Hepion Pharmaceuticals, Inc. · OTC:HEPA
Hepion Pharmaceuticals — ContraVir Pharmaceuticals — Investor Presentation (January 2019)
32 slides from Hepion Pharmaceuticals's investor presentation, Jan 2, 2019
Slide 1: 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 2: Snapshot: A Liver Disease Company
Snapshot A Liver Disease Company Committed to developing therapeutic drugs for liver disease arising from chronic viral infection (HBV, HCV, HDV) and NASH (non-alcoholic steatohepatitis) “ Nearly 45% of all deaths in the developed world are attributed to some type of chronic fibroproliferative disea
Slide 3: Corporate Overview
Corporate Overview Products CRV431: Novel, high-potency, cyclophilin inhibitor that targets multiple stages of liver disease Anti-fibrotic, anti-viral, and anti-cancer properties (pleiotropic) Strong preclinical proof of concept Strong safety profile in preclinical and Phase 1 clinical studies Orall
Slide 4: Liver Disease Targeting Common Pathways to End-Stage Liver Disease
Viral Hepatitis (HBV/HCV/HDV) Collagen deposition (scarring) NAFLD/ NASH Alcohol INJURY/STEATOSIS Cell injury/death Stellate cell activation Cellular transformation and metastasis Inflammatory cell infiltration/activation INFLAMMATION FIBROSIS CIRRHOSIS/CANCER Liver Disease Targeting Common Pathways
Slide 5: Robust Pipeline of Treatments for Liver Disease
Robust Pipeline of Treatments for Liver Disease Preclinical, Mid-, and Late-Stage Product Candidates Preclinical Phase 1 Phase 2 Phase 3 CRV431 NASH CRV431 Hepatitis B TXL™ Hepatitis B (out-licensing opportunity) “In our large combined tertiary center cohorts, patients with concomitant NASH and CHB
Slide 6: Experienced Scientific Leadership
Experienced Scientific Leadership Scientific Advisory Board Carol L. Brosgart, M.D. (USA) Senior Advisor on Science and Policy, Division of Viral Hepatitis at CDC (Tenofovir Developer) Jordan Feld, M.D., M.P.H. (Canada) Clinician-scientist , Western Hospital Liver Clinic & McLaughlin-Rotman Centre f
Slide 7: Viral Hepatitis: Anti-HBV and HCV Activities
Viral Hepatitis 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, HBeAg, cccDNA, and pgRNA. HCV
Slide 8: HBV: Despite vaccine, no curative treatment
HBV Despite vaccine, there is no curative treatment Up to 25% of people with chronic HBV infection die prematurely from liver failure, cirrhosis, or liver cancer HBV-related ESLD or HCC responsible for >0.5-1 million deaths per year, currently represent 5-10% of liver transplant cases Cumulative sal
Slide 9: Hepatitis B: Finding a Functional Cure
Hepatitis B Finding a Functional Cure 1William Blair & Co.2016 >$200 billion Potential global market for a curative regimen (cumulative, over 20 years)1 The New Goal of HBV Therapy Limited efficacy of current antiviral treatments towards cure highlights need for new therapeutics in HBV Viremia (viru
Slide 10: Hepatitis B Portfolio Highlights
Hepatitis B Portfolio Highlights Composition of matter coverage up to 2031 TXL™ - Virus-Targeting Nucleotide Analog Highly Potent Lipid Prodrug of Tenofovir Enhanced liver targeting is expected to improve safety and drive efficacy at a lower target dose Decreased potential for renal and bone toxicit
Slide 11: Combination Platform HBV
Combination Platform HBV Demonstrates distinct, complementary MOA Snapshot of Synergy in AD38 cells (in vitro) CRV431 and Nucleotide Analog Combination Shows In Vitro Synergistic Activity 1 10 100 1000 0 50 100 Drug nM % I n h i b i t i o n H B V D N A Observed TXL + CRV431 combination synergy Expec
Slide 12: Anti-HBV Activity in HBV Transgenic Mice
Anti-HBV Activity in HBV Transgenic Mice CRV431 and TXL™ CRV431 and TXL reduce HBV DNA. Combination treatment shows additive-to-synergistic efficacy. CRV431, but not TXL, reduces HBsAg. HBV DNA HBsAg 0 200 400 600 800 1,000 1,200 H B s A g n g / m l s e r u m 25% ¯ P £ 0.0001 Vehicle 10 m/k/d CRV431
Slide 13: Currently Marketed Tenofovir Compounds
Currently Marketed Safe and effective in treatment of chronic HBV and HIV Nucleotide analog reverse transcriptase inhibitor Tenofovir Compounds First Generation Tenofovir Disoproxil Fumarate (TDF) Brand name: Viread® Bioavailability is about 25% (fasting), with systemic exposure increased by 40% wit
Slide 14: TXL De-Risked Development Asset
TXL™ De-Risked Development Asset Well-tolerated up to 100 mg daily, with no safety signal No dose adjustments for patients with severe renal impairment Potential for decreased bone and kidney toxicity Profile consistent with target organ specificity (liver) resulting in fewer “off-target” effects Si
Slide 15: NASH: Currently no approved drug treatments
NASH Currently no approved drug treatments for NASH Second leading etiology of hepatocellular carcinoma and liver transplantation in the United States 4 HCC is 5th most common cancer in men and 7th most common cancer in women. HCC contributes approximately 5.6% of all human cancers. HCC annual globa
