Company Presentation

NASDAQ: GALE
www.galenabiopharma.com
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 target revenue from the sales of the Company’s
products, the future expectations, plans and prospects for the development and
commercialization of the Company's product candidates, including patient
enrollment in our clinical trials, and 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 forwardlooking 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
CORPORATE OVERVIEW
Diversified biopharmaceutical company focused on oncology with
a rich development pipeline supported by a commercial franchise
Abstral® (fentanyl)
Commercial
•  Sublingual Tablets approved for
breakthrough cancer pain
NeuVax™ (nelipepimut-S)
Immunotherapy
Franchise
Zuplenz® (ondansetron)
•  Oral soluble film for nausea and vomiting
caused by surgery, highly and moderately
emetogenic chemotherapy, and radiation
therapy
GALE-301 (Folate Binding Protein)
•  A novel cancer immunotherapy targeting
the HER2 protein
•  Novel immunotherapy for patients with
ovarian and endometrial cancer in Phase 2
•  Phase 3 PRESENT multinational trial
ongoing under SPA
•  Immunological and early Phase 2 clinical
data
•  Franchise of mid-stage trials ongoing or
planned
•  Unmet medical need
•  High recurrence rates with poor outcomes
3
PRODUCT PIPELINE
Product
Therapeutic Area
Phase 1
Phase 2
Phase 3
NDA
Approved
Commercial
Abstral® (fentanyl)
Sublingual Tablets
Breakthrough Cancer Pain
ZUPLENZ® (ondansetron)
Oral Soluble Film
Antiemetic for CINV, RINV, PONV
Immunotherapy
NeuVax™
Breast cancer node-positive,
HER2 IHC 1+/2+
NeuVax™ + Herceptin®
Breast cancer node-positive & triple
negative, HER2 IHC 1+/2+
NeuVax™ + Herceptin®
Breast cancer neoadjuvant, nodepositive & negative, HER2 IHC 3+
NeuVax™
Gastric carcinoma
HER2 IHC 1+/2+ or 3+
GALE-301 (Folate Binding Protein)
Ovarian & Endometrial Carcinomas
PRESENT Trial
Hematology
GALE-401 (Anagrelide CR)
MPN-related thrombocytosis
Ongoing
Planned
*NeuVax is an investigational product. Efficacy has not been established. Herceptin is a registered trademark of Genentech.
4
COMMERCIAL
5
ESTABLISHED COMMERCIAL FRANCHISE
Current products
Commercial franchise
targeting oncology
supportive care
established as channel for future
products from our pipeline
u 
u 
Customer base
represents call point for
both current
commercial products
and future pipeline
products
Will be accretive and
provide ongoing
financial support to the
company’s programs
Current products
Commercial
Channel
u 
Abstral® (fentanyl)
sublingual tablets
u 
Zuplenz® (ondansetron)
oral soluble film
targeting
oncology
Proven
ability
to distribute,
supportive
care
market
and promote
u 
Galena Patient Services
(GPS) provides
reimbursement and
access support to
healthcare providers and
patients
u 
Patient Assistance
Program (PAP)
u 
MCO, Contracting, Sales
infrastructure
6
ABSTRAL® (FENTANYL) SUBLINGUAL TABLETS
u 
Approved for Breakthrough Cancer Pain (BTcP) in
opioid tolerant adult patients
u 
Launched in Q4, 2013
u 
Innovative technology
•  Mucoadhesive technology allows for rapid
dissolution
•  Micronized fentanyl for rapid absorption
•  Sublingual tablet dissolves under the tongue in
seconds
ü  Provides rapid relief of
•  Conveniently packaged in single-dose, easy-tocarry blister packs
Abstral
breakthrough pain
ü  Provides pain relief for the entire
breakthrough episode
Sources: Chrvala CA, Caspi A. Abstral (fentanyl sublingual tablets for breakthrough cancer pain). P&T Product Profiler.
