Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), January 7, 2026 - GENFIT (Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced its provisional financial calendar for 2026. 2026 Financial Calendar February 26, 2026Publication of revenue and cash position at December 31, 2025April 2, 2026Publication of Full Year 2025 financial statements The 2025 Universal Registration ...

Phase 1 results confirm investigational drug-candidate G1090N has a favorable safety and tolerability profile, supporting further clinical evaluationCompelling anti-inflammatory activity of G1090N was evidenced through functional ex vivo assays on blood samples from study participants and cirrhotic donors, showing inhibition of pro-inflammatory pathwayFindings provide a solid foundation for advancing G1090N into Phase 2 proof-of-concept studies across the ACLF continuum Lille (France), Cambridge (Massachuse ...

Highly encouraging early data from the ongoing Phase 1b study evaluating investigational drug GNS561 with a MEK inhibitor (MEKi) in KRAS mutated cholangiocarcinoma (CCA), positioning this novel combination as a potential new therapeutic approach for difficult-to-treat cancers: No dose limiting toxicity reached to date, enabling recruitment of a third patient cohortGNS561 and MEKi combination demonstrated disease stabilization in all evaluable patients with evidence of tumor shrinkage in a subset of patients ...

Highly encouraging early data from the ongoing Phase 1b study evaluating investigational drug GNS561 with a MEK inhibitor (MEKi) in KRAS mutated cholangiocarcinoma (CCA), positioning this novel combination as a potential new therapeutic approach for difficult-to-treat cancers: No dose limiting toxicity reached to date, enabling recruitment of a third patient cohortGNS561 and MEKi combination demonstrated disease stabilization in all evaluable patients with evidence of tumor shrinkage in a subset of patients ...

Core Insights - GENFIT has appointed Dr. Pejvack Motlagh as the new Chief Medical Officer, who will oversee the company's clinical development strategy and execution [1][2][5] - Dr. Motlagh brings over 20 years of experience in the pharmaceutical and biotechnology sectors, with a strong background in drug development across various therapeutic areas [3][4] - The company focuses on addressing unmet medical needs in rare and life-threatening liver diseases, particularly Acute on-Chronic Liver Failure (ACLF) and related conditions [6][7] Company Overview - GENFIT is a biopharmaceutical company dedicated to improving the lives of patients with rare liver diseases, with a history of over two decades in liver disease research and development [6] - The company is headquartered in Lille, France, with additional offices in Paris, Zurich, and Cambridge, MA, and is listed on the Euronext regulated market [9] - GENFIT's R&D portfolio includes therapeutic assets targeting ACLF, acute decompensation, hepatic encephalopathy, cholangiocarcinoma, urea cycle disorders, and organic acidemias [7] Recent Developments - The appointment of Dr. Motlagh is seen as pivotal for advancing GENFIT's clinical programs, particularly in the context of increasing focus on ACLF within the liver disease community [5] - The company achieved accelerated approval for Iqirvo® (elafibranor) in 2024 for the treatment of Primary Biliary Cholangitis (PBC), which is now marketed in several countries [8] - GENFIT also has a diagnostic franchise, including NIS2+® for detecting Metabolic dysfunction-associated steatohepatitis (MASH) [8]

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 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]