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Galena presentation 11 may 16
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- 2. FORWARD LOOKING STATEMENT Thispresentation 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. LATE-PHASE, ONCOLOGY FOCUSED IMMUNOTHERAPYCOMPANY Targeted, 1st in Class therapies for prevention of cancer recurrence Focused in large markets in areas of major unmet medical need • Phase 3, PRESENT, breast cancer clinical trial ongoing under SPA Pioneering immunotherapy technology for cancer • Induce, activate and cause proliferation of Cytotoxic T-Cells • Proven Mechanism of Action through Expansion of Tumor Specific CTLs 3 0 5 10 15 20 25 0.5 1.5 2.5 3.5 4.5 5.5 6.5 7.5 8.5 9.5 10.5 Year Hazardofrecurrencebyyearlyinterval Total Node 0 Node 1-3 Node (4+) Tumour size (<1cm) Tumour size (1.1-3cm) Tumour size (>3cm) ER+ ER- Premen Postmen 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
- 4. DEVELOPMENT PIPELINE Product TherapeuticArea 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 PRESENT *NeuVax is an investigational product. Efficacy has not been established. Herceptin is a registered trademark of Genentech. Ongoing Planned VADIS 4 2b
- 5. Adds ~10k patients >$3B Combo: Highrisk, HER2 3+ NEUVAX: SIGNIFICANT U.S. COMMERCIAL OPPORTUNITY 5 adds ~10k patients >$2.5B Combo Node Pos or Neg HER2 1+, 2+ HLA-A2, A3, A24, A26 PRESENT 50-60k patients >$2B Source: Global Data 2015/Medtrack. Pricing estimates based on a 20% premium to the current average annual price of Herceptin® (U.S. Dollars).
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- 7. NOVEL DEVELOPMENT STRATEGY: SECONDARYPREVENTION IN CANCER SURVIVORS 7 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
- 8. PREVENTING RECURRENCE: UNMET MEDICALNEED NEUVAX PHASE 3 PRESENT TRIAL DEMOGRAPHIC: Node positive, Stage 2a - 3a, HER2 1+/2+, HLA A2/A3 Local or Metastatic recurrent disease = 8 Poor prognosis and/or Death Patients have a ~25% Recurrence Rate Prevention of recurrences saves lives! Sources: 1 http://www.cancer.org/cancer/breastcancer/detailedguide/breast-cancer-survival-by-stage; 2 Sledge GW Jr: Curing Metastatic Breast Cancer. J Oncol Pract 12:6-10, 2016 5 year survival rate of metastatic cancer = 22%1 “Low Tumor volume” equates to improved overall survival 2 Occult tumor cells micrometastasis macrometastisis metastatic disease
- 9. UNIQUELY POSITIONED 14.5million cancer survivors in US (NCI Cancer Survivorship) • Projected to 19 million survivors in 2024 Increase in survival due to decades of productive research, improved screening/prevention, and effective treatments Survival leads to patients living longer • 64% alive after 5 years of diagnosis • 41% alive after 10 years of diagnosis • 15% alive after 20 years or longer Galena peptide vaccines – NeuVax and GALE-301 are uniquely positioned to maintain survivorship 9Source: DeSantis CE et al. CA Cancer J Clin 2014: 64:252-271
- 10. CANCER IMMUNOTHERAPY WITH INNOVATIVE TECHNOLOGY Overcoming Cancerby Activating and Expanding Cytotoxic T-Cells 10
- 11. FIRST-IN-CLASS, TARGETED IMMUNOTHERAPY PIPELINE 11 Harnessingthe power of the immune system in the adjuvant setting Exploits specificity of natural immune surveillance Adjuvant patients have healthy immune systems Systemic protection Goal is to prevent recurrence Recurrences are almost always fatal Minimal toxicity and improved safety profile Boosters provide long term protective effect Well-validated targets HER2 Folate binding protein (FBP) Current Programs NeuVax™ (nelipepimut-S) • Breast: HER2 1+, 2+ and 3+; DCIS • Gastric trial planned GALE-301 & GALE-302 • Ovarian Adjuvant Setting = Minimal Residual Disease
- 12. T-Cell Activating Receptors InhibitoryReceptors 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 12 Checkpoint inhibitors Indirect Immune Modulators Co-stimulators Immune Inhibitory Enzymes CAR T Technology TCR Technology
- 13. T-Cell Activating Receptors InhibitoryReceptors 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 13 Checkpoint inhibitors Indirect Immune Modulators Co-stimulators Immune Inhibitory Enzymes
