HEMATOLOGY &

ONCOLOGY FOCUSED

COMPANY

January 11, 2017

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.

2

DIVERSIFIED PIPELINE

Diversified

pipeline with

multiple mid-

to late stage

clinical trials

HEMATOLOGY

•GALE-401 (Anagrelide Controlled Release)

•Targeting MPNs

•Phase 3 Initiation in ET in Q2

IMMUNOTHERAPY

• NeuVax™ (nelipepimut-S)

• Targeting HER2

• Multiple Phase 2 clinical trials ongoing & planned

IMMUNOTHERAPY

•GALE-301/GALE-302

•Targeting Folate Binding Protein

•Early stage trials ongoing

3

DEVELOPMENT PIPELINE

PRODUCT THERAPETIC AREA PHASE 1 PHASE 2 PHASE 3 BLA / NDA

Hematology

GALE-401 (Anagrelide CR) Essential Thrombocythemia

Immunotherapy: Breast Cancer

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

*NeuVax is an investigational product. Efficacy has not been established. Herceptin is a registered trademark of Genentech.

Ongoing Planned

4

2b

VADIS

GALE-401

Anagrelide Controlled Release (CR)

ANAGRELIDE

Anagrelide immediate release (IR) approved by the FDA to treat Myleoproliferative Neoplasms (MPNs)

• Indicated for the treatment of patients with thrombocythemia, secondary to myeloproliferative disorders to reduce the elevated platelet count and the risk of thrombo-embolic events

• Only drug approved to treat Essential Thrombocythemia (ET)

Anagrelide suppresses megakaryocytopoiesis by inhibiting PDE III-dependent and PDE III-independent mechanisms

No DNA damaging or cytotoxic effect

6

GALE-401: ANAGRELIDE CONTROLLED RELEASE (CR)

A proprietary, controlled release (CR) formulation of anagrelide

• 505(b)2 regulatory path allows for abbreviated submission package and potentially faster approval timelines

• Strong IP through 2029

Six trials conducted to date

• Five Phase 1 studies in healthy volunteers

• Phase 2 pilot study in patients with myeloproliferative neoplasms (MPNs)

Potential Clinical Benefits

• Consistent efficacy

• Potentially faster onset of action and indication of improved tolerability compared to anagrelide IR

• More convenient treatment regimen

• Favorable PK profile

Multiple life cycle management opportunities

7

Re

sult

s Reduces Cmax

Maintains Area Under the Curve (AUC)

Lowers peak plasma concentration

Maintains Platelet Lowering

GALE-401 PHASE 1 TRIALS

8 Multiple Phase 1 studies in n=98 healthy volunteers; Agrylin is a registered trademark of Shire.

Anagrelide CR Platelet Lowering GALE-401 Median Cmax

Anagrelide IR Median Cmax

GALE-401: PHASE 2 PILOT STUDY FINAL RESULTS

9 Source: Verstovsek et al, Final Results of Anagrelide Controlled-Release (Gale-401) Safety, Efficacy and Pharmacokinetics

in Subjects with Myeloproliferative Neoplasms (Mpn)-Related Thrombocytosis, ASH 2015 Poster Presentation.

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)

• 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

Safety profile indicates a potential benefit for GALE-401 compared to anagrelide IR

GALE-401 DEMONSTRATES IMPROVED AE PROFILES IN KEY CATEGORIES

Related Adverse Events (AEs)

GALE-401*

(N=18)

n (%)

AGRYLIN^

(n=942)

%

Cardiac 6 (33) 42

General# 5 (27.8) 83

Gastrointestinal 9 (50) 92

Respiratory, thoracic and mediastinal 2 (11) 18

Skin and subcutaneous tissue 2 (11) 14

Musculoskeletal and connective tissue 1 (6) 6

Nervous system 9 (50) 65

Vascular 3 (16) <5

Hepatobiliary 2 (11) <5

Blood and Lymphatic 1 (6) <5

Number of AEs/patient 2.3 3.3

10 Not a head-to-head trial. *GALE-401 related AE data from Phase 2 study; ^Anagrelide IR data from the product label. #General AEs referred to fatigue, peripheral edema, and malaise