2011;36(2):2-28. ABSTRAL PI. Portland, OR: Galena Biopharma, Inc. 2013. England R, Maddocks M, Manderson C, ZadoraChrzastowska S, Wilcock A. How practical are transmucosal fentanyl products for breakthrough cancer pain? novel use of
placebo formulations to survey user opinion. BMJ Support Palliat Care. 2011;1:349-351.
Please see full prescribing information at www.abstral.com
7
BREAKTHROUGH CANCER PAIN
NCCN 2013 Guidelines recommend use of a rapid-onset opioid for BTcP*
Cancer pain is caused by damage to body tissues related to disease activity
(e.g., tumors pressing on nerves) or by treatments (e.g., surgery, chemo, radiation).
Breakthrough cancer pain (BTcP) is different from
persistent pain treated with long- and short-acting
opioids
Short-acting opioids do not start working until rapidonset BTcP has subsided, leaving patients with
long-lasting sedative effects
Characteristics of breakthrough cancer pain
Fast
Maximum severity within 3 minutes
Short
Median of 30 minutes
Frequent
4-7 episodes per day
Unpredictable
Usually not associated with specific
behavior or physical activity
>50%
of patients
with cancer
have BTcP
*when BTcP is not attributed to inadequate dosing of short- or long-acting opioids for persistent pain
Sources: Portenoy RK, Hagen NA. Breakthrough pain: definition, prevalence and characteristics. Pain. 1990;41(3):273-281. 2. Zeppetella G.
Breakthrough pain in cancer patients. Clin Oncol (R Coll Radiol). 2011;23(6):393-398.; Portenoy RK, Payne D, Jacobsen P. Breakthrough pain:
characteristics and impact in patients with cancer pain. Pain. 1999;81(1-2):129-134.Bennett D, Burton AW, Fishman S, et al. Consensus panel
recommendations for the assessment and management of breakthrough pain: part I assessment. Pharm Ther. 2005;30(5):296-301.
Please see full prescribing information at www.abstral.com
8
KEY PATIENT BENEFITS
u 
Easy administration and disposal
u 
Available in six, sugar free, alcohol free
strengths
u 
Hassle-free with no special disposal or
biohazard requirements
u 
Noninvasive delivery is tolerable for patients
who have
•  Nausea, vomiting, mucositis, dysphagia, or
SIMPLE
TO CARRY.
Step 1: Peel
SIMPLE
TO TAKE.
Step 2: Place
odynophagia
SIMPLE
TO DISCARD.
•  Difficulty administering medication
Step 3: Dispose
Source: England R, Maddocks M, Manderson C, Zadora-Chrzastowska S, Wilcock A. How practical are transmucosal fentanyl
products for breakthrough cancer pain? novel use of placebo formulations to survey user opinion. BMJ Support Palliat Care.
2011;1:349-351. Raber-Durlacher JE, Brennan MT, Verdonck-de Leeuw IM, et al. Swallowing dysfunction in cancer patients.
Support Care Cancer. 2012;20(3):433-443.
