Genfit Sa · EURONEXT:GNFT
Genfit Sa — Investor Presentation (September 2023)
21 slides from Genfit Sa's investor presentation, Sep 12, 2023
Slide 1: Corporate Presentation – Investor Events
Corporate Presentation Investor Events SEPTEMBER 12, 2023
Slide 2: Disclaimer & Forward-Looking Statement
Disclaimer & Forward -Looking Statement 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 DERIVE
Slide 3: GENFIT Highlights
GENFIT Highlights Who we are French biopharmaceutical company Dual-listed on EURONEXT & NASDAQ (GNFT) Our pipeline Improving the life of patients ELAFIBRANOR in PBC (Positive Phase 3) with liver diseases 5 assets in ACLF and its complications Specific focus on rare and severe liver VS-01 (Phase 2) d
Slide 4: Pipeline: Programs from Early-stage to Commercialization
Pipeline: 10 Programs from Early -stage to Commercialization Preclinical Phase 1 Phase 2 Phase 3 Next steps2 ELAFIBRANOR3 in PBC Orphan Drug Designation by the FDA & EMA | Breakthrough Therapy Designation by the FDA ✓ Positive Ph3 data, expected filing EoY2023 2 VS-01 in ACLF Orphan Drug Designation
Slide 5: Market Potential: an Overall ~12.5bn USD Opportunity
Market Potential: an Overall ~12.5bn USD Opportunity Estimated Overall Market Size (US+UE5) by 2030, bnUSD Assumptions(3) • Prevalence: 155K (EU5) / 80k (US) for grade 1 / 2 ACLF patients • Drug price could amount to $30-40k per patient in US in secondary prevention for ACLF1/2. ACLF 2.2 1.6 3.8 Wit
Slide 6: Several Catalysts over the Next Few Years
Several Catalysts over the Next Few Years Elafibranor • Expected Filing in • Potential US and in PBC* US and Europe** European approval & commercialization* 2023 2024 2025 • VS-01-ACLF • VS-01-ACLF • VS-02 HE Ph2 1st patient screening Ph2 clinical efficacy data IND enabling studies completion • GNS5
Slide 7: Acute-on-Chronic Liver Failure (ACLF), a Growing Health Burden
Acute-on-Chronic Liver Failure (ACLF), a Growing Health Burden Definition, Epidemiology & Costs The Higher the ACLF Grade, the Higher the Mortality ACLF = Abrupt life-threatening worsening of pre-existing chronic liver disease (CLD)/cirrhosis 28d-mortality • Characterised by pronounced systemic • Hi
Slide 8: ACLF, a Multifactorial Syndrome
ACLF, a Multifactorial Syndrome Liver Disease Etiology & Pathogenesis CEREBRAL DYSFUNCTION/FAILURE Liver Disease Etiology1 CIRCULATORY › ALD › MASLD FAILURE › DILI › Autoimmune & cholestatic diseases › Viral Hepatitis › Hereditary diseases IMPAIRED GUT BARRIER RESPIRATORY BACTERIAL FAILURE TRANSLOCA
Slide 9: Our Scientific Approach: A Diverse Portfolio with Complementary MoAs
Our Scientific Approach: A Diverse Portfolio with Complementary MoAs We are developing a diverse drug portfolio with complementary mechanisms of action, to better address the complexities of ACLF and improve treatment outcomes. VS-01-ACLF NTZ SRT-015 CLM-022 VS-02-HE Peritoneal Oral Injectable Oral
Slide 10: Our Scientific Approach: Targeting the Golden Treatment Window
Our Scientific Approach: Targeting the Golden Treatment Window VS-01 NTZ Multiorgan support in the early course of ACLF SRT-015 CLM-022 VS-02-HE TREATMENTS GOALS - DYSBIOSIS - PAMPS R esolve ACLF - BACTERIAL TRANSLOCATION Recovery I mprove survival C hance of liver transplant Transplantation (Tx) in
Slide 11: VS-01, our Liposomal-based Technology for Ammonia Clearance in Blood
VS-01, our Liposomal -based Technology for Ammonia Clearance in Blood Standard of care VS-01 in brief Ascites drainage Targets first-line treatment for ACLF to reverse the disease Delivered via in-place peritoneal access catheter Targets multiorgan support: VS-01 VS-01 scavenging liposomes brain, li