ADVANTAGES OF CR FORMULATION

11

Anagrelide IR^ GALE-401* Benefits

w/CR Formulation

Therapeutic index# Limited - dose escalation to

optimal effect is challenging Larger - Possibility of achieving

desired effect with lower dose

Pharmacokinetics (PK)

• Half life

• Cmax

• 2-3 hours

• 4x GALE-401

Improved PK profile

• 20 hours

• 25% of IR

Onset of Action As early as 4 weeks As early as 1 week for faster

onset of action

Doses per day 2 to 4 times a day 2 times a day

Targeting 1x/day in future trials

Dosing regimen 2 to 10 mg per day Mean 2 mg per day

Safety Profile

• Treatment Related AEs

• # of AE/Patient

• 42.1%

• 3.3 • 30%

• 2.3

Not a head-to-head trial. ^Anagrelide IR data from the product label/Agrylin Package Insert. *GALE-401 profile from Phase 1 and 2 studies. #Therapeutic Index distance between therapeutic dose curve and toxic dose.

ESSENTIAL THROMBOCYTHEMIA (ET)

One of the major MPNs

Characterized by increased number of platelets

• ET is a neoplastic stem cell disorder causing dysregulated production of large numbers of abnormal megakaryocytes

Chronic condition

• Median Overall Survival: 14.7 years

• Up to 50% of patients may be asymptomatic at presentation

Associated with vascular complications

12

Arrows indicate Megakaryocytes

ET has Larger Number of Megakayocytes

Sources: Haematologica. 2009 June; 94(6): 865, Am J Hematology. 2008 May;83(5):359)

ET OVERVIEW

Diagnosis

• Chronic hematologic malignancy with no known cause

• Clinical presentation of symptoms

• Diagnostic tools

• Blood test

• Bone marrow biopsy

• Gene mutation test

Common Symptoms

• Headache

• Vision disturbances or migraines

• Dizziness or lightheadedness

• Coldness or blueness of fingers or toes

• Burning, redness, and pain in the hands and feet

Thrombotic Complications

• Stroke

• Transient ischemic attack (TIA)

• Heart attack

• DVT or pulmonary embolus

• Blood clotting in unusual locations

Risk Factors

• Women 1.5x more likely

• Patients >60 years old, with 20% <40 years

• Mutations

• JAK2 - 50%

• CALR ~25%

13 Source: MPN Research Foundation

ET: CURRENT TREATMENT OPTIONS

Hydroxyurea

Other Therapies

•Generally initial treatment option

•Cytotoxic Myelosuppressive drug (reduces other blood cells as well)

• Increased risk of developing acute leukemia after long term

•Avoided in younger patients

•~25% of patients intolerant/refractory

• Anagrelide IR

• Interferon

• Busulfan • Retry hydroxyurea • Observation

14

PIVOTAL, PHASE 3 TRIAL

15

Failed or Intolerant to Hydroxyurea

GALE-401

(Anagrelide CR)

BEST AVAILABLE THERAPY

Anagrelide IR (sizable population)

Interferon

Busulfan

Retry hydroxyurea

Observation

Sources: Mehta et al, (2014) Epidemiology of myeloproliferative neoplasms in the United States, Leukemia & Lymphoma; Sever et al (2014) Therapeutic options for patients with polycythemia vera and essential thrombocythemia refractory/resistant to hydroxyurea, Leukemia & Lymphoma

Targeting the reduction of platelets in ET patients

• Limited competition with very few agents in development

• US Prevalence: 135,000 - 175,000

Estimate up to 25% of those patients who fail or are intolerant to initial treatment with hydroxyurea may be trial candidates

Planned next steps

• Q1: Finalize Phase 3 clinical trial protocol

• Q2: Initiate pivotal trial

Expected trial completion YE 2019

NEUVAX™ (nelipepimut-S)

Targeting HER2

ELICITS A STRONG CD8+ T-CELL RESPONSE

NeuVax contains the immunodominant peptide derived from the extracellular region of the HER2 protein

