"above all else, guard your heart, it is the wellspring of life"
TRANSCRIPT
“Above all else, guard your heart, it is the wellspring of life”Proverbs 4:23
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Forward Looking StatementStatements contained in this presentation that are not historical facts are forward-looking
statements, as the term is defined in the Private Securities Litigation Reform Act of 1995. You can identify these forward-looking statements by the use of words such as “expects,” “plans,” “estimates,” “projects,” “promises,” “intends,” “believes,” and similar expressions that do not relate to historical matters. Such forward-looking statements are subject to risks and uncertainties that can cause actual results to differ materially from those currently anticipated, due to a number of factors, which include, but are not limited to, to identify strategic partners or, if identified, the inability to enter into an acceptable agreement with such strategic partners and successfully concluding the development and regulatory processes. All forward-looking statements in this presentation are made as of the date of this presentation, based upon information known to management as of the date hereof. VasoGenix assumes no obligation to update or revise any of its forward-looking statements even if experience or future changes show that indicated results or events will not be realized.
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Significance of Heart Failure #1 Patient Diagnosis Over Age 65 #1 Cause of Death Over Age 65 #1 Hospital Expense at $15 Billion Over 1 Million Hospitalizations Annually
80% Over Age 65 Will Die of Heart Failure
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Current Treatments Diuretics to Remove Excess Fluids ACE Inhibitors for Hypertension Beta Blockers to Slow Heart Rate Vasodilators to Reduce Heart Pumping Effort
Multiple Drugs Required for Treatment
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Goals of Our Therapy Reduce Hospital Readmission Rate by Half Reduce Annual Hospital Costs by $6 Billion Eliminate 400,000 Readmissions
Save $16,000 per Hospital Visit
Provide Longer and Healthier Quality of Life
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Calcitonin Gene Related Peptide (Human CGRP)
Significant Body of Research
Clinical Profile Improves Cardiac Function Maintains Kidney Blood Flow Cardioprotective Reduces Cardiac Inflammation
Excellent Human Safety Profile
CalcitoninGene Related
Peptide
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Clinical ExpectationsOptimized Dose of 0.008 µg/kg/min
Cardiac Output ⇧ 72%Left Ventricular Stroke Index ⇧ 60%Pulmonary Capillary Wedge Pressure ⇩ 37%Pulmonary Vascular Resistance ⇩ 22%Neurohormonal Response ⇨ 0%Renal Blood Flow ⇧ 34%Glomerular Filtration Rate ⇧ 43%Heart Rate ⇨ 0%
Source: Anand 1991 & Shekhar 1991
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Product #1: In-Hospital Provides Combined Benefits of Several
Drugs IV Administration Stabilization of Symptoms Reduce Hospitalization Time
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Product #2: Post-Hospital Controlled Release Drug Easy to Administer Requires Only Periodic Administration Continuous Treatment
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Product #2: Post-Hospital First 7 days after discharge
Greatest unmet need in heart failure treatment
Cardiologists are frustrated Very few treatment options
CGRP recognized as having the right therapeutic qualities to meet this need Stabilizes heart failure symptoms and reduces
rehospitalizations
Major Market Differentiation
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Intellectual Property 13 US and Foreign Patent Applications
Heart Failure Acute MI Renal Insufficiency Controlled Release
5 Patents In Process Analogs Broad Drug Applications
Heart and Kidney Focused
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VasoGenix Leadership Team Board of Directors
Lee Southard, PhD – Chairman Jerome Halperin – Former CEO Food & Drug Law Institute Richard Dunn, PhD – Former Sr. VP Drug Delivery Research, QLT/Atrix
Laboratories Donald Braun, PhD – Vice President, Clinical Research, Cancer
Treatment Centers of America Thomas Noffsinger, PhD – Former Assistant Vice-Chancellor, KUMC
Research Institute Scientific Advisory Board Clinical Research Steering Committee
Experience from Drug Discovery to FDA Approval
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ManagementDr. G. Lee SouthardPresident & Chief Executive Officer Atrix Laboratories, Inc.
Founder, President, CEO & CSO 1987–1998 Increased Share Price from $.50 to $29 Company Sold to QLT Inc. for $855 million
Vipont Pharmaceuticals, Inc. Co-founder, VP R&D 1981-1986 Increased Share Price from $.50 to $15 Company Sold to Colgate-Palmolive for $94 million
Big Pharma Executive Experience Eli Lilly Johnson & Johnson
10 FDA Approved Drug and Device Products
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ManagementJeff SouthardCo-FounderVice President Drug Development 6 New Drugs to Market 3 New Medical Devices 5 Patents Issued, 3 Patents Pending 13 Publications and Presentations Big Pharma and CRO Experience
20 Years Drug Discovery and Development
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Using SpecialistsPartners in Development
Pre-Clinical Testing Xenometrics Acceleration, LLC GEL Analytics, Inc. Fleishman-Hillard Kidney Institute of Kansas University Medical
Center (KUMC) Mid America Cardiology Associates at KUMC
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CGRP Analog Profiling
Pre-Clinical Research University of Kansas Hospital
Center for Advanced Heart Care
The Kidney Institute at theUniversity of Kansas Medical Center
NIDDK Training Center
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Using SpecialistsPartners in Development
Research Collaborations Tulane University School of Medicine
CGRP Protects Heart Cells from Death During Heart Attack Heart Failure Conditions(American Heart Association 2005)
Cleveland Clinic Lerner Research InstituteCGRP Receptors in Heart Failure Patients Are
Upregulated 38%(American Heart Association 2007)
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Using SpecialistsPartners in Development
Manufacturing New England Peptides, LLC PolyPeptide Laboratories, Inc.
Regulatory Consulting Beckloff Associates, Inc. LIPICKY, LLC
Clinical Testing Cleveland Clinic Averion
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Clinical Trials
Proof of Concept and Phase I/II
Heart and Vascular Institute
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Development Timeline
Milestone Focused Plan
Yr.7Yr.6Yr.5Yr.4Yr.3Yr.2Yr.1 Yr.8Non-clinical
INDPhase I/IIPhase III
NDARevenue
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Why VasoGenix?
CGRP analogs are 1 of the 5
Source: PhRMA, March 2005
VasoGenix management has proven track record for success.
Company developmental partners are the best in the business.
Addresses greatest unmet need in heart failure today.
Early Cardiologist’s acceptance Early human clinical data
supports safety and efficacy = Lower developmental risk.
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Previous Financing Raised $4 Million to Date
Synthesis of New Analogs of CGRP Initial Development of Controlled Release Drug Pre-IND Meeting with FDA Expansion of Intellectual Property Established Development Plan with Kansas
Partners
Revenue Projection Revenue ($ million) Product Use
Year 1 Year 2 Year 3 Year 4 Year 5 Year 6
In-Hospital IV Drug Treatment 58 127 210 308 423 558
CRD – 1st Time Discharge Pt. 43 94 156 228 314 415
CRD – Rehospitalized Pt. 85 186 301 435 589 766
CRD –Outpatient Clinic Pt. - 64 156 268 399 551
Total Treatment Revenue $186 $471 $823 $1,239 $1,725 $2,290
License 10% 10% 10% 10% 10% 10%
Total Royalty $19 $47 $82 $124 $173 $229
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One Drug Four Revenue Streams
VasoGenix Pharmaceuticals8527 Bluejacket StreetLenexa, Kansas 66214
Dr. G. Lee Southard Jeff [email protected] [email protected]