Under the amended agreement, CTTQ will provide up to $30 million in milestone payments to Inventiva, further bolstering the company's resources as it prepares for the potential regulatory approval and commercialization of lanifibranor. This strategic partnership, combined with the substantial equity financing, positions Inventiva to maximize the impact of lanifibranor and bring this much-needed therapy to patients worldwide.

Addressing the Urgent Need for Effective NASH Treatments

NASH, a progressive form of non-alcoholic fatty liver disease (NAFLD), is a growing global health concern, affecting an estimated 17 million adults in the United States alone. The disease is characterized by inflammation, liver cell damage, and the accumulation of fat in the liver, which can lead to fibrosis, cirrhosis, and ultimately, liver failure. Currently, there are no approved pharmacological treatments for NASH, leaving patients with limited options and facing the risk of severe liver-related complications.Lanifibranor's unique dual mechanism of action, targeting both insulin sensitivity and direct antifibrotic effects, positions it as a potential "best-in-class" oral therapy for NASH. The positive results from the Phase 2b NATIVE study, demonstrating lanifibranor's ability to improve both fibrosis and NASH resolution, have generated significant excitement among clinicians and patients alike. With the support of this transformative financing, Inventiva is poised to advance lanifibranor through the pivotal NATiV3 trial and, if successful, bring this much-needed treatment to the millions of NASH patients worldwide.

Navigating the Path to Regulatory Approval and Commercialization

The successful completion of the NATiV3 trial and the subsequent regulatory approval process will be crucial milestones for Inventiva and the NASH community. The company's experienced leadership team, bolstered by the addition of industry luminaries like Dr. Pruzanski and Dr. Akkaraju, is well-equipped to navigate the complex regulatory landscape and prepare for the potential commercialization of lanifibranor.The strategic partnership with CTTQ, which includes milestone payments tied to the equity financing and the NATiV3 trial results, further strengthens Inventiva's financial position and global reach. This collaboration will be instrumental in ensuring the successful launch and widespread availability of lanifibranor, should it receive regulatory approval.As Inventiva embarks on this pivotal phase of its journey, the company's unwavering commitment to advancing innovative therapies for patients with unmet medical needs is more evident than ever. With the support of its investors, the expertise of its leadership team, and the promise of lanifibranor, Inventiva is poised to make a lasting impact on the lives of those affected by NASH.