“ Above all else, guard your heart, it is the wellspring of life” Proverbs 4:23
Forward Looking Statement
Significance of Heart Failure <ul><li>#1 Patient Diagnosis Over Age 65  </li></ul><ul><li>#1 Cause of Death Over Age 65 </...
Current Treatments <ul><li>Diuretics to Remove Excess Fluids </li></ul><ul><li>ACE Inhibitors for Hypertension </li></ul><...
Goals of Our Therapy <ul><li>Reduce Hospital Readmission Rate by Half  </li></ul><ul><li>Reduce Annual Hospital Costs by $...
Calcitonin Gene Related Peptide   (Human CGRP) <ul><li>Significant Body of Research </li></ul><ul><li>Clinical Profile </l...
Clinical Expectations Optimized Dose of 0.008  µ g/kg/min Source: Anand 1991 & Shekhar 1991 Cardiac Output ⇧ 72% Left Vent...
Product #1: In-Hospital <ul><li>Provides Combined Benefits of Several Drugs </li></ul><ul><li>IV Administration </li></ul>...
Product #2: Post-Hospital <ul><li>Controlled Release Drug </li></ul><ul><li>Easy to Administer </li></ul><ul><li>Requires ...
Product #2: Post-Hospital <ul><li>First 7 days after discharge </li></ul><ul><ul><li>Greatest unmet need in heart failure ...
Intellectual Property <ul><li>13 US and Foreign Patent Applications </li></ul><ul><ul><li>Heart Failure  </li></ul></ul><u...
VasoGenix Leadership Team <ul><li>Board of Directors </li></ul><ul><ul><li>Lee Southard, PhD – Chairman  </li></ul></ul><u...
Management <ul><li>Dr. G. Lee Southard </li></ul><ul><li>President & Chief Executive Officer </li></ul><ul><li>Atrix Labor...
Management <ul><li>Jeff Southard </li></ul><ul><li>Co-Founder </li></ul><ul><li>Vice President Drug Development </li></ul>...
Using Specialists Partners in Development <ul><li>Pre-Clinical Testing </li></ul><ul><ul><li>Xenometrics </li></ul></ul><u...
Pre-Clinical Research  CGRP Analog Profiling University of Kansas Hospital Center for Advanced Heart Care The Kidney Insti...
Using Specialists Partners in Development <ul><li>Research Collaborations </li></ul><ul><ul><li>Tulane University School o...
Using Specialists Partners in Development <ul><li>Manufacturing </li></ul><ul><ul><li>New England Peptides, LLC </li></ul>...
Clinical Trials Proof of Concept and Phase I/II Heart and Vascular Institute
Development Timeline Milestone Focused Plan Yr.7 Yr.6 Yr.5 Yr.4 Yr.3 Yr.2 Yr.1 Yr.8 Non-clinical IND Phase I/II Phase III ...
Why VasoGenix? CGRP analogs are 1 of the 5 Source: PhRMA, March 2005 <ul><li>VasoGenix management has  proven track record...
Previous Financing <ul><li>Raised $4 Million to Date </li></ul><ul><ul><li>Synthesis of New Analogs of CGRP </li></ul></ul...
Revenue Projection One Drug    Four Revenue Streams $229 $173 $124 $82 $47 $19 Total Royalty 10% 10% 10% 10% 10% 10% Lice...
VasoGenix Pharmaceuticals 8527 Bluejacket Street Lenexa, Kansas 66214 Dr. G. Lee Southard Jeff Southard [email_address] [e...
Upcoming SlideShare
Loading in...5
×

"Above all else, guard your heart, it is the wellspring of life"

301
-1

Published on

0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total Views
301
On Slideshare
0
From Embeds
0
Number of Embeds
1
Actions
Shares
0
Downloads
1
Comments
0
Likes
0
Embeds 0
No embeds

