galena presentation 3 june 16
TRANSCRIPT
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ONCOLOGY FOCUSED IMMUNOTHERAPY COMPANY
Targeting Cancer Survivorship
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FORWARD LOOKING STATEMENT
This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about future expectations, plans and prospects for the development and commercialization of the Company's product candidates, including patient enrollment in our clinical trials, present or future licensing, collaborative or financing arrangements, expected outcomes with regulatory agencies, and projected market opportunities for product candidates are subject to a number of risks, uncertainties and assumptions, including those identified under Risk Factors in the Companys most recently filed Annual Report on Form 10-K and Quarterly Report on Form 10-Q and in other filings the Company periodically makes with the SEC. Actual results may differ materially from those contemplated by these forward-looking statements. The Company does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this presentation.
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LATE-PHASE, ONCOLOGY FOCUSED IMMUNOTHERAPY COMPANY
Targeted, 1st in Class therapies for prevention of cancer recurrence
Focused in large markets in areas of major unmet medical need Phase 3, PRESENT, breast cancer
clinical trial ongoing under SPA
Pioneering immunotherapy technology for cancer Induce, activate and cause
proliferation of Cytotoxic T-Cells Proven Mechanism of Action
through Expansion of Tumor Specific CTLs
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0.5 1.5 2.5 3.5 4.5 5.5 6.5 7.5 8.5 9.5 10.5Year
Haza
rd o
f rec
urre
nce
by y
early
inte
rval Total
Node 0Node 1-3Node (4+)Tumour size (3cm)ER+ER-PremenPostmen
Source: Early Breast Cancer Trialists Collaborative Group. Lancet. 1998;351:1451 ; Update of Houghton. J Clin Oncol. 2005; 23(16S):24s. Abstract 582 Saphner et al., J Clin Oncol. 14: 2738-2746, 1996
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DEVELOPMENT PIPELINE
Product Therapeutic Area Phase 1 Phase 2 Phase 3 BLA / NDA
Immunotherapy: Breast Cancer
NeuVax (nelipepimut-S) Node-positiveHER2 IHC 1+/2+
NeuVax + Herceptin Node-positive or node negative/triple negative HER2 IHC 1+/2+
NeuVax + Herceptin High risk, node-positive or negative, HER2 IHC 3+
NeuVax Ductal Carcinoma in Situ (DCIS)
Immunotherapy: Gastric Cancer
NeuVax Gastric, HER2 IHC 1+/2+/3+
Immunotherapy: Gynecological Cancer
GALE-301 Ovarian & Endometrial
GALE-301 + GALE-302 Ovarian & Breast
Hematology
GALE-401 (Anagrelide CR) MPN-related thrombocytosis
PRESENT
*NeuVax is an investigational product. Efficacy has not been established. Herceptin is a registered trademark of Genentech.
Ongoing Planned
VADIS
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2b
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Adds ~10k patients>$3B
Combo: High risk, HER2 3+
NEUVAX:SIGNIFICANT U.S. COMMERCIAL OPPORTUNITY
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adds ~10k patients>$2.5B
Combo Node Pos or NegHER2 1+, 2+
HLA-A2, A3, A24, A26
PRESENT50-60k patients
>$2B
Source: Global Data 2015/Medtrack. Pricing estimates based on a 20% premium to the current average annual price of Herceptin (U.S. Dollars).
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REDEFINING THE STANDARD OF CARE
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NOVEL DEVELOPMENT STRATEGY: SECONDARY PREVENTION IN CANCER SURVIVORS
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RECEIVES PRIMARY TREATMENT
Surgery Chemotherapy and/or Radiation
Disease freesurvivor
Breast: HER2, 1+/2+25% recurrence rate in 3 yrs
No FDA Approved targeted therapies
Breast: HER2, 3+ High Risk20% recurrence rate
DECLAREDTO PREVENT RECURRENCE / METASTATIC DISEASE
Breast: Ductal Carcinoma in Situ8-10% progression to invasive
Ovarian Cancer~50% recurrence rate in 1 yr
No FDA Approved targeted therapies
Watch & Wait, or
Repetitive therapies
TOLD
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PREVENTING RECURRENCE: UNMET MEDICAL NEED
NEUVAX PHASE 3 PRESENT TRIAL DEMOGRAPHIC:
Node positive, Stage 2a - 3a, HER2 1+/2+, HLA A2/A3
Local or Metastatic recurrent disease =
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Poor prognosis and/or Death
Patients have a ~25% Recurrence Rate
Prevention of recurrences saves lives!
