AVTH ppt JAN 2014w_cons

Report
AV THERAPEUTICS
A New York Based Biotechnology Company
Investor presentation
“Better Treatment of Cancer through Innovation”
Except for historical information, the statements made in this presentation are forward
looking statements involving significant risks and uncertainties.
JAN 2014
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Forward-Looking Disclosure
All statements pertaining to future financial and/or operating results, future growth in research,
technology, clinical development, and potential opportunities for AV Therapeutic(The Company)
products and services, along with other statements about the future expectations, beliefs, goals, plans,
or prospects expressed by management constitute forward-looking statements.
Any statements that are not historical fact (including, but not limited, to statements that contain words
such as "will," "believes," "plans," "anticipates," "expects," "estimates") should also be considered to be
forward-looking statements.
Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent
in the development and/or commercialization of potential products, uncertainty in the results of clinical
trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual
property rights and other risks discussed in the Company’s registration statement on Form S-1 and
other reports filed with the Securities and Exchange Commission which is available for review at
www.sec.gov.
Actual results may differ materially from the results anticipated in these forward-looking statements and
as such should be evaluated together with the many uncertainties that affect the Company's business.
The Company disclaims any intent or obligation to update these forward-looking statements.
.
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AV Therapeutics Stock Basics
OTCQB Symbol:
AVTH
Shares Outstanding:
75.3 Million
Public Float:
14 Million
Inside Ownership:
66.3%
Market Cap:
$45.9 Million
Data as of January 9, 2014
.
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Company Overview
• Developing cancer therapeutics & immunotherapeutic
vaccines that can be used alone or in combination with
prevalent treatment modalities such as chemotherapy
and radiation to treat active disease and to prevent
metastases and recurrence.
• Based on the ability of certain proprietary reagents to
re-educate or reprogram an immune system to target
previously unidentified micro-metastases.
• Clinically developing both approaches for metastatic
and early-stage prostate cancer.
.
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AV Therapeutics: Developing Safer and More
Effective Chemotherapeutic Agents
Capridine:
-Patented drug
-Specific activity
against prostate
cancer
World-class
team of
physicians and
clinical
researchers
Preliminary
efficacy on range
of cancers
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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
Robert Pollock,
President
•Over 40 years
business experience.
Founder and
managing partner of
Continuum Partners,
a global network
security and business
development
consulting firm.
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”
.
Jan Geliebter,
Ph.D., Secretary,
VP Genomic
Platforms
Debabrata
Banerjee, Ph.D.,
VP Preclinical
Development
•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 BCGbased prostate
cancer vaccine
•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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The Problem - Prostate Cancer
High Incidence
• Prostate Cancer is
the most common
type of cancer in
men in the USA
• Annual
expenditures
exceed $15 billion
Limited efficacy for
metastatic disease
• Radiation,
hormonal and
chemotherapy
remain palliative
High Toxicity
• Severe bone
marrow toxicity
and poor
tolerance
Effective drug based therapy and immunotherapy
is an unmet clinical need in prostate cancer
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Loss of Androgen Receptor Early Step in
Prostate Tumor Progression
Hormone
Dependent
Hormone
Independent
Loss of
Androgen
Receptor
Upregulation
of ER-b
Upregulation of
CDC25 group
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The Solution: Capridine-β (C-1748)
• Capridine is a patented chemotherapy drug
• National Cancer Institute Tested Capridine for Prostate Cancer and other
Cancers
• Research funded by Dept. of Defense and National Institute of Health
• Capridine and 200 of its derivatives are patented for use as anti-cancer
agents
• Limited Side Effects
• Low Bone Toxicity
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Capridine-b Kills Prostate Cancer Preferentially
Prostate cancer cell with Capridine-b
Bone marrow cells with Capridine-b
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Prostate cancer cells are ten to 100 fold more sensitive to
Capridine-b than bone marrow cells
Data on file AV Therapeutics, Inc.
.
Capridine-β is a Potent Anticancer Drug
in Several Cancers
*
*Mitoxantrane
Data on file AV Therapeutics, Inc.
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Salient Features of Capridine-β
Capridine-β is
active against
taxane resistant
prostate cancer
cells
Capridine- β iactive
on hormone
dependent and
independent
Prostate cancer
(CaP) xenografts
Capridine-β does
not kill bone
marrow cells or
white blood cells
Capridine-β has a
wide predicted
human therapeutic
dose range
Data on file AV Therapeutics, Inc.
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Cell lines
IC50 Values (nM)
Taxane
Capridine
LnCaP
>100nM
15nM
PC3
16-20nM
5nM
DU145
15-20nM
5nM
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Development Plan for Capridine b – Next Steps
Limited rodent
and dog
toxicology with
formulated
product
Drug
manufacture
and formulation
under GMP
conditions
Stability
testing of the
formulated
product
IND
application
Pharmacokinetics and
pharmacodynamics
.
Phase I/II
clinical
trials
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Vaccine Response to Capridine
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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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Clinical Research Partner
The Prostate Cancer Clinical Trials Consortium
Howard Scher MD, Head of Clinical Consortium
Confidential - not for distribution
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Investment Highlights
• Outstanding physicians and world-renown clinical researchers
• Developed Capridine, a patented drug having specific activity
against prostate cancer
• Capridine addresses a $2 billion market for treatment of
prostate cancer
• U.S. patent on combination of capridines with other agents
• National Cancer Institute tested prostate cancer specific drug
• Over $6 million dollars invested in development (pre-AVT)
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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
• World-Class, internationally recognized, scientists and clinicians (PhD’s and
MDs) from A+ institutions
• World class medical research collaborators and Scientific Advisory Board
• All IP is patent protected
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