Elafibranor

Cash and cash equivalents totaled €101.1 million as of December 31, 2025 Revenues amounted to €65.4 million as of December 31, 2025 Ipsen’s strong performance with Iqirvo® in PBC (>$200M net sales in year one) triggered GENFIT’s €17.0 million ($20.0 million) milestone, included in reported revenues, but not yet reflected in the cash position ACLF and CCA programs progressing according to plan Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), February 26, 2026 - GENFIT (Euronext: GNFT), a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announces its fourth quarter 2025 revenues and cash position results1 and provides a corporate update. I. Cash position As of December 31, 2025, the Company’s cash and cash equivalents amounted to €101.1 million compared with €81.8 million as of December 31, 2024 and €119.0 million as of September 30, 2025. In 2025, cash utilization is mainly the result of our research and development efforts in our Acute on-Chronic Liver Failure (ACLF) franchise (notably VS-01, NTZ/G1090N, SRT-015, CLM-022, and VS-02 HE), as well as GNS561 in cholangiocarcinoma (CCA). Cash utilization is offset notably by the €26.55 million milestone received in July 2025 (invoiced in May 2025) upon pricing and reimbursement approval of Iqirvo® (elafibranor) in Italy, the third major European country to do so, as part of our long-term strategic partnership with Ipsen (the “Ipsen Agreement”) signed in December 2021. In January 2026, GENFIT exercised its option to receive (and did in fact receive) the second installment of the Royalty Financing agreement totaling €30.0 million. Both this amount, as well as the first commercial milestone of €17.0 million ($20.0 million) that GENFIT will receive as part of the Ipsen Agreement, are not included in cash and cash equivalents as of December 31, 2025. We expect that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements beyond the end of 2028, enabling the Company to further develop its R&D pipeline focused on ACLF and support general corporate purposes. This is based on current assumptions and programs and does not include exceptional events. This estimation assumes (i) our expectation to receive significant future commercial milestone revenue pursuant to the Ipsen Agreement and Ipsen meeting its sales-based thresholds and (ii) drawing down the third and final, optional installment under the Royalty Financing agreement. RevenueRevenues for 2025 amounted to €65.4 million compared to €67.0 million for the same period in 2024. Royalty revenue is entirely attributable to worldwide sales of Iqirvo® (elafibranor), which amounted to $208 million in 2025. Milestone revenue in 2025 is comprised of two milestones: GENFIT’s first commercial milestone of €17.0 