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2016 ANNUAL MEETING
OF STOCKHOLDERS
July 14, 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
DEVELOPMENT PIPELINE
Product Therapeutic Area Phase 1 Phase 2 Phase 3 BLA / NDA
Immunotherapy: Breast Cancer
NeuVax™ (nelipepimut-S)
Node-positive
HER2 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
Hematology
GALE-401 (Anagrelide CR) MPN-related thrombocytosis
*NeuVax is an investigational product. Efficacy has not been established. Herceptin is a registered trademark of Genentech.
Ongoing Planned
VADIS
3
2b
StoppedPRESENT
PRESENT CURRENT STATUS
 IDMC recommend the trial stop for futility
• Study drug and all procedures have stopped
 Investigation ongoing
• Compiled team with addition of outside experts and the Company
remains blinded to the data
• Operational elements under review include:
 Database and data analysis (programming)
 Randomization
 Manufacturing and packaging elements such as filling, labeling and
kit assembly
• Biology and immunology
• Anticipated timeline: up to 3 months or longer
4
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
5
Checkpoint
inhibitors
Indirect Immune
Modulators
Co-stimulators
Immune Inhibitory
Enzymes
CAR T
Technology
TCR
Technology
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
6
Checkpoint
inhibitors
Indirect Immune
Modulators
Co-stimulators
Immune Inhibitory
Enzymes
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
7
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
NOVEL DEVELOPMENT STRATEGY:
SECONDARY PREVENTION IN CANCER SURVIVORS
8
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
Risk
20% recurrence rate
DECLARED
TO PREVENT
RECURRENCE /
METASTATIC DISEASE
Breast: Ductal Carcinoma in
Situ
8-10% progression to invasive
Ovarian Cancer
~50% recurrence rate in 1 yr
No FDA Approved
targeted therapies
• Watch &
Wait, or
• Repetitive
therapies
TOLD
NEUVAX: DEVELOPMENT COLLABORATIONS
Phase Treatment
HER2
Status
Indication Trial Status
Protocol
Defined
# of Patients
Collaborations
3
Single agent
PRESENT
Study
1+, 2+
BREAST
Node Positive
HLA A2+, A3+
STOPPED
700
(enrolled 758)
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+
Recruiting
U.S. only
4 centers
48
2 Single agent
1+,
2+,3+
GASTRIC
HLA A2+, A3+
Planned
India Only
50
9
Targeting Folate Binding
Protein
GALE-301 &
GALE-302
GALE-301 & GALE-302:
CURRENT CLINICAL DEVELOPMENT
11
Phase Treatment Cancer Type
Target
Indication
Current
Status
# of Enrolled
Patients
1/2a GALE-301
Ovarian,
Endometrial
HLA A2+
Ovarian Enrolled 51
1b
GALE-301 &
GALE-302
Ovarian, Breast
HLA A2+
Ovarian /
Breast
Enrolled 39
GALE-301: OPTIMAL DOSE GROUP SHOWS
PRELIMINARY EFFICACY
Source: Peoples, et. al, Poster Presentation, American Society of Clinical Oncology 2015 12
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
GALE-401
Anagrelide CR
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 Results
•Well tolerated with primarily Grade 1 and 2 toxicities
•Efficacy compares favorably to historical anagrelide IR
14
ESSENTIAL THROMBOCYTHEMIA (ET):
CURRENT STANDARD OF CARE
15
• 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
• Limited third line use
• Non cytotoxic drug
• Not used in most patients because requires
injection and has flu like symptoms
• Used mostly in pregnant women
• Generally second line
• Non cytotoxic drug
• Decreases platelets formation
• Not associated with increased risk of
leukemia
• Side effects: palpitations, headaches
• About one-third are intolerant to Anagrelide
• Hydroxyurea and/or Anagrelide
Treatment Failure
Sources: Leukemia and Lymphoma Society: Essential Thrombocythemia Facts Cervantes, F. Hematology 2011; 215-221
Hydroxyurea
Anagrelide IR
Interferon alpha
Unmet Need
CORPORATE
OVERVIEW
16
FINANCIAL OVERVIEW
Cash Position (as of June 30, 2016) $19.6 million
Debt Financing (May 10, 2016) + $24 million (restricted cash)
Litigation Settlement (July 1, 2016) - $2.3 million
Projected Quarterly Burn $9 - $11 million
Shares Outstanding (as of March 31, 2016) 182 million
Market Cap (as of July 12, 2016) ~$75 million
17
July 2016 Financing $11.7 million (net proceeds)
Common Stock Issued 28,000,000 shares
2016 MILESTONES
18
PROGRAM MILESTONE
PROJECTED
DATE
NeuVax™
(nelipepimut-S)
PRESENT: Achieve 70 Qualifying DFS Events ✓
Fast Track Designation ✓
PRESENT: Interim analysis Stopped
Initiate DCIS trial Q2
Combo H&N 1+/2+ Interim safety data Q4
GALE-301
GALE-302
Present 301/302 booster data ✓
Present GALE-301 Phase 2a two year data ✓
Orphan Drug Designation ✓
Present GALE-301 Biomarker & Dosing Data Q4
GALE-401
(anagrelide CR)
Present combined safety data ✓
Confirmation of 505(b)2 pathway 2H
Publish final Phase 2 report Q4
LEADERSHIP TEAM
19
 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 Communications
IR Sense, Hana Biosciences, Knight Equity
Markets, Bear Stearns, Goldman Sachs
 Gavin Choy, Pharm.D., SVP, Clinical Sciences &
Operations
Otsuka, 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 &
Compliance
Nektar Therapeutics, Bayhill Therapeutics,
Berlex Laboratories, Serono, Parexel, Biogen
WHY WE’RE HERE
20
Source: San Antonio Express 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