Please see full prescribing information at www.abstral.com
9
ZUPLENZ® (ONDANSETRON)
ORAL SOLUBLE FILM
Active ingredient is the Gold Standard
u  ASCO Connection Nov 2014: Ondansetron named one of the
“Top 5” Advances in Modern Oncology
Innovative technology
u  PharmFilm® oral soluble film technology
u  Rapidly dissolves in mouth in about 10 seconds
Approved for
u 
u 
u 
Highly and moderately emetogenic chemotherapy induced
nausea and vomiting (CINV)
Radiotherapy induced nausea and vomiting (RINV)
Post-operative nausea and vomiting (PONV)
Synergistic
u  Oncology supportive care
u  Leverage our commercial channel and distribution expertise
u  Common call point with Abstral and will utilize GPS
PharmFilm® is a registered trademark of MonosolRx
Please see full prescribing information at www.zuplenz.com
10
Zuplenz Product Advantages
Delivers the
trusted efficacy
and safety of
ondansetron
Convenient
oral soluble film
eliminates the burden of
swallowing pills during
periods of emesis
Does not
require water
ideal in cases of
oral irritation
Please see full prescribing information at www.zuplenz.com
Soothing
peppermint
flavor, no gritty
aftertaste
11
GALENA COMMERCIAL CAPABILITIES
u 
Successful launch with growing
market share
u 
Established oncology relationships
u 
Strong distribution channel
u 
Galena Patient Services
u 
Enhanced gross to net ratio
u 
Consistent growth in prescriber base
u 
Zuplenz leverages established
commercial team
Please see full prescribing information at www.abstral.com
12
CANCER
IMMUNOTHERAPY
13
IMMUNO-ONCOLOGY FRANCHISE
First-in-Class, Targeted Immunotherapy
Harnessing the
power of the
immune system in
the adjuvant setting
u 
u 
u 
Exploits specificity
of natural immune
surveillance
Adjuvant patients
have healthy
immune systems
Systemic
protection
Well-validated
targets
Goal is to prevent
recurrence
u 
u 
u 
Recurrences are
almost always fatal
Minimal toxicity
and improved
safety profile
Boosters provide
long term
protective effect
u 
HER2
u 
Folate binding
protein (FBP)
Current
Programs
u 
NeuVax™
(nelipepimut-S)
•  Breast: HER2
1+, 2+ and 3+
•  Gastric trial
planned
u 
GALE-301 (FBP)
•  Ovarian
•  Endometrial
14
ADVANCING STANDARDS OF CARE
ASCO Connection Nov 2014: Cancer Survivorship Continues to Grow
Breast Cancer Incidence and Mortality, US
250,000
Number of New Cases and Deaths
200,000
150,000
New Cases
Deaths-US
100,000
50,000
-
Source: US National Cancer Institute’s Surveillance Epidemiology and End Results (SEER) Data base
15
RECURRENCE HAZARD RATES ARE DEPENDENT
ON KNOWN PROGNOSTIC FACTORS
Prominent early peak of recurrences (~3 years)
in absence of adjuvant therapy
Hazard of recurrence by yearly interval
25
Total
Node 0
20
Node 1-3
Node (4+)
15
Tumour size (<1cm)
Tumour size (1.1-3cm)
10
Tumour size (>3cm)
ER+
ER-
5
Premen
0
Postmen
0.5
1.5
2.5
3.5
4.5
5.5
6.5
7.5
8.5
9.5
10.5
Year
Source: Early Breast Cancer Trialists’ Collaborative Group. Lancet. 1998;351:1451 Update of Houghton.
J Clin Oncol. 2005; 23(16S):24s. Abstract 582 Saphner et al., J Clin Oncol. 14: 2738-2746, 1996
16
NEUVAX: HER2 IMMUNODOMINANT PEPTIDE
NeuVax contains the
immunodominant peptide derived
from the extracellular region of the
HER2 protein
u  Peptide (aa 369-377)
immunotherapy administered as
intradermal injection
u 
u 
MHC Class I: HLA A2/A3
KI FGSLAFL
17
ELICITS A STRONG CD8+ T-CELL RESPONSE
NeuVax Specific CD-8 CTLs: Pre-, Post,
Mean and Long-Term (6 months)
2.5
u 
u 
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
% NeuVax specific CD8+ T cells
u 
1.8
2.0
1.5
1.0
0.5
0.0
0.7
0.5
0.4
Pre
Max
Mean
Long-Term
Source: Peoples GE, et al (2005) JCO, 23(300, 7536-7545; Mittendorf EA, et al (2006) Surgery, 139(3): 407-418.
