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ONCOLOGY FOCUSED IMMUNOTHERAPY COMPANY Targeting Cancer Survivorship
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  • ONCOLOGY FOCUSED IMMUNOTHERAPY COMPANY

    Targeting Cancer Survivorship

  • 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.

    2

  • 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

    3

    0

    5

    10

    15

    20

    25

    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

  • 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

    4

    2b

  • Adds ~10k patients>$3B

    Combo: High risk, HER2 3+

    NEUVAX:SIGNIFICANT U.S. COMMERCIAL OPPORTUNITY

    5

    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).

  • REDEFINING THE STANDARD OF CARE

    6

  • NOVEL DEVELOPMENT STRATEGY: SECONDARY PREVENTION IN CANCER SURVIVORS

    7

    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

  • 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 =

    8

    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

  • 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

  • CANCER IMMUNOTHERAPY WITH INNOVATIVE TECHNOLOGY

    Overcoming Cancer by Activating and Expanding Cytotoxic T-Cells

    10

  • FIRST-IN-CLASS, TARGETED IMMUNOTHERAPY PIPELINE

    11

    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

  • 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

    12

    Checkpoint inhibitors

    Indirect Immune Modulators

    Co-stimulators

    Immune Inhibitory Enzymes

    CAR TTechnology

    TCRTechnology

  • 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

    13

    Checkpoint inhibitors

    Indirect Immune Modulators

    Co-stimulators

    Immune Inhibitory Enzymes

  • 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

    14

    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

  • NEUVAX (nelipepimut-S)

    Targeting HER2

  • 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

    16

    K I F G S L A F L

  • 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

  • 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

  • NEUVAX: SN-33 PHASE 2 HER2 IHC 1+/2+

    19Source: 2012 San Antonio Breast Cancer Poster, Mazanet, et al.

  • 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

    20

  • 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

    21

    Prevention of Recurrence in Early-Stage, Node Positive Breast Cancer with Low to Intermediate Her2 Expression with NeuVax Treatment

  • 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

    22

  • 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

    23

    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

  • 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

    24

  • Targeting Folate Binding Protein

    GALE-301 & GALE-302

  • 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

  • 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

  • GALE-301 & GALE 302: PHASE 1DELAYED-TYPE HYPERSENSITIVITY

    28

    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

  • GALE-401

    Anagrelide Controlled Release (CR)

  • 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

    30

  • CORPORATE OVERVIEW

    31

  • 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

  • LEADERSHIP TEAM

    33

    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

  • 2016 MILESTONES

    34

    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

  • 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

    35

  • 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

  • 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


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