- 14. T-Cell CD28 OX40 GITR CD122 CD27 CD360 HVEM CD137 CTLA-4 PD-1 TIM-3 BTLA VISTA LAG-3 Activating Receptors InhibitoryReceptors OUR VACCINES STIMULATE T-CELL PROLIFERATION AND EXPANSION 14 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
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- 16. NEUVAX: HER2 IMMUNODOMINANTPEPTIDE 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 16 K I F G S L A F L
- 17. ELICITS A STRONGCD8+ 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 17 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
- 18. POSITIVE SAFETY PROFILE NeuVax is well-tolerated in multiple clinical trials Phase 1/2 showed predominantly Grade 1/2 Adverse Events caused by GM-CSF (n=53) • Injection site reactions in nearly all patients demonstrating the activated dendritic cells • Systemic toxicities caused by GM-CSF Fatigue (64%) Headache (42%) Myalgia/Other Pain (30%) August 2015 • Independent Data Monitoring Committee (IDMC) recommended to the Company that it can reduce the cardiac toxicity monitoring in its Phase 3 PRESENT clinical trial 18 Sources: Choy, et al, poster presentation 33rd Annual Chemotherapy Foundation Symposium: Nov 2015; Mittendorf- Annals of Oncology 25: 1735–1742, 2014
- 19. NEUVAX: SN-33 PHASE2 HER2 IHC 1+/2+ 19Source: 2012 San Antonio Breast Cancer Poster, Mazanet, et al.
- 20. PHASE 3, PRESENTTRIAL Prevention of Recurrence in Early-Stage, Node Positive Breast Cancer with Low to Intermediate Her2 Expression with NeuVax Treatment Trial being run under FDA-approved SPA Enrollment completed in April 2015 (n=758) • Adjuvant breast cancer patients, Node Positive, HER2 1+/2+, HLA A2/A3+ Patient friendly regimen via intradermal injection • Primary Vaccine Series – injection once a month for 6 months • Booster Series – injection once every 6 months Upcoming Key Milestones • Interim safety/futility analysis: 2Q16 • Primary Endpoint: 2018 20
- 21. PHASE 3 PRESENTTRIAL PER SPA 1 2 3 4 Interim analysis by DSMB at n=70 events Endpoint DFS at n=141 events /36 months Dosing by Month + 1 booster dose every 6 months thereafter 5 6 Adjuvant breast cancer patients, randomized 1:1 Double blind Node positive HLA A2/A3+ HER2 IHC 1+/2+ Stratified by stage, type of surgery, hormone receptor, and menopausal status Enrollment complete: n=758 Patients Study Population + GM-CSF Placebo + GM-CSF 21 Prevention of Recurrence in Early-Stage, Node Positive Breast Cancer with Low to Intermediate Her2 Expression with NeuVax Treatment
- 22. PRESENT INTERIM ANALYSIS 70Events Confirmed by the EAC • Endpoint Adjudication Committee confirms 70 events • Independent team of 2 Oncologists and 1 Radiologist Galena Compiles Data • Prepares a detailed review on 70 patients with events and overall safety data set (n=758) • Submits to IDMC IDMC Evaluates • Evaluates 70 patients with events and overall safety data set (n=758) • Makes recommendation on futility and continuation of trial Interim Analysis Results •Estimated timing: End of Q2 22
- 23. PRIMARY PREVENTION Expansion potentialfor safe vaccine in DCIS METASTATIC DISEASE Expansion potential in combination with checkpoint inhibitors /immune modulators NEUVAX: ACROSS THE BREAST CANCER TREATMENT SPECTRUM 23 PROOF OF CONCEPT: Established in population with no standard of care treatment options SECONDARY PREVENTION IDEAL SETTING: Adjuvant treatment in patient population with no evidence of disease MOST ADVANCED: PRESENT is the largest and only Phase 3 breast cancer vaccine trial
- 24. NEUVAX: DEVELOPMENT COLLABORATIONS PhaseTreatment HER2 Status Indication Trial Status Protocol Defined # of Patients Collaborations 3 Single agent PRESENT Study 1+, 2+ BREAST Node Positive HLA A2+, A3+ Enrolled 13 countries ~140 centers 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+ Planned U.S. only 4 centers 48 2 Single agent 1+, 2+,3+ GASTRIC HLA A2+, A3+ Planned India Only 50 24
