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GENFIT’s MASH Diagnostics Technology Long -Term Commercial Opportunity S e p t e m b e r 9 , 2 0 2 6
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Forward Looking Statements 2 IMPORTANT NOTICE – YOU MUST READ THE FOLLOWING BEFORE CONTINUING. THIS PRESENTATION HAS BEEN PREPARED BY GENFIT AND IS FOR INFORMATION PURPOSES ONLY. CERTAIN OF THE INFORMATION CONTAINED HEREIN CONCERNING ECONOMIC TRENDS AND PERFORMANCE IS BASED UPON OR DERIVED FROM INFORMATION PROVIDED BY THIRD-PARTY CONSULTANTS AND OTHER INDUSTRY SOURCES. WHILE GENFIT BELIEVES THAT SUCH INFORMATION IS ACCURATE AND THAT THE SOURCES FROM WHICH IT HAS BEEN OBTAINED ARE RELIABLE, GENFIT HAS NOT INDEPENDENTLY VERIFIED THE ASSUMPTIONS ON WHICH PROJECTIONS OF FUTURE TRENDS AND PERFORMANCE ARE BASED. IT MAKES NO GUARANTEE, EXPRESS OR IMPLIED, AS TO THE ACCURACY AND COMPLETENESS OF SUCH INFORMATION. This presentation contains certain forward-looking statements with respect to GENFIT, including, but not limited to, statements regarding the potential market opportunity for products based on GENFIT's NIS® technology, the future adoption, commercialization and reimbursement of such products, and the impact of the development of the therapeutic MASH market on the diagnostics market, potential royalty streams and other revenues that could be generated therefrom, the future development of the MASH diagnostics market, guideline inclusion, market access, and expected demand for non-invasive diagnostic testing. 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. Certain statements included in this press release are based on market analyses and projections prepared by IQVIA and commissioned by GENFIT. Such analyses are based on numerous assumptions, including assumptions regarding patient identification, disease prevalence, treatment adoption, reimbursement coverage, physician behavior, testing frequency, market penetration and other market factors. The projections described in this press release do not constitute forecasts of GENFIT's future revenues, financial performance or royalty income. Actual market adoption, testing volumes, product sales and economic outcomes may differ materially from those projected. 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, uncertainties relating to the development, validation, regulatory acceptance and commercialization of diagnostic products, the timing and scope of reimbursement decisions and payer coverage, inclusion in clinical practice guidelines, physician adoption and testing practices, the availability and uptake of therapies for MASH, regulatory developments, the ability to establish and maintain commercial partnerships, evolving competition in the MASH diagnostics field, market acceptance of competing technologies 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.
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Vlad Ratziu, MD, PhD Professor of Hepatology, Sorbonne University Pitié-Salpêtrière Hospital Institute for Cardiometabolism and Nutrition (ICAN) Paris Editor-in-Chief, Journal of Hepatology Pascal Prigent GENFIT CEO Pascal Caisey GENFIT COO Today’s Speakers
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Pascal Prigent GENFIT CEO Welcome and Introduction
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25+ Years of Focus on Liver Diseases 5 Partnerships with pharma Building R&D expertise through Big Pharma collaborations A shift to in-house programs Drug discovery of elafibranor and subsequent development in MASH Inception and early years 1999-2004 MASH: metabolic dysfunction-associated steatohepatitis | PBC: Primary Biliary Cholangitis | PSC: Primary Sclerosing Cholangitis | ACLF: Acute-on-Chronic Liver Failure | CCA: Cholangiocarcinoma 2026 The MASH years 2005-2020 The turning point MASH Ph3 results not supportive of MA Pivot to PBC and later CCA and ACLF Ipsen deal The reinvention 2020-2025 GENFIT today GENFIT was among the first companies focusing on MASH Pioneering efforts in the Liver Forum (KOL, regulatory, patients) For over 15 years MASH was our primary focus Elafibranor royalty-based stream NISTM technology Pipeline: ▪ Clinical: GNS561 Ph2, NTZ Ph2 ▪ Research: various ACLF programs
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GENFIT recognized early the need for a single, non-invasive blood-based solution serving all stakeholders across the MASH care pathway Everybody Needs a Scalable, Reliable Diagnostic Tool Patients Physicians Drug Makers Payers Diagnostics Manufacturers
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Over the years, GENFIT leveraged its scientific expertise, extensive expert network and unique Phase 2 and Phase 3 tissue and blood sample datasets to develop a differentiated non-invasive technology addressing critical diagnostic and monitoring gaps The Journey: a Decade of Development Testing of hundreds of variables Selection of the most predictive variables Development of a unique algorithm Validation against independent cohorts Optimization for future industrialization Publications in several scientific journals Inclusion in international guidelines Recognition by Independent consortia Commercial availability1 in the U.S. EASL, EASL, EASO, AGA, ADA, KASL First reimbursement2 in the U.S. Inclusion in several clinical trials Phase 2 Phase 3 1: via partner Labcorp, as a Laboratory Developed Test (LDT) 2: Medicare coverage for eligible U.S. patients
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Why Now: bottleneck shifting from treatment availability to patient identification, disease stratification and long-term management Resmetirom Approval & Blockbuster Sales in Year One The first approved MASH therapy validates the market and creates urgency to identify treatable patients Imminent Entry of Additional Molecules, incl. GLP-1s Expanding treatment options raise the value of accurate, scalable diagnosis to find the right patients Shifting Physician & Market Behavior Watch & Wait Find & Treat Therapy-driven proactive care shifting physicians’ behavior toward earlier action Passive Awareness Broad identification & monitoring Updated guidelines recommend broader identification of at-risk patients, boosting diagnosis, referral, treatment rates and monitoring Today the MASH Market Reaches an Inflection Point
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Vlad Ratziu, MD, PhD Professor of Hepatology, Sorbonne University Pitié-Salpêtrière Hospital Institute for Cardiometabolism and Nutrition (ICAN) Paris Editor-in-Chief, Journal of Hepatology Identifying Patients with At-Risk MASH: A Major Unmet Need Across the MASLD/MASH Continuum
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MASLD, the New Nomenclature for NAFLD Rinella ME et al. A multi-society Delphi consensus statement on new fatty liver disease nomenclature. Annals of Hepatology, (2023): 101133.
