Ovarian & Breast Cancer

January 30, 2018 | Author: Anonymous | Category: Science, Health Science, Immunology
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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.

Corporate Presentation TAPIMMUNE 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.

OPPORTUNITY Corporate Presentation 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

TAPIMMUNE

Corporate Presentation 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

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 Corporate Presentation 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

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

Product

Indication

TPIV100 Class II antigens

Her2/neu breast cancer

TPIV110 Class I + II antigens Her2/neu breast cancer

TPIV200 Folate Receptor Alpha Ovarian/breast cancer Q2 2014

TPIV120 (PolyStart™ Class I/II antigens) TPIV 300 (Class I antigens)

Her2/neu breast cancer

Smallpox Emerging viral threats

Preclinical

Phase I

Phase II

Lead Clinical Programs Corporate Presentation 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

HER2/neu Clinical Status Corporate Presentation July 2012

Her2neu Breast Cancer - Mayo Clinic Rochester MN

Phase l

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 lb/ll

Class II + Class I (p373-382) antigens (4+1) To start Q4, 2014 Small safety study 100-150 patient multicenter phase II

HER2/neu Clinical Program Corporate Presentation 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

Lead Clinical Programs Corporate Presentation 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

Ovarian Trial Clinical Status Corporate Presentation 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

Corporate

Trial 1: Breast Cancer

Trial 2: Ovarian Cancer

Q2

Restructure

Q3

Q4

NASDAQ Start Phase Ib/II

HER2/neu+ breast cancer Folate Alpha Licensing of Breast/Ovarian Phase I program

Pre-Clinical

PolyStart™

Bio-Threat

Viral Disease

Start Phase II

PolyStart IP

Finish Preclinical FDA meeting

Smallpox Partnership

Multiple Inflection Points and Value Drivers

Corporate Presentation COLLABORATORS & ADVISORS 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

Management and Advisors Corporate Presentation July 2012

Glynn Wilson, PhD

Bob Florkiewicz, PhD

CEO 25 years experience in product & corporate development

Head of Research 25 years experience, academic and biotech

SmithKline Beecham, Ciba-Geigy, Tacora

Denis Corin Corporate Finance Beckman, Novartis

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

Corporate Presentation CAP STRUCTURE and COMPS July 2012

Reorganized Feb 2014

TPIV - TAPIMMUNE INC Capital Structure Shares Outstanding Public Float Debt Elimination Market cap Stock Price

Post Restructure 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

Market Cap

105,240,000 26,000,000 240,150,000 157,490,000 53,400,000

$ $ $ $ $

250,000,000 180,000,000 565,550,000 453,560,000 317,730,000

Stock Price $2.50 $6.50 $2.39 $2.88 $5.99

OPPORTUNITY Corporate Presentation 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]

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