Via Pharmaceuticals Inc · OTC:VIAP
Via Pharmaceuticals — Investor Presentation (October 2009)
47 slides from Via Pharmaceuticals's investor presentation, Oct 9, 2009
Slide 1: Investor Presentation October 2009
Investor Presentation October 2009 V 10.4; 10 09 09
Slide 2: Safe Harbor
SAFE HARBOR This presentation contains "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors that ma
Slide 3: Executive Summary
Executive Summary VIA is Developing Drugs Targeting Novel Mechanisms in Cardiometabolic Disease - Large Unmet Medical Need Despite Successful Treatments The Lead Product VIA-2291, is a Disease Modifying, Phase 3-Ready Drug which Targets Reduction of Major Adverse Cardiovascular Events (MACE) Caused
Slide 4: Cardiometabolic Disease Spectrum
Cardiometabolic Disease Spectrum Obesity/ Other Factors Hepatic Steatosis Dyslipidemia Insulin resistance NASH/ Cirrhosis Hypertension Atherosclerosis Type 2 Diabetes MACE Retinopathy Neuropathy Nephropathy 5-LO THR- B THR- B THR- B DGAT - -1 DGAT - -1 DGAT - -1 Genetics/Environment Risk Factor Trea
Slide 5: VIA-2291: Lead Asset
VIA-2291: Lead Asset Compound/Target Area of Focus Research Pre-Clinical Phase 1 Phase 2 Phase 3 VIA-2291(Atreleuton) / 5-LO Inhibitor MACE Reduction in Coronary Artery Disease Patients VIA-3196 Thyroid Hormone Receptor-^ (THR-^) Agonist Hypercholesterolemia/Dyslipidemia, Insulin Sensitization, NASH
Slide 6: Large Global Market for MACE Drugs
Large Global Market for MACE Drugs Sources: IMS Health, company annual reports Total market = $65B 6 Billions of dollars - 2008
Slide 7: Large Unmet Need in Treatment of MACE
Large Unmet Need in Treatment of MACE Risk not addressed Reduction in MACE Lipitor Zocor Pravachol Plavix 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% IDEAL Prove IT HPS 4S LIPID CARE CAPRIE Relative Risk Reduction 7 30.3 Million Patients In US and Europe and 2.7 Million At "High Risk" Following ACS
Slide 8: Inflammation Causes Plaque Rupture and MACE
8 Stable plaque MACE Inflammation Causes Plaque Rupture and MACE Thin fibrous cap Large fatty core Thick fibrous cap Small fatty core Reducing inflammation to stabilize plaque: A new paradigm for treating CV disease Unstable plaque Leukotrienes Proteases Cytokines Necrotic Core
Slide 9: Leukotrienes Strongly Implicated in Atherosclerosis
Leukotrienes Strongly Implicated in Atherosclerosis Leukotrienes are Potent Chemoattractants for Inflammatory Cells and Increase Vascular Permeability Human Genetic Data, Multiple Studies in Patients and Animal Models, Including VIA's Own Data, Support the Critical Role of Leukotrienes in Atheroscle
Slide 10: VIA-2291: Potent and De-risked Drug
VIA-2291: Potent and De-risked Drug Diligence of 35 Compounds Identified ABT-761 at Abbott Laboratories Once daily oral dosing Highly potent and specific inhibitor of 5-LO Significant patient experience at doses up to 600 mg Furthest in development of all 5-LO inhibitors Strong Development Program a
Slide 11: VIA-2291: Strong I.P. Position Protects Market Exclusivity
VIA-2291: Strong I.P. Position Protects Market Exclusivity Composition of Matter Patent Protection provided through: - - November 2012 in United States (US 5,288,751) - - November 2013 in EU (France, Germany, UK, Italy, Spain) (667,855) VIA-2291 is a New Chemical Entity 5-year period of exclusivity
Slide 12: VIA-2291: Product Positioning - MACE
VIA-2291: Product Positioning - MACE ATTRIBUTE Expected Target Profile Efficacy Treatment with VIA-2291 in addition to standard therapy is indicated to reduce the rate of combined risk of myocardial infarction, stroke, or cardiovascular death in high risk patients post- ACS event or with Coronary Ar
Slide 13: VIA-2291: Phase 2 Program
VIA-2291: Phase 2 Program Double-blind placebo controlled trials on top of standard of care 13 Trial VIA-2291-01: Acute Coronary Syndrome (ACS) VIA-2291-02: Carotid Endarterectomy (CEA) VIA-2291-03: Fluoro- Deoxyglucose Positron Emission Tomography (FDG-PET) Patients 191 50 50 Duration 12 weeks - bi
Slide 14: VIA-2291: Phase 2 Objectives Met
VIA-2291: Phase 2 Objectives Met Potent Inhibition of Leukotrienes by VIA-2291 Confirmed Dose dependent inhibition of leukotrienes B4 and E4 100 mg dose inhibits leukotriene B4 by approximately 90% at 24 hr trough Systemic and Plaque Anti-inflammatory Effects Observed Statistically significant inhib
Slide 15: VIA-2291: Phase 2 Trial Safety Profile
VIA-2291: Phase 2 Trial Safety Profile All Trials Monitored by Data Safety Monitoring Board (DSMB) VIA-2291 Was Generally Well-tolerated at All Doses Tested No Drug-related Serious Adverse Events (SAEs) Reported Reversible Laboratory Findings in VIA-2291 Treated Patients DSMB: Safety Findings Suppor
Slide 16: VIA-2291: Key Data Correlate With MACE Benefit
5-LO Inhibition Reduced Vascular Inflammation Increased Plaque Stability Reduction in MACE VIA-2291: Key Data Correlate With MACE Benefit ACS CEA MDCT FDG-PET LTB4 & LTE4 Inhibition LTB4 & LTE4 Inhibition Reduction of hsCRP Reduction of Proteases Reduction of Necrotic Core Plaque Burden Reduced Infl
Slide 17: MDCT: Plaque Burden and New Lesions
MDCT: Plaque Burden and New Lesions p <0.01 17
Slide 18: MDCT Analysis - Non-Calcified Plaque Burden
MDCT Analysis - Non-Calcified Plaque Burden * White arrows indicate location of lesion * 18
Slide 19: Moderate Clinical Trial Cost to Complete Registration
Moderate Clinical Trial Cost to Complete Registration 19 End of Phase 2a Meeting Held with FDA May 2009 Safety and biological data reviewed from ACS and CEA clinical studies Guidance from the FDA will be incorporated into the VIA-2291 registration and Phase 3 program Submission of the Phase 3 plan t
Slide 20: VIA-2291: Large Market Opportunity
Research for Commercial Market Plan Done by Inventiv Health, 2007 Target Secondary Prevention in Post-ACS Patients Primary Research Potential Prescribing Physicians Third Party Payers Pharmacists Cardiology Key Opinion Leaders Primary and Interventional Cardiologists Will Be Core Prescribing Base th
Slide 21: Competitive Landscape: Anti-Inflammatory Drugs for MACE
Competitive Landscape: Anti-Inflammatory Drugs for MACE Phase 2 Phase 3 Darapladib (Lp-PLA2) GSK AG-1067 (antioxidant) Atherogenics/ Salutria Missed primary endpoint in Phase 3 20% reduction in hard CV endpoints Setileuton (5-LO) Merck DG-051 (LTA4H) DeCode Modest reduction in LDL, hsCRP in clinical
Slide 22: VIA-2291: Strong Asset for Commercial Partnering
VIA-2291: Strong Asset for Commercial Partnering 22 VIA-2291 Represents an Attractive Partnering Asset Because of Its Key Attributes Phase 3 ready asset with clear, affordable development plan to registration Large commercial market accessible with specialty sales force First-in-class 5-LO inhibitor
Slide 23: THRb and DGAT1: Expanding Product Pipeline
Compound/Target Area of Focus Research Pre-Clinical Phase 1 Phase 2 Phase 3 VIA-2291(Atreleuton) / 5-LO Inhibitor MACE Reduction in Coronary Artery Disease Patients VIA-3196 Thyroid Hormone Receptor-^ (THR-^) Agonist Hypercholesterolemia/Dyslipidemia, Insulin Sensitization, NASH Diacylglycerol Acyl
Slide 24: Large Global Market for Dyslipidemia Drugs
Large Global Market for Dyslipidemia Drugs Source: IMS Health MIDAS MAT Jun 2009 Total market = $36B 24 Billions of dollars - 2008
