Sellas Life Sciences Group, Inc. · NASDAQ:SLS
Sellas Life Sciences — Galena Biopharma — Merger or Acquisition (August 2017)
22 slides from Sellas Life Sciences's merger presentation, Aug 8, 2017
Slide 1: Galena Biopharma and SELLAS Life Sciences to Combine
Galena Biopharma and SELLAS Life Sciences to Combine AUGUST 8, 2017
Slide 2: Galena Forward Looking Statement
GALENA FORWARD LOOKING STATEMENT Some of the information contained in this presentation may include forward-looking statements about strategy, future operations, future financial position, prospects, plans and objectives of management of Galena, SELLAS or the combined company. Examples of such state
Slide 3: Conference Call Participants
GALENA BIOPHARMA PRESENTER: Stephen Ghiglieri Interim Chief Executive Officer & Chief Financial Officer OTHER PARTICIPANTS: Remy Bernarda, IRC SVP, Investor Relations & Corporate Communications Thomas J. Knapp, Esq Interim General Counsel & Corporate Secretary SELLAS LIFE SCIENCES PRESENTER: Angelos
Slide 4: Galena-SELLAS Proposed Reverse Merger Transaction
GALENA-SELLAS PROPOSED REVERSE MERGER TRANSACTION •Follows Galena’s extensive review of strategic alternatives •All-stock transaction: Galena to acquire all outstanding shares of SELLAS in exchange for newly issued shares of Galena common stock •On a pro forma, fully diluted basis*, Galena stockhold
Slide 5: Galena Biopharma Overview
•Focused on developing hematology and oncology therapeutics that address unmet medical needs •Immunotherapy: • Lead Asset is NeuVax™ (nelipepimut-S), an immune therapy targeting the HER2 protein • Three Phase 2 investigator sponsored clinical trials (ISTs) ongoing in breast cancer • Phase 2b in Comb
Slide 6: Combined Company Highlights
•Late-stage cancer immunotherapy pipeline •Galinpepimut-S: • Innovative properties that differentiate it from other products in this class • Two Phase 3 ready indications with favorable safety and compelling efficacy (overall survival) profiles from completed Phase 2 trials • Overall survival in Pha
Slide 7: Leadership Team and Planned Board of Directors
LEADERSHIP TEAM Name POSITION PRIOR EXPERIENCE / AFFILIATIONS Angelos M. Stergiou, MD, ScD h.c. Chief Executive Officer Paion AG, Biovest International, Accentia, Analytica, Avanex Life Sciences Nicholas J. Sarlis, MD, PhD, FACP Chief Medical Officer NIH, MD Anderson, Sanofi, Incyte William Pollett,
Slide 8: SELLAS Overview
SELLAS OVERVIEW 8 •Focused on developing novel immune therapies for cancer •Lead asset is galinpepimut-S, an immune therapy targeting the Wilms Tumor 1 (WT1) protein • WT1 - top-ranked by the National Cancer Institute among cancer antigens for immunotherapy •Technology licensed from Memorial Sloan K
Slide 9: SELLAS/Galena Combined Development Pipeline
SELLAS/ GALENA COMBINED DEVELOPMENT PIPELINE 9 GALINPEPIMUT-S (GPS) – DEVELOPMENT PROGRAMS Ovarian Cancer (comb. w/ Nivolumab - BMS) PROGRAM PRECLINICAL PHASE 1 PHASE 2 PHASE 3 Multiple Myeloma Immune Combination Trial WT1-Lm Product (ADXS) In-Licensed WT1 Delivery Technology Ph 2 Study – Ongoing Ph
Slide 10: WT1: Top-Ranked Cancer Antigen by the NCI
Data shown are based on published literature; list of citations below: Dupont, 2004; Acs, 2004; Menssen, 2000; Rosenfeld, 2003; Oji, 1999; Al-Hussaini, 2004; Rodeck, 1994; Menssen, 1995; Campbell, 1998; Foster, 2001; Loeb, 2001; Dennis, 2002; Oji, 2002, 2003 and 2004 (multiple publications); Waldstr
Slide 11: Galinpepimut-S (GPS): Key Features
GALINPEPIMUT-S (GPS): KEY FEATURES 11 is substantially
Slide 12: Galinpepimut-S: Key Differentiators
