Keith Ignotz, President and CEO - PowerPoint PPT Presentation

Title: Keith Ignotz, President and CEO


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A New Beginning for Diabetes Therapy
Keith Ignotz, President and CEO Jerry L. Nadler
MD, Chief Science Officer
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A New Beginning for Diabetes Therapy
We are developing a pipeline of drugs for unmet
medical needs in diabetes. They have the
potential to become the standard of care by
arresting the disease, restoring insulin
production, and halting long-term complications.
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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, Chief Science
  Officer
• Division Chief, University of Virginia
• Director, Center of Excellence in Diabetes
• 25 years RD 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

Board of Directors Jack Singer, M.D. Chief
Medical Officer CTI Board James Farinholt, Jr.,
Tall Oaks Capital Treasurer Mary Ann Latona
Nadler, Secretary, VP RA/Product
Dev. Scientific Advisory Board Comprised of
leading experts in diabetes, islet cell
transplant, and ß-cell biology
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Strategy

• Build operations incrementally
• Control direct costs
• Utilize partners/service suppliers
• Maintain minimum staff
• Internal focus on Orphan indications with
  emphasis on non-dilutive financing
• Develop block busters to Proof of Principal
  Phase 2
• Out-license/sell larger market segments

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Diabetes Today
Type 1 diabetes autoimmune disease caused when
the body turns on itself and destroys its own
islet cells

• Affects 21M Americans 16M at risk
• 4.8M Americans take insulin
• Insulin is life support not a cure
• Islet transplantation one approach to treat some
  T1D
• 135B spent/year in America
• Kills 225,000 annually
• 13B market opportunity for DiaKine

Type 2 diabetes caused by a reduction insulins
ability to lower blood sugar and islet cell
destruction due to inflammation
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DiaKine Drugs Protect
Human islets produce insulin. DiaKines drugs
preserve and protect insulin-producing cells from
destruction by the immune system. Protecting
insulin producing cells is the key to halting
diabetes either by transplant or drug therapy
Inflammatory cytokines destroy human islets
No treatment Healthy Islet
DiaKine Drug protects human islets from
destruction by inflammatory cytokines!
Treatment with DiaKine Drug Healthy Islet
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Worldwide License
Worldwide license for platform technology,
includes pipeline of orally bioavailable drugs

• Global license for diabetes, and related
  complications
• Lead compound LSF
• Investigational New Drug (IND) in place
• GLP Toxicology package
• CMC package
• Four Phase 1 studies completed
• Platform technology feeds pipeline with new drug
  discoveries covering potentially additional
  indications

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Oral Drug Candidates

• 2 ready to move from discovery to development
• Screened for toxicity in over 70 non-glp tests
• Orally bioavailable in primates
• Excellent preclinical efficacy
• Provides 2 year advance in development
• Rational design retires significant safety risk

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Product Pipeline
3 Lead Molecules - 8 Therapeutic
Indications Media product with near-term launch
LSF, IV
LSF, SC
DT 22669
DT 22669
DT 23552
DT 23552
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Patent Portfolio

• Large intellectual property portfolio includes
  broad method of use and composition of matter
  protection

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Transplant Market Products

• 150 million potential as procedure matures over
  the next 60 months
• Further growth with advances in xenotransplant
  and engineered cell technology

Ancillary product islet cell media Used to
manufacture islets
Adjunct therapy to post-operative islet cell
transplant patients
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Type1/LADA Products

• 3.8 billion 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)
• Positive results from P2 Islet Transplant Trial
  will translate to protecting insulin producing
  cells in T1D and T2D

Halt progression of newly diagnosed Type 1
diabetes and LADA
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Type 2/Complications Products

• Insulin-dependent Type 2 - 5.8 billion market
  opportunity
• 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

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DiaKine Financing

• NIH supported Phase 2 Clinical Trial
• Produced clinical trial supplies
• Conducting trial
• Up to 1.5 million onset bridge convertible note
  underway
• Seeking A round of high, single digit M

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RD Allocations
Islet Transplant LSF adjunct therapy, ancillary
use 6
New Drug Discovery/Preclinical Development 17
Type 1 LSF SC 29
LADA/type 2/complications Orals DT22669 and
DT23552 48
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DiaKine Summary

• Pipeline of drugs provides access to 13 billion
  markets
• Extensive patent portfolio
• License provides average 4 year jump on RD,
  reduces technical risk and quickens time to
  market
• Orphan drug strategy to commercialize small
  market indications
• Take large market indications to Phase 2 and
  out-license/sell
• Imminent start to 75M NIH-funded Phase 2 islet
  transplant study with LSF

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A New Beginning for Diabetes Therapy
Keith Ignotz, President and CEO Jerry L. Nadler
MD, Chief Science Officer