Genfit SA · EURONEXT:GNFT
Genfit SA — Investor Presentation (October 2025)
27 slides from Genfit SA's investor presentation, Oct 6, 2025
Slide 1: Corporate Overview
Corporate Overview O c tobe r 2025
Slide 2: Disclaimer
Disclaimer 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 B
Slide 3: 1. Who we are
1.Who we are 2. R&D focus 3. Iqirvo® in PBC 4. Takeaways
Slide 4: Highlights
Highlights Lille (HQs) & Paris Zurich Cambridge, MA French biopharmaceutical company Dual-listed on EURONEXT & 4 assets in in ACLF3 NASDAQ (GNFT) • G1090N ACLF (HV, POC) • SRT-015 ACLF (preclinical) 25+ years in liver diseases, taking • CLM-022 ACLF (preclinical) early assets to commercial stage1 •
Slide 5: 25 Years of Liver Disease Innovation: Expertise from Discovery to Launch
25 Years of Liver Disease Innovation: Expertise from Discovery to Launch Inception Clinical development Pivot to acute, rare and life-threatening & early years in chronic liver diseases liver diseases with high unmet needs 1999 2022 Development of Development of elafibranor in MASH ▪ 6 programs R&D
Slide 6: Pipeline
Pipeline ► RESEARCH & DEVELOPMENT1 Preclinical Phase 1 Phase 2 Next expected/targeted steps2 G1090N3 HVC -> HID, RIE POCF initiation targeted 1H26 and efficacy data 2H26 ACLF SRT-0154 Potential initiation of FIHG targeted 2H26 Continuum* CLM-0225 Potential initiation of FIHG targeted 1H27 VS-02-HE P
Slide 7: Targeted Markets: High unmet medical needs
Targeted Markets High unmet medical needs ACLF CCA Prevalence of ACLF $52,000 294,000 in 2021, US, EU4 & UK Prevalence ~$3.1Bn Average cost per hospitalization per patient in US 20,000 to 30,000 Market estimates ~300,000 patients by 2036 for US, EU4 & UK for US, EU4 & UK Growing at Epidemic Rates $6
Slide 8: 2. R&D focus
Acute-On-Chronic Liver Failure (ACLF) Life-threatening worsening of pre-existing advanced chronic liver disease covering a broad spectrum of conditions across a disease continuum including acute decompensation (AD) of liver cirrhosis and hepatic encephalopathy (HE) G1090N │ SRT-015 │ CLM-022 │ VS-02
Slide 9: What is ACLF?
What is ACLF? Chronic Liver Disease Cirrhosis Precipitant Multi-system failure 23-74% mortality at 28 days = UNDERLYING CONDITION = TRIGGER = CASCADE OF ORGAN FAILURES ► NO APPROVED DRUGS Kidney Failure Cerebral Alcohol Viruses Bacterial Failure Consumption Infection Compensated The liver is scarred
Slide 10: Pathophysiology of ACLF
Pathophysiology of ACLF LIVER CIRRHOSIS ▪ Immune-mediated tissue damage Portal Possible complications Hyperammonemia ▪ Mitochondrial dysfunction Hypertension ▪ Oxidative Stress Ascites / Variceal bleeding / infection / other • Cell Death Increased Portal • DAMPs Hypertension Gut/Liver axis • Dysbios
Slide 11: Our Approach to ACLF: Assets Targeting Multiple Pathways
Our Approach to ACLF: 4 Assets Targeting Multiple Pathways LIVER CIRRHOSIS 1-2 ▪ Immune-mediated tissue damage Portal Possible complications Hyperammonemia ▪ Mitochondrial dysfunction Hypertension ▪ Oxidative Stress Ascites / Variceal bleeding / 4 infection / other 1-2-3 • Cell Death Increased Porta
Slide 12: Our ACLF Pipeline: Complementary Mechanisms of Action
Our ACLF Pipeline: Complementary Mechanisms of Action We are developing a diversified pipeline based on pathophysiology to better address the complexities of the condition and improve treatment outcomes G1090N SRT-015 CLM-022 VS-02-HE Oral Injectable Oral Anti-inflammatory ASK1 NLRP3 inflammasome Ur
Slide 13: G1090N Anti-inflammatory
G1090N G1090N Findings to date: NTZ antibacterial Anti-inflammatory ✓ Protects liver, kidney & brain in rat model of ACLF activity through inhibition of PFOR and anti-bacterial ✓ Prevents cell death via anti-apoptotic and anti- Oral necroptotic effects ✓ Reduces PAMPs-induced inflammation ✓ Counters
Slide 14: G1090N Next Steps: Phase 1 study in healthy volunteers