million ($20.0 million) after Ipsen’s Iqirvo® exceeded the $200 million threshold in its first full year of net sales, and GENFIT’s milestone of €26.55 million upon pricing and reimbursement approval of Iqirvo® (elafibranor) in Italy, the third major European country to do so. II. Corporate update and program highlights Acute On-Chronic Liver Failure (ACLF) The key highlight for this pipeline segment in the fourth quarter 2025 was the progress of our lead program, G1090N, which generated preliminary Phase 1 data readout showing a safety profile and a robust anti-Inflammatory activity evidenced through functional ex vivo assays on blood samples from study participants and cirrhotic donors. As communicated earlier, GENFIT will engage with regulatory authorities to determine the best approach for progressing to a Phase 2 proof-of-concept in inflammatory conditions such as ACLF, where systemic immune dysregulation is a critical driver of disease progression. Other assets developed to address the unmet medical need in ACLF continued their preclinical evaluation during the fourth quarter of 2025 to fully assess their potential before advancing into clinical development. Cholangiocarcinoma (CCA) The main highlight in this indication in the fourth quarter of 2025 was the highly encouraging early data delivered from the ongoing Phase 1b study evaluating investigational drug GNS561 with a MEK inhibitor (MEKi) in KRAS mutated CCA, positioning this novel combination as a potential new therapeutic approach for difficult-to-treat cancers. Phase 1b dose escalation continues as planned to confirm the activity signal, with new data for next patient cohorts and recommended Phase 2 combination doses expected in the first half of 2026. Phase 2 initiation remains targeted for the second half of 2026. Ipsen’s Iqirvo® (elafibranor) in Primary Biliary Cholangitis (PBC) and Primary Sclerosing Cholangitis (PSC) PBC: Iqirvo®’s net sales for the fourth quarter 2025 amounted to $88 million, bringing full-year 2025 sales to $208 million, triggering the first commercial milestone payment to GENFIT one year ahead of schedule. PSC: Ipsen confirmed the initiation of the first and only global Phase 3 clinical trial, addressing a significant unmet medical need, as no approved therapies currently exist for this severe and progressive disease. PSC represents a substantial untapped market opportunity, comparable in size to second line PBC. Should Iqirvo® ultimately receive regulatory approval for this indication, GENFIT would be eligible for additional milestone payments as well as additional double‑digit royalties. END ABOUT GENFIT GENFIT is a biopharmaceutical company committed to improving the lives of patients with rare, life-threatening liver diseases whose