HEMATOLOGY &

ONCOLOGY FOCUSED

COMPANY

November 28, 2016

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 Q2, 2017

IMMUNOTHERAPY

• NeuVax™ (nelipepimut-S)

• Targeting HER2

• Multiple mid-stage 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

VADIS

4

2b

GALE-401

Anagrelide Controlled

Release (CR)

ANAGRELIDE

Anagrelide suppresses megakaryocytopoiesis by inhibiting PDE III-

dependent and PDE III-independent mechanisms

No DNA damaging or cytotoxic effect

Immediate release version indicated for the treatment of patients with

thrombocythemia, secondary to myeloproliferative disorders to reduce

the elevated platelet count and the risk of thrombosis, and to ameliorate

associated symptoms including thrombo-hemorrhagic events

Approved to treat Myleoproliferative Neoplasms (MPNs)

• Only drug approved to treat Essential Thrombocythemia (ET)

6

GALE-401 (Anagrelide Controlled Release)

GALE-401 is a proprietary, controlled release (CR) formulation of anagrelide

• FDA approved product with known mechanism of action

• Advantageous 505(b)2 regulatory path to be confirmed with the FDA

• Strong IP through 2029

Six trials conducted to date

• Five Phase 1 studies in healthy volunteers

• Phase 2 pilot study in patients with MPNs

Potential Clinical Benefits

• Potentially faster onset of action

• Consistent efficacy

• Indication of improved tolerability vs anagrelide IR

Multiple life cycle management opportunities

7

GALE-401: PHASE 1 TRIAL RESULTS

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

Anagrelide CR

Plasma Levels

pg

/mL

Anagrelide CR Platelet Lowering

Res

ult

s Reduces Cmax

Maintains Area Under the Curve (AUC)

Lowers peak plasma concentration

Maintains Platelet Lowering

GALE-401: PHASE 2 PILOT STUDY RESULTS

9

0.0%

5.0%

10.0%

15.0%

20.0%

25.0%

30.0%

Vaccine Control

% o

f S

ub

jec

ts

Recurrence

24.0% 13.3%

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

Figure 2. Platelet Response

1 8 15 22 29 36 43 50 57 64 71 78 85 99 113 127 141 155 169 197 225

18 18 18 18 18 18 15 14 14 14 13 13 13 13 13 13 12 12 11 11 11

1.0 1.4 1.8 1.9 2.0 2.2 2.4 2.5 2.4 2.2 2.0 2.1 2.1 1.9 1.8 1.9 2.0 1.9 1.8 1.9 1.8

Study Days

N=

Avg. daily dose

0

200

400

600

800

1000

1200

1400

Mean Platelet Count (± SD)

Pla

tele

t C

ou

nt

(x10

9/L

)

Figure 2. Platelet Response

1 8 15 22 29 36 43 50 57 64 71 78 85 99 113 127 141 155 169 197 225

18 18 18 18 18 18 15 14 14 14 13 13 13 13 13 13 12 12 11 11 11

1.0 1.4 1.8 1.9 2.0 2.2 2.4 2.5 2.4 2.2 2.0 2.1 2.1 1.9 1.8 1.9 2.0 1.9 1.8 1.9 1.8

Study Days

N=

Avg. daily dose

0

200

400

600

800

1000

1200

1400

Mean Platelet Count (± SD)

Pla

tele

t C

ou

nt

(x10

9/L

)

Figure 2. Platelet Response

1 8 15 22 29 36 43 50 57 64 71 78 85 99 113 127 141 155 169 197 225

18 18 18 18 18 18 15 14 14 14 13 13 13 13 13 13 12 12 11 11 11

1.0 1.4 1.8 1.9 2.0 2.2 2.4 2.5 2.4 2.2 2.0 2.1 2.1 1.9 1.8 1.9 2.0 1.9 1.8 1.9 1.8

Study Days

N=

Avg. daily dose

0

200

400

600

800

1000

1200

1400

Mean Platelet Count (± SD)

Pla

tele

t C

ou

nt

(x10

9/L

)

Figure 2. Platelet Response

1 8 15 22 29 36 43 50 57 64 71 78 85 99 113 127 141 155 169 197 225

18 18 18 18 18 18 15 14 14 14 13 13 13 13 13 13 12 12 11 11 11

1.0 1.4 1.8 1.9 2.0 2.2 2.4 2.5 2.4 2.2 2.0 2.1 2.1 1.9 1.8 1.9 2.0 1.9 1.8 1.9 1.8

