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1 NASDAQ: GALE

2 FORWARD LOOKING STATEMENT This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 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

3 DIVERSIFIED ONCOLOGY BIOPHARMACEUTICAL COMPANY Rich development pipeline complemented by a commercial franchise NeuVax (nelipepimut-s) GALE-301 (Folate Binding Protein) A novel cancer immunotherapy targeting the HER2 protein Phase 3 PRESENT multinational trial ongoing under SPA Unmet medical need Franchise of mid-stage trials ongoing or planned Novel immunotherapy for patients with ovarian and endometrial cancer Immunological and early Phase 2 clinical data Unmet medical need High recurrence rates with poor outcomes Abstral (fentanyl) Sublingual Tablets approved for breakthrough cancer pain Zuplenz (ondansetron) Oral soluble film for nausea and vomiting caused by surgery, highly and moderately emetogenic chemotherapy, and radiation therapy IMMUNOTHERAPY FRANCHISE COMMERCIAL FRANCHISE 3

4 PRODUCT PIPELINE Product Therapeutic Area Phase 1 Phase 2 Phase 3 Approved Commercial Abstral (fentanyl) Sublingual Tablets ZUPLENZ (ondansetron) Oral Soluble Film Breakthrough Cancer Pain Antiemetic for CINV, RINV, PONV Immunotherapy NeuVax NeuVax + Herceptin NeuVax + Herceptin NeuVax Breast cancer node-positive, HER2 IHC 1+/2+ Breast cancer node-positive & triple negative, HER2 IHC 1+/2+ Breast cancer neoadjuvant, nodepositive & negative, HER2 IHC 3+ Gastric carcinoma HER2 IHC 1+/2+ or 3+ PRESENT Trial GALE-301 (Folate Binding Protein) Ovarian & Endometrial Carcinomas 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

5 PRESENT 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 5

6 CANCER IMMUNOTHERAPY NeuVax (nelipepimut-s) 6

7 IMMUNO-ONCOLOGY UNLOCKING THE POWER OF THE T-CELL CAR T Technology Indirect Immune Modulators Co-stimulators Checkpoint inhibitors Immune Inhibitory Enzymes TCR Technology 7

8 LACK OF REACTIVE T-CELLS MAY RENDER SOME TOOLS INEFFECTIVE IN MANY CANCERS Indirect Immune Modulators Co-stimulators Checkpoint inhibitors Immune Inhibitory Enzymes 8

9 NEUVAX STIMULATES T CELL PROLIFERATION AND EXPANSION Indirect Immune Modulators Costimulators Checkpoin t inhibitors Immune Inhibitory Enzymes T cells T cells T cells T cells T cells T cells T cells T cells T cells T cells 9

10 GALENA IMMUNO-ONCOLOGY FRANCHISE First-in-Class, Targeted Immunotherapy Harnessing the power of the immune system in the adjuvant setting Goal is to prevent recurrence Well-validated targets Current Programs u Exploits specificity of natural immune surveillance u Adjuvant patients have healthy immune systems u Systemic protection u Recurrences are almost always fatal u Minimal toxicity and improved safety profile u Boosters provide long term protective effect u HER2 u Folate binding protein (FBP) u NeuVax (nelipepimut-s) Breast: HER2 1+, 2+ and 3+ Gastric trial planned u GALE-301 (FBP) Ovarian Endometrial 10

11 HER2 u Oncogene in the EGFR family u Overexpressed in variety of human tumors u Historically associated with poor prognosis u 4 Levels by IHC HER2 IHC Expression Breast Cancer Prevalence Approved Treatments Galena Target Trial % Mul,ple DoD Hercep,n Combina,on Trial 2+ None PRESENT Trial Hercep,n Combina,on Trial 50 60% 1+ None PRESENT Trial Hercep,n Combina,on Trial 0 Not being evaluated 11

12 NEUVAX: HER2 IMMUNODOMINANT PEPTIDE u NeuVax contains the immunodominant peptide derived from the extracellular region of the HER2 protein u Peptide (aa ) immunotherapy administered as intradermal injection u MHC Class I: HLA A2/A3 K I F G S L A F L 12

13 ELICITS A STRONG CD8+ T-CELL RESPONSE u NeuVax binds to antigen presenting cells (APCs) u NeuVax stimulates APCs to activate CD8+ cytotoxic T lymphocytes (CTLs) u CTLs rapidly replicate to seek out and destroy HER2 expressing tumor cells and micro-metastases u NeuVax in combination with GM-CSF given once a month for 6 months % NeuVax specific CD8+ T cells NeuVax Specific CD-8 CTLs: Pre-, Post, Mean and Long-Term (6 months) Pre Max Mean Long-Term Source: Peoples GE, et al (2005) JCO, 23(300, ; Mittendorf EA, et al (2006) Surgery, 139(3):

