Hepion Pharmaceuticals, Inc. · OTC:HEPA
Hepion Pharmaceuticals — IPO Roadshow (February 2021)
21 slides from Hepion Pharmaceuticals's IPO roadshow presentation, Feb 12, 2021
Slide 1: A Better Approach to Drug Development for Liver Diseases
A BETTER APPROACH TO DRUG DEVELOPMENT FOR LIVER DISEASES February 202 1 | INVESTOR PRESENTATION smart drug smart technology smart development Filed pursuant to Rule 433 of the Securities Act of 1933 Issuer Free Writing Prospectus dated February 12 , 2021
Slide 2: Forward-Looking Statements and Offering Notice
2 This presentation may contain forward - looking statements within the meaning of Section 27 A of the Securities Act of 1933 and Section 21 E of the Securities Exchange Act of 1934 . Such forward - looking statements are characterized by future or conditional verbs such as “may,” “will,” “expect,”
Slide 3: The Need and Opportunity in NASH Drug Development
3 THE NEED AND OPPORTUNITY IN NASH DRUG DEVELOPMENT NAFLD n on - a lcoholic f atty l iver d isease • “Fatty liver” disease associated with obesity, diabetes, hypertension, etc. • Approx. 25% of global population (up to 100 million in U.S.) 3 NASH leads to cirrhosis, liver cancer (HCC), end stage liv
Slide 4: The Challenges of NASH Drug Development
4 THE CHALLENGES OF NASH DRUG DEVELOPMENT Regulatory agencies require regression of several indices of liver disease by histological analysis: • Fatty deposits, cell death, inflammation and/or liver scarring ( fibrosis) Most study outcomes have been disappointing: • High placebo responses • Low resp
Slide 5: Hepion's Approach: Smart Strategy #1
5 HEPION’S APPROACH SMART S TRATEGY #1 NAFLD: A multi system disease by Pablo Echeverria 5 toxic lipids cell death liver cancer inflammation fibrosis
Slide 6: Hepion's Approach: Smart Strategy #2
6 HEPION’S APPROACH Most NASH drug candidates are agonists that amplify homeostatic processes to help regress disease PPAR agonist s FGF agonists 6 SMART S TRATEGY #2 FXR agonists GLP - 1 agonists THRβ agonists Cyclophilin inhibitors reduce harmful processes that drive disease progression
Slide 7: Hepion's Approach: AI-POWR, Smart Strategy #3
7 AI - POWR Œ NEURAL NETWORK MACHINE LEARNING BIG DATA DEEP LEARNING MULTI - OMICS NASH HEPION’S APPROACH ▪ Understand disease mechanisms ▪ Identify biomarkers ▪ Track disease progression and regression ▪ Predict drug responders ▪ Precision medicine 7 SMART S TRATEGY #3
Slide 8: Pipeline
8 IND 1376787 IND 142904 IND 151344 PIPELINE Program Pre - Clinical Phase 1 * Phase 2 Phase 3 NDA Submission NASH COVID - 19 Will proceed if externally funded HBV Open to partnerships * Separate Phase 1 programs were not conducted for each separate indication. The Phase 1 program was comprised of Si
Slide 9: Genesis of CRV431: Why Target Cyclophilins?
