Core Viewpoint - GENFIT is actively participating in the EASL Annual Congress 2025, showcasing its commitment to advancing research in Acute-on-Chronic Liver Failure (ACLF) through six poster presentations and various events aimed at enhancing awareness and collaboration within the hepatology community [1][24]. Posters - Six posters accepted for presentation at the EASL Congress focus on GENFIT's assets related to ACLF, including real-world data research [2]. - Poster 1 discusses the investigational drug VS-01 and its effects on metabolite accumulation in patients with acutely decompensated liver cirrhosis [3]. - Poster 2 presents findings on the efficacy of the ASK1 inhibitor SRT-015 in disease models [4]. - Poster 3 highlights CLM-022 as a potential treatment for inflammatory liver diseases [4]. - Poster 4 examines NTZ's role in alleviating hepatocyte cell death in ACLF models [5]. - Poster 5 utilizes a machine-learning algorithm to identify at-risk subpopulations in ACLF patients [6]. - Poster 6 focuses on the development of models for detecting MASH resolution and fibrosis improvement [7]. Events - GENFIT will participate in an EASL Studio session discussing ACLF, moderated by Professor Debbie Shawcross, with industry representatives including GENFIT and Boehringer Ingelheim [8]. - A co-hosted event with EF CLIF on May 7, 2025, will explore scientific insights and updates on GENFIT's ACLF pipeline [10]. - A KOL ACLF Advisory Board meeting will facilitate discussions on collaboration opportunities and data-driven decision-making [11]. - An UNVEIL-IT® study meeting will take place on May 8, 2025, involving key opinion leaders and investigators in ACLF [13]. - A new ACLF Patient Advocacy Council session will focus on awareness and regulatory engagement from a patient perspective [14]. - GENFIT will engage in a roundtable discussion on the use of AI tools in hepatology drug development [15]. About ACLF - ACLF is characterized by hepatic and extrahepatic organ dysfunctions, with a high short-term mortality rate ranging from 23% to 74% within 28 days [18]. - The prevalence of ACLF was estimated at approximately 294,000 in the US, EU4, and UK in 2021, projected to reach around 300,000 by 2036 [18]. - The incidence of ACLF has been increasing at an epidemic rate, with a 26% rise between 2006 and 2014, attributed to factors such as an aging population and higher prevalence of liver diseases [18]. About GENFIT - GENFIT is a late-stage biopharmaceutical company focused on rare, life-threatening liver diseases, with a diverse R&D portfolio targeting ACLF [19]. - The company has five assets under development for ACLF, including VS-01, G1090N, SRT-015, CLM-022, and VS-02-HE, utilizing various mechanisms of action [19]. - GENFIT has a history of successful drug development, including the accelerated approval of elafibranor for Primary Biliary Cholangitis [21].

Core Points - GENFIT, a biopharmaceutical company, focuses on improving the lives of patients with rare and life-threatening liver diseases and has filed its 2024 Universal Registration Document and Annual Report on Form 20-F [1][2] Company Overview - GENFIT is dedicated to addressing unmet medical needs in liver diseases, particularly Acute-on-Chronic Liver Failure (ACLF), with a diverse R&D portfolio that includes five assets under development: VS-01, G1090N, SRT-015, CLM-022, and VS-02-HE [2] - The company has a strong history in liver disease research, with over two decades of experience and expertise in developing high-potential molecules, evidenced by the accelerated approval of Iqirvo (elafibranor) for Primary Biliary Cholangitis (PBC) [2] - GENFIT also has a diagnostic franchise targeting Metabolic dysfunction-associated steatohepatitis (MASH) and blood ammonia levels [2] Financial Reporting - The 2024 Universal Registration Document and the Annual Report on Form 20-F are publicly available for free on GENFIT's website and the websites of the AMF and SEC [2][5] - The annual financial report includes the annual management report, Board of Directors' report on corporate governance, and Statutory Auditors' reports on financial statements [4]

