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].

Core Insights - GENFIT is advancing its Acute on-Chronic Liver Failure (ACLF) pipeline with new clinical trials set to launch in early 2025, aiming for multiple data readouts by the end of the year [1][2][6] Clinical Trials and Data Readouts - Two new clinical trials are expected to initiate in the first quarter of 2025, focusing on VS-01 and G1090N, a new formulation of NTZ [2][6] - A total of four clinical data readouts are anticipated by the end of 2025, including results from the ongoing UNVEIL-IT® Phase 2 trial and the GNS561 Phase 1b trial in cholangiocarcinoma [2][10] - The first trial will be a proof-of-concept study for VS-01, while the second will confirm the commitment to NTZ with G1090N [5][8] Strategic Development and Insights - The design of the new trials is informed by real-world evidence from over 270,000 U.S. patients, which has provided insights into ACLF risk profiles and management practices [2][7] - The trials will include a subset of patients with acute decompensation (AD) at high risk of progressing to ACLF, broadening the inclusion criteria to address both stages of the disease [3][4] - The integrated approach aims to facilitate faster patient recruitment and a more efficient assessment of drug candidates' therapeutic potential [3][4] Collaboration and Expert Insights - Collaboration with academic partners and insights from key opinion leaders (KOLs) have shaped the strategic direction of the ACLF pipeline [7][4] - KOLs emphasize the importance of including high-risk patients in clinical trials due to their rapid transition between AD and ACLF [4][5] Financial Outlook - GENFIT has announced a strengthened financial outlook, which, along with the anticipated clinical developments, positions the company for robust operations in the coming years [2][10]

GENFIT signs royalty financing deal with HealthCare Royalty (HCRx) providing up to €185 million non-dilutive capital: €130 million upfront, with eligibility to receive up to €55 million in two additional instalments based on near-term milestonesClosing subject to approval by the 2025 OCEANE bondholders at upcoming bondholders meetingFinancing would extend cash runway beyond the end of 2027, assuming drawdown of all instalmentsProceeds to further strengthen the development of the ACLF pipeline In return, HCR ...

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), January 29, 2025 - GENFIT (Nasdaq and 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 2025. 2025 Financial Calendar February 27, 2025 Publication of revenue and cash position at December 31, 2024 April 24, 2025 Publication of Full Year 2024 financial statements   The 2024 ...

Cash and cash equivalents totaled €96.0 million as of September 30, 2024€59.7 million in revenues for the nine months ended September 30, 2024, including the €48.7 million milestone invoiced in June 2024 (received in August 2024) upon first sale of Ipsen’s Iqirvo® (elafibranor) in the U.S. for the treatment of Primary Biliary Cholangitis (PBC)  Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland); November 7, 2024 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical ...

Financial Performance - Total revenues and other income for the half-year ended June 30, 2024, amounted to €61,199, a significant increase from €15,374 in the same period in 2023, representing a growth of approximately 297%[37]. - Revenue for the half-year ended June 30, 2024, was €58,973, compared to €11,482 for the same period in 2023, indicating a growth of about 414%[38]. - The licensing agreement with Ipsen contributed €48.7 million in milestone revenue following the first commercial sale of Iqirvo®/elafibranor in the U.S. during the first six months of 2024[38]. - The company reported a net profit of €30.3 million for the first half of 2024, compared to a net loss of €20.9 million in the first half of 2023[53]. - Cash flow used in operating activities improved to an outflow of €11.2 million in the first half of 2024 from an outflow of €25.1 million in the first half of 2023[55][56]. - 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[142]. - The company has never generated significant recurring revenue from product sales and does not expect to achieve profitability in the foreseeable future[141]. - The company reported a decrease in cash and cash equivalents to €61,645 thousand at the end of June 30, 2024, down from €111,826 thousand at the beginning of the period[172]. Product Development and Approvals - Iqirvo®/elafibranor received U.S. FDA accelerated approval as a first-in-class treatment for Primary Biliary Cholangitis (PBC) on June 10, 2024[13]. - The approval of Iqirvo® is based on the reduction of alkaline phosphatase (ALP), with ongoing requirements for confirmatory trials to verify clinical benefits[15]. - The company is developing several drug candidates for ACLF, a condition with no approved treatments, increasing the risks associated with their clinical development[71]. - The FDA granted accelerated approval for Iqirvo®/elafibranor for the treatment of PBC in June 2024, but it is not approved in other territories[88]. - The company is exploring accelerated regulatory approval pathways for GNS561 in Cholangiocarcinoma and VS-01 in ACLF, leveraging Orphan Drug Designation from the FDA[101]. - The successful commercialization of Iqirvo®/elafibranor in PBC in the U.S. is crucial for the company's near and medium-term capital resources[102]. Research and Development - GENFIT's R&D pipeline includes five assets targeting Acute-on-Chronic Liver Failure (ACLF) and two assets for other life-threatening diseases[9]. - The company has a diversified R&D portfolio with a focus on rare liver diseases characterized by unmet medical needs[5]. - For the first half of 2024, research and development expenses totaled €19.0 million, a decrease from €25.6 million in the same period of 2023[43][44]. - The company is focused on developing innovative drugs and diagnostic tools for metabolic, inflammatory, autoimmune, and fibrotic diseases, particularly those affecting the liver[174]. Financial Outlook and Risks - GENFIT expects to receive future milestone revenue of approximately €26.5 million, in addition to €13.3 million and €48.7 million already received in February and August 2024, respectively[35]. - The company faces significant challenges in patient enrollment for clinical trials due to the rarity of conditions like ACLF and CCA, which may delay trial timelines[86]. - The company acknowledges that development failures can occur at any stage, impacting the ability to obtain regulatory approvals[79]. - The company may need to incur additional debt to meet future financing needs, which could affect its ability to repay existing obligations[161]. - The company has a history of recorded losses, except for the year ended December 31, 2021, and expects to continue incurring losses as it develops its product candidates[148]. Collaborations and Partnerships - Ipsen's licensing agreement for elafibranor includes milestone payments and royalties on sales, enhancing GENFIT's revenue stream[10]. - The collaboration with Ipsen has resulted in significant milestone payments linked to the development and commercialization of Iqirvo®/elafibranor in PBC, but there is no assurance of timely realization of these payments[143]. Market and Regulatory Environment - The commercial success of Iqirvo®/elafibranor will depend on acceptance among the medical community, given the limited number of approved treatments for PBC[118]. - Regulatory authorities may impose additional conditions or require more data before granting approvals, impacting the timeline for market entry[112]. - Government pricing restrictions and healthcare payor initiatives may negatively impact revenue generation even with regulatory approvals[122]. - The market acceptance of the company's product candidates will be influenced by competition, clinical safety, efficacy, and reimbursement availability[119].