Core Viewpoint - GENFIT has received Orphan Drug Designation (ODD) from the U.S. FDA for its investigational drug NTZ (nitazoxanide) aimed at treating Acute-on-Chronic Liver Failure (ACLF), a severe condition with no approved therapies [1][6]. Group 1: Drug Development and Clinical Trials - G1090N is GENFIT's lead investigational program targeting ACLF, recognized by the FDA for its potential to address this life-threatening condition characterized by rapid deterioration and high mortality [2][6]. - Recent Phase 1 data showed a favorable safety and tolerability profile for G1090N in healthy volunteers, along with significant anti-inflammatory activity in ex vivo models, supporting the advancement to Phase 2 clinical development expected in the second half of 2026 [3][6]. Group 2: Regulatory and Market Implications - The ODD designation provides GENFIT with various development incentives, including FDA regulatory guidance, user fee reductions, and eligibility for seven-year U.S. market exclusivity upon FDA approval [3][6]. - The company aims to leverage this designation to enhance its development strategy and prospects in the ACLF segment, which is critical given the unmet medical needs in this area [5][6]. Group 3: Company Background and Focus - GENFIT is a biopharmaceutical company focused on rare and life-threatening liver diseases, with over two decades of research and development experience [4]. - The company also targets other serious conditions such as cholangiocarcinoma, urea cycle disorders, and organic acidemias, maintaining a diverse R&D portfolio [4].

Core Viewpoint - GENFIT, a biopharmaceutical company focused on rare liver diseases, reported its fourth quarter 2025 financial results, highlighting a decrease in revenues and a strong cash position to support ongoing research and development efforts. Cash Position - As of December 31, 2025, the company's cash and cash equivalents were €101.1 million, an increase from €81.8 million at the end of 2024 but a decrease from €119.0 million as of September 30, 2025 [2][4]. - Cash utilization in 2025 was primarily due to research and development activities in the Acute on-Chronic Liver Failure (ACLF) franchise and cholangiocarcinoma (CCA) programs [3]. Revenue - Total revenues for 2025 were €65.4 million, down from €67.0 million in 2024 [6]. - Royalty revenue increased significantly to €21.8 million in 2025, compared to €2.7 million in 2024, driven by worldwide sales of Iqirvo® (elafibranor), which reached $208 million [7]. - Milestone revenue decreased to €43.6 million in 2025 from €48.7 million in 2024, with significant contributions from the Ipsen Agreement [8][9]. Corporate Update and Program Highlights - The company is advancing its lead program G1090N, which has shown promising Phase 1 data, and plans to engage with regulatory authorities for a Phase 2 proof-of-concept study in ACLF [12]. - In cholangiocarcinoma, early data from the Phase 1b study of GNS561 in combination with a MEK inhibitor is encouraging, with further data expected in the first half of 2026 [12]. - Iqirvo®'s net sales for Q4 2025 were $88 million, contributing to a total of $208 million for the year, which triggered a €17.0 million milestone payment to GENFIT [12].

Core Insights - GENFIT announced a strong commercial performance of Iqirvo® in its first full year, achieving net sales of US$208M, which triggered a US$20M milestone payment from Ipsen ahead of schedule [2][8] - The partnership with Ipsen is highlighted as a key factor in the commercial success, reinforcing GENFIT's financial position and leading to an additional €30M tranche under a royalty-financing agreement with HCRx [2][3] - Ipsen has initiated a Phase 3 clinical trial for Iqirvo® in primary sclerosing cholangitis (PSC), representing a significant market opportunity, with potential for additional milestone payments and royalties for GENFIT [3][8] Financial Performance - Iqirvo® net sales reached US$208M in 2025, with US$88M reported in Q4 2025 [2][8] - The early achievement of the milestone payment is expected to enhance GENFIT's financial flexibility [2] - The company anticipates a landmark year in 2026, with ongoing clinical programs and new data expected [5] Clinical Development - GENFIT is advancing its oncology program, specifically the Phase 1b study of GNS561 in cholangiocarcinoma (CCA), which is progressing as planned with no dose-limiting toxicities reported [4][8] - Recruitment for the next dose-escalation cohort has been completed, with multi-cohort readouts expected by the end of the first half of 2026 [4][8] - The company is also preparing for a Phase 2 study evaluating G1090N in acute on-chronic liver failure (ACLF) patients [5] Company Overview - GENFIT is focused on rare and life-threatening liver diseases, with a strong history in liver disease research and development [7] - The company has a diverse R&D portfolio, including therapies for cholangiocarcinoma, urea cycle disorders, and organic acidemias [9] - GENFIT is headquartered in Lille, France, and is listed on the Euronext regulated market [9]

