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 presents promising preclinical data for investigational drug G1090N, aimed at treating Acute-on-Chronic Liver Failure (ACLF) with nitazoxanide (NTZ) [1][4] - The drug is designed to optimize dose-response and provide dosing flexibility for patients with varying degrees of renal or hepatic impairment [1][4] - Preclinical findings indicate NTZ's efficacy in reducing systemic inflammation and improving organ function in ACLF disease models [3][6] Company Overview - GENFIT is a biopharmaceutical company focused on rare and life-threatening liver diseases, with over two decades of research and development experience [5] - The company has a diversified R&D portfolio targeting conditions associated with ACLF, including Acute Decompensation and Hepatic Encephalopathy [5] - GENFIT has successfully developed and commercially launched Iqirvo® (elafibranor) for Primary Biliary Cholangitis, demonstrating its capability in advancing high-potential molecules [5] Research and Development - A Phase 1 First-in-Human study for G1090N is currently underway, with safety data expected by the end of 2025 [4][6] - Initial efficacy signals from ex-vivo functional assays are also anticipated at the same time [4][6] - The company aims to initiate a Phase 2 proof-of-concept study in the first half of 2026, contingent on positive results from ongoing studies [7]

Core Insights - GENFIT presents promising preclinical data on investigational drug G1090N, a novel formulation of nitazoxanide (NTZ), aimed at treating acute-on-chronic liver failure (ACLF) [1][9] - The drug is designed to optimize dose-response and provide dosing flexibility for patients with varying degrees of renal or hepatic impairment [1] Preclinical Findings - Preclinical studies indicate that NTZ has beneficial effects on systemic inflammation and organ function in ACLF disease models, showing a reduction in inflammatory cytokines and rapid restoration of hepatic and renal functions [2][3][6] - The efficacy of NTZ was demonstrated when administered post-ACLF trigger, highlighting its potential as a therapeutic approach for ACLF [3][4] Clinical Development - A Phase 1 First-in-Human study is currently underway, with safety data and initial efficacy signals expected by the end of 2025 [4][6] - Positive results from the ongoing study could lead to further clinical development and a potential Phase 2 proof-of-concept study in the first half of 2026 [2][6] Company Overview - GENFIT is a biopharmaceutical company focused on rare and life-threatening liver diseases, with a diverse R&D portfolio targeting conditions such as ACLF, cholangiocarcinoma, and urea cycle disorders [5][6] - The company has a history of successful drug development, including the accelerated approval of Iqirvo® (elafibranor) for Primary Biliary Cholangitis [5]

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 SA reported an EPS of -$0.24, significantly below the expected $1.19, indicating financial challenges [1][6] - The company's revenue was approximately $40.3 million, falling short of the estimated $114.7 million, reflecting difficulties in meeting market expectations [1][6] Financial Position - As of June 30, 2025, GENFIT had cash and cash equivalents of €107.5 million, excluding a €26.5 million milestone payment received in July 2025 [2] - The revenues for the first half of 2025 were €33.5 million, supported by the milestone payment, with strong sales of Iqirvo noted in the primary biliary cholangitis (PBC) market [3] Strategic Decisions - The company has discontinued the VS-01 program, extending its cash runway beyond 2028, which provides flexibility for future business initiatives [4] - GENFIT is advancing its pipeline, with Phase 1b data for GNS561 in cholangiocarcinoma expected by the end of 2025, alongside safety data for G1090N in ACLF [4] Valuation Metrics - The price-to-sales ratio is 2.53, and the enterprise value to sales ratio is 2.25, reflecting the company's market valuation [5] - A debt-to-equity ratio of 0.90 indicates a balanced use of debt and equity, while a current ratio of 1.23 suggests reasonable liquidity [5]