medical needs remain largely unmet. GENFIT is a pioneer in liver disease research and development with a rich history and a solid scientific heritage spanning more than two decades. Today, GENFIT focuses on Acute on-chronic Liver Failure (ACLF) and associated conditions such as acute decompensation (AD) and hepatic encephalopathy (HE). It develops therapeutic assets which have complementary mechanisms of action, selected to address key pathophysiological pathways. GENFIT also targets other serious diseases, such as cholangiocarcinoma (CCA), urea cycle disorders (UCD) and organic acidemia (OA). Its R&D portfolio, covering several stages of development, ensures a constant news flow. GENFIT's expertise in developing high-potential molecules – from early to advanced pre-commercialization stages – culminated in 2024 with the accelerated approval of Iqirvo® (elafibranor) by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom for the treatment of Primary Biliary Cholangitis (PBC). Iqirvo® is now marketed in several countries.2 Beyond therapies, GENFIT also has a diagnostic franchise including NIS2+® for the detection of Metabolic dysfunction-associated steatohepatitis (MASH, formerly known as NASH for non-alcoholic steatohepatitis). GENFIT, a BCorp™ certified company since 2025, is headquartered in Lille, France and has offices in Paris (France), Zurich (Switzerland) and Cambridge, MA (USA). The Company is listed on the Euronext regulated market in Paris, Compartment B (Euronext: GNFT). In 2021, Ipsen became one of GENFIT's largest shareholders, acquiring an 8% stake in the Company's capital. www.genfit.com FORWARD LOOKING STATEMENTS This press release contains certain forward-looking statements with respect to GENFIT, including, but not limited to, statements about the Company’s cash runway and the development of its clinical and preclinical programs, to the timelines for obtaining results from ongoing studies and initiating upcoming studies, to upcoming discussions with regulatory authorities, to the potential regulatory approval of its product candidates, and to the projected sales of Iqirvo® in PSC should it be approved for this indication. The use of certain words, such as "believe", "potential", "expect", “target”, “may”, “will”, "should", "could", "if" and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on the current expectations and reasonable assumptions of the Company’s management, these forward-looking statements are subject to numerous known and unknown risks and uncertainties, which could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking statements. These risks and uncertainties include, among others, the uncertainties inherent in research and development, including in relation to non-clinical