Transcript Ovarian & Breast Cancer
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.
July 2012
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
.
July 2012
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
July 2012
Harnessing the Power of Immune System
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
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
July 2012 New Frontier in Treatment of Cancer
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
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 Indication
TPIV100 Class II antigens Her2/neu breast cancer TPIV110 Class I + II antigens Her2/neu breast cancer TPIV200 Folate Receptor Alpha Q2 2014 Ovarian/breast cancer TPIV120 (PolyStart™ Class I/II antigens) Her2/neu breast cancer TPIV 300 (Class I antigens) Smallpox Emerging viral threats July 2012
Preclinical Phase I Phase II
July 2012
Trial 1: Her2neu Breast Cancer - Mayo Clinic Rochester MN
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
July 2012
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, 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 Class II + Class I (p373-382) antigens (4+1) To start Q4, 2014 Small safety study 100-150 patient multicenter phase II
July 2012
Her2neu Breast Cancer - Mayo Clinic Rochester MN
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
July 2012
Trial 2: Stage II/II Ovarian & Breast Cancer - Mayo Clinic
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
July 2012
T Trial 2: Ovarian & Breast Cancer (Folate Alpha) - Mayo Clinic Rochester MN 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
Corporate Pre-Clinical Bio-Threat
Restructure
Trial 1: Breast Cancer
HER2/neu + breast cancer
Trial 2: Ovarian Cancer
Folate Alpha Breast/Ovarian Licensing of Phase I program PolyStart ™ Viral Disease PolyStart IP NASDAQ Start Phase Ib/II Start Phase II Smallpox Partnership Finish Preclinical FDA meeting
Multiple Inflection Points and Value Drivers
July 2012
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
Glynn Wilson, PhD CEO
25 years experience in product & corporate development SmithKline Beecham, Ciba-Geigy, Tacora July 2012
Denis Corin Corporate Finance
Beckman, Novartis
Bob Florkiewicz, PhD Head of Research
25 years experience, academic and biotech Synergen, TSRI, UW, GSK, Seed IP Law Group
Mark Reddish Advisor: Development, Board
25 years experience in cancer vaccines and biodefense Biomira, ID Biomedical, Baxter, Bayer AG
TPIV - TAPIMMUNE INC Capital Structure Post Restructure
Shares Outstanding Public Float Debt Elimination Market cap Stock Price 16,000,000 2,000,000 ~$5,000,000 ~$30,000,000 $2.00
Comparrisons in Immunotherapy and Biotech
GALE (Galena) LBIO (Lion Bio) INO (Inovio) DNDN (Dendreon) NWBO (Nothwest Bio)
Shares Out
105,240,000 26,000,000 240,150,000 157,490,000 53,400,000
Market Cap Stock Price
$ 250,000,000 $ 180,000,000 $ 565,550,000 $2.50
$6.50
$2.39
$ 453,560,000 $ 317,730,000 $2.88
$5.99
July 2012
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
CONTACT
Glynn Wilson Chief Executive Officer [email protected]
Denis Corin Corporate Finance [email protected]