Hepion Pharmaceuticals, Inc. · OTC:HEPA
Hepion Pharmaceuticals — ContraVir Pharmaceuticals — Investor Presentation (May 2015)
27 slides from Hepion Pharmaceuticals's investor presentation, May 28, 2015
Slide 1: Investor Presentation May 2015
Investor Presentation May 2015 James Sapirstein, CEO Nasdaq: CTRV
Slide 2: Safe Harbor Statement
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,” “will,” “expect,” “intend,”
Slide 3: Corporate Overview
Corporate Overview Company Profile Advanced clinical stage drug development company with a Virology focus Value Drivers FV-100: Reduced shingles-associated, post-herpetic neuralgia (PHN) in Phase 2 trials Initiating Phase 3 trial CMX157: Novel, high potency lipid conjugate of tenofovir Phase 2-ready
Slide 4: Experienced Leadership
Leadership History Experienced Leadership James Sapirstein, R.Ph. Chief Executive Officer 30+ years of biotech/pharma experience, including leading 6 product launches Key in the development and launch of tenofovir Seasoned public and private co. executive John Sullivan-Bolyai, M.D., MPH Chief Medica
Slide 5: Scientific Advisory Board and Board of Directors
Scientific Advisory Board Nathaniel Katz, M.D. (Chair) Global PHN Expert Renu Gupta, M.D. Renowned Antiviral Academic Carol S. Brosgart, M.D. Tenofovir Developer Richard Whitley, M.D. Herpes Virus Expert Experienced Leadership Board of Directors Gary Jacob, Ph.D. (Chair) CEO, Synergy Pharmaceuticals
Slide 6: Global Antiviral Market
Global Antiviral Market 5 $38 billion (2013) Projected to grow to $44 billion by 2018 Well-Served Segments Poorly-Served Segments Focused on high-need segments Potential to capture expanding markets Human Immunodeficiency Virus (HIV) Hepatitis C (HCV) Seasonal Flu Herpes Zoster Virus (HZV) Hepatitis
Slide 7: Antiviral Pipeline
Antiviral Pipeline FV-100 Reduced shingles-associated PHN in Phase 2 trials Initiating Phase 3 trial CMX157 Novel, high potency lipid conjugate of tenofovir Phase 2-ready for HBV Preclinical Phase 1 Phase 2 Phase 3 FV-100 Shingles and PHN CMX157 Hepatitis B
Slide 8: Poised to Capture Growing Demand in PHN
1Yih WK, et al. BMC Public Health, 5,2005; 2Leung J et al. Clin Infect Dis 2011;52:332-340; 3Rimland D. Clin Infect Dis. 2010;50. Ref. 1, 2 Ref. 3 Poised to Capture Growing Demand in PHN Global market expansion driven by aging population PHN Disease Mild to excruciating pain long after shingles rash
Slide 9: FV-100: Potential to be First Approved Antiviral Therapy for PHN Pain
Highly specific nucleoside analogue designed for rapid and potent inhibition of HZV replication within dorsal root ganglion FV-100: Potential to be First Approved Antiviral Therapy for PHN Pain Differentiated Profile Oral pro-drug formulation more readily absorbed Potential improvement in dosing con
Slide 10: HZV Treatments
Acyclovir Valacyclovir Famciclovir FV-100 Formulation(s) IV, PO (capsule, tablet, suspension), topical PO (tablet, caplet) PO (tablets, which contain lactose) PO Dose 800mg PO 5x/day for 7-10 days 1000mg PO 3x/day for 7 days 500mg PO 3x/day for 7 days 400mg PO 1x/day for 7 days Specificity for HZV +
Slide 11: Annual Prescriptions & Market Share
Annual Prescriptions & Market Share 20 million prescriptions annually (U.S.) 5.8% Rx growth since 2010 (annualized average) Majority of prescriptions are generic Source: NPA Data - 12 months ending 12/31/2012 Highly Competitive Profile: Opportunity for QD dosing Efficacy profile superior to valacycl
Slide 12: FV-100 Clinical Highlights
FV-100 Clinical Highlights Demonstrated Safety and Efficacy >350 patients treated with FV-100 Phase 1 (N=3) and Phase 2 (N=1) studies completed Clinically meaningful reduction in PHN occurrence vs. valacyclovir (Valtrex) Meaningful reduction in time to resolution of clinically significant pain 8-10%
Slide 13: FV-100 Key Results (Study 005)
FV-100 Key Results (Study 005) PNH Endpoint Favors FV-100 Both FV-100 arms performed better than valacyclovir at reducing the percent of patients reporting PHN pain at 90 days Secondary pain endpoints consistently favor FV-100 Pain endpoints are FV-100 dose dependent Study 007 (Phase 3) will further
Slide 14: FV-100 Pivotal Trial vs. Valacyclovir (Study 007)
FV-100 Pivotal Trial vs. Valacyclovir (Study 007) Basic Design Multi-center, randomized, double-blind, parallel-group, comparative study (N=825) Three-arms, 275 patients/arm: FV-100 400mg QD FV-100 400mg BID Valacyclovir 1000mg TID 7-day treatment with follow up through day 120 Up to 200 US centers
