tap immune presentation

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1 New Generation of T-cell Therapeutics April, 2017 NASDAQ: TPIV

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Page 1: Tap Immune Presentation

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New Generation of T-cell Therapeutics

April, 2017

NASDAQ: TPIV

Page 2: Tap Immune Presentation

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Certain statements contained herein are forward-looking statements withinthe meaning of the safe harbor provisions of the Private Securities LitigationReform Act of 1995. Forward-looking statements in this document include, butare not limited to, statements relating to long-term stability, the Company'splan of operations and finances, the potential for the Company's vaccines andproposed clinical trials.

The reader is cautioned that any such forward-looking statements are notguarantees of future performance and that actual results may differ materiallyfrom estimates in the forward-looking statements. The Company undertakesno obligation to revise these forward-looking statements to reflect events orcircumstances after the date hereof.

Safe Harbor Statement

Page 3: Tap Immune Presentation

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• Lead Vaccine Candidate in Four Phase 2 Clinical Studies Focused on Women’s Cancers: Breast, Ovarian

• Robust, sustained immune responses in Phase 1• FDA Fast Track and Orphan Disease Designation

• T-Cell Vaccines Overcome Deficiencies of Earlier Approaches• Carefully selected antigens generate memory T-cell response

against tumor-overexpressed self-antigens

• Addresses Tumors Resistant to Other Immunotherapies• T-cell impermeable, immunologically inert tumors with high recurrence• Standalone or in combination: chemotherapy and/or immunotherapy

Emerging Leader in T-Cell Immunotherapy

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• Initially Focused on Ovarian and Breast Cancers• Resistant to most immunotherapies• Time to recurrence is relatively short • Survival prognosis is extremely poor after recurrence

• Large U.S. Market (newly diagnosed patients per year): • Ovarian Cancer: ~30,000 • Breast Cancer: 40,000 triple-negative; ~220,000 HER2/neu

• Addressing Treatment- Patients in Need• Prevent recurrence (consolidation therapy)• Improve outcomes for patients resistant to first-line therapies

• Phase 2 Collaborations with Industry & Clinical Leaders:

Significant Opportunity in Women’s Cancers

Page 5: Tap Immune Presentation

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Multi-epitope peptide vaccines:• TPIV 200 against Folate Receptor Alpha

• Ovarian; TNBC; NSCLC• TPIV 100/110 against HER2neu

• Her2neu; ovarian; colorectal

PolyStart™:• DNA vector for multiple antigens

• Self antigens/neo-antigens

Technologies & Targets

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• Target-driven: Does Not Rely on Exposing Neo-Antigens • Molecules over-expressed by majority of cancer cells (90% ovarian) ;

correlate with disease prognosis

• Discovered through translational medicine• Naturally processed antigens derived from patient immune responses• MHC class I and II antigens activate CD4+ (helper) and CD8+ (Killer) T cells

• Elicits durable “memory” anti-tumor response• Targets primary tumor and metastases/circulating tumor cells

• Off-the-Shelf Product • Easy, low-cost manufacturing

TPIV 200

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• TPIV 200

Clinical Pipeline – Phase I Results

Ovarian and Breast Cancer patients at

Safe and well tolerated

95% evaluable patients generated robust T-cell responses

100% demonstrated T-cell responses lasting >6 months

Abstract published – ASCO 2015

Led to significant collaborations, multiple Phase II studies

Page 8: Tap Immune Presentation

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Indication Design Preclin. Phase 1 Phase 2 Sponsors/Collaborators

TPIV 200

Ovarian Cancer(platinum-resistant)

Combo with durvalumab(anti PD-L1)

Triple-NegativeBreast Cancer

Dose & BoostSafety

Ovarian Cancer(platinum-sensitive)

Time to progression

Triple-NegativeBreast Cancer

Time to progression

TPIV 110 Her2/neu Breast Cancer

Preparing Phase 1/2

Enrolling Phase 2

Mid-Stage Pipeline - Multiple Shots on Goal

Enrolling Phase 2

Phase 2-Ready

Enrolling Phase 2

IND filing in 2017

Fully Funded

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Phase 2 Study Design: TPIV 200 + Durvalumab

Currently Enrolling Platinum-Resistant Ovarian Cancer Patients:• Disease progression within six months of recent platinum-based therapy• Progression while receiving platinum-based therapy• No prior treatment with PD-1 or PD-L1 inhibitors

