GNFT Reports First-Half 2025 Net Loss Amidst Program Discontinuation and Revenue Decrease

GENFIT (GNFT.US) announced a net loss of €9.96 million for the first half of 2025, a significant decline from the €30.31 million net profit reported in the first half of 2024. Revenues and other income also decreased by 41.6% to €35.67 million, down from €61.20 million in the prior year period. This shift reflects a period of strategic adjustments and increased operating expenses.

Strategic Program Adjustments and Pipeline Focus

GENFIT made a key decision to discontinue its VS-01 program in Acute on-Chronic Liver Failure (ACLF) due to a Serious Adverse Event reported in a clinical trial. This strategic pivot allows the company to reprioritize development on Urea Cycle Disorder (UCD) for VS-01, where it sees significant unmet medical need and potential based on preclinical data.

The company remains committed to ACLF, accelerating the development of four other assets with different mechanisms of action and administration routes. This includes G1090N, SRT-015, CLM-022, and VS-02-HE, with safety and early efficacy data for G1090N expected by the end of 2025.

Iqirvo® Performance and Market Dynamics

A new milestone payment of €26.5 million was received in May 2025 following pricing and reimbursement approval for Iqirvo® (elafibranor) in Italy for Primary Biliary Cholangitis (PBC). Ipsen, GENFIT's partner, reported accelerated sales growth for Iqirvo® in the first half of 2025 across the U.S. and Europe, driven by increasing patient uptake.

Further supporting Iqirvo®'s market position, a key competitor, Intercept Pharmaceuticals, withdrew OCALIVA® (obeticholic acid) from the U.S. market for PBC in September 2025. This move is anticipated to create favorable market dynamics for Iqirvo®'s sales trajectory.

Financial Position and Outlook

Cash and cash equivalents increased to €107.5 million as of June 30, 2025, up from €81.8 million at December 31, 2024. This figure excludes a €26.5 million milestone payment received in July 2025. The discontinuation of the VS-01 program and a royalty financing agreement are projected to extend GENFIT’s cash runway beyond 2028.

Operating expenses rose to €35.6 million in the first half of 2025 from €30.0 million in the prior year, primarily due to increased research and development activities, particularly related to the VS-01 program before its discontinuation. Financial expenses also surged to a loss of €10.2 million, mainly due to debt issuance costs and charges from the royalty financing agreement.