Sellas Life Sciences Group, Inc. · NASDAQ:SLS
Sellas Life Sciences — Galena Biopharma — FY2015 Earnings Presentation
27 slides from Sellas Life Sciences's earnings presentation, Mar 10, 2016
Slide 1: Q4 & Year End 2015 Earnings Report & Corporate Update
Q4 & YEAR END, 2015 Earnings Report & 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 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 John T. Burns, CPA Controller & Principal Accounting Officer Other Participants Remy Bernarda, MBA SVP, Investor Relations & Co
Slide 4: Overview
OVERVIEW Mark W. Schwartz, Ph.D. President & Chief Executive Officer
Slide 5: 2015 Milestones
2015 MILESTONES NeuVax™ Enroll N=700 into PRESENT trial Complete enrollment in Phase 3 PRESENT trial GALE-301 GALE- 302 Report Top-Line Phase 2a clinical data Report 1-Year Phase 2a analysis Report GALE-301 + GALE-302 Phase 1b data GALE-401 (anagrelide CR) Report Top-Line efficacy and sa
Slide 6: Development Pipeline
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 negati
Slide 7: Clinical Development
CLINICAL DEVELOPMENT Bijan Nejadnik, M.D. Executive Vice President, Chief Medical Officer 7
Slide 8: Phase 3 PRESENT Trial per SPA
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 9: 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 Central Imaging: Independent radiology group to evaluate radiographic images • Team
Slide 10: Endpoint Adjudication Committee (EAC)
ENDPOINT ADJUDICATION COMMITTEE (EAC) Patient is Symptomatic •Physician identifies a potential event •Submits the case for evaluation Result Sent to Central Imaging for Assessment •Independent readers (3 radiologists) evaluate the patient scans Independent Medical Group Collects & Reviews •Receives
Slide 11: 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 12: 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 13: Ductal Carcinoma in Situ (DCIS)
DUCTAL CARCINOMA IN SITU (DCIS) Cancer that starts inside the milk ducts The most common type of breast cancer • 60,000 new cases a year 13 Sources: American Cancer Society; National Cancer Institute
Slide 14: NeuVax: VADIS Trial (DCIS)
NEUVAX: VADIS TRIAL (DCIS) 14 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 • E
Slide 15: GALE-301 & GALE-302: Current Clinical Development
GALE-301 & GALE-302: CURRENT CLINICAL DEVELOPMENT 15 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 16: GALE-401 Anagrelide Controlled Release (CR)
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
Slide 17: Clinical Development
CLINICAL DEVELOPMENT Bijan Nejadnik, M.D. Executive Vice President, Chief Medical Officer 17
Slide 18: Finance
FINANCE John T. Burns, CPA Controller & Principal Accounting Officer 18
Slide 19: Statements of Operations
STATEMENTS OF OPERATIONS iw 2018 2074 2015 2014 Opeaing expenses: Research and development $ 4,849 $ 211 $23,611 $27,674 3,482 10,609 16,226 Total operating expenses 7,589 93 34,220 43,900 Operating loss (7,589) (9,693) (34,220) (43,900)] Non-operating income (expense): Litigation settlement (5,282)
Slide 20: Non-Recurring Expenses
NON-RECURRING EXPENSES QuarterEnded = Year ended Dec 31, 2015 2015 Non-recurring charges included in loss from discontinued operations: Impairment charge form classification as held for sale (non-cash) $ - 8,071 Loss on sale of commercial business assets (non-cash) $ 4,549 $ 4,549 Severance and exit
Slide 21: Cash & Cash Equivalents
CASH & CASH EQUIVALENTS For the Year Ended December 31, 2015 2014 Cash flows from continuing operations: Cash flows used in continuing operating activities, 8 (38,802) $ (37,037) Cash flows used in continuing investing activities (354) (2472) 43,845 24,260 Total cash 4,689 (15,249) Cash flows from d
Slide 22: Financial Overview
FINANCIAL OVERVIEW Cash Position (as of 2/29/15) $38.2 million Q1 Remaining Burn $2.5-$3.5 million Q2 Projected Burn $13-$15 million Includes legal settlement & fees ~$4-$5 million Debt (as of 12/31/15) $4.7 million Shares Outstanding 182 million Market Cap (9 March 16) ~$170 million 22
Slide 23: Milestones & Closing Remarks
MILESTONES & CLOSING REMARKS Mark W. Schwartz, Ph.D. President and Chief Executive Officer 23
Slide 24: NeuVax: Significant U.S. Commercial Opportunity
Adds ~10k patients >$3B Combo: High risk, HER2 3+ NEUVAX: SIGNIFICANT U.S. COMMERCIAL OPPORTUNITY 24 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 curren
Slide 25: 2016 Milestones
2016 MILESTONES 25 PROGRAM MILESTONE PROJECTED DATE NeuVax™ (nelipepimut-S) Initiate DCIS trial March/April PRESENT: Reach 70 events March/April 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 Q2 Prese
Slide 26: 1st in Class Programs with Expansion Opportunities
1st IN CLASS PROGRAMS 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
Slide 27: 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