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 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]

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Core Insights - Ipsen announced new data on IQIRVO (elafibranor) at the European Association for the Study of the Liver congress, highlighting its efficacy in treating primary biliary cholangitis (PBC) [1] Group 1: Clinical Data and Efficacy - Additional analyses from the ELATIVE study indicate that patients with PBC treated with IQIRVO experienced greater improvements in fatigue after 52 weeks compared to placebo, with 42.9% of IQIRVO patients showing improvement versus 31.3% in the placebo group [2] - Among patients with moderate-to-severe fatigue at baseline, 66.7% of those treated with IQIRVO achieved clinically meaningful improvements, compared to 31.3% in the placebo group [2] - The positive effect of IQIRVO on fatigue appears to occur independently of its effect on pruritus [2] Group 2: Mechanistic Insights - A comprehensive proteomic analysis revealed changes in the expression of over 20 proteins involved in inflammation, immune response, and key symptomatic domains of PBC, including fatigue, in patients treated with IQIRVO [3] - The observed effects on fatigue-associated proteomic signatures are linked to PPARα activation [3][6] Group 3: Treatment Context and Approvals - IQIRVO is an oral, once-daily PPAR agonist that improves cholestasis and has anti-inflammatory effects, and it was granted Breakthrough Therapy Designation by the FDA in 2019 [5] - The drug received accelerated approval from the FDA in June 2024, conditional approval from the European Commission in September 2024, and approval from the UK MHRA in October 2024 for treating PBC in adults with inadequate response to UDCA [5] - Ipsen licensed the exclusive worldwide rights to elafibranor from GENFIT in 2021, and IQIRVO is currently undergoing regulatory processes with other authorities [5] Group 4: Disease Context - PBC is a rare autoimmune liver disease affecting approximately 100,000 people in the US and 165,000 in Europe, predominantly women, and can lead to severe complications if untreated [4]

Core Viewpoint - GENFIT successfully obtained unanimous approval from bondholders for all proposed resolutions regarding the 2025 OCEANEs, enabling the company to proceed with the Royalty Financing and related transactions [1][3]. Bondholder Meeting Results - The bondholders' meeting for the 2025 OCEANEs was held on March 10, 2025, with a quorum of 95.79% and 100% of votes cast in favor of the resolutions [3]. - The approval allows GENFIT to amend the negative pledge clause, facilitating the Royalty Financing with HCRx [2][3]. Royalty Financing and Repurchase Agreement - The Royalty Financing, signed on January 30, 2025, is contingent upon the bondholders' approval of the amendment to the negative pledge clause [2]. - GENFIT proposed a Put Option Agreement to bondholders, offering to repurchase the 2025 OCEANEs at EUR 32.75 per bond, with a deadline for exercising this option set for March 19, 2025 [4][8]. - The settlement for the repurchase is expected on March 26, 2025, and the repurchased bonds will be canceled [5]. Consent Fee Payment - A consent fee of EUR 0.90 will be paid to holders of the outstanding 2025 OCEANEs after the repurchase, with payment expected on April 14, 2025 [6][7]. Upcoming Events Timeline - Key dates include: - March 19, 2025: Deadline for exercising the put option - March 26, 2025: Repurchase settlement date - April 14, 2025: Payment of the consent fee [8]. Company Overview - GENFIT is a biopharmaceutical company focused on rare and life-threatening liver diseases, with a diverse R&D portfolio including five assets under development for Acute-on-Chronic Liver Failure (ACLF) [9]. - The company has a strong history in liver disease research and has achieved accelerated approval for its drug Iqirvo® (elafibranor) for Primary Biliary Cholangitis (PBC) [9].