GENFIT to Host Virtual KOL Event Focused on MASH Diagnostics on September 9, 2026  

• Presentations will highlight the clinical utility and long-term commercial opportunity of GENFIT’s proprietary NIS platform, a non-invasive diagnostic technology for MASH
  
  

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), September 3, 2026 - GENFIT (Euronext: GNFT), a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced that it will host a virtual key opinion leader (KOL) event on Wednesday, September 9, 2026 at 10:00 AM ET. The event will highlight the evolving landscape of diagnostic testing for Metabolic dysfunction-Associated SteatoHepatitis (MASH) and will feature Dr. Vlad Ratziu, MD, PhD (Sorbonne University, Pitié-Salpêtrière Hospital, Institute for Cardiometabolism and Nutrition, Paris). To register, click here.

Professor Ratziu will discuss the clinical unmet need in MASH diagnostics and highlight the clinical utility of GENFIT’s non-invasive testing technology, NIS4® and new generation NIS2+®, at a time when treatment options are expanding rapidly. GENFIT’s technology is recognized by international expert consortia as a leading non-invasive solution which is uniquely positioned, as it captures both disease activity and fibrotic burden, helping identify at-risk MASH patients and supporting more informed clinical decision-making. The technology is included in both European and U.S. clinical guidelines.

In a recent milestone for the field, Labcorp's NASHnext®, based on NIS4®, became eligible for reimbursement under the Clinical Laboratory Fee Schedule for patients who meet coverage criteria, effective August 10, 2026. This development may support broader adoption and pave the way for future coverage by private insurers.

Company management will then provide perspectives on the commercial opportunity, revenue potential, and GENFIT's development strategy aimed at further broadening patient access.

END

ABOUT VLAD RATZIU, MD, PHD

Professor Vlad Ratziu received his medical training at Paris V, René Descartes University, completed a two-year research fellowship at the Liver Center at UCSF, and earned a doctoral degree from Paris VII Diderot University for his work on the pathophysiology of viral and metabolic liver fibrosis.
His research centers on steatotic liver disease; the mechanisms, risk factors, and progression of liver fibrosis in viral and metabolic disease; and the treatment of viral hepatitis and hepatocellular carcinoma. He has coordinated or participated in numerous therapeutic trials in MASH and in European FP7, Horizon 2020, and Innovative Medicines Initiative 2 consortia. He is founder and organizing-committee member of the NASH–TAG meetings. He has published more than 460 articles (H-index of 113) in top-tier specialty journals and has been named among Clarivate's top 1% Highly Cited Researchers from 2022 to 2025.

ABOUT NASHNEXT®, NIS4® AND NIS2+®

With a high and growing prevalence of metabolic risk factors in the U.S., early detection of at-risk MASH could benefit a U.S. patient population in the high tens of millions of individuals, highlighting a significant unmet medical need. Liver biopsy currently remains the clinical standard for diagnosing at-risk MASH, but its use is highly constrained by its invasive and costly nature and difficult scalability. Labcorp’s NASHnext® is a non-invasive diagnostic test to easily identify patients with at-risk MASH (Metabolic dysfunction-Associated SteatoHepatitis). It is powered by GENFIT’s proprietary non-invasive diagnostic technology NIS4®. NIS4® and next-generation technology NIS2+® have been widely recognized over the past few years as showing a unique performance in identifying patients with at-risk MASH. This recognition is reflected through a growing body of scientific evidence (including publications in The Lancet and Nature Medicine), inclusion in joint guidelines from several international scientific societies (EASL-EASD-EASO), strong visibility within major consortia in the U.S. and Europe (NIMBLE and LITMUS), and its use in most large clinical trials conducted by key industry players in MASH. Today NASHnext® is available through Labcorp OnDemand, a digital interface where patients can order the test online. GENFIT is actively seeking to advance partnerships with pharmaceutical companies to support wider deployment of non-invasive testing for at-risk MASH and accelerate adoption in line with the expansion of MASH therapies. GENFIT is also exploring the development of an IVD-labeled (In Vitro Diagnostic) version of its non-invasive diagnostic technology, either independently or in collaboration with a diagnostic-focused partner, with the selected approach expected to reflect the most appropriate route to maximize long-term value for GENFIT.
  

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.¹   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 regarding the clinical utility, commercial potential, adoption and future development of GENFIT's proprietary non-invasive diagnostic technologies, including NIS4® and NIS2+®, the potential impact of reimbursement and payer coverage on adoption of such technologies, the market opportunity and revenue potential associated with GENFIT's diagnostic franchise, and GENFIT's in vitro diagnostic (IVD) development strategy and objectives to broaden patient access. 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 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. 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

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 Elafibranor is marketed and commercialized, notably in the U.S and Europe, by Ipsen under the trademark Iqirvo®

Attachment

• GENFIT to Host Virtual KOL Event Focused on MASH Diagnostics on September 9, 2026