On August 13, 2020 SELLAS Life Sciences Group, Inc. (Nasdaq:SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, reported financial results for the quarter ended June 30, 2020 (Press release, Sellas Life Sciences, AUG 13, 2020, View Source [SID1234563598]).
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"We are pleased that our ongoing studies for galinpepimut-S (GPS) – our Phase 3 REGAL study in patients with acute myeloid leukemia (AML) who have achieved complete remission after second-line anti-leukemic therapy (CR2), our Phase 1/2 basket study of GPS in combination with Merck’s pembrolizumab (KEYTRUDA), and the Phase 1 investigator-sponsored clinical trial (IST) of GPS in combination with Bristol-Myers Squibb’s anti-PD-1 therapy, nivolumab (Opdivo), in patients with malignant pleural mesothelioma (MPM) – are all proceeding on track despite these challenging times," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "During the second quarter of 2020, we established the independent Data Monitoring Committee (DMC) for the REGAL study comprised of esteemed members of the medical, scientific and biostatistical communities as well as a Steering Committee for the study."
Dr. Stergiou added, "We are also pleased to have strengthened our balance sheet with the closing of our private placement financing in early August, as the proceeds will be used to continue to progress our GPS program."
Second Quarter 2020 Pipeline Highlights
Galinpepimut-S (GPS) Program
In May 2020, SELLAS announced the formation of the Independent Data Monitoring Committee (DMC) for its pivotal Phase 3 REGAL clinical trial in AML CR2 patients. The DMC, comprised of an independent group of medical, scientific and biostatistics experts, is responsible for reviewing and evaluating patient safety and efficacy data for the REGAL study. The DMC currently consists of four members: Moshe Talpaz, M.D., Associate Director of Translational Research and Associate Chief of the Division of Hematology/Oncology at the University of Michigan Comprehensive Cancer Center and Chair of the DMC; Thomas Fleming, Ph.D., Professor and former department chair of the University of Washington Department of Biostatistics, Member of the Fred Hutchinson Cancer Research Center, former Director of the Statistical Center for HIV/AIDS Prevention Trial Network, NIAID, Special Government Employee for the FDA, and for more than 25 years, a regular member of several FDA Advisory Committees; Miguel-Angel Perales, M.D., Chief, Adult Bone Marrow Transplant Service at Memorial Sloan Kettering Cancer Center (MSKCC); and Stephane de Botton, M.D., Head of the Hematology Department at the Gustave Roussy Cancer Campus in Paