HEMATOLOGY &

ONCOLOGY FOCUSED

COMPANY

September 22, 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

TARGETING AREAS OF UNMET MEDICAL NEED

Hematology

GALE-401

• Proprietary controlled release

version of anagrelide

• Targeting 3rd Line Essential

Thrombocythemia (ET)

• Phase 3 initiation expected in

Q2, 2017

Plan to develop under 505(b)2

pathway

Immunotherapy

NeuVax™ (nelipepimut-S)

• Development in key settings

Combination with trastuzumab in HER2 1+/2+

Combination with trastuzumab in HER2 3+

DCIS

Gastric

GALE-301/GALE-302

• Targeted development in gynecological cancers

3

Diversified pipeline with multiple mid-to late stage clinical trials

focused in hematology-oncology

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) including Essential Thrombocythemia (ET)

6

ANAGRELIDE IMMEDIATE RELEASE (IR) AEs

Related Adverse Events (AEs)AGRYLINa

(n=942)%

Cardiac 42

Generalc 83

Gastrointestinal 92

Respiratory, thoracic and mediastinal 18

Skin and subcutaneous tissue 14

Musculoskeletal and connective tissue 6

Nervous system 65

Vascular <5

Hepatobiliary <5

Blood and Lymphatic <5

Number of AEs/patient 3.3

a Anagrelide IR ADR data from the product labelc General AEs referred to fatigue, peripheral edema, and malaise

Most common

reasons for

discontinuation

7Sources: 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; Agrylin is a registered trademark of Shire.

Approximately 25% – 30%

of patients are intolerant

to Anagrelide IR

GALE-401 PHASE 1 TRIALS: CR FORMULATION

MAINTAINS PLATELET LOWERING & REDUCES Cmax

8Multiple Phase 1 studies in n=86 healthy volunteers; Agrylin is a registered trademark of Shire.

Anagrelide CR Plasma Levels

pg

/mL

Anagrelide CR Platelet Lowering

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

• Lower peak plasma concentration

• Maintain the Area Under the Curve (AUC)

GALE-401 DEMONSTRATES IMPROVED AE PROFILES

IN KEY CATEGORIES

Related Adverse Events (AEs)GALE-401a

(N=18)n (%)

AGRYLINb

(n=942)%

Cardiac 6 (33) 42

Generalc 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

A Anagrelide CR Related AE data from the Phase 2 study; Source: Table 4, 2/12/2016b Anagrelide IR ADR data from the product labelc General AEs referred to fatigue, peripheral edema, and malaise

9

GALE-401 PHASE 2 STUDY SUPPORTS TARGETING IR INTOLERANT POPULATION

0

50

100

150

200

250

6001 2002 9001

On IR On GALE-401

Mean 7days 106 days

Median 7days 75 days

Max 7days 196 days

Min 7days 47 days

Three patients that discontinued IR were

on GALE-401 for average of 106 daysTwo IR intolerant patients were on

GALE-401 for 660 days and 450 days

0

200

400

600

800

1000

1200

1400

1600

2001 6005

On GALE-401

On IR

10

GALE-401: TARGET PRODUCT PROFILE (TPP) vs ANAGRELIDE IR

11

Anagrelide IRGALE-401

TPPGALE-401Benefits

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

WiderPossibility of achieving desired effect with lower dose

Pharmacokinetics (PK) • Half life• Cmax

• 2-3 hours• 4x GALE-401

• 20 hours• 25% of IR

Improved PK profile

Onset of Action As early as 4 weeks As early as 1 week Faster onset of action

Doses per day2 to 4 times a day^

Label: starting at doses of 0.5-2.0 mg every 6 hours

Target: 1 a day2x/day based on P2Targeting 1x/day in P3

Dosing regimen 2 to 10 mg per day^ Target: Mean 2 mg per day

PK profile may improvedosing regimen leading to better patient compliance

Safety• Related TEAEs• # of AE/Patient

• 42.1%• 3.3

• 30%• 2.3

Better tolerated

*Therapeutic Index distance between therapeutic dose curve and toxic dose; ^Agrylin Package Insert

ESSENTIAL THROMBOCYTHEMIA (ET)

ET is a neoplastic stem cell

disorder causing dysregulated

production of large numbers

of abnormal megakaryocytes

resulting in elevated platelets

Chronic condition

• Median OS – 14.7 years

• Up to 50% of patients may be

asymptomatic at presentation

Associated with vascular

complications

• Increased risk of thrombosis and

cardiovascular events

• Patients older than 60 at greatest

risk of complications

12

Arrows:

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):CURRENT U.S. STANDARD OF CARE