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- 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 DOSEGROUP SHOWS PRELIMINARY EFFICACY Source: Peoples, et. al, Poster Presentation, European Cancer Congress 2015 27 Phase 1/2a trial ongoing Phase 1: Determined optimal dose and demonstrated safety and potent immune response Phase 2a Preliminary data in 1000 mcg dose group: • At 12 months median follow-up: Vaccine group: 2 clinical recurrences (13.3%) n=15 Control group: 12 recurrences (55%) n=22 • Two year DFS estimate in 1000 mcg dose group is 85.7% vaccine vs. 33.6% control (p<.02) • GALE-301 plus GM-CSF is well tolerated and elicits a strong in vivo immune response with primarily Grade 1 and Grade 2 toxicities 2 Year DFS Estimate by Dose Cohort
- 28. GALE-301 & GALE302: PHASE 1 DELAYED-TYPE HYPERSENSITIVITY 28 LEGEND EE = E39 (GALE-301) x 6 inoculations (n=12) EE’ = E39 (GALE-301) x 3 inoculations followed by E39’ (GALE-302) x 3 inoculations (n=14) E’E = E39’ (GALE-302) x 3 inoculations followed by E39 (GALE-301) x 3 inoculations (n=13) R0 = baseline (pre-vaccination) RC1 = 1 month after completion of the PVS RC6 = 6 months after completion of the PVS and pre-booster Source: Mittendorf et. al., Poster Presentation, Society of the Immunotherapy of Cancer 2015
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- 30. 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 30
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- 32. 1st IN CLASSPROGRAMS WITH EXPANSION OPPORTUNITIES Mid-stage clinical trials have proven T-cell generation • NeuVax™ (nelipepimut-S) Phase 2 trial demonstrated 2% of the patient’s T-Cells become CD8+, HER2 directed • GALE-301 Phase 1/2: Two year DFS estimate in optimal dose group is 85.7% vaccine vs. 33.6% control (p<.02) Targeting “high value” settings: Prevention of recurrence in breast and ovarian cancer are areas of clear unmet medical needs • No approved drugs for these women with limited late stage competition Multiple trials ongoing as stand-alone therapies and in-combination with other agents Breast & Ovarian are just a start – HER2 and Folate Binding Protein expressed in numerous cancer types HER2 Breast Gastric Prostate Non-Small Cell Lung Bladder Colorectal Ovarian Head & Neck Folate Binding Protein Ovarian Endometrial Breast 32
- 33. LEADERSHIP TEAM 33 MarkW. 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
- 34. 2016 MILESTONES 34 PROGRAM MILESTONE PROJECTED DATE NeuVax™ (nelipepimut-S) PRESENT:Achieve 70 Qualifying DFS Events ✓ Initiate DCIS trial Q2 PRESENT: Interim analysis Q2 Combo H&N 1+/2+ Interim safety data Q4 Combo H&N 1+/2+ A24/A26 data Q4 GALE-301 GALE-302 Present 301/302 booster data ✓ Present GALE-301 Phase 2a two year data Q4 GALE-401 (anagrelide CR) Present combined safety data Q2 Confirmation of 505(b)2 pathway 2H Publish final Phase 2 report Q4
- 35. FINANCIAL OVERVIEW Cash Position(as of March 31, 2016) $34.7 million Debt Financing (May 10, 2016) + $23.4 million Payoff Remaining Oxford Debt (May 10, 2016) - $3.1 million Q2 Projected Operating Burn $13 - $15 million Includes legal settlement & fees ~$4-$5 million Future Projected Quarterly Burn $9 - $11 million Shares Outstanding 182 million Market Cap (as of May 9, 2016) ~$240 million 35
- 36. WHY WE’RE HERE 36 Source: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
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Editor's Notes
- #17 Immunodominant Extracellular Domain (aa 1-652)
- #18 This image shows single T cell next to a single cancer cell and as we all know, metastatic foci of disease consist of millions of cancer cells so I would contend that it may be difficult to stimulate enough immune response to attack a foci of millions of cancer cells. Instead of developing vaccines like traditional chemotherapies large bulky or metastatic disease, Dr. Peoples and his group has hypothesized that vaccines will be more effective in the adjuvant setting when there is minimal disease.
- #20 Looking at the boosted population from SN-33, we can we there is a large treatment difference between the groups in DFS at 36 months. For this analysis the DFS was 36 months, the duration of the booster therapy. This is basically the TPP (target patient population) discussed in the question. Of note, no patients receiving booster inoculations had a recurrence through 36 months, which is the Ph 3 PRESENT study endpoint.