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MASLD, A Worldwide Public Health Concern Younossi, Zobair M., et al. The global epidemiology of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH): a systematic review. Hepatology (Baltimore, Md.) 77.4 (2023): 1335. • MASLD is the most common cause of chronic liver disease (CLD) worldwide, and the most rapidly increasing global contributor to the disease burden related to the complications of CLD, including cirrhosis and liver cancer • MASLD/MASH has become the second leading cause of end-stage liver disease and indication for liver transplants, and the fastest growing etiology of hepatocellular carcinoma (HCC) • Driven by the pandemic of obesity and type-2 diabetes (T2D), among other factors
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MASLD, A Rapidly Rising Disease, Associated with T2DM and Obesity Pandemic Younossi, Zobair M., et al. "The global epidemiology of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH): a systematic review." Hepatology (Baltimore, Md.) 77.4 (2023): 1335. Younossi, Zobair M., et al. "The global epidemiology of NAFLD and NASH in patients with type 2 diabetes: a systematic review and meta-analysis." Journal of hepatology 71.4 (2019): 793-801. Younossi, Zobair M. "Non-alcoholic fatty liver disease–a global public health perspective." Journal of hepatology 70.3 (2019): 531-544. +50.4% prevalence increase, from 25% in 1990-2006 to 38% in 2016-2019, p <0.001 Fig: Global rates of NAFLD increasing over time • ≥400 millions people were living with diabetes (2015), and caused an estimated 1.5 million deaths (2012) • In US, ~29 millions thought to have T2DM, 8.1 millions undiagnosed and 1.4 millions new diagnosis every year. • WHO anticipates that worldwide deaths from T2DM will double by 2030 • WHO determined that worldwide, overweight and obesity rates tripled since 1975, ≥1.9 billion (39%) adults are overweight, 650 millions (13%) are obese • MASLD prevalence proportional with increase in BMI, >90% for very obese individuals undergoing weight reduction procedures and surgeries.
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257M with risk factors for metabolic disease 86M with elevated LFT and/or steatosis 167M diagnosed with metabolic disease Patients expected to be receiving regular medical attention due to MASLD-related risk factors = subpopulation who would benefit from simple, reliable and scalable testing to identify “At-Risk MASH” By 2033, Nearly 90 Million U.S. Patients in Care due to MASLD-related Risk Factors Prevalence of MASH risk factor: NIDDK, CDC_1,CDC_2, CDC_3, Tsao et al., Overlap of MASH risk factor indications: Wang et a Xia et al., Hu et al., NCHS_1, NCHS_2, NCHS_3 Alva et al., CDC, NIDDK, Hu et al., CDC_2, Bajaj et al., Xu et al. IQVIA Claims data (NIS4 2020 Forecast), Carmen et al., 2025 IQVIA survey 2026 prevalent pool of 230 M with 1.6% growth
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MASLD: a Complex Continuum of Histopathological Liver Conditions1-10 1. Preiss D, Sattar N. Clin Sci (Lond). 2008;115(5):141-150. 2. Pereira K, et al. J Clin Imaging Sci. 2015;5:32. 3. Perumpail BJ, et al. World J Gastroenterol. 2017;23(47):8263-8276. 4. Angulo P, et al. Gastroenterology. 2015;149(2):389- 397.e10. 5. Sanyal AJ, et al. Presented at: American Association for the Study of Liver Diseases Annual Meeting. 2019 (abstr 1190). 6. Mazzarelli C, et al. Liver Transpl. 2018;24(7):961-968. 7. McPherson S, et al. J Hepatol. 2015;62(5):1148- 1155. 8. Singh S, et al. Clin Gastroenterol Hepatol. 2015;13(4):643-654.e1-9. 9. Sanyal AJ, et al. Hepatology. 2019;70(6):1913-1927. 10. Harrison SA, Ratziu V, et al. Lancet Gastroenterol Hepatol. 2020. Epub 2020 Aug 4. Disease evolution Lipogenesis Inflammation & Cells injuries Fibrosis Healthy liver MASLD Pure steatosis • Cirrhosis • Acute decompensation • Hepatocellular Carcinoma (HCC) • Other liver related events MASH Steatosis & lobular inflammation & ballooning MASH with Fibrosis The natural history of MASLD can be nonlinear, with potentially rapid progression (or regression) of disease. MASLD Activity Score [MAS] (0-8) Steatosis (0-3) Lobular inflammation (0-3) Ballooning (0-2) • Scoring established by histopathological examination of a liver biopsy (LB) • MAS score corresponds to the sum of 3 histological scores
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At-risk MASH: A Specific Stage of Interest in MASLD Harrison SA, Ratziu V, et al. Lancet Gastroenterol Hepatol. 2020. ; Harrison, Stephen A., et al. "Prospective evaluation of the prevalence of non-alcoholic fatty liver disease and steatohepatitis in a large middle-aged US cohort." Journal of hepatology 75.2 (2021): 284-291. Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment. US Food & Drug Administration,2020 Taylor, et al. Gastroenterology. 2020;158:1611-1625. ; Baratta, et al. Clin. Gastroenterol. Hepatol., 2020; 18(1):2324-2331. Noureddin, Mazen, et al. "Predicting NAFLD prevalence in the United States using National Health and Nutrition Examination Survey 2017–2018 transient elastography data and application of machine learning." Hepatology Communications 6.7 (2022): 1537-1548. MASLD Activity Score 0 1 2 3 4 5 6 7 8 Fibrosis Score 0 1 2 At-risk MASH 3 4 • At-risk MASH is defined as patients having biopsy-confirmed MASH with a MAS≥4 and F≥2 • Most MASH clinical trials evaluating new drugs are recruiting at-risk MASH patients, as the targeted population to be treated and on which primary endpoints are evaluated as requested by authorities. • At-risk MASH was shown to be about 4.4% in the general U.S. population and up to 18.3% in patients with T2D Individuals with at-risk MASH generally have a higher risk of disease progression, all-cause mortality, cardiovascular disease and liver-related morbidity (i.e., liver cancer, decompensated cirrhosis) Disease progression engine Progression stage “At-risk MASH” does not mean ‘at risk of developing MASH’ With metabolic risk factors, MASLD, etc. With MASH With “At-Risk MASH”
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Phase 3 Registrational Trials Patient profile Selection for pharmacotherapy Excluded Randomized TRIALS CLINICAL PRACTICE At-risk MASH: Registrational Trials vs. Clinical Practice
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Phase 3 registrational trials Patient profile Selection for pharmacotherapy NAS>4 Fibrosis stage 2 or 3 VCTE, or ELF …NAS>4 Fibrosis stage 2 or 3NIS2+ 50% had LSM outside 10-15 kPa* 19% LSM <8 kPa; 32% LSM >15kPa# 25% had ELF<9,2* 21% had ELF<9,2# *MAESTRO NASH trial Hepatology AASLD guidance 2025 # ESSENCE trial Hepatology AASLD guidance 2026 At-risk MASH: Registrational Trials vs. Clinical Practice
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► No existing approach reliably identifies at-risk MASH at scale Liver Biopsy Imaging Existing Blood-Based Tests The historical reference standard Invasive procedure with risk of bleeding, pain, and complications Samples a tiny fraction of the liver — subject to significant sampling variability Not scalable or repeatable — impractical for population screening or routine monitoring Patient reluctance limits uptake and follow-up testing MRI-PDFF, elastography (e.g. FibroScan) Measures fat content or liver stiffness, but not inflammation or ballooning directly Cannot reliably grade disease activity — only part of the MASH definition Requires specialized equipment; limited access outside major centers Results can be indeterminate in patients with obesity or ascites Liver enzymes (ALT/AST), legacy panels Standard liver enzymes are often normal even in confirmed MASH Not specific — cannot reliably distinguish MASH from simple steatosis Many legacy panels yield indeterminate results, requiring biopsy to confirm Not validated to identify the at-risk (MAS ≥ 4, F2/F3) population specifically Limitations of Current Diagnostic Approaches
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NIS4®/NIS2+® Technologies: From Scientific Evidence to Broad Recognition Vlad Ratziu, MD, PhD Professor of Hepatology, Sorbonne University Pitié-Salpêtrière Hospital Institute for Cardiometabolism and Nutrition (ICAN) Paris Editor-in-Chief, Journal of Hepatology
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NIS4® Biomarkers Show Strong Biological Plausibility for Association with MASH Activity and Fibrosis 4 Biomarkers1 To 109 Variables1 From A2M HbA1c YKL-40 Associated with repression/deactivation of SIRT1, AMPK, HNF4α and PPARα, which may contribute to hepatocyte apoptosis, fibrosis and lipid metabolism1,4 Selected among >2000 miRNA through omics analyses Promotes liver fibrosis through inhibition of matrix protein catabolism in inflammatory/injured liver1 Associated with activated macrophages; a biomarker of liver fibrosis1 Marker of altered glucose homeostasis; associated with inflammation and liver fibrosis in MASH1-3 Comparison of NIS4 vs individual biomarker components to identify patients with at-risk MASH within the discovery cohort (n=239) miR-34a-5p 1. Harrison SA, Ratziu V, et al. The lancet Gastroenterology & hepatology, 5(11), 970-985, 2020. 2. Chao HW, et al. Int J Mol Sci. 2019;20(2):298. 3. Kumagai E,et al. Sci Rep. 2016;6:35282. 4. Cermelli S et al. PLoS One. 2011;6(8):e23937.
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21 NIS2+® – An Optimization of NIS4® Technology NIS4® (2020) • miR-34a-5p • YKL-40 • Alpha-2 macroglobulin • HbA1c NIS2+® (2022) • miR-34a-5p • YKL-40 • Sex information /
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22 NIS2+® Showed Improved Diagnostic Performances Resolve-It Phase 3 MASH clinical trial database – N=2035 Harrison, Stephen A., et al. "NIS2+ , an optimisation of the blood-based biomarker NIS4® technology for the detection of at-risk NASH: a prospective derivation and validation study." Journal of Hepatology 79.3 (2023): 758-767 NIS2+® is not impacted by age, T2DM status, sex, BMI, hypertension or dyslipidemia, allowing physicians to interpret results irrespective of patients’ characteristics Figure 2. NIS2+® score interpretation and diagnostic performances
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Age as an Important Confounding Factor for NITs: Stable Score Distributions with NIS2+® Patients of all ages are affected by MASLD, even if age is a risk factor for MASLD so that prevalence of MASLD is rising with age • It’s known and published that biomarkers and some NITs are impacted by age, limiting the interpretation of test score vs cutoffs when being applied to patients ranging different ages • It’s of major importance for market penetration and large-scale use to provide physician with a robust tool which could be easily interpreted irrespective of age of patients • Genfit developed NIS2+ as a robust test against age, among other characteristics Fig. NITs scores distributions by age and at-risk MASH status Fig. Impact of age on clinical performances of NITs for the detection of at-risk MASH, utilizing Youden cutoffs NIS2+ NIS2+
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24 NIS2+® Diagnostic Performance Recognized by International Expert Consortia (1/2) Non-Invasive Biomarkers of MetaBolic Liver DiseasE (NIMBLE) Stage 1 validation – N=1073 Sanyal, Arun J., et al. "Diagnostic performance of circulating biomarkers for non-alcoholic steatohepatitis." Nature medicine 29.10 (2023): 2656-2664. Asgharpour, Amon, et al. "Validation of the diagnostic enrichment utility of NIS2+ for varying phenotypes of metabolic dysfunction associated steatotic liver disease." Hepatology. Vol. 80, 2024. p. S575-S576. NIS2+® AUROC for at-risk MASH = 0.825 (N=810) “NIS2+® significantly enriches the likelihood of identifying those with at-risk MASH in a population with MASLD. Its performance is weighted towards identification of those with stage 2 fibrosis and is as good as its predecessor NIS4® for its intended use.” Manuscript in preparation Topline results from NIMBLE consortium, stage 1 (N=1073) NIS4® utility has been recognized in a Stage 1 study undertaken by the Non- Invasive Biomarkers of Metabolic Liver Disease (NIMBLE) initiative, with unique performances
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25 Pavlides, Michael, et al. "Prospective validation of imaging and serum diagnostic biomarkers of steatohepatitis and fibrosis in MASLD: the LITMUS Imaging Study." Nature Medicine (2026): 1-11. NIS2+ NIS2+ NIS2+® Diagnostic Performance Recognized by International Expert Consortia (2/2) Liver Investigation: Testing Marker Utility in Steatohepatitis (LITMUS) Imaging Study – N=357
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26 NIS2+® Showed Consistent Performance for Screening in Primary Care Settings Kalavalapalli, Srilaxmi et al. “High Prevalence of Metabolic Dysfunction-Associated Steatohepatitis With Significant Fibrosis in Primary Care and Endocrinology Clinics.” Diabetes, obesity & metabolism vol. 28,7 (2026): 6184-6193. “NIS2+ compared to VCTE-LSM (or FAST) detected more people with stage F2 in intermediate risk groups (i.e., with obesity only or nonobese with T2D), a preliminary observation that warrants additional studies. […] Our results provide the groundwork for NIS2+ to be considered in primary care as a valid diagnostic complement to the current 2-tier approach (FIB-4 +/− VCTE- LSM) or an alternative blood-based test when transient elastography or other imaging is unavailable.” Figure 1. Prevalence of at-risk MASH determined by NIS2+ (NIS2+ ≥ 0.68) stratified by body mass index (BMI) category and presence of T2D. Figure 2. Box plots of imaging biomarkers across NIS2+ risk categories (low, intermediate and at-risk MASH)
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27 Serial Measurements of NIS2+® Allow for Effective Monitoring of Disease Evolution Sanyal, Arun J., et al. "Serial measurements of NIS2+® enable monitoring disease evolution in patients with MASH: A retrospective cohort analysis." Hepatology Communications 9.12 (2025): e0844. Theocharidou, Eleni, et al. "Non-invasive Assessment and Therapeutic Targeting in Metabolic Dysfunction-Associated Steatohepatitis (MASH): Overcoming the Dissonance Between Drug Development and Precision Medicine" Drugs (2026): 1-25. “Emerging data support the role of serial measurement of NIS2+® as a surrogate for disease evolution. Changes in NIS2+® show excellent correlation with histological changes in MASH, reflecting improvement or deterioration, and can be used for disease monitoring. They also correlate with MASH resolution and fibrosis improvement, and could be a useful non-invasive tool for assessing response to treatment in patients with ‘at-risk’ MASH” Theocharidou, Eleni, et al. Drugs (2026): 1-25
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28 GENFIT’s NIS Technology Now Reported in Major Clinical Guidelines and Used in Clinical Trials of Leading Pharma Companies NIS technology in clinical guidelines NIS4® for monitoring treatment response in independant publications from clinical trials “Reductions in ALT, AST, GGT, NIS4®, MRI-PDFF, and cT1 were significantly greater among participants achieving MASH resolution without worsening of fibrosis (responders) compared with those not achieving this endpoint (non-responders).”
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NIS2+ Could Significantly Reduce Liver Biopsy Rates (LBFR) and Overall Costs of MASH Clinical Trials Using NIS2+, the LBFR could have been reduced to <30% and a 16% (-$2.6M) reduction in overall cost could have been reached NIS2+TM FIB4 NIS2+TM FIB4
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NIS2+ Directly Measures the Biological Components Targeted by Current and Emerging MASH Therapies: Disease Activity and Fibrosis (Published Data) Criteria NIS2+ FIB-4 ELF FibroScan (VCTE/FAST) Captures MASH disease activity Yes No No Limited (FAST only) Captures fibrosis Yes Indirectly Yes Yes Designed for at-risk MASH diagnosis (MASH + F≥2) Yes No No Partially At-risk MASH AUROC (LITMUS data) 0.83 0,64 Significantly lower than NIS2+ 0.67 (intermediate FIB-4 population) ~0.73 (FAST) What are the diagnostic tools specifically needed to manage treatment-eligible F2-F3 patients? Detection of F2 patients Strong / weighted toward F2 disease Weak Moderate Moderate Monitoring disease activity / Correlation with MASH resolution Yes No Limited Limited Advanced fibrosis (F≥3) AUROC 0.64 NA 0.74 ~0.81 Current & Emerging MASH Therapies: GLP-1s / THR-β agonists / FGF21 analogues / Combination therapies Treatment target in all FDA authorized registration trials* = MASH activity + F2-F3 fibrosis Source : LITMUS & NIMBLE publications, NIS2+ publications *: Anania F et al, Nonalcoholic Steatohepatitis: Current Thinking From the Division of Hepatology and Nutrition at the Food and Drug Administration, Hepatology 2021
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Pascal Caisey GENFIT COO Qualifying the Market Opportunity: Insights from IQVIA Research NIS2+: Enabling Scalable Adoption of MASH Therapies
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IQVIA Template (V4.0.0) 100% 50% 75% 25% Bright Blue Indigo Bright Teal Bright Green Emerald 5% Charcoal Red Draft 32 In the MASH therapy era, the bottleneck is no longer treatment availability, it’s finding/staging the right patients early and monitoring them well GENFIT Sought to Evaluate How NIS2+ Will Redefine the Market for MASH Diagnostics Quantitative Survey (n=50) Qualitative Interviews (n=5) Surveyed gastroenterologists, hepatologists, endocrinologists, and primary care to capture broad provider perspectives on diagnostic practices, treatment landscape, and NIS2+ positioning Interviewed key opinion leaders to gather deep expert insights on treatment paradigm shifts, validating quantitative trends, and exploring nuanced clinical desigion-making factors Research Methodology Triangulated primary research findings with IQVIA experts ensuring robust, credible insights from breadth and depth of input to minimize bias and maximize strategic confidence IQVIA | GENFIT | NIS2+ Opportunity | GLI Meeting Overall Project Goal Evaluate need, fit, and opportunity for NIS2+ to improve MASH diagnostic & monitoring in the US
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IQVIA Template (V4.0.0) 100% 50% 75% 25% Bright Blue Indigo Bright Teal Bright Green Emerald 5% Charcoal Red Draft © 2026. All rights reserved. IQVIA® is a registered trademark of IQVIA Inc. in the United States, the European Union, and various other countries. Final Readout The MASH therapy era changes the growth equation May 2026
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IQVIA Template (V4.0.0) 100% 50% 75% 25% Bright Blue Indigo Bright Teal Bright Green Emerald 5% Charcoal Red Draft 34 IQVIA | GENFIT | NIS2+ Forecast | Final Report 257M with risk factors for metabolic disease ≈90M with elevated LFT +1 risk factor (86M with steatosis) 167M diagnosed with a metabolic disease Large Addressable Patient Population With Over 99% of Eligible Patients Still Untreated MASH is emerging as one of the largest new chronic care markets • ~90M patients with elevated LFTs and ≥1 metabolic risk might have MASH and could be at-risk. They should be systematically screened for MASH to enable timely diagnosis, referral, and treatment. • As a result, MASH Dx has the potential to: • Significantly expand the diagnosed patient population • Accelerate referral and treatment initiation directly by PCPs or Specialists ≈17M patients have MASH 5-7M At-risk MASH 50 000 treated (2025) Less than 1% of eligible patients Indication: MASH with F2-F3 fibrosis Projections 2033
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IQVIA Template (V4.0.0) 100% 50% 75% 25% Bright Blue Indigo Bright Teal Bright Green Emerald 5% Charcoal Red Draft Only a Small Fraction (1%) of Eligible Patients Currently Receive Treatment Yet Almost Half (47%) of Treated Patients are Outside the Approved Indication Insights from IQVIA Research*Current MASH market ● Lack of awareness about MASH and more specifically tests to detect it: less than 1% of eligible patients currently receive treatment. ● Lack of trust in current tests: even when at-risk MASH is identified only about half of patients are treated ● Poor specificity: 47% of treated patients are F0-F1 or F4 patients = Off label patients At risk of developing MASH : 90M With MASH: 17M Approved indication At-Risk MASH: 7M 50 000 treated with only half estimated to meet the at-risk MASH indication.
