Genfit Sa · EURONEXT:GNFT
Genfit Sa — Investor Presentation (June 2020)
20 slides from Genfit Sa's investor presentation, Jun 19, 2020
Slide 1: Corporate Presentation 2020
CORPORATE PRESENTATION 2020 2020 June 19, 2020
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: GENFIT: Pioneering Diagnostic and Therapeutic Solutions
GENFIT: Pioneering Diagnostic and Therapeutic Solutions Target Indications Milestones Pipeline Pioneer Next Steps 3
Slide 4: A Glimpse of GENFIT
A Glimpse of GENFIT Key upcoming Multiple candidates A pipeline in milestones and target indications development Phase 3 in NASH Elafibranor Partnership with Terns for Developing innovative • Biopsy re-read and in depth R&D and commercialization of • NASH liver manifestation of elafibranor in Greate
Slide 5: Development Pipeline
Development Pipeline Program and indication Target Development stage* Elafibranor programs in NASH (incl. RESOLVE-IT)** PPAR α/δ Phase 3 – Decision on continuation for clinical outcomes to be made in the Fall 2020 Elafibranor in PBC PPAR α/δ Phase 3 NIS4TM Diagnostic in NASH with fibrosis NAS>4, F2+
Slide 6: Corporate Timeline
Corporate Timeline Elafibranor programs in NASH (incl. RESOLVE-IT)** Corporate update RESOLVE-IT NASH (Elafibranor) Phase 3 interim data readout 2019 2020** 2021 NIS4™ Technology Licensing to a major commercial lab for use in clinical diagnostics*** PBC (Elafibranor) Phase 3 trial initiation NIS4™ T
Slide 7: Elafibranor in Clinical Development for Primary Biliary Cholangitis (PBC)
Elafibranor in Clinical Development for Primary Biliary Cholangitis (PBC) Cholestatic, Prevalence Typically affects autoimmune disease Successful Phase 2a in general population: women 30-65 affecting intrahepatic trial in PBC6 0.04% (~40/100k)3 years old4 bile ducts3,4 PBC: A Severe, chronic liver c
Slide 8: Elafibranor Achieved Primary Endpoint in Phase 2a PBC Study
Elafibranor Achieved Primary Endpoint in Phase 2a PBC Study Change at week 12 in serum alkaline phosphatase (ALP) from baseline1 ALP % Change vs. baseline1 ALP % change vs. baseline (Mean+SD) - - 48 41 (n=45, 12W) % % +3% adjusted -52% vs pbo -44% vs pbo *Non-parametric randomization ANCOVA with bas
Slide 9: Elafibranor Shows Strong Competitive Profile on Composite Endpoint in Phase 2a PBC Study
Elafibranor Shows Strong Competitive Profile on Composite Endpoint in Phase 2a PBC Study Top-line comparison efficacy in Phase 2 (12-week data) Elafibranor1,* Ocaliva2, ** (GENFIT) (INTERCEPT) 80mg 120mg pbo 10mg pbo Primary endpoint ALP (% change vs baseline) -48% -41% 3% -24% -3% Composite endpoin
Slide 10: Efficacy and Safety Data Support Progression of Elafibranor into a Phase 3 Trial in PBC
Efficacy and Safety Data Support Progression of Elafibranor into a Phase 3 Trial in PBC Beneficial effect on1… Pruritus trend 1 VAS* % change from baseline to W12 PBC markers Metabolic markers Bile Acid Precursors • - 24% (elafibranor 80mg) • - 49% (elafibranor 120mg) GGT • Total cholesterol • C4 •
Slide 11: Addressing Current NASH Identification Limitations to Improve NASH Diagnosis
Addressing Current NASH Identification Limitations to Improve NASH Diagnosis Biopsy: the imperfect reference standard1-9 • Significantly invasive and patient reluctance • Sampling errors Liver biopsy: INVASIVE • Potential complications • Limited number of hepatologists • Costly procedure and patholo
