AV THERAPEUTICSInvestor presentation 2013Confidential - not for distributionExcept for historical information, the stateme...
• Corporate Headquarters20 East 68th StreetNew York, NY 10065Suite 204• Research FacilitiesNew York Medical CollegeCancer ...
Professional AdvisorsCorporate CounselSichenzia Ross Friedman FerenceLLP,61 Broadway, New York, NYDarrin OcasioConsultants...
Management Team• Abraham Mittelman , M.D., Chief Executive Officer and Chairman of theBoardOncologist and professor at New...
AV Therapeutics - Overview• AVT is a Biotechnology company focused on:• Targeted drug based cancer therapies that are safe...
IP position of AV Therapeutics• Two patents on Capridine : Dr. Raj Tiwari and Dr. Jerzy Konopa fromGdansk, Poland are co-i...
The Problem - Prostate Cancer• Prostate Cancer is the most common type of cancer in men inthe USA• Annual expenditures exc...
The Solution - Capridine• Identified a new class of patent protected nitro-acridine drugsknown as Capridines• NCI tested p...
Confidential - not for distribution 9
Prostate cancer cells are ten to 100 fold more sensitive to capridine-β than leukemic cells(HL-6O)12Data on file AV Therap...
Capridine-β is a more potent anticancer drugthan Mitoxantrone in several cancersConfidential - not for distributionData on...
Treatment started week 1, once weekly for 7 – 9 weeks3456Data on file AV Therapeutics, Inc.Capridine - β Inhibits Hormone-...
Cell linesIC50 Values (nM)Taxane CapridineLnCaP >100nM 15nMPC3 16-20nM 5nMDU145 15-20nM 5nMConfidential - not for distribu...
6 h 12 hC 5 nM 10 nM 5 nM 10 nMActinAndrogen receptorCapridine-β induces the androgen receptor in hormoneindependent DU-14...
Unique Features of Capridine• Capridine is active against taxane resistant prostate cancercells, hormone dependent and hor...
CapridineConfidential - not for distribution 16
Capridine-β Advantage• Based on the results of Pre-Clinical Studies,Capridine-β has minimal bone marrow toxicitywith a wid...
Development Plan for Capridine – Next Steps• Drug manufacture and formulation under GMP conditions• Stability testing of t...
Summary• Preclinical studies complete for Capridine. Unique properties include noblood toxicity and wide therapeutic dose ...
Scientific Advisory Board• Joseph Bertino, MD, Associate Director and Chief Scientific Officer, The Cancer Institute ofNew...
Medical Advisors/Collaborators• Dan Petrylak, M.D. - Director of the Prostate Cancer Program, YaleUniversity• Ashutosh Tew...
Clinical Research PartnerConfidential - not for distributionThe Prostate Cancer Clinical Trials ConsortiumHoward Scher MD,...
IP position of AV Therapeutics• Two patents on Capridine : Dr. Raj Tiwari and Dr. Jerzy Konopa fromGdansk, Poland are co-i...
Pros-Vax Peptide Therapeutic Vaccine• Synthetic peptide vaccine (Pros-Vax) that mimics cancerproteins, induces the host’s ...
Immunization with peptide vaccines preventsmetastatic prostate cancer growthUnimmunized rat Immunized ratsBTE6-LX-8bProVac...
CapridinePeptidevaccineConfidential - not for distribution 26
Business Strategy, Use of Capital and Time LinePRIVATE PLACEMENT MEMORANDUM• 12 Million Units Each Consisting of One Share...
Current Capital Structure• Authorized Common shares: 50,000,000• Issued & outstanding: 17,739,561• Number of shareholders:...
