1. AV THERAPEUTICS
Investor presentation 2013
Confidential - not for distribution
Except for historical information, the statements made in this presentation are forward
looking statements involving significant risks and uncertainties.
“Treatment and Prevention of Prostate Cancer through Innovation”
A New York Based Biotechnology Company
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2. • Corporate Headquarters
20 East 68th Street
New York, NY 10065
Suite 204
• Research Facilities
New York Medical College
Cancer Institute of New Jersey
AV Therapeutics
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4. Management Team
• Abraham Mittelman , M.D., Chief Executive Officer and Chairman of the
Board
Oncologist and professor at New York Medical College (NYMC) with over 30 years of experience in patient treatment and clinical trials.
Over 200 peer reviewed publications and presentations, trained at Memorial Sloan Kettering Cancer Center (Memorial).
• Raj Tiwari, Ph.D., Chief Scientific Officer
Professor of Microbiology & Immunology and Graduate Program Director at NYMC. Over 30 years of research experience with over 150
peer reviewed publications and presentations. Trained at Memorial, inventor of several patents involving Capridine and Peptide based
Cancer Vaccine Technology.
• Morton Coleman, M.D., Vice President, Director of Clinical Development
Clinical Professor at Weill Medical College of Cornell University and Director of the Center for Lymphoma and Myeloma at New York
Presbyterian Hospital – Weill Cornell. Chairman, Medical Affiliate Board of Lymphoma Research Foundation, over 400 publications and
designated one of the “Best Doctors in America”
• Robert Pollock, President
Over 40 years business experience. Founder and managing partner of Continuum Partners, a global network security and business
development consulting firm.
• Jan Geliebter, Ph.D., Secretary, VP Genomic Platforms
Professor of Microbiology & Immunology at NYMC with over 30 years of cancer research experience and over 100 peer reviewed
publications. Holder of multiple patents, including a BCG-based prostate cancer vaccine
• Debabrata Banerjee, Ph.D., VP Preclinical Development
Associate Professor of Medicine and Pharmacology, The Cancer Institute of New Jersey. Over 25 years of experience in preclinical and
experimental therapeutics with over 125 publications and presentations. Inventor of several patents.
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5. AV Therapeutics - Overview
• AVT is a Biotechnology company focused on:
• Targeted drug based cancer therapies that are safer and
more effective than current chemotherapeutic agents
• Proprietary peptide based immunotherapeutic vaccine
technology platform
• Scientists at AVT have developed Capridine:
• A patented drug having specific activity against prostate
cancer
• Outstanding physicians and clinical researchers
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6. IP position of AV Therapeutics
• Two patents on Capridine : Dr. Raj Tiwari and Dr. Jerzy Konopa from
Gdansk, Poland are co-inventors. US, EU (19 countries], Mexico,
Canada, Israel, valid till 2021 with 6 years extension possibility
– One Patent are for synthesis and 200 other substituted
derivatives and sub-licensed to AVT
– Composition of matter patent on capridine in combination with
other therapeutics
• Third US patent on a novel technology using synthetic off the shelf easily
synthesizable peptides with a broad application “ Immunogens for treatment of
neoplastic and infectious diseases”
• Fourth US patent on the delivery of immunogens “ Immunotherapy for prostate
cancer using Bacille-Calmette-Guerin expressing prostate specific antigens”.
Confidential - not for distributionData on file AV Therapeutics, Inc. 6
7. The Problem - Prostate Cancer
• Prostate Cancer is the most common type of cancer in men in
the USA
• Annual expenditures exceed $15 billion
• Current therapies have limited efficacy for metastatic disease
• Current chemotherapeutic regimens are associated with
severe bone marrow toxicity and poor tolerance
• Current immunotherapy (Provenge) is expensive and has
minimal efficacy
• Radiation, hormonal and chemotherapy remain palliative
Confidential - not for distribution
Effective drug based therapy and immunotherapy
is an unmet clinical need in prostate cancer
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8. The Solution - Capridine
• Identified a new class of patent protected nitro-acridine drugs
known as Capridines
• NCI tested prostate cancer specific drug
• Over 6 million dollars invested in development (pre-AVT)
• Limited side affects
– Low blood and bone marrow toxicity
• High therapeutic index for prostate
– Low amount of drug, high efficacy
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10. Prostate cancer cells are ten to 100 fold more sensitive to capridine-β than leukemic cells
(HL-6O)
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Data on file AV Therapeutics, Inc.
Capridine-β has Differential IC50 Values in
CaP and Leukemic Cells
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11. Capridine-β is a more potent anticancer drug
than Mitoxantrone in several cancers
Confidential - not for distributionData on file AV Therapeutics, Inc. 11
12. Treatment started week 1, once weekly for 7 – 9 weeks
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Data on file AV Therapeutics, Inc.