No notes for slide
  • Our Forward Looking Statement slide that lets you know that what is not historical fact are forward-looking statements, and that actual results may differ materially from those anticipated.
  • When attending a conference such as this I can’t help but be humbled by the significance of what we are doing at VasoGenix. You see when I look out over the multitude of people here today, I realize that 80% of the people in attendance today will die of heart failure. I realize what lay ahead for those of us who receive this diagnosis and its costs both emotional and monetary. My daughter was diagnosed with heart failure when she was 1 ½ and received a heart transplant at 3 ½, and now at 15 leads a very productive life. I know the cost, and I know what it takes to make a difference in heart failure.
  • Go through slide How do we expect accomplish this? With a drug that safe, provides unique benefits to heart, and offers flexible routes of administration. The combination of which differentiates our drug from all others.
  • Each of the bullet points in the clinical profile are significant on their own and lower the risk inherent in drug dev. prog. And there are other drugs on the market and in development that claim to accomplish one or two of these criteria. But what sets CGRP apart is that this is one drug accomplishing all four criteria. The significant body of research, the clinical profile, and the safety profile is what gets cardiologist’s exited about CGRP’s potential. It is why the leading cardiologist’s at the Cleveland Clinic (the world’s #1 heart center), Stanford, Harvard, Duke, NYU and several others encouraged us to pursue development in heart failure.
  • These 8 categories are what cardiologist look at to assess heart function in heart failure patients. For those in the medical field you may recognize the significance of these values. For those who are not, the values are equal to or exceed the standard of care therapies, and the arrows are moving in the correct directions. The red text is CGRP’s effect on the kidney function and is important since heart failure is a leading cause of kidney failure.
  • We are developing two products that go hand-in-hand. Cardiologist have told they like the idea of giving drug “A” in the hospital and sending the patient home with drug “A”. Particularly a drug with this profile. Go through slide It is important to note that it is not our goal to replace the standard of care therapies. But to augment what is already being done in the hospital and out-patient setting
  • Which brings us to our next product. Go through slide It is administered by injection under the skin as a liquid and solidifies upon exposure to the fluid in the body. It is about the size of BB or garden pea and biodegrades or dissolves over the period of a month. It is the potential of this product that gets cardiologist’s excited about CGRP, and it is this product that is expected to address the most critical need in heart failure treatment.
  • The first 7-days after discharge are where cardiologist’s have the fewest options and greatest frustration. As they say in the KTEC Pipeline Program it is their source of “greatest pain”. Based on the patient’s condition upon discharge doctors and nurses can tell you who will be back in 7-days or two weeks or even a month. 20% of heart failure patients are rehospitalized within 30 days following discharge, and another 50% within 6 months. We are developing a 7-day controlled release initially that addresses this need, and is a major market differentiator. 1 month and 3 month releases are planned.
  • Go through slide As a result our diligent effort in establishing a strong intellectual property position. Our IP is both offensive and defensive in nature. The analog patent is a composition of matter patent covering all aspects of CGRP’s cardiovascular potential and 12 analogs of CGRP. This patent represents our offensive IP, and the original 13 US and foreign patents now take up defensive positions to prevent development of the native CGRP peptide.
  • Revenue projections are based on 4 potential revenue streams, one for in hospital administration and for three out patient use. Year one is base on a modest 2.5% market share to 15% at year 6. However, historically heart failure drugs typically debut much higher, and assumes a licensing agreement with a Pharma partner.
  • "Above all else, guard your heart, it is the wellspring of life"