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Avth 6262013

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Avth 6262013

  1. 1. AV THERAPEUTICSInvestor presentation 2013Confidential - not for distributionExcept for historical information, the statements made in this presentation are forwardlooking statements involving significant risks and uncertainties.“Treatment and Prevention of Prostate Cancer through Innovation”A New York Based Biotechnology Company1
  2. 2. • Corporate Headquarters20 East 68th StreetNew York, NY 10065Suite 204• Research FacilitiesNew York Medical CollegeCancer Institute of New JerseyAV TherapeuticsConfidential - not for distribution 2
  3. 3. Professional AdvisorsCorporate CounselSichenzia Ross Friedman FerenceLLP,61 Broadway, New York, NYDarrin OcasioConsultantsObjective EquityRed ChipConfidential - not for distribution 3
  4. 4. Management Team• Abraham Mittelman , M.D., Chief Executive Officer and Chairman of theBoardOncologist 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 basedCancer Vaccine Technology.• Morton Coleman, M.D., Vice President, Director of Clinical DevelopmentClinical Professor at Weill Medical College of Cornell University and Director of the Center for Lymphoma and Myeloma at New YorkPresbyterian Hospital – Weill Cornell. Chairman, Medical Affiliate Board of Lymphoma Research Foundation, over 400 publications anddesignated 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 reviewedpublications. 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 andexperimental therapeutics with over 125 publications and presentations. Inventor of several patents.Confidential - not for distribution 4
  5. 5. AV Therapeutics - Overview• AVT is a Biotechnology company focused on:• Targeted drug based cancer therapies that are safer andmore effective than current chemotherapeutic agents• Proprietary peptide based immunotherapeutic vaccinetechnology platform• Scientists at AVT have developed Capridine:• A patented drug having specific activity against prostatecancer• Outstanding physicians and clinical researchersConfidential - not for distribution 5
  6. 6. IP position of AV Therapeutics• Two patents on Capridine : Dr. Raj Tiwari and Dr. Jerzy Konopa fromGdansk, 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 substitutedderivatives and sub-licensed to AVT– Composition of matter patent on capridine in combination withother therapeutics• Third US patent on a novel technology using synthetic off the shelf easilysynthesizable peptides with a broad application “ Immunogens for treatment ofneoplastic and infectious diseases”• Fourth US patent on the delivery of immunogens “ Immunotherapy for prostatecancer using Bacille-Calmette-Guerin expressing prostate specific antigens”.Confidential - not for distributionData on file AV Therapeutics, Inc. 6
  7. 7. The Problem - Prostate Cancer• Prostate Cancer is the most common type of cancer in men inthe USA• Annual expenditures exceed $15 billion• Current therapies have limited efficacy for metastatic disease• Current chemotherapeutic regimens are associated withsevere bone marrow toxicity and poor tolerance• Current immunotherapy (Provenge) is expensive and hasminimal efficacy• Radiation, hormonal and chemotherapy remain palliativeConfidential - not for distributionEffective drug based therapy and immunotherapyis an unmet clinical need in prostate cancer7
  8. 8. The Solution - Capridine• Identified a new class of patent protected nitro-acridine drugsknown 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 efficacyConfidential - not for distribution 8
  9. 9. Confidential - not for distribution 9
  10. 10. Prostate cancer cells are ten to 100 fold more sensitive to capridine-β than leukemic cells(HL-6O)12Data on file AV Therapeutics, Inc.Capridine-β has Differential IC50 Values inCaP and Leukemic Cells10Confidential - not for distribution
  11. 11. Capridine-β is a more potent anticancer drugthan Mitoxantrone in several cancersConfidential - not for distributionData on file AV Therapeutics, Inc. 11
  12. 12. Treatment started week 1, once weekly for 7 – 9 weeks3456Data on file AV Therapeutics, Inc.Capridine - β Inhibits Hormone-Responsive and Non-Responsive CaPXenografts in Nude Mice12Confidential - not for distribution
  13. 13. Cell linesIC50 Values (nM)Taxane CapridineLnCaP >100nM 15nMPC3 16-20nM 5nMDU145 15-20nM 5nMConfidential - not for distribution 13Capridine is superior to taxane and is effective on taxane resistant prostate cancer
  14. 14. 6 h 12 hC 5 nM 10 nM 5 nM 10 nMActinAndrogen receptorCapridine-β induces the androgen receptor in hormoneindependent DU-145 cellsConfidential - not for distribution 14
  15. 15. Unique Features of Capridine• Capridine is active against taxane resistant prostate cancercells, hormone dependent and hormone independentprostate cancer xenografts and is non-myelosuppressive• Capridine renders aggressive hormone independent CaP cellshormone sensitive and thus can synergize with anti-androgentherapy in CapConfidential - not for distributionData on file AV Therapeutics, Inc. 15
