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At the Forefront of Immunotherapy OTCQB: TPIV 1551 Eastlake Ave E Suite 100 Seattle, WA www.TapImmune.com.

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Presentation on theme: "At the Forefront of Immunotherapy OTCQB: TPIV 1551 Eastlake Ave E Suite 100 Seattle, WA www.TapImmune.com."— Presentation transcript:

1 At the Forefront of Immunotherapy OTCQB: TPIV 1551 Eastlake Ave E Suite 100 Seattle, WA

2 CAUTIONARY STATEMENT REGARDING FORWARD LOOKING STATEMENTS Certain statements contained herein are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of Forward-looking statements in this document include, but are not limited to, statements relating to long-term stability, the Company's plan of operations and finances, the potential for the Company's vaccines and proposed clinical trials. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and that actual results may differ materially from estimates in the forward-looking statements. The Company undertakes no obligation to revise these forward-looking statements to reflect events or circumstances after the date hereof.

3 Corporate Presentation July 2012 TAPIMMUNE A New Frontier in Immunotherapy TapImmune is an Immunotherapy company specializing in the development of the most comprehensive and innovative immunotherapeutics in cancer and infectious diseases.

4 Corporate Presentation July 2012 OPPORTUNITY Why invest in TapImmune now? Unique and Broad product opportunities in cancer & infectious disease Two Phase I Clinical Trials ready to progress to Phase II HER2/neu breast cancer vaccine potential blockbuster Ovarian Cancer Urgently Needed Therapeutic with blockbuster potential HUGE market opportunities in multiple therapeutic indications PolyStart™ expression vector is a significant advance in vaccine technologies Strong management & advisory team Leverage of key collaborations with leading institutions Series of preclinical and clinical value inflexion points Significantly undervalued and poised for significant growth An approach with the potential to change lives and excellent entry level valuation

5 Corporate Presentation July 2012 Leading Immunotherapy Approach: CANCER Making tumors visible to T-cells Stimulating T-killer cells AND T-helper cells Applicable to broad patient populations INFECTIOUS DISEASE Up-regulation of Antigen Presentation Stimulating T-killer cells & T-helper cells Applicable Multiple Infectious Diseases and Biothreats TAPIMMUNE Harnessing the Power of Immune System

6 Corporate Presentation July 2012 The Immune System The body’s immune system is designed to fight cancer & viral infections Cancers evade the immune system allowing tumor growth PROBLEM: cancer evades the immune system and current approaches do not address ALL the reasons adequately Reasons:  The Cancer Markers (antigens) are NOT presented to the Immune System  Low or Absent T A P (Antigen Transporter)  Epitopes are NOT Naturally Processed (NPE)  T cell response is SHORT lived (No Helper Cells CD4)  T cell response is NOT a KILLER cell response (CD8 ) Reasons:  The Cancer Markers (antigens) are NOT presented to the Immune System  Low or Absent T A P (Antigen Transporter)  Epitopes are NOT Naturally Processed (NPE)  T cell response is SHORT lived (No Helper Cells CD4)  T cell response is NOT a KILLER cell response (CD8 )

7 Corporate Presentation July 2012 The Immunotherapy Space New Frontier in Treatment of Cancer PROBLEM: To Stimulate the Immunse System to Effectively KILL Tumors Traditional Approaches Chemotherapy, Radiation, Surgery, Small Molecules New Immunotherapies Immune Checkpoint Blockade (BMS; Merck) Monoclonal antibodies (Roche) T-Cell Therapies Ex-Vivo: Adoptive T-cell transfer (LBIO;Juno) Dendritic cell transfer (NWBIO;DNDN; PBMD) In Vivo: Antigen stimulation (ONTY;GALE;IMUC) BOTH Antigen presentation & T Cell stimulation (TPIV) Traditional Approaches Chemotherapy, Radiation, Surgery, Small Molecules New Immunotherapies Immune Checkpoint Blockade (BMS; Merck) Monoclonal antibodies (Roche) T-Cell Therapies Ex-Vivo: Adoptive T-cell transfer (LBIO;Juno) Dendritic cell transfer (NWBIO;DNDN; PBMD) In Vivo: Antigen stimulation (ONTY;GALE;IMUC) BOTH Antigen presentation & T Cell stimulation (TPIV)

