Genfit Sa · EURONEXT:GNFT
Genfit Sa — Investor Presentation (October 2021)
27 slides from Genfit Sa's investor presentation, Oct 18, 2021
Slide 1: Corporate Presentation
Corporate Presentation October 2021 October 18, 2021
Slide 2: Disclaimer & Forward Looking Statements
Disclaimer & Forward Looking Statements 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: Update on Implementation of Corporate Roadmap
Update on Implementation of Corporate Roadmap Lead program in PBC Therapeutics Pipeline • R&D rationalized in 1H21: focus on ACLF and • Phase 3 ELATIVE™1 evaluating drug-candidate elfibranor2: Cholestatic diseases, leveraging the potential of patient enrollment started in 3Q20 GENFIT’s internal asse
Slide 4: Therapeutics: Cholestatic diseases
Therapeutics: Cholestatic diseases
Slide 5: Cholestatic Diseases: Multiple Opportunities, Beyond Lead Program in PBC
Cholestatic Diseases: Multiple Opportunities, Beyond Lead Program in PBC High unmet medical need in cholestatic diseases GENFIT’s rationale PBC ▪ In-house expertise (discovery to late stage) in severe liver ▪ Standard of Care (SoC): still unmet medical need calling for new differentiated therapies1
Slide 6: Cholestatic Diseases: Characterized by Inflammation and Fibrosis of the Bile Ducts
Cholestatic Diseases: Characterized by Inflammation and Fibrosis of the Bile Ducts 1: Synthesis by liver 2: Transport to the bile duct, and detoxification 3: Storage by gallbladder 4: Export to the intestine 5: Passive/active absorption by small intestine 6A: 95% 5% 6B: Reabsorption Excretion Entero
Slide 7: PPARs Mechanism of Action in Cholestatic Diseases
PPARs Mechanism of Action in Cholestatic Diseases Increase Bile Acid Detoxification Intracellular bile CYP3A4 | SULT2A1 | UGT2B4 acid metabolism PPARα/PPARδ Decrease Bile Acid Synthesis PPARs activation CYP7A1 | CEP27A1 | CYP8B1 Increase Bile Acid Output Effects on apical BSEP | MRP2 membrane transp
Slide 8: Literature on PPARs in Cholestatic Diseases
Literature on PPARs in Cholestatic Diseases PPAR Proof of Concept in Cholestatic Disease Reduced Levels of ALP May be Associated with Improved Outcomes in PSC • Stanich PP , Bjornsson E , Gossard AA et al. Alkaline phosphatase normalization is associated with better prognosis in primary sclerosing c
Slide 9: Elafibranor as a Potential Treatment for PBC (1/4)
Elafibranor as a Potential Treatment for PBC (1/4) 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 defined as Alkaline p
Slide 10: Elafibranor as a Potential Treatment for PBC (2/4)
Elafibranor as a Potential Treatment for PBC (2/4) Elafibranor Phase 2a PBC Study Statistically significant treatment effects in both 80mg and 120mg doses on the primary end-point (confirmed in mITT* set) of serum alkaline phosphatase (ALP) change from baseline Change from baseline in ALP at week 12
Slide 11: Elafibranor as a Potential Treatment for PBC (3/4)
Elafibranor as a Potential Treatment for PBC (3/4) 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 12: Elafibranor as a Potential Treatment for PBC (4/4)
Elafibranor as a Potential Treatment for PBC (4/4) Phase 2a Efficacy and Safety Data Support ELATIVE™ Phase 3 PBC Trial Elafibranor demonstrated beneficial effects Pruritus trend1 on clinically proven markers of PBC1 Cholestatic Markers Inflammation Markers GGT IgM hsCRP - 24% (elafibranor 80mg) • -
Slide 13: Therapeutics: Acute on chronic liver failure
Therapeutics: Acute on chronic liver failure
Slide 14: ACLF: a New Growth Opportunity for GENFIT
ACLF: 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 Market opportunity GENFIT’s
Slide 15: 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 16: NTZ and PPARs May Address Multiple Relevant Pathways in ACLF
NTZ effects NTZ and PPARs May Address Multiple Relevant Pathways in ACLF 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 17: 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 18: Evidence Generated by GNFT – NTZ in ACLF
Evidence Generated by GNFT – NTZ in ACLF In vivo model #1 In vivo model #2 (ACLF) n=2 CCL4= 15 weeks n=10 n=7 CCL4= 15 weeks n=8 n=10 Activity on liver failure markers Activity on kidneyfailure markers Activity on inflammatory markers 16384 $$ 30 150 # T o ta l b ilir u b in (µ m o l/l) ## 8192 C r
Slide 19: Diagnostics: NASH
Diagnostics: NASH @ceverr
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 miRNA Science
NIS4® Technology: An Innovative Approach Built Upon miRNA Science 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 NASHNext™ NIS4® Technology NIS4® LDT* Powered by NIS4® Technology Learn more NIS4® IVD Disease Progres
Slide 26: Development Roadmap
Development Roadmap 2020 2021 2022 2023 Phase 2 online Publication In J. Hepatol. Cholestatic diseases Topline efficacy PBC Elafibranor Phase 3 ELATIVETM data - 1Q/2Q Exploratory study (Treatment naïve population) PSC Elafibranor Phase 2 (proof of concept) Nitazoxanide Phase 1 ACLF Elafibranor Phase
Slide 27: GENFIT: A Pioneer in the Diagnosis and Treatment of Liver Disorders
GENFIT: A Pioneer in the Diagnosis and Treatment of Liver Disorders Leader in PPAR research Pioneer in NASH and PBC Proven team with global scientific, regulatory, and commercialization expertise Milestones Cholestatic diseases Therapeutics 3Q20 ELATIVE™ Clinical study beginning of enrolment 1Q2