Slide 12: VS-01-ACLF: FIH Ph1b Study Efficacy Results on Liver & Brain Function
VS-01-ACLF: FIH Ph1b Study Efficacy Results on Liver & Brain Function 1 IMPROVMENT OF OVERALL DOSE-DEPENDENT AMMONIA IMPROVEMENT IN LIVER DISEASE SEVERITY REMOVAL FROM THE BODY PSYCHOMETRIC TESTS FOR HE e.g., assessed by Child-Pugh Score (CPS) Ammonia clearance increased with VS-01 dosage in e.g., n
Slide 13: VS-01-ACLF: FIH Ph1b Study Efficacy Results on Metabolites & Inflammation
VS-01-ACLF: FIH Ph1b Study Efficacy Results on Metabolites & Inflammation 1 REDUCTION OF ACLF-RELATED METABOLITES2 VS-01 reduced plasma metabolites associated with organ failures3 VS-01 reduced plasma metabolites associated with bacterial infection4 b a b a c c Two abstracts presented Abstract selec
Slide 14: NTZ, Antiparasitic with Anti-Inflammatory and Antibacterial Effects
NTZ, Antiparasitic with Anti -Inflammatory and Antibacterial Effects NTZ in brief Antiparasitic medication used to treat infections Several clinical trials and observational studies1,2 reported anti-inflammatory and anti-bacterial effects of NTZ in human Supporting Evidence Preclinical › Reduces LPS
Slide 15: NTZ, Activity in Disease Models Support ACLF Clinical Development
NTZ, Activity in Disease Models Support ACLF Clinical Development NTZ reduces LPS-induced inflammation in healthy rats* NTZ has beneficial effects on liver function markers (bil, alb) in models of cirrhosis* NTZ reduces brain edema in models of ACLF (BDL) NTZ reduces inflammation markers in models o
Slide 16: 3 Early-stage Programs for the Treatment of ACLF and its Complications
3 Early-stage Programs for the Treatment of ACLF and its Complications SRT-0151 in ACLF Supporting evidence Preclinical and clinical2 ASK1 › In kidney diseases, limits renal inflammation, apoptosis and fibrosis First-in-Human › In liver diseases, prevents hepatocyte death, inflammation and fibrosis
Slide 17: Other Therapeutic Areas: GNS561 for the Treatment of KRAS-mutated CCA
Other Therapeutic Areas: GNS561 for the Treatment of KRAS -mutated CCA About CCA GNS561, a clinical-stage candidate that localizes in lysosome where it binds › Malignancy of the bile ducts => as cancer and inhibits PPT1, resulting in: grows, leads to damage to the liver and other organs › lysosomal
Slide 18: Other Therapeutic Areas: VS-01, ammonia clearance in HAC
Other Therapeutic Areas: VS -01, ammonia clearance in HAC About Urea Cycle Disorders (UCD) VS-01 in UCD/OA, an existing asset leveraged and Organic Acidemias (OA) in another indication › Groups of congenital metabolic diseases › Peritoneal route well adapted to › Complementary to other therapeutical
Slide 19: Diagnostic Program: NIS2+ for the Identification of at-risk NASH
Diagnostic Program: NIS2+ TM for the Identification of at -risk NASH NASH diagnosis in brief We developed and validated NIS2+ ™, an optimization of the NIS4® technology for the diagnosis of at-risk NASH › 6.7M patients have NASH and significant fibrosis (F≥2) in the US1 but only 900,000 are diagnose
Slide 20: Conclusion
Conclusion Potential Large and Frequent future diversified newsflow revenues ACLF as pipeline from PBC pipeline advances program Potential future milestones and 5 programs under development Up to 7 data readouts royalty revenues expected to further to address ACLF, a severe disease expected in the c
Slide 21: We thank you for your attention
We thank you for your attention SEPTEMBER 12, 2023