and pre-clinical programs, reproducibility of preclinical results, the translation of animal model data to human biology, in relation to safety of drug candidates, cost of, progression of, and results from, our ongoing and planned clinical trials, patient recruitment, review and approvals by regulatory authorities in the United States, Europe and worldwide, of our drug and diagnostic candidates, pricing, approval and commercial success of elafibranor in the relevant jurisdictions, exchange rate fluctuations, and our continued ability to raise capital to fund our development, as well as those risks and uncertainties discussed or identified in the Company’s public filings with the AMF, including those listed in Chapter 2 "Risk Factors and Internal Control" of the Company's 2024 Universal Registration Document filed on April 29, 2025 (no. 25-0331) with the Autorité des marchés financiers ("AMF"), which is available on GENFIT's website (www.genfit.fr) and the AMF's website (www.amf.org), and those discussed in the public documents and reports filed with the U.S. Securities and Exchange Commission ("SEC"), including the Company’s 2024 Annual Report on Form 20-F filed with the SEC on April 29, 2025 and subsequent filings and reports filed with the AMF or SEC or otherwise made public, by the Company. In addition, even if the results, performance, financial position and liquidity of the Company and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. These forward-looking statements speak only as of the date of publication of this press release. Other than as required by applicable law, the Company does not undertake any obligation to update or revise any forward-looking information or statements, whether as a result of new information, future events or otherwise. CONTACTS GENFIT | InvestorsJean-Christophe Marcoux – Chief Corporate Affairs Officer | Tel: +33 3 2016 4000 | jean-christophe.marcoux@genfit.com GENFIT | MediaBruno ARABIAN – Agence Maarc | Tel : 06 87 88 47 26 | bruno.arabian@maarc.fr Stephanie Boyer – Press relations | Tel: +333 2016 4000 | stephanie.boyer@genfit.com GENFIT | 885 Avenue Eugène Avinée, 59120 Loos - FRANCE | +333 2016 4000 | www.genfit.com 1 Unaudited financial information under IFRS2 Elafibranor is marketed and commercialized, notably in the U.S and Europe, by Ipsen under the trademark Iqirvo® Attachment GENFIT Reports Fourth Quarter 2025 Financial Information and Provides a Corporate Update