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2016 Annual Meeting Highlights

  • 1. 2016 ANNUAL MEETING OF STOCKHOLDERS July 14, 2016
  • 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. DEVELOPMENT PIPELINE Product Therapeutic Area Phase 1 Phase 2 Phase 3 BLA / NDA Immunotherapy: Breast Cancer NeuVax™ (nelipepimut-S) Node-positive HER2 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 Hematology GALE-401 (Anagrelide CR) MPN-related thrombocytosis *NeuVax is an investigational product. Efficacy has not been established. Herceptin is a registered trademark of Genentech. Ongoing Planned VADIS 3 2b StoppedPRESENT
  • 4. PRESENT CURRENT STATUS  IDMC recommend the trial stop for futility • Study drug and all procedures have stopped  Investigation ongoing • Compiled team with addition of outside experts and the Company remains blinded to the data • Operational elements under review include:  Database and data analysis (programming)  Randomization  Manufacturing and packaging elements such as filling, labeling and kit assembly • Biology and immunology • Anticipated timeline: up to 3 months or longer 4
  • 5. 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 5 Checkpoint inhibitors Indirect Immune Modulators Co-stimulators Immune Inhibitory Enzymes CAR T Technology TCR Technology
  • 6. 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 6 Checkpoint inhibitors Indirect Immune Modulators Co-stimulators Immune Inhibitory Enzymes
  • 7. 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 7 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
  • 8. NOVEL DEVELOPMENT STRATEGY: SECONDARY PREVENTION IN CANCER SURVIVORS 8 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 Risk 20% recurrence rate DECLARED TO PREVENT RECURRENCE / METASTATIC DISEASE Breast: Ductal Carcinoma in Situ 8-10% progression to invasive Ovarian Cancer ~50% recurrence rate in 1 yr No FDA Approved targeted therapies • Watch & Wait, or • Repetitive therapies TOLD
  • 9. NEUVAX: DEVELOPMENT COLLABORATIONS Phase Treatment HER2 Status Indication Trial Status Protocol Defined # of Patients Collaborations 3 Single agent PRESENT Study 1+, 2+ BREAST Node Positive HLA A2+, A3+ STOPPED 700 (enrolled 758) 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+ Recruiting U.S. only 4 centers 48 2 Single agent 1+, 2+,3+ GASTRIC HLA A2+, A3+ Planned India Only 50 9
  • 11. GALE-301 & GALE-302: CURRENT CLINICAL DEVELOPMENT 11 Phase Treatment Cancer Type Target Indication Current Status # of Enrolled Patients 1/2a GALE-301 Ovarian, Endometrial HLA A2+ Ovarian Enrolled 51 1b GALE-301 & GALE-302 Ovarian, Breast HLA A2+ Ovarian / Breast Enrolled 39
  • 12. GALE-301: OPTIMAL DOSE GROUP SHOWS PRELIMINARY EFFICACY Source: Peoples, et. al, Poster Presentation, American Society of Clinical Oncology 2015 12 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
  • 14. 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 Results •Well tolerated with primarily Grade 1 and 2 toxicities •Efficacy compares favorably to historical anagrelide IR 14
  • 15. ESSENTIAL THROMBOCYTHEMIA (ET): CURRENT STANDARD OF CARE 15 • 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 • Limited third line use • Non cytotoxic drug • Not used in most patients because requires injection and has flu like symptoms • Used mostly in pregnant women • Generally second line • Non cytotoxic drug • Decreases platelets formation • Not associated with increased risk of leukemia • Side effects: palpitations, headaches • About one-third are intolerant to Anagrelide • Hydroxyurea and/or Anagrelide Treatment Failure Sources: Leukemia and Lymphoma Society: Essential Thrombocythemia Facts Cervantes, F. Hematology 2011; 215-221 Hydroxyurea Anagrelide IR Interferon alpha Unmet Need
  • 17. FINANCIAL OVERVIEW Cash Position (as of June 30, 2016) $19.6 million Debt Financing (May 10, 2016) + $24 million (restricted cash) Litigation Settlement (July 1, 2016) - $2.3 million Projected Quarterly Burn $9 - $11 million Shares Outstanding (as of March 31, 2016) 182 million Market Cap (as of July 12, 2016) ~$75 million 17 July 2016 Financing $11.7 million (net proceeds) Common Stock Issued 28,000,000 shares
  • 18. 2016 MILESTONES 18 PROGRAM MILESTONE PROJECTED DATE NeuVax™ (nelipepimut-S) PRESENT: Achieve 70 Qualifying DFS Events ✓ Fast Track Designation ✓ PRESENT: Interim analysis Stopped Initiate DCIS trial Q2 Combo H&N 1+/2+ Interim safety data Q4 GALE-301 GALE-302 Present 301/302 booster data ✓ Present GALE-301 Phase 2a two year data ✓ Orphan Drug Designation ✓ Present GALE-301 Biomarker & Dosing Data Q4 GALE-401 (anagrelide CR) Present combined safety data ✓ Confirmation of 505(b)2 pathway 2H Publish final Phase 2 report Q4
  • 19. LEADERSHIP TEAM 19  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 Communications IR Sense, Hana Biosciences, Knight Equity Markets, Bear Stearns, Goldman Sachs  Gavin Choy, Pharm.D., SVP, Clinical Sciences & Operations Otsuka, 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 & Compliance Nektar Therapeutics, Bayhill Therapeutics, Berlex Laboratories, Serono, Parexel, Biogen
  • 20. WHY WE’RE HERE 20 Source: San Antonio Express 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