9 GENESIS OF N N H O OH O N N O O N N O O N N H OO N H N OO N H O N N H O OH O N N O O N N O O N N H OO N H N OO N H O NH O N N H O OH O N N O O N N O O N N H OO N H N OO N H O CH 2 Why Target Cyclophilins? Cyclophilins shown to play deleterious roles in: Viral Hepatitis • Cancers • Acute And Chroni
Slide 10: Multiple Therapeutic Actions Through Cyclophilin Inhibition
10 MULTIPLE THERAPEUTIC ACTIONS THROUGH CYCLOPHILIN INHIBITION Cyclophilin A (cytosol and secreted) Secreted from injured cells and acts as proinflammatory cytokine by binding to CD147 Cyclophilin B (endoplasmic reticulum) Promotes fibrotic scarring by controlling collagen production CRV431 Pan - Cy
Slide 11: Antifibrotic and Other Preclinical Activities
11 ANTIFIBROTIC AND OTHER PRECLINICAL ACTIVITIES 11 Human Cell Cultures CRV431 Effects Hepatic stellate cells, fibroblasts (multiple organs) TGF β or endogenous stimulation ź fibrotic gene expression ź procollagen and fibronectin secretion Blood platelets Collagen and thrombin stimulation ź procoagu
Slide 12: In-House Artificial Intelligence Program
12 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: Gene Expression Analysis
13 Gene Expression Analysis NASH is heterogenous disease, underpinned by complex biochemical and pathological processes. Cluster By Response • Learn response rates for treatment and placebo • Identify patterns predicting response • Select patients (trial enrichment) INDIVIDUAL GENES 13 AI - POWR Œ I
Slide 14: NASH Clinical Program
NASH CLINICAL PROGRAM Phase 1 completed Phase 2b in planning – starting Q3 2021 Phase 2a ongoing – completion Q2 2021 14
Slide 15: Phase 1 Healthy Subjects: Safety, Tolerability and PK
15 PHASE 1 HEALTHY SUBJECTS - SAFETY, TOLERABILITY AND PK Single Ascending Dose (SAD) Multiple Ascending Dose (MAD) Drug - Drug Interaction (DDI) x N = 32 (24 CRV431; 8 Placebo) x Doses: 75 mg, 225 mg, 375mg, 525 mg (single doses) x Drug Exposure is in the range in which efficacy was demonstrated in
Slide 16: Phase 2a NASH Subjects: Safety, Tolerability and PK
16 PHASE 2A NASH SUBJECTS - SAFETY, TOLERABILITY AND PK ▪ 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 metabol
Slide 17: Phase 2b NASH Subjects: Efficacy
17 PHASE 2B NASH SUBJECTS - EFFICACY 17 Multivariate multi - omics - trait AI - analysis to update CRV431 activity biomarkers in F2/F3 NASH for Phase 3 Patient/Biomarker Selection ▪ Efficacy of once daily ( qd ) 75 mg and 225 mg doses of CRV431 in biopsy proven NASH F2 and F3 patients compared to pl
Slide 18: 2021 Anticipated Events
18 2021 ANTICIPATED EVENTS Complete Ongoing Phase 2a NASH program by Q1 - Q2, 2021 Complete long - term animal toxicology (Q2, 2021) Continue to optimize and scale - up chemistry and manufacturing Complete additional clinical Drug - Drug Interaction study (Q2, 2021) Prepare for NASH Phase 2b (to sta
Slide 19: Highlights
19 HIGHLIGHTS STATUS, EXPERIENCE, RESOURCES ▪ Oral, once - daily, multi - modal drug candidate – CRV431 ▪ Clinical Phase 2a NASH trial in progress ▪ Clinical Phase 2b NASH trial planned for Q2/3 2021 start ▪ Strong safety/tolerability profile in preclinical and Phase 1 ▪ Anti - fibrotic, anti - infl
Slide 20: Capitalization Table Pre-Offering
20 CAPITALIZATION TABLE PRE - OFFERING – As of 9/30/2020 20 Shares of Common Stock Outstanding 32,025,153 Series A Convertible Preferred Stock 1 $855,810 Series C Convertible Preferred Stock 2 $1,817,000 Warrants (WAEP $19.35) 2,536,566 Options (WAEP $5.96) 2,464,771 1 Aggregate liquidation value. T
Slide 21: Contact Us
CONTACT US Hepion Pharmaceuticals Inc. 399 Thornall Street, First Floor Edison, New Jersey, USA, 08837 Email: rfoster@hepionpharma.com www.hepionpharma.com
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