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

17 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

0.4

1.8

0.7 0.5

0.0

0.5

1.0

1.5

2.0

2.5

% N

eu

Va

x sp

ecific

CD

8+

T c

ells

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

Pre Max Mean Long-Term

T-Cell

CD28

OX40

GITR

CD122

CD27

CD360

HVEM

CD137

CTLA-4

PD-1

TIM-3

BTLA

VISTA

LAG-3

Activating Receptors Inhibitory Receptors

NEUVAX STIMULATES T-CELL PROLIFERATION AND EXPANSION

18

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

CORRELATION BETWEEN HER2 & MHC-1

There is an inverse correlation between HER2 and MHC class I

HER2 overexpression is associated with decreased expression of components of the antigen processing/ presentation pathway

19

COMBINATION IMMUNOTHERAPY ENHANCES ANTIGEN PRESENTATION

Trastuzumab/HER2 complexes are internalized and processed by proteasomes into short peptides

which are then presented on MHC class I molecules

PBMC from HER2/neu peptide, E75, vaccinated patients efficiently recognize and

lyse trastuzumab-treated HER2/neu-expressing tumor cell lines

20

Trastuzumab

HER2/neu

Breast tumor cell

HER2/neu –derived peptide presented on MHC-I

HER2/neu-derived peptide

20.0

25.0

30.0

35.0

40.0

45.0

50.0

55.0

60.0

Av

era

ge

% C

yto

tox

icit

y 5

1 C

r

0 ug 10 ug 50 ug

* p=0.015

Trastuzumab

Hypothesis: Trastuzumab treatment will enhance response to vaccination by making tumor cells more

visible to T-cells/immune system

Interim Analysis at 1 Year

DFS

Standard of Care: Standard Herceptin dosing every 3 weeks for 1 year 6 doses of NeuVax given every 3 weeks starting with third dose of Herceptin

+ 1 booster dose every 6 months thereafter

+ Dosing to disease progression;

36 mo follow up

Primary Endpoint

DFS at 24 mos.

300 adjuvant breast cancer patients, randomized 1:1

Single blind (subject)

Node positive or high risk node negative

HLA A2/A3+

HLA A24/A26+

HER2 IHC 1+/2+

Stratified by nodal status and HER2 status

Study Population

NEUVAX+TRASTUZUMAB: HER2 1+/2+ PHASE 2 STUDY

GM-CSF

+ GM-CSF

21

NEUVAX: MULTIPLE SETTINGS AND COMBINATION STRATEGY

Phase Treatment

HER2 Status Indication Trial Status

Targeted

Enrollment

Completion

Planned

Data

Readouts

Collaborations

2b

Combination

w/trastuzumab

HER2 1+, 2+

BREAST

Node Positive or

High Risk Node

Negative

HLA A2+, A3+,

A24+, A26+

Enrolling

U.S. only

33 centers

n=300

Q2 2017

Q2, 2018

Interim

Analysis

1H, 2019

Final Data

2

Combination

w/trastuzumab

high risk

HER2 3+

BREAST

Node Positive

HLA A2+, A3+

Enrolling

U.S. only

28 centers

n=100

Q4 2017

1H, 2019

Interim

Analysis

2

Single agent

VADIS Study

HER2 1+, 2+,

3+

BREAST

Ductal Carcinoma

in Situ (DCIS)

HLA A2+

Enrolling

U.S. only

4 centers

N=48

2

Single agent

HER2 1+, 2+,

3+

GASTRIC

HLA A2+, A3+

Planned

India Only

N=50

22

Targeting Folate Binding Protein

GALE-301 & GALE-302

GALE-301 & GALE-302

24 Source: U.S. Ovarian Cancer http://seer.cancer.gov/statfacts/html/ovary.html

Targeted cancer immunotherapies: GALE-301 (E39) & GALE-302 (E39’)

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, American Society of Clinical Oncology 2016 25

Phase 1/2a trial ongoing

Phase 1: Determined optimal dose and demonstrated safety and potent immune response

Phase 2a Preliminary data:

• At 16 months median follow-up:

Overall recurrence rate was 44.8% in the VG versus 54.5% in the CG (p=0.58),

Recurrence rate of 23.5% in patients who received booster inoculations.

