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]

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 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 Points - GENFIT has announced the effective voluntary delisting of its American Depositary Shares (ADSs) from the Nasdaq Global Select Market, with each ADS representing one ordinary share of the company [1] - The company has filed a Form 15F with the SEC to suspend its reporting obligations under the Securities Exchange Act of 1934, with the deregistration expected to be effective 90 days after the filing [1] Company Information - GENFIT is a biopharmaceutical company focused on improving the lives of patients with rare and life-threatening liver diseases, with a history of over two decades in liver disease research and development [7] - The company is headquartered in Lille, France, and has additional offices in Paris, Zurich, and Cambridge, MA [11] - GENFIT's R&D portfolio includes therapeutic assets targeting conditions such as Acute on-chronic Liver Failure (ACLF), cholangiocarcinoma (CCA), and urea cycle disorders (UCD) [8] ADS Holder Information - The Bank of New York Mellon serves as the depositary for GENFIT's ADS facility, and the company intends to terminate the Deposit Agreement on or about February 6, 2026 [2] - ADS holders have until February 9, 2026, to surrender their ADSs for the underlying ordinary shares, with applicable fees for cancellation and cable services [3] - After February 9, 2026, the depositary may sell the underlying ordinary shares, and ADS holders must surrender their securities to obtain payment of the sale proceeds, net of expenses [4][6]

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]