Ipsen SA 益普生    公司在全球拥有超过 5,300 名员工。全球领导团队中，女性占比达到 55%。在 35 个国家设有直接机构。公司崇尚去风险化与聚焦，旨在解决长期困扰公司的Somatuline（兰瑞肽）专利悬崖问题。通过内部与外部创新丰富管线，例如利用重组神经毒素领域的全球领导地位，开发长效神经毒素。在罕见病和肿瘤领域推出了多款重要疗法，巩固了其在细分领域的领导地位；在治疗复杂罕见癌症，包括上皮样肉瘤、神经内分泌肿瘤（NETs）和肾细胞癌（RCC）。专注于改善特定儿童脑肿瘤患者的治疗效果。内部开发下一代神经毒素等核心技术。通过战略伙伴关系探索前沿治疗方式。利用端到端的研发能力，高效推进管线中 “first-in-class” 和 “best-in-class” 的分子，优先选择能快速惠及患者的项目。 战略与商业模式    Ipsen 已彻底完成从一家混合型药企向纯粹的生物制药公司（Global Specialty Care Biopharma）的转型。通过果断剥离非核心的消费者健康业务（Consumer HealthCare），公司将全部资源集中在高壁垒、高附加值的三大核心领域：肿瘤、罕见病和神经科学。这种“做减法”的战略极大地提高了资本效率，使其核心运营利润率维持在35%左右的行业高位。    外部创新（External Innovation）已取代内部发现，成为增长的第一引擎。不同于Big Pharma依赖庞大的内部研发中心，Ipsen 将自己定位为“资产整合者”。其战略逻辑利用强劲的资产负债表，通过许可引进（In-licensing）或并购（M&A）获取处于临床中后期（Mid-to-late stage）的资产。这种模式显著降低了早期药物发现的高失败率风险，同时利用其覆盖全球（特别是中、美、欧）的商业化网络实现资产价值最大化。    Ipsen 强调“全球化规模，本地化聚焦”。特别是在美国市场，Ipsen 正在积极扩张其商业足迹，以承接新购入资产（如Iqirvo和Bylvay）的落地。Ipsen的战略愿景并非追求全覆盖，而是在细分市场（Niche Market）做到全球第一，成为特定疾病领域的“特种部队”。 核心领域 肿瘤学 (Oncology)（占比约70%）    Cabometyx（卡博替尼片） (RCC（肾细胞癌）/HCC（肝细胞癌）) 和 Onivyde（伊立替康脂质体注射液），胰腺癌，是当前的支柱。    正在从传统的实体瘤向血液瘤（血液系统肿瘤）拓展（通过Epizyme（艾匹zyme公司）收购获得Tazverik他泽司他，并布局下一代免疫疗法ImCheck（艾姆克公司）的ICT01，针对γ9δ2 T细胞（伽马9德尔塔2 T细胞）） 罕见病 (Rare Disease)     建立了全球领先的罕见肝病（Rare Liver，罕见肝病）特许经营权。 • Iqirvo（艾启沃） (Elafibranor，伊拉非布兰)： 治疗原发性胆汁性胆管炎 (PBC，原发性胆汁性胆管炎)，Best-in-class（同类最佳）潜力。 • Bylvay（蓓尔唯） (Odevixibat，奥德昔巴特)： 覆盖 PFIC（进行性家族性肝内胆汁淤积症） 和 ALGS（阿拉杰里综合征） 等儿科胆汁淤积症。 • 罕见骨病： Sohonos（索霍诺斯） (Palovarotene，帕洛伐罗汀) 是全球首个获批用于 FOP（进行性骨化性纤维发育不良） 的药物。 神经科学 (Neuroscience)     围绕 Dysport（吉适） (肉毒毒素) 构建。不仅在医美（医疗美容），更在治疗性适应症（痉挛）上拥有极强统治力。正在开发长效版本（LANT，长效肉毒毒素候选药物）以对抗竞品。 其他/前沿探索：    通过与 Marengo 和 Skyhawk 的合作，探索 RNA剪接（RNA剪切） 和 T细胞激活平台（T细胞激活平台），意图攻克“不可成药”靶点。 图2：三大治疗领域的临床管线概览（来源：Ipsen-Integrated-annual-report-2024-1.pdf，第24页） 技术平台 肉毒毒素工程 (Toxin Engineering)    Ipsen 在英国 Wrexham 拥有一流的研发与制造中心，专注于肉毒杆菌毒素（BoNT）的重组与修饰。这是公司的核心护城河。 毒素生产涉及极高的生物安全标准和复杂的发酵工艺，极难被仿制。长效神经毒素（Long-Acting Neurotoxins）。其在研平台致力于通过蛋白工程技术，开发半衰期更长的重组毒素（如IPN10200），旨在减少患者注射频率，直接对标艾伯维的Botox。 RNA 剪接调节平台 (RNA Splicing)：     通过与 Skyhawk Therapeutics 的合作，Ipsen 进入了小分子靶向RNA的领域。该技术旨在纠正神经系统罕见病中的RNA错误剪接，这为Ipsen在肉毒毒素之外，打开了治疗神经退行性疾病（如亨廷顿舞蹈症等）的新窗口。 T细胞重编程平台 (T-Cell Engagers)：     通过与 Marengo Therapeutics 的合作，引入 TriSTAR 平台。该技术不同于传统的CAR-T或双抗，它通过特异性激活Vβ T细胞亚群来攻击“冷肿瘤”。这标志着Ipsen的技术触角延伸至下一代免疫肿瘤学。 病毒载体技术 (Viral Vectors)：     针对罕见病基因治疗的递送系统探索。    总结： Ipsen 的技术平台策略是实用主义的。它不追求拥有所有底层技术，而是通过掌握核心制造工艺（毒素、缓释制剂）确立防守优势，同时通过灵活的BD接入前沿技术（RNA、免疫平台）以博取未来的爆发。 核心产品    产品组合协同性强： Dysport、 Somatuline提供稳定现金流（合计20亿欧元/年），Iqirvo、Bylvay贡献长期增量，Cabometyx主导肿瘤领域增长。2. 中国市场成关键变量：多款产品纳入医保，渗透率快速提升，成为全球增长核心极。3. 壁垒支撑估值：独家适应症、技术工艺、临床数据构建核心竞争优势，保障长期商业化价值。 Bylvay® (odevixibat) 全球推出的首款用于进行性家族性肝内胆汁淤积症（PFIC）的治疗药物。 已获批用于治疗 Alagille 综合征相关的胆汁淤积性瘙痒（美国），并在欧洲以 Kayfanda® 品牌名上市。 IQIRVO® (elafibranor) 作为首款原发性胆汁性胆管炎（PBC）一线疗法，在美欧加速获批。 其全球上市确立了益普生在罕见胆汁淤积性肝病领域的领导地位。 Onivyde® (irinotecan) NALIRIFOX 在美国推出，作为转移性胰腺腺癌（mPDAC）成人患者的一线治疗。 有望成为该领域新的标准治疗方案，为患者提供更优选择。 Somatuline®（Lanreotide） 长效生长抑素类似物，GEP-NET治疗一线标杆，肽自组装凝胶剂型，无需冷链、可自我注射，GEP-NET领域中位PFS 32.8个月（显著优于竞品奥曲肽微球）。2024年全球销售额12亿欧元，中国市场销售额8亿元（+25% YoY），医保覆盖后渗透率加速提升。全球SSA市场份额40%，凭借剂型与疗效优势，持续追赶诺华（58%份额） Dysport®（AboBoNT-A） 全球第二大A型肉毒毒素品牌，神经肌肉治疗与医美领域双栖现金牛，工艺壁垒极高。