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IQVIA Template (V4.0.0) 100% 50% 75% 25% Bright Blue Indigo Bright Teal Bright Green Emerald 5% Charcoal Red Draft 36 Why Are So Few Patients Treated Despite a Large Eligible Population? (1/2) No efficient way to identify at-risk MASH patients at scale ▪ Current screening pathways are inadequate for identifying at-risk MASH patients at scale ▪ Existing diagnostic tools fail to fully address clinical and operational needs ▪ As a result, many at-risk MASH patients remain undiagnosed until advanced fibrosis develops Liver biopsy is invasive, costly, and unsuitable for broad screening ▪ Liver biopsy remains the diagnostic gold standard but is unsuitable for population-scale screening due to its invasive nature, cost (~US$2,000-4,000 per procedure), and associated patient risks. ▪ Beyond procedural limitations, biopsy suffers from sampling variability and inter-/intra-reader variability, creating challenges for consistent disease assessment ▪ There is a growing need for non-invasive, scalable and accessible diagnostic solutions capable of identifying patients efficiently outside specialist centers Limited physician confidence in first-line blood tests such as FIB-4 ▪ Designed to exclude advanced fibrosis, not to identify at-risk MASH ▪ Poor specificity for at-risk MASH + Does not measure disease activity ➔ Limited ability to detect disease activity (MASH) and F2–F3 patients ▪ Large indeterminate “grey zone” ▪ FIB-4 is an effective rule-out tool, but not a stand-alone test IQVIA | GENFIT | NIS2+ Forecast | Final Report Source: Quantitative survey of MASH treaters (n=50) and qualitative discussions with MASH KOLs (n=5); IQVIA expertise Insights from IQVIA Research*
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IQVIA Template (V4.0.0) 100% 50% 75% 25% Bright Blue Indigo Bright Teal Bright Green Emerald 5% Charcoal Red Draft 37 FibroScan requires specialized equipment and is primarily available in specialist settings for fibrosis measurement Today Imaging is utilized more frequently than blood-based biomarkers despite : • Limited accessibility: appointment availability may delay patient evaluation and diagnosis. • Limited performance for at risk MASH : • Measures liver stiffness, not MASH disease activity • Cannot directly identify at-risk MASH (MASH + F2/F3 fibrosis) • Limited ability to distinguish fibrosis due to active MASH versus other causes Low awareness and adoption of alternative diagnostic modalities ▪ Limited awareness of MASH leads to missed or delayed recognition of early symptoms and confusion with other metabolic conditions ▪ Even when MASH is suspected, blood testing practices inconsistent with lack of sensitivity and specificity for inflammation or fibrosis ▪ GI and HI have mixed confidence in existing blood tests, often performing 2 NITs to validate results. ▪ Only small % of patients suspected of MASH are referred by PCPs & without biomarker testing ► Fragmented diagnostic pathway delays patient identification and treatment initiation Until recently, the absence of approved therapies provided little incentive to diagnose ▪ No therapeutic actionability: Physicians had limited incentives to actively identify MASH patients in the absence of approved treatment options ▪ Low PCP prioritization: MASH screening was often deprioritized relative to other cardiometabolic conditions. ▪ Complex diagnostic pathway: Multi-step assessment and specialist referral created significant barriers to diagnosis. ▪ Low patient awareness and engagement: Most at-risk patients were unaware of their disease status and progression risk. ► The clinical & economic value of broad screening was difficult to demonstrate without available therapies The next breakthrough in MASH is not another drug. It's the ability to identify patients at scale Why Are So Few Patients Treated Despite a Large Eligible Population? (2/2) Insights from IQVIA Research*
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IQVIA Template (V4.0.0) 100% 50% 75% 25% Bright Blue Indigo Bright Teal Bright Green Emerald 5% Charcoal Red Draft 38 PHARMA IS THE PRIMARY DRIVER OF MASH MARKET DEVELOPMENT THROUGH THE LAUNCH OF NEW THERAPIES GREATER PHYSICIAN AWARENESS & EDUCATION MORE TREATMENT ELIGIBLE PATIENTS IDENTIFIED HIGHER PRESCRIBING & TREATMENT PERSISTENCE GREATER NEED FOR TREATMENT MONITORING The Virtuous Circle: Effective Therapies Create the Reason to Diagnose, the Urgency to Refer and the Need to Monitor