Sources: 1 http://www.cancer.org/cancer/breastcancer/detailedguide/breast-cancer-survival-by-stage; 2 Sledge GW Jr: Curing Metastatic Breast Cancer. J Oncol Pract 12:6-10, 2016
5 year survival rate of metastatic cancer = 22%1
Low Tumor volume equates to improved overall survival 2
Occult tumor cells micrometastasis macrometastisis metastatic disease
http://www.cancer.org/cancer/breastcancer/detailedguide/breast-cancer-survival-by-stage
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UNIQUELY POSITIONED
14.5 million cancer survivors in US (NCI Cancer Survivorship)
Projected to 19 million survivors in 2024
Increase in survival due to decades of productive research, improved screening/prevention, and effective treatments
Survival leads to patients living longer 64% alive after 5 years of diagnosis 41% alive after 10 years of diagnosis 15% alive after 20 years or longer
Galena peptide vaccines NeuVax and GALE-301 are uniquely positioned to maintain survivorship
9Source: DeSantis CE et al. CA Cancer J Clin 2014: 64:252-271
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CANCER IMMUNOTHERAPY WITH INNOVATIVE TECHNOLOGY
Overcoming Cancer by Activating and Expanding Cytotoxic T-Cells
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FIRST-IN-CLASS, TARGETED IMMUNOTHERAPY PIPELINE
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Harnessing the power of the
immune system in the adjuvant setting
Exploits specificity of natural immune surveillance
Adjuvant patients have healthy immune systems
Systemic protection
Goal is to prevent recurrence
Recurrences are almost always fatal
Minimal toxicity and improved safety profile
Boosters provide long term protective effect
Well-validated targets
HER2
Folate binding protein (FBP)
Current Programs
NeuVax (nelipepimut-S)
Breast: HER2 1+, 2+ and 3+; DCIS
Gastric trial planned
GALE-301 & GALE-302
Ovarian
Adjuvant Setting = Minimal Residual Disease
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T-Cell
Activating Receptors Inhibitory Receptors
CD28
OX40
GITR
CD122
CD27
CD360
HVEM
CD137
CTLA-4
PD-1
TIM-3
BTLA
VISTA
LAG-3
IMMUNO-ONCOLOGY:UNLOCKING THE POWER OF THE T-CELL
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Checkpoint inhibitors
Indirect Immune Modulators
Co-stimulators
Immune Inhibitory Enzymes
CAR TTechnology
TCRTechnology
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T-Cell
Activating Receptors Inhibitory Receptors
CD28
OX40
GITR
CD122
CD27
CD360
HVEM
CD137
CTLA-4
PD-1
TIM-3
BTLA
VISTA
LAG-3
LACK OF REACTIVE T-CELLS MAY RENDER SOME TOOLS INEFFECTIVE IN MANY CANCERS
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Checkpoint inhibitors
Indirect Immune Modulators
Co-stimulators
Immune Inhibitory Enzymes
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T-Cell
CD28OX40
GITR
CD122
CD27
CD360
HVEM
CD137
CTLA-4
PD-1
TIM-3
BTLA
VISTA
LAG-3
Activating Receptors Inhibitory Receptors
OUR VACCINES STIMULATE T-CELL PROLIFERATION AND EXPANSION
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T cells
Checkpoint inhibitors
Indirect Immune Modulators
Co-stimulators
Immune Inhibitory Enzymes
T cells
T cells
T cells
T cells
T cells
T cells
T cells
T cells
T cells
GALE-301
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NEUVAX (nelipepimut-S)
Targeting HER2
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NEUVAX: HER2 IMMUNODOMINANT PEPTIDE
NeuVax contains the immunodominant peptide derived from the extracellular region of the HER2 protein
Peptide (aa 369-377) immunotherapy administered as intradermal injection
MHC Class I: HLA A2/A3
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K I F G S L A F L
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ELICITS A STRONG CD8+ T-CELL RESPONSE
NeuVax binds to antigen presenting cells (APCs)
NeuVax stimulates APCs to activate CD8+ cytotoxic T lymphocytes (CTLs)
