SlideShare una empresa de Scribd logo
1 de 32
Descargar para leer sin conexión
HEMATOLOGY &
ONCOLOGY FOCUSED
COMPANY
September 13, 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
NEEDS
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
Committed to the development and commercialization of hematology and
oncology therapeutics that address unmet medical needs
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
Confidential 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
8
Multiple 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)
ESSENTIAL THROMBOCYTHEMIA (ET)
 ET is a neoplastic stem cell
disorder causing dysregulated
production of large numbers
of abnormal megakaryocytes
resulting in elevated platelets
 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
9
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
10
• 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: TARGET PRODUCT PROFILE (TPP)
vs ANAGRELIDE IR
Confidential 11
Anagrelide IR
GALE-401
TPP
Comment
PK
• Half life
• Cmax
• 2-3 hours
• 4X GALE-401
• 20 hours
• 25% of IR
Improved PK profile
Safety
• Related TEAEs
• # of AE/Patient
• 42.1%
• 3.3
• 30%
• 2.3
Better tolerated
Onset of Action As early as 4 weeks As early as 1 week Faster onset of
benefit
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 2 X day based on
PII
Targeting 1 X day in
PIII
Dose regiment (compliance) Dose
(mg) needed per day
2 to 10 mg a day Target: Mean 2 mg a day Potentially as result
of improved PK
Therapeutic window (distance
between therapeutic dose curve and
toxic dose)
Narrow (dose escalation
to optimal effect is
challenging)
Wider Possibility of
increasing the dose
to desired effect for
GALE-401
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
12
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: 505b(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 2Q, 2017
13
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
15
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
16
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
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
17
Checkpoint
inhibitors
Indirect Immune
Modulators
Co-stimulators
Immune Inhibitory
Enzymes
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
18
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
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
GALE-301
Trastuzamab
IMMUNO-ONCOLOGY: COMBINATION STRATEGY
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 Ag processing/
presentation pathway
 Hypothesis: Trastuzumab
treatment will enhance
response to vaccination
 By making tumor cells
more visible to T-
cells/immune system.
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
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
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
24
Targeting Folate Binding
Protein
GALE-301 &
GALE-302
GALE-301 & GALE-302
26Source: 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 27
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
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
 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 8, 2016) ~$80 million
30
2H, 2016 MILESTONES
31
PROGRAM MILESTONE
PROJECTED
DATE
GALE-401
(anagrelide CR)
Present combined P1 & P2 safety data ✓
Confirmation of 505(b)2 pathway 2H
Submit final Phase 2 report Q4
NeuVax™
(nelipepimut-S)
Fast Track Designation ✓
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 primary analysis ✓
Orphan Drug Designation ✓
Present GALE-301 Biomarker & Dosing Data Q4
THANK YOU
NASDAQ: GALE

Más contenido relacionado

La actualidad más candente

Q2, 2016 earnings slides final2
Q2, 2016 earnings slides   final2Q2, 2016 earnings slides   final2
Q2, 2016 earnings slides final2Galenabio
 
Galena presentation 8 feb 16
Galena presentation  8 feb 16Galena presentation  8 feb 16
Galena presentation 8 feb 16Galenabio
 
Greenwich LifeSciences (GLSI) November 2021
Greenwich LifeSciences (GLSI) November 2021Greenwich LifeSciences (GLSI) November 2021
Greenwich LifeSciences (GLSI) November 2021RedChip Companies, Inc.
 
Opexa therapeutics corporate presentation june 2014 for print
Opexa therapeutics corporate presentation june 2014 for printOpexa therapeutics corporate presentation june 2014 for print
Opexa therapeutics corporate presentation june 2014 for printRedChip Companies, Inc.
 
Opexa therapeutics corporate presentation june 2014
Opexa therapeutics corporate presentation june 2014Opexa therapeutics corporate presentation june 2014
Opexa therapeutics corporate presentation june 2014OpexaTherapeutics
 
Opexa Therapeutics Corporate Presentation July 2014
Opexa Therapeutics Corporate Presentation July 2014Opexa Therapeutics Corporate Presentation July 2014
Opexa Therapeutics Corporate Presentation July 2014OpexaTherapeutics
 
