Sellas Life Sciences Group, Inc. · NASDAQ:SLS
Sellas Life Sciences — Galena Biopharma — Q3 2016 Earnings Presentation
26 slides from Sellas Life Sciences's earnings presentation, Nov 9, 2016
Slide 1: Q3, 2016 Financial Results & Corporate Update
Q3, 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 Stephen Ghiglieri Executive Vice President, Chief Financial
Slide 4: Opening Remarks
OPENING REMARKS Mark W. Schwartz, Ph.D. President and Chief Executive Officer 4
Slide 5: Pseudo-Progression with Immunotherapy
Pseudo-Progression with Immunotherapy Definition: Appearance of progression on radiographic imaging due to increased tumor size (swelling) from tumor infiltrating lymphocytes (TIL’s) and other immune cells • A growing or new tumor detected via imaging isn't always progressing cancer Discovery of
Slide 6: Clinical Development
CLINICAL DEVELOPMENT Bijan Nejadnik, M.D. Executive Vice President, Chief Medical Officer 6
Slide 7: PRESENT Phase 3 Top-Line Interim Results
PHASE 3 PRESENT TOP-LINE INTERIM RESULTS
Slide 8: PRESENT Top-Line Interim DFS Results
PRESENT Top-Line Interim DFS Results NeuVax Arm Control Arm Data based on interim data cut. p-value = 0.07 Median time on trial 19.7 months
Slide 9: Imaging in the PRESENT Trial
Imaging in the PRESENT Trial NeuVax Arm Control Arm 1st Imaging ~Month 12 2nd Imaging ~Month 24 3rd Imaging ~Month 36 Pre-treatment Imaging DFS Adjudicated Events Diagnosed by Clinical Presentation Proactive Imaging 66% of DFS events found via Proactive Imaging 24 47 Data based on interim data cut.
Slide 10: Composition of DFS events at Interim Analysis
Composition of 71 DFS events at Interim Analysis 10 DFS Event NeuVax Arm (n = 376) Control Arm (n = 382) Recurrence of Primary Cancer 36 (9.6%) 23 (6.0%) Occurrence of another Cancer 5 (1.3%) 4 (1.0%) Death from any cause 2 (0.5%) 1 (0.3%) 0 3 6 9 12 15 18 21 24 27 30 33 36 Active Placebo T im e t o
Slide 11: Pseudo-Progression in Cancer Immunotherapy & The PRESENT Trial
Pseudo-Progression in Cancer Immunotherapy & The PRESENT Trial In adjuvant setting, immunological therapies require extended clinical monitoring over time to evaluate their effectiveness in preventing recurrences of clinical significance This inflammation can be potentially beneficial, but paradoxic
Slide 12: Summary: Pseudo-Recurrence
Summary Low rate of recurrence seen in the control arm may have resulted from an overall improvement in the standard of care Existing lesions were discovered by proactive imaging • May not have had any clinical significance at the time of identification • Lesions changed by inflammation and may
Slide 13: Immunotherapy Programs: NeuVax, GALE-301/GALE-302
IMMUNOTHERAPY PROGRAMS 13 NeuVax™ (nelipepimut-S) GALE-301/GALE-302
Slide 14: Development Pipeline
DEVELOPMENT PIPELINE PRODUCT THERAPETIC 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 15: GALE-401 Anagrelide Controlled Release (CR)
GALE-401 Anagrelide Controlled Release (CR) 15
Slide 16: Essential Thrombocythemia (ET)
Essential Thrombocythemia (ET) Diagnosis • Chronic hematologic malignancy with no known cause • Symptoms • Diagnostic tools • Blood test • Bone marrow biopsy • Gene mutation test Common Symptoms • Headache • Vision disturbances or migraines • Dizziness or lightheadedness • Coldness or blueness of fi
Slide 17: Current ET Treatment Options
Current ET Treatment Options Hydroxyurea • Generally first line therapy • Cytotoxic Myelosuppressive drug (reduces other blood cells as well) • Increased risk of developing acute leukemia after long term • Avoided in younger patients • ~25% of patients intolerant/refractory Anagrelide IR • Poor tole
Slide 18: 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 19: GALE-401 ET Development Opportunity
GALE-401 ET Development Opportunity Diagnosed patient population for ET • US Prevalence: 135,000 - 175,000 Limited competition with very few agents in development Multiple life cycle management opportunities Next steps • End of Phase 2 meeting with the FDA • Finalize the Phase 3 clinical tri
Slide 20: Finance
FINANCE John Burns Vice President, Finance and Corporate Controller 20
Slide 21: Statements of Operations
STATEMENTS OF OPERATIONS < \ 2016 2018 2016 2015 Operating expenses: Research ar velopment $ 3,624 $ 5,740 $ 15,242 $ 18,762 General and administrative 2,848 2,895 9,490 7,869 fotal rating expenses 6472 Total oper 8.635 24,732 26,631 Operating loss [ (6,472) (6,635) (24,732) 126.631) i a lon-operati
Slide 22: Q3 2016 Cash Burn
Q3 2016 CASH BURN Beginning Cash Position (as of June 30, 2016) $19.6 million Net proceeds from equity financing $11.7 million Reduction in restricted cash $5.5 million Cash burn from continuing operations ($7.7 million) Cash burn from discontinued operations ($2.1 million) Cash burn on litigation s
Slide 23: Financial Overview
FINANCIAL OVERVIEW Cash Position (as of 30 Sept 16) $24.5 million Restricted Cash (as of 30 Sept 16 - $18.5 relating to Debenture) $18.9 million Projected Q4 Cash Burn from Operations $7 - $9 million Shares Outstanding (as of 31 Oct 16) 217 million 23
Slide 24: Finance
FINANCE Stephen Ghiglieri Executive Vice President, Chief Financial Officer 24
Slide 25: Milestones & Closing Remarks
MILESTONES & CLOSING REMARKS Mark W. Schwartz, Ph.D. President and Chief Executive Officer 25
Slide 26: 2H 2016 Milestones
2H, 2016 MILESTONES 26 PROGRAM MILESTONE PROJECTED DATE GALE-401 (anagrelide CR) Present combined safety data ✓ Confirmation of 505(b)2 pathway 2H NeuVax™ (nelipepimut-S) Fast Track Designation ✓ Combo H&N 1+/2+ Interim safety data ✓ Initiate DCIS trial Q4 GALE-301 GALE-302 Present 301/302 booster d