  16. 16. CapridineConfidential - not for distribution 16
  17. 17. Capridine-β Advantage• Based on the results of Pre-Clinical Studies,Capridine-β has minimal bone marrow toxicitywith a wide therapeutic range active againsttaxane resistant CaP cells• Capridine-β can be added to other drugs thuslowering chemotherapy associated toxicitiesConfidential - not for distributionData on file AV Therapeutics, Inc. 17
  18. 18. 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 trialsConfidential - not for distribution 18
  19. 19. Summary• Preclinical studies complete for Capridine. Unique properties include noblood toxicity and wide therapeutic dose range with specificity towardsprostate cancer - ready to commence phase I and II human trials• A world-class, internationally recognized, well published scientists andclinicians (PhD’s and MDs) from A+ institutions• World class medical research collaborators and Scientific Advisory Board• All IPs patent protectedConfidential - not for distribution 19
  20. 20. Scientific Advisory Board• Joseph Bertino, MD, Associate Director and Chief Scientific Officer, The Cancer Institute ofNew Jersey and past President of the American Association for Cancer Research and The AmericanAssociation of Clinical Oncologists, organizations of over 50,000 researchers, worldwide. He is thefounding Editor of the Journal of Clinical Oncology.• Charles Cantor, PhD, is Director of the Center for Advanced Biotechnology at BostonUniversity and Chief Scientific Officer at Sequenom, Inc. in La Jolla (a publicly traded company). Hehas published more than 400 articles, and has been awarded more than sixty (60) patents. He ismost known for his authoring of the book, Genomics: The Science and Technology Behind theHuman Genome Project.• Roy G. Smith, PhD, is the Director of then Huffington Center on Aging, Professor in theDepartment of Molecular and Cellular Biology, and Professor in the Department of Medicine atBaylor College of Medicine. He was previously Vice President of Basic Research at Merck and wasresponsible 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 Centerand the Scientific Founder of Antigenics. He is among the founding members of the Academy ofCancer Immunology.Confidential - not for distribution 20
  21. 21. Medical Advisors/Collaborators• Dan Petrylak, M.D. - Director of the Prostate Cancer Program, YaleUniversity• Ashutosh Tewari, M.D., - Director of the Prostate Cancer Institute and theLeFrak Robotic Surgery Center at Weil Cornell Medical College [Tentative]• Derek Raghavan, M.D. – President of the Levine Cancer Institute at theCarolinas Healthcare System, formerly, Chairman and Director of theTaussig Cancer Center at the Cleveland Clinic• Christopher Logothetis, M.D. – Department Chair, Department ofGenitourinary Medical Oncology, Division of Cancer Medicine, TheUniversity of Texas MD Anderson Cancer CenterConfidential - not for distribution 21
  22. 22. Clinical Research PartnerConfidential - not for distributionThe Prostate Cancer Clinical Trials ConsortiumHoward Scher MD, Head of Clinical Consortium22
  23. 23. IP position of AV Therapeutics• Two patents on Capridine : Dr. Raj Tiwari and Dr. Jerzy Konopa fromGdansk, 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 substitutedderivatives and sub-licensed to AVT– Composition of matter patent on capridine in combination withother therapeutics• Third US patent on a novel technology using synthetic off the shelf easilysynthesizable peptides with a broad application “ Immunogens for treatment ofneoplastic and infectious diseases”• Fourth US patent on the delivery of immunogens “ Immunotherapy for prostatecancer using Bacille-Calmette-Guerin expressing prostate specific antigens”.Confidential - not for distributionData on file AV Therapeutics, Inc. 23
  24. 24. 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 recurrenceConfidential - not for distribution 24
  25. 25. Immunization with peptide vaccines preventsmetastatic prostate cancer growthUnimmunized rat Immunized ratsBTE6-LX-8bProVac 1BTE6-X-15-7ProVac 2Confidential - not for distribution 25
  26. 26. CapridinePeptidevaccineConfidential - not for distribution 26
  27. 27. Business Strategy, Use of Capital and Time LinePRIVATE PLACEMENT MEMORANDUM• 12 Million Units Each Consisting of One Share of Common Stock (0.50cents a share) and One Warrant (0.75 cents). Shares of Common StockMaximum $6,000,000 Public offering by reverse merger or S1 filing afterthe 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 $10,000,000Confidential - not for distribution 27
  28. 28. 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 millionGrants, NIH, Department of Defense and other: 6 millionFriends and Family: 1 millionConfidential - not for distribution 28

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