Analyzing ASCO 2016: Developments, takeaways, and implications from the confe...
Analyzing ASCO 2016: Developments, takeaways, and implications from the confe...Analyzing ASCO 2016: Developments, takeaways, and implications from the confe...
Analyzing ASCO 2016: Developments, takeaways, and implications from the confe...Pharma Intelligence
 
Protalix analyst day presentation
Protalix analyst day presentationProtalix analyst day presentation
Protalix analyst day presentationJames Hilbert
 
Pharma R&D Annual Review 2016 Webinar
Pharma R&D Annual Review 2016 WebinarPharma R&D Annual Review 2016 Webinar
Pharma R&D Annual Review 2016 WebinarPharma Intelligence
 
biOasis Technologies, Inc. Presentation - October 2014
biOasis Technologies, Inc. Presentation - October 2014biOasis Technologies, Inc. Presentation - October 2014
biOasis Technologies, Inc. Presentation - October 2014graemedick
 
Phase 1 data presentation final with appendix
Phase 1 data presentation final with appendixPhase 1 data presentation final with appendix
Phase 1 data presentation final with appendixBellusHealth
 
Androgel Safety Information
Androgel Safety InformationAndrogel Safety Information
Androgel Safety InformationDavid Castle
 
Direct Hit Power Point Presentation
Direct Hit Power Point PresentationDirect Hit Power Point Presentation
Direct Hit Power Point PresentationDirectMrBobby
 
Bc Presentation Web 052810
Bc Presentation Web 052810Bc Presentation Web 052810
Bc Presentation Web 052810sfdeam
 
Transdel Pharmaceuticals Inc., (TDLP.OB)
Transdel Pharmaceuticals Inc., (TDLP.OB)Transdel Pharmaceuticals Inc., (TDLP.OB)
Transdel Pharmaceuticals Inc., (TDLP.OB)Brett_Johnson
 
Global Transactions in Pharma/Biotech
Global Transactions in Pharma/BiotechGlobal Transactions in Pharma/Biotech
Global Transactions in Pharma/BiotechPharma Intelligence
 
Drugs failed in clinical trials
Drugs failed in clinical trialsDrugs failed in clinical trials
Drugs failed in clinical trialsAnkanSarkar11
 

La actualidad más candente (19)

Q2, 2016 earnings slides final2
Q2, 2016 earnings slides   final2Q2, 2016 earnings slides   final2
Q2, 2016 earnings slides final2
 
Galena presentation 8 feb 16
Galena presentation  8 feb 16Galena presentation  8 feb 16
Galena presentation 8 feb 16
 
Greenwich LifeSciences (GLSI) November 2021
Greenwich LifeSciences (GLSI) November 2021Greenwich LifeSciences (GLSI) November 2021
Greenwich LifeSciences (GLSI) November 2021
 
Opexa therapeutics corporate presentation june 2014 for print
Opexa therapeutics corporate presentation june 2014 for printOpexa therapeutics corporate presentation june 2014 for print
Opexa therapeutics corporate presentation june 2014 for print
 
Opexa therapeutics corporate presentation june 2014
Opexa therapeutics corporate presentation june 2014Opexa therapeutics corporate presentation june 2014
Opexa therapeutics corporate presentation june 2014
 
Opexa Therapeutics Corporate Presentation July 2014
Opexa Therapeutics Corporate Presentation July 2014Opexa Therapeutics Corporate Presentation July 2014
Opexa Therapeutics Corporate Presentation July 2014
 
Analyzing ASCO 2016: Developments, takeaways, and implications from the confe...
Analyzing ASCO 2016: Developments, takeaways, and implications from the confe...Analyzing ASCO 2016: Developments, takeaways, and implications from the confe...
Analyzing ASCO 2016: Developments, takeaways, and implications from the confe...
 
Introducing ROSALIND
Introducing ROSALINDIntroducing ROSALIND
Introducing ROSALIND
 
Protalix analyst day presentation
Protalix analyst day presentationProtalix analyst day presentation
Protalix analyst day presentation
 
Pharma R&D Annual Review 2016 Webinar
Pharma R&D Annual Review 2016 WebinarPharma R&D Annual Review 2016 Webinar
Pharma R&D Annual Review 2016 Webinar
 
biOasis Technologies, Inc. Presentation - October 2014
biOasis Technologies, Inc. Presentation - October 2014biOasis Technologies, Inc. Presentation - October 2014
biOasis Technologies, Inc. Presentation - October 2014
 
