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Management. Keith D. Ignotz, CEO and President25 years experience as a senior medical company executive ? 14 yrs in diabetes8th company/division start up IPO and two company salesDr. Jerry L. Nadler, ChairmanDivision Chief, University of VirginiaDirector, Center of Excellence in Diabetes25 y
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2. Management Keith D. Ignotz, CEO and President
25 years experience as a senior medical company executive 14 yrs in diabetes
8th company/division start up
IPO and two company sales
Dr. Jerry L. Nadler, Chairman
Division Chief, University of Virginia
Director, Center of Excellence in Diabetes
25 years R&D experience in causes and complications of diabetes
Advisory Panel Member Type 1 Diabetes funding, NIH-NIDDK
Advisory Panel Member JDRF new technology development and funding
4. DiaKine Therapeutics CDC says diabetes is at epidemic levels in the U.S. and growing globally
$13 billion in potential market opportunities
Proprietary compounds
Imminent start to Phase 2 human islet transplant study
Worldwide license provides 4 years in time savings, on R&D cost reduction and shortens time to market
Extended pipeline includes oral immune modulators tested in primates
Non-toxic in pharma screen
5. The Company Lead compound Lisofylline (LSF) was originally developed for cancer treatment with excellent safety profile
Dr. Jerry Nadler of the University of Virginia researched anti-inflammatory properties of LSF and related compounds that could potentially cure the root cause of insulin-dependent diabetes
Global license for diabetes and related complications from Cell Therapeutics (CTI)
Investigational New Drug (IND) protocol in place
50 plus patents and applications
Extensive portfolio of compounds for additional drugs
Manufacturing data and drug substance
Safety data >600 patients tested
6. DiaKine Diabetes Universe Insulin-dependent diabetes is an autoimmune disease (like multiple sclerosis) caused when the body turns on itself and destroys its own islet cells
13 million Americans with diabetes
Additional 16 million at risk
4.8 million Americans take insulin
Insulin is life support not a cure
About $135 billion spent on diabetes each year in America
Diabetes kills 200,000 annually
7. Lisofylline
8. LSF media for islet cell transplants
sales projected for 2007 80% gross margins
Adjunct therapy to islet cell transplants
Reverse/arrest progression of type1 and type 2 diabetes
Treatment of diabetic complications Product Indications
9. Transplant Market Product
Pre-transplant LSF media improve functional yield of donor cells
Post-transplant LSF protects against rejection due to inflammatory cytokine response
$150 million potential as procedure matures over the next 60 months
Market transitioning from two organs per patient to four patients per organ
10. Islet Cell Media Revenue Projections
11. Type 1/LADA Market Arrest beta cell destruction/preserve beta cell mass
Restore endogenous insulin production
$3 billion annual market opportunity
30,000 new cases of Type 1 in U.S. each year
200,000 new cases of LADA in U.S. each year (10% up to 20% of all diabetics)
12. Follow-on Products Orals for insulin-dependent Type 2 and LADA - $2 billion potential market
Diabetic complications
Retinopathy
21% of newly diagnosed Type 2s have it
12,000 to 24,000 cases of blindness each year
Kidney disease
20% of diabetics have kidney disease
43% of new cases due to diabetes
13. Product Development Status
14. R&D Allocations
15. Strategy Build operations incrementally as business and scientific milestones are met
Establish fully integrated global product development operation
R&D
Contract manufacturing
Marketing and sales through strategic partners
Joint venture collaborations
Plan to sell one or more business segments to strategic acquirer for dividend and reinvestment
16. DiaKine Summary Proprietary compounds
$13 billion potential market opportunities
Imminent start to NIH-funded Phase 2 islet transplant study with LSF
License provides 4 year jump on R&D, leads to Phase 2 trial and quickens time to market
Mining large library of compounds for new indications
17. DiaKine Financing $250,000 (estimated) in non-dilutive NIH support to prepare for use in clinical trial and islet cell transplant study
Up to $1.5 million onset bridge convertible note underway
Seeking $9.5 million A round
Use of funds
Conduct clinical trials, expand product pipeline and general corporate purposes