Regulatory Approvals and Market Authorization - Iqirvo® (elafibranor) received accelerated approval from the FDA in June 2024, conditional market approval from the European Commission in September 2024, and approval from the MHRA in October 2024[46]. - The marketing authorizations obtained for Iqirvo® (elafibranor) in PBC may not guarantee similar authorizations in other territories or for other indications[49]. - Regulatory approval does not guarantee marketing authorization in other countries or for different indications[54]. - The approval process for drug candidates in the US and EEA requires extensive preclinical and clinical data, which can be long and costly[50]. - Regulatory authorities may impose limitations on the indicated uses for approved products, affecting marketing strategies[71]. - Regulatory approvals may carry conditions that limit the market for products or impose warnings, making effective marketing more challenging[103]. - The company must comply with ongoing regulatory requirements, including safety reporting and quality control, which could impact operational efficiency[104]. Financial Performance and Revenue Generation - The company's future revenues and financial situation mainly depend on the commercial success of Iqirvo® (elafibranor) in PBC in the countries where it has marketing authorization[47]. - The company recorded a net loss of €28,894 thousand for the year ended December 31, 2023, compared to a net loss of €23,719 thousand for the year ended December 31, 2022[214]. - The company has never generated any direct profits from the sale of approved products and does not expect to become profitable from such sales in the foreseeable future[215]. - Significant revenue has come from one-time upfront payments received in 2019 under a license agreement with Terns Pharmaceuticals and milestone payments under a license agreement with Ipsen since 2021[216]. - Revenues from agreements with Labcorp/Covance for the use of NIS4® diagnostic technology have been insignificant, with future growth dependent on external factors[217]. - The collaboration and license agreement with Ipsen provides for additional regulatory and commercial milestones and significant royalties on net sales of Iqirvo® (elafibranor), but there is no assurance of timely achievement[215]. - The company’s ability to sustainably reduce losses and maintain shareholder equity is unproven and may never be achieved[213]. - Indirect revenues from royalty payments under licensing agreements depend on the success of development and marketing by partners[213]. Development Risks and Challenges - A significant part of the development pipeline results from the acquisition of licensing rights or intellectual property from other companies, which increases the risk associated with these programs[30]. - The company is currently developing drug candidates for ACLF, a condition with no approved treatments, which poses additional risks in patient recruitment for clinical trials[29]. - The company has limited experience in recruiting patients for clinical trials in ACLF, which may delay the development process[29]. - Development failure can occur at any stage of preclinical or clinical development, impacting the ability to receive regulatory approval[31]. - Delays in clinical trials could significantly increase product development costs, impairing financing capacity and limiting regulatory approvals[44]. - The company faces risks related to combination treatments, including potential withdrawal of approval for existing treatments used in combination[57]. - The company faces significant risks if it cannot establish its own sales, marketing, and distribution capabilities, which could lead to lower revenue and profitability[102]. - The company relies heavily on third-party contractors for clinical trials and manufacturing, which may lead to increased costs and delays if these parties fail to meet obligations[127]. Intellectual Property and Patent Challenges - The company invests significant resources in obtaining and maintaining patent protection, which is essential for its competitive advantage and profitability[167]. - Patent applications are costly and time-consuming, and failure to secure adequate patent protection could harm the company's ability to commercialize its product candidates[169]. - Changes in patent law, such as the transition to a "first-to-file" system, may negatively impact the company's ability to obtain and enforce patents[174]. - The company may face challenges in patent litigation, including the risk of patents being found invalid or unenforceable, which could harm its business[172]. - The company expects to seek extensions of patent terms under the Hatch-Waxman Amendments, which could be critical for its product candidates[177]. - The company relies on trade secret protection for proprietary technology, but such protection is difficult to enforce, and breaches could harm its competitive position[179]. - The company faces challenges in enforcing intellectual property rights globally, as legal protections vary significantly by jurisdiction, particularly in developing countries[185]. Market Acceptance and Competitive Landscape - The competitive landscape includes drugs like Gilead's Livdelzi® for PBC, which could significantly influence the market acceptance of elafibranor and other candidates[97]. - Market acceptance of Iqirvo® (elafibranor) and other products will depend on their acceptance among the medical community and healthcare payors[98]. - The company may face challenges in establishing sales, marketing, and distribution capabilities for elafibranor and other product candidates if they are approved[99]. - Government pricing restrictions and reimbursement policies may negatively affect the company's revenue generation capabilities[115]. - Coverage and adequate reimbursement from third-party payors are critical for the acceptance of new products, and variability in these factors can significantly impact demand[116]. - Legislative changes, such as the Inflation Reduction Act of 2022, may impose additional pricing pressures and affect the company's ability to raise prices[119]. Cybersecurity and Data Privacy Risks - The company’s internal IT systems and those of its collaborators may be vulnerable to security breaches, potentially disrupting product development and commercialization[160]. - The company collects and stores sensitive data, including legally protected patient health information and personally identifiable information, which poses risks of data breaches and cybersecurity incidents[161]. - The complexity and number of cybersecurity threats are increasing, potentially harming market perception and leading to regulatory actions or private litigation related to data privacy[163]. - The company faces risks related to the misappropriation and leakage of critical data maintained in its information systems and those of its vendors[162]. - Compliance with data privacy laws in the U.S. and EU, and breaches could negatively impact its operations[197]. Strategic Collaborations and Partnerships - The company may need to collaborate with third parties to advance product candidates due to limited access to capital[75]. - The company has exclusive licensing agreements with Ipsen for elafibranor and with Labcorp and Q2 for NIS4® technology, which may not guarantee revenue generation[140]. - The company faces risks related to collaborations, including potential failure to achieve widespread clinical or commercial use of products developed with partners like Labcorp, Ipsen, and Terns Pharmaceuticals[144]. - Future collaborations may require additional expenditures and could dilute existing shareholders[142]. - The company has entered into a licensing agreement with Seal Rock Therapeutics for exclusive worldwide rights to the ASK1 inhibitor SRT-015, aimed at developing an injectable formulation for acute liver disease and ACLF[158]. - In May 2023, the company also entered into a licensing agreement with Celloram for worldwide rights to the inflammasome inhibitor CLM-022, targeting liver diseases and ACLF, with potential milestone payments and royalties[158]. Operational and Compliance Challenges - The company must invest significant resources in regulatory compliance to maintain approvals for its product candidates[114]. - The company faces penalties and enforcement actions if it fails to comply with regulatory obligations, which could adversely affect its business[113]. - The company faces risks related to compliance with various data protection laws, which could increase operational costs and complexity[206]. - Compliance with healthcare laws and regulations is costly and non-compliance could lead to severe penalties, including exclusion from government-funded healthcare programs[196]. - The company may face challenges in attracting and retaining qualified personnel, which is critical for its success in new therapeutic areas[153].

