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2016 shareholder meeting presentation final

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2016 shareholder meeting presentation final

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2016 shareholder meeting presentation final

  1. 1. 2016 ANNUAL MEETING OF STOCKHOLDERS July 14, 2016
  2. 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. 3. DEVELOPMENT PIPELINE Product Therapeutic Area Phase 1 Phase 2 Phase 3 BLA / NDA Immunotherapy: Breast Cancer NeuVax™ (nelipepimut-S) Node-positive HER2 IHC 1+/2+ NeuVax™ + Herceptin® Node-positive or node negative/triple negative HER2 IHC 1+/2+ NeuVax™ + Herceptin® High risk, node-positive or negative, HER2 IHC 3+ NeuVax™ Ductal Carcinoma in Situ (DCIS) Immunotherapy: Gastric Cancer NeuVax™ Gastric, HER2 IHC 1+/2+/3+ Immunotherapy: Gynecological Cancer GALE-301 Ovarian & Endometrial GALE-301 + GALE-302 Ovarian & Breast Hematology GALE-401 (Anagrelide CR) MPN-related thrombocytosis *NeuVax is an investigational product. Efficacy has not been established. Herceptin is a registered trademark of Genentech. Ongoing Planned VADIS 3 2b StoppedPRESENT
  4. 4. PRESENT CURRENT STATUS  IDMC recommend the trial stop for futility • Study drug and all procedures have stopped  Investigation ongoing • Compiled team with addition of outside experts and the Company remains blinded to the data • Operational elements under review include:  Database and data analysis (programming)  Randomization  Manufacturing and packaging elements such as filling, labeling and kit assembly • Biology and immunology • Anticipated timeline: up to 3 months or longer 4
  5. 5. T-Cell Activating Receptors Inhibitory Receptors CD28 OX40 GITR CD122 CD27 CD360 HVEM CD137 CTLA-4 PD-1 TIM-3 BTLA VISTA LAG-3 IMMUNO-ONCOLOGY: UNLOCKING THE POWER OF THE T-CELL 5 Checkpoint inhibitors Indirect Immune Modulators Co-stimulators Immune Inhibitory Enzymes CAR T Technology TCR Technology
  6. 6. T-Cell Activating Receptors Inhibitory Receptors CD28 OX40 GITR CD122 CD27 CD360 HVEM CD137 CTLA-4 PD-1 TIM-3 BTLA VISTA LAG-3 LACK OF REACTIVE T-CELLS MAY RENDER SOME TOOLS INEFFECTIVE IN MANY CANCERS 6 Checkpoint inhibitors Indirect Immune Modulators Co-stimulators Immune Inhibitory Enzymes
  7. 7. T-Cell CD28 OX40 GITR CD122 CD27 CD360 HVEM CD137 CTLA-4 PD-1 TIM-3 BTLA VISTA LAG-3 Activating Receptors Inhibitory Receptors OUR VACCINES STIMULATE T-CELL PROLIFERATION AND EXPANSION 7 T cells Checkpoint inhibitors Indirect Immune Modulators Co- stimulators Immune Inhibitory Enzymes T cells T cells T cells T cells T cells T cells T cells T cells T cells GALE-301
  8. 8. NOVEL DEVELOPMENT STRATEGY: SECONDARY PREVENTION IN CANCER SURVIVORS 8 RECEIVES PRIMARY TREATMENT • Surgery • Chemotherapy • and/or Radiation Disease free “survivor” Breast: HER2, 1+/2+ 25% recurrence rate in 3 yrs No FDA Approved targeted therapies Breast: HER2, 3+ High Risk 20% recurrence rate DECLARED TO PREVENT RECURRENCE / METASTATIC DISEASE Breast: Ductal Carcinoma in Situ 8-10% progression to invasive Ovarian Cancer ~50% recurrence rate in 1 yr No FDA Approved targeted therapies • Watch & Wait, or • Repetitive therapies TOLD
  9. 9. NEUVAX: DEVELOPMENT COLLABORATIONS Phase Treatment HER2 Status Indication Trial Status Protocol Defined # of Patients Collaborations 3 Single agent PRESENT Study 1+, 2+ BREAST Node Positive HLA A2+, A3+ STOPPED 700 (enrolled 758) 2b Combination with trastuzumab 1+, 2+ BREAST Node Positive or High Risk Node Negative HLA A2+, A3+, A24+, A26+ Enrolling U.S. only 33 centers 300 2 Combination with trastuzumab 3+ high risk BREAST Node Positive HLA A2+, A3+ Enrolling U.S. only 28 centers 100 2 Single agent VADIS Study 1+, 2+,3+ BREAST Ductal Carcinoma in Situ (DCIS) HLA A2+ Recruiting U.S. only 4 centers 48 2 Single agent 1+, 2+,3+ GASTRIC HLA A2+, A3+ Planned India Only 50 9
  10. 10. Targeting Folate Binding Protein GALE-301 & GALE-302
  11. 11. GALE-301 & GALE-302: CURRENT CLINICAL DEVELOPMENT 11 Phase Treatment Cancer Type Target Indication Current Status # of Enrolled Patients 1/2a GALE-301 Ovarian, Endometrial HLA A2+ Ovarian Enrolled 51 1b GALE-301 & GALE-302 Ovarian, Breast HLA A2+ Ovarian / Breast Enrolled 39