    1. 1. “ Above all else, guard your heart, it is the wellspring of life” Proverbs 4:23
    2. 2. Forward Looking Statement
    3. 3. Significance of Heart Failure <ul><li>#1 Patient Diagnosis Over Age 65 </li></ul><ul><li>#1 Cause of Death Over Age 65 </li></ul><ul><li>#1 Hospital Expense at $15 Billion </li></ul><ul><li>Over 1 Million Hospitalizations Annually </li></ul>80% Over Age 65 Will Die of Heart Failure
    4. 4. Current Treatments <ul><li>Diuretics to Remove Excess Fluids </li></ul><ul><li>ACE Inhibitors for Hypertension </li></ul><ul><li>Beta Blockers to Slow Heart Rate </li></ul><ul><li>Vasodilators to Reduce Heart Pumping Effort </li></ul>Multiple Drugs Required for Treatment
    5. 5. Goals of Our Therapy <ul><li>Reduce Hospital Readmission Rate by Half </li></ul><ul><li>Reduce Annual Hospital Costs by $6 Billion </li></ul><ul><li>Eliminate 400,000 Readmissions </li></ul><ul><ul><li>Save $16,000 per Hospital Visit </li></ul></ul><ul><li>Provide Longer and Healthier Quality of Life </li></ul>
    6. 6. Calcitonin Gene Related Peptide (Human CGRP) <ul><li>Significant Body of Research </li></ul><ul><li>Clinical Profile </li></ul><ul><ul><li>Improves Cardiac Function </li></ul></ul><ul><ul><li>Maintains Kidney Blood Flow </li></ul></ul><ul><ul><li>Cardioprotective </li></ul></ul><ul><ul><li>Reduces Cardiac Inflammation </li></ul></ul><ul><li>Excellent Human Safety Profile </li></ul>Calcitonin Gene Related Peptide
    7. 7. Clinical Expectations Optimized Dose of 0.008 µ g/kg/min Source: Anand 1991 & Shekhar 1991 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%
    8. 8. Product #1: In-Hospital <ul><li>Provides Combined Benefits of Several Drugs </li></ul><ul><li>IV Administration </li></ul><ul><li>Stabilization of Symptoms </li></ul><ul><li>Reduce Hospitalization Time </li></ul>
    9. 9. Product #2: Post-Hospital <ul><li>Controlled Release Drug </li></ul><ul><li>Easy to Administer </li></ul><ul><li>Requires Only Periodic Administration </li></ul><ul><li>Continuous Treatment </li></ul>
    10. 10. Product #2: Post-Hospital <ul><li>First 7 days after discharge </li></ul><ul><ul><li>Greatest unmet need in heart failure treatment </li></ul></ul><ul><li>Cardiologists are frustrated </li></ul><ul><ul><li>Very few treatment options </li></ul></ul><ul><li>CGRP recognized as having the right therapeutic qualities to meet this need </li></ul><ul><ul><li>Stabilizes heart failure symptoms and reduces rehospitalizations </li></ul></ul>Major Market Differentiation
    11. 11. Intellectual Property <ul><li>13 US and Foreign Patent Applications </li></ul><ul><ul><li>Heart Failure </li></ul></ul><ul><ul><li>Acute MI </li></ul></ul><ul><ul><li>Renal Insufficiency </li></ul></ul><ul><ul><li>Controlled Release </li></ul></ul><ul><li>5 Patents In Process </li></ul><ul><ul><li>Analogs </li></ul></ul><ul><ul><li>Broad Drug Applications </li></ul></ul>Heart and Kidney Focused
    12. 12. VasoGenix Leadership Team <ul><li>Board of Directors </li></ul><ul><ul><li>Lee Southard, PhD – Chairman </li></ul></ul><ul><ul><li>Jerome Halperin – Former CEO Food & Drug Law Institute </li></ul></ul><ul><ul><li>Richard Dunn, PhD – Former Sr. VP Drug Delivery Research, QLT/Atrix Laboratories </li></ul></ul><ul><ul><li>Donald Braun, PhD – Vice President, Clinical Research, Cancer Treatment Centers of America </li></ul></ul><ul><ul><li>Thomas Noffsinger, PhD – Former Assistant Vice-Chancellor, KUMC Research Institute </li></ul></ul><ul><li>Scientific Advisory Board </li></ul><ul><li>Clinical Research Steering Committee </li></ul>Experience from Drug Discovery to FDA Approval
    13. 13. Management <ul><li>Dr. G. Lee Southard </li></ul><ul><li>President & Chief Executive Officer </li></ul><ul><li>Atrix Laboratories, Inc. </li></ul><ul><ul><li>Founder, President, CEO & CSO 1987–1998 </li></ul></ul><ul><ul><li>Increased Share Price from $.50 to $29 </li></ul></ul><ul><ul><li>Company Sold to QLT Inc. for $855 million </li></ul></ul><ul><li>Vipont Pharmaceuticals, Inc. </li></ul><ul><ul><li>Co-founder, VP R&D 1981-1986 </li></ul></ul><ul><ul><li>Increased Share Price from $.50 to $15 </li></ul></ul><ul><ul><li>Company Sold to Colgate-Palmolive for $94 million </li></ul></ul><ul><li>Big Pharma Executive Experience </li></ul><ul><ul><li>Eli Lilly </li></ul></ul><ul><ul><li>Johnson & Johnson </li></ul></ul>10 FDA Approved Drug and Device Products
