Genfit Sa · EURONEXT:GNFT
Genfit Sa — Investor Presentation (April 2022)
27 slides from Genfit Sa's investor presentation, April 2022
Slide 1: Corporate Presentation April 2022
Corporate Presentation April 2022
Slide 2: Disclaimer & Looking Forward Statement
Disclaimer & Looking Forward 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 DERIVED
Slide 3: About GENFIT
About GENFIT Mission & Expertise • French late-stage biopharmaceutical company dedicated to improving the lives 120+ collaborators of patients with severe chronic liver diseases • Pioneer in the field of nuclear receptor-based drug discovery, GENFIT has a robust and 400+ trademarks diversified pipel
Slide 4: Therapeutics: Cholestatic diseases
Therapeutics: Cholestatic diseases Therapeutics: ACLF Diagnostics: NASH
Slide 5: Cholestatic Diseases: Multiple Opportunities, from Preclinical Research to Market Access
Cholestatic Diseases: Multiple Opportunities, from Preclinical Research to Market Access Primary Biliary Cholangitis (PBC) Cholangiocarcinoma (CCA) Description Description ▪ Chronic liver disease in which bile ducts in the liver are gradually destroyed. ▪ Cholangiocarcinoma is a rare liver malignanc
Slide 6: Cholestatic Diseases: Characterized by Inflammation and Destruction of Bile Ducts
Cholestatic Diseases: Characterized by Inflammation and Destruction of Bile Ducts PBC: Liver Bile ducts gradually destroyed = Smaller bile ducts bile acid circulation & toxicity Inflammation 1 Liver Intrahepatic bile ducts Fibrosis Common bile duct Bile duct 2 Stomach Bile acid Bile flow CCA: Ga
Slide 7: Elafibranor as a Potential Treatment for PBC (1/3)
Elafibranor as a Potential Treatment for PBC (1/3) Elafibranor Phase 2a PBC Study Statistically significant treatment effects with both 80mg and 120mg doses on the primary end-point* of serum alkaline phosphatase (ALP) change from baseline Change from baseline in ALP at week 121 ALP % Change vs. bas
Slide 8: Elafibranor as a Potential Treatment for PBC (2/3)
Elafibranor as a Potential Treatment for PBC (2/3) Elafibranor is a Competitive 2L Candidate for PBC Elafibranor*2 Phase 2a Ocaliva™3, Phase 3 POISE Week 12 Data Month 12 Data NCT03124108 NCT01473524 EudraCT2016-003817-80 80mg Placebo 10mg Placebo (N=15) (N=14) (N=73) (N=72) Composite endpoint Compo
Slide 9: Elafibranor as a Potential Treatment for PBC (3/3)
Elafibranor as a Potential Treatment for PBC (3/3) ELATIVE™ – a Pivotal Phase 3 Study in Patients with PBC Randomized 2:1, double blind, placebo-controlled, global study1 N=100 Elafibranor (PPAR α/ẟ agonist) 80mg N=50 Placebo Day 1 Week 52 Primary Endpoint Response to treatment at Week 52 defined as
Slide 10: GNS561 as a Potential Treatment for CCA
GNS561 as a Potential Treatment for CCA GNS561 Mechanism of Action • GNS561 is a clinical-stage candidate inhibiting autophagy which causes a cascade of events, leading to tumor cell apoptosis (cell death)1: lysosomal accumulation of unbound zinc ion (Zn2+), inhibition of PPT-1 and cathepsin act
Slide 11: Autophagy inhibition: Highlights from the Literature for Potential Treatment for CCA
Autophagy inhibition: Highlights from the Literature for Potential Treatment for CCA Monotherapy Combo with MEKi/ERKi Combo with chemotherapy F. Bassissi et al. Chih-Shia Lee et al. Yu-Jie Hou et al. GNS561 : a new quinoline derivative with high efficacy on cancer stem cells in MAP kinase and autoph
Slide 12: Therapeutics: ACLF
Therapeutics: Cholestatic diseases Therapeutics: Therapeutics: ACLF Acute on chronic liver failure Diagnostics: NASH
Slide 13: Acute on Chronic Liver Failure: a New Growth Opportunity for GENFIT
Acute on Chronic Liver Failure: a New Growth Opportunity for GENFIT High unmet medical need in ACLF ▪ Life threatening disease with high mortality at 30-90 days1 ▪ Standard of Care (SoC): no approved drugs2 ▪ Medical need: a therapy that helps patients to survive ACLF without liver transplantation M
Slide 14: Natural History of AD and ACLF in Cirrhotic Patients
Natural History of AD and ACLF in Cirrhotic Patients • ACLF Definition : acute deterioration of preexisting chronic liver disease, usually related to a precipitating event and associated with increased mortality at three months due to multi-system organ failure. • Precipitating factors : Infection (
Slide 15: NTZ and PPARs May Address Multiple Relevant Pathways in ACLF