TPIV 200 + GM-CSF (1x / cycle I.D.; day 1; cycles 1-6)

Durvalumab (2x / cycle I.V.; day 1 and day 15; cycles 1-12)

Cycle Follow UpUntil Progression

1 2 3 4 5 6 7 8 9 10 11 12

Radiographic Tumor Assessment(every 12 weeks)

Patients: 40 total: over 50% recruited; MSKCC plus 6 satellite sitesPrimary Endpoint: Overall Response Rate (RECIST*)Upcoming Milestones: Interim analysis & Go/No Go decision September 2017

* Pre-defined deviations from RECIST will be permitted to allow select patients deemed to be benefitting from treatment to receive continued therapy

Sponsor: MSKCC

Page 10: Tap Immune Presentation

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Phase 2 Study Design: TPIV 200 Maintenance Therapy

Currently Enrolling Recurrent Platinum-Sensitive Ovarian Cancer Patients:• Confirmed sensitivity (CR/PR or SD after last platinum regimen)• Start study treatment within 12 weeks of last platinum-based dose

Treatment Period(I.D. at 4-week intervals)

Month

18-month Follow Up

1 2 3 4 5 6

Radiographic Tumor Assessment(every ~12 weeks; up to two years)

Patients: 100: up to 15 sitesPrimary Endpoint: Time to disease progression/recurrence (RESIST)Secondary Endpoints: Overall Survival, Response Rate (CRs+PRs; CRs+PRs+SDs; irRESIST), CA 125 response, Progression-Free Rate at 6 months (PFR)Upcoming Milestones: Interim analysis Q3 2018

Sponsor: TapImmune

< 12 weeks

Platinum Therapy

Randomize 1:1

TPIV 200 + GM-CSF (Active)

GM-CSF Alone (Control)

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Sponsor: TapImmune

Phase 2 Study Design: TPIV 200 for Triple-Negative Breast

Currently Enrolling Stage IIb-III Triple-Negative Breast Cancer Patients:• Completed surgery and radio/chemotherapy <360 days from consent• 4-arm study: High/Low dose TPIV 200 +/- cyclophosphamide (CP)

CP: 300 mg/m2

60min infusionTPIV 200: I.D. injection500µg (high) and 165µg (low)/peptide

>60 days

Radio/Chemotherapy

Randomize 1:1:1:1

Arm 1: TPIV 200 + GM-CSF ( + CP)

Arm 4: TPIV 200 + GM-CSF ( - CP)

Arm 3: TPIV 200 + GM-CSF ( + CP)

Arm 2: TPIV 200 + GM-CSF ( - CP)

+ CP

- CP

+ CP

- CP

Patients 80: Positive DSMB recommendation after 25%; full recruitment by end of 2017 at 12 sitesUpcoming Milestone : interim analysis Q4, 2017

Page 12: Tap Immune Presentation

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TPIV 110 Clinical Development Plan

Sponsor/IND Holder

Collaborators N Status Indication Study Design

n/a TBD Planned2017 start Breast Cancer Phase 1b/2a

TBD 2017 start DCIS Breast Cancer Phase 1b/2a

TapImmune

TapImmune

Page 13: Tap Immune Presentation

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Combination Immunotherapy is the Future in Oncology

SOC = standard of care

SOC

Ipilimumab

Ipilimumab +Anti-PD-1

Time

%Su

rviv

al

0

100Combination Therapy:• Vaccines• Checkpoint Inhibitors• Adjuvants• Oncolytic Viruses• CAR T Cells

Checkpoint Inhibitors

Chemotherapy

TapImmune Opportunity: Unlock Promise of Immunotherapy for Certain Cancers That Do Not Respond to Checkpoint Inhibitors

Page 14: Tap Immune Presentation

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PolyStart™ - Proprietary Protein Expression System

• Unique Protein Expression Technology that Increases Potency of DNA-based Immunotherapies

• Driving incremental value for TapImmune• Proprietary technology invented and owned by TPIV• Applications for oncology and infectious diseases• Application to self-antigens and neo-antigens in cancer• High potential to monetize via out-license to partners

• Advancing in preclinical studies• Recent patent approvals• New constructs for breast and ovarian cancer synthesized

Enhanced Immune Response

Enhanced Antigen Presentation to Killer T-cells

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PolyStart™ and Poly-Antigen Array (PAA)

