Hepion Pharmaceuticals, Inc. · OTC:HEPA
Hepion Pharmaceuticals — Investor Presentation (October 2019)
21 slides from Hepion Pharmaceuticals's investor presentation, October 2019
Slide 1: Corporate Presentation 2019
1 C O R P O R AT E P R E S E N TAT I O N • 2 0 1 9 Nasdaq: HEPA Nasdaq: HEPA
Slide 2: Forward-Looking Statements
Forward-Looking 2 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: Snapshot: A Liver Disease Company
Snapshot 3 A Liver Disease Company Committed to developing pleiotropic drug therapy for treatment of chronic liver diseases, including NASH (non- alcoholic steatohepatitis) and other liver diseases (HBV, HCV, HDV) “…Nearly 45% of all deaths in the developed world are attributed to some type of chron
Slide 4: Corporate Overview
Corporate Overview 4 Product CRV431: Novel, high-potency, cyclophilin inhibitor that targets multiple stages of liver disease, including NASH • Anti-fibrotic, anti-viral, and anti-cancer properties (pleiotropic) • Strong preclinical proof of concept • Strong safety profile in preclinical and Phase 1
Slide 5: Development Phase
Development Phase 5 Discovery Phase 1 Phase 3 CRV431 Preclinical Phase 2 • IND for HBV – Phase 1 Single Ascending Dose completed • IND for HBV – Multiple Ascending Dose in progress, Q3-2019 • IND for NASH – Approved, Q3-2019 “In our large combined tertiary center cohorts, patients with concomitant N
Slide 6: CRV431 in NASH
CRV431 in NASH 6 Cyclophilin Inhibitors Target Multiple Liver Disease Stages INJURY/STEATOSIS INFLAMMATION FIBROSIS CIRRHOSIS/CANCER • Antiviral activity • Suppress pro-inflammatory • Reduce collagen production • Block cancer cell adaptation (HBV, HCV, HDV, HIV-1) pathways mediated by from hepatic s
Slide 7: CRV431 Anti-Inflammatory/Steatosis
CRV431 Anti-Inflammatory/Steatosis 7 Efficacy in STAM Murine NASH Model 3, 6, or 11 weeks oral CRV431 treatment ( s t e a to s is + in f la m m a tio n + b a llo o n in g ) ( s t e a to s is + in f la m m a tio n + b a llo o n in g ) ( s t e a to s is + in f la m m a tio n + b a llo o n in g ) p = 0
Slide 8: Anti-Fibrotic Efficacy in STAM Murine NASH Model
CRV431 Anti-Fibrotic 8 Efficacy in STAM Murine NASH Model 3, 6, or 11 weeks oral CRV431 treatment p < 0 .0 1 p = 0 .0 3 p = 0 .0 1 p = 0.014 2 .5 ns 4 6 5 S ir iu s r e d - p o s itiv e fib r o s is Sirius red-positive fibrosis S ir iu s r e d - p o s itiv e fib r o s is S ir iu s r e d - p o s itiv
Slide 9: Anti-Fibrotic Efficacy in Carbon Tetrachloride Murine Model
CRV431 Anti-Fibrotic 9 Efficacy in Carbon Tetrachloride Murine Model P = 0.008 6 weeks carbon tetrachloride (i.p.) + drug treatment (oral): P = 0.32 • Vehicle 4 • CRV431 50 mg/kg/day Sirius red-positive fibrosis P = 0.005 P = 0.03 P = 0.05 • Obeticholic acid (OCA) 10 mg/kg/day (%of sampled area) 3 •
Slide 10: CRV431 for Liver Disease: Liver Morphology in NASH Mice
CRV431 for Liver Disease 10 Liver morphology in NASH Mice Vehicle treatment, 11 weeks CRV431 treatment, 50 mg/kg, PO, 11 weeks (enlarged fatty liver) (normalized liver) Nasdaq: HEPA
Slide 11: Putative Anti-Fibrotic Mechanism of Action
Putative Anti-Fibrotic Mechanism of Action 11 Collagen reduction • Role of cyclophilins in formation of collagen involved in at least two ways: L y s y l O x id a s e ( L O X ) G e n e E x p r e s s io n 1. Peptidyl prolyl isomerase (cyclophilin) activity confers 2.5 R e la tiv e e x p re s s io n v
