Sellas Life Sciences Group, Inc. · NASDAQ:SLS
Sellas Life Sciences — Galena Biopharma — Q3 2015 Earnings Presentation
21 slides from Sellas Life Sciences's earnings presentation, Nov 9, 2015
Slide 1: Q3, 2015 Earnings Report & Business Update
Q3, 2015 Earnings Report & Business 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 our 2015 revenue from the sale of Abstral®, our launch of Zuplenz®, the divest
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 Gavin Choy, PharmD Senior Vice President, Clinical Sciences and Operations Ryan Dunlap, CPA Vice President & Chief Financial
Slide 4: Overview
OVERVIEW Mark W. Schwartz, Ph.D. President & Chief Executive Officer
Slide 5: November 2012 Development Pipeline
NOVEMBER 2012 DEVELOPMENT PIPELINE Product Therapeutic Area Phase 1 Phase 2 Phase 3 BLA / NDA NeuVax™ Node-positive HER2 IHC 1+/2+ NeuVax™ + Herceptin® Node-positive or node negative/triple negative HER2 IHC 1+/2+ GALE-301 Ovarian & Endometrial PRESENT *NeuVax is an investigational product. Efficacy
Slide 6: November 2015 Development Pipeline
NOVEMBER 2015 DEVELOPMENT PIPELINE Product Therapeutic Area Phase 1 Phase 2 Phase 3 BLA / NDA Immunotherapy: Breast Cancer NeuVax™ 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
Slide 7: Finance
FINANCE Ryan Dunlap, CPA Vice President & CFO 7
Slide 8: Condensed Consolidated Statement of Comprehensive Loss
CONDENSED CONSOLIDATED STATEMENT OF COMPREHENSIVE LOSS (in 000s)(unaudited) 8
Slide 9: Q3 2015 Cash Roll-Forward
Q3 2015 CASH ROLL-FORWARD (000s rounded) Beginning Cash, January 1, 2015 $23,700 Financing Activities $47,600 Operating Burn – Continuing Operations ($27,800) Operating Burn – Discontinued Operations ($5,000) Investing Burn – Continuing Operations ($300) Investing Burn – Discontinued Operations ($50
Slide 10: Introduction
INTRODUCTION Bijan Nejadnik, M.D. Executive Vice President, Chief Medical Officer 10
Slide 11: Uniquely Positioned
UNIQUELY POSITIONED 14.5 million 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
Slide 12: Clinical Development
CLINICAL DEVELOPMENT Gavin Choy, PharmD Senior Vice President, Clinical Sciences and Operations 12
Slide 13: NeuVax: Breast Cancer Programs
NEUVAX: BREAST CANCER PROGRAMS Phase Treatment Cancer Type Indication Status Protocol Defined # of Patients Collaborations 3 Single agent PRESENT Study Breast Node Positive HER2 1+, 2+ HLA A2/A3+ Enrolled 13 countries ~140 centers 700 (enrolled 758) 2b Combination with trastuzumab Breast Node Positi
Slide 14: GALE-301 & GALE-302: Current Clinical Development
GALE-301 & GALE-302: CURRENT CLINICAL DEVELOPMENT 14 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 Enrolled 39
Slide 15: GALE-301: Phase 1/2a Trial
GALE-301: PHASE 1/2a TRIAL 1 2 3 4 Dosing by Month + 1 booster dose every 6 months thereafter 5 6 Disease free (NED) ovarian and endometrial after SoC Rx Node positive HLA A2+ - Vaccine HLA A2- Control N = 51 Study Population GALE-301 + GM-CSF 100 mg GALE-301 + GM-CSF 500 mg GALE-301 + GM-CS
Slide 16: Phase 1/2a Trial Results: Optimal Dose Group Preliminary Efficacy
PHASE 1/2a TRIAL RESULTS: OPTIMAL DOSE GROUP 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: Greene et al, ECC 2015 16 Phase 1: Determined optimal dose and demonstrated safety and potent immune response Phase 2a: Prelim
Slide 17: GALE-301 & GALE-302: Phase 1b Trial
GALE-301 (E39) & GALE-302 (E39’): PHASE 1b TRIAL 1 2 3 4 Dosing by Month + 1 booster dose every 6 months x2 5 6 Disease free (NED) ovarian and breast cancer after SoC Rx Node positive HLA A2+ (Vaccine) HLA A2- (Control) Post menopausal N = 39 Study Population GALE-301 + GM-CSF x 6 Phase 1
Slide 18: GALE-301 & GALE-302: Delayed-Type Hypersensitivity
GALE-301 & GALE 302: DELAYED-TYPE HYPERSENSITIVITY 18 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 (
Slide 19: Thank You
THANK YOU Mark W. Schwartz, Ph.D. President and Chief Executive Officer 19
Slide 20: Upcoming Milestones
UPCOMING MILESTONES NeuVax™ Enroll N=700 into PRESENT trial Complete enrollment in Phase 3 PRESENT trial • Initiate DCIS trial (1Q16) • PRESENT: reach 70 events (1Q16) • PRESENT: interim analysis (2Q16) GALE-301 GALE- 302 Report Top-Line Phase 2a clinical data Report 1-Year Phase 2a analysis
Slide 21: Why We're Here
WHY WE’RE HERE 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 wonderf