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 Viewpoint - GENFIT has decided to discontinue its VS-01 program in Acute-on-Chronic Liver Failure (ACLF) and will focus on developing VS-01 for Urea Cycle Disorder (UCD) due to safety concerns and the need for additional data [1][2][3] Company Strategy - The decision to halt the VS-01 program in ACLF was influenced by a Serious Adverse Event (SAE) reported during the UNVEIL-IT® clinical trial, leading to a review by the independent Data Monitoring Committee [2] - GENFIT will continue preclinical evaluation of VS-01 in UCD, which presents a significant unmet medical need, particularly for children [3] - The company remains committed to ACLF and related conditions, aiming to accelerate the development of four other assets in this area, which utilize different mechanisms of action [4] Financial Implications - The discontinuation of the VS-01 program is expected to lead to a substantial reduction in operating expenses, providing strategic flexibility and extending the projected cash runway by at least one year [6][11] - GENFIT anticipates sharing Phase 1b data for cholangiocarcinoma (CCA) by year-end, indicating ongoing investment in other life-threatening indications [5] Research and Development Focus - GENFIT has a diversified R&D portfolio targeting various liver diseases, including ACLF, Acute Decompensation (AD), Hepatic Encephalopathy (HE), UCD, and CCA [7] - The company has engaged with key opinion leaders (KOLs) and received positive feedback on its clinical strategy for ACLF, reinforcing confidence in its development plans [4]

Company Overview - GENFIT is a biopharmaceutical company focused on improving the lives of patients with rare and life-threatening liver diseases, with a strong emphasis on unmet medical needs [2] - The company has a diversified and rapidly expanding R&D portfolio, particularly targeting Acute-on-Chronic Liver Failure (ACLF) with five assets under development [2] - GENFIT has expertise in developing high-potential molecules and has achieved accelerated approval for its drug Iqirvo® (elafibranor) for Primary Biliary Cholangitis (PBC) [2] Financial Summary - As of June 30, 2025, the liquidity contract with Crédit Industriel et Commercial reported total trading of €398,484.67 [4] - The buy side recorded 1,412,901 shares traded for a total amount of €5,016,550.43, while the sell side recorded 1,419,301 shares for €5,061,074.96 [4] - The total number of trades during the first half of 2025 was 2,673 on the buy side and 1,894 on the sell side [4] Research and Development Focus - GENFIT's ACLF franchise includes five assets: VS-01, G1090N, SRT-015, CLM-022, and VS-02-HE, which utilize different mechanisms of action [2] - The company also targets other serious diseases such as cholangiocarcinoma (CCA), urea cycle disorder (UCD), and organic acidemia (OA) [2] - GENFIT has a diagnostic franchise that includes NIS2+® for Metabolic dysfunction-associated steatohepatitis (MASH) and TS-01 focusing on blood ammonia levels [2] Market Position - GENFIT is headquartered in Lille, France, with additional offices in Paris, Zurich, and Cambridge, MA [2] - The company is listed on the Nasdaq Global Select Market and Euronext regulated market in Paris [2] - In 2021, Ipsen became one of GENFIT's largest shareholders, acquiring an 8% stake in the company [2]

Core Viewpoint - GENFIT has announced that Ipsen's Iqirvo® has received pricing and reimbursement approval in Italy for Primary Biliary Cholangitis (PBC), marking a significant milestone for the company [1][2]. Group 1: Financial Impact - The approval in Italy triggers a milestone payment of €26.5 million under the Licensing and Collaboration Agreement with Ipsen, which is due upon pricing and reimbursement in three major European markets [2]. - This payment will support the advancement of GENFIT's pipeline focused on Acute On-Chronic Liver Failure (ACLF) and other serious diseases [2]. Group 2: Company Overview - GENFIT is a biopharmaceutical company dedicated to addressing unmet medical needs in patients with rare and life-threatening liver diseases, with over two decades of research and development experience [3]. - The company has a diversified R&D portfolio, including five assets under development for ACLF and other serious diseases such as cholangiocarcinoma, urea cycle disorder, and organic acidemia [3]. - GENFIT has successfully achieved accelerated approval for Iqirvo® (elafibranor) from major regulatory agencies, including the U.S. FDA and the European Medicines Agency [3]. Group 3: Strategic Partnerships - Ipsen became one of GENFIT's largest shareholders in 2021, acquiring an 8% stake in the company, indicating a strong partnership and commitment to the collaboration [3].