Slide 25: Unmet Needs in Dyslipidemia Treatment
Unmet Needs in Dyslipidemia Treatment 70% of High Risk Cardiovascular Patients Not Achieving LDL Cholesterol Goals Some patients don't tolerate statins (~5%) particularly high dose statins Diabetics in Particular Have Additional Risks and Therapeutic Needs for Lipid Modifiers Patients Achieving LDL
Slide 26: Large Global Market for Diabetes Drugs
Large Global Market for Diabetes Drugs Sources: IMS Health, company annual reports, Feb 2009 Consumer Reports Treating Type-2 Diabetes, package inserts Total Market = $24B 26 Billions of dollars - 2008
Slide 27: Unmet Needs in Diabetes Treatments
Unmet Needs in Diabetes Treatments Rapidly Expanding Incidence of Diabetes Word-wide Largely Due to Environmental Factors and Increase in Obesity Despite A1C Lowering No Improvement in Cardiovascular Outcomes 70% of Diabetics Die of CV Disease New FDA Guidance on Anti-Diabetic Therapies Prevention o
Slide 28: VIA-3196: Liver Targeted THR-beta Compound
VIA-3196: Liver Targeted THR-beta Compound for Dyslipidemia and Diabetes Thyroid Gland T4 e T3 Liver T4 T3 Heart Liver Bone CNS TR Target Tissues TSH Goal: Development of THR-b selective agonists with targeted hepatic uptake to achieve metabolic endpoints without undesirable effects associated with
Slide 29: VIA-3196: Program Snapshot
VIA-3196: Program Snapshot Asset Licensed from Roche December 2008 Worldwide rights, Composition of Matter patent protection through 2026 Rigorous preclinical program based on disease mechanism biology IND Ready Candidate with Target Product Profile of: Oral, once a day, small molecule drug Clinical
Slide 30: VIA-3196: Product Positioning - Hypercholesterolemia/Dyslipidemia
VIA-3196: Product Positioning- Hypercholesterolemia/Dyslipidemia ATTRIBUTE Expected Target Profile Efficacy Reduction in LDL-cholesterol (~40%) within 2wks (MAD) Dose-dependent reductions in LDL-cholesterol (~40%), triglycerides (30%) and lipoprotein-a (Lp-a) in hypercholesteremic pts; Same magnitud
Slide 31: VIA-3196: Product Positioning - Insulin Sensitization/NASH
VIA-3196: Product Positioning - Insulin Sensitization/NASH ATTRIBUTE Expected Target Profile Efficacy VIA-3196 is designed to reduce cardiovascular risk in patients with type 2 diabetes and incremental/additional cardiovascular risk factors Weight neutral insulin sensitizer Reduction of hepatic lipi
Slide 32: VIA-3196: Summary of Pre-clinical Results
Safety of 3196 Relative to other THR-Beta Compounds in Development Inactive in the heart in thryroidectomized rats No adverse treatment-related changes in any organ examined in dogs No ALT elevations at relevant doses Efficacy Synergy with atorvastatin in cholesterol lowering in hypercholesterolemic
Slide 33: VIA 3196: Project Plans
VIA 3196: Project Plans Phase 1- SAD and MAD study -2010 Ongoing CMC and IND Preparation Will demonstrate LDL lowering while maintaining separation from TSH lowering Phase 2a Clinical Trial One month study: Demonstrate LDL lowering in concert with statins One month study in diabetics to show evidenc
Slide 34: Competitive Landscape THR Analogs
Competitive Landscape THR Analogs Phase 1 Phase 2 Preclinical KB2115 (eprotirome) KaraBio 25 - 100ug QD for 12 wks 14-26% LDL^ on top of statin DITPA Titan / JHopkins 180mg BID for 12 wks not tolerated in HF. LDL^ 45 and 90mg BID in hypercholesterolemia MB-7811 Metabasis sobetirome QuatRx 25ug - 40m
Slide 35: DGAT1 Inhibitors for Weight Control, Insulin Sensitization, and Dyslipidemia
DGAT1 Inhibitors for Weight Control, Insulin Sensitization, and Dyslipidemia GLP-1: Glucagon-like peptide 1 PYY: Peptide YY PYY GLP-1 DGAT1 Enzyme is Present in Intestine, Liver And Adipose and is The Last Step in Triglyceride Synthesis DGAT1 Inhibitors Act in the Intestine to Reduce Triglyceride Ab
