Hepion Pharmaceuticals, Inc. · OTC:HEPA
Hepion Pharmaceuticals — Investor Presentation (June 2021)
20 slides from Hepion Pharmaceuticals's investor presentation, June 2021
Slide 1: A Better Approach to Drug Development for Liver Diseases
A BETTER APPROACH TO DRUG DEVELOPMENT FOR LIVER DISEASES June 2021 | I N V E S T O R P R E S E N TAT I O N smart drug smart technology smart development
Slide 2: Forward-Looking Statements
FORWARD-LOOKING STATEMENTS This presentation may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such forward-looking statements are characterized by future or conditional verbs such as “may,”
Slide 3: The Need and Opportunity in NASH Drug Development
THE NEED AND OPPORTUNITY IN NASH DRUG DEVELOPMENT NASH is a Healthcare Crisis NASH leads to Soon to be lead Large cost to cirrhosis, liver cancer reason for liver healthcare (HCC), end stage liver transplantation system disease, and death No drugs are approved for treating NASH NAFLD NASH non-alcoho
Slide 4: The Challenges of NASH Drug Development
THE CHALLENGES OF NASH DRUG DEVELOPMENT NASH Resolution 14% 27% Simtuzamab Simtuzamab Placebo Regulatory agencies require regression of several Selonsertib Obeticholic acid Low dose Medium dose indices of liver disease by histological analysis: Cenicriviroc Aramchol Elafibranor Aldefermin High dose
Slide 5: Hepion's Approach: Smart Strategy #1
HEPION’S APPROACH SMART STRATEGY #1 Target Multiple Disease Processes With a Single Agent inflammation toxic lipids fibrosis cell death liver cancer NAFLD: A multi system disease by Pablo Echeverria 5
Slide 6: Hepion's Approach: Smart Strategy #2
HEPION’S APPROACH SMART STRATEGY #2 Attenuate Disease Drivers Most NASH drug candidates are agonists that amplify PPAR agonists FXR agonists THRβ agonists homeostatic processes to help regress disease FGF agonists GLP-1 agonists Cyclophilin inhibitors reduce harmful processes that drive disease prog
Slide 7: Hepion's Approach: Smart Strategy #3
HEPION’S APPROACH SMART STRATEGY #3 State-of-the-art Bioinformatics and Artificial Intelligence NEURAL MACHINE NETWORK LEARNING ▪ Understand disease mechanisms ▪ Identify biomarkers NASH AI-POWR™ BIG DATA ▪ Track disease progression and regression ▪ Predict drug responders MULTI-OMICS DEEP LEARNING
Slide 8: Pipeline
PIPELINE Program Pre-Clinical Phase 1* Phase 2 Phase 3 NDA Submission Projected NDA filing NASH IND 142904 2025/26 Will proceed if COVID-19 IND 151344 externally funded Open to HBV IND 1376787 partnerships *Separate Phase 1 programs were not conducted for each separate indication. The Phase 1 progra
Slide 9: Genesis of CRV431
GENESIS OF Theory Prediction and Experimentation Findings Modifying Cyclosporine A can Modifications that increase calcineurin binding and immunosuppression Inhibition of each cyclophilin greatly change its binding and (voclosporin) isoform produces distinct functional properties therapeutic effects
Slide 10: Multiple Therapeutic Actions Through Cyclophilin Inhibition
MULTIPLE THERAPEUTIC ACTIONS THROUGH CYCLOPHILIN INHIBITION CD147 pro-inflammatory receptors Cyclophilin A CRV431 Pan-Cyclophilin (cytosol and secreted) x x INFLAMMATION Inhibitor Secreted from injured cells and Cyp A (Ki ≈ 1 nM) acts as proinflammatory cytokine by binding to CD147 Procollagen Cyclo
