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 ...

一、公司PBC项目进展 - Ipsen的elafibranor（Iqirvo®）在美国和欧洲有积极商业和监管进展，美国6月10日获批后上市进展顺利，欧洲方面9月20日获EMA批准、10月9日获英国MHRA批准、10月22日获英国NICE批准[3] - 德国和英国的近期报销使公司更接近2650万欧元的里程碑付款（需欧洲主要国家第三次定价和报销批准）[3] 二、公司ACLF业务发展 - 公司将在2024年肝脏会议展示ACLF相关的临床前数据（4个海报）和主导3个关键活动（涉及专家、患者等多方参与）[4][5] - 过去12个月公司在理解ACLF连续体方面取得进展，相关成果将为正在进行和即将进行的试验设计提供信息[6][7] - UNVEIL - IT®试验因入组低于预期修改协议，预计2025年下半年出结果，改进措施包括调整入组标准和解决新技术相关后勤挑战[8] - 通过对美国超27万患者医疗索赔数据的深度分析（利用AI和机器学习技术），获得ACLF特定患者亚群风险概况等关键见解[9] - 与专家建立新的临床前模型，已生成的数据涵盖多种疾病模型和配方，以支持战略决策[10] - 与相关学会合作（如EF CLIF、美国专家等），通过独特数据源获得重要见解并加速与领域内关键领导者的讨论[11] - 预计2025年底有4个临床试验的数据读出，2025年上半年将启动3个新临床试验（评估VS - 01、NTZ和SRT - 015）[12] - 预计2025年底获得UNVEIL - IT试验的2期数据，同时推进ACLF管线中的3个临床阶段资产[13] - CLM - 022预计2024年底获得临床前概念验证，VS - 02 - HE预计2025年完成IND启用研究[13] 三、公司GNS561在KRAS突变胆管癌中的进展 - 1b/2a期临床试验正在进行，预计2024年底获得1b期初步数据，2025年底获得最终数据[13] 四、公司NIS2+®在MASH中的进展 - 公司将在2024年肝脏会议展示NIS2+®作为MASH患者监测工具的新数据（3个海报）[14] - 自2024年6月NIS2+®被认可为检测高危MASH的关键工具以来取得重大进展，技术已涵盖筛查、监测需求，超20个临床MASH试验使用该技术，更多出版物提及[14] - 公司目标是开发NIS2+®的IVD版本（与商业伙伴合作或自主开发）[14] 五、公司概况 - 公司是致力于改善罕见和危及生命肝病患者生活的晚期生物制药公司，有20多年的肝病研发历史[15] - 公司建立了多元化且快速扩张的研发组合，专注于ACLF，其ACLF业务包括5个在研资产，还有针对其他严重疾病的资产，在分子开发和商业化前有专长（如elafibranor的加速批准）[15] - 公司除疗法外还有诊断业务（如NIS2+®在MASH中的应用和TS - 01关注血氨水平）[16] - 公司总部位于法国里尔，在巴黎、苏黎世、美国剑桥设有办事处，在纳斯达克和泛欧交易所上市，2021年Ipsen成为最大股东之一（持股8%）[16]

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 ...

| --- | --- | |-------|---------------------------------------------| | | | | | and Financial Report at June 30, 2024 | Table of Contents | --- | --- | --- | |-------|-------------------------------------------------------------------------------------------------------------|-------| | | | | | | | | | 1. | OVERVIEW OF THE GROUP AND ITS MAIN R&D PROGRAMS | 2 | | 2. | HALF-YEAR MANAGEMENT REPORT | 4 | | 2.1 | Key Events of the First Half of 2024 and Main Events after the Reporting Period | 4 | | 2.2 | Strate ...

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 ...

Quorum of 27.25% on first convening; allowing approval of all the resolutions Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), May 22, 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 results of the Combined Shareholders Meeting which took place on May 22, 2024. The quorum on first convening amounted to 27.25% and shareholders approve ...

Exhibit 99.1 GENFIT Announces Publication of the 2023 Universal Registration Document and the 2023 Annual Report on Form 20-F GENFIT's 2023 Universal Registration Document includes, in particular: ABOUT GENFIT GENFIT is a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases characterized by high unmet medical needs. GENFIT is a pioneer in liver disease research and development with a rich history and strong scientific heritage spanni ...