CTLs rapidly replicate to seek out and destroy HER2 expressing tumor cells and micro-metastases
Booster series maintains long term immunologic response
Demonstrated inter- and intra-antigenic epitope spreading
17Sources: Peoples GE, et al (2005) JCO, 23(300, 7536-7545; Mittendorf EA, et al (2006) Surgery, 139(3): 407-418. Peoples, et al, ASCO 2012 Poster Presentation
0.4
1.8
0.70.5
0.0
0.5
1.0
1.5
2.0
2.5
% N
euVa
xsp
ecifi
c C
D8+
T c
ells
NeuVax Specific CD-8 CTLs: Pre-, Post, Mean and Long-Term (6 months)
Pre Max Mean Long-Term
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POSITIVE SAFETY PROFILE
NeuVax is well-tolerated in multiple clinical trials
Phase 1/2 showed predominantly Grade 1/2 Adverse Events caused by GM-CSF(n=53) Injection site reactions in nearly all patients
demonstrating the activated dendritic cells Systemic toxicities caused by GM-CSF Fatigue (64%) Headache (42%) Myalgia/Other Pain (30%)
August 2015 Independent Data Monitoring Committee
(IDMC) recommended to the Company that it can reduce the cardiac toxicity monitoring in its Phase 3 PRESENT clinical trial
18Sources: Choy, et al, poster presentation 33rd Annual Chemotherapy Foundation
Symposium: Nov 2015; Mittendorf- Annals of Oncology 25: 17351742, 2014
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NEUVAX: SN-33 PHASE 2 HER2 IHC 1+/2+
19Source: 2012 San Antonio Breast Cancer Poster, Mazanet, et al.
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PHASE 3, PRESENT TRIAL
Prevention of Recurrence in Early-Stage, Node Positive Breast Cancer with Low to Intermediate Her2 Expression with NeuVax Treatment Trial being run under FDA-approved SPA
Enrollment completed in April 2015 (n=758) Adjuvant breast cancer patients, Node Positive, HER2 1+/2+, HLA A2/A3+
Patient friendly regimen via intradermal injection Primary Vaccine Series injection once a month for 6 months Booster Series injection once every 6 months
Upcoming Key Milestones Interim safety/futility analysis: 2Q16 Primary Endpoint: 2018
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PHASE 3 PRESENT TRIAL PER SPA
1 2 3 4
Interim analysis by DSMB at n=70 events
Endpoint DFS at n=141 events /36 months
Dosing by Month + 1 booster dose every 6 months thereafter
5 6
Adjuvant breast cancer patients, randomized 1:1
Double blind
Node positive
HLA A2/A3+
HER2 IHC 1+/2+
Stratified by stage, type of surgery, hormone receptor, and menopausal status
Enrollment complete: n=758 Patients
Study Population + GM-CSF
Placebo + GM-CSF
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Prevention of Recurrence in Early-Stage, Node Positive Breast Cancer with Low to Intermediate Her2 Expression with NeuVax Treatment
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PRESENT INTERIM ANALYSIS
70 Events Confirmed by the EAC
Endpoint Adjudication Committee confirms 70 events
Independent team of 2 Oncologists and 1 Radiologist
Galena Compiles
Data
Prepares a detailed review on 70 patients with events and overall safety data set (n=758)
Submits to IDMC
IDMC Evaluates
Evaluates 70 patients with events and overall safety data set (n=758)
Makes recommendation on futility and continuation of trial
Interim Analysis Results
Estimated timing: End of Q2
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PRIMARY PREVENTIONExpansion potential for safe vaccine in DCIS
METASTATIC DISEASEExpansion potential in combination with checkpoint inhibitors /immune modulators
NEUVAX: ACROSS THE BREAST CANCER TREATMENT SPECTRUM
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PROOF OF CONCEPT: Established in population with no standard of care treatment options
SECONDARY PREVENTION
IDEAL SETTING: Adjuvant treatment in patient population with no evidence of disease
MOST ADVANCED: PRESENT is the largest and only Phase 3 breast cancer vaccine trial
