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AV THERAPEUTICS Investor presenta6on Confiden’al not for distribu’on Except for historical information, the statements made in this presentation are forward looking statements involving significant risks and uncertainties. “Be9er Treatment of Cancer through Innova6on” A New York Based Biotechnology Company 1

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AV  THERAPEUTICS  

Investor  presenta6on  

Confiden'al  -­‐  not  for  distribu'on  

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

“Be9er  Treatment  of  Cancer  through  Innova6on”  

A  New  York  Based  Biotechnology  Company  

1  

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AV  Therapeu6cs:    Developing  Safer  and  More  Effec6ve  Chemotherapeu6c  Agents  

Capridine:  -­‐Patented  drug    

-­‐Specific  ac'vity  against  prostate  cancer  plus  an  

immuno-­‐therapeu'c  vaccine    

Preliminary  efficacy  on  range  

of  cancers  

World-­‐class  team  of  

physicians  and  clinical  

researchers  

Confiden'al  -­‐  not  for  distribu'on   2  

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Capridine-­‐β  (C-­‐1748)  

Confiden'al  -­‐  not  for  distribu'on  

Deriva6ve   R1   R2   R3   R4  

C-­‐1748   H   (CH2)2OH   CH3   H  

Data  on  file  AV  Therapeu6cs,  Inc.   3  

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Management  Team  

Abraham  Mi9elman  ,  M.D.,  Chief  Execu6ve  Officer  and  Chairman  of  the  Board  

• Oncologist  and  Associate  Prof.  at  New  York  Medical  College  (NYMC)  with  over  30  years  of  experience  in  pa'ent  treatment  and  clinical  trials.      

Raj  Tiwari,  Ph.D.,  Chief  Scien6fic  Officer  

• Professor  of  Microbiology  &  Immunology  and  Graduate  Program  Director  at  NYMC  with  over    30  years  of    Cancer  Research,  inventor  of  AVTs  IPs  related  to  Capridine  and  Pep'de    Vaccine  Technology.  

Morton  Coleman,  M.D.,  Vice  President,  Director  of  Clinical  Development    

• Clinical  Professor  at  Weill  Medical  College,  Cornell  University,  Director  of  the  Center  for  Lymphoma  and  Myeloma  at  New  York  Presbyterian  Hospital      

Robert  Pollock,  President  

• Over  40  years  business  experience.  Founder  and  managing  partner  of  Con'nuum  Partners,  a  global  network  security  and  business  development  consul'ng  firm.  

Jan  Geliebter,  Ph.D.,  Secretary,  VP  Genomic  Plaborms  • Professor  of  Microbiology  &  Immunology  at  NYMC  with  over  30    years  of  Cancer  Research  experience  Holder  of  mul'ple  patents,  including  AVTs  IP    BCG-­‐based  prostate  cancer  vaccine  

Debabrata  Banerjee,  Ph.D.,  VP  Preclinical  Development  • Associate  Professor  of  Medicine  and    Pharmacology,  Rutgers  University  with  Over  30  years  of  experience  in  preclinical  and  exptal  therapeu'cs    and  Inventor  of  several  patents.  

Confiden'al  -­‐  not  for  distribu'on   4  

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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  metasta'c  disease  

•  Radia'on,  hormonal  and  chemotherapy  remain  pallia've  

High  Toxicity  

•  Severe  bone  marrow  toxicity  and  poor  tolerance  

Confiden'al  -­‐  not  for  distribu'on  

Effective    drug  based  therapy  and  immunotherapy  is  an  unmet  clinical  need  in  prostate  cancer    

5  

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•  Low amount of drug, high efficacy

• Low blood and bone marrow toxicity •  Over 6 million dollars

invested in development (pre-AVT)

•  Capridines and 200 of their derivatives are patent protected for use as anticancer agents in US, EU, Mexico, Canada, Israel

The  Solu6on:  Capridine-­‐β  (C-­‐1748)  

NCI  tested  prostate  cancer  

specific  drug  

Limited  side  affects  

High  therapeu'c  index  for  prostate  

Patent-­‐protected  

Confiden'al  -­‐  not  for  distribu'on   6  

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Prostate cancer cells (DU-145) are ten to 100 fold more sensitive to Capridine-β than leukemic cells (HL-6O)

1  2  

Capridine-β Kills Prostate Cancer Preferentially

Confiden'al  -­‐  not  for  distribu'on  

DU-145 Cells Treated with Capridine-β HL-60 Cells Treated with Capridine-β

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Capridine-­‐β    is  a  Potent  An6cancer  Drug  in  Several  Cancers    

0"

10"

20"

30"

40"

50"

60"

Uterus" Leuk" Breast" Colon" lymph" Sarc" Prostate"

Mul$p

les(o

f(effe

c$vene

ss(of(

(CAP

((com

pared(to(M

ITX(

Cap""MITX"

Confiden'al  -­‐  not  for  distribu'on  

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

8  

*

*Mitoxantrane

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

1  

3  

2  

Capridine - β Inhibits Hormone-Responsive and Non-Responsive Xenografts in Nude Mice