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IQVIA Template (V4.0.0) 100% 50% 75% 25% Bright Blue Indigo Bright Teal Bright Green Emerald 5% Charcoal Red Draft 39 Why Pharma Needs Scalable Diagnostic tool to Unlock the Full MASH Opportunity IQVIA | GENFIT | NIS2+ Forecast | Final Report ▪ Therapeutic innovation creates clinical actionability ▪ Efficient patient identification is the primary bottleneck to treatment uptake ▪ Scalable diagnostic solutions are essential to unlock the treatable population ▪ PCP engagement requires simple, accessible diagnostic pathways ▪ Disease activity and fibrosis assessment increase treatment confidence ▪ Longitudinal monitoring supports treatment optimization ▪ Market access and reimbursement depend on robust diagnostic evidence Broad adoption of MASH therapies and diagnostics are mutually reinforcing More therapies drive testing demand, while better diagnostics accelerate therapy adoption. Source: Quantitative survey of MASH treaters (n=50) and qualitative discussions with MASH KOLs (n=5); IQVIA analysis
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IQVIA Template (V4.0.0) 100% 50% 75% 25% Bright Blue Indigo Bright Teal Bright Green Emerald 5% Charcoal Red Draft 40 NIS2+ Differentiates From Existing Biomarker Tests Through Simplicity, Sensitivity, and Workflow Fit IQVIA | GENFIT | NIS2+ Opportunity | GLI Meeting 40% 46% 14% All respondents (n=50) 33% 63% 4% GI / Heps (n=27) 48% 26% 26% PCPs / Endos (n=23) Not differentiated (1-3) Somewhat differentiated (4-7) Highly to exceptionally differentiated (8-10) Source: Quantitative survey of MASH treaters (n=50) and qualitative discussions with MASH KOLs (n=5) NIS2+ differentiation vs. other blood-based panels ● Point-of-care accessibility available at any phlebotomy site ● Dual sensitivity for inflammation and fibrosis staging provides comprehensive disease characterization ● Workflow simplicity for PCPs and Endocrinologists compared to complex imaging logistics Competitive Landscape Context ● FIB-4: Cheap and embedded in workflows but has limited sensitivity in gray zones ● FibroScan: Only looks at fibrosis, and specialists prefer immediate results, but accessibility limited in PCPs ● ELF/FibroTest: Good diagnostic accuracy for fibrosis only, but limited ability to detect earlier stage patients NIS2+ has incremental meaningful advantages over other blood tests, and its success hinges on longitudinal data, payer adoption, and outcome linkage New value proposition for PCP/Endo : Triage + referral efficiency with both disease activity & fibrosis staging NIS2+ Strengths per physicians Insights from IQVIA Research*
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NIS2+ Directly Measures the Biological Components Targeted by Current and Emerging MASH Therapies: Disease Activity and Fibrosis (Published Data) 41 Criteria NIS2+ FIB-4 ELF FibroScan (VCTE/FAST) Captures MASH disease activity Yes No No Limited (FAST only) Captures fibrosis Yes Indirectly Yes Yes Designed for at-risk MASH diagnosis (MASH + F≥2) Yes No No Partially At-risk MASH AUROC (LITMUS data) 0.83 0,64 Significantly lower than NIS2+ 0.67 (intermediate FIB-4 population) ~0.73 (FAST) What are the diagnostic tools specifically needed to manage treatment-eligible F2-F3 patients? Detection of F2 patients Strong / weighted toward F2 disease Weak Moderate Moderate Monitoring disease activity / Correlation with MASH resolution Yes No Limited Limited Advanced fibrosis (F≥3) AUROC 0.64 NA 0.74 ~0.81 Source : LITMUS & NIMBLE publications, NIS2+ publications Current & Emerging MASH Therapies: GLP-1s / THR-β agonists / FGF21 analogues / Combination therapies Treatment target in all FDA authorized registration trials* = MASH activity + F2-F3 fibrosis *: Anania F et al, Nonalcoholic Steatohepatitis: Current Thinking From the Division of Hepatology and Nutrition at the Food and Drug Administration, Hepatology 2021
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IQVIA Template (V4.0.0) 100% 50% 75% 25% Bright Blue Indigo Bright Teal Bright Green Emerald 5% Charcoal Red Draft 42 Monitoring Increases Duration, Persistence and Value Per Patient (cf. LDL, Hb1c monitoring cases …) IQVIA | GENFIT | NIS2+ Forecast | Final Report 257M with risk factors for metabolic disease Diagnosis 1.7M NIS2+ Monitoring 5.7M NIS2+ 7.4M NIS2+ volume (LDT + IVD) Base Case Peak Year 2033 90M with elevated LFT +1 risk factor 167M diagnosed with metabolic disease • Monitoring is a highly differentiate case vs other diagnostic tests • While the eligible population is large (90M), NIS2+ volume is driven primarily by monitoring treatment response and disease progression / regression • Key Value of Monitoring For Pharma : • Demonstrates treatment effectiveness in real-world settings • Improves patient persistence and adherence • Optimizes treatment decisions • Strengthens payer value proposition with real-world outcome data supporting reimbursement and market access. For GENFIT : • Recurring testing revenue • Expanded testing volume per patient • Stronger partnerships with Pharma • Higher barriers to entry for competitors Source: Quantitative survey of MASH treaters (n=50)