无血清发酵工艺构建技术壁垒，扩散半径适中（3cm），适配肢体痉挛与面部除皱，免疫原性低。2024年全球销售额8亿欧元，新兴市场（中国、东南亚）增速超15%；市场份额约25%，性价比优于保妥适。拓展儿童脑瘫、下尿路障碍新适应症，研发长效制剂提升依从性 Iqirvo®（Elafibranor） 首个获批的PPARα/δ双重激动剂，Ipsen未来5年核心增长引擎，填补PBC二线治疗近十年空白。双重激活PPAR受体，调节胆汁酸代谢、抗炎抗纤维化，瘙痒症状改善优于传统FXR激动剂。ELATIVE研究中，63%患者ALP降低≥40%，51%患者瘙痒评分改善≥30%，不良反应停药率＜5%，耐受性优异。全球PBC患者20-30万人，2029年销售额预计超10亿美元；同步拓展NASH、PSC适应症，延长生命周期。 Bylvay®（Odevixibat） 首创IBAT抑制剂，儿科罕见病领域独家性产品，拥有罕见病优先审评券（PRV）战略价值。选择性抑制回肠胆汁酸重吸收，降低肝脏毒性，不影响脂溶性维生素吸收，适配儿童患者。全球唯一PFIC治疗药物、首个ALGS瘙痒治疗药物，患者忠诚度100%，无替代疗法竞争。儿科罕见病定价弹性大，2029年全球销售额预计8亿美元；胆道闭锁适应症进入III期，进一步打开增长空间。 Cabometyx®（Cabozantinib） 多靶点TKI，晚期肾癌一线联合免疫标准疗法，Ipsen肿瘤管线核心支柱。抑制MET、VEGFR等9个靶点，调节肿瘤微环境，与免疫治疗协同增效，降低进展/死亡风险。CheckMate 9ER研究中，联合纳武利尤单抗使晚期RCC中位PFS达16.6个月（vs 对照组8.3个月），ORR 55%。2024年全球销售额12亿欧元，2029年预计超15亿欧元；拓展肝癌、神经内分泌肿瘤适应症，联合用药延长生命周期。 核心在研管线 IPN10200 (LANT，肉毒素)： 处于 Phase III 准备阶段。目标是在医美（眉间纹）和治疗（痉挛、偏头痛）领域替代现有短效毒素。这是 Ipsen 最大的潜在重磅产品之一。 Bylvay (IBAT抑制剂，治疗胆道闭锁 - BA)： 正在进行 Phase III (BOLD) 试验。胆道闭锁的患儿数量远多于 PFIC 和 ALGS，若获批，将显著提升 Bylvay 的销售峰值潜力. Fidrisertib (FOP)： Phase II (FALKON) 试验中。作为 ALK2 激酶抑制剂，旨在阻断 FOP 的病理核心——骨形态发生蛋白（BMP）信号通路的过度激活，有望比第一代药物 Sohonos 更有效. ICT01 (ImCheck)： 即将进入注册性临床。针对一线不适合化疗的 AML 患者，有望填补巨大的临床空白。 Tovorafenib (pLGG)： 正在进行 Phase III (FIREFLY-2) 试验，针对一线需要治疗的儿童低级别胶质瘤，旨在替代传统的化疗方案. IPN01194 / IPN01195： 针对 MAPK 通路的下一代抑制剂，旨在克服现有 BRAF/MEK 抑制剂的耐药性问题，用于治疗实体瘤. 重点交易 合作伙伴 合作形式 领域 核心资产/技术 交易结构与战略逻辑 ImCheck Therapeutics 2025年12月收购 (Acquisition) 肿瘤 (IO) ICT01 (γ9δ2 T细胞激活剂) 结构：€3.5亿首付 + 里程碑付款，总额可达€10亿。 逻辑：获得 First-in-class 的免疫治疗资产，补充血液肿瘤管线。这是对“非传统T细胞疗法”的一次豪赌，旨在突破 PD-1/L1 的治疗瓶颈. Day One Biopharmaceuticals 2024年7月许可引进 (In-licensing) 肿瘤 (儿科) Tovorafenib (pLGG) 结构：$1.11亿首付（含股权投资） + 里程碑。 逻辑：获取除美国以外的全球权益。利用 Ipsen 强大的欧洲及全球商业网络变现，Day One 则保留美国市场。这是典型的“地域互补”型合作. Marengo Therapeutics 2024年6月扩大战略合作 (Strategic Partnership) 肿瘤 (实体瘤) TriSTAR 平台 (TCEs) 结构：高达$12亿的里程碑付款。 逻辑：针对“冷肿瘤”的攻坚战。通过特异性激活 Vβ T 细胞，解决传统免疫疗法无效的难题。这属于“技术平台型”合作，旨在储备未来资产. Skyhawk Therapeutics 2024年4月研发合作 (R&D Collaboration) 神经科学 RNA 剪接调节小分子 结构：高达$18亿的里程碑付款。 逻辑：布局未来技术。利用小分子靶向 RNA，治疗难以成药的神经系统罕见病，补充毒素以外的神经管线，实现技术路线的多元化. 重点案例 1：收购 Albireo (2023年 M&A) • 交易金额：约 9.52亿美元（含预付款和CVR）。 • 核心资产： Bylvay (Odevixibat) 及整个胆汁酸调节剂管线。 • 交易解读：这是一笔教科书式的**“补强收购 (Bolt-on)”**。 ￮ 战略契合：完美契合 Ipsen 的罕见病战略。 ￮ 协同效应： Ipsen 利用其现有的全球消化/肝病销售网络，迅速放大了 Bylvay 的商业价值。 ￮ 价值判断：直接确立了 Ipsen 在儿科罕见肝病领域的全球统治地位。 重点案例 2：与 Day One Biopharmaceuticals 的独家许可 (2024年 Licensing) • 涉及资产： Tovorafenib (泛RAF抑制剂，治疗儿科脑胶质瘤 pLGG)。 • 交易结构： 1.11亿美元首付款 (含股权投资) + 约 3.5亿美元 里程碑 + 销售分成。 • 交易解读：典型的**“地域互补 (Geographic Split)”** 模式。 ￮ 逻辑： Day One 保留美国权益，Ipsen 获得除美国以外的全球权益。 ￮ 双赢： Day One 这种小型 Biotech 难以在欧洲建立商业团队，而 Ipsen 在欧洲拥有强大的肿瘤销售网络。这是一笔低风险、高杠杆的交易，直接变现了 Ipsen 的渠道价值。 价值判断    罕见病（Bylvay/IQIRVO）与神经科学（Dysport）提供中短期增长；肿瘤领域通过 Onivyde 一线拓展、MAPK 管线与外部引入资产形成催化剂。 END 扫码关注 医药投资并购俱乐部 获得更多讯息