9  Confiden'al  -­‐  not  for  distribu'on  

4

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Loss  of  Androgen  Receptor  Early  Step  in  Prostate  Tumor  Progression  

Hormone Dependent

Confiden'al  -­‐  not  for  distribu'on   10  

Hormone Independent

Loss of Androgen Receptor

Upregulation of ER-β

Upregulation of CDC25 group

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6 h 12 h C 5 nM 10 nM 5 nM 10 nM

Actin

Androgen receptor

Capridine-­‐β  renders  Hormone-­‐Independent  DU-­‐145  CaP  Cells  Hormone  sensi6ve    

Confiden'al  -­‐  not  for  distribu'on   11  

0  

0.5  

1  

1.5  

Control   5nm  (6hr)   10nm  (6hr)   5nm  (12hr)   10nm  (12hr)  

Induction of Androgen Receptor in DU-145 Cells

Rel

ativ

e D

ensi

ty

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Cell  lines  IC50  Values  (nM)  

 

Taxane                                                      Capridine  

LnCaP   >100nM   15nM  

PC3   16-­‐20nM   5nM  

DU145   15-­‐20nM   5nM  

Confiden'al  -­‐  not  for  distribu'on   12  

Capridine  is  superior  to  taxane  and  is  effec've  on  taxane  resistant  prostate  cancer    

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Salient  Features  of  Capridine-­‐β  

Capridine-­‐β  is  ac've  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  therapeu'c  dose  range    

Capridine-­‐  β  is  ac've  on  hormone  dependent  and  independent  

Prostate  cancer  (CaP)  xenografs  

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Confiden'al  -­‐  not  for  distribu'on   14  

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Development  Plan  for  Capridine β –  Next  Steps  

Drug  manufacture  

and  formula'on  under  GMP  condi'ons  

Stability  tes'ng  of  the  formulated  product  

Limited  rodent  and  dog  

toxicology  with  formulated  product  

Pharmacokine'cs  and  pharmacodynamics  

IND  applica'on  

Phase  I/II  clinical  trials  

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Confiden'al  -­‐  not  for  distribu'on  

Howard  Scher  MD,  Head    of  Clinical  Consor6um    

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Scien6fic  Advisory  Board  

•    Joseph  Ber6no,  MD,  Associate  Director  and  Chief  Scien'fic  Officer,  The  Cancer  Ins'tute  of  New  Jersey  and  past  President  of  the  American  Associa'on  for  Cancer  Research  and  The  American  Associa'on  of  Clinical  Oncologists,  organiza'ons  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  Scien'fic  Officer  at  Sequenom,  Inc.  in  La  Jolla  (a  publicly  traded  company).  He  has  published  more  than  400  ar'cles,  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  iden'fying  new  drug  targets  for  metabolic  diseases    

 •    Pramod  Srivastava,  PhD,  is  a  Professor  of  immunology  at  the  University  of  Connec'cut,  

where  he  holds  an  Endowed  Chair  in  Cancer  Immunology  and  is  the  Director  of  the  Cancer  Center  and  the  Scien'fic  Founder  of  An'genics.  He  is  among  the  founding  members  of  the  Academy  of  Cancer  Immunology.    

Confiden'al  -­‐  not  for  distribu'on   17  

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Use  of  proceeds  for  development  of  Capridine  

Confiden6al  -­‐  not  for  distribu6on  

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  

1,000   500   1,500  $3  million    

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

Strategy    Output   Output  

Output  

Activities     Activities    

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Summary  

•  Preclinical  studies  complete  for  Capridine.    Unique  proper'es  include  no  blood  toxicity  and  wide  therapeu6c  dose  range  with  specificity  towards  prostate  cancer  -­‐  ready  to  commence  phase  I  and  II  human  trials      

 •  A  world-­‐class,  interna'onally  recognized,  well  published  scien'sts  and  

clinicians  (PhD’s  and  MDs)  from  A+  ins'tu'ons    

•  World  class  medical  research  collaborators  and  Scien'fic  Advisory  Board  

•  All  IP  is  patent  protected    

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Pros-­‐Vax  Pep6de  Therapeu6c  Vaccine    

•  Synthe'c   pep'de   vaccine   (Pros-­‐Vax)   that   mimics   cancer  proteins,  induces  the  host’s  immune  response  directed  against  mul'ple  cancer-­‐specific  proteins  

•  Easily  manufactured,  small  molecule  drug  

•  Preclinical  studies  complete  •  Expected  to  eliminate  micrometasa'c  and  residual    

disease  and  hence  prevent  recurrence    

Confiden'al  -­‐  not  for  distribu'on   20  

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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  

Confiden'al  -­‐  not  for  distribu'on   21  

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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    $3.5  million  raise  by  PPM  @  $0.20/share  and  a  warrant  to  purchase  one  half  of  a  share  of  the  Company’s  common  stock          

 Confiden'al  -­‐  not  for  distribu'on   22