At the Forefront of Immunotherapy OTCQB: TPIV 1551 Eastlake Ave E Suite 100 Seattle, WA
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Transcript of At the Forefront of Immunotherapy OTCQB: TPIV 1551 Eastlake Ave E Suite 100 Seattle, WA
At the Forefront of Immunotherapy
OTCQB: TPIV
1551 Eastlake Ave ESuite 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.
Corporate PresentationJuly 2012TAPIMMUNE
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.
Corporate PresentationJuly 2012OPPORTUNITY
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
Corporate PresentationJuly 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
TAPIMMUNEHarnessing the Power of Immune System
Corporate PresentationJuly 2012The 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)
Corporate PresentationJuly 2012 The Immunotherapy Space
New Frontier in Treatment of Cancer
PROBLEM: To Stimulate the Immunse System to Effectively KILL Tumors
Traditional ApproachesChemotherapy, Radiation, Surgery, Small Molecules
New ImmunotherapiesImmune Checkpoint Blockade (BMS; Merck)
Monoclonal antibodies (Roche)
T-Cell TherapiesEx-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)
Corporate PresentationJuly 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)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
Corporate PresentationJuly 2012Product Pipeline
Product Indication Preclinical Phase I Phase II
TPIV100 Class II antigens Her2/neu breast
cancer
TPIV110Class I + II antigens
Her2/neu breast cancer
TPIV200Folate Receptor AlphaQ2 2014
Ovarian/breast cancer
TPIV120 (PolyStart™ Class I/II antigens)
Her2/neu breast cancer
TPIV 300(Class I antigens)
Smallpox
Emerging viral threats
Corporate PresentationJuly 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
Corporate PresentationJuly 2012HER2/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, 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, 2014Small safety study100-150 patient multicenter phase II
Corporate PresentationJuly 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 (p373-382) - 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, 479-488
SOLUTION: most COMPREHENSIVE immunotherapeutic in development
Corporate PresentationJuly 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
Lead Clinical Programs Trial 2: Stage II/II Ovarian & Breast Cancer - Mayo Clinic
URGEN CLINCAL NEED - LARGE MARKET OPPORTUNITY
Corporate PresentationJuly 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 observedPromising Interim Results – Support progression to Phase ll
Licensing of Phase I
program
Restructure
StartPhase Ib/II
HER2/neu+
breast cancer
PolyStart IP
Folate AlphaBreast/Ovarian
PolyStart™
Finish Preclinical
FDA meetingViral Disease Smallpox Partnership
Start Phase II
TapImmune: 2014 Upcoming Milestones
Q1 Q2 Q3 Q4
NASDAQ
Multiple Inflection Points and Value Drivers
Corporate
Trial 1: Breast Cancer
Trial 2: Ovarian Cancer
Pre-Clinical
Bio-Threat
Corporate PresentationJuly 2012
COLLABORATORS & ADVISORSWorld 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 , BoardProduct Development: Cancer vaccines and Biodefense:Biomira, ID Biomedical, Baxter, Bayer AG
Denis Corin Corporate Finance
Corporate PresentationJuly 2012Management and Advisors
Mark ReddishAdvisor: Development, Board 25 years experience in cancer vaccines and biodefense Biomira, ID Biomedical, Baxter, Bayer AG
Denis CorinCorporate FinanceBeckman, Novartis
Glynn Wilson, PhDCEO25 years experience in product & corporate developmentSmithKline Beecham, Ciba-Geigy, Tacora
Bob Florkiewicz, PhDHead of Research25 years experience, academic and biotechSynergen, TSRI, UW, GSK, Seed IP Law Group
Corporate PresentationJuly 2012
CAP STRUCTURE and COMPSReorganized Feb 2014
TPIV - TAPIMMUNE INCCapital 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 $2.50LBIO (Lion Bio) 26,000,000 $ 180,000,000 $6.50INO (Inovio) 240,150,000 $ 565,550,000 $2.39DNDN (Dendreon) 157,490,000 $ 453,560,000 $2.88NWBO (Nothwest Bio) 53,400,000 $ 317,730,000
$5.99
Corporate PresentationJuly 2012OPPORTUNITY
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