Via Pharmaceuticals Inc · OTC:VIAP
Via Pharmaceuticals — Investor Presentation (November 2008)
34 slides from Via Pharmaceuticals's investor presentation, Nov 12, 2008
Slide 1: Investor Presentation November, 2008
Investor Presentation November, 2008
Slide 2: Safe Harbor
2 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
Slide 3: VIA Investment Highlights
3 VIA Investment Highlights Inflammation -- root cause of cardiovascular disease resulting in heart attack and stroke Lead compound, VIA-2291 has best-in-class potential Potent, oral, once-daily compound inhibits key mediator of inflammation Presented data from comprehensive Phase 2 program at Ameri
Slide 4: VIA-2291 Late Stage Clinical Development Plan
4 2006 2007 2008 2009 VIA-2291 Phase 2 Program Carotid Endarterectomy (CEA) Acute Coronary Syndrome (ACS) FDG PET VIA-2291 Late Stage Clinical Development Plan Phase 2 Proof of Concept Program designed to provide weight of evidence pointing to efficacy
Slide 5: VIA-2291: Significantly De-risked Product
5 VIA-2291: Significantly De-risked Product Second generation 5-LO Inhibitor Strong product characteristics Once daily oral dosing Highly specific Potential for greater therapeutic index Extensive clinical experience - more than 1,300 patients exposed 20 Phase 1 studies, 6 Phase 2 studies, 2 Phase 3
Slide 6: Significant Findings Presented at AHA
APPEARS SAFE VIA-2291 appeared safe and well-tolerated NOVEL MOA Potent, statistically significant and dose-dependent inhibition of leukotriene production INFLAM- MATION REDUCED CEA: Significant reduction of hs-CRP at 12 weeks ACS: Significant reduction of hs-CRP at 24 weeks Significant Findings Pre
Slide 7: Inflammation Matters in Cardiovascular Disease
7 Inflammation Matters in Cardiovascular Disease
Slide 8: Risk Factor Profile of Two Individuals
Risk Factor Profile of Two Individuals WC 65 year old man, healthy, with no prior known heart disease Obese; hypertensive ?Cholesterol, ?Diabetic Smoker; alcohol use Father died of stroke Sedentary life style Framingham score >17 JF 52 year old man, healthy with no prior known heart disease Extremel
Slide 9: What Are We Missing?
Sir Winston Churchill Lived to age 91 Jim Fixx Died of MI at age 52 What Are We Missing? 9
Slide 10: Inflammation is Key to All Stages of CV Disease
10 Inflammation is Key to All Stages of CV Disease Early stages of atherosclerosis Inflammatory process Early atherosclerotic lesions Vulnerable plaque Stable plaque Healthy artery MACE Plaque rupture is a cause of Major Adverse Cardiovascular Events
Slide 11: Large Market with Significant Unmet Medical Need
11 Large Market with Significant Unmet Medical Need 30.3 million patients in US and Europe and 2.7 million at "high risk" following ACS events Current therapies treat only risk factors Cardiovascular Spend in 7 major World Markets >$115 billion in 2006 Source: Data Monitor 2007 $28.7 B $20.8 B $16.1
Slide 12: Available Therapies ONLY Reduce MACE by ~30%
12 Available Therapies ONLY Reduce MACE by 20 - 30% IDEAL Prove IT HPS 4S LIPID CARE CAPRIE Reduction in MACE 0.11 0.16 0.24 0.32 0.25 0.23 19 Risk not addressed 0.88000000026296 0.83000000013148 0.75 0.67 0.74 0.76 81 Lipitor Zocor Pravachol Published Results Plavix
Slide 13: Lead Compound VIA-2291 in Comprehensive Late-Stage Phase 2 Clinical Trial Program
13 Lead Compound VIA-2291 in Comprehensive Late-Stage Phase 2 Clinical Trial Program
Slide 14: Leukotrienes Mediate Vascular Inflammation
Leukotrienes Mediate Vascular Inflammation 5-LO is the rate limiting enzyme LTB4 recruits and activates inflammatory cells in unstable plaque 5LO is a validated pharmaceutical target VIA identified 5-LO as target for atherosclerosis Human genetic data implicates 5-LO in MACE Expression data in mouse
Slide 15: Innovative, Comprehensive Clinical Strategy
CEA ACS FDG-PET Safety 3 doses tested Inhibition of 5-LO Inflammatory biomarkers Coronary lesions on MDCT scan in a patient sub-study Utilizing leading edge technology to demonstrate impact on inflammation Creating strong weight of evidence Safety Inhibition of 5-LO Inflammatory biomarkers Plaque in
Slide 16: Summary of Findings
Summary of Findings ACS Appears safe and well- tolerated Significant leukotriene inhibition as measured by LTB4 and LTE4 Significant reduction of hs- CRP at 24 weeks in highest dose group vs. placebo CEA Appears safe and well- tolerated Significant leukotriene inhibition as measured by LTB4 and LTE4
Slide 17: ACS Trial
