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]

Lille (France), Cambridge (Massachusetts, United States), (Zurich, Switzerland); November 20, 2025 – GENFIT (Nasdaq and Euronext: GNFT), a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announces that the Company’s voluntary delisting of American Depositary Shares (“ADSs”) representing its ordinary shares from The Nasdaq Global Select Market (“Nasdaq”) has become effective. Each ADS represents one ordinary share of the Company. The ...

Core Insights - GENFIT has announced a research collaboration with EVerZom to enhance its Acute-On-Chronic Liver Failure (ACLF) research using exosome-based regenerative technology [1][2][3] Company Overview - GENFIT is a biopharmaceutical company focused on rare and life-threatening liver diseases, with over two decades of experience in liver disease research and development [5][6] - The company is currently targeting ACLF and related conditions, developing therapeutic assets that address key pathophysiological pathways [6] Collaboration Details - The collaboration aims to conduct exploratory studies to evaluate the efficacy of the drug candidate EViv in ACLF, with a decision point on clinical development expected within 18 months [2][3] - GENFIT has exclusive rights to explore a novel mechanism of action for organ repair through this collaboration, which combines EVerZom's exosome expertise with GENFIT's leadership in ACLF [3][4] Drug Candidate Information - EViv utilizes a proprietary exosome platform to offer a new approach to regenerative therapy for ACLF, with GENFIT having the option to license the drug for clinical development pending positive proof-of-concept results [3][8] - EVerZom's exosomes are derived from mesenchymal stem cells, known for their regenerative properties, providing advantages such as increased stability and enhanced patient safety [4][8] Market Position - GENFIT has a proven track record in advancing therapies, highlighted by the accelerated approval of Iqirvo® (elafibranor) for treating Primary Biliary Cholangitis (PBC) in 2024 [7] - The company also has a diagnostic franchise, including NIS2+® for detecting Metabolic dysfunction-associated steatohepatitis (MASH) [9]

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 - The article discusses the importance of enabling Javascript and cookies in browsers to prevent access issues [1] Group 1 - The article highlights that users may face blocks if ad-blockers are enabled [1]

Core Points - GENFIT has announced its intention to voluntarily delist its American Depositary Shares (ADSs) from the Nasdaq Stock Market, effective prior to the opening of trading on November 20, 2025 [1] - The company remains committed to its listing on Euronext Paris, which has been its primary trading market since April 2014 [2][3] Company Strategy - The decision to delist from Nasdaq is aimed at streamlining operations and focusing resources, enhancing operational efficiency in line with the current pipeline development stage [3][8] - GENFIT plans to file a Form 25 to initiate the removal of the ADS listing, which will be effective ten days after the filing [3] Financial and Operational Details - GENFIT's financial foundation is supported by the successful development and commercialization of elafibranor for Primary Biliary Cholangitis (PBC) [3] - The company intends to maintain high standards of corporate governance and transparency while complying with French and European financial market regulations [3] Information for ADS Holders - ADS holders will have until approximately February 6, 2026, to surrender their ADSs for the underlying ordinary shares, with applicable fees for cancellation and cable services [4][5] - After the delisting, the Depositary may sell the underlying ordinary shares, and ADS holders must surrender their securities to obtain payment of the sale proceeds [6][8] Company Overview - GENFIT is a biopharmaceutical company focused on rare and life-threatening liver diseases, with a history of over two decades in liver disease research and development [10][11] - The company has developed therapeutic assets targeting conditions such as Acute on-chronic Liver Failure (ACLF) and has a diagnostic franchise for detecting metabolic dysfunction-associated steatohepatitis [11][12]

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]