Core Insights - GENFIT announced that Ipsen will present late-breaking data on elafibranor, demonstrating a favorable safety profile and significant efficacy in treating Primary Sclerosing Cholangitis (PSC) at the EASL Congress on May 10, 2025 [1][4] Efficacy Results - The Phase 2 ELMWOOD trial results showed that patients on elafibranor experienced significant dose-dependent reductions in alkaline phosphatase (ALP) levels, with reductions of −103.2 U/L and −171.1 U/L for the 80 mg and 120 mg doses respectively, compared to a placebo increase of +32.1 U/L (p < 0.0001) [2] - Improvements in other liver biochemical parameters, including alanine aminotransferase (ALT) and gamma-glutamyl transferase (GGT), were also observed, indicating a positive impact on disease progression [2] - Patients on elafibranor showed stabilization in Enhanced Liver Fibrosis (ELF) at week 12 compared to placebo [2] - The 120 mg dose of elafibranor led to significant improvements in pruritus, as measured by the Worst Itch Numeric Rating Scale (WI NRS), with scores of -0.96 versus -0.28 for placebo (p < 0.05) [2] Product Information - Elafibranor is a first-in-class oral peroxisome proliferator-activated receptor (PPAR) agonist, which has been marketed in the U.S., EU, and UK under the trademark Iqirvo® since June 2024 for Primary Biliary Cholangitis (PBC) [3][6] - The drug was developed by GENFIT and licensed to Ipsen in 2021, with exclusive worldwide rights except for certain regions in Asia [3][6] Company Overview - GENFIT is a biopharmaceutical company focused on rare and life-threatening liver diseases, with a strong emphasis on research and development [7] - The company has a diversified R&D portfolio, including assets targeting Acute-on-Chronic Liver Failure (ACLF) and other serious diseases [8] - GENFIT has established a diagnostic franchise, demonstrating its commitment to addressing unmet medical needs in liver disease [8]

Core Viewpoint - GENFIT has successfully completed a royalty financing transaction with HealthCare Royalty (HCRx), providing significant financial resources to support its development programs and reduce convertible debt burden without dilution for shareholders [1][2][3]. Financial Transaction Details - The royalty financing includes an upfront payment of €130 million, with the potential for an additional €55 million contingent on achieving near-term milestones [3][7]. - GENFIT will repurchase 1,882,891 of its 2025 OCEANEs at a price of €32.75 per bond, totaling approximately €61.66 million, which represents 99% of the outstanding OCEANEs [6][7]. - The repurchase is expected to reduce GENFIT's convertible debt to €586 thousand [7]. Future Financial Outlook - The financing arrangement extends GENFIT's cash runway beyond 2027, allowing the company to fund its operating expenses and capital expenditures [4][7]. - The company anticipates receiving significant milestone revenue in 2025, including a €26.55 million milestone pending regulatory approval for Iqirvo® (elafibranor) [4][5]. Pipeline Development - With the new financial backing, GENFIT is positioned to advance its Acute-on-Chronic Liver Failure (ACLF) pipeline, which includes several promising assets at various stages of development [5][7]. - The company retains rights to receive regulatory, commercial, and sales-based milestone payments under its agreement with Ipsen [3][4]. Repurchase Implementation - The settlement of the repurchase is scheduled for March 26, 2025, and the repurchased OCEANEs will be canceled [8]. - A consent fee of €0.90 per bond will be paid on April 14, 2025, to bondholders who participated in the repurchase [9].