Slide 16: NASH: A Rapidly Growing Liver Disease With No Approved Drug Therapies
NASH A Rapidly Growing Liver Disease With No Approved Drug Therapies 1Douglas Johnson Report 2018 >$20 billion Projected annual global market for NASH treatments (2025 projected)1 Meeting an unmet need Estimated global prevalence of NASH is 4% of the population and growing Supportive medications lim
Slide 17: CRV431 in NASH: Cyclophilin Inhibitors Target Multiple Liver Disease Stages
INJURY/STEATOSIS INFLAMMATION FIBROSIS CIRRHOSIS/CANCER CRV431 in NASH Cyclophilin Inhibitors Target Multiple Liver Disease Stages Antiviral activity (HBV, HCV, HDV, HIV-1) Suppress cell death by inhibiting mitochondrial pore regulator, cyclophilin D Suppress pro-inflammatory pathways mediated by ex
Slide 18: CRV431 Anti-Inflammatory/Steatosis Activity in NASH Mice
CRV431 Anti-Inflammatory/Steatosis Activity in NASH Mice STUDY #1: Stelic Institute (Japan) 3-week, oral CRV431 treatment STUDY #2: Scripps Institute (USA) 6-week, oral CRV431 treatment STUDY #3: Scripps Institute (USA) 11-week, oral CRV431 treatment 3, 6, or 11 weeks oral CRV431 treatment 0 2 4 6 8
Slide 19: CRV431 Anti-Fibrotic Activity in NASH Mice
CRV431 Anti-Fibrotic Activity in NASH Mice STUDY #1: Stelic Institute (Japan) 3-week, oral CRV431 treatment STUDY #2: Scripps Institute (USA) 6-week, oral CRV431 treatment Magnitude of anti-fibrotic effects are similar to other NASH drugs in development STUDY #3: Scripps Institute (USA) 11-week, ora
Slide 20: Liver Morphology in NASH Mice
CRV431 for Liver Disease Liver morphology in NASH Mice Vehicle treatment, 11 weeks (enlarged fatty liver) CRV431 treatment, 50 mg/kg, PO, 11 weeks (normalized liver)
Slide 21: CRV431 Anti-Cancer Activity in NASH Mice
CRV431 Anti-Cancer Activity in NASH Mice STUDY: Scripps Research Institute (USA) 10-week, oral CRV431 treatment 44% reduction in tumor number; 52% reduction in tumor score, reflecting number and size of tumors Score = 0 (no nodules) Score = 7 (many large nodules) 10 weeks oral CRV431 treatment Vehic
Slide 22: Single Ascending Dose (SAD) Study
Single Ascending Dose (SAD) Study (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 healthy volunte
Slide 23: CRV431 Mean Pharmacokinetic Parameters
Dose Tmax, h (range) Cmax, ng/mL (SD) AUC, ng.h/mL (SD) t½, h (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) 1655±250 102,087±43,612 98.5±24.1 Drug exposure is linear up to 375m
Slide 24: Safety Profile and Conclusions
Safety Profile and Conclusions 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 Conclusions In the SAD doses we
Slide 25: CRV431 Advantages in Treating Liver Disease
CRV431 Advantages in Treating Liver Disease First-in-class cyclophilin inhibitor Broad range of liver-protective mechanisms due to targeting multiple cyclophilins The only investigational drug targeting both CHB and NASH Later-stage disease focus (fibrosis, HCC) differentiates CRV431 from most NASH
Slide 26: Financials and Value Drivers
Financials and Value Drivers
Slide 27: Financial Share Statistics
Financial Share Statistics Trading Symbol NASDAQ:CTRV Stock Price (11/19/18) $0.51 52-Week Range $0.46 - $4.32 Avg. Volume .350M Cash (9/30/18) $9.0M Current Capital Structure – 9.30.18 16.3M shares of common 0.8M options for common 7.6M warrants for common 85,581 shares of preferred series A 2,253
Slide 28: Value Drivers: Strategic Focus
Value Strategic Focus Develop CRV431 for liver disease including fibrosis and HCC while addressing HBV as risk factor Outlicense/partner TXL™ Experienced Team and Advisors Significant expertise in drug discovery and development Recognized global leaders Drivers
Slide 29: Thank You
Thank You Corporate Contact: Robert Foster rfoster@contravir.com Investor Relations: Stephen Kilmer skilmer@contravir.com Tel: 646.274.3580
Slide 30: SAD Study – CRV431 Adverse Events
Severity Relationship to Drug Adverse Event Description Treatment Number of Subjects With TEAE Number of TEAE G1 G2 Unrelated Related Scratchy throat 75 mg 1 1 1 0 0 1 Extreme craving for salt 75 mg 1 1 1 0 0 1 Pustules 75 mg 1 1 1 0 1 0 Pruritus 225 mg 1 2 2 0 2 0 Dry skin 225 mg 1 2 2 0 2 0 Papula
Slide 31: SAD Study - Placebo Adverse Events
Severity Relationship to Drug Adverse Event Description Treatment Number of Subjects With TEAE Number of TEAE G1 G2 Unrelated Related Papular rash Placebo 1 1 1 0 0 1 Pruritus Placebo 1 1 1 0 0 1 Chapped lips Placebo 1 1 1 0 1 0 Vasovagal reaction related to blood draw Placebo 1 1 0 1 1 0 Nausea Pla
Slide 32: SAD Study - Placebo Adverse Events
SAD Study - Placebo Adverse Events Relationship to Org 5 Paco 1 : FEET ° : aoped oe acto A 1 Paap) 1 ° \varoagal econ elated to ood daw cabo 1 1 o 4 1 ° pcos race a 1 AO 1 ° Pain at veipnctare ste, nec cabo 1 1 1 0 1 ° hes conn wth tng cabo 1 1 RES 1 ° Sonmolnce acto 1 1 o 4 1 ° tan aco 1 1 AO 1 ° e
ContraVir Pharmaceuticals — Investor Presentation (January 2019) on 6ix