Core Insights - GENFIT announced a US$20 million milestone payment from Ipsen due to the strong commercial performance of Iqirvo® in its first full year, with net sales reaching US$208 million in 2025, exceeding initial expectations [2][3][8] Financial Performance - Iqirvo® achieved first-year net sales of US$208 million, leading to a milestone payment from Ipsen ahead of schedule, which strengthens GENFIT's financial position [2][8] - An additional €30 million tranche was received under GENFIT's royalty-financing agreement with HCRx, enhancing financial flexibility without dilution [2] Clinical Developments - Ipsen initiated the first global Phase 3 clinical trial for primary sclerosing cholangitis (PSC), addressing a significant unmet medical need, with potential for additional milestone payments and double-digit royalties for GENFIT if approved [3][8] - GENFIT's ongoing Phase 1b study in cholangiocarcinoma (CCA) is progressing as planned, with a new dose-escalation cohort fully enrolled and no dose-limiting toxicities reported [4][8] Future Outlook - The CEO of GENFIT expressed optimism about the commercial trajectory of Iqirvo® and the progress of the GNS561 program, anticipating significant developments in 2026 [5] - GENFIT plans to publish its 4Q25 revenue and cash position on February 26, 2026, indicating a commitment to transparency and ongoing communication with stakeholders [5]

Core Viewpoint - GENFIT, a biopharmaceutical company focused on rare and life-threatening liver diseases, announced its provisional financial calendar for 2026, highlighting key dates for financial disclosures and shareholder meetings [1][10]. Financial Calendar - February 26, 2026: Publication of revenue and cash position as of December 31, 2025 [2] - April 2, 2026: Publication of Full Year 2025 financial statements and the 2025 Universal Registration Document [2] - May 21, 2026: Publication of revenue and cash position as of March 31, 2026 [2] - June 15, 2026: Annual Shareholders Meeting [2] - September 29, 2026: Publication of the half-year 2026 financial statements [2] - November 5, 2026: Publication of revenue and cash position as of September 30, 2026 [2] - The calendar is subject to change [2]. Company Overview - GENFIT is dedicated to improving the lives of patients with rare liver diseases and has over two decades of experience in liver disease research and development [3][4]. - The company focuses on Acute on-chronic Liver Failure (ACLF) and related conditions, developing therapeutic assets targeting key pathophysiological pathways [4]. - GENFIT also addresses other serious diseases, including cholangiocarcinoma (CCA), urea cycle disorders (UCD), and organic acidemias (OA) [4]. Product Development - In 2024, GENFIT received accelerated approval for Iqirvo® (elafibranor) from the FDA, EMA, and MHRA for treating Primary Biliary Cholangitis (PBC), and it is now marketed in several countries [5]. - The company has a diagnostic franchise, including NIS2+® for detecting Metabolic dysfunction-associated steatohepatitis (MASH) [6]. Corporate Structure - GENFIT is a BCorp™ certified company since 2025, headquartered in Lille, France, with additional offices in Paris, Zurich, and Cambridge, MA [7]. - The company is listed on the Euronext regulated market in Paris, Compartment B (Euronext: GNFT) [7]. - Ipsen became one of GENFIT's largest shareholders in 2021, acquiring an 8% stake in the company [7].