Slide 36: DGAT1: Program Snapshot
DGAT1: Program Snapshot Licensed from Roche December 2008 Worldwide rights to assets Broad patent estate Robust program based on clinically relevant disease mechanism biology Near Term Milestone is Identification of Lead Compound Several potential clinical candidates to select from Potential Indicat
Slide 37: DGAT1: Product Positioning - Diabetes, Dyslipidemia
DGAT1: Product Positioning - Diabetes, Dyslipidemia 37 ATTRIBUTE-DIABETES Expected Target Profile Efficacy DGAT1 is an anti-diabetic agent that will reduce cardiovascular risk in patients with type 2 diabetes Weight control, insulin sensitizer Safety and Tolerability Safe as compared with current in
Slide 38: VIA DGAT1 Inhibitors: Summary of Pre-clinical Results
Positive Effects on Body Weight and Insulin Sensitivity in Rodent Models Weight Benefit Accompanied by Decreased Food Intake Increased Insulin Sensitivity by Reducing DAG Levels Decreased Triglyceride Levels After Meal Differentiated from Competitors by Improved Safety Profile and Increased Insulin
Slide 39: DGAT1 Inhibitor: Project Plans
Identification of Lead Compound - 2010 IND-enabling Toxicology Studies Time frame approximately 1 year Phase 1 Studies Biomarkers to demonstrate mechanism of action DGAT1 Inhibitor : Project Plans 39
Slide 40: Competitive Landscape DGAT1 Inhibitors
Competitive Landscape DGAT1 Inhibitors Phase 1 Phase 2 Preclinical LCQ908 Novartis Dose proportional PK VIA DGAT1 DGAT1 inhib Abbott DGAT1 inhib Astra Zeneca DGAT1 inhib Otsuka PF-04620110 Pfizer 12 wk dose ranging trial ongoing in 720 diabetic pts on stable metformin Data pending (2010) DGAT1 inhib
Slide 41: Milestones, Management, and Advisors
Milestones, Management, and Advisors 41
Slide 42: Accomplishments & Upcoming Milestones
Accomplishments & Upcoming Milestones 2007 - 2009 Accomplishments Initiated FDG-PET Phase 2 Expanded clinical advisory board and KOL network Addition of Dr. Rebecca Taub - Sr. VP R&D Reported positive results from CEA and ACS trials at AHA Strong metabolic assets acquired from Roche VIA-2291 intelle
Slide 43: Experienced Leadership Team
Personnel Position Experience Larry Cohen, PhD CEO Zyomyx, Progenitor, Somatix, Therion, Harvard Medical Becky Taub, MD SVP R&D Roche, Bristol-Myers Squibb, Dupont, U Penn-HHMI Brendan Rae, PhD, JD SVP Bus Dev Roche, Purdue Pharma Jim Stewart SVP CFO ACT, CN Biosciences, Ventro, E&Y Tom Quertermous,
Slide 44: Advisory Boards
Advisory Boards Scientific Advisory Board Israel Charo, MD, PhD UCSF Marco Conti, MD Stanford Medical School Garret FitzGerald, MD University of Pennsylvania Colin Funk, PhD Queens University Christopher Glass, MD, PhD UCSD Todd Klingler, PhD XDx, Inc. Thomas Quertermous, MD Stanford Medical School
Slide 45: Financial Summary
Cash position: Cash balance $4.5 million at 9.30.09 Cash burn in Q2-09 of approximately $1.2 million per month Cash burn trending down to $1.0 million / month as trials wind down Bay City Capital Notes of $10.0 million outstanding Capitalization summary: 20.6 million common shares outstanding 83.3 m
Slide 46: Executive Summary
Executive Summary VIA is Developing Drugs Targeting Novel Mechanisms in Cardiometabolic Disease - Large Unmet Medical Need Despite Successful Treatments The Lead Product VIA-2291, is a Disease Modifying, Phase 3-Ready Drug which Targets Reduction of Major Adverse Cardiovascular Events (MACE) Caused
Slide 47: VIA Pharmaceuticals
—— VIA pharmaceuticals VIA
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