Slide deck providing background informaton for SEKRIS Biomedical, Inc.

1. Innovative DNA Immunotherapies

2. Mission
To develop and commercialize an antiinflammatory DNA technology which
has the potential to treat diseases such as
Type 1 Diabetes, Multiple Sclerosis,
Lupus, Rheumatoid Arthritis, Asthma
and allergies.
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3. Problem
Inflammatory Disorders
Example: Autoimmune diseases
24 million people in U.S.
↑ 3-5% rate
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4. Current approaches to
control inflammation can
cause infections and cancers
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5. Solution
Control unwanted inflammation
Specifically and safely
ADI
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6. Apoptotic DNA
Immunotherapy (ADI)
Next generation DNA immunotherapy
Natural control of inflammation
Programmable and versatile
Teaches body to distinguish between
friendly and dangerous cells
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7. Type 1 Diabetes
2-3 million people in U.S.
ADI
1 DNA injection / week for 8 weeks
NOD mice develop autoimmune (type 1)
diabetes between ages of 11 – 21 weeks
Observe until
40 weeks old
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8. ADI Treatment of T1D
Untreated
ADI Treated
No diabetes during treatment
80% lasting response
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9. ADI for Skin Graft
Lost graft
Graft survived
Hair growth
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10. Competition in T1D
Differentiating
Points
SEKRIS
Diamyd Andromeda
Other
DNA
Safe Repeated Delivery
+
-
-
+
Immune Modulators
3
1
2
1
Tolerogenic Apoptosis
+
-
-
-
Impacts Key Immune
Cells
+
-
-
-
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11. Competitive Advantages
1. ADI does not rely on a single mechanistic approach. Each
component affects different arms of the immune system.
2. ADI activates key immune cells known to maintain tolerance in
both mice and humans.
3. ADI has been successfully applied to 2 different models of
inflammatory disorders: Type 1 diabetes and skin allografts.
4. ADI is plasmid DNA-based and expected to be safe.
5. ADI can be safely and repeatedly administered to achieve its full
potential therapeutic effect thereby increasing its potency for
more aggressive inflammatory conditions.
6. ADI is a DNA-based product that will be administered in very
small quantities and is cost effective.
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12. Team
CEO/President
Shahrokh Shabahang, DDS, MS, PhD
Business Advisors
Charles Crocker, MBA
Neil Desai, PhD
CMO
Joachim-Friedrich Kapp, MD, PhD
Clinical Advisors
Alan Garber, MD, PhD
Peter Gottlieb, MD
Joachim-Friedrich Kapp, MD, PhD
Gen Counsel/Assistant
Board Secretary
Jan Sundberg, JD
Acting CFO
CSO
David Chariton, MA
Leonard Bailey, MD
Legal Advisors
Accounting Advisor
Science Advisors
James Hill, MD, JD MWE
(IP)
Kelly Allen & Associates
(CPA)
Leonard Bailey, MD
The Eclipse Group
(Corporate and Securities)
Gilles Benichou, PhD
John Rossi, PhD
Gerald Nepom, MD, PhD
Daniel Salomon, MD
Mark Peakman, MSc, PhD
Roland Tisch, PhD
Jay Skyler, MD, MACP
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13. Timeline
Year 1
Clinical
Program for
T1D in
Germany
ADI
Technology
Transplantation
Program
GMP
Manufacturing
(Aldevron)
Year 2
Meeting
with PEI
Tox Plan
(LPT)
Initiation of
C.T.s
Collaboration with
Gilles Benichou at MGH
Manufacturing
Licensing
Opportunity with
Bacterial Strain
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14. Budget
Operating Expenses
Year 1
R&D at MGH/Harvard Transplant Labs
Intellectual Property
Personnel
GMP Manufacturing
Licensing Fees to Loma Linda University
GLP Safety/Toxicology Studies
Legal
Accounting
Regulatory - IND Submission
Milestone Payments to Loma Linda University
Office Expenses
Total Operating Expenses
$132,000
$120,000
$316,410
$250,000
$149,000
$375,000
$60,000
$18,000
$0
$75,000
$91,200
$1,646,610
Year 2
$132,000
$120,000
$316,410
$0
$25,000
$375,000
$60,000
$18,900
$55,000
$100,000
$94,350
$1,236,660
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15. Game changing platform technology
Potent, safe and patient friendly
Impactful
Platform to build an industry
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