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NASDAQ: GALE www.galenabiopharma.com 1 Forward Looking Statements 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 the future expectations, plans and prospects for the development and commercialization of the Company's products 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 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 Galena Biopharma: Summary Biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care Revenue generating in 2013 with launch of Abstral® (fentanyl) Sublingual Tablets approved for breakthrough cancer pain NeuVax™ (nelipepimut-S) is a novel cancer immunotherapy which targets the HER2 protein, with promising Phase 1/2 clinical results Phase 3 PRESENT multicenter, multinational trial of 700 patients with SPA ongoing in HER2 IHC 1+/2+ low-to-intermediate, node positive, adjuvant breast cancer patients Phase 2b NeuVax + Herceptin® (trastuzumab) combination trial in 300 node positive and negative adjuvant breast cancer patients GALE-401 (Anagrelide CR) is a patented controlled release formulation of anagrelide that will use the 505 (b)2 regulatory pathway to seek approval for Essential Thrombocythemia. Multiple Phase 1 studies in n=86 subjects demonstrated that GALE-401 reduces Cmax by ~70% and delivers 100% of AUC Dose-dependent reduction in platelets GALE-301 (Folate Binding Protein (FBP)) is a novel immunotherapy for patients with ovarian and endometrial cancer in Phase 2 Galena Biopharma: Product Pipeline Collaborations Product Abstral® (fentanyl) Sublingual Tablet Target Clinical / Regulatory Collaboration U.S. ownership acquired from Breakthrough cancer pain FDA-Approved Gastric trial & India commercialization NeuVax™ (nelipepimut-S) Node positive HER2 negative breast cancer (low-tointermediate expression, IHC levels of 1+ or 2+ and a FISH rating of less than 2.0) Phase 3 PRESENT Trial under FDAapproved SPA Israel Commercialization Companion Diagnostic South Korea Commercialization NeuVax™ + Herceptin® (trastuzamab) Node positive HER2 negative breast cancer (low-tointermediate expression, IHC levels of 1+ or 2+ and a FISH rating of less than 2.0) Clinical Collaboration Phase 2b 5 5 Commercial 6 Abstral® (fentanyl) Sublingual Tablets Approved for Breakthrough Cancer Pain (BTcP) Galena acquired U.S. rights in Mar-2013 Market leader in Europe with $54M sales by ProStrakan/Kyowa Hakko Kirin; marketed in Canada by Paladin Labs; approved in Japan by Kyowa Hakko Kirin. Q4 2013 product launch into ~$400 MM market The innovative Abstral formulation: Delivers the analgesic power and increased bioavailability of micronized fentanyl in a more convenient sublingual tablet which rapidly dissolves under the tongue in seconds, Provides rapid relief of breakthrough pain in minutes, and; Matches the duration of the entire pain episode. Please see full prescribing information at www.abstral.com 7 Abstral for Breakthrough Cancer Pain 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). Abstral® (fentanyl) Sublingual Tablets are an important treatment option for inadequately controlled breakthrough cancer pain (BTcP) which: BTCP episodes can last anywhere from several seconds to hours with the average episode lasting 30 or so minutes. Occurs in approximately 1/3 of patients being treated for cancer and up to 80% of patients with later stage disease. May happen anytime and anywhere during the disease process. It is not just an end of life issue. Sources: Paice, et al. Cancer Pain (2011); MA, Müller-Schwefe GHH. Curr. Med. Res. Opin. (2011);27:1385-94; Portenoy RK, Hagen NA. Breakthrough pain: definition, prevalence and characteristics. Pain. 1990;41(3):273-281; 5. 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 Mean Pain Relief over time for BTcP episodes treated with Abstral and placebo Source: Rauck RL et al. Curr Med Res Opin 2009; 25(12): 2877-2885 Please see full prescribing information at www.abstral.com 9 Daily Supply of Abstral v. Leading Competitor Please see full prescribing information at www.abstral.com The majority of patients preferred Abstral over their previous BTcP medication(s) Source: Überall M, Müller-Schwefe GHH. Curr Med Res Opin 2011; 27(7): 1385-1394. Please see full prescribing information at www.abstral.com 11 Cancer Immunotherapy 12 NeuVax contains the immunodominant peptide derived from the extracellular region of the HER2 protein (nelipepimut-S) • Stimulates HER2 Directed CD8+ Killer T cells • Off-the-shelf peptide (aa 369-377) cancer immunotherapy • MHC Class I: HLA A2/A3 KI FGSLAFL 13 NeuVax (nelipepimut-S) Development Approach: Focus on minimal disease (adjuvant) setting to prevent breast cancer recurrence 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. Increased presence of circulating tumor cells (CTC) predict DFS and OS--suggesting a dormancy of isolated micrometastases which over time, leads to recurrence. NeuVax elicits a robust, specific and durable killer CD-8 Cytotoxic T Lymphocyte (CTL) response to lyse HER2 expressing tumor cells. NeuVax binds to antigen expressing cells (APCs) (in green). NeuVax stimulated APCs activate CD8+ cytotoxic T lymphocytes (CTLs) (in blue) which rapidly replicate to seek out and destroy Her 2 expressing tumor cells and micro-metastases. Sources: Giordano et al. Is breast cancer survival improving? Cancer. 2004;100:44-52; Saphner et al. Annual hazard rates of recurrence for breast cancer after primary therapy. J Clin Oncol. 1996; 14: 2738-2746; Lucci et al. Circulating tumor cells in non-metastatic breast cancer: a prospective study. The Lancet Oncology. Jul 2012; 13(7): 688-695.` 14 Recurrence Hazard Rates Are Dependent on Known Prognostic Factors Prominent early peak of recurrences (~ 3 yrs) in absence of adjuvant therapy, particularly in ER- disease 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+ 5 ERPremen Postmen 0 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 15 Presence of Circulating Tumor Cells (CTCs) is an independent predictor of relapse and mortality in non-metastatic breast cancer Brain Lymph nodes Pleura Skin Liver Lung Bone Source: Lucci et al. Circulating tumour cells in non-metastatic breast cancer: a prospective study. The Lancet Oncology. Jul 2012; 13(7): 688-695. 16 NeuVax (nelipepimut-S) Phase 1/2 Trials (n=187) NeuVax (nelipepimut-S) Enrollment n=195 6 withdrew and 1 lost to follow up prior to starting trial; 1 excluded Total Evaluable n=187 Node Positive (SN-33) N=97 Vaccine HLA-A2/A3+ n=53 Control HLA-A2/A3n=44 Node Negative (SN-34) N=90 Vaccine HLA-A2/A3+ n=55 Control HLA-A2/A3n=35 17 Local & Systemic Toxicity is Minimal: Node-Negative & Node-Positive Patients 100% 82% 72% % of Patients 75% Local Local Systemic Sytemic 50% 25% 18% 13% 11% 4% 0% 0% Grade 0 0% Grade 1 Grade 2 Grade 3 0% 0% 0% 0% Grade 4 Grade 5 18 SN-33 Phase 1/2 Intent-to-Treat at 60 mos (n=97) ITT patients in this phase 1/2 trial favored VG in DFS at 24 months (VG 90.6%, CG 79.5%, p=0.1194); at 60 months, the VG continues to have fewer recurrences than the CG (VG 84.7% vs. 77.1%) NeuVax (nelipepimut-S) Booster Series Immunologic Response 3.50 3.00 R² = 0.8494 Dimer response 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 B4 (n=20) Booster Inoculation Pre Post B5 B5 (n=12) Pre Post B6B6 (n=8) 20 SN-33 Phase 2 HER2 IHC 1+/2+ (N=45) When the HER2 positive patients were removed from the population, the Phase 2 HER2 IHC 1+2/+ VG 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%). NeuVax Phase 2 Conclusions NeuVax (nelipepimut-S) elicits strong HER2 directed immunity Well–tolerated Demonstrates dose response Booster series increases anti-tumor activity and maintains immune response over time NeuVax demonstrated a statistically significant increase in Disease Free Survival (DFS) at the Phase 3 endpoint Phase 3 target patient population defined: node positive, HLA A2/3, HER2 IHC 1+/2+ or low to intermediate patients. Phase 3 FDA approved SPA (Special Protocol Assessment) established primary endpoint as 36 month DFS 22 NeuVax: 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 Endpoint DFS at by DSMB at n=141 events/36 mos. n=70 events + GM-CSF Study Population 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 + Dosing to disease progression or 36 months 23 Phase 2a: NeuVax +/- Herceptin® (trastuzumab) Adjuvant Immunotherapy (24 mos) Preclinical data demonstrated synergy of combining trastuzumab and NeuVax by enhancing tumor antigen presentation Phase 2a compared vaccine and trastuzumab (Herceptin) v trastuzumab alone: n=32 trastuzumab monotherapy recurrence rate = 12.5% (4/32) n=30 trastuzumab + vaccine recurrence rate = 0% (0/30) HER2/neu –derived peptide presented on MHC-I Trastuzumab HER2/neu Breast tumor cell HER2/neuderived peptide Trastuzumab/HER2 complexes are internalized and processed by proteasomes into short peptides which are then presented on MHC class I molecules. Source: Sears et al. J Clin Oncol; 29:2011 (suppl; abstr 564); Source: Mittendorf EA, et al (2006. Ann Surg Oncol;13:1085-98. 