Phase 1 data presentation final with appendix
Phase 1 data presentation final with appendixPhase 1 data presentation final with appendix
Phase 1 data presentation final with appendix
 
Androgel Safety Information
Androgel Safety InformationAndrogel Safety Information
Androgel Safety Information
 
Direct Hit Power Point Presentation
Direct Hit Power Point PresentationDirect Hit Power Point Presentation
Direct Hit Power Point Presentation
 
Bc Presentation Web 052810
Bc Presentation Web 052810Bc Presentation Web 052810
Bc Presentation Web 052810
 
Transdel Pharmaceuticals Inc., (TDLP.OB)
Transdel Pharmaceuticals Inc., (TDLP.OB)Transdel Pharmaceuticals Inc., (TDLP.OB)
Transdel Pharmaceuticals Inc., (TDLP.OB)
 
Global Transactions in Pharma/Biotech
Global Transactions in Pharma/BiotechGlobal Transactions in Pharma/Biotech
Global Transactions in Pharma/Biotech
 
Drugs failed in clinical trials
Drugs failed in clinical trialsDrugs failed in clinical trials
Drugs failed in clinical trials
 
05 opxa
05 opxa05 opxa
05 opxa
 

Destacado

Galena Biopharma Company Presentation
Galena Biopharma Company PresentationGalena Biopharma Company Presentation
Galena Biopharma Company PresentationGalenabio
 
Galena presentation 14 mar 16
Galena presentation   14 mar 16 Galena presentation   14 mar 16
Galena presentation 14 mar 16 Galenabio
 
Oncology Focused Immunotherapy Company
Oncology Focused Immunotherapy CompanyOncology Focused Immunotherapy Company
Oncology Focused Immunotherapy CompanyGalenabio
 
08 16 investor presentation
08 16 investor presentation08 16 investor presentation
08 16 investor presentationinvestorplygem
 
Galena presentation 8 apr 16
Galena presentation   8 apr 16 Galena presentation   8 apr 16
Galena presentation 8 apr 16 Galenabio
 
Galena presentation 3 june 16
Galena presentation   3 june 16Galena presentation   3 june 16
Galena presentation 3 june 16Galenabio
 
Pgem q2 2016 earnings slides final
Pgem q2 2016 earnings slides finalPgem q2 2016 earnings slides final
Pgem q2 2016 earnings slides finalinvestorplygem
 
Galena presentation 11 may 16
Galena presentation   11 may 16 Galena presentation   11 may 16
Galena presentation 11 may 16 Galenabio
 
2016 shareholder meeting presentation final
2016 shareholder meeting presentation final2016 shareholder meeting presentation final
2016 shareholder meeting presentation finalGalenabio
 
Pgem q3 2016 earnings slides final
Pgem q3 2016 earnings slides finalPgem q3 2016 earnings slides final
Pgem q3 2016 earnings slides finalinvestorplygem
 
Galena presentation
Galena presentationGalena presentation
Galena presentationGalenabio
 
Pgem q4 2016 earnings slides final
Pgem q4 2016 earnings slides finalPgem q4 2016 earnings slides final
Pgem q4 2016 earnings slides finalinvestorplygem
 

Destacado (12)

Galena Biopharma Company Presentation
Galena Biopharma Company PresentationGalena Biopharma Company Presentation
Galena Biopharma Company Presentation
 
Galena presentation 14 mar 16
Galena presentation   14 mar 16 Galena presentation   14 mar 16
Galena presentation 14 mar 16
 
Oncology Focused Immunotherapy Company
Oncology Focused Immunotherapy CompanyOncology Focused Immunotherapy Company
Oncology Focused Immunotherapy Company
 
08 16 investor presentation
08 16 investor presentation08 16 investor presentation
08 16 investor presentation
 
Galena presentation 8 apr 16
Galena presentation   8 apr 16 Galena presentation   8 apr 16
Galena presentation 8 apr 16
 
Galena presentation 3 june 16
Galena presentation   3 june 16Galena presentation   3 june 16
Galena presentation 3 june 16
 
Pgem q2 2016 earnings slides final
Pgem q2 2016 earnings slides finalPgem q2 2016 earnings slides final
Pgem q2 2016 earnings slides final
 
Galena presentation 11 may 16
Galena presentation   11 may 16 Galena presentation   11 may 16
Galena presentation 11 may 16
 
2016 shareholder meeting presentation final
2016 shareholder meeting presentation final2016 shareholder meeting presentation final
2016 shareholder meeting presentation final
 
Pgem q3 2016 earnings slides final
Pgem q3 2016 earnings slides finalPgem q3 2016 earnings slides final
Pgem q3 2016 earnings slides final
 
Galena presentation
Galena presentationGalena presentation
Galena presentation
 
Pgem q4 2016 earnings slides final
Pgem q4 2016 earnings slides finalPgem q4 2016 earnings slides final
Pgem q4 2016 earnings slides final
 

Similar a Galena presentation 13 sept 16

May 2016 Corporate Presentation
May 2016 Corporate PresentationMay 2016 Corporate Presentation
May 2016 Corporate Presentationoncolyticsinc
 
Technology overview
Technology overviewTechnology overview
Technology overviewtargovax2017
 
Investor Call
Investor CallInvestor Call
Investor Callmerckir
 
Opexa therapeutics-corporate-presentation-november-2015
Opexa therapeutics-corporate-presentation-november-2015Opexa therapeutics-corporate-presentation-november-2015
Opexa therapeutics-corporate-presentation-november-2015OpexaTherapeutics
 
SciTech Development - Pediatric Oncology Focus
SciTech Development - Pediatric Oncology FocusSciTech Development - Pediatric Oncology Focus
SciTech Development - Pediatric Oncology FocusSciTech Development
 
Opexa therapeutics corporate presentation march 2016
Opexa therapeutics corporate presentation march 2016Opexa therapeutics corporate presentation march 2016
Opexa therapeutics corporate presentation march 2016OpexaTherapeutics
 
Targovax Next generation immune activators for solid tumors
Targovax Next generation immune activators for solid tumorsTargovax Next generation immune activators for solid tumors
Targovax Next generation immune activators for solid tumorsRoarFredriksen1
 
Opexa therapeutics corporate presentation july 2016
Opexa therapeutics corporate presentation july 2016Opexa therapeutics corporate presentation july 2016
Opexa therapeutics corporate presentation july 2016OpexaTherapeutics
 
Opexa therapeutics corporate presentation may 2016
Opexa therapeutics corporate presentation may 2016Opexa therapeutics corporate presentation may 2016
Opexa therapeutics corporate presentation may 2016OpexaTherapeutics
 
Opexa Therapeutics December 2015 Corporate Presentation
Opexa Therapeutics December 2015 Corporate PresentationOpexa Therapeutics December 2015 Corporate Presentation
Opexa Therapeutics December 2015 Corporate PresentationOpexaTherapeutics
 
Opexa therapeutics corporate presentation september 2016
Opexa therapeutics corporate presentation september 2016Opexa therapeutics corporate presentation september 2016
Opexa therapeutics corporate presentation september 2016OpexaTherapeutics
 
10th european life science ceo forum
10th european life science ceo forum10th european life science ceo forum
10th european life science ceo forumtargovax2017
 
Novel Strategies for Attacking the Epidermal Growth Factor Receptor
Novel Strategies for Attacking the Epidermal Growth Factor ReceptorNovel Strategies for Attacking the Epidermal Growth Factor Receptor
Novel Strategies for Attacking the Epidermal Growth Factor ReceptorOSUCCC - James
 
November 2017 Corporate Presentation
November 2017 Corporate PresentationNovember 2017 Corporate Presentation
November 2017 Corporate Presentationoncolyticsinc
 
Opexa therapeutics corporate presentation february 2016 web
Opexa therapeutics corporate presentation february 2016 webOpexa therapeutics corporate presentation february 2016 web
Opexa therapeutics corporate presentation february 2016 webOpexaTherapeutics
 
October 2017 Corporate Presentation
October 2017 Corporate PresentationOctober 2017 Corporate Presentation
October 2017 Corporate Presentationoncolyticsinc
 
November 2017 Corporate Presentation
November 2017 Corporate PresentationNovember 2017 Corporate Presentation
November 2017 Corporate Presentationoncolyticsinc
 
September 2016 Corporate Presentation
September 2016 Corporate PresentationSeptember 2016 Corporate Presentation
September 2016 Corporate Presentationoncolyticsinc
 

Similar a Galena presentation 13 sept 16 (19)

May 2016 Corporate Presentation
May 2016 Corporate PresentationMay 2016 Corporate Presentation
May 2016 Corporate Presentation
 