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NEUVAX: DEVELOPMENT COLLABORATIONS
Phase Treatment HER2 Status Indication Trial StatusProtocol Defined
# of PatientsCollaborations
3Single agent
PRESENTStudy
1+, 2+BREAST
Node PositiveHLA A2+, A3+
Enrolled13 countries~140 centers
700(enrolled 758)
2bCombination
with trastuzumab
1+, 2+
BREAST Node Positive or High Risk Node Negative
HLA A2+, A3+, A24+, A26+
EnrollingU.S. only
33 centers300
2Combination
with trastuzumab
3+ high risk
BREASTNode PositiveHLA A2+, A3+
EnrollingU.S. only
28 centers100
2 Single agentVADIS Study1+,
2+,3+
BREASTDuctal Carcinoma in
Situ (DCIS)HLA A2+
PlannedU.S. only4 centers
48
2 Single agent 1+, 2+,3+GASTRIC
HLA A2+, A3+Planned
India Only 50
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Targeting Folate Binding Protein
GALE-301 & GALE-302
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GALE-301 & GALE-302
26Source: U.S. Ovarian Cancer http://seer.cancer.gov/statfacts/html/ovary.html
Targeted cancer immunotherapy
Folate Binding Protein (FBP) is over-expressed (20-80 fold) in >90% of ovarian and endometrial cancers
FBP has very limited tissue distribution and expression in non-malignant tissue making it an ideal immunotherapy target
Current treatments are generic Carboplatin and paclitaxel High recurrence rate
Most patients relapse with poor prognosis
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GALE-301: OPTIMAL DOSE GROUP SHOWS PRELIMINARY EFFICACY
Source: Peoples, et. al, Poster Presentation, European Cancer Congress 2015 27
Phase 1/2a trial ongoing Phase 1: Determined optimal dose and
demonstrated safety and potent immune response
Phase 2a Preliminary data in 1000 mcg dose group:
At 12 months median follow-up:
Vaccine group: 2 clinical recurrences (13.3%) n=15
Control group: 12 recurrences (55%) n=22
Two year DFS estimate in 1000 mcg dose group is 85.7% vaccine vs. 33.6% control (p
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GALE-301 & GALE 302: PHASE 1DELAYED-TYPE HYPERSENSITIVITY
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LEGENDEE = E39 (GALE-301) x 6 inoculations (n=12)EE = E39 (GALE-301) x 3 inoculations followed by E39 (GALE-302) x 3 inoculations (n=14)EE = E39 (GALE-302) x 3 inoculations followed by E39 (GALE-301) x 3 inoculations (n=13)
R0 = baseline (pre-vaccination)RC1 = 1 month after completion of the PVSRC6 = 6 months after completion of the PVS and pre-booster
Source: Mittendorf et. al., Poster Presentation, Society of the Immunotherapy of Cancer 2015
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GALE-401
Anagrelide Controlled Release (CR)
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GALE-401 ANAGRELIDE CONTROLLED RELEASE (CR)
Anagrelide
Active ingredient Reduces the elevated platelet count and the risk of thrombosis in patients with
myeloproliferative neoplasms (MPNs) MPNs are hematological malignancies in which the bone marrow cells develop and function
abnormally
Immediate Release
Approved for the treatment of patients with thrombocythemia, secondary to MPNs IR formulation can cause unacceptable side effects believed to be Cmax-related and has largely
limited the use due to early treatment withdrawal
GALE-401
Controlled Release (CR) formulation may decrease the frequency or severity of side effects Phase 2, Proof-of-Concept Trial Results
Well tolerated with primarily Grade 1 and 2 toxicities Efficacy compares favorably to historical anagrelide IR
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CORPORATE OVERVIEW
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1st IN CLASS PROGRAMS WITH EXPANSION OPPORTUNITIES
Mid-stage clinical trials have proven T-cell generation NeuVax (nelipepimut-S) Phase 2 trial demonstrated 2% of the patients
T-Cells become CD8+, HER2 directed
GALE-301 Phase 1/2: Two year DFS estimate in optimal dose group is 85.7% vaccine vs. 33.6% control (p