Slide 15: HBV Market Opportunity
15.4%* growth in chronic HBV patients in the U.S. through 2033 350 million chronic HBV patients worldwide 750 thousand HBV-related deaths in 2010 UK France Spain 10.3% 9.2% 7.5% *European Growth in Chronic HBV Cases HBV Market Opportunity HBV-related ESLD or HCC are responsible for > 0.5-1 million d
Slide 16: CMX157
CMX157 CMX157 Polymerase inhibitor Lipid conjugate of tenofovir (TFV) In-licensed from Chimerix in stock-only transaction Enhanced Absorption Technology Lipid side chains facilitate more efficient uptake and significantly enhances tissue penetration Phase 2-ready Will be developed for HBV New patent
Slide 17: Factors Driving Selection of Direct-Acting HBV Therapies and US Sales
Factors Driving Selection of Direct-Acting HBV Therapies and US Sales *Nucleos(t)ide Analogs 2014 U.S. Sales of Current HBV Drugs Nucleosid(t)e Immuno-modulator Baraclude Epivir Hepsera Tyzeka Viread® Total Pegasys $303.1M $3.6M $31.2M $96.8M $392.2M $929.9M $103M Relative Importance of Factors Effi
Slide 18: FDA Approved Direct-Acting Antivirals for Chronic HBV
FDA Approved Direct-Acting Antivirals for the Treatment of Chronic HBV Viread®* Baraclude Tyzeka Hepsera Epivir Efficacy +++ +++ ++++ ++ ++ Adverse events Renal toxicity; Decreased BMD Lactic acidosis; Hepato-megaly Lactic acidosis; Myopathy Nephro-toxicity; Lactic acidosis Lactic acidosis; Hepato-m
Slide 19: Advantages of CMX157
Advantages of CMX157 Novel and Highly Potent Prodrug of Tenofovir Enhanced Efficacy and Safety Increased bioavailability by harnessing lipid uptake mechanisms Decreased renal and bone toxicity by reducing circulating TFV Enhanced Potency >4x more potent in HBV than TFV in vitro >200x more potent in
Slide 20: CMX157 Phase 1 Study Results
CMX157 Phase 1 Study Results Basic Design Randomized, double-blind, placebo-controlled, single-dose, dose escalation study First-in-man, single site, in healthy volunteers Preliminary evaluation of pharmacokinetics (PK) vs. tenofovir (Viread®) Endpoints Safety and tolerability following single-dose
Slide 21: CMX157 Development Strategy
CMX157 Development Strategy CMX157 Development Develop for global use Dosing studies Study prospective dosing regimens and combination therapies TVF Safety Database Access Database created over last decade FDA Discussions Negotiate appropriate clinical plan Potential for a 505(B)2 Pathway to Approva
Slide 22: Goal of HBV Therapy: HBV Cure
Reduction of viremia below threshold of detection in 95–100% with virtually no emergence of resistance Goal of HBV Therapy HBV Cure Eradication of the intrahepatic replication of the virus Current: Reduction in Viremia Future: Functional Cure (cccDNA eradication)
Slide 23: HBV Targets: Combinations Toward a Functional Cure
In-Direct Acting Antivirals Direct Acting Antivirals (DAAs) In use Polymerase Potential Rnase H RNAi Capsid Inhibitors rcDNA-cccDNA conversion cccDNA inhibitors CMX157 ContraVir is Open to Potential Combination Partnerships With CMX157 HBV Targets: Combinations Toward a Functional Cure Immuno-Modula
Slide 24: 2015 Corporate Strategic Goals
c 23 FV-100 Study 007 Initiation Results of Drug-Drug Interaction Study (with Ritonavir) Initiate Phase 1/2a CMX157 Study in HBV 2015 Corporate Strategic Goals Possible Acquisition/Licensing of a New Compound
Slide 25: Financial Milestones
Financial Milestones NASDAQ: CTRV Financial Information as of March 31, 2015 22,273,397 common shares outstanding Approximately $8.9 million in cash Capital Structure 22.3 million common 3.8 million options for common 1.25 million shares of preferred series A 120k shares of preferred series B Closin
Slide 26: Corporate Summary
Corporate Summary Strategic Focus Develop and commercialize novel drug treatments to improve the lives of patients suffering from chronic viral infections Mid-to-Late Stage Pipeline FV-100: Reduced shingles-associated post-herpetic neuralgia (PHN) in clinical trials; Initiating Phase 3 trial CMX157:
Slide 27: CMX157 Clinical Strategy
CMX157 Clinical Strategy Phase 1 Ascending Dose Proof of Concept HBV Patients Open to Combination Partnerships Monotherapy Acceleration Opportunity 505(B)2 Pathway Approval for Combination Therapy
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