14 BOOSTER SERIES MAINTAINS LONG TERM IMMUNOLOGIC RESPONSE NeuVax Specific CD8+ T cell response to Booster Regimen 3.50 % NeuVax specific CD8+ T cells R² = Pre Post Pre Post Pre Post Pre Post Pre Post Pre Post B1 (n=53) B2 (n=34) B3 (n=24) B4 (n=20) B5 (n=12) B6 (n=8) B1 B2 B3 B4 B5 B6 Booster Inoculation Sources: Peoples, et al, ASCO 2012 Poster Presentation 14

15 ADVANCING STANDARDS OF CARE ASCO Connection Nov 2014: Cancer Survivorship Continues to Grow Number of New Cases and Deaths 250, , , ,000 50,000 Breast Cancer Incidence and Mortality, US New Cases NeuVax Development Strategy u Prevent breast cancer recurrence Systemic recurrence = very poor overall survival u Adjuvant therapy After standard of care (SOC) surgery, chemotherapy, radiotherapy - Source: US National Cancer Institute s Surveillance Epidemiology and End Results (SEER) Data base 15

16 RECURRENCE HAZARD RATES ARE DEPENDENT ON KNOWN PROGNOSTIC FACTORS 25% of resectable node-positive breast cancer patients will relapse within 3 years 25 Hazard of recurrence by yearly interval Total Node 0 Node 1-3 Node (4+) Tumour size (<1cm) Tumour size (1.1-3cm) Tumour size (>3cm) ER+ ER- Premen Postmen 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: ,

17 PHASE 1/2 TRIALS Objectives of Trial: Safety Optimal dose and schedule Immunologic response (biologic efficacy) Clinical efficacy (DFS; recurrence rate) NeuVax (nelipepimut-s) Enrollment n=195 Total Evaluable n=187 6 withdrew and 1 lost to follow up prior to starting trial; 1 excluded Node Positive (SN-33) N=97 Node Negative (SN-34) N=90 Vaccine HLA-A2/A3+ n=53 Control HLA-A2/A3- n=44 Vaccine HLA-A2/A3+ n=55 Control HLA-A2/A3- n=35 17

18 LOCAL & SYSTEMIC TOXICITY IS MINIMAL Node-negative & Node-positive Patients % of Vaccinated Patients % of Vaccinated Patients Local Systemic Local Toxicity Systemic Toxicity Local Toxicity Systemic Toxicity PRIMARY VACCINATION SERIES BOOSTER SERIES 18

19 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%). 19

20 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 Study Population 700 adjuvant breast cancer patients, randomized 1:1 Double blind Node positive + GM-CSF Interim analysis by DSMB at n=70 events Endpoint DFS at n=141 events / 36 months HLA A2/A3+ HER2 IHC 1+/2+ Placebo + GM-CSF Stratified by stage, type of surgery, hormone receptor, and menopausal status Dosing by Month booster dose every 6 months thereafter 20

21 NEUVAX: CURRENT CLINICAL DEVELOPMENT Phase Treatment Indication Current Status Protocol Defined # of Patients Collaborations 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 Combination with Herceptin Breast, HER2 3+ Enrolling U.S. only Single agent Gastric HER2 1+,2+,3+ Planned India sites only ~90 21

22 NEUVAX FRANCHISE EXPANSION OPPORTUNITIES 1 Development Priority Ductal carcinoma in situ (DCIS) 2 Colorectal Cancer 3 Breast Cancer HER2 1+/2+ Prostate Cancer Bladder Cancer Breast Cancer HER2 1+/2+ and 3+ w/herceptin Breast Cancer Node Negative, HER2 1+/2+ Non Small Cell Lung Cancer Gastric Cancer HER2 1+/2+/3+ Breast Cancer HER2 1+/2+/3+ w/ Checkpoint Inhibitor Ovarian Cancer 22

23 CANCER IMMUNOTHERAPY GALE-301 Folate Binding Protein 23

24 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 24

25 GALE-301: FOLATE BINDING PROTEIN (FBP) Phase 1/2a trial ongoing u Phase 1: Determined optimal dose and demonstrated safety and potent immune response 60.0%$ 50.0%$ Recurrence:'13'Month'Median'Follow'Up' 50% u Phase 2a: Enrollment completed ahead of schedule due to high demand u Preliminary data shows: 38% reduction in relative 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 %'of'subjects' 40.0%$ 30.0%$ 20.0%$ 10.0%$ 0.0%$ 31% Vaccine' Control' u 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

26 HEMATOLOGY 26

27 GALE-401 ANAGRELIDE CONTROLLED RELEASE (CR) 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 Believed to be C max -related and has largely limited the use due to early treatment withdrawal GALE-401 u Controlled Release (CR) formulation expected to decrease the frequency or severity of side effects u Phase 2, Proof-of- Concept, Trial Ongoing u If successful, Galena will seek approval via the 505(b)(2) regulatory pathway Source: Anagrelide Package Insert 27

28 GALE-401 CR FORMULATION MAINTAINS PLATELET LOWERING WHILE REDUCING C max Anagrelide CR Plasma Levels Anagrelide CR Platelet Lowering pg/ml Multiple Phase 1 studies in n=98 healthy volunteers Agrylin is a registered trademark of Shire. 28

