Hepion Pharmaceuticals, Inc. · OTC:HEPA
Hepion Pharmaceuticals — Investor Presentation (November 2020)
25 slides from Hepion Pharmaceuticals's investor presentation, Nov 18, 2020
Slide 1: AI-Driven Bioinformatics Platform to Accelerate Development of a Novel NASH Therapeutic
Our jjAI-Driven Bioinformatics Platform is Expected to Accelerate the Development of a Novel NASH Therapeutic and Create Pathways to Optimize Efficacy Filed pursuant to Rule 433 of the Securities Act of 1933 Issuer Free Writing Prospectus dated November 18, 2020 Relating to the Preliminary Prospectu
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 cost to develop one new drug is $2.6 billion
The cost to develop one New Drug is $2.6 Billion: the approval FDA Rejects NASH Therapeutic, June 2020 rate for Drugs Entering clinical development is less than 12% Fails Phase 3 Trial, May 2020 Tufts Center for the Study of Drug Development, 2019 AI-driven bioinformatics has the potential to transf
Slide 4: Highlights
HIGHLIGHTS ▪ Clinical phase 2a NASH program currently underway TWO VALUE DRIVERS ▪ Anticipated that Artificial Intelligence and Smart Algorithms Platform (AI-POWR™) will help to identify and optimize AI-Driven, A Therapy for NASH with responder outcomes indications for several Bioinformatic Platform
Slide 5: Pipeline
PIPELINE NDA THERAPY PROGRAM PRE-CLINICAL Phase 1* Phase 2 Phase 3 SUBMISSION NASH IND 142904 CRV431 205 COVID-19 pIND 151344 CRV431 206 HBV IND 1376787 Open to Partnerships *Separate Phase 1 programs were not conducted for each separate indication. The Phase 1 program was comprised of Single and Mu
Slide 6: About Us: AI-Driven Bioinformatics Platform
ABOUT US We Have Developed an AI-Driven Bioinformatics Platform Which is Expected to Accelerate Cost-Effective Clinical Trials Study Design to Increase Response Rates p. 6
Slide 7: Bioinformatics Accelerates Development of Our Own Therapies and Can Be Used as a Platform
Bioinformatics ACCELERATES the Development of Our OWN THERAPIES and can be used as a PLATFORM AI P O W R Supervised and unsupervised Precision medicine based on Omics, including genomics, proteomics, World, accessing world Response and clinical AI-enabled machine learning genetics, environment, and
Slide 8: Identifying Responders Increases Signal-to-Noise
Identifying Responders Increases “Signal-to-Noise” Supervised and Unsupervised Machine Learning Algorithms Model Inputs and Run Scenarios to Constantly Increase Response Rates AI-POWR™ Expected to Produce a Concentrated Set of Responders Which we Believe Will: ▪ Help to identify responders a priori
Slide 9: Components of AI-POWR
Components AI-POWR™ ACCESSING DATA Inputs AI DATA-PROCESSING DEFENDING OUTCOMES Are All Publicly Available, for everyone Is the Tough, and Proprietary part Are the Ultimate Goals of Bioinformatic AI Platforms. Big Data Access Scripting Algorithms / AI Demonstrate Improved Response We all have access
Slide 10: The Net Benefits of AI-Driven Bioinformatic Trials and Study Design
THE NET BENEFITS of AI-Driven, Bioinformatic Trials and Study Design Anticipated Increase Trial Success Rates Shorten Trial Timelines Decrease Costs Benefits of AI- Phase I-III selection and biomarker Modeling results, adjusting variables Shortening intervals between trials verification reduce varia
Slide 11: A cyclophilin inhibitor in development using AI-POWR to treat NASH
a cyclophilin inhibitor in development using AI-POWRTM to produce anticipated market-leading efficacy rates to treat NASH
Slide 12: CRV431 for NASH
CRV431 for NASH THERAPY DISCOVERY PRE-CLINICAL Phase 1 Phase 2 Phase 3 NDA SUBMISSION Synthesized and Projected screened NDA Filing ~200 molecules 2025 Identified CRV431 as Single and Phase 2a lead molecule Multiple 'AMBITION' Clinical Ascending Trial Ongoing Dosing Completed Efficacy Models:
Slide 13: The Genesis of CRV431: Why Target Cyclophilins