Capridine - β Inhibits Hormone-Responsive and Non-Responsive CaP
Xenografts in Nude Mice
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13. Cell lines
IC50 Values (nM)
Taxane Capridine
LnCaP >100nM 15nM
PC3 16-20nM 5nM
DU145 15-20nM 5nM
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Capridine is superior to taxane and is effective on taxane resistant prostate cancer
14. 6 h 12 h
C 5 nM 10 nM 5 nM 10 nM
Actin
Androgen receptor
Capridine-β induces the androgen receptor in hormone
independent DU-145 cells
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15. Unique Features of Capridine
• Capridine is active against taxane resistant prostate cancer
cells, hormone dependent and hormone independent
prostate cancer xenografts and is non-myelosuppressive
• Capridine renders aggressive hormone independent CaP cells
hormone sensitive and thus can synergize with anti-androgen
therapy in Cap
Confidential - not for distributionData on file AV Therapeutics, Inc. 15
17. Capridine-β Advantage
• Based on the results of Pre-Clinical Studies,
Capridine-β has minimal bone marrow toxicity
with a wide therapeutic range active against
taxane resistant CaP cells
• Capridine-β can be added to other drugs thus
lowering chemotherapy associated toxicities
Confidential - not for distributionData on file AV Therapeutics, Inc. 17
18. Development Plan for Capridine – Next Steps
• Drug manufacture and formulation under GMP conditions
• Stability testing of the formulated product
• Limited rodent and dog toxicology with formulated product
• Pharmacokinetics and pharmacodynamics
• IND application
• Phase I/II clinical trials
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19. Summary
• Preclinical studies complete for Capridine. Unique properties include no
blood toxicity and wide therapeutic dose range with specificity towards
prostate cancer - ready to commence phase I and II human trials
• A world-class, internationally recognized, well published scientists and
clinicians (PhD’s and MDs) from A+ institutions
• World class medical research collaborators and Scientific Advisory Board
• All IPs patent protected
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20. Scientific Advisory Board
• Joseph Bertino, MD, Associate Director and Chief Scientific Officer, The Cancer Institute of
New Jersey and past President of the American Association for Cancer Research and The American
Association of Clinical Oncologists, organizations of over 50,000 researchers, worldwide. He is the
founding Editor of the Journal of Clinical Oncology.
• Charles Cantor, PhD, is Director of the Center for Advanced Biotechnology at Boston
University and Chief Scientific Officer at Sequenom, Inc. in La Jolla (a publicly traded company). He
has published more than 400 articles, and has been awarded more than sixty (60) patents. He is
most known for his authoring of the book, Genomics: The Science and Technology Behind the
Human Genome Project.
• Roy G. Smith, PhD, is the Director of then Huffington Center on Aging, Professor in the
Department of Molecular and Cellular Biology, and Professor in the Department of Medicine at
Baylor College of Medicine. He was previously Vice President of Basic Research at Merck and was
responsible for identifying new drug targets for metabolic diseases
• Pramod Srivastava, PhD, is a Professor of immunology at the University of Connecticut,
where he holds an Endowed Chair in Cancer Immunology and is the Director of the Cancer Center
and the Scientific Founder of Antigenics. He is among the founding members of the Academy of
Cancer Immunology.
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21. Medical Advisors/Collaborators
• Dan Petrylak, M.D. - Director of the Prostate Cancer Program, Yale
University
• Ashutosh Tewari, M.D., - Director of the Prostate Cancer Institute and the
LeFrak Robotic Surgery Center at Weil Cornell Medical College [Tentative]
• Derek Raghavan, M.D. – President of the Levine Cancer Institute at the
Carolinas Healthcare System, formerly, Chairman and Director of the
Taussig Cancer Center at the Cleveland Clinic
• Christopher Logothetis, M.D. – Department Chair, Department of
Genitourinary Medical Oncology, Division of Cancer Medicine, The
University of Texas MD Anderson Cancer Center
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22. Clinical Research Partner
Confidential - not for distribution
The Prostate Cancer Clinical Trials Consortium
Howard Scher MD, Head of Clinical Consortium
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23. IP position of AV Therapeutics
• Two patents on Capridine : Dr. Raj Tiwari and Dr. Jerzy Konopa from
Gdansk, Poland are co-inventors. US, EU (19 countries], Mexico,
Canada, Israel, valid till 2021 with 6 years extension possibility
– One Patent are for synthesis and 200 other substituted
derivatives and sub-licensed to AVT
– Composition of matter patent on capridine in combination with
other therapeutics
• Third US patent on a novel technology using synthetic off the shelf easily
synthesizable peptides with a broad application “ Immunogens for treatment of
neoplastic and infectious diseases”
• Fourth US patent on the delivery of immunogens “ Immunotherapy for prostate
cancer using Bacille-Calmette-Guerin expressing prostate specific antigens”.
Confidential - not for distributionData on file AV Therapeutics, Inc. 23
24. Pros-Vax Peptide Therapeutic Vaccine
• Synthetic peptide vaccine (Pros-Vax) that mimics cancer
proteins, induces the host’s immune response directed against
multiple cancer-specific proteins
• Easily manufactured, small molecule drug
• Preclinical studies complete
• Expected to eliminate micrometasatic and residual
disease and hence prevent recurrence
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25. Immunization with peptide vaccines prevents
metastatic prostate cancer growth
Unimmunized rat Immunized rats
BTE6-LX-8b
ProVac 1
BTE6-X-15-7
ProVac 2
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27. Business Strategy, Use of Capital and Time Line
PRIVATE PLACEMENT MEMORANDUM
• 12 Million Units Each Consisting of One Share of Common Stock (0.50
cents a share) and One Warrant (0.75 cents). Shares of Common Stock
Maximum $6,000,000 Public offering by reverse merger or S1 filing after
the IND application [6-9 months]
• Clinical product synthesis and testing [months,0-6] 2,500,000
• IND application for phase I [months 6-9] 1,000,000
• Initiation and completion phase I [months 9-15] 1,600,000
• Vaccine development [months 0-15] 4,000,000
• Operation and Expense 900,000
• Total Expenses $10,000,000
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28. Current Capital Structure
• Authorized Common shares: 50,000,000
• Issued & outstanding: 17,739,561
• Number of shareholders: 32
• Management ownership: 86%*
*may change based on consultant agreement (s)
Total Capital invested to date : 7 million
Grants, NIH, Department of Defense and other: 6 million
Friends and Family: 1 million
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