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LEADERSHIP TEAM
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Mark W. Schwartz, Ph.D., President & CEOApthera, Bayhill Therapeutics, Calyx Therapeutics, Trega Biosciences, Incyte Genomics, DuPont Diagnostics
Bijan Nejadnik, M.D., Executive Vice President, Chief Medical Officer Jazz Pharmaceuticals, Johnson & Johnson, Stanford, Johns Hopkins, UC Davis
Remy Bernarda, SVP, Investor Relations & Corporate CommunicationsIR Sense, Hana Biosciences, Knight Equity Markets, Bear Stearns, Goldman Sachs
Gavin Choy, Pharm.D., SVP, Clinical Sciences & OperationsOtsuka, Astex, SuperGen, Hana Biosciences, Gilead, Stanford University Medical Center, Department of Veteran Affairs
Tom Knapp, Esq., Interim General Counsel Sucampo, Exemplar Law Partners, NorthWestern Energy, Paul Hastings, The Boeing Company
Joe Lasaga, VP, Business Development & Alliance ManagementNektar Therapeutics, Rigel
Pat Murphy, VP, Regulatory Affairs & ComplianceNektar Therapeutics, Bayhill Therapeutics, Berlex Laboratories, Serono, Parexel, Biogen
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2016 MILESTONES
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PROGRAM MILESTONEPROJECTED
DATE
NeuVax(nelipepimut-S)
PRESENT: Achieve 70 Qualifying DFS Events Fast Track Designation Initiate DCIS trial Q2
PRESENT: Interim analysis Q2
Combo H&N 1+/2+ Interim safety data Q4
Combo H&N 1+/2+ A24/A26 data Q4
GALE-301GALE-302
Present 301/302 booster data Present GALE-301 Phase 2a two year data Q4
GALE-401 (anagrelide CR)
Present combined safety data Q2
Confirmation of 505(b)2 pathway 2H
Publish final Phase 2 report Q4
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FINANCIAL OVERVIEW
Cash Position (as of March 31, 2016) $34.7 million
Debt Financing (May 10, 2016) + $23.4 million
Payoff Remaining Oxford Debt (May 10, 2016) - $3.1 million
Q2 Projected Operating Burn $13 - $15 million
Includes legal settlement & fees ~$4-$5 million
Future Projected Quarterly Burn $9 - $11 million
Shares Outstanding 182 million
Market Cap (as of June 2, 2016) ~$375 million
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WHY WERE HERE
36Source: E75 vaccine's final tests start in S.A. By Don Finley, January 22, 2012; Photo credit: Kin Man Hui/San Antonio Express-News/ZUMAPress
I've had several friends who've had (breast cancer) and thenit came back and they had to go through treatment again. So this would be wonderful, not to have to come back.
First NeuVax Phase 3 patient
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THANK YOU
NASDAQ: GALE
ONCOLOGY FOCUSED IMMUNOTHERAPY COMPANYFORWARD LOOKING STATEMENTLATE-PHASE, ONCOLOGY FOCUSED IMMUNOTHERAPY COMPANYDEVELOPMENT PIPELINENEUVAX:SIGNIFICANT U.S. COMMERCIAL OPPORTUNITYREDEFINING THE STANDARD OF CARENOVEL DEVELOPMENT STRATEGY: SECONDARY PREVENTION IN CANCER SURVIVORSPREVENTING RECURRENCE: UNMET MEDICAL NEEDUNIQUELY POSITIONEDCancer Immunotherapy with Innovative TechnologyFIRST-IN-CLASS, TARGETED IMMUNOTHERAPY PIPELINEIMMUNO-ONCOLOGY:UNLOCKING THE POWER OF THE T-CELLLACK OF REACTIVE T-CELLS MAY RENDER SOME TOOLS INEFFECTIVE IN MANY CANCERSOUR VACCINES STIMULATE T-CELL PROLIFERATION AND EXPANSIONNEUVAX (nelipepimut-S)NEUVAX: HER2 IMMUNODOMINANT PEPTIDE ELICITS A STRONG CD8+ T-CELL RESPONSEPOSITIVE SAFETY PROFILENEUVAX: SN-33 PHASE 2 HER2 IHC 1+/2+PHASE 3, PRESENT TRIALPHASE 3 PRESENT TRIAL PER SPAPRESENT INTERIM ANALYSISNEUVAX: ACROSS THE BREAST CANCER TREATMENT SPECTRUMNEUVAX: DEVELOPMENT COLLABORATIONSGALE-301 & GALE-302GALE-301 & GALE-302GALE-301: OPTIMAL DOSE GROUP SHOWS PRELIMINARY EFFICACYGALE-301 & GALE 302: PHASE 1DELAYED-TYPE HYPERSENSITIVITYGALE-401GALE-401 ANAGRELIDE CONTROLLED RELEASE (CR)CORPORATE OVERVIEW1st IN CLASS PROGRAMS WITH EXPANSION OPPORTUNITIESLEADERSHIP TEAM2016 MILESTONESFINANCIAL OVERVIEWWHY WERE HERETHANK YOU