Modular Design: PAA portion designed for rapid, straight forward replacement

5’……….CUG….CUG…CUG……..AUG………..(PAA)…..TAA…3’

PolyStart Portion PAA Portion(T-Cell Epitopes)

NH2

mRNA

Translation NH2 NH2 NH2

PAA COOHPAAPAAPAA

COOHCOOHCOOH

(one mole)

(four moles)

4 aa

kDa3525

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Protein antigens are a key component of most cancer immunotherapy

DNA approach is attractive, but protein expression is variable to poor

Normally : 1 DNA 1 RNA 1 Protein

PolyStart : 1 DNA + PolyStart™ 4 or more Proteins

Page 16: Tap Immune Presentation

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Experienced Management TeamGlynn Wilson, Ph.D.Founder, Chairman & CEO• Extensive track record of success in corporate management and product development at major

multinational pharmaceutical companies and startups. Former Worldwide Head of Drug Delivery at SmithKline Beecham and Research Area Head in Advanced Drug Delivery at Ciba-Geigy.

John Bonfiglio, Ph.D., MBAPresident and COO• 30 plus years in development and executive roles in pharmaceutical/biotechnology – large and small

companies. C-level roles at Peregrine Pharmaceuticals, Cypress Biosciences, the Immune Response Corporation, Argos Therapeutics, Oragenics.

Michael LoiaconoCFO & Chief Accounting Officer• 25 plus years of financial management experience and executive roles in private and publicly traded

organizations such as Global Axcess.

Robert Florkiewicz, Ph.D.Director of Research• Extensive experience in molecular biology research and intellectual property development at Scripps

Institute, Synergen, ID Bio Medical and Seed Intellectual Law Group.

Elizabeth DonnellyDirector of Administration• 20 years of experience in Human Resources and Administration with APL Logistics, System Designs,

Ability Network, and Interline Brands.

Page 17: Tap Immune Presentation

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Medical and Scientific Advisors

Keith Knutson, Ph.D.• Director, Immunotherapy and Cancer Vaccine Program, Mayo Clinic,

Jacksonville, FL • Discoverer of current HER2/neu and FRA peptide antigens

Edith A. Perez, M.D.• Deputy Director at Large for Mayo Clinic Cancer Center in Jacksonville, FL • Professor at Mayo Clinic College of Medicine and Chair of the Mayo Clinic

Breast Cancer Translational Genomics Program

Mark Pegram, M.D.• Director of the Breast Cancer Oncology Program at Stanford Women’s Cancer

Center• Co-director of Stanford’s Molecular Therapeutics Program

Page 18: Tap Immune Presentation

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Clinical and Partnership Strategies in 2017

Initiative

Complete Phase 2 proof-of-concept studies

Seek Pharma/Biotech partners for late-stage development and commercialization

Explore combination regimens

Seek synergistic technologies for acquisition, licensing or joint R&D, e.g. antigens; checkpoint inhibitors

Seek to monetize PolyStart™ expression platform

Status

Four Phase 2’s Ongoing~$17 million in non-dilutive funding

Ongoing

Ongoing Phase 2 vaccine + AZ’s anti-PD-L1 (durvalumab)

Focusing on cancer immunity cycle and women’s cancers

Working to establish collaborations in cancer & viral disease

Page 19: Tap Immune Presentation

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Why Invest in TapImmune Now?

Potential to be dominant player in T-cell cancer vaccines

Highly vetted technology: Mayo Clinic, DoD, AstraZeneca, Sloan Kettering

Evaluating cancer vaccines in four Phase 2 studies – FDA Fast Track, Orphan Disease Status

Compelling Phase 1 data show durable immune response against vaccine targets

Multiple upcoming clinical value inflection points

Internally developed Next Generation Vaccine Technology -PolyStart

Capital efficient development strategy

Experienced management and advisory team

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Equity Overview

Capital Structure Shares Outstanding 8.4MPublic Float 6.7MMarket cap 40M (03/06/17)Stock Price $4.73 (03/23/17)Volume (3m): ~48 K

2016 FinancingWarrant exercise ($6.0M)Private Placement ($3.1M)

TapImmune trades on NASDAQ (TPIV)

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CONTACT:

GLYNN WILSON

Chief Executive Officer

[email protected]

NASDAQ: TPIV