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 Company’s 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

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

Haz

ard

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curr

ence

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ly in

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al

TotalNode 0

Node 1-3Node (4+)

Tumour size (<1cm)Tumour size (1.1-3cm)

Tumour size (>3cm)ER+

ER-Premen

Postmen

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

GALE-301 + GALE-302 Ovarian

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

2b

1b

2b

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Adds ~10k patients>$3B

Combo: High risk, HER2 3+

NEUVAX:SIGNIFICANT U.S. COMMERCIAL OPPORTUNITY

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

RECEIVES PRIMARY TREATMENT

• Surgery

• Chemotherapy

• and/or Radiation

Disease free“survivor”

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 Situ 8-10% progression to invasive

Ovarian Cancer

~50% recurrence rate in 1 yrNo 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 =

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

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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

Source: 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

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

Checkpoint inhibitors

Indirect Immune Modulators

Co-stimulators

Immune Inhibitory Enzymes

CAR TTechnology

TCRTechnology

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TUMOR-SPECIFIC CYTOTOXIC T-CELLS ARE CRUCIAL FOR EFFICACY OF IMMUNOMODULATORY ANTIBODIES

Peptide based vaccination such as NeuVax effectively induce, activate and expand Cytotoxic T-Cells (CTLs)

Immunomodulatory antibodies should be administered when tumor-specific CTLs are present. If the number of CTLs is insufficient, they should be induced.

Source: Aerts, Cancer Res; 73(8) April 15, 2013 2385

It is evident that approaches to increase T-Cell expansion, homing, and effector functions while simultaneously targeting immunosuppression are needed

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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

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

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

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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

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

Sources: 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

0.00.20.40.60.81.01.21.41.61.82.0

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1.8

0.70.5

NeuVax Specific CD-8 CTLs: Pre-, Post, Mean and Long-Term (6 months)

% N

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ax s

peci

fic C

D8+

T c

ells

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

Sources: Choy, et al, poster presentation 33rd Annual Chemotherapy Foundation Symposium: Nov 2015; Mittendorf- Annals of Oncology 25: 1735–1742, 2014

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

Source: 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

• Final 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

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

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NEUVAX: BREAST CANCER FRANCHISE

Phase Treatment HER2

Status Indication Trial StatusProtocol Defined

# of PatientsCollaborations

3Single agent

PRESENT Study

1+, 2+ Node PositiveHLA A2+, A3+

Enrolled13 countries~140 centers

700(enrolled 758)

2bCombination

with trastuzumab

1+, 2+Node Positive or High

Risk Node NegativeHLA A2+, A3+,

A24+, A26+

EnrollingU.S. only

34 centers300

2Combination

with trastuzumab

3+ high risk

Node PositiveHLA A2, A3+

EnrollingU.S. only

30 centers100

2 Single agentVADIS Study

1+, 2+,3+

Ductal Carcinoma in Situ (DCIS)HLA A2+

Planned4 U.S. sites 48

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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

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

Targeting Folate Binding Protein

GALE-301 & GALE-302

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GALE-301 & GALE-302

Source: 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-301/302 FILLS AN UNMET MEDICAL NEED FOR A SIGNIFICANT NUMBER OF OVARIAN CANCER PATIENTS

Limited competition in early stage setting represents a large commercial opportunity

2021 2022 2023 2024 2025 2026 2027 2028 20290

2000

4000

6000

8000

10000

12000

14000

16000

18000Estimated HLA-A2+ Qualified Patient Population

ASSUMPTIONS• Avg 80% of NED

patients post-surgery• 70% Penetration• 80-90% PVS/Booster

compliance• High Recurrence rates• No adjuvant

treatment options outside chemo

Source: DR/Decision Resources, LLC

CURRENT CLINICAL DEVELOPMENT

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Phase Treatment Cancer Type Target Indication

Current Status

# of Enrolled Patients

1/2a GALE-301Ovarian,

EndometrialHLA A2+

Ovarian Enrolled 51

1b GALE-301 & GALE-302

Ovarian, Breast HLA A2+ Ovarian Enrolled 39

GALE-301: OPTIMAL DOSE GROUP SHOWS PRELIMINARY EFFICACY

Source: Peoples, et. al, Poster Presentation, European Cancer Congress 2015 29

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<.02)

• GALE-301 plus GM-CSF is well tolerated and elicits a strong in vivo immune response with primarily Grade 1 and Grade 2 toxicities

2 Year DFS Estimate by Dose Cohort

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GALE-301 & GALE 302:DELAYED-TYPE HYPERSENSITIVITY

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)E’E = 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)

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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 Ongoing• Galena to seek confirmation of the 505(b)(2) regulatory pathway

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GALE-401: PHASE 2 PILOT STUDY FINAL RESULTS

Source: ASH 2015 Poster Presentation, Verstovsek et al.

Well tolerated with primarily Grade 1 and 2 toxicities in n=14/18

Efficacy compares favorably to historical anagrelide IR

• Platelet response: ORR = 83.3% (15/18) CR = 61.1% (11/18) PR = 22.2% (4/18)

• Median time to response was 1 to 9 weeks (defined as platelet count ≤ 600 x109/L)

Anagrelide IR historical time to response ranged from 4 to 12 weeks

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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 patient’s

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<.02)

Targeting “high value” settings: Prevention of recurrence in breast and ovarian cancer are areas of clear unmet medical needs • No approved drugs for these women with limited late stage competition

Multiple trials ongoing as stand-alone therapies and in-combination with other agents

Breast & Ovarian are just a start – HER2 and Folate Binding Protein expressed in numerous cancer types

HER2

Breast

Gastric

Prostate

Non-Small Cell Lung

Bladder

Colorectal

Ovarian

Folate Binding Protein

Ovarian

Endometrial

Breast

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LEADERSHIP TEAM

Mark W. Schwartz, Ph.D., President & CEO Apthera, 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 Management

Nektar Therapeutics, Rigel

Pat Murphy, VP, Regulatory Affairs & ComplianceNektar Therapeutics, Bayhill Therapeutics, Berlex Laboratories, Serono, Parexel, Biogen

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2016 MILESTONES

PROGRAM MILESTONE PROJECTED DATE

NeuVax™ (nelipepimut-S)

Initiate DCIS trial Q1

PRESENT: Reach 70 events Q1

PRESENT: Interim analysis Q2

H&N 1+/2+ Interim safety data Q4

H&N 1+/2+ A24/A26 data Q4

GALE-301GALE-302

Present 301/302 booster data Q2

Initiate Phase 2b clinical trial Q3

Present GALE-301 Phase 2a two year data Q4

GALE-401 (anagrelide CR)

Confirmation of 505(b)2 pathway 2H

Publish final Phase 2 report Q4

FINANCIAL OVERVIEW

Cash Position (as of 9/30/15) $34.8 million

Divestiture Impact (non-recurring Q4 to 1H)

$11.75 million income from sale $5-$6 million expenses to close operations

Legal settlement and associated expenses (non-recurring Q4 to 1H) $3-$5 million

Net proceeds from January offering (Q1) $20.1 million

Debt (as of 9/30/15) $5.7 million

2016 Projected Quarterly Burn $11-$13 million

Shares Outstanding 182 million

Market Cap (5 February 16) ~$120 million

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WHY WE’RE HERE

Source: 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 then…it 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