8 Corporate Presentation July 2012 The TapImmune Approach Prime BOTH sides of the tumor Killing equation Proprietary peptide antigens used to stimulate a broad based T - Helper cell response (CD4) LONG-LIVED KILLER T-cells to actually KILL the tumor (CD8) Prime BOTH sides of the tumor Killing equation Proprietary peptide antigens used to stimulate a broad based T - Helper cell response (CD4) LONG-LIVED KILLER T-cells to actually KILL the tumor (CD8) These Proprietary Antigens allow us to treat: Wider patient populations Multiple Indications Multiple Therapeutic Areas (Cancer and Infectious Disease) These Proprietary Antigens allow us to treat: Wider patient populations Multiple Indications Multiple Therapeutic Areas (Cancer and Infectious Disease) SOLUTION: most COMPREHENSIVE immunotherapeutic in development

9 Corporate Presentation July 2012 Product Pipeline ProductIndicationPreclinicalPhase IPhase II TPIV100 Class II antigensHer2/neu breast cancer TPIV110 Class I + II antigensHer2/neu breast cancer TPIV200 Folate Receptor Alpha Q Ovarian/breast cancer TPIV120 (PolyStart™ Class I/II antigens) Her2/neu breast cancer TPIV 300 (Class I antigens) Smallpox Emerging viral threats

10 Corporate Presentation July 2012 HER2/neu positive breast cancer is one of most aggressive forms HER2/neu is overexpressed in ~ 30% breast cancer patients (total 220,000 /yr) Roche’s monoclonal antibody, Herceptin (current standard of care) can only treat ~ 20% of these patients (+$6 billion sales in 2013) Herceptin does not stimulate Killer T-cells – it slows/retards tumor growth In Contrast: We believe TapImmune’s comprehensive combination of Killers and Helpers has the potential to provide Long Lasting Immune Response in upto 84% of the HER2/neu positive patient population. A $ Multi-Billion product potential meeting an UNSATISFIED CLINICAL NEED in a very LARGE Market Lead Clinical Programs Trial 1: Her2neu Breast Cancer - Mayo Clinic Rochester MN Herceptin Facts: Late Stage Survival improved by 4.5 Months. Early stage treatment resulted in a 9.5% improvement on recurrence. 70% of Her2neu+ patients do NOT respond to treatment

11 Corporate Presentation July 2012 HER2/neu Clinical Status Her2neu Breast Cancer - Mayo Clinic Rochester MN Phase l Phase lb/ll Class II antigens (4 epitopes NPE) discovered in breast cancer patients - Clin. Cancer Res. (2010) 16, Patients post Herceptin 6 x monthly intradermal + GMCSF Interim safety checkpoint completed Positive Immune responses on first 6 patients (interim data) Excellent Results – Support progression to Phase ll Class II + Class I (p ) antigens (4+1) To start Q4, 2014 Small safety study patient multicenter phase II

12 Corporate Presentation July 2012 HER2/neu Clinical Program Her2neu Breast Cancer - Mayo Clinic Rochester MN Peptide Antigens to stimulate BOTH: T-helper cells – Long Lasting Antigens discovered in breast cancer patients Naturally Processed Epitopes (NPE’s) Killer T-cells (p ) - Kills Tumor Cells Leading HER2/neu Vaccine Candidate Compared to NeuVax by Galena: 4-5x greater KILLING activity against human tumor cell targets See: J.Immonol. (2013) 190, SOLUTION: most COMPREHENSIVE immunotherapeutic in development

13 Corporate Presentation July 2012 Folate Receptor Alpha is expressed over 95% of ovarian cancers, for which the only treatment options are surgery and chemotherapy Very important and urgent clinical need for a new therapeutic. Time to recurrence is relatively short for this type of cancer and survival prognosis is extremely poor after recurrence. US alone, approximately 30,000 ovarian cancer patients newly diagnosed every year. Phase llb/2 advancement expected in late Orphan Drug Application – Pending FDA Another $ Multi-Billion product potential with an UNSATISFIED CLINICAL NEED Lead Clinical Programs Trial 2: Stage II/II Ovarian & Breast Cancer - Mayo Clinic URGEN CLINCAL NEED - LARGE MARKET OPPORTUNITY