    14. 14. Management <ul><li>Jeff Southard </li></ul><ul><li>Co-Founder </li></ul><ul><li>Vice President Drug Development </li></ul><ul><li>6 New Drugs to Market </li></ul><ul><li>3 New Medical Devices </li></ul><ul><li>5 Patents Issued, 3 Patents Pending </li></ul><ul><li>13 Publications and Presentations </li></ul><ul><li>Big Pharma and CRO Experience </li></ul>20 Years Drug Discovery and Development
    15. 15. Using Specialists Partners in Development <ul><li>Pre-Clinical Testing </li></ul><ul><ul><li>Xenometrics </li></ul></ul><ul><ul><li>Acceleration, LLC </li></ul></ul><ul><ul><li>GEL Analytics, Inc. </li></ul></ul><ul><ul><li>Fleishman-Hillard </li></ul></ul><ul><ul><li>Kidney Institute of Kansas University Medical Center (KUMC) </li></ul></ul><ul><ul><li>Mid America Cardiology Associates at KUMC </li></ul></ul>
    16. 16. Pre-Clinical Research CGRP Analog Profiling University of Kansas Hospital Center for Advanced Heart Care The Kidney Institute at the University of Kansas Medical Center NIDDK Training Center
    17. 17. Using Specialists Partners in Development <ul><li>Research Collaborations </li></ul><ul><ul><li>Tulane University School of Medicine </li></ul></ul><ul><ul><ul><li>CGRP Protects Heart Cells from Death During Heart Attack Heart Failure Conditions </li></ul></ul></ul><ul><ul><ul><li>(American Heart Association 2005) </li></ul></ul></ul><ul><ul><li>Cleveland Clinic Lerner Research Institute </li></ul></ul><ul><ul><ul><li>CGRP Receptors in Heart Failure Patients Are Upregulated 38% </li></ul></ul></ul><ul><ul><ul><li>(American Heart Association 2007) </li></ul></ul></ul>
    18. 18. Using Specialists Partners in Development <ul><li>Manufacturing </li></ul><ul><ul><li>New England Peptides, LLC </li></ul></ul><ul><ul><li>PolyPeptide Laboratories, Inc. </li></ul></ul><ul><li>Regulatory Consulting </li></ul><ul><ul><li>Beckloff Associates, Inc. </li></ul></ul><ul><ul><li>LIPICKY, LLC </li></ul></ul><ul><li>Clinical Testing </li></ul><ul><ul><li>Cleveland Clinic </li></ul></ul><ul><ul><li>Averion </li></ul></ul>
    19. 19. Clinical Trials Proof of Concept and Phase I/II Heart and Vascular Institute
    20. 20. Development Timeline Milestone Focused Plan Yr.7 Yr.6 Yr.5 Yr.4 Yr.3 Yr.2 Yr.1 Yr.8 Non-clinical IND Phase I/II Phase III NDA Revenue 
    21. 21. Why VasoGenix? CGRP analogs are 1 of the 5 Source: PhRMA, March 2005 <ul><li>VasoGenix management has proven track record for success. </li></ul><ul><li>Company developmental partners are the best in the business . </li></ul><ul><li>Addresses greatest unmet need in heart failure today. </li></ul><ul><li>Early Cardiologist’s acceptance </li></ul><ul><li>Early human clinical data supports safety and efficacy = Lower developmental risk. </li></ul>
    22. 22. Previous Financing <ul><li>Raised $4 Million to Date </li></ul><ul><ul><li>Synthesis of New Analogs of CGRP </li></ul></ul><ul><ul><li>Initial Development of Controlled Release Drug </li></ul></ul><ul><ul><li>Pre-IND Meeting with FDA </li></ul></ul><ul><ul><li>Expansion of Intellectual Property </li></ul></ul><ul><ul><li>Established Development Plan with Kansas Partners </li></ul></ul>
    23. 23. Revenue Projection One Drug  Four Revenue Streams $229 $173 $124 $82 $47 $19 Total Royalty 10% 10% 10% 10% 10% 10% License $2,290 $1,725 $1,239 $823 $471 $186 Total Treatment Revenue 551 399 268 156 64 - CRD –Outpatient Clinic Pt. 766 589 435 301 186 85 CRD – Rehospitalized Pt. 415 314 228 156 94 43 CRD – 1 st Time Discharge Pt. 558 423 308 210 127 58 In-Hospital IV Drug Treatment Year 6 Year 5 Year 4 Year 3 Year 2 Year 1 Revenue ($ million) Product Use
    24. 24. VasoGenix Pharmaceuticals 8527 Bluejacket Street Lenexa, Kansas 66214 Dr. G. Lee Southard Jeff Southard [email_address] [email_address]
    1. A particular slide catching your eye?

      Clipping is a handy way to collect important slides you want to go back to later.

    ×