Sellas Life Sciences Group, Inc. · NASDAQ:SLS
Sellas Life Sciences — Galena Biopharma — Q2 2016 Earnings Presentation
19 slides from Sellas Life Sciences's earnings presentation, Aug 9, 2016
Slide 1: Q2, 2016 Financial Results & Corporate Update
Q2, 2016 Financial Results & Corporate Update
Slide 2: Forward Looking Statement
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 the divestiture of the commercial operations including the two commercial prod
Slide 3: Earnings Call Participants
EARNINGS CALL PARTICIPANTS Presenters Mark W. Schwartz, Ph.D. President & Chief Executive Officer Bijan Nejadnik, M.D. Executive Vice President, Chief Medical Officer John T. Burns, CPA Vice President, Finance and Corporate Controller Other Participants Remy Bernarda, IRC SVP, Investor Relatio
Slide 4: Opening Remarks
OPENING REMARKS Mark W. Schwartz, Ph.D. President and Chief Executive Officer 4
Slide 5: Development Pipeline
DEVELOPMENT PIPELINE Product Therapeutic Area Phase 1 Phase 2 Phase 3 BLA / NDA Hematology GALE-401 (Anagrelide CR) Essential Thrombocythemia Immunotherapy: Breast Cancer NeuVax™ + Herceptin® Node-positive or node negative/triple negative HER2 IHC 1+/2+ NeuVax™ + Herceptin® High risk, node-positive
Slide 6: Clinical Development
CLINICAL DEVELOPMENT Bijan Nejadnik, M.D. Executive Vice President, Chief Medical Officer 6
Slide 7: GALE-401 Anagrelide Controlled Release (CR)
GALE-401 7 Anagrelide Controlled Release (CR)
Slide 8: GALE-401 Development Summary
GALE-401 Development Summary Potential Clinical Benefits from Phase 2 trial • Potentially faster onset of action • Consistent efficacy • Indication of improved tolerability vs anagrelide IR • Twice a day dosing with a PK profile supportive of once-a-day dosing Strong Development Rational • Novel
Slide 9: Essential Thrombocythemia (ET): Current U.S. Standard of Care
ESSENTIAL THROMBOCYTHEMIA (ET): CURRENT U.S. STANDARD OF CARE 9 • 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 intoleran
Slide 10: GALE-401 ET Development Opportunity
GALE-401 ET Development Opportunity Significant unmet medical need • No alternatives after Anagrelide IR and Hydroxyurea Diagnosed patient population for ET • US Prevalence: 135,000 - 175,000 ~75% of diagnosed patients receive treatment ~9,000 third line patients Limited competition with v
Slide 11: Immunotherapy Programs
IMMUNOTHERAPY PROGRAMS 11 NeuVax™ (nelipepimut-S) GALE-301/GALE-302
Slide 12: NeuVax: Current Clinical Trials
NEUVAX: CURRENT CLINICAL TRIALS Phase Treatment HER2 Status Indication Trial Status Protocol Defined # of Patients Collaborations 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 tras
Slide 13: GALE-301 & GALE-302: Current Clinical Development
GALE-301 & GALE-302: CURRENT CLINICAL DEVELOPMENT 13 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
Slide 14: GALE-301: Optimal Dose Group Shows Preliminary Efficacy
GALE-301: OPTIMAL DOSE GROUP SHOWS PRELIMINARY EFFICACY 0.0% 5.0% 10.0% 15.0% 20.0% 25.0% 30.0% Vaccine Control % of Subj e ct s Recurrence 24.0% 13.3% Source: Peoples, et. al, Poster Presentation, American Society of Clinical Oncology 2016 14 Phase 1/2a trial ongoing Phase 1: Determined optimal d
Slide 15: Finance
FINANCE John Burns Vice President, Finance and Corporate Controller 15
Slide 16: Statements of Operations
STATEMENTS OF OPERATIONS Three Months Ended ‘Six Months Ended dune 30, June 30, 2016 2015 2016 2015 Operating expenses: Research and development $ 6175 $ 7197 $ 11,618 $ 13,022 3,117 88 6,642 4 Total coe expenses 9,292 9,083 18,260 17,995 Operating lo E m é Non error income ae Sain settlement (1,800
Slide 17: Financial Overview
FINANCIAL OVERVIEW Cash Position (as of June 30, 2016) $19.6 million Financing (July 13, 2016) + $11.7 million Debt Financing (May 10, 2016) + $24 million (restricted cash) Projected Quarterly Burn Q3, 2016 $12 - $13 million Q4, 2016 $8 - $10 million Shares Outstanding (as of July 31, 2016) 214 mill
Slide 18: Milestones & Closing Remarks
MILESTONES & CLOSING REMARKS Mark W. Schwartz, Ph.D. President and Chief Executive Officer 18
Slide 19: 2H, 2016 Milestones
2H, 2016 MILESTONES 19 PROGRAM MILESTONE PROJECTED DATE GALE-401 (anagrelide CR) Present combined safety data ✓ Confirmation of 505(b)2 pathway 2H Submit final Phase 2 report Q4 NeuVax™ (nelipepimut-S) Fast Track Designation ✓ Initiate DCIS trial Q2 Combo H&N 1+/2+ Interim safety data Q4 GALE-301 GA