GALINPEPIMUT-S: KEY DIFFERENTIATORS GALINPEPIMUT-S CR or MRD is the preferred setting for treatment as monotherapy Heteroclitic peptides ↑ Immune response ↓ potential for tolerance Multivalent polypeptide structure drives differentiated immuno- therapeutic efficacy Potential combination approaches u
Slide 13: Galinpepimut-S AML Phase 1 and 2 Clinical Program Conclusions
PRIVATE AND CONFIDENTIAL •Prolonged median overall survival: 67.6 months (all ages) •Aggregate population of patients > 60 years (Phase 3 Population): median overall survival (mOS) = 32.2 months in Phase 1 / 35.5 months in Phase 2 •88% of patients had evidence of immune response by either CD8+ or CD
Slide 14: Galinpepimut-S: Patients in AML CR2 at Moffitt Cancer Center
Brayer, 2015 • Independent trial at the Moffit Cancer Center (Tampa, FL) in patients after second complete remission (CR2) •AML pts receiving > 2 administrations of galinpepimut-S compared to group of paired patients in CR2 treated at Moffit Cancer Center during a similar time period • 10 patients t
Slide 15: Historical Comparisons: Alternate Therapies vs. Galinpepimut-S in AML CR1
INDICATION INTERVENTION MEDIAN AGE (Y) PATIENT NUMBERS 2 YR OS (%) > 60y CR1 1 Chemotherapy 67 471 30 >60y CR1 2 Bone Marrow Transplant 64 191 36 All ages CR1 3 Chemotherapy 54 6283 42 All ages CR1 4 Antibody-Drug Conjugate 57 132 53 All ages CR1 5 Galinpepimut-S 66 32 69 Galinpepimut-S <60 14 79 Ga
Slide 16: SELLAS Phase 3 Trial Discussed with the FDA
SELLAS PHASE 3 TRIAL DISCUSSED WITH THE FDA 16 Aspects of the study related to development and approval-related items such as study design, endpoints, statistical analysis plan, CMC were agreed upon with FDA PLANNED PHASE 3 DOUBLE-BLIND, PLACEBO-CONTROLLED MULTICENTER STUDY IN AML CR1 • N 390 evalua
Slide 17: Galinpepimut-S: Phase 2 Randomized Malignant Pleural Mesothelioma
•Controlled, randomized blinded Phase 2 study with galinpepimut-S after surgery and other treatment •Galinpepimut-S increased overall survival (OS) vs. control group •Median overall survival: 24.8 vs. 16.6 months (HR: 0.51) •Median overall survival for patients with complete (R0) resections: 39.3 vs
Slide 18: Galinpepimut-S: Phase 2 in Multiple Myeloma
18 GALINPEPIMUT-S: PHASE 2 IN MULTIPLE MYELOMA •Phase 1/2, open-label study of GPS in myeloma patients following stem cell transplant •Primary objective was to assess T-cell responses 12‒14 weeks after initial GPS administration •Secondary objectives included safety, WT1 expression on malignant plas
Slide 19: Additional SELLAS Development Programs
•Ovarian cancer trial: galinpepimut-S + nivolumab • Open-label, non-randomized Phase 1/2 trial • In patients with recurrent ovarian cancer who are in second or greater clinical remission following chemotherapy • Investigator-sponsored trial (galinpepimut-S + nivolumab) in a different cancer type exp
Slide 20: Scientific Advisors
20 NAME POSITION David Scheinberg, MD, PhD Chair, Experimental Therapeutics Center at Memorial Sloan Kettering Cancer Center (MSKCC) Jedd D. Wolchok, MD, PhD Chief, Melanoma & Immunotherapeutics Service at Memorial Sloan Kettering Cancer Center (MSKCC) Jeffrey Weber, MD, PhD Deputy Director of the P
Slide 21: Anticipated Milestones
21 PROGRAM MILESTONE PROJECTED DATE Galinpepimut-S Interim data from nivolumab combination trial in ovarian cancer Q4 2017 Galinpepimut-S Updated data from Phase 2 multiple myeloma trial Q4 2017 Galinpepimut-S Initiate CML Phase 2 randomized trial Q1 2018 Galinpepimut-S Initiate AML Phase 2 randomiz
Slide 22: o YELLAS
o YELLAS GALENA il wre sciENCES GROUP BIOPHARMA AUGUST 8, 2017
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