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 ...

PBC program (licensed to Ipsen): Ipsen to present new data on elafibranor at The Liver Meeting® 2024Launch of Iqirvo® (elafibranor)1 on track with expectations; encouraging feedback from healthcare providers and payers in the U.S.UK NICE reimbursement approved and first reimbursed sales in Germany in October 2024Next €26.5M milestone payment by Ipsen pending a third pricing and reimbursement approval in Europe Scientific progress in ACLF to be featured at The Liver Meeting® 2024, with 4 posters presenting n ...

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].

131,000 shares €700 885.51 On the buy side: 2,256 On the sell side: 2,012 Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland) July 9, 2024 – 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 the half-year report of the liquidity contract with Crédit Industriel et Commercial. During this same period, the number of trades were: ABOUT GENFIT and our con ...

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), June 17, 2024 - 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 the inclusion of NIS2+® as a key tool for detecting at-risk MASH1 in the European Clinical Practice Guidelines on the management of metabolic dysfunction-associated steatotic liver disease (MASLD). The guidelines were developed as a ...

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), May 29, 2024 - 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 detailed its presence at the EASL Congress™ 2024. GENFIT accelerates its research in Acute on-Chronic Liver Failure (ACLF) EF CLIF and GENFIT partnership event GENFIT will co-host an event with the European Foundation for the Study of Chronic L ...