18
BOOSTER SERIES MAINTAINS LONG TERM
IMMUNOLOGIC RESPONSE
NeuVax Specific CD8+ T cell response to Booster Regimen
3.50
% NeuVax specific CD8+ T cells
3.00
R² = 0.84944
2.50
2.00
1.50
1.00
0.50
0.00
Pre Post B1 (n=53) B1
Pre Post B2 (n=34) B2
Pre Post B3 (n=24) B3
Pre Post B4 (n=20) B4
Pre Post B5 (n=12) B5
Pre Post B6 (n=8) B6
Booster Inoculation
Sources: Peoples, et al, ASCO 2012 Poster Presentation
19
NEUVAX DEVELOPMENT STRATEGY
u  Adjuvant
therapy after standard of care (SOC) surgery,
chemotherapy, radiotherapy
u  Prevent
breast cancer recurrence
•  Systemic recurrence = very poor overall survival
•  25% of resectable node-positive breast cancer patients, despite having
no evidence of disease following surgery and chemo/radiation therapy, will
still relapse within 3 years
u  NeuVax
+ GM-CSF
•  Node Positive
•  HER2 1+, 2+, 3+
20
PHASE 1/2 TRIALS
NeuVax (nelipepimut-S)
Enrollment
n=195
Objectives of Trial:
•  Safety
•  Optimal dose and schedule
•  Immunologic response
(biologic efficacy)
Total Evaluable
n=187
•  Clinical efficacy
(DFS; recurrence rate)
Node Positive
(SN-33)
N=97
Vaccine
HLA-A2/A3+
n=53
6 withdrew and 1 lost to
follow up prior to starting
trial; 1 excluded
Control
HLA-A2/A3n=44
Node Negative
(SN-34)
N=90
Vaccine
HLA-A2/A3+
n=55
Control
HLA-A2/A3n=35
21
LOCAL & SYSTEMIC TOXICITY IS MINIMAL
(A)
(B)
% of Vaccinated Patients
% of Vaccinated Patients
Node-negative & Node-positive Patients
Local Toxicity
Systemic Toxicity
PRIMARY VACCINATION SERIES
Local
Systemic
Local Toxicity
Systemic Toxicity
BOOSTER SERIES
22
SN-33 Phase 2 HER2 IHC 1+/2+ (N=45)
When the HER2 3+ patients were excluded from the population, the Phase 2 HER2 IHC 1+2/+ Vaccine Group had a significantly
improved DFS at 24 months (100% vs. 77.8%, p=0.035); at 60 months, VG retains a 20.3% difference (VG 94.4% vs. CG 74.1%).
23
PHASE 2 CONCLUSIONS
NeuVax demonstrated a statistically improved Disease Free Survival (DFS) at 36 months
(100% vs. 77.8%, p=0.035)
Phase 3 target patient population defined:
u 
• 
Node positive, HLA A2/3, HER2 IHC 1+/2+ or low to intermediate patients
• 
Dose and schedule
Defined development path based on Phase 2 interim data, confirmed by final data
Phase 3 FDA approved SPA (Special Protocol Assessment) established primary endpoint as 36 month DFS
u 
• 
SPA: Initiated 2007 / Approved 2009
u 
Validated at 24 (2010) and 36 (2011) month landmark analyses
u 
Exploratory ITT population (n=97) showed a 33% relative reduction of recurrence at 60 months
NeuVax elicits strong HER2 directed immunity
u 
Well–tolerated
u 
Demonstrates dose response
u 
Booster series maintains immune response over time
24
PHASE 3 PRESENT TRIAL PER SPA
Prevention of Recurrence in Early-Stage, Node Positive Breast Cancer with
Low to Intermediate Her2 Expression with NeuVax Treatment
Interim analysis
by DSMB at
n=70 events
Study Population
Endpoint DFS at
n=141 events /
36 months
+ GM-CSF
700 adjuvant breast cancer
patients, randomized 1:1
§  Double blind
§  Node positive
§  HLA A2/A3+
Placebo + GM-CSF
§  HER2 IHC 1+/2+
§  Stratified by stage, type of
surgery, hormone receptor,
and menopausal status
Dosing by Month
1
2
3
4
5
6
+ 1 booster
dose every
6 months
thereafter
25
SIGNIFICANT MARKET OPPORTUNITY
Newly Diagnosed Breast Cancer Patients Annually:
~230,000 in US(1) ~450,000 in EU(2)