Technology overview
Technology overviewTechnology overview
Technology overview
 
Investor Call
Investor CallInvestor Call
Investor Call
 
Opexa therapeutics-corporate-presentation-november-2015
Opexa therapeutics-corporate-presentation-november-2015Opexa therapeutics-corporate-presentation-november-2015
Opexa therapeutics-corporate-presentation-november-2015
 
SciTech Development - Pediatric Oncology Focus
SciTech Development - Pediatric Oncology FocusSciTech Development - Pediatric Oncology Focus
SciTech Development - Pediatric Oncology Focus
 
Opexa therapeutics corporate presentation march 2016
Opexa therapeutics corporate presentation march 2016Opexa therapeutics corporate presentation march 2016
Opexa therapeutics corporate presentation march 2016
 
Targovax Next generation immune activators for solid tumors
Targovax Next generation immune activators for solid tumorsTargovax Next generation immune activators for solid tumors
Targovax Next generation immune activators for solid tumors
 
Opexa therapeutics corporate presentation july 2016
Opexa therapeutics corporate presentation july 2016Opexa therapeutics corporate presentation july 2016
Opexa therapeutics corporate presentation july 2016
 
Opexa therapeutics corporate presentation may 2016
Opexa therapeutics corporate presentation may 2016Opexa therapeutics corporate presentation may 2016
Opexa therapeutics corporate presentation may 2016
 
Dendreon.Final
Dendreon.FinalDendreon.Final
Dendreon.Final
 
Opexa Therapeutics December 2015 Corporate Presentation
Opexa Therapeutics December 2015 Corporate PresentationOpexa Therapeutics December 2015 Corporate Presentation
Opexa Therapeutics December 2015 Corporate Presentation
 
Opexa therapeutics corporate presentation september 2016
Opexa therapeutics corporate presentation september 2016Opexa therapeutics corporate presentation september 2016
Opexa therapeutics corporate presentation september 2016
 
10th european life science ceo forum
10th european life science ceo forum10th european life science ceo forum
10th european life science ceo forum
 
Novel Strategies for Attacking the Epidermal Growth Factor Receptor
Novel Strategies for Attacking the Epidermal Growth Factor ReceptorNovel Strategies for Attacking the Epidermal Growth Factor Receptor
Novel Strategies for Attacking the Epidermal Growth Factor Receptor
 
November 2017 Corporate Presentation
November 2017 Corporate PresentationNovember 2017 Corporate Presentation
November 2017 Corporate Presentation
 
Opexa therapeutics corporate presentation february 2016 web
Opexa therapeutics corporate presentation february 2016 webOpexa therapeutics corporate presentation february 2016 web
Opexa therapeutics corporate presentation february 2016 web
 
October 2017 Corporate Presentation
October 2017 Corporate PresentationOctober 2017 Corporate Presentation
October 2017 Corporate Presentation
 
November 2017 Corporate Presentation
November 2017 Corporate PresentationNovember 2017 Corporate Presentation
November 2017 Corporate Presentation
 
September 2016 Corporate Presentation
September 2016 Corporate PresentationSeptember 2016 Corporate Presentation
September 2016 Corporate Presentation
 

Último

Collective Mining | Corporate Presentation - May 2024
Collective Mining | Corporate Presentation - May 2024Collective Mining | Corporate Presentation - May 2024
Collective Mining | Corporate Presentation - May 2024CollectiveMining1
 
Corporate Presentation Probe May 2024.pdf
Corporate Presentation Probe May 2024.pdfCorporate Presentation Probe May 2024.pdf
Corporate Presentation Probe May 2024.pdfProbe Gold
 
VIP 7001035870 Find & Meet Hyderabad Call Girls Banjara Hills high-profile Ca...
VIP 7001035870 Find & Meet Hyderabad Call Girls Banjara Hills high-profile Ca...VIP 7001035870 Find & Meet Hyderabad Call Girls Banjara Hills high-profile Ca...
VIP 7001035870 Find & Meet Hyderabad Call Girls Banjara Hills high-profile Ca...aditipandeya
 
Nicola Mining Inc. Corporate Presentation May 2024
Nicola Mining Inc. Corporate Presentation May 2024Nicola Mining Inc. Corporate Presentation May 2024
Nicola Mining Inc. Corporate Presentation May 2024nicola_mining
 