G1090N CT.gov #: NCT07110441 Ongoing Phase 1, open-label study to assess pharmacokinetics, safety, and tolerability G1090N of G1090N in healthy subjects Anti-inflammatory and anti-bacterial Oral Investigational drug G1090N is a Key inclusion criteria promising therapy in ACLF due to: • Healthy Volun
Slide 15: SRT-015
SRT-015 SRT-015 Findings to date: ASK1 ✓ Positive effect of oral investigational drug SRT-015 on survival of mice in sepsis inhibitor ✓ In vivo efficacy demonstrated in ALF models with IV bolus (AASLD24 poster) Injectable AASLD EASL 2024 2025 ► Intravenous administration after Acetaminophen (APAP) i
Slide 16: CLM-022
CLM-022 Findings to date: CLM-022 ✓ Investigational drug CLM-022 dose-dependently inhibits IL-1β secretion NLRP3 ✓ In vivo efficacy demonstrated in ALF models inflammasome -► a potent inhibitor of NLRP3 inflammasome-mediated pyroptosis inhibitor -► a potential treatment for acute and chronic inflamm
Slide 17: VS-02-HE
VS-02-HE About ▪ One of the most common complications of liver cirrhosis and ACLF A central nervous system disorder representing a diverse spectrum of neurologic symptoms VS-02-HE Hepatic ▪ ▪ Excess ammonia induces alteration of cell metabolism and can result in brain edema Urease inhibitor Encephal
Slide 18: GENFIT Establishing Leadership as ACLF Rises on the Scientific Agenda
GENFIT Establishing Leadership as ACLF Rises on the Scientific Agenda Leveraging Strategic dialogue Building knowledge, Real-world Data EF CLIF partnership: with experts: onboarding the >270,000 U.S patients Access to unique data ACLF KOL Advisory ecosystem: corresponding to our and cutting-edge Boa
Slide 19: 2. R&D focus: Cholangiocarcinoma
Acute-On-Chronic Liver Failure (ACLF) G1090N │ SRT-015 │ CLM-022 │ VS-02-HE Cholangiocarcinoma (CCA) Malignancy of bile ducts. Without treatment <20% of patients survive 5 years from diagnosis1. KRAS mutation is not addressed by current treatments. GNS561 Urea Cycle Disorders (UCD) & Organic Acidemi
Slide 20: GNS561 in CCA
GNS561 in CCA GNS561 Findings to date: PPT1 inhibitor in ✓ Autophagy allows cancer cells to become resistant to the cellular stress induced by chemotherapy and targeted therapy combination with a MEK inhibitor Oral ✓ Phase 1: Safety profile, exposure, and preliminary signal of activity support the i
Slide 21: GNS561 in CCA: Phase 1b/2a study
GNS561 in CCA CT.gov #: NCT05874414 GNS561 A Phase 1b/a open-label, multicenter study to evaluate safety, pharmacokinetics (PK), pharmacodynamics PPT1 inhibitor in (PD) and efficacy of GNS561 in combination with trametinib in advanced KRAS mutated CCA after failure of combination with standard-of-ca
Slide 22: 2. R&D focus: UCD & OA
Acute-On-Chronic Liver Failure (ACLF) G1090N │ SRT-015 │ CLM-022 │ VS-02-HE Cholangiocarcinoma (CCA) GNS561 Urea Cycle Disorders (UCD) & Organic Acidemias (OA) Ultra-rare disease: 1,900 HAC2,3,4 per year in children in US+EU4+UK. High mortality (75% at 5 years2). Survivors often have severe brain in
Slide 23: VS-01-HAC in UCD/OA
VS-01-HAC in UCD/OA Findings to date: VS-01-HAC ✓ Preclinical proof of concept: Potential first-line • Investigational drug VS-01 demonstrated superior ammonia clearance than commercial peritoneal dialysis treatment or in-vivo1,2,3,4 bridging therapy Peritoneal • Ammonia clearance in adult patients
Slide 24: 3. Iqirvo in PBC
1. Who we are 2. R&D focus 3.Iqirvo® in PBC 4. Takeaways
Slide 25: Solid Commercial Performance from Ipsen in PBC
Solid Commercial Performance from Ipsen in PBC 1. 2. Rapid regulatory approvals1 Successful commercial launch Iqirvo® sales (global, quarterly) since commercial launch2 €36M June September October May 2025 €23M 2024 2024 2024 3 major EU countries FDA EMA MHRA Reimbursement €14M €8M 3Q24 4Q24 1Q25 2Q
Slide 26: 4. Takeaways
1. Who we are 2. R&D focus 3. Iqirvo® in PBC 4.Takeaways
Slide 27: Takeaways
Takeaways Strong financial position 1 • 3+ years of cash (all programs financed) • Encouraging Iqirvo® commercial sales trajectory Diversified pipeline, multiple shots on goals 2 • 6 programs • 2 data readouts end of 2025 Established leadership in ACLF 3 • Strategic engagements with the ecosystem •