avth ppt jan 2014

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AV THERAPEUTICS Investor presentation JAN 2014 Except for historical information, the statements made in this presentation are forward looking statements involving significant risks and uncertainties. “Better Treatment of Cancer through Innovation” A New York Based Biotechnology Company 1

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AVTH Presentation

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Page 1: Avth ppt jan 2014

AV THERAPEUTICS

Investor presentation

JAN 2014

Except for historical information, the statements made in this presentation are forward looking statements involving significant risks and uncertainties.

“Better Treatment of Cancer through Innovation”

A New York Based Biotechnology Company

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Page 2: Avth ppt jan 2014

Forward-Looking DisclosureAll 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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Page 3: Avth ppt jan 2014

AV Therapeutics Stock Basics

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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

Page 4: Avth ppt jan 2014

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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Page 5: Avth ppt jan 2014

AV Therapeutics: Developing Safer and More Effective Chemotherapeutic Agents

Capridine:-Patented drug -Specific activity against prostate

cancer

Preliminary efficacy on range

of cancers

World-class team of

physicians and clinical

researchers

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Page 6: Avth ppt jan 2014

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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Page 7: Avth ppt jan 2014

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

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Effective drug based therapy and immunotherapy

is an unmet clinical need in prostate cancer

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Page 8: Avth ppt jan 2014

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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

Page 9: Avth ppt jan 2014

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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Page 10: Avth ppt jan 2014

Prostate cancer cells are ten to 100 fold more sensitive to Capridine-b than bone marrow cells

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Data on file AV Therapeutics, Inc.

Capridine-b Kills Prostate Cancer Preferentially

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Prostate cancer cell with Capridine-b Bone marrow cells with Capridine-b

Page 11: Avth ppt jan 2014

Capridine-β is a Potent Anticancer Drugin Several Cancers

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Comparisons between the two drugs are based on IC50 values IC50 is the drug concentration required to kill 50% cells

Data on file AV Therapeutics, Inc. 11

*

*Mitoxantrane

Page 12: Avth ppt jan 2014

Salient Features of Capridine-β

Capridine-β is active against

taxane resistant prostate cancer

cells

Capridine-β does not kill bone

marrow cells or white blood cells

Capridine-β has a wide predicted

human therapeutic dose range

Capridine- β iactive on hormone

dependent and independent

Prostate cancer (CaP) xenografts

.Data on file AV Therapeutics, Inc. 12

Page 13: Avth ppt jan 2014

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Cell linesIC50 Values (nM)

Taxane Capridine

LnCaP >100nM 15nM

PC3 16-20nM 5nM

DU145 15-20nM 5nM

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Page 14: Avth ppt jan 2014

Development Plan for Capridine b – 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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Page 15: Avth ppt jan 2014

Vaccine Response to Capridine

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Page 16: Avth ppt jan 2014

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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Page 17: Avth ppt jan 2014

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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Page 18: Avth ppt jan 2014

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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