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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 label
c General AEs referred to fatigue, peripheral edema, and malaise
Most common
reasons for
discontinuation
7
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; 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, 2/12/2016
b Anagrelide IR ADR data from the product label
c 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 days
Two 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 IR
GALE-401
TPP
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
• 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 day
2 to 4 times a day^
Label: starting at doses of 0.5-
2.0 mg every 6 hours
Target: 1 a day
2x/day based on P2
Targeting 1x/day in P3
Dosing regimen 2 to 10 mg per day^ Target: Mean 2 mg per
day
PK profile may improve
dosing 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
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
%NeuVaxspecificCD8+Tcells
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
Average%Cytotoxicity51Cr
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 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+
Suspended
U.S. only
4 centers
48
2 Single agent
1+,
2+,3+
GASTRIC
HLA A2+, A3+
Planned
India Only
50
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 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
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 MILESTONE
PROJECTED
DATE 2016
PROJECTED
DATE 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-301
GALE-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

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Galena presentation 22 sept 16

  • 2. 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
  • 3. 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
  • 4. 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
  • 6. 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
  • 7. 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 label c General AEs referred to fatigue, peripheral edema, and malaise Most common reasons for discontinuation 7 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; Agrylin is a registered trademark of Shire. Approximately 25% – 30% of patients are intolerant to Anagrelide IR
  • 8. 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)
  • 9. 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, 2/12/2016 b Anagrelide IR ADR data from the product label c General AEs referred to fatigue, peripheral edema, and malaise 9
  • 10. 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 days Two 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
  • 11. GALE-401: TARGET PRODUCT PROFILE (TPP) vs ANAGRELIDE IR 11 Anagrelide IR GALE-401 TPP 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 • 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 day 2 to 4 times a day^ Label: starting at doses of 0.5- 2.0 mg every 6 hours Target: 1 a day 2x/day based on P2 Targeting 1x/day in P3 Dosing regimen 2 to 10 mg per day^ Target: Mean 2 mg per day PK profile may improve dosing 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
  • 12. 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)
  • 13. 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
  • 14. 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
  • 16. 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
  • 17. 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 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 %NeuVaxspecificCD8+Tcells NeuVax Specific CD-8 CTLs: Pre-, Post, Mean and Long-Term (6 months) Pre Max Mean Long-Term
  • 18. 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
  • 19. 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.”
  • 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 Hypothesis: Trastuzumab treatment will enhance response to vaccination by making tumor cells more visible to T- cells/immune system 20
  • 21. 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 Average%Cytotoxicity51Cr 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
  • 22. 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
  • 23. NEUVAX: CURRENT CLINICAL TRIALS 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+ Suspended U.S. only 4 centers 48 2 Single agent 1+, 2+,3+ GASTRIC HLA A2+, A3+ Planned India Only 50 23
  • 25. 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
  • 26. GALE-301: OPTIMAL DOSE GROUP SHOWS PRELIMINARY EFFICACY 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
  • 28. 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
  • 29. 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
  • 30. MILESTONES 30 PROGRAM MILESTONE PROJECTED DATE 2016 PROJECTED DATE 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-301 GALE-302 Present 301/302 booster data ✓ Present GALE-301 Phase 2a primary analysis ✓ Orphan Drug Designation ✓ Present GALE-301 Biomarker & Dosing Data Q4