NTZ and PPARs May Address Multiple Relevant Pathways in ACLF NTZ effects PPARs effects Gut microbiota dysbiosis (>90% anaerobic Gram negative) Cirrhotic liver Bacterial overgrowth Decreased bacterial diversity Impaired intestinal barrier and increased bacteria translocation: Bacterial products (PAMP
Slide 16: Highlights from the Literature on NTZ and PPARs in ACLF
Highlights from the Literature on NTZ and PPARs in ACLF NTZ PPARs • Anti-infectious properties may act on intestinal microbiota • In ACLF, an over-activation of the innate immune-system induces a dysbiosis/overgrowth and improve intestinal barrier. critical energetic adaptation i) increased aerobic
Slide 17: Pre-clinical Evidence Generated by GNFT – NTZ in ACLF (1/2)
Pre-clinical Evidence Generated by GNFT – NTZ in ACLF (1/2) In vivo model #1 In vivo model #2 (ACLF) n=2 CCL4= 15 weeks n=10 CCL4= 15 weeks n=7 n=10 n=8 Activity on liver failure markers Activity on kidney failure markers ¤ 16384 $$ 32 150 Activity on inflammatory markers ¤ T o ta l b ilir u b in (µ
Slide 18: Pre-clinical Evidence Generated by GNFT – NTZ in ACLF (2/2)
Pre-clinical Evidence Generated by GNFT – NTZ in ACLF (2/2) In vivo model #3 (ACLF) In vivo model #4 (sepsis) n=24/grp CLP Controls (vehicle) Brain edema Kidney function marker n=24/grp NTZ 100mpk NTZ treatment 100 mg/kg/d NTZ Circulating cytokines Hepatic TNFα expression Renal TNFα expression D o s
Slide 19: Diagnostics: NASH
Therapeutics: Cholestatic diseases Therapeutics: ACLF Diagnostics: NASH
Slide 20: NIS4 Technology to Diagnose Millions of Patients with Active NASH and Fibrosis
NIS4® Technology to Diagnose Millions of Patients with Active NASH and Fibrosis High unmet medical need in NASH diagnostics GENFIT’s rationale ▪ 6.7M patients have NASH and significant fibrosis (F≥2) in the US1†, only 900,000 To identify patients with at-risk NASH, GENFIT has invested in a are diagn
Slide 21: NIS4: A Proprietary and Differentiated Technology for the Diagnosis of At-Risk NASH
NIS4®: A Proprietary and Differentiated Technology for the Diagnosis of At-Risk NASH Currently Available NASH Activity Fibrosis Standard Ordering HCP Method Designed for NASH Diagnostic Method NIS4®,1 Any healthcare provider Non-invasive BIOPSY Hepatologist/GI Invasive - ULTRASOUND Steatosis Only -
Slide 22: NIS4 Technology: An Innovative Approach Built Upon a Blood Test
NIS4® Technology: An Innovative Approach Built Upon a Blood Test1 NIS4® is the only non-invasive, blood-based technology Comparison of NIS4 vs individual biomarker components to identify specifically designed to assess both NASH activity patients with at-risk NASH* within the discovery cohort (n=239
Slide 23: NIS4 Technology Published in The Lancet Gastroenterology & Hepatology
NIS4® Technology Published in The Lancet Gastroenterology & Hepatology A blood-based biomarker panel (NIS4) for non-invasive diagnosis of non-alcoholic steatohepatitis and liver fibrosis: a prospective derivation and global validation study1 Stephen A. Harrison, Vlad Ratziu et. al. | Accepted for pu
Slide 24: The Progression and Future of NIS4 Technology
The Progression and Future of NIS4® Technology A test powered by clinically validated NIS4® technology is the simple solution to identify at-risk NASH patients Licensing of NIS4® Commercial availability of NIS4® Technology Licensing of NIS4® Technology Launch of NASHnext® based Technology for resear
Slide 25: NASH Diagnostics: Accelerating Technology
NASH Diagnostics: Accelerating Technology A platform of fit-for-purpose NASH diagnostic solutions Today, addressing the unmet need of identifying Commercial NIS4® Research* people with at-risk NASH NIS4® Technology NIS4® LDT* NASHNext® Powered by NIS4® Technology Learn more NIS4® IVD Disease Progres
Slide 26: R&D Roadmap
R&D Roadmap 2020 2021 2022 2023 Development Chol. D. - PBC Phase 2 online Publication In J. Hepatol. End of patient screening1 Elafibranor* Phase 3 ELATIVETM (Further clinical development to be led by Ipsen*) Topline Results - 2Q23 Chol. D. - CCA Program start Phase 1b/2 trial GNS561** ACLF Phase 1
Slide 27: Our Core Values / Our Strengths
Our Core Values Innovation to Serve Collaboration Drive our Mission to be a Pioneer Patients in the Diagnosis and Treatment Improving the health Recognizing and valuing diversity and quality of the lives of patients as a source of strength of Liver Disorders A portfolio focused on disease A recogniz