VIP 7001035870 Find & Meet Hyderabad Call Girls Abids high-profile Call Girl
VIP 7001035870 Find & Meet Hyderabad Call Girls Abids high-profile Call GirlVIP 7001035870 Find & Meet Hyderabad Call Girls Abids high-profile Call Girl
VIP 7001035870 Find & Meet Hyderabad Call Girls Abids high-profile Call Girladitipandeya
 
Call Girls Chandigarh Just Call 8868886958 Top Class Call Girl Service Available
Call Girls Chandigarh Just Call 8868886958 Top Class Call Girl Service AvailableCall Girls Chandigarh Just Call 8868886958 Top Class Call Girl Service Available
Call Girls Chandigarh Just Call 8868886958 Top Class Call Girl Service AvailableSheetaleventcompany
 
B2 Interpret the brief.docxccccccccccccccc
B2 Interpret the brief.docxcccccccccccccccB2 Interpret the brief.docxccccccccccccccc
B2 Interpret the brief.docxcccccccccccccccMollyBrown86
 
Teck Investor Presentation, April 24, 2024
Teck Investor Presentation, April 24, 2024Teck Investor Presentation, April 24, 2024
Teck Investor Presentation, April 24, 2024TeckResourcesLtd
 
SME IPO and sme ipo listing consultants .pptx
SME IPO and sme ipo listing consultants .pptxSME IPO and sme ipo listing consultants .pptx
SME IPO and sme ipo listing consultants .pptxindia IPO
 

Último (20)

young call girls in Mahavir Nagar 🔝 9953056974 🔝 Delhi escort Service
young call girls in Mahavir Nagar 🔝 9953056974 🔝 Delhi escort Serviceyoung call girls in Mahavir Nagar 🔝 9953056974 🔝 Delhi escort Service
young call girls in Mahavir Nagar 🔝 9953056974 🔝 Delhi escort Service
 
Collective Mining | Corporate Presentation - May 2024
Collective Mining | Corporate Presentation - May 2024Collective Mining | Corporate Presentation - May 2024
Collective Mining | Corporate Presentation - May 2024
 
Russian Call Girls Rohini Sector 3 💓 Delhi 9999965857 @Sabina Modi VVIP MODEL...
Russian Call Girls Rohini Sector 3 💓 Delhi 9999965857 @Sabina Modi VVIP MODEL...Russian Call Girls Rohini Sector 3 💓 Delhi 9999965857 @Sabina Modi VVIP MODEL...
Russian Call Girls Rohini Sector 3 💓 Delhi 9999965857 @Sabina Modi VVIP MODEL...
 
Corporate Presentation Probe May 2024.pdf
Corporate Presentation Probe May 2024.pdfCorporate Presentation Probe May 2024.pdf
Corporate Presentation Probe May 2024.pdf
 
@9999965857 🫦 Sexy Desi Call Girls Karol Bagh 💓 High Profile Escorts Delhi 🫶
@9999965857 🫦 Sexy Desi Call Girls Karol Bagh 💓 High Profile Escorts Delhi 🫶@9999965857 🫦 Sexy Desi Call Girls Karol Bagh 💓 High Profile Escorts Delhi 🫶
@9999965857 🫦 Sexy Desi Call Girls Karol Bagh 💓 High Profile Escorts Delhi 🫶
 
VIP 7001035870 Find & Meet Hyderabad Call Girls Banjara Hills high-profile Ca...
VIP 7001035870 Find & Meet Hyderabad Call Girls Banjara Hills high-profile Ca...VIP 7001035870 Find & Meet Hyderabad Call Girls Banjara Hills high-profile Ca...
VIP 7001035870 Find & Meet Hyderabad Call Girls Banjara Hills high-profile Ca...
 
Nicola Mining Inc. Corporate Presentation May 2024
Nicola Mining Inc. Corporate Presentation May 2024Nicola Mining Inc. Corporate Presentation May 2024
Nicola Mining Inc. Corporate Presentation May 2024
 
Russian Call Girls Rohini Sector 22 💓 Delhi 9999965857 @Sabina Modi VVIP MODE...
Russian Call Girls Rohini Sector 22 💓 Delhi 9999965857 @Sabina Modi VVIP MODE...Russian Call Girls Rohini Sector 22 💓 Delhi 9999965857 @Sabina Modi VVIP MODE...
Russian Call Girls Rohini Sector 22 💓 Delhi 9999965857 @Sabina Modi VVIP MODE...
 
