Sellas Life Sciences Group, Inc. · NASDAQ:SLS
Sellas Life Sciences — Galena Biopharma — Q1 2016 Earnings Presentation
19 slides from Sellas Life Sciences's earnings presentation, May 10, 2016
Slide 1: Q1, 2016 Financial Results & Corporate Update
Q1, 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 Controller & Principal Accounting Officer Other Participants Remy Bernarda, IRC SVP, Investor Relations & Co
Slide 4: Opening Remarks
OPENING REMARKS Mark W. Schwartz, Ph.D. President and Chief Executive Officer 4
Slide 5: Clinical Development
CLINICAL DEVELOPMENT Bijan Nejadnik, M.D. Executive Vice President, Chief Medical Officer 5
Slide 6: PRESENT Trial: Prevention of Recurrence in Early-Stage Breast Cancer with NeuVax
PHASE 3 PRESENT TRIAL PER SPA 1 2 3 4 Interim analysis by IDMC 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+ Stratifi
Slide 7: PRESENT Trial Definitions
PRESENT TRIAL DEFINITIONS Qualifying Event: • A recurrence of the primary cancer, either locally (breast), regionally (lymph nodes), or distantly (metastatic) • Occurrence of another cancer • Death from any cause Interim Analysis: a pre-specified safety and futility analysis on the first 70 adju
Slide 8: PRESENT Interim Analysis
PRESENT INTERIM ANALYSIS 70 Events Confirmed by the EAC 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 f
Slide 9: NeuVax: VADIS Trial (DCIS)
NEUVAX: VADIS TRIAL (DCIS) 9 Program Goal: Broaden footprint of NeuVax development to include primary prevention. Should the study results be positive, NeuVax may potentially be evaluated in a large randomized trial for primary prevention of invasive breast cancer. • Study Objectives: Primary • Ev
Slide 10: NeuVax: Development Collaborations
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+ Enrolled 13 countries ~140 centers 700 (enrolled 758) 2b Combination with trastuzumab 1+, 2+ BREA
Slide 11: GALE-301 & GALE-302: Current Clinical Development
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
Slide 12: Essential Thrombocythemia (ET): Current Standard of Care
ESSENTIAL THROMBOCYTHEMIA (ET): CURRENT STANDARD OF CARE 12 • 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/re
Slide 13: Finance
FINANCE John Burns Controller and Principal Accounting Officer 13
Slide 14: Statements of Operations
STATEMENTS OF OPERATIONS ‘Three Months Ended March 31, Operating expenses: Research and development $ 5,443 $ 5,825 General and administrative 3,525, 3,087 Total operating expenses 8,968 8912 Operating loss (6.968) 6.912) Non-operating income (expense) ‘Change in fair value of warrants potentially s
Slide 15: Cash & Cash Equivalents
CASH & CASH EQUIVALENT. For the Three Months Ended March 31, 2016 2015 Cash flows from continuing operations: Cash flows used in continuing operating activities $ (9,741) $ (10,497) Cash flows used in continuing investing activities (6) (18) Cash flows provided by continuing financing activities 41,
Slide 16: Financial Overview
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 Operating Burn
Slide 17: Milestones & Closing Remarks
MILESTONES & CLOSING REMARKS Mark W. Schwartz, Ph.D. President and Chief Executive Officer 17
Slide 18: 2016 Milestones
2016 MILESTONES 18 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
Slide 19: 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