Sellas Life Sciences Group, Inc. · NASDAQ:SLS
Sellas Life Sciences — Galena Biopharma — Q2 2015 Earnings Presentation
29 slides from Sellas Life Sciences's earnings presentation, Aug 6, 2015
Slide 1: Galena Biopharma
at, wv GALENA BIQOPHARMA
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 target revenue from the sales of the Company’s products, the future expectatio
Slide 3: Earnings Call Participants
EARNINGS CALL PARTICIPANTS Presenters Mark W. Schwartz, Ph.D. President and Chief Executive Officer Gavin Choy, PharmD Senior Vice President, Clinical Sciences and Operations Christopher Lento, MBA Senior Vice President, Commercial Operations Ryan Dunlap, CPA Vice President & Chief Financial
Slide 4: Q2 Overview
Q2 Overview Mark W. Schwartz, Ph.D. President and Chief Executive Officer
Slide 5: 2015 Milestones
2015 MILESTONES Commercial Report $8-10 million net revenue for 2014 Launch Zuplenz in the U.S. • Achieve $15-18 million net revenue in 2015 NeuVax™ Enroll N=700 into PRESENT trial Complete enrollment in Phase 3 PRESENT trial • PRESENT trial interim analysis (Q4,‘15/Q1,‘16) GALE-301 (FBP)
Slide 6: Clinical Development
CLINICAL DEVELOPMENT Gavin Choy, PharmD Senior Vice President, Clinical Sciences and Operations 6
Slide 7: Phase 3 PRESENT Trial Design per SPA
PHASE 3 PRESENT TRIAL PER SPA 1 2 3 4 Interim analysis by DSMB 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 8: NeuVax Clinical Development Programs
NEUVAX CLINICAL DEVELOPMENT PROGRAMS Phase Treatment Indication Status Protocol Defined # of Patients 3 Single agent PRESENT Study Breast, 1+, 2+ Enrolled, 13 countries, ~140 centers 700 (enrolled 758) 2 Combination with Herceptin Breast, 1+, 2+ Enrolling, US only, 32 centers 300 2 Combination with
Slide 9: NeuVax + Trastuzumab: HER2 1+/2+ Phase 2 Study
Primary Endpoint DFS at 24 mos. Standard of Care: Standard Herceptin dosing every 3 weeks for 1 year + 1 booster dose every 6 months thereafter + Dosing to disease progression or 36 months 6 doses of NeuVax given every 3 weeks starting with third dose of Herceptin Secondary Endpoint DFS at 36 mos. 3
Slide 10: NeuVax + Trastuzumab: HER2 3+ DoD Study
10 NEUVAX+TRASTUZUMAB: HER2 3+ DoD STUDY
Slide 11: NeuVax: Across the Breast Cancer Treatment Spectrum
NEUVAX: ACROSS THE BREAST CANCER TREATMENT SPECTRUM NeuVax SECONDARY PREVENTION Proof of Concept: Established in population with no standard of care treatment options Ideal Setting: Adjuvant treatment in patient population with no evidence of disease Most advanced: PRESENT is the largest breast canc
Slide 12: GALE-301: Folate Binding Protein (FBP)
GALE-301: FOLATE BINDING PROTEIN (FBP) 12 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: U.S. Ovarian Cancer http://seer.cancer.gov/statfacts/html/ovary.html Targeted cancer immunotherapy FBP is over-expressed (20-80 fold) in >90% of ovari
Slide 13: 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, Abstract Presentation, ASCO 2015 13 Phase 1/2a trial ongoing Phase 1: Determined optimal dose and demonstrated safety and
Slide 14: GALE-401: Phase 2 Pilot Study Preliminary Results
GALE-401: PHASE 2 PILOT STUDY PRELIMINARY RESULTS 14 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: EHA 2015 Poster Presentation, Verstovsek et al. Well tolerated with primarily Grade 1 and 2 toxicities in n=16/18 Efficacy compares favorabl
Slide 15: Commercial: Abstral
COMMERCIAL: ABSTRAL® Christopher Lento Senior Vice President, Commercial Operations 15
Slide 16: Gross Revenue vs. Net Revenue (Since Acquisition)
GROSS REVENUE vs. NET REVENUE (Since Acquisition) 16
Slide 17: Paid Transactions vs. Quantity Dispensed
17 PAID TRANSACTIONS vs. QUANTITY DISPENSED (April 2014 to June 2015)
Slide 18: Average Transaction Price
18 AVERAGE TRANSACTION PRICE (April 2014 to June 2015)
Slide 19: Sales by Specialty (2015 YTD)
SALES BY SPECIALTY (2015 YTD) 19 Oncology Includes Medical Oncology Radiation Oncology Palliative Care Source: Galena REMS Data
Slide 20: Commercial: Zuplenz
COMMERCIAL: ZUPLENZ® Christopher Lento Senior Vice President, Commercial Operations 20
Slide 21: Introducing Zuplenz
INTRODUCING ZUPLENZ® 21 Source: Image taken from Zuplenz.com
Slide 22: Commercial Opportunity
COMMERCIAL OPPORTUNITY 22 Delivers the trusted efficacy and safety of ondansetron Convenient oral soluble film eliminates the burden of swallowing pills during periods of emesis Does not require water ideal in cases of oral irritation Pleasant peppermint flavor, no gritty aftertaste
Slide 23: Galena Commercial Team: Promotion/Targeting Mix
GALENA COMMERCIAL TEAM: PROMOTION/TARGETING MIX • ZUPLENZ (PONV) • ABSTRAL (BTcP) • ZUPLENZ (PONV) • ABSTRAL (BTcP) • ZUPLENZ (RINV/PONV) • ABSTRAL (BTcP) • ZUPLENZ (CINV) Medical Oncologists Radiation & Surgical Oncologists Non- Oncology Specialties Pain Specialists (oncology patients) 23
Slide 24: Galena Patient Services
24 Source: Image taken from galenapatientservices.com
Slide 25: Finance
FINANCE Ryan Dunlap, CPA Vice President & CFO 25
Slide 26: Abstral Net Revenue
ABSTRAL NET REVENUE Three Months Ended E $ (Thousands) E ° 06/30/15 06/30/14 Period Ending $ (Thousands) 10,000 Six Months Ended 06/30/15, 06/30/14 Period Ending FB Net revenue [Pp Gress to net deductions ]
Slide 27: Condensed Consolidated Statement of Comprehensive Loss
CONDENSED CONSOLIDATED STATEMENT OF COMPREHENSIVE LOSS (in 000s)(unaudited) 27 June 30, 2015 Net revenue $ 3,382 Costs and expenses: Cost of revenue (excluding amortization of certain acquired intangible assets) 468 Research and development 7,290 Selling, general, and administrative 6,451 Amortizati
Slide 28: Q2 2015 Cash Roll-Forward
Q2 2015 CASH ROLL-FORWARD 28 Confidential Information (000s rounded) Beginning Cash, April 1, 2015 $52,860 Financing Activities $5,280 Operating Burn ($11,900) Debt Service ($1,000) Ending Cash, March 31, 2015 $45,280
Slide 29: Thank You
THANK YOU Mark W. Schwartz, Ph.D. President and Chief Executive Officer 29