Call Girls 🫤 Mukherjee Nagar ➡️ 9999965857 ➡️ Delhi 🫦 Russian Escorts FULL ...
Call Girls 🫤 Mukherjee Nagar ➡️ 9999965857  ➡️ Delhi 🫦  Russian Escorts FULL ...Call Girls 🫤 Mukherjee Nagar ➡️ 9999965857  ➡️ Delhi 🫦  Russian Escorts FULL ...
Call Girls 🫤 Mukherjee Nagar ➡️ 9999965857 ➡️ Delhi 🫦 Russian Escorts FULL ...
 
VIP 7001035870 Find & Meet Hyderabad Call Girls Abids high-profile Call Girl
VIP 7001035870 Find & Meet Hyderabad Call Girls Abids high-profile Call GirlVIP 7001035870 Find & Meet Hyderabad Call Girls Abids high-profile Call Girl
VIP 7001035870 Find & Meet Hyderabad Call Girls Abids high-profile Call Girl
 
Call Girls In Kalkaji 📱 9999965857 🤩 Delhi 🫦 HOT AND SEXY VVIP 🍎 SERVICE
Call Girls In Kalkaji 📱  9999965857  🤩 Delhi 🫦 HOT AND SEXY VVIP 🍎 SERVICECall Girls In Kalkaji 📱  9999965857  🤩 Delhi 🫦 HOT AND SEXY VVIP 🍎 SERVICE
Call Girls In Kalkaji 📱 9999965857 🤩 Delhi 🫦 HOT AND SEXY VVIP 🍎 SERVICE
 
(👉゚9999965857 ゚)👉 VIP Call Girls Friends Colony 👉 Delhi 👈 : 9999 Cash Payment...
(👉゚9999965857 ゚)👉 VIP Call Girls Friends Colony 👉 Delhi 👈 : 9999 Cash Payment...(👉゚9999965857 ゚)👉 VIP Call Girls Friends Colony 👉 Delhi 👈 : 9999 Cash Payment...
(👉゚9999965857 ゚)👉 VIP Call Girls Friends Colony 👉 Delhi 👈 : 9999 Cash Payment...
 
Call Girls Chandigarh Just Call 8868886958 Top Class Call Girl Service Available
Call Girls Chandigarh Just Call 8868886958 Top Class Call Girl Service AvailableCall Girls Chandigarh Just Call 8868886958 Top Class Call Girl Service Available
Call Girls Chandigarh Just Call 8868886958 Top Class Call Girl Service Available
 
Vip Call Girls Vasant Kunj ➡️ Delhi ➡️ 9999965857 No Advance 24HRS Live
Vip Call Girls Vasant Kunj ➡️ Delhi ➡️ 9999965857 No Advance 24HRS LiveVip Call Girls Vasant Kunj ➡️ Delhi ➡️ 9999965857 No Advance 24HRS Live
Vip Call Girls Vasant Kunj ➡️ Delhi ➡️ 9999965857 No Advance 24HRS Live
 
B2 Interpret the brief.docxccccccccccccccc
B2 Interpret the brief.docxcccccccccccccccB2 Interpret the brief.docxccccccccccccccc
B2 Interpret the brief.docxccccccccccccccc
 
Call Girls In Vasant Kunj 📱 9999965857 🤩 Delhi 🫦 HOT AND SEXY VVIP 🍎 SERVICE
Call Girls In Vasant Kunj 📱  9999965857  🤩 Delhi 🫦 HOT AND SEXY VVIP 🍎 SERVICECall Girls In Vasant Kunj 📱  9999965857  🤩 Delhi 🫦 HOT AND SEXY VVIP 🍎 SERVICE
Call Girls In Vasant Kunj 📱 9999965857 🤩 Delhi 🫦 HOT AND SEXY VVIP 🍎 SERVICE
 
Rohini Sector 17 Call Girls Delhi 9999965857 @Sabina Saikh No Advance
Rohini Sector 17 Call Girls Delhi 9999965857 @Sabina Saikh No AdvanceRohini Sector 17 Call Girls Delhi 9999965857 @Sabina Saikh No Advance
Rohini Sector 17 Call Girls Delhi 9999965857 @Sabina Saikh No Advance
 
