Core Insights - GENFIT reported its third quarter 2025 financial results, highlighting a focus on developing treatments for rare and life-threatening liver diseases, particularly Acute on-Chronic Liver Failure (ACLF) [1][22] Financial Performance - As of September 30, 2025, the company's cash and cash equivalents increased to €119.0 million from €107.5 million as of June 30, 2025, and €81.8 million as of December 31, 2024 [2][10] - Revenue for the first nine months of 2025 was €39.2 million, a decrease from €59.7 million in the same period of 2024 [5] - The revenue was primarily driven by a Licensing and Collaboration Agreement with Ipsen, which included €12.6 million in royalty revenue and €26.5 million in milestone revenue from pricing and reimbursement approvals for Iqirvo (elafibranor) in three major European markets [6][10] Pipeline Development - The company is advancing its ACLF pipeline, with several programs in various stages of development: - G1090N is undergoing a Phase 1 First-in-Human study, with safety data expected by the end of 2025 [7] - SRT-015 aims to improve formulation for increased exposure, with a potential first-in-human trial in the second half of 2026 [7] - CLM-022 is in experiments to confirm therapeutic efficacy, with a first-in-human trial potentially starting in the first half of 2027 [8] - VS-02-HE is being developed as an oral formulation targeting gut ammonia production, with a first-in-human trial expected in the second half of 2027 [9] - GNS561 is in a Phase 1b clinical trial for cholangiocarcinoma, with data readout expected by the end of 2025 [11] Market Position - Iqirvo (elafibranor) continues to show solid growth in both U.S. and European markets for Primary Biliary Cholangitis (PBC), as reported by Ipsen [13]

Core Insights - GENFIT announced its first half 2025 financial results and a corporate update, highlighting the discontinuation of the VS-01 program in ACLF and a shift in focus towards Urea Cycle Disorder (UCD) [1][3][4] - The company reported cash and cash equivalents of €107.5 million as of June 30, 2025, which is an increase from €81.8 million at the end of 2024, and anticipates extending its cash runway beyond 2028 [3][22][23] Business Highlights - The decision to discontinue the VS-01 program was influenced by a serious adverse event in a clinical trial, leading to a focus on UCD, which presents a significant unmet medical need [2][4] - Revenues for the first half of 2025 amounted to €35.7 million, a decrease from €61.2 million in the same period of 2024, primarily due to reduced milestone payments [25][26] - Operating expenses increased to €35.6 million in the first half of 2025 from €30.0 million in the first half of 2024, largely driven by research and development costs [27][28] Financial Performance - The net loss for the first half of 2025 was €10.0 million, compared to a net profit of €30.3 million in the first half of 2024 [30][61] - Financial income for the period resulted in a loss of €10.2 million, significantly higher than the loss of €0.9 million in the same period of 2024, attributed to increased financial charges from the Royalty Financing agreement [29][59] - The company expects to fund its operations and capital expenditures beyond 2028 based on current assumptions and anticipated revenue from collaborations [23][11] Pipeline and Future Outlook - Key milestones for the second half of 2025 include expected safety data and early efficacy markers for G1090N, with a proof-of-concept study planned for the first half of 2026 [16] - The company is also working on several other programs targeting ACLF and related conditions, with ongoing preclinical evaluations and trials expected to commence in the coming years [4][19][21] - GENFIT's acquisition of full intellectual property rights for GNS561 from Genoscience Pharma enhances its development capabilities in cholangiocarcinoma [10]