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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 1

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Page 1: Avth 6262013

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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• 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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Professional Advisors

Corporate Counsel Sichenzia Ross Friedman Ference

LLP, 61 Broadway, New York, NY

Darrin Ocasio

Consultants Objective Equity

Red Chip

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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 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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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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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 distribution Data on file AV Therapeutics, Inc. 6

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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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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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Prostate cancer cells are ten to 100 fold more sensitive to capridine-β than leukemic cells (HL-6O)

1 2

Data on file AV Therapeutics, Inc.

Capridine-β has Differential IC50 Values in CaP and Leukemic Cells

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Capridine-β is a more potent anticancer drug than Mitoxantrone in several cancers

Confidential - not for distribution Data on file AV Therapeutics, Inc. 11

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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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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

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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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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 distribution Data on file AV Therapeutics, Inc. 15

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Capridine

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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 distribution Data on file AV Therapeutics, Inc. 17

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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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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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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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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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Clinical Research Partner

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The Prostate Cancer Clinical Trials Consortium Howard Scher MD, Head of Clinical Consortium

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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 distribution Data on file AV Therapeutics, Inc. 23

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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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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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Capridine

Peptide vaccine

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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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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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