THE GENESIS OF CRV431 Theory Prediction and Experimentation Findings Modifying Cyclosporine A Modifications of Cyclosporine A can either eliminate or enhance Inhibition of each cyclophilin can greatly increase its immunosuppression. Our team’s past discovery, voclosporin, isoform produces distinct i
Slide 14: Patent Portfolio
Patent Portfolio Composition of Matter CRV431 Formulation Family Family 1 47 2 International PCT Application Issued Patents US Patent Application Nov 2019 Treatment of Fibrotic Disease in Anti-Fibrotic and Anti-Cancer Multiple Organs Activities Family Family US Provisional Patent Application 4 US Pr
Slide 15: CRV431 Mode of Action
CRV431 MODE OF ACTION Cyclophilin enzymes regulate the structure and activity of many proteins throughout the body Cyclophilin A (cytosol and secreted) Secreted from injured cells and acts as proinflammatory cytokine by binding to CD147. Binds to Cyclophilin A • Hijacked by viruses to assist in vira
Slide 16: The Development of CRV431 Using AI-POWR
The Development of CRV431 Using AI-POWR™
Slide 17: Preclinical Antifibrotic Efficacy
Preclinical Antifibrotic Efficacy FIBROSIS – a response to chronic injury – is a major cause of organ dysfunction and its reduction is the primary goal in the treatment of NASH Human Cell Cultures CRV431 Effects Hepatic stellate cells, fibroblasts TGFβ or endogenous stimulation ▼fibrotic gene expres
Slide 18: Phase 1 Studies: Safety, Tolerability and Pharmacokinetics
PHASE 1 STUDIES – Safety, tolerability and pharmacokinetics (PK) CRV431 in Healthy Subjects 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
Slide 19: Example of AI-POWR Utility with CRV431 in NASH/NAFLD Liver Slices
Example of AI-POWR™ Utility with CRV431 in NASH/NAFLD Liver Slices AI-POWR™ Rapid and Early Identification of Key NASH-Related Genes Altered by 3-Days CRV431 Gene Implications for NASH Fold p-value (Down-regulation, loss-of-function, Change ▪ NASH/NAFLD is heterogenous polymorphism) TM6SF2 Linked to
Slide 20: Ongoing Phase 2a AI-Powered Pilot Study
ONGOING PHASE 2a AI-POWERED PILOT STUDY OBJECTIVES ▪ Evaluate the safety and tolerability of once daily (qd) 75 mg and 225 mg dose of CRV431 in presumed nonalcoholic steatohepatitis (NASH) fibrosis stage 2 (F2)/fibrosis stage 3 (F3) patients compared to placebo control over 28 days of dosing ▪ Measu
Slide 21: Phase 2b AI-POWR NASH Registration Trial
PHASE 2b AI-POWR NASH REGISTRATION TRIAL OBJECTIVES: • Evaluate the efficacy of once daily (qd) 75 mg and 225 mg dose of CRV431 in biopsy proven NASH fibrosis stages F2 and F3 patients compared to placebo over 6 months of dosing. • Measure antifibrotic activity of CRV431 • Validate antifibrotic biom
Slide 22: Anticipated Events
ANTICIPATED EVENTS CRV431 ▪ Complete Ongoing Phase 2A NASH program (first dosing (75 mg) cohort completed November 2020) ✓ Enrolled the last patient in the 75 mg cohort ✓ DSMB recommended the study continue with 225 mg dose cohort ✓ Clinically significant reductions observed in the liver safety para
Slide 23: Capitalization Table Pre-Offering
CAPITALIZATION TABLE PRE-OFFERING As of September 30, 2020 Shares of Common Stock Outstanding 9,025,153 Series A Convertible Preferred Stock1 $855,810 Series C Convertible Preferred Stock2 $1,817,000 Warrants (WAEP $19.35) 2,536,566 Options (WAEP $5.96) 2,464,771 1 Aggregate liquidation value. The S
Slide 24: Summary Highlights
SUMMARY HIGHLIGHTS ▪ CRV431: ▪ Safe and well-tolerated ▪ Is currently in Phase 2a (Pilot) NASH patient study, 75 mg dosing cohort with first read-out expected Q4, 2020 ▪ Expected to initiate Phase 2b in NASH patients, mid-year 2021 ▪ AI-POWR: ▪ Expected to continue to drive CRV431 progress in NASH a
Slide 25: Contact Us
HEPA CONTACT US Robert T. Foster, PharmD, PhD Chief Executive Officer HEPION PHARMACEUTICALS INC. 399 Thornall Street, First Floor Edison, New Jersey, USA, 08837 www.hepionpharma.com Email: rfoster@hepionpharma.com p. 25
Hepion Pharmaceuticals — Investor Presentation (November 2020) on 6ix