ACS Trial 168 patients completed trial and randomized 48 evaluable patients to placebo, 44 patients to 25 mg, 38 patients to 50 mg and 38 to 100 mg More than 80 continued on for an additional 12 weeks to complete Sub-study Demographics well balanced between groups Med age 56 85% Male BMI~ 29 <20% Di
Slide 18: ACS Study Met Primary Endpoint
18 18 ACS Study Met Primary Endpoint Error Bars represent 95% CI Primary Endpoint: Change from baseline in ex vivo stimulated Leukotriene B4 (LTB4) production Highly significant reduction from baseline at all doses measured at trough drug concentrations Dose related effect observed Reductions occur
Slide 19: CEA Trial
CEA Trial 35 patients were evaluable with 19 randomized to placebo and 16 to VIA-2291 100mg Demographics well balanced between groups Med age 68 50% Male, 50% Female BMI~ 27 >50% Diabetes >80% Hypertension Common Medications ~60% statins ~90% anti-platelet agents Anti-diabetics and anti-hypertensive
Slide 20: VIA-2291 Inhibits LTB4 Production
VIA-2291 Inhibits LTB4 Production 20
Slide 21: hsCRP is Significantly Reduced after Months
hsCRP is Significantly Reduced after 3 Months 100mg VIA-2291 N=30 21
Slide 22: Phase 2 Trial - FDG PET
22 Phase 2 Trial - FDG PET Tahara, et al 2006 Trial Design Population Coronary artery disease Acute Coronary Syndrome Description 50 patients within 1 - 3 months of an ACS event Randomized, double-blind 24 weeks, 100 mg/day or placebo Positron Emission Tomography with fluorodeoxyglucose tracer (FDG
Slide 23: Investigator Commentary on VIA-2291
23 "VIA-2291 has the potential to be the first drug to specifically target one cardiovascular inflammatory pathway. These data support further development of this drug, including larger outcomes trials." Jean-Claude Tardif, Director of the Montreal Heart Institute Research Centre, professor of medic
Slide 24: Broad Pipeline
Broad Pipeline a VIA
Slide 25: Broad Development Pipeline
25 Broad Development Pipeline Compound/Target Area of Focus Research Pre-Clinical Phase 1 Phase 2 Phase 3 VIA-2291 / 5-LO Carotid Endarterectomy Acute Coronary Syndrome FDG PET PDE 4 Vascular Inflammation Additional Compounds Inflammation
Slide 26: VIA Proprietary Technology Platform
26 VIA Proprietary Technology Platform 4 year, $30 million study at Stanford headed by VIA Founder/CSO Inflammation key in human atherosclerosis Extensive data from work in mouse model confirms human findings >3,000 patient study confirms inflammatory genes in heart attack and stroke Database for pr
Slide 27: Broad Pool of Anti Inflammatory Compounds
27 Broad Pool of Anti Inflammatory Compounds Qualified Targets Anti inflammatory Compounds Identified Opportunities Preclinical Clinical Stage LOs (5-LO, 12-LO, FLAP) 189 109 75 34 Leukotrienes (LTA4, LTB4, LTC4, LTD4 189 189 135 54 PPARs (^,^,^) 99 92 52 40 PDEs (mostly PDE4) 153 153 95 58 Chemokin
Slide 28: Significant Progress
Significant Progress 2 VIA
Slide 29: Accomplishments & Upcoming Milestones
Accomplishments & Upcoming Milestones 2007 - 2008 Accomplishments Launched VIA Pharmaceuticals as public company Raised $25 million in PIPE financing Initiated preclinical programs DSMB review confirmed safety and pharmacological effect Initiated FDG-PET Phase 2 Formed expanded clinical advisory boa
Slide 30: Experienced Management Team
Personnel Position Experience Larry Cohen, PhD CEO Zyomyx, Progenitor, Somatix, Therion Oye Olukotun, MD, MPH CMO Bristol-Myers Squibb, Mallinckrodt, Esperion Tom Quertermous, MD Founder and SAB Chair Dept Cardiovascular Medicine, Stanford Medical School Mike Perry, DVM, PhD CDO Baxter, Novartis, Sc
Slide 31: World Class Advisors
World Class Advisors Scientific Advisory Board Israel Charo, MD, PhD UCSF Christopher Glass, MD, PhD UCSD Colin Funk, PhD Queens University Garret FitzGerald, MD University of Pennsylvania Marco Conti, MD Stanford Medical School Todd Klingler, PhD XDx, Inc. Clinical Advisory Board Marc Pfeffer, MD,
Slide 32: Financial Update
32 Financial Update Cash balance - approximately $7.5 million at September 30, 2008 Cash burn - approximately $1.8 - 1.9 million / month Total common shares outstanding 19.7 million Fully diluted shares outstanding 23.7 million
Slide 33: VIA Investment Highlights
33 VIA Investment Highlights Inflammation -- root cause of cardiovascular disease resulting in heart attack and stroke Lead product candidate, VIA-2291 has best-in-class potential VIA-2291 has strong value proposition Building pipeline utilizing proprietary technology platform licensed from Stanford
Slide 34: VIA Pharmaceuticals
—— VIA pharmaceuticals VIA
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