Slide 11: Antifibrotic and Other Preclinical Activities
ANTIFIBROTIC AND OTHER PRECLINICAL ACTIVITIES Human Cell Cultures CRV431 Effects Hepatic stellate cells, fibroblasts TGFβ or endogenous stimulation ▼fibrotic gene expression (multiple organs) ▼procollagen and fibronectin secretion Blood platelets Collagen and thrombin stimulation ▼procoagulant plate
Slide 12: In-House Artificial Intelligence Program
IN-HOUSE ARTIFICIAL INTELLIGENCE PROGRAM ▪ Multi-omics analyses – 25,000 data points per patient ▪ Identify biomarkers that predict response to CRV431 ▪ Optimize and de-risk clinical trials through patient matching to CRV431 – precision medicine 12
Slide 13: AI-POWR Illustrations
AI-POWR™ INDIVIDUAL PATIENTS ILLUSTRATIONS 1 2 PLACEBO Gene Expression Analysis low NASH is heterogenous disease, expression 3 underpinned by complex biochemical high 4 and pathological processes. expression 5 DRUG 6 INDIVIDUAL GENES Cluster By Response Non- Responders • Learn response rates for AI:
Slide 14: NASH Clinical Program
NASH CLINICAL PROGRAM Phase 1 completed Phase 2a enrolment complete – data Q2 2021 Phase 2b in planning – starting Q4 2021 14
Slide 15: Phase 1 Healthy Subjects - Safety, Tolerability and PK
PHASE 1 HEALTHY SUBJECTS - SAFETY, TOLERABILITY AND PK Single Ascending Dose (SAD) Multiple Ascending Dose (MAD) Drug-Drug Interaction (DDI) ✓ N = 32 (24 CRV431; 8 Placebo) ✓ N = 25 (All CRV431) ✓ N= 18 ✓ Doses: 75 mg, 225 mg, 375mg, ✓ Doses: 75 mg, 150 mg, 225 mg, ✓ Single CRV431 375 mg Drug 525 mg
Slide 16: Phase 2a NASH Subjects - Safety, Tolerability and PK
PHASE 2A NASH SUBJECTS - SAFETY, TOLERABILITY AND PK OBJECTIVES ▪ Safety and tolerability of once daily (qd) 75 mg and 225 mg doses of CRV431 in presumed NASH fibrosis stage 2 (F2)/fibrosis stage 3 (F3) patients compared to placebo control for 28 days ▪ Exploratory biomarkers of fibrosis and lipid m
Slide 17: Phase 2b NASH Subjects - Efficacy
PHASE 2B NASH SUBJECTS - EFFICACY OBJECTIVES ▪ Efficacy of once daily (qd) oral dosing of CRV431 in biopsy proven NASH F2 and F3 patients compared to placebo ▪ 1-point reduction in fibrosis score in liver biopsies (pathologist and AI read) ▪ AI-POWR identification of biomarkers of CRV431 response f
Slide 18: 2021 Anticipated Events
2021 ANTICIPATED EVENTS CRV431 Complete Ongoing Phase 2a NASH program (Q2, 2021) Complete long-term animal toxicology (Q2, 2021) Continue to optimize and scale-up chemistry and manufacturing Complete additional clinical Drug-Drug (CYP3A4) Interaction study (Q2, 2021) Prepare for NASH Phase 2b (to st
Slide 19: Highlights: Status, Experience, Resources
HIGHLIGHTS STATUS, EXPERIENCE, RESOURCES TWO ▪ Oral, once-daily, multi-modal drug candidate – CRV431 VALUE DRIVERS ▪ Clinical Phase 2a NASH trial completing Q2 ▪ Clinical Phase 2b NASH trial planned for Q4 2021 start ▪ Strong safety/tolerability profile in preclinical and Phase 1 A Therapy for AI-Dr
Slide 20: Contact Us
CONTACT US Robert T. Foster, PharmD, Ph.D. Chief Executive Officer Hepion Pharmaceuticals Inc. 399 Thornall Street, First Floor Edison, New Jersey, USA, 08837 Email: rfoster@hepionpharma.com www.hepionpharma.com
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