Slide 12: NIS4: A Clinically Validated Diagnostic Blood Testing Technology
NIS4™ : A Clinically Validated* Diagnostic Blood Testing Technology to Identify Both NASH and Fibrosis2 NIS4™ – an algorithm developed to identify patients with “at-risk NASH” (NAS≥4; F≥2) • 4 biomarker panel: miR-34a, Alpha2-macroglobulin (A2M), YKL-40, Hemoglobin A1c (HbA1c), output score ranging
Slide 13: NIS4: A Diagnostic Technology to Aid in the Future Diagnosis and Treatment of NASH
NIS4™ : A Diagnostic Technology to Aid in the Future Diagnosis and Treatment of NASH Primary Care Providers, Hepatologists, Gastroenterologists, Endocrinologists Hepatologists, Gastroenterologists, Endocrinologists 1 HCP evaluates patients’ risk factors 2 HCP orders NASH Dx Test 2 Severe and complic
Slide 14: Future Development and Commercialization of NIS4 Technology
Future Development and Commercialization of NIS4™ Technology Achieved milestones and a clear plan Dual-track for regulatory development and commercialization Accomplishments Potential to be the only clinically validated NIT for • Licensing of NIS4™ technology to LabCorp-Covance diagnosis of NASH act
Slide 15: RESOLVE-IT: Phase 3 Clinical Trial Design for Elafibranor in Adults with NASH and Fibrosis
RESOLVE-IT: Phase 3 Clinical Trial Design for Elafibranor in Adults with NASH and Fibrosis INTERIM ANALYSIS 2Q 2020 ~1000+ Patients For Accelerated Market Authorization Subpart H (FDA) / Conditional approval (EMA) Initiation End of Q1 2016 Study Phase 3 Trial: 72w Phase 3 Extension Phase: Event Driv
Slide 16: RESOLVE-IT: Baseline Characteristics
RESOLVE-IT: Baseline Characteristics Interim efficacy results at 72 weeks1 Characteristics Statistics Elafibranor Placebo Overall ITT* Set (F2/F3) N 717 353 1070 Age (Years) Mean (SD) 54.35 (12.06) 55.04 (11.10) 54.58 (11.75) Sex - Female N (%) 283 (39.5) 137 (38.8) 420 (39.3) - Male N (%) 434 (60.5
Slide 17: RESOLVE-IT: Surrogate Efficacy Analysis
RESOLVE-IT: Surrogate Efficacy Analysis Phase 3 Data Results1 • Evaluation of the effect of elafibranor 120mg compared to placebo in 1,070 patients (ITT population) at 72 weeks, randomized 2:1 • Biopsy was collected for inclusion into the trial and a follow-up liver biopsy was collected at week 72 t
Slide 18: RESOLVE-IT: Surrogate Efficacy Analysis Continued and Next Steps
RESOLVE-IT: Surrogate Efficacy Analysis Continued and Next Steps Results Favorable Safety and Tolerability Profile Key Findings Elafibranor was generally well tolerated over 72 weeks • Top-line results do not support an application for • Performance was in-line with previous studies accelerated appr
Slide 19: NTZ Advancing in a Phase 2a Investigator-led Study for NASH Induced Fibrosis
NTZ Advancing in a Phase 2a Investigator-led Study for NASH Induced Fibrosis Identified by a phenotypic screen Using primary human stellate cells TGFb Profibrotic signal Vitamin A HSC activation droplet Hepatic stellate cell (HSC) Myofibroblast Potential for Phase 2a Study in Established safety Pote
Slide 20: GENFIT: Driving Identification, Diagnosis and Treatment of Liver Disorders
GENFIT: Driving Identification, Diagnosis and Treatment of Liver Disorders Pipeline Target Indications Milestones NASH, PBC, and fibrosis Partnership with Terns: Elafibranor in NASH - R&D collaboration Diagnosis of NASH with fibrosis - Elafibranor’s rights in Elafibranor in PBC Greater China (NASH/P