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 - Ipsen announced new data on IQIRVO for Primary Biliary Cholangitis (PBC) from the ELATIVE trial, to be presented at The Liver Meeting 2025 [1] Group 1: Clinical Trial Results - Interim data from the ELATIVE trial showed that IQIRVO led to sustained improvements in cholestasis biomarkers and stabilization of fibrosis markers over three years in 115 patients [2] - At week 182, 72% of patients on IQIRVO maintained a biochemical response, with a 47% reduction in alkaline phosphatase (ALP) from baseline [2] - Improvements in fatigue and pruritus symptoms were consistent, with a well-characterized safety profile and no new safety signals identified [2][4] Group 2: Expert Commentary - Dr. Cynthia Levy emphasized the importance of long-term treatment data for PBC, noting that IQIRVO shows effective treatment with a reassuring safety profile [3] - Sandra Silvestri highlighted IQIRVO's potential to manage disease progression markers and improve quality of life for PBC patients [4] Group 3: Mechanistic Insights - Further analysis from the ELATIVE trial indicated a relationship between changes in fatigue-associated proteins and reported fatigue outcomes in patients treated with IQIRVO [3] - The data suggests that IQIRVO, as a PPAR α/δ agonist, may modulate pathways involved in energy metabolism and mitochondrial function, addressing fatigue in PBC patients [3][6] Group 4: Trial Design and Background - The ELATIVE trial is a Phase III, multi-center, randomized, double-blind, placebo-controlled study evaluating elafibranor 80mg once daily versus placebo for PBC patients with inadequate response to ursodeoxycholic acid (UDCA) [5] - The trial enrolled 161 patients, with ongoing open-label long-term extension [5] Group 5: Product Information - IQIRVO (elafibranor) is an oral PPAR agonist that improves cholestasis and has anti-inflammatory effects, granted Breakthrough Therapy Designation by the FDA in 2019 [7] - It received accelerated approval from the FDA in June 2024 and conditional approval from the EMA and UK MHRA in late 2024 for treating PBC [7] Group 6: Disease Context - Primary Biliary Cholangitis is a rare autoimmune liver disease affecting approximately 100,000 people in the US and 165,000 in Europe, primarily women [8]

Core Insights - GENFIT is participating in the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® 2025, showcasing its commitment to addressing rare and life-threatening liver diseases [1][10] Pipeline Developments - GENFIT will present new data on its lead program G1090N, a reformulation of nitazoxanide, focusing on its efficacy in treating Acute on-Chronic Liver Failure (ACLF) [2] - The company will also present data on SRT-015, an ASK1 inhibitor that reduces systemic inflammation and promotes immune defense mechanisms in ACLF models [3] - Additional presentations will cover CLM-022, an NLRP3 inflammasome inhibitor, and the effects of VS-01 on systemic inflammation and liver injury, although VS-01 has been discontinued in ACLF [3] Real-World Evidence and Biomarkers - An oral presentation will highlight real-world evidence characterizing patients admitted for acute decompensation, emphasizing management differences [4] - Posters will present new data on biomarkers for cirrhosis, including the effectiveness of single circulating biomarkers sVCAM-1 and TSP2 in detecting fibrosis progression [7] Collaborations and Additional Data - Ipsen will present data on Iqirvo® (elafibranor) in Primary Biliary Cholangitis (PBC) and Primary Sclerosing Cholangitis (PSC), supporting its efficacy and safety profile [11] - The data presented will underscore Iqirvo®'s potential in addressing disease progression and symptom burden in rare cholestatic liver diseases [8] Company Overview - GENFIT is dedicated to improving the lives of patients with rare liver diseases and has a strong focus on ACLF and related conditions [10][12] - The company has a rich history in liver disease research and has achieved accelerated approval for Iqirvo® in multiple jurisdictions [13][14]

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]

Core Insights - Ipsen announced new data on IQIRVO (elafibranor) at the European Association for the Study of the Liver congress, highlighting its efficacy in treating primary biliary cholangitis (PBC) [1] Group 1: Clinical Data and Efficacy - Additional analyses from the ELATIVE study indicate that patients with PBC treated with IQIRVO experienced greater improvements in fatigue after 52 weeks compared to placebo, with 42.9% of IQIRVO patients showing improvement versus 31.3% in the placebo group [2] - Among patients with moderate-to-severe fatigue at baseline, 66.7% of those treated with IQIRVO achieved clinically meaningful improvements, compared to 31.3% in the placebo group [2] - The positive effect of IQIRVO on fatigue appears to occur independently of its effect on pruritus [2] Group 2: Mechanistic Insights - A comprehensive proteomic analysis revealed changes in the expression of over 20 proteins involved in inflammation, immune response, and key symptomatic domains of PBC, including fatigue, in patients treated with IQIRVO [3] - The observed effects on fatigue-associated proteomic signatures are linked to PPARα activation [3][6] Group 3: Treatment Context and Approvals - IQIRVO is an oral, once-daily PPAR agonist that improves cholestasis and has anti-inflammatory effects, and it was granted Breakthrough Therapy Designation by the FDA in 2019 [5] - The drug received accelerated approval from the FDA in June 2024, conditional approval from the European Commission in September 2024, and approval from the UK MHRA in October 2024 for treating PBC in adults with inadequate response to UDCA [5] - Ipsen licensed the exclusive worldwide rights to elafibranor from GENFIT in 2021, and IQIRVO is currently undergoing regulatory processes with other authorities [5] Group 4: Disease Context - PBC is a rare autoimmune liver disease affecting approximately 100,000 people in the US and 165,000 in Europe, predominantly women, and can lead to severe complications if untreated [4]