HLA A2/A3(3)
(75%)
HER2 1+/2+(4)
(50-60%)
Node Positive(5)
(30-40%)
Addressable Patient
Population
U.S. = 30,000 – 40,000
EU = 50,000 – 80,000
Sources: (1)American Cancer Society 2011 Breast Cancer Facts and Figures; (2) WHO; (3)TD. Distribution of HLA
antigens in North American Caucasians, North American Blacks and Asians; (4)Slamon DJ, et al. Science
1987;235:177-82; (5)Intl Journal of Breast Cancer Volume 2011, Review Article: A. Pazaiti & Ian S. Fentimen
26
NEUVAX: CURRENT CLINICAL DEVELOPMENT
Phase
Treatment
Indication
Current
Status
Protocol
Defined
# of Patients
3
Single agent
“PRESENT”
Study
Breast,
HER2 1+, 2+
Enrolling,
13 countries,
143 centers
700
2b
Combination
with
Herceptin
Breast,
HER2 1+, 2+
Enrolling,
23 U.S. centers
300
2
Combination
with
Herceptin
Breast,
HER2 3+
Enrolling
U.S. only
100
2
Single agent
Gastric
HER2 1+,2+,3+
Planned
India sites only
~90
Collaborations
27
GALE-301: FOLATE BINDING PROTEIN (FBP)
u  Targeted
cancer
immunotherapy
u  FBP
is over-expressed (20-80
fold) in >90% of ovarian and
endometrial cancers
u  FBP
has very limited tissue
distribution and expression in
non-malignant tissue making it
an ideal immunotherapy target
u  Current treatments are generic
•  Carboplatin and paclitaxel
•  High recurrence rate
u  Most
patients relapse with poor
prognosis
Source: U.S. Ovarian Cancer http://seer.cancer.gov/statfacts/html/ovary.html
28
GALE-301: FOLATE BINDING PROTEIN (FBP)
Phase 1/2a trial ongoing
u 
u 
Phase 1: Determined optimal dose and
demonstrated safety and potent
immune response
60.0%$
Phase 2a: Enrollment completed
ahead of schedule due to high demand
40.0%$
Preliminary data shows:
•  38% reduction in risk of recurrence
•  GALE-301 plus GM-CSF is well
tolerated and elicits a strong in vivo
immune response with primarily
Grade 1 and Grade 2 toxicities
u 
50% 50.0%$
%'of'Subjects'
u 
Recurrence:'13'Month'Median'Follow'Up'
31% 30.0%$
20.0%$
10.0%$
0.0%$
Vaccine'
Control'
Top-line data to be presented mid-year
2015
*Preliminary results after a median follow-up of 13 months, there have been 9/29 recurrences (31%) in
the vaccine group vs. 11/22 recurrences (50%) in the CG (p=0.17) .
Source: Peoples, et. al, Poster Presentation, SITC 2014
29
HEMATOLOGY
30
GALE-401
ANAGRELIDE CONTROLLED RELEASE (CR)
GALE-401
Indication & Current Treatment
u 
Active ingredient = anagrelide
u 
Anagrelide reduces the elevated platelet count
and the risk of thrombosis
u 
Immediate release (IR) version approved for the
treatment of patients with thrombocythemia,
secondary to myeloproliferative neoplasms
(MPNs)
•  MPNs are hematological malignancies in which the
bone marrow cells develop and function abnormally
u 
IR formulation can cause unacceptable side
effects
u 
Controlled Release (CR)
formulation expected to
decrease the frequency or
severity of side effects
u 
Phase 2, Proof-ofConcept, Trial Ongoing
u 
If successful, Galena will
seek approval via the
505(b)(2) regulatory
pathway
•  Believed to be Cmax-related and has largely limited the
use due to early treatment withdrawal
Source: Anagrelide Package Insert
31
GALE-401 – CR FORMULATION MAINTAINS PLATELET
LOWERING WHILE REDUCING Cmax
Anagrelide CR Platelet Lowering
pg/mL
Anagrelide CR Plasma Levels
Multiple Phase 1 studies in n=86 healthy volunteers
Agrylin is a registered trademark of Shire.