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].

Cash Position - As of December 31, 2024, the company's cash and cash equivalents amounted to €81.8 million, an increase from €77.8 million as of December 31, 2023, but a decrease from €96.0 million as of September 30, 2024 [1][8] Revenue Performance - Revenues for 2024 reached €67.0 million, significantly up from €28.6 million in 2023 [4][8] - The revenue breakdown for 2024 includes €48.7 million from a milestone payment invoiced to Ipsen, €2.7 million from royalty revenue from U.S. sales of Iqirvo/elafibranor, €15.3 million from the partial recognition of deferred income, and €0.1 million from services rendered under Transition Services Agreements [5][8] Strategic Partnerships and Financing - The company received a €48.7 million milestone in August 2024 as part of its long-term strategic partnership with Ipsen, which was established in December 2021 [2] - A royalty financing deal was signed, providing up to €185 million in non-dilutive capital to fund operating expenses and capital expenditures beyond the end of 2027, contingent on future milestone revenues and approvals [3] Upcoming Financial Communications - The company plans to release its full-year 2024 financial results on April 24, 2025, along with the 2024 Universal Registration Document and the Annual Report on Form 20-F by the end of April 2025 [9]

Put Option Agreements signed to date with 2025 OCEANEs holders representing 95.3% of the outstanding 2025 OCEANEs2025 OCEANEs holders' general meeting convened for March 10, 2025 Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), February 21, 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 it has signed Put Option Agreements with 2025 OCEANEs ho ...

Core Viewpoint - GENFIT has amended the final terms of its dual proposal to the holders of the 2025 OCEANEs, which includes a repurchase offer and a consent fee for outstanding bonds after the repurchase [1][19]. Financial Context - On January 30, 2025, GENFIT entered into a non-dilutive capped royalty financing agreement with HealthCare Royalty for up to €185 million, significantly extending its cash runway [2]. - The financing will be repaid from royalties on sales of Iqirvo® (elafibranor) under a partnership with Ipsen [3]. Terms of the Proposal - The proposal includes amending the negative pledge clause of the 2025 OCEANEs to allow GENFIT to grant security interests, which is necessary for the closing of the royalty financing [4]. - GENFIT proposes to repurchase the 2025 OCEANEs at €32.75 per bond or alternatively pay a consent fee of €0.90 per bond for those still outstanding after the repurchase [7][8]. Approval Process - Both the repurchase and consent fee are contingent upon the approval of the Amendment of Terms by the general meeting of the 2025 OCEANEs holders and the closing of the royalty financing [10]. - A general meeting of the 2025 OCEANEs holders is expected to be convened in early March 2025 to discuss these proposals [14]. Additional Information - GENFIT has a clean-up call option at par if the total number of outstanding 2025 OCEANEs falls to 15% or less of the originally issued amount [13]. - The company is committed to not exercising this option until the 2025 OCEANEs reach maturity [13].

Core Viewpoint - GENFIT has announced the final terms for a dual proposal to the holders of its 2025 OCEANEs, which includes a repurchase offer and a consent fee, following a non-dilutive capped royalty financing agreement with HealthCare Royalty for up to €185 million [2][19]. Group 1: Royalty Financing and Cash Runway - The Royalty Financing agreement with HealthCare Royalty (HCRx) allows GENFIT to extend its cash runway significantly, even after repaying its convertible bonds due on October 16, 2025 [2]. - HCRx will be compensated through a portion of the royalties from the sales of Iqirvo® (elafibranor) under a strategic partnership with Ipsen [3]. Group 2: Terms of the 2025 OCEANEs - The 2025 OCEANEs contain a negative pledge clause that restricts GENFIT from granting security interests on its assets, which necessitates an amendment for the Royalty Financing to proceed [4]. - GENFIT proposes to repurchase the 2025 OCEANEs at €32.00 per bond or alternatively pay a consent fee of €0.60 per bond for those still outstanding after the bondholder meeting [7][8]. Group 3: Consent and Repurchase Process - The repurchase and consent fee proposals are contingent upon the approval of the Amendment of Terms by the general meeting of the 2025 OCEANEs holders and the closing of the Royalty Financing [9][13]. - Holders who do not enter into the Put Option Agreement or do not exercise their option will receive the consent fee after the repurchase [9][11]. Group 4: Future Steps and Meetings - GENFIT plans to convene a general meeting of the 2025 OCEANEs holders in early March to discuss the proposals, with a Consent Solicitation Memorandum to be published [13]. - The results of the general meeting and the closing of the Royalty Financing will be communicated in subsequent press releases [13].