Slide 12: CRV431 Anti-Cancer Activity in NASH Mice
CRV431 Anti-Cancer 12 Activity in NASH Mice 10 weeks oral CRV431 treatment N u m b e r o f T u m o r N o d u le s T u m o r S c o r e ( n u m b e r x s iz e ) p = 0 .0 2 p = 0 .0 5 15 Score = 0 N u m b e r o f n o d u le s p e r liv e r 7 6 (no nodules) H C C n o d u le s c o re 10 5 4 3 Score = 7 5
Slide 13: CRV431 Decreases Inflammation and Fibrosis on Human Precision Cut Liver Slices
CRV431 on Human Precision Cut Liver Slices 13 CRV431 Decreases Inflammation and Fibrosis (UK Study Group) Picrosirius Red Staining of Fibrotic Collagen CONCLUSIONS • TGFβ +PDGF stimulation increased inflammation and fibrosis Percentage area stained (%) 12 Time 0 (baseline) markers, and TGFβ/PDGF rec
Slide 14: Single Ascending Dose (SAD) Study
Single Ascending Dose (SAD) Study 14 (CTRV-CRV431-101) Objectives • To evaluate the safety and tolerability of single oral doses of CRV431 at increasing dose levels • To evaluate the pharmacokinetics of CRV431 Design • Randomized, Partially blinded, Placebo-controlled, sequential SAD Study in health
Slide 15: CRV431 Mean Pharmacokinetic Parameters
CRV431 15 Mean Pharmacokinetic Parameters AUC0-inf, Tmax, h Cmax, ng/mL t½, h Dose (range) (SD) ng*h/mL (SD) (SD) 75 mg 4 (2-10) 334±106 20,917±3,780 73.6±15.2 225 mg 1.3 (1-2) 1,368±221 84,422±32,373 97.3±18.4 375 mg 1.5 (1-3) 1,488±176 103,833±30,916 110.8±36.2 525 mg 1 (1-1) 1,655±250 102,087±43,
Slide 16: Safety Profile and Conclusions
Safety Profile and Conclusions 16 SAD Study Safety Profile • No SAE’s were reported in the SAD Study • AE’s from the SAD study have been mild to moderate and mostly unrelated to study drug • There were no Grade 3 or Grade 4 laboratory abnormalities • Vital signs and ECGs were unremarkable Conclusion
Slide 17: Viral Hepatitis: Anti-HBV and HCV Activities
Viral Hepatitis 17 Anti-HBV and HCV Activities CRV431 anti-viral activities toward hepatitis B virus (HBV) and hepatitis C virus (HCV) expected to reduce liver disease arising from viral hepatitis HBV CRV431 decreases several HBV markers in cell culture and an animal model, including HBV DNA, HBsAg,
Slide 18: CRV431 Advantages in Treating Liver Disease
CRV431 Advantages 18 in Treating Liver Disease • First-in-class cyclophilin inhibitor (inhibits peptidyl prolyl isomerase) • Broad range of liver-protective mechanisms (pleiotropic) due to targeting multiple cyclophilins • The only investigational drug targeting both viral hepatitis and liver diseas
Slide 19: Non-Clinical Events
Non-Clinical Events 2019 19 Fibrofind human Precision Cut Liver Slice culture, Part A, data 2019 H2 • In-house in vitro - stellate cell, data • Ongoing Mode of Action studies, ongoing and collaborations Q4 • Physiogenex rat thioacetamide (Part A), fibrosis data • Precision cut liver slices (PCLS,
Slide 20: Clinical Timelines/Events
Clinical Timelines/Events 2019 20 NASH IND, authorization to proceed Clinical 28-day study, oral CRV431 escalating dose, once daily, initiated 2020 H1 • Clinical 28-day study, oral CRV431 Multiple Ascending Dose (MAD), once daily, data • Phase 2 NASH biomarker pilot study, 1-month CRV431 repeat
Slide 21: Thank You
21 Thank You Corporate Contact: Investor Relations: Robert Foster Stephen Kilmer rfoster@hepionpharma.com skilmer@hepionpharma.com Tel: 646.274.3580 Nasdaq: HEPA
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