13

• Generally first line therapy for ET

• Cytotoxic Myelosuppressive drug (reduces

other blood cells as well)

• Increased risk of developing acute leukemia

after long term; avoided in younger patients

• About 25% of patients are

intolerant/refractory

• Off-label third line use

• Non cytotoxic drug

• Not used in most patients because requires

injection and is associated with flu like

symptoms

• Used mostly in pregnant women

• Generally second line therapy for ET

• Non cytotoxic drug

• Decreases platelets formation

• Not associated with increased risk of

leukemia

• Side effects: palpitations, headaches

• About one-third are intolerant to Anagrelide

IR

• Hydroxyurea and Anagrelide

Treatment Failure

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

1st Line: Hydroxyurea

2nd Line: Anagrelide IR

Interferon alpha

3rd Line: Unmet Need

GALE-401 ET DEVELOPMENT OPPORTUNITY

Clinical Need

Significant unmet medical need

• No approved therapies after

Anagrelide IR and Hydroxyurea

Diagnosed ET patient population

• US Prevalence: 135,000 - 175,000

• An estimated 9,000 3rd line patients in

the US

Chronic Disease

Development Path

Advantageous development and

regulatory path: 505(b) 2

Limited competition with very few

agents in development

Multiple life cycle management

opportunities

Next steps

• Finalize the Phase 3 clinical trial

design

• End of Phase 2 FDA meeting

• Initiate pivotal trial in Q2, 2017

14Sources: 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

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

0.7

0.5

0.0

0.5

1.0

1.5

2.0

2.5

% N

eu

Va

xsp

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

OUR VACCINES STIMULATE 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

Trastuzuma

b

IMMUNO-ONCOLOGY: COMBINATION STRATEGY

19

“There is growing evidence that a

multimodality approach targeting

different aspects of the immune

system may yield the greatest

clinical benefit.”

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

Hypothesis: Trastuzumab treatment will

enhance response to vaccination by making tumor

cells more visible to T-cells/immune system

20

COMBINATION IMMUNOTHERAPY ENHANCES ANTIGEN PRESENTATION

Trastuzumab

HER2/neu

Breast

tumor cell

HER2/neu –derived peptide

presented on MHC-I

HER2/neu-

derived

peptide

Trastuzumab/HER2 complexes are internalized

and processed by proteasomes into short

peptides which are then presented on

MHC class I molecules.

Source: Mittendorf EA, et al (2006). Ann Surg Oncol;13:1085-98.

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

22

Trastuzumab

PBMC from HER2/neu peptide, E75,

vaccinated patients efficiently recognize

and lyse trastuzumab-treated HER2/neu-

expressing tumor cell lines

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

22

NEUVAX: CURRENT CLINICAL TRIALS

Phase Treatment HER2 Status

Indication Trial StatusProtocol Defined

# of PatientsCollaborations

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

2Single agentVADIS Study

1+, 2+,3+

BREASTDuctal Carcinoma in

Situ (DCIS)HLA A2+

SuspendedU.S. only4 centers

48

2 Single agent1+,

2+,3+GASTRIC

HLA A2+, A3+Planned

India Only50

23

Targeting Folate Binding

Protein

GALE-301 &

GALE-302

GALE-301 & GALE-302

25Source: 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, American Society of Clinical Oncology 201626

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

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

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

Joe Lasaga

VP, Business Development & Alliance

Management

Nektar Therapeutics, Rigel

Pharmaceuticals

FINANCIAL OVERVIEW

Cash Position (as of June 30, 2016) $19.6 million

Financing (July 13, 2016) + $11.7 million

Debt Financing (Amended Aug 22, 2016) + $24 million ($18.5M restricted cash)

Projected Quarterly Burn

Q3, 2016 $12 - $13 million

Q4, 2016 $8 - $10 million

Shares Outstanding (as of July 31, 2016) 214 million

Market Cap (as of September 20, 2016) ~$80 million

29

MILESTONES

30

PROGRAM MILESTONEPROJECTEDDATE 2016

PROJECTEDDATE 2017

GALE-401 (anagrelide CR)

Present combined P1 & P2 safety data ✓

Confirmation of 505(b)2 pathway 2H

Phase 3 Initiation Q2

Phase 3 Dose Verification Q4

NeuVax™

(nelipepimut-S)

Fast Track Designation ✓

Initiate DCIS trial Q4

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

Combo H&N Enrollment Complete Year-end

Combo H&N Interim Efficacy Q4

GALE-301GALE-302

Present 301/302 booster data ✓

Present GALE-301 Phase 2a primary analysis ✓

Orphan Drug Designation ✓

Present GALE-301 Biomarker & Dosing Data Q4

THANK YOU

NASDAQ: GALE