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GENFIT to Highlight Progress in ACLF and MASH Diagnostics at AASLD The Liver Meeting® 2026

  • ACLF – Advancing a multi-target therapeutic strategy
    • GENFIT to host a scientific event on November 8, 2026 to outline its ACLF strategy and unveil a comprehensive clinical data package supporting the advancement of nangibotide into Phase 2 in this indication
    • Three poster presentations will provide new insights into the role of inflammation and immune dysregulation in acute liver failure, as well as further clinically relevant evidence of nitazoxanide’s anti-inflammatory activity, supporting its development in ACLF
    • Management to present at dedicated scientific meeting with NACSELD, a leading North American research consortium in cirrhosis and ACLF, to deepen scientific engagement
  • MASH Diagnostics – Unlocking the opportunity as MASH treatment uptake expands
    • Taking a leading role in the Global Liver Institute’s Beyond the Biopsy – National Implementation Forum, bringing together drug manufacturers such as Novo Nordisk, Eli Lilly and Madrigal as well as KOLs to drive ecosystem-wide action on earlier patient identification and improved awareness of when, why and how to diagnose and monitor MASH
    • GENFIT’s expert panel on November 6, 2026, will highlight the importance of non-invasive testing in MASH for early detection of patients with active fibrotic MASH and monitoring of treatment response, as well as the unique potential of NIS™ Technology through converging perspectives from hepatology, diabetology, endocrinology, the pharmaceutical industry, and patients

Lille (France), Cambridge (Massachusetts, United States), November 2, 2026 - GENFIT (Euronext: GNFT), a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced a broad program of scientific and strategic activities taking place at the AASLD The Liver Meeting® 2026, highlighting progress across its therapeutic programs in Acute on-Chronic Liver Failure (ACLF) and diagnostics activities in Metabolic dysfunction-associated steatohepatitis (MASH).

ACLF – Advancing a multi-target therapeutic strategy

Scientific Event – November 8, 2026 |Advancing Clinical Development in ACLF
Building on Extensive Clinical Evidence and Research
The event will feature Professor Jennifer Lai (UC San Francisco) as a guest speaker, and will outline GENFIT’s multi-target approach to ACLF, aimed at addressing the complex pathophysiology of the disease through complementary therapeutic mechanisms. It will also provide an in-depth review of nangibotide, GENFIT’s TREM-1 modulator combining a strong biological rationale including safety data and promising efficacy signals across multiple organ systems from previous clinical studies in different indications. The development package for nangibotide includes an existing body of clinical evidence at the proposed dose, as well as available clinical supply and regulatory data informing GENFIT’s decision to advance into Phase 2 in ACLF.

Scientific posters to be presented – November 6, 2026 | 1:00–2:00 p.m. MT

  • Poster #2284: RIPK1 inhibition attenuates NET release and hemorrhagic liver injury in D-Galactosamine/LPS mice
  • Poster #2273: D-Galactosamine/LPS Acute Liver Failure Recapitulates Emergency Granulopoiesis-like Signatures Across the Bone Marrow–Spleen–Liver Axis
  • Poster #2034: Ex vivo blood assays demonstrate systemic anti-inflammatory activity of G1090N, a novel formulation of nitazoxanide, and support further clinical evaluation in acute-on-chronic liver failure (ACLF)

ACLF is characterized by high systemic inflammation and profound immune dysregulation. By bridging systemic immune dysregulation and pharmacological intervention, posters #2284 and #2273 presented at The Liver Meeting® will provide new insights into the role of the immune system, particularly neutrophils, in acute liver failure conditions. In addition, poster #2034 will provide further evidence of nitazoxanide’s anti-inflammatory activity, using blood samples collected in a clinical setting, supporting its clinical development in ACLF.

NACSELD Meeting – November 5, 2026
The North American Consortium for the Study of End-Stage Liver Disease (NACSELD), a leading multicenter research consortium focused on improving outcomes in cirrhosis and ACLF, will host a dedicated scientific meeting to provide an opportunity to discuss the evolving understanding of ACLF, key unmet needs and priorities for future therapeutic development, deepening scientific engagement. Building on GENFIT’s established partnership with NACSELD, management will present its ACLF strategy at this meeting chaired by Professor Jasmohan S. Bajaj, MD, MS, FAASLD, of Virginia Commonwealth University.