Study Days

N=

Avg. daily dose

0

200

400

600

800

1000

1200

1400

Mean Platelet Count (± SD)

Pla

tele

t C

ou

nt

(x10

9/L

)

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 ANAGRELIDE CONTROLLED RELEASE (CR): GALE-401

11

Anagrelide IR^ GALE-401*

Benefits

Therapeutic index# Narrow - dose escalation to optimal effect is challenging

Wider - 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)

MPN 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

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

Essential Thrombocythemia (ET)

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

Current ET Treatment Options

Hydroxyurea

• 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

• Only approved therapy for ET

• Poor tolerability and compliance thought to be related to blood concentrations

• Non cytotoxic drug

• Not associated with increased risk of leukemia

• Significant side effects

Aspirin

• Given to reduce the risk of blood clotting

• Does not lower platelet counts

• May help relieve the burning sensation in patient’s hands and feet (erythromelagia)

Other Therapies

• Interferon

•Busulfan

•Retry hydroxyurea

•Observation

14 Sources: Leukemia and Lymphoma Society: Essential Thrombocythemia Facts Cervantes, F. Hematology 2011; 215-221

PIVOTAL, PHASE 3 TRIAL STRATEGY

Targeting the reduction of platelets in ET patients

• US Prevalence: 135,000 - 175,000

~75% of diagnosed patients receive treatment

• Limited competition with very few agents in development

Planned next steps

• End of Phase 2 meeting with the FDA (Q4, 2016)

• Finalize the Phase 3 clinical trial design

• Initiate pivotal trial (Q2, 2017)

15 Sources: Harrison et al N Engl J Med 2005;353:33-45; Mehta et al, (2014) Epidemiology of myeloproliferative

neoplasms in the United States, Leukemia & Lymphoma, 55:3, 595-600, DOI: 10.3109/10428194.2013.813500

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

17

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

18 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 s

pe

cific

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

19

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

NEUVAX: MULTIPLE SETTINGS AND COMBINATION STRATEGY

Phase Treatment HER2 Status

Indication Trial Status Protocol Defined

# of Patients Collaborations

2b Combination

with trastuzumab

1+, 2+

BREAST Node Positive or High Risk Node Negative

HLA A2+, A3+, A24+, A26+

Enrolling U.S. only

33 centers 300

2 Combination

with trastuzumab

3+ high risk

BREAST Node Positive HLA A2+, A3+

Enrolling U.S. only

28 centers 100

2 Single agent VADIS Study

1+, 2+,3+

BREAST Ductal Carcinoma in

Situ (DCIS) HLA A2+

Planned U.S. only 4 centers

48

2 Single agent 1+,

2+,3+ GASTRIC

HLA A2+, A3+ Planned

India Only 50

20

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

21

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

22

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

Ave

rage

% C

yto

toxi

city

51

Cr

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

DFS at

12 months

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 months

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

23

Targeting Folate Binding

Protein

GALE-301 &

GALE-302

GALE-301 & GALE-302

25

0.0%

5.0%

10.0%

15.0%

20.0%

25.0%

30.0%

Vaccine Control

% o

f S

ub

jec

ts

Recurrence

24.0% 13.3%

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

0.0%

5.0%

10.0%

15.0%

20.0%

25.0%

30.0%

Vaccine Control

% o

f S

ub

jec

ts

Recurrence

24.0% 13.3%

Source: Peoples, et. al, Poster Presentation, American Society of Clinical Oncology 2016 26

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

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: Peoples, et. al, 2016 poster presentations at the CRI-CIMT-EATI-AACR International Cancer Immunotherapy

Conference, American College of Surgeons Clinical Congress, and Society for Immunotherapy of Cancer Conference 27

CORPORATE

OVERVIEW

28

LEADERSHIP TEAM

29

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 Q4 Cash Burn from Operations $7 - $9 million

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

Market Cap (as of November 28, 2016) ~$36 million

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

2H, 2016 MILESTONES

31

PROGRAM MILESTONE PROJECTED

DATE

GALE-401 (anagrelide CR)

Present combined safety data ✓

Confirmation of 505(b)2 pathway 2H

NeuVax™ (nelipepimut-S)

Fast Track Designation ✓

Combo H&N 1+/2+ Interim safety data ✓

Initiate DCIS trial Q4

GALE-301 GALE-302

Present 301/302 booster data ✓

Present GALE-301 Phase 2a primary analysis ✓

Orphan Drug Designation ✓

Present GALE-301 Biomarker & Dosing Data ✓

THANK YOU

NASDAQ: GALE