  12. 12. GALE-301: OPTIMAL DOSE GROUP SHOWS PRELIMINARY EFFICACY Source: Peoples, et. al, Poster Presentation, American Society of Clinical Oncology 2015 12 Phase 1/2a trial ongoing  Phase 1: Determined optimal dose and demonstrated safety and potent immune response  Phase 2a Preliminary data: • At 16 months median follow-up:  Overall recurrence rate was 44.8% in the VG versus 54.5% in the CG (p=0.58),  Recurrence rate of 23.5% in patients who received booster inoculations. • Two year DFS estimate in 1000 mcg dose group is 73.5% vaccine vs. 38.1% control (p=.03) • GALE-301 plus GM-CSF is well tolerated and elicits a strong in vivo immune response with primarily Grade 1 and Grade 2 toxicities Estimated 24 months Disease Free Survival by Dosing Cohort
  13. 13. GALE-401 Anagrelide CR
  14. 14. GALE-401 ANAGRELIDE CONTROLLED RELEASE (CR) Anagrelide •Active ingredient •Reduces the elevated platelet count and the risk of thrombosis in patients with myeloproliferative neoplasms (MPNs) •MPNs are hematological malignancies in which the bone marrow cells develop and function abnormally Immediate Release •Approved for the treatment of patients with thrombocythemia, secondary to MPNs •IR formulation can cause unacceptable side effects believed to be Cmax-related and has largely limited the use due to early treatment withdrawal GALE-401 •Controlled Release (CR) formulation may decrease the frequency or severity of side effects •Phase 2, Proof-of-Concept Trial Results •Well tolerated with primarily Grade 1 and 2 toxicities •Efficacy compares favorably to historical anagrelide IR 14
  15. 15. ESSENTIAL THROMBOCYTHEMIA (ET): CURRENT STANDARD OF CARE 15 • Generally first line therapy for ET • Cytotoxic Myelosuppressive drug (reduces other blood cells as well) • Increased risk of developing acute leukemia after long term; avoided in younger patients • About 25% of patients are intolerant/refractory • Limited third line use • Non cytotoxic drug • Not used in most patients because requires injection and has flu like symptoms • Used mostly in pregnant women • Generally second line • Non cytotoxic drug • Decreases platelets formation • Not associated with increased risk of leukemia • Side effects: palpitations, headaches • About one-third are intolerant to Anagrelide • Hydroxyurea and/or Anagrelide Treatment Failure Sources: Leukemia and Lymphoma Society: Essential Thrombocythemia Facts Cervantes, F. Hematology 2011; 215-221 Hydroxyurea Anagrelide IR Interferon alpha Unmet Need
  16. 16. CORPORATE OVERVIEW 16
  17. 17. FINANCIAL OVERVIEW Cash Position (as of June 30, 2016) $19.6 million Debt Financing (May 10, 2016) + $24 million (restricted cash) Litigation Settlement (July 1, 2016) - $2.3 million Projected Quarterly Burn $9 - $11 million Shares Outstanding (as of March 31, 2016) 182 million Market Cap (as of July 12, 2016) ~$75 million 17 July 2016 Financing $11.7 million (net proceeds) Common Stock Issued 28,000,000 shares
  18. 18. 2016 MILESTONES 18 PROGRAM MILESTONE PROJECTED DATE NeuVax™ (nelipepimut-S) PRESENT: Achieve 70 Qualifying DFS Events ✓ Fast Track Designation ✓ PRESENT: Interim analysis Stopped Initiate DCIS trial Q2 Combo H&N 1+/2+ Interim safety data Q4 GALE-301 GALE-302 Present 301/302 booster data ✓ Present GALE-301 Phase 2a two year data ✓ Orphan Drug Designation ✓ Present GALE-301 Biomarker & Dosing Data Q4 GALE-401 (anagrelide CR) Present combined safety data ✓ Confirmation of 505(b)2 pathway 2H Publish final Phase 2 report Q4
  19. 19. LEADERSHIP TEAM 19  Mark W. Schwartz, Ph.D., President & CEO Apthera, Bayhill Therapeutics, Calyx Therapeutics, Trega Biosciences, Incyte Genomics, DuPont Diagnostics  Bijan Nejadnik, M.D., Executive Vice President, Chief Medical Officer Jazz Pharmaceuticals, Johnson & Johnson, Stanford, Johns Hopkins, UC Davis  Remy Bernarda, SVP, Investor Relations & Corporate Communications IR Sense, Hana Biosciences, Knight Equity Markets, Bear Stearns, Goldman Sachs  Gavin Choy, Pharm.D., SVP, Clinical Sciences & Operations Otsuka, Astex, SuperGen, Hana Biosciences, Gilead, Stanford University Medical Center, Department of Veteran Affairs  Tom Knapp, Esq., Interim General Counsel Sucampo, Exemplar Law Partners, NorthWestern Energy, Paul Hastings, The Boeing Company  Joe Lasaga, VP, Business Development & Alliance Management Nektar Therapeutics, Rigel  Pat Murphy, VP, Regulatory Affairs & Compliance Nektar Therapeutics, Bayhill Therapeutics, Berlex Laboratories, Serono, Parexel, Biogen
  20. 20. WHY WE’RE HERE 20 Source: San Antonio Express E75 vaccine's final tests start in S.A. By Don Finley, January 22, 2012; Photo credit: Kin Man Hui/San Antonio Express-News/ZUMAPress “I've had several friends who've had (breast cancer) and then…it came back and they had to go through treatment again. So this would be wonderful, not to have to come back.” – First NeuVax Phase 3 patient
  21. 21. THANK YOU

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