crowdfunder presentation
DESCRIPTION
Slide deck providing background informaton for SEKRIS Biomedical, Inc.TRANSCRIPT
Innovative DNA Immunotherapies
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Mission
To develop and commercialize an anti-inflammatory 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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Problem
Inflammatory Disorders
Example: Autoimmune diseases
24 million people in U.S.
↑ 3-5% rate
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Current approaches to control inflammation can
cause infections and cancers
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Control unwanted inflammation
Specifically and safely
ADI
Solution
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Next generation DNA immunotherapy
Natural control of inflammation
Programmable and versatile
Teaches body to distinguish between friendly and dangerous cells
Apoptotic DNA Immunotherapy (ADI)
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2-3 million people in U.S.
Type 1 Diabetes
NOD mice develop autoimmune (type 1) diabetes between ages of 11 – 21 weeks
Observe until 40 weeks old
1 DNA injection / week for 8 weeks
ADI
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ADI Treatment of T1D
Untreated ADI Treated
No diabetes during treatment 80% lasting response
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ADI for Skin Graft
Lost graft Graft survived Hair growth
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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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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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Team CEO/President
Shahrokh Shabahang, DDS, MS, PhD
CMO
Joachim-Friedrich Kapp, MD, PhD
Clinical Advisors
Alan Garber, MD, PhD
Peter Gottlieb, MD
Joachim-Friedrich Kapp, MD, PhD
Gerald Nepom, MD, PhD
Mark Peakman, MSc, PhD
Jay Skyler, MD, MACP
Gen Counsel/Assistant Board Secretary
Jan Sundberg, JD
Legal Advisors
James Hill, MD, JD MWE (IP)
The Eclipse Group (Corporate and Securities)
Acting CFO
David Chariton, MA
Accounting Advisor
Kelly Allen & Associates (CPA)
CSO
Leonard Bailey, MD
Science Advisors
Leonard Bailey, MD
Gilles Benichou, PhD
John Rossi, PhD
Daniel Salomon, MD
Roland Tisch, PhD
Business Advisors
Charles Crocker, MBA
Neil Desai, PhD
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Timeline
Year 2 Year 1
ADI Technology
Clinical Program for
T1D in Germany
GMP Manufacturing
(Aldevron)
Meeting with PEI
Tox Plan (LPT)
Initiation of C.T.s
Transplantation Program
Collaboration with Gilles Benichou at MGH
Manufacturing Licensing
Opportunity with Bacterial Strain
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Budget Operating Expenses Year 1 Year 2
R&D at MGH/Harvard Transplant Labs $132,000 $132,000 Intellectual Property $120,000 $120,000
Personnel $316,410 $316,410 GMP Manufacturing $250,000 $0
Licensing Fees to Loma Linda University $149,000 $25,000 GLP Safety/Toxicology Studies $375,000 $375,000
Legal $60,000 $60,000 Accounting $18,000 $18,900
Regulatory - IND Submission $0 $55,000 Milestone Payments to Loma Linda University $75,000 $100,000
Office Expenses $91,200 $94,350 Total Operating Expenses $1,646,610 $1,236,660
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Potent, safe and patient friendly
Impactful
Platform to build an industry
Game changing platform technology