Avth investor presentationredchip-13

AV THERAPEUTICS

Investor presentation

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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http://www.avtherapeutics.com/index.html


Safe Harbor Statement

All statements pertaining to future financial and/or operating results, future growth in research,technology, clinical development, and potential opportunities for AV Therapeutics, Inc. (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 wordssuch as "will," "believes," "plans," "anticipates," "expects," "estimates") should also be considered to beforward-looking statements.

Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherentin the development and/or commercialization of potential products, uncertainty in the results of clinicaltrials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectualproperty rights and other risks discussed in the Company’s registration statement on Form S-1 andother reports filed with the Securities and Exchange Commission which is available for review atwww.sec.gov.

Actual results may differ materially from the results anticipated in these forward-looking statementsand as such should be evaluated together with the many uncertainties that affect the Company'sbusiness.

The Company disclaims any intent or obligation to update these forward-looking statements.

Confidential - not for distribution 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




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




Management Team

• Abraham Mittelman , M.D., Chief Executive Officer and Chairman of the BoardOncologist 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 OfficerProfessor of Microbiology & Immunology and Graduate Program Director at NYMC. Over 30 years of research experience with over 150peer 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, PresidentOver 40 years business experience. Founder and managing partner of Continuum Partners, a global network security and businessdevelopment consulting firm.

• Jan Geliebter, Ph.D., Secretary, VP Genomic PlatformsProfessor 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 DevelopmentAssociate 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.




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


Effective drug based therapy and immunotherapyis 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 that has specific targeted activity towards prostate, colon and other cancers– Dr. Raj Tiwari and Dr. Jerzy Konopa from Gdansk, Poland are co-

inventors

– Patents are for composition and use and sub-licensed to AVT

– Protected in • USA

• EU

• Mexico

• Canada

• Israel




Capridine-β (C-1748)

• Capridines and 200 of their derivatives are patent protected for use as anticancer agents

• US patent on combination of capridines with other agents

• 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

Confidential - not for distributionData on file AV Therapeutics, Inc. 9



Capridine-β (C-1748)


Derivative R1 R2 R3 R4

C-1748 H (CH2)2OH CH3 H

Data on file AV Therapeutics, Inc. 10



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

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Data on file AV Therapeutics, Inc.

Capridine-b has Differential IC50 Values in

CaP and Leukemic Cells

11Confidential - not for distribution



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




Treatment started week 1, once weekly for 7 – 9 weeks

3

4

56

Data on file AV Therapeutics, Inc.

Capridine - b Inhibits Hormone-Responsive and Non-Responsive CaP

Xenografts in Nude Mice

13Confidential - not for distribution



Cell linesIC50 Values (nM)

Taxane Capridine

LnCaP >100nM 15nM

PC3 16-20nM 5nM

DU145 15-20nM 5nM


DNA cross-linking induced by Capridine b in different

tumor cells incubated with compounds for 14 h

0.01 0.1 1 10 100Drug concentration [ M]

0

20

40

60

80

cro

ss-l

inked

[%]

m

HeLa S3

LnCaP

CEM

HT-29


1. Loss of androgen receptor

2. Upregulation of ER-β

3. Upregulation of CDC25 group of proteins

Hormone dependant Hormone

independent

Prostate cancer


http://www.webdogpro.com/logos/arrow.jpg

http://www.webdogpro.com/logos/arrow.jpg

6 h 12 h

C 5 nM 10 nM 5 nM 10 nM

Actin

Androgen receptor

Series1

Capridine-β induces the androgen receptor in hormone

independent DU-145 cells


Salient Features of Capridine-β

• Capridine- β is active on hormone dependent and independent Prostate cancer (CaP) xenografts

• Anti cancer doses of Capridine-β in animals and MTD values in dogs (1.84mg/Kg) extrapolated to humans has a wide human therapeutic dose range

• Specificity towards CaP and high differential IC50 values for hematopoietic cells making Capridine-β a non-myelo-suppressive chemotherapeutic agent




Salient Features of Capridine-β

• Capridine-β is active against taxane resistant prostate cancer cells, hormone dependent and hormone independent prostate cancer xenografts and is non-myelosuppressive

• Capridine- β renders aggressive hormone independent CaPcells hormone sensitive and thus can synergize with anti-androgen therapy in Cap

• The cell cycle kinase cdk-4 and the tumor suppressor gene p16 are the specific targets of capridine-β in prostate cancer




Capridine


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




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




Pros-Vax Peptide Therapeutic Vaccine

• Synthetic peptide vaccine (Pros-Vax) that mimics cancerproteins, induces the host’s immune response directed againstmultiple cancer-specific proteins

• Easily manufactured, small molecule drug

• Preclinical studies complete

• Expected to eliminate micrometasatic and residualdisease and hence prevent recurrence


Immunization with peptide vaccines prevents metastatic prostate cancer growth

Unimmunized rat Immunized rats

BTE6-LX-8b ProVac 1

BTE6-X-15-7 ProVac 2


Capridine

Peptide

vaccine


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.




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




Clinical Research Partner


The Prostate Cancer Clinical Trials Consortium

Howard Scher MD, Head of Clinical Consortium

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Use of proceeds for development of Capridine


Clinical product

synthesis and testing

IND application & FDA approval for

Phase I

Initiation and

completion of Phase I

Overall development

Cost ($000)

Activities

•GMP synthesis•Stability•Toxicology•Formulation

• Contractual services for IND• Data analysis and compilation• Chem manufacture write up• Comp lab mechanism studies

• Multicenter Phase I• Consortium lead•60 patients

• Clinical development of Capridine

Output

•Capridine IND•Approval for Phase I

• Phase I/ II trial

• Licensing of Capridine to strategic partner

• Continue development

2,500 1,000 1,6005.1 million

months 0-6 Months 6-12 months 12-18

Strategy Output Output

Output

Activities Activities

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Development of peptide vaccines for prostate cancer

Peptide

vaccines for

prostate

cancer

Peptide

vaccines

Pilot clinical

trial Marketing and

other strategies

Cost ($000)

Activities

• Peptide identification

• Tox testing

• Tech Assessment

• Peptides human Pca

antigens

• Preclinical testing

•I

• peptide synthesis

• IND submission

• Adjuvant development

•Acquisition of other

synergistic products

•cost of capital

Output

• therapeutic

Peptides ready

For clinical trial

• Limited Phase I/II trial• Phase I/ II trial

• Licensing of peptide

products to big pharma

• marketing

collaboration with

peptides and acquired

products

•Adjuvant marketing

1,000,000 1,500,000 1,500,0004,000,000

Months 1-12 Months 12-24 months 12-24

Exit strategy Output Output

Activities Activities Activities


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




Current Capital Structure

• Authorized Common shares : 200,000,000

• Outstanding AVT principals and prior investors: 58,000,000

• Barry Honig and PubCo Group investors : 17,000,000

• Proposed 2.5 m raise by PPM @ $0.20/share : 12,500,000

• Proposed reverse merger with a PUBCO with Barry Honig as lead investor




Clinical Research Partner

Howard I. Scher, MD, Head of Clinical Consortium

– Memorial Sloan-Kettering Cancer Center

– Chief, Genitourinary Oncology Service

– D. Wayne Calloway Chair in Urologic Oncology

Education: MD Degree New York University School of Medicine

Fellowships: MSKCC, NY Hospital - Cornell Medical Center

Board Certifications: Internal Medicine, Medical Oncology

Clinical Expertise: Prostate Cancer, Genitourinary Malignancies, Immunotherapy


The Prostate Cancer Clinical Trials Consortium

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Date post:	19-May-2015
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