Core Insights - GENFIT announced that its lead investigational drug candidate G1090N for Acute-On-Chronic Liver Failure (ACLF) has shown a favorable Phase 1 safety profile and strong anti-inflammatory activity in ex-vivo studies [1][7][8] Phase 1 Trial Results - The Phase 1 trial was an open-label study assessing the safety, tolerability, and pharmacokinetics of G1090N, involving 76 healthy volunteers across Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) phases [3][7] - G1090N demonstrated a favorable safety profile, supporting further clinical evaluation [7] Ex Vivo Studies - Ex vivo studies indicated that G1090N modulates inflammation-related signaling pathways, showing significant inhibition of pro-inflammatory pathways [4][7] - The drug exhibited up to 76% statistically significant inhibition of LPS-induced IL-6 and TNFα cytokine production in assays using blood samples from healthy volunteers [8] Next Steps in Development - GENFIT plans to engage with regulatory authorities, including the U.S. FDA, to determine the best approach for advancing G1090N into Phase 2 proof-of-concept studies for inflammatory conditions like ACLF [4][7] Company Overview - GENFIT is a biopharmaceutical company focused on rare and life-threatening liver diseases, with over two decades of research and development experience [6][12] - The company has a history of developing high-potential molecules, including the recent accelerated approval of Iqirvo® (elafibranor) for Primary Biliary Cholangitis [10]

Core Insights - GENFIT reports encouraging preliminary Phase 1b data for GNS561 in combination with a MEK inhibitor for treating advanced KRAS mutated cholangiocarcinoma (CCA) [1][6] Clinical Trial Context and Objective - CCA is a rare and aggressive bile duct cancer with limited treatment options and poor prognosis [2] - GNS561 is an investigational small molecule targeting PPT1, aiming to inhibit autophagy and promote cancer cell death [2] - The ongoing Phase 1b study evaluates the safety and tolerability of GNS561 combined with trametinib, a MEK inhibitor, in patients who have failed prior therapies [2] Preliminary Results - The analysis included 9 patients, with 4 reaching tumor assessment at week 6, showing disease control and tumor reduction [3][6] - Disease stabilization was observed in all evaluated patients, with tumor shrinkage noted in a subgroup [7] Clinical Impact - The combination of GNS561 and MEK inhibitors shows potential to address critical unmet medical needs in oncology, particularly for patients with advanced solid tumors [4] - The consistent disease stabilization and tumor shrinkage suggest meaningful clinical benefits, warranting further investigation [4] Next Development Steps - Phase 1b dose escalation will continue, with new data expected in Q1 2026 to establish recommended Phase 2 doses [8] - Phase 2 initiation is targeted for the second half of 2026 [8] About GNS561 - GNS561 is a first-in-class investigational agent with a novel mechanism of action, developed for advanced solid tumors [10] - GENFIT acquired full intellectual property rights for GNS561 in early 2025, expanding its development capabilities [10] About GENFIT - GENFIT is a biopharmaceutical company focused on rare, life-threatening liver diseases, with a history of over two decades in liver disease research [12] - The company has a diverse R&D portfolio, including therapies for cholangiocarcinoma and other serious diseases [12]

Core Insights - GENFIT reports encouraging preliminary Phase 1b data for GNS561 in combination with a MEK inhibitor for treating advanced KRAS mutated cholangiocarcinoma (CCA) [1][6] Clinical Trial Context and Objective - CCA is a rare and aggressive bile duct cancer with limited treatment options and poor prognosis [2] - GNS561 is an investigational small molecule targeting PPT1, aiming to inhibit autophagy and promote cancer cell death [2] - The ongoing Phase 1b study evaluates the safety and tolerability of GNS561 combined with trametinib, a MEK inhibitor, in patients who have failed prior therapies [2] Preliminary Results - The analysis included 9 patients, with 4 reaching tumor assessment at week 6, showing disease control and tumor reduction [3][6] - Disease stabilization was observed in all evaluated patients, with tumor shrinkage noted in a subgroup [7] Clinical Impact - The combination of GNS561 and MEK inhibitors shows potential to address critical unmet medical needs in oncology, particularly for patients with advanced solid tumors [4] - The consistent disease stabilization and tumor shrinkage suggest meaningful clinical benefits, warranting further investigation [4] Next Development Steps - Phase 1b dose escalation will continue, with new data expected in Q1 2026 to establish recommended Phase 2 doses [8] - Phase 2 initiation is targeted for the second half of 2026 [8] About GNS561 - GNS561 is a first-in-class investigational agent with a novel mechanism of action, developed for advanced solid tumors [10] - GENFIT acquired full intellectual property rights for GNS561 in early 2025, expanding its development capabilities [10] About GENFIT - GENFIT is a biopharmaceutical company focused on rare, life-threatening liver diseases, with a history of over two decades in liver disease research [12] - The company has a diverse R&D portfolio, including therapies for cholangiocarcinoma and other serious diseases [12]

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 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]