Hepion Pharmaceuticals, Inc. · OTC:HEPA
Hepion Pharmaceuticals — Investor Presentation (October 2020)
21 slides from Hepion Pharmaceuticals's investor presentation, Oct 16, 2020
Slide 1: AI-Driven Bioinformatics Platform Accelerating Development of a Novel NASH Therapeutic
Our AI-Drive n Bioinformatics Platform is Acce le rating the Deve lopme nt of a Nove l NASH The rapeutic and Cre ating Pathways to Optimize Efficacy HEPA October 2020 InvestorPresentation
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 deve lop one New Drug is $2.6 Billion: the approval FDA Rejects NASH Therapeutic, June 2020 rate for Drugs Ente ring clinical deve lopme nt is le ss than 12% Fails Phase 3 Trial, May 2020 Tufts Center for the Study of Drug Development, 2019 Re ce nt FDA approval of AI-drive n bioinformat
Slide 4: Highlights
HIGHLIGHTS Clinical phase 2a NASH program curre ntly unde rway TWO VALUE DRIVERS Artificial Inte llige nce and Smart Algorithms Platform (AI- POWR™) to ide ntify and optimize re sponde r outcome s AI-Driven, A Therapy for NASH with Bioinformatic Strong safety/tole rability profile in pre clini
Slide 5: Pipeline
PIPELINE NDA THERAPY PROGRAM PRE-CLINICAL Pha s e 1 * Pha s e 2 Pha s e 3 SUBMISSION NASH IND 142904 CRV431 205 COVID-19 pIND 151344 CRV431 206 HBV IND 1376787 Op e n to Pa rtne rs hip s *Separate Phase 1 programs were not conducted for each separate indication. The Phase 1 program was comprised of
Slide 6: We Have Developed an AI-Driven Bioinformatics Platform
ABOUT US We Have Deve lope d an AI-Drive n Bioinformatics Platform to Acce le rate Cost-Effe ctive Clinical Trials Study De sign to Incre ase Re sponse Rate s p. 6
Slide 7: Bioinformatics Accelerates Development of Our Own Therapies and Can Be a Platform
Bioinformatics ACCELERATES the Development of Our OWN THERAPIES and can be used as a PLATFORM AI P O W R Supe rvise d and unsupe rvise d Pre cision me dicine base d on Omics, including ge nomics, prote omics, World, acce ssing world Re sponse and clinical AI-e nable d machine le arning ge ne tics, e
Slide 8: Identifying Responders Increases Signal-to-Noise
Identifying Responders Increases “Signal-to-Noise” Sup e r vis e d a nd Uns up e r vis e d Ma c hine Le a rning Alg orithm s Mode l Inputs and Run Sce narios to Constantly Incre ase Re sponse Rate s AI-POWR™ Prod uc e s a Conc e ntrate d Se t of Re s p ond e rs Optimize to ide ntify re sponde rs a
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 Da ta Ac c e s s S c r ip tin g Alg o r ith m s / AI De m o n s tr a te Im p r o ve d
Slide 10: The Net Benefits of AI-Driven, Bioinformatic Trials and Study Design
THE NET BENEFITS of AI-Driven, Bioinformatic Trials and Study Design Antic ip a te d Inc re as e Tria l Suc c e s s Rate s Shor te n Tria l Tim e line s De c re as e Cos ts Be ne fits of AI- Phase I-III se le ction and biomarke r Mode ling re sults, adjusting variable s Shorte ning inte rvals betwe
Slide 11: A cyclophilin inhibitor in accelerated development using AI-POWR
a cyclophilin inhibitor in acce le rate d deve lopme nt using AI-POWRTM to produce anticipate d market-le ading efficacy rate s to tre at NASH
Slide 12: CRV431 for NASH
CRV431 for NASH THERAPY DISCOVERY PRE-CLINICAL Pha s e 1 Pha s e 2 Pha s e 3 NDA SUBMISSION Synthesized and Proje cte d screened NDA Filing ~200 molecules 2025 Identified CRV431 as Single and Phase 2a lead molecule Multiple 'AMBITION' Clinical Ascending Trial Ongoing Dosing Completed Efficacy
Slide 13: The Genesis of CRV431 / Why Target Cyclophilins
THE GENESIS OF CRV431 The ory Pre d ic tion a nd Exp e rim e ntation Find ing s Modifying Cyclosporine A Modifications of Cyclosporine A can e ithe r e liminate or e nhance Inhibition of e ach cyclophilin can gre atly incre ase its immunosuppre ssion. Our te am’s past discove ry, voclosporin, isofor
Slide 14: CRV431 Mode of Action
CRV431 MODE OF ACTION Cyclophilin e nzyme s re gulate the structure and activity of many prote ins throughout the body Cyc lop hilin A (cytosol and secreted) Se cre te d from injure d ce lls and acts as proinflammatory cytokine by binding to CD147. Binds to Cyclophilin A • Hijacke d by viruse s to a
Slide 15: The Development of CRV431 Using AI-POWR
The Deve lopme nt of CRV431 Using AI-POWR™
Slide 16: Preclinical Antifibrotic Efficacy
Preclinical Antifibrotic Efficacy FIBROSIS – a re sponse to chronic injury – is a major cause of organ dysfunction and its re duction is the primary goal in the tre atme nt of NASH Hum a n Ce ll Culture s CRV431 Effe c ts Hepatic stellate cells, fibroblasts TGFβ or endogenous stimulation ▼fibrotic g
Slide 17: Phase 1 Studies – Safety, Tolerability and Pharmacokinetics
PHASE 1 STUDIES – Safety, tolerability and pharmacokinetics (PK) CRV431 in Healthy Subjects Single As c e nd ing Dos e (SAD) Multip le As c e nd ing Dos e (MAD) Drug -Drug Inte ra c tion (DDI) N = 32 (24 CRV431; 8 Placebo). N = 25 (All CRV431). N= 18 Doses: 75 mg, 225 mg, 375mg, Doses: 75
Slide 18: 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 Ge ne Implications for NAS H Fold p-value (Down-re gulation, loss -of-function, Change NASH/NAFLD is heterogenous polymorphism) TM6SF2 Linke
Slide 19: Phase 2a AI-Powered Pilot Study
PHASE 2a AI-POWERED PILOT STUDY OBJ ECTIVES 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 Measure anti
Slide 20: Events
EVENTS CRV431 Complete Phase 2A NASH program (first cohort completion expected Q4, 2020) Complete long-term animal toxicology (Q2, 2021) Continue to optimize and scale -up chemistry and manufacturing (ongoing) Complete Additional Clinical Drug-Drug Interaction Studies (Q2, 2021) Prepare fo
Slide 21: Contact Us
HEPA CONTACT US Rob e r t T. Fos te r, Pha rm D, PhD Chie f Exe c utive Offic e r HEPION PHARMACEUTICALS INC. 399 Thornall Street, First Floor Edison, New Jersey, USA, 08837 www.he p ionp ha rm a .c om Email: rfoster@hepionpharma.com p. 21
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