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IQVIA Template (V4.0.0) 100% 50% 75% 25% Bright Blue Indigo Bright Teal Bright Green Emerald 5% Charcoal Red Draft 43 IVD is critical to unlock the full value of pharma partnerships For pharma, broad patient identification requires an IVD solution LDT can establish the market, but IVD is needed to scale it. LDT = Time to market and lower risk Limited investment Early market development Generates clinical utility data Restricted scalability and value capture IVD = scale and value creation Broader adoption by laboratories Greater accessibility for PCPs and endocrinologists Larger diagnostic and monitoring volumes Higher long-term economics Stronger strategic control and asset value Completion target: 2028 Start: 1H26 Why GENFIT Should Pursue IVD Beyond LDT: LDT Validates the market. IVD Scales the Market.
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Translating the Opportunity into Revenue: Corporate Guidance
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A Decade of Vision and Execution Now Entering the Next Phase: Progressive Adoption and Commercial Scale-Up 2015 2028 Two historically complementary programs Therapeutic program (elafibranor in MASH1) Diagnostic program (NIS non-invasive technology for the identification of patients with at-risk MASH) 6 major scientific publications (Nature Medicine, The Lancet Gastro & Hep, Journal of Hepatology, etc.), and >20 congress posters & oral presentations Recognition by leading EU and US consortia (LITMUS, NIMBLE) Deployment in large-scale clinical trials Inclusion in international clinical guidelines (EASL / EASD / EASO – ADA – AGA - KASL) Strategic groundwork and pre-positioning Key steps toward large-scale adoption Commercial rollout via Labcorp’s offering Reimbursement of NASHnext® (Labcorp) by Medicare for patients meeting eligibility criteria Strategic partnerships with major pharmaceutical and diagnostic players Development of an IVD kit for NIS2+® and proceed with large-scale commercialization 2020 2026 3 1 2 4 DIAGNOSTIC MONITORING + 1. At the time of the elafibranor development the indication was still named NASH and was only more recently changed into MASH 2027
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Base Case volume assumptions across the patient testing journey, from initial diagnosis to long-term monitoring Diagnosis 1.7M NIS2+ tests Monitoring 5.7M NIS2+ tests + = Base Case Total 7.4M NIS2+ volume Volume Split: Diagnostic Testing vs. Monitoring Diagnostic Testing — 23% Monitoring — 77% Monitoring Drives the Majority of Base Case NIS2+ Volume 10.3M total NIS2+ volume in the Base Case — ongoing monitoring outweighs initial diagnosis and re-testing combined Expected Adoption Dynamics: Diagnostics vs. Monitoring Volume peak year 2033 (U.S.)
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The diagnostics opportunity is no longer constrained by therapy availability, but by the ability to identify and manage eligible patients at scale IVD Unlocks a ~$1.5B Peak Annual Laboratory Market Opportunity1 $0 $150 $300 $450 $600 $750 $900 $1 050 $1 200 $1 350 $1 500 2026 2027 2028 2029 2030 2031 2032 2033 2034 2035 2036 High Base Low ~10M ~300M >1B ~1.5B (in million USD for the lab) Year NIS2+ Estimated Revenue to Partner Lab (LDT+IVD) 1: Laboratory Market Opportunity is not GENFIT revenue, which would be based on royalties from licensing fees
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Assumptions overview ▪ Number of patients at the various stages of the funnel is based on averages of published epidemiological data and generally aligned with other industry communications. ▪ Conservative adoption assumption: in the model NIS2+ is expected to capture only ~35% of frontline blood- based testing, even though 60% of prescribers currently see NIS2+ as clearly differentiated and better than other tests. ▪ Access: payer coverage has been capped at 60%, reached gradually over a four-year ramp-up period which seems conservative considering current Medicare coverage of NIS4. This has been combined with a 40-60% (industry benchmark) IVD manufacturer to laboratory discount assumption. ▪ Longitudinal monitoring as an approved use of the IVD kit ▪ 2028 as the target year for broad commercialization: the IVD launch is expected in 2028. This means that the broader access and adoption typically seen when a diagnostic moves from specialized LDT use will start at that point.
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Q&A
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Merci Beaucoup