Teck Investor Presentation, April 24, 2024
Teck Investor Presentation, April 24, 2024Teck Investor Presentation, April 24, 2024
Teck Investor Presentation, April 24, 2024
 
SME IPO and sme ipo listing consultants .pptx
SME IPO and sme ipo listing consultants .pptxSME IPO and sme ipo listing consultants .pptx
SME IPO and sme ipo listing consultants .pptx
 
Call Girls In South Delhi 📱 9999965857 🤩 Delhi 🫦 HOT AND SEXY VVIP 🍎 SERVICE
Call Girls In South Delhi 📱  9999965857  🤩 Delhi 🫦 HOT AND SEXY VVIP 🍎 SERVICECall Girls In South Delhi 📱  9999965857  🤩 Delhi 🫦 HOT AND SEXY VVIP 🍎 SERVICE
Call Girls In South Delhi 📱 9999965857 🤩 Delhi 🫦 HOT AND SEXY VVIP 🍎 SERVICE
 

Galena presentation 13 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 NEEDS 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 Committed to the development and commercialization of hematology and oncology therapeutics that address unmet medical needs
  • 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 Confidential 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 8 Multiple 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. ESSENTIAL THROMBOCYTHEMIA (ET)  ET is a neoplastic stem cell disorder causing dysregulated production of large numbers of abnormal megakaryocytes resulting in elevated platelets  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 9 Arrows: Megakaryocytes ET has Larger Number of Megakayocytes Source: Haematologica. 2009 June; 94(6): 865, Am J Hematology. 2008 May;83(5):359)
  • 10. ESSENTIAL THROMBOCYTHEMIA (ET): CURRENT U.S. STANDARD OF CARE 10 • 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
  • 11. GALE-401: TARGET PRODUCT PROFILE (TPP) vs ANAGRELIDE IR Confidential 11 Anagrelide IR GALE-401 TPP Comment PK • Half life • Cmax • 2-3 hours • 4X GALE-401 • 20 hours • 25% of IR Improved PK profile Safety • Related TEAEs • # of AE/Patient • 42.1% • 3.3 • 30% • 2.3 Better tolerated Onset of Action As early as 4 weeks As early as 1 week Faster onset of benefit 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 2 X day based on PII Targeting 1 X day in PIII Dose regiment (compliance) Dose (mg) needed per day 2 to 10 mg a day Target: Mean 2 mg a day Potentially as result of improved PK Therapeutic window (distance between therapeutic dose curve and toxic dose) Narrow (dose escalation to optimal effect is challenging) Wider Possibility of increasing the dose to desired effect for GALE-401
  • 12. 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 12
  • 13. 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: 505b(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 2Q, 2017 13 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
  • 15. 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 15 K I F G S L A F L
  • 16. 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 16 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
  • 17. 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 17 Checkpoint inhibitors Indirect Immune Modulators Co-stimulators Immune Inhibitory Enzymes
  • 18. 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 18 Checkpoint inhibitors Indirect Immune Modulators Co-stimulators Immune Inhibitory Enzymes
  • 19. 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 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 GALE-301 Trastuzamab
  • 21. 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 Ag processing/ presentation pathway  Hypothesis: Trastuzumab treatment will enhance response to vaccination  By making tumor cells more visible to T- cells/immune system. 21
  • 22. 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 PBMC from HER2/neu peptide, E75, vaccinated patients efficiently recognize and lyse trastuzumab-treated HER2/neu- expressing tumor cell lines 22
  • 23. 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 23
  • 24. 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 24
  • 26. GALE-301 & GALE-302 26Source: 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
  • 27. GALE-301: OPTIMAL DOSE GROUP SHOWS PRELIMINARY EFFICACY Source: Peoples, et. al, Poster Presentation, American Society of Clinical Oncology 2016 27 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
  • 29. 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  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
  • 30. 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 8, 2016) ~$80 million 30
  • 31. 2H, 2016 MILESTONES 31 PROGRAM MILESTONE PROJECTED DATE GALE-401 (anagrelide CR) Present combined P1 & P2 safety data ✓ Confirmation of 505(b)2 pathway 2H Submit final Phase 2 report Q4 NeuVax™ (nelipepimut-S) Fast Track Designation ✓ 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 primary analysis ✓ Orphan Drug Designation ✓ Present GALE-301 Biomarker & Dosing Data Q4