MASH Diagnostics – Unlocking the opportunity as MASH treatment uptake expands

“Beyond the Biopsy” National Implementation Forum – November 4, 2026 | Global Liver Institute’s Initiative
The Global Liver Institute’s “Beyond the Biopsy “ National Implementation Forum will bring together clinical experts, patients, and diagnostics and pharmaceutical companies to address the practical barriers to implementing non-invasive MASH diagnostics at scale. Building on patient experiences and insights about LITMUS and NIMBLE, discussions moderated by Professor Brent A. Tetri, MD, will examine how to translate diagnostic innovation into real-world implementation across clinical pathways, access, reimbursement and policy. This involvement further strengthens GENFIT’s ties with Eli Lilly, Novo Nordisk, Madrigal and other leading pharmaceutical companies at the forefront of bringing new treatment options to tens of millions of patients in need. Larry Holden, CEO of the Global Liver Institute commented: “We are reaching an important inflection point in MASH: effective treatments are becoming available, making the ability to identify the right patients, particularly those with at-risk MASH, increasingly critical. Bringing together diagnostic innovators such as GENFIT, leading drug companies including Eli Lilly, Novo Nordisk and Madrigal, clinical experts from hepatology to endocrinology, patients and payers around the same table is exactly the type of dialogue needed to move from scientific progress to real-world implementation. As a pioneer in non-invasive MASH diagnostics, GENFIT has helped shape the field and continues to drive its evolution, with a clear vision of a future where therapeutic advances go hand in hand with effective patient identification and disease monitoring.”

Expert Panel – November 6, 2026 | Non-Invasive Diagnostics for At-Risk MASH
NISTM Technology Reshaping Patient Identification and Access to Care1
Professor Vlad Ratziu, MD, PhD (Sorbonne University, Pitié-Salpêtrière Hospital, IHU ICAN) and Professor Kenneth Cusi, MD, FACP, FACE (University of Florida, Division of Endocrinology, Diabetes & Metabolism) will share complementary hepatology and metabolic disease perspectives, while Wayne Eskridge and Henry Chang from the Fatty Liver Foundation will highlight how a simple and reliable blood-based technology could transform the patient journey and improve patient outcomes. Ashley Hamilton Chasick (Global Lead, Diagnostics Partnerships, Novo Nordisk), will complement these perspectives with an industry view on the importance of adopting non-invasive diagnostics in clinical practice to support earlier identification and monitoring of patients with at-risk MASH. The discussion will address current challenges in identifying and managing patients with at-risk MASH, a population characterized not only by fibrosis, but also by disease activity. It will highlight the growing role of non-invasive diagnostics as treatment uptake expands, and the potential contribution of GENFIT’s NIS™ Technology. Independent consortia in the US and Europe have validated GENFIT’s technology: NIMBLE identified it as the only one, among those evaluated, specifically intended to diagnose at-risk MASH, while LITMUS showed that it achieved the highest diagnostic accuracy among the blood-based, imaging and combined modalities evaluated for at-risk MASH. At-risk MASH is consistent with the population enrolled in the pivotal Phase 3 trials that supported the approval of currently approved MASH therapies.

GENFIT’s partner Ipsen is also expected to communicate on elafibranor during The Liver Meeting® 2026.

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 second-line 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) 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 regarding the development and potential therapeutic profile of nangibotide, the potential role of TREM-1 in Acute-on-Chronic Liver Failure (ACLF), the initiation, design, conduct, timing and results of future clinical trials, including the planned Phase 2a proof-of-concept study in ACLF, the potential clinical benefits, safety profile and therapeutic value of nangibotide, the potential relevance on future clinical investigations of efficacy signals and safety data observed in prior clinical studies conducted in other indications, the expected timing of data readouts, regulatory interactions and future development activities, the potential role, clinical utility and adoption of non-invasive MASH diagnostics, including GENFIT’s NIS™ Technology, in patient identification, disease monitoring and access to care; the potential opportunities associated with increasing uptake of MASH treatments, as well as the Company's strategic plans and objectives. 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 relating to the the Company’s ability to advance its therapeutic programs and initiate and complete clinical trials; uncertainties relating to regulatory requirements and decisions, patient enrollment, clinical trial execution, safety findings, manufacturing and clinical supply; the possibility that findings from prior studies in other indications, preclinical research or ex vivo assays may not predict safety, efficacy or clinical benefit in patients with ACLF; uncertainties relating to the clinical utility, further validation, adoption and use of non-invasive MASH diagnostics, including for disease or treatment- response monitoring; changes in clinical practice, treatment uptake, reimbursement, access and applicable regulatory requirements; and the Company’s dependence on partners and other third parties whose plans and activities may change. Those risks and uncertainties also include those 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 2025 Universal Registration Document filed on April 3, 2026 (no. 26-0221) 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 reports filed with the AMF or otherwise made public, by the Company including the Half-Year 2026 Business and Financial Report. 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 | Investors

Jean-Christophe Marcoux – Chief Corporate Affairs Officer | Tel: +33 3 2016 4000 |
jean-christophe.marcoux@genfit.com

Kevin Gardner – Life Science Advisors | kgardner@lifesciadvisors.com

GENFIT | Media

Bruno 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 NIS™ Technology refers to NIS4® and its next-generation version, NIS2+® | NASHnext® (based on NIS4 technology) reimbursement by Medicare under the Clinical Laboratory Fee Schedule to Medicare patients that meet coverage criteria became effective on August 10, 2026 | NIS2+® is currently available through Labcorp in the United States as a Laboratory Developed Test (LDT). It has not been cleared or approved by the U.S. Food,and Drug Administration (FDA) and is not CE marked in the European Union
2 Elafibranor is marketed and commercialized, notably in the U.S and Europe, by Ipsen under the trademark Iqirvo®

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