24 NeuVax + Herceptin: Phase 2b Trial Primary Endpoint DFS at 24 mos. Secondary Endpoint DFS at 36 mos. Study Population 300 adjuvant breast cancer patients, randomized 1:1 Single blind (subject) Node positive or negative HLA A2/A3+ HER2 negative 1+/2+ + Stratified by nodal status and HER2 status First patient enrollment in 1H, 2013 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 or 36 months 25 NeuVax: 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%) U.S. = 30,000 – 40,000 EU = 50,000 – 80,000 Addressable Node Positive Population Sources: (1)American Cancer Society 2011 Breast Cancer Facts and Figures; WHO; (2)TD. Distribution of HLA antigens in North American Caucasians, North American Blacks and Asians; (3)Slamon DJ, et al. Science 1987;235:177-82; (4)Intl Journal of Breast Cancer Volume 2011, Review Article: A. Pazaiti & Ian S. Fentimen 26 GALE-301 (Folate Binding Protein (FBP)) targeted cancer immunotherapy E39 DTH Response (mm) 40 35 30 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. 25 20 15 10 Status: Phase 1 complete. Phase 2 initiated Q1 14. 5 0 Pre-Vaccine Post-Vaccine 27 Hematology 28 GALE-401 (Anagrelide CR) • GALE-401 (Anagrelide CR) being developed to treat Essential Thrombocythemia (ET). • ET is an acquired disease of the bone marrow, characterized by highly elevated platelet counts which increases the risk of thrombotic events. • • Orphan disease with 8K incidence; and 80-100K prevalence Active ingredient anagrelide immediate release (IR) (Agrylin®; Shire) in use since late 1990s for the treatment of ET. Despite several advantages over HU and demonstrating non-inferiority, the Cmaxrelated side effect profile of anagrelide immediate release has largely limited the drug to second line use. GALE-401 is a patented controlled release formulation of anagrelide that will use the 505(b)2 regulatory pathway to seek approval for ET. Multiple Phase 1 studies in n=86 subjects demonstrated dose-dependent platelet reduction, while reducing Cmax by ~70% and delivering 100% of AUC. Target product profile is increased tolerability vs anagrelide IR while maintaining efficacy, thus allowing more patients to achieve target platelet levels; and potentially enabling treatment expansion to larger and younger patient populations. 29 Essential Thrombocythemia (ET) is a neoplastic stem cell disorder causing dysregulated production of large numbers of abnormal platelets Normal Peripheral Smear Normal platelet count: 150 – 450 x 103/uL 30 Essential Thrombocythemia (ET) —Note Large Number and Size of Platelets Platelet count: 1 - 5 x 106/uL 30 Phase 1: GALE-401 (Anagrelide CR) vs IR Novel ANA-CR Formulation Maintains 100% of AUC While Reducing Cmax by 70% 31 31 Phase 1: GALE-401 (Anagrelide CR) PK with Multiple Dose Comparisons CR (GALE-401) IR (Agrylin) Ratio CR : IR Cmax (pg/mL) 633 2210 29% AUC0-t (pg*h/mL) 4409 5456 81% AUC0-inf (pg*h/mL) 5543 5586 99% Parameter Source: Ph 1 GALE-401 Study ANA 105 32 Corporate Overview 33 Leadership Team Mark J. Ahn, Ph.D., President & CEO, Genentech, Amgen, Hana Biosciences, Bristol Myers Squibb Remy Bernarda, VP, Marketing & Communications, Hana Biosciences, Goldman Sachs, Bear Stearns, Knight Equity Markets Gavin Choy, Pharm.D., Sr. VP, Clinical Operations, Astex, Hana Biosciences, Gilead, Stanford University Medical Center Ryan Dunlap, CPA, VP & CFO, Moss Adams, Nike, KPMG, PricewaterhouseCoopers Brian L. Hamilton, M.D., Ph.D., EVP & Chief Medical Officer, Astra Zeneca, Onyx Pharmaceuticals, Ziopharm, Wyeth, Alkermes, Astra Robert Laliberte, MS, VP, Clinical Operations & Clinical Science, Curis, Ziopharm, Celldex, Ariad, Wyeth, Centocor, DuPont Merck Christopher S. Lento, VP, Sales & Commercial Operations, Astra Zeneca, Genentech BioOncology, US Oncology/McKesson, Abraxis Bioscience, Altos Solutions Pat Murphy, VP, Regulatory Affairs & Compliance, Nektar Therapeutics, Bayhill Therapeutics, Berlex Laboratories, Serono, Parexel, Biogen Mark W. Schwartz, Ph.D., EVP & COO, Apthera, Bayhill Therapeutics, Calyx Therapeutics, Trega Biosciences, Incyte Genomics, DuPont Diagnostics 34 Financial Overview Cash, Cash Equivalents, Marketable Securities (31 Mar 14) $52.4 million 2014 Net Revenue Guidance $11-$15 million Debt $10 million Projected Quarterly Burn ~$7-8 million Shares Outstanding (31 Mar 14) 118 million Market Cap (4 June 14) ~$265 million 35 2014 Milestones Abstral® (fentanyl) Sublingual Tablets • Achieve $11-$15 million in Net Revenues • Enroll 1,000 patients in RELIEF Trial NeuVax™ (nelipepimut-S) Expand partnerships outside U.S. • Complete enrollment in Phase 3 PRESENT trial GALE-301 (FBP) Initiate Phase 2 • Report Phase 1 data • Complete Phase 2 enrollment GALE-401 (anagrelide CR) • Initiate Phase 2 in Essential Thrombocythemia 36 “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 37 Click to edit Master title style NASDAQ: GALE www.galenabiopharma.com 38