32
GALE-401 PHASE 2 STUDY
Study Population
u 
Adult patients with thrombocytosis due to
myeoproliferative neoplasms (MPNs)
including PV, PMF, CML, or ET
u 
Platelet count >600 x 109/L
u 
Requirement for platelet reduction therapy
as per investigator
u 
Not previously found to be refractory to
anagrelide
Phase 2
Patients: MPN including PV, CML, PMF, or ET
(N=20 pts)
Primary Objective:
•  Estimate the response rate in terms
of platelet reduction
Secondary Objectives:
•  Assess safety and tolerability
•  Characterize pharmacokinetics (PK) profile
•  Assess genetic markers that may correlate
with outcome
Treatment Plan:
•  Initiate at 0.5 mg b.i.d.
•  Titrate dose (0.5 mg/day q 1-2 wks) until
target platelet count reached
(150 – 400 x109/L)
33
CORPORATE
OVERVIEW
34
MILESTONES
Commercial
•  Achieve $8-10 million net revenue for 2014
•  Launch Zuplenz in the U.S.
•  Achieve $15-18 million net revenue in 2015
NeuVax™
ü  Initiate Phase 2 HER2 3+ combo trial – Q4, 2014
•  Complete enrollment in Phase 3 PRESENT trial
in Q1, 2015
•  Initiate Phase 2 gastric cancer trial
•  PRESENT trial interim analysis
GALE-301 (FBP)
ü  Report Preliminary Phase 2a clinical data (SITC)
•  Report Top-Line Phase 2a clinical data
GALE-401
(anagrelide CR)
ü  Complete Phase 2 enrollment – 4Q, 2014
ü  Report Phase 1 data (ASH)
•  Report Top-Line efficacy and safety data
35
LEADERSHIP TEAM
u 
Mark W. Schwartz, Ph.D., President & CEO
u 
Apthera, Bayhill Therapeutics, Calyx Therapeutics,
Trega Biosciences, Incyte Genomics, DuPont
Diagnostics
u 
u 
Remy Bernarda, VP, Marketing &
Communications
IR Sense, Hana Biosciences, Knight Equity Markets,
Bear Stearns, Goldman Sachs
u 
u 
Ryan Dunlap, CPA, VP & CFO
Moss Adams, Nike, KPMG, PricewaterhouseCoopers
Joe Lasaga, VP Business Development &
Alliance Management
Nektar Therapeutics, Rigel
u 
Christopher S. Lento, VP, Commercial
Astra Zeneca, Genentech BioOncology, US Oncology/
McKesson, Abraxis Bioscience, Altos Solutions
Gavin Choy, Pharm.D., Senior VP,
Clinical Operations
Astex, Hana Biosciences, Gilead, Stanford University
Medical Center
Margaret Kivinski, General Counsel
Spectrum Pharmaceuticals, Edwards Lifesciences,
Masimo Corp., TherOx, Beckman Coulter, Loeb & Loeb
u 
Pat Murphy, VP, Regulatory Affairs &
Compliance
Nektar Therapeutics, Bayhill Therapeutics, Berlex
Laboratories, Serono, Parexel, Biogen
36
FINANCIAL OVERVIEW (as of September 30, 2014)
Cash, Cash Equivalents, Marketable
Securities
$24.6 million
YTD Revenues
$6.1 million
Debt
$9.3 million
Projected Quarterly Burn
~$8-10 million
Shares Outstanding
121 million
Market Cap (20 Jan 14)
~$200 million
37
WHY WE’RE HERE
“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
Source: E75 vaccine's final tests start in S.A. By Don Finley, January 22, 2012
http://www.mysanantonio.com/news/local_news/article/E75-vaccine-s-final-tests-start-in-S-A-2653101.php#ixzz1mJkcuHUQ
38
THANK YOU