29 COMMERCIAL 29

30 ESTABLISHED COMMERCIAL FRANCHISE Goals Expertise Products u Grow relationships in the oncology setting u Set the foundation for the launch of NeuVax and pipeline programs u Become profitable and accretive u Add additional products (e.g. supportive care/ therapeutics) u Product Distribution u Managed Care u Sales & Marketing u Patient & Provider Support Galena Patient Services (GPS) Patient Assistance Programs u Abstral (fentanyl) sublingual tablets u Zuplenz (ondansetron) oral soluble film 30

31 ABSTRAL (FENTANYL) SUBLINGUAL TABLETS Breakthrough cancer pain (BTcP) is different from persistent pain treated with long- and short-acting opioids Abstral u Approved for Breakthrough Cancer Pain (BTcP) in opioid tolerant adult patients u NCCN 2013 Guidelines recommend use of a rapid-onset opioid for BTcP ü Innovative mucoadhesive technology allows for rapid dissolution and rapid absorption of micronized fentanyl ü Provides rapid relief of 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 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: Please see full prescribing information at 31

32 KEY PATIENT BENEFITS u Easy administration with no special disposal or biohazard requirements Sublingual tablet dissolves under the tongue in seconds Conveniently packaged in single-dose, easy-to-carry blister packs u Available in six, sugar free, alcohol free strengths u Hassle-free Noninvasive delivery is tolerable for patients who have Nausea, vomiting, mucositis, dysphagia, or odynophagia Difficulty administering medication Step 1: Peel Step 2: Place Step 3: Dispose SIMPLE TO CARRY. SIMPLE TO TAKE. SIMPLE TO DISCARD. 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: Raber-Durlacher JE, Brennan MT, Verdonck-de Leeuw IM, et al. Swallowing dysfunction in cancer patients. Support Care Cancer. 2012;20(3): Please see full prescribing information at 32

33 GROSS REVENUE VS. NET REVENUE (Since Acquisition) Please see full prescribing information at 33

34 AVERAGE TRANSACTION PRICE (2014) Please see full prescribing information at 34

35 SALES BY SPECIALTY (Q4, 2014) Oncology Sales Growth from <1% at acquisition to 20% to date Oncology Includes Medical Oncology Radia,on Oncology Pallia,ve Care Source: Galena REMS Data Please see full prescribing information at 35

36 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 Highly and moderately emetogenic chemotherapy induced nausea and vomiting (CINV) u Radiotherapy induced nausea and vomiting (RINV) u 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 36

37 ZUPLENZ PATIENT BENEFITS 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 Soothing peppermint flavor, no gritty aftertaste Please see full prescribing information at 37

38 CORPORATE OVERVIEW 38

39 2015 MILESTONES Commercial NeuVax GALE-301 (FBP) GALE-401 (anagrelide CR) ü Report $8-10 million net revenue for 2014 Launch Zuplenz in the U.S. Achieve $15-18 million net revenue in 2015 ü Enroll N=700 into PRESENT trial ü Complete enrollment in Phase 3 PRESENT trial PRESENT trial interim analysis (Q4/Q1,2016) Complete enrollment in Combination 1+/2+ trial (Q4/Q1,2016) Report Top-Line Phase 2a clinical data Report Final Phase 2a data Report Top-Line efficacy and safety data Report Final Phase 2 data 39

40 2015 & FUTURE MILESTONES 40

41 LEADERSHIP TEAM u Mark W. Schwartz, Ph.D., President & CEO Apthera, Bayhill Therapeutics, Calyx Therapeutics, Trega Biosciences, Incyte Genomics, DuPont Diagnostics u Remy Bernarda, SVP, Investor Relations & Corporate Communications IR Sense, Hana Biosciences, Knight Equity Markets, Bear Stearns, Goldman Sachs u Gavin Choy, Pharm.D., SVP, Clinical Sciences & Operations Astex, Hana Biosciences, Gilead, Stanford University Medical Center u Ryan Dunlap, CPA, VP & CFO Moss Adams, Nike, KPMG, PricewaterhouseCoopers u Margaret Kivinski, General Counsel Spectrum Pharmaceuticals, Edwards Lifesciences, Masimo Corp., TherOx, Beckman Coulter, Loeb & Loeb u Joe Lasaga, VP Business Development & Alliance Management Nektar Therapeutics, Rigel u Christopher S. Lento, SVP, Commercial Astra Zeneca, Genentech BioOncology, US Oncology/ McKesson, Abraxis Bioscience, Altos Solutions u Pat Murphy, VP, Regulatory Affairs & Compliance Nektar Therapeutics, Bayhill Therapeutics, Berlex Laboratories, Serono, Parexel, Biogen 41

42 FINANCIAL OVERVIEW (as of December 31, 2014) Cash, Cash Equivalents, Marketable Securities Subsequent Financing $23.7 million 40.8 million 2014 Net Revenue $9.3 million Debt Projected Quarterly Burn for 2015 Shares Outstanding Market Cap (10 April 15) $8.4 million ~$10 million 158 million ~$218 million 42

43 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,

44 THANK YOU

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