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At the Forefront of Immunotherapy OTCQB: TPIV 1551 Eastlake Ave E Suite 100 Seattle, WA www.TapImmune.com. CAUTIONARY STATEMENT REGARDING FORWARD LOOKING STATEMENTS.
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At the Forefront of Immunotherapy OTCQB: TPIV 1551 Eastlake Ave E Suite 100 Seattle, WA www.TapImmune.com
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 1995. 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.
TAPIMMUNE A New Frontier in Immunotherapy Corporate Presentation July 2012 TapImmune is an Immunotherapy company specializing in the development of the most comprehensive and innovative immunotherapeutics in cancer and infectious diseases.
OPPORTUNITY Why invest in TapImmune now? Corporate Presentation July 2012 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
TAPIMMUNE Harnessing the Power of Immune System 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
The Immune System Corporate Presentation July 2012 The body’s immune system is designed to fight cancer & viral infections Cancers evade the immune system allowing tumor growth • 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) PROBLEM: cancer evades the immune system and current approaches do not address ALL the reasons adequately
The Immunotherapy Space New Frontier in Treatment of Cancer Corporate Presentation July 2012 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) PROBLEM: To Stimulate the Immunse System to Effectively KILL Tumors
The TapImmune Approach Corporate Presentation July 2012 • 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) SOLUTION: most COMPREHENSIVE immunotherapeutic in development
Product Pipeline Corporate Presentation July 2012
Lead Clinical Programs Trial 1: Her2neu Breast Cancer - Mayo Clinic Rochester MN 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 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
HER2/neu Clinical Status Her2neu Breast Cancer - Mayo Clinic Rochester MN Corporate Presentation July 2012 • Class II antigens (4 epitopes NPE) discovered in breast cancer patients - Clin. Cancer Res. (2010) 16, 825-83 • 22 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 Phase l • Class II + Class I (p373-382) antigens (4+1) • To start Q4, 2014 • Small safety study • 100-150 patient multicenter phase II Phase lb/ll
HER2/neu Clinical Program Her2neu Breast Cancer - Mayo Clinic Rochester MN Corporate Presentation July 2012 Leading HER2/neu Vaccine Candidate • Peptide Antigens to stimulate BOTH: • T-helper cells – Long Lasting • Antigens discovered in breast cancer patients • Naturally Processed Epitopes (NPE’s) • Killer T-cells (p373-382) - Kills Tumor Cells Compared to NeuVax by Galena: 4-5x greater KILLING activity against human tumor cell targets See: J.Immonol. (2013) 190, 479-488 SOLUTION: most COMPREHENSIVE immunotherapeutic in development
Lead Clinical Programs Trial 2: Stage II/II Ovarian & Breast Cancer - Mayo Clinic 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 2014. • Orphan Drug Application – Pending FDA • Another $ Multi-Billion product potential with an UNSATISFIED CLINICAL NEED URGEN CLINCAL NEED - LARGE MARKET OPPORTUNITY
Ovarian Trial Clinical Status T Trial 2: Ovarian & Breast Cancer (Folate Alpha) - Mayo Clinic Rochester MN Corporate Presentation July 2012 Phase l • 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 Phase ll Expected to Start in 2014 with Orphan Drug Application - FDA Pending Antigens Applicable to Ovarian and Triple Negative Breast Cancer
TapImmune: 2014 Upcoming Milestones Q1 Q2 Q3 Q4 Restructure NASDAQ Corporate Start Phase Ib/II HER2/neu+ breast cancer Trial 1: Breast Cancer Folate Alpha Breast/Ovarian Licensing of Phase I program Trial 2: Ovarian Cancer Start Phase II Pre-Clinical PolyStart™ PolyStart IP Finish Preclinical FDA meeting Bio-Threat Viral Disease Smallpox Partnership Multiple Inflection Points and Value Drivers
COLLABORATORS & ADVISORS World Class Team Corporate Presentation July 2012 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
Mark Reddish Advisor: Development, Board 25 years experience in cancer vaccines and biodefense Biomira, ID Biomedical, Baxter, Bayer AG Glynn Wilson, PhD CEO 25 years experience in product & corporate development SmithKline Beecham, Ciba-Geigy, Tacora Management and Advisors Corporate Presentation July 2012 Bob Florkiewicz, PhD Head of Research 25 years experience, academic and biotech Synergen, TSRI, UW, GSK, Seed IP Law Group Denis Corin Corporate Finance Beckman, Novartis
CAP STRUCTURE and COMPS Reorganized Feb 2014 Corporate Presentation July 2012 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 Out Market 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
OPPORTUNITY Why invest in TapImmune now? Corporate Presentation July 2012 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
CONTACT Glynn Wilson Chief Executive Officer gwilson@tapimmune.com Denis Corin Corporate Finance dcorin@tapimmune.com