• Two year DFS estimate in 1000 mcg dose group is 73.5% vaccine vs. 38.1% control (p=.03)

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

Estimated 24 months Disease Free Survival by

Dosing Cohort

CURRENT CLINICAL DEVELOPMENT

26

Phase Treatment Cancer Type Current

Status

# of Enrolled

Patients

1/2a GALE-301 Ovarian, Endometrial

HLA A2+ Ongoing 51

1b GALE-301 &

GALE-302

Ovarian, Breast

HLA A2+ Ongoing 39

Multiple data presentations inform the design & target patient populations for future trials

Low expressors appear to show improved disease free survival (DFS) due to immunotolerance from significantly higher endogenous exposure to the FBP antigen

Different doses/schedules appear to correspond to various types of cancer:

• Breast patients = lower FBP exposure and may require lower 500mcg dose

• Ovarian patients = higher FBP expression and may require higher 1000mcg dose

• E39’ (GALE-302) may prevent T-Cell exhaustion

Sources: KM Peace, et. al, Phase Ib Trial of Two Folate Binding Protein (FBP) Peptide Booster Vaccines (E39 and E39′) in Breast and Ovarian Cancer Patients, SITC 2016; Jackson et. al, A Phase Ib Trial Comparing Different Doses/Schedules of a Folate Binding Protein(FBP)-derived Peptide Vaccine,

E39, and its Attenuated Version, E39’, to Induce Long-term FBP-specific Immunity in Disease-free Cancer Patients. ACS Oral Presentation 2016.

CORPORATE OVERVIEW

27

LEADERSHIP TEAM

28

Mark W. Schwartz, Ph.D. President & CEO Apthera, Bayhill Therapeutics, Calyx Therapeutics, Trega Biosciences, Incyte Genomics, DuPont Diagnostics

Bijan Nejadnik, M.D. Executive VP, Chief Medical Officer Jazz Pharmaceuticals, Johnson & Johnson, Stanford, Johns Hopkins, UC Davis

Stephen Ghiglieri EVP, Chief Financial Officer MedData Inc., NeurogesX, Hansen Medical, Inc., Oacis Healthcare Systems, Oclassen Pharmaceuticals

Remy Bernarda, SVP, Investor Relations & Corporate Communications IR Sense, Hana Biosciences, Knight Equity Markets, Bear Stearns, Goldman Sachs

John Burns, CPA VP, Finance & Corporate Controller Pixelworks, Moss Adams

Tom Knapp, Esq. Interim General Counsel Sucampo, Exemplar Law Partners, NorthWestern Energy, Paul Hastings, The Boeing Company

FINANCIAL OVERVIEW

Cash Position (as of 30 Sept 16) $24.5 million

Restricted Cash (as of 30 Sept 16 - $18.5 relating to Debenture)

$18.9 million

Projected Cash Burn from Operations

Q4, 2016 $7 - $9 million

Quarterly in 2017 $7 - $8.5 million⌃

Shares Outstanding (as of 31 Oct 16) 10.85 million*

Market Cap (as of 6 Jan 17) ~$25 million

29 ⌃Specific guidance expected in Q1 after finalization of Phase 3 trial details.

*Shares adjusted to account for reverse stock split effective November 14, 2016

2017 MILESTONES

30

PROGRAM MILESTONE PROJECTED

DATE

GALE-401

(anagrelide CR)

Finalize Phase 3 Clinical Trial Protocol Q1

Initiate Phase 3 Clinical Trial Q2

NeuVax™

(nelipepimut-S)

Enroll first patient in DCIS Trial Q1

Complete enrollment in

NeuVax/Trastuzumab 1+/2+ Combination

Trial

Q2

Complete enrollment in

NeuVax/Trastuzumab 3+ Combination Trial Q4

Interim Data Analysis: NeuVax/Trastuzumab

1+/2+ Combination Trial Q2, 2018

GALE-301

GALE-302 Review data and develop path forward 2H

THANK YOU

NASDAQ: GALE