14 Corporate Presentation July 2012 Ovarian Trial Clinical Status T Trial 2: Ovarian & Breast Cancer (Folate Alpha) - Mayo Clinic Rochester MN Phase l Phase ll Expected to Start in 2014 with Orphan Drug Application - FDA Pending Antigens Applicable to Ovarian and Triple Negative Breast Cancer 22 patients with Stage II-III Breast, Ovarian, Peritoneal, Fallopian Tube Cancer Interim safety checkpoint completed Positive Immune responses observed Promising Interim Results – Support progression to Phase ll

15 Licensing of Phase I program Restructure Start Phase Ib/II HER2/neu + breast cancer PolyStart IP Folate Alpha Breast/Ovarian PolyStart™Finish Preclinical FDA meeting Viral DiseaseSmallpox Partnership Start Phase II TapImmune: 2014 Upcoming Milestones Q1Q2Q3Q4 NASDAQ Multiple Inflection Points and Value Drivers Corporate Trial 1: Breast Cancer Trial 2: Ovarian Cancer Pre-Clinical Bio-Threat

16 Corporate Presentation July 2012 COLLABORATORS & ADVISORS World Class Team Dr Keith Knutson (Vaccine & Gene Therapy Institute of Florida/Mayo Clinic): Director, Cancer Immunology and Immunotherapy Program, VGTI; Adjunct Faculty - Immunology, Mayo Clinic Dr Greg Poland: (Mayo Clinic) Head of Vaccines; Infectious disease/biodefense Dr Mac Cheever (Fred Hutchinson Cancer Research Center) Director Solid Tumor Research; Professor of Medicine/Oncology at the University of Washington (Seattle) & Director of the NCI-funded Cancer Immunotherapy Trials Network (CITN) Mark Reddish Advisor: Development, Board Product Development: Cancer vaccines and Biodefense: Biomira, ID Biomedical, Baxter, Bayer AG Denis Corin Corporate Finance

17 Corporate Presentation July 2012 Management and Advisors Mark Reddish Advisor: Development, Board 25 years experience in cancer vaccines and biodefense Biomira, ID Biomedical, Baxter, Bayer AG Denis Corin Corporate Finance Beckman, Novartis Glynn Wilson, PhD CEO 25 years experience in product & corporate development SmithKline Beecham, Ciba-Geigy, Tacora Bob Florkiewicz, PhD Head of Research 25 years experience, academic and biotech Synergen, TSRI, UW, GSK, Seed IP Law Group

18 Corporate Presentation July 2012 CAP STRUCTURE and COMPS Reorganized Feb 2014 TPIV - TAPIMMUNE INC Capital Structure Post Restructure Shares Outstanding 16,000,000 Public Float 2,000,000 Debt Elimination ~$5,000,000 Market cap ~$30,000,000 Stock Price$2.00 Comparrisons in Immunotherapy and Biotech Shares OutMarket Cap Stock Price GALE (Galena)105,240,000$ 250,000,000 $2.50 LBIO (Lion Bio) 26,000,000$ 180,000,000 $6.50 INO (Inovio)240,150,000$ 565,550,000 $2.39 DNDN (Dendreon)157,490,000$ 453,560,000 $2.88 NWBO (Nothwest Bio) 53,400,000$ 317,730,000 $5.99

19 Corporate Presentation July 2012 OPPORTUNITY Why invest in TapImmune now? Unique and Broad product opportunities in cancer & infectious disease Two Phase I Clinical Trials ready to progress to Phase II HER2/neu breast cancer vaccine potential blockbuster Ovarian Cancer Urgently Needed Therapeutic with blockbuster potential HUGE market opportunities in multiple therapeutic indications PolyStart™ expression vector is a significant advance in vaccine technologies Strong management & advisory team Leverage of key collaborations with leading institutions Series of preclinical and clinical value inflexion points Significantly undervalued and poised for significant growth An approach with the potential to change lives and excellent entry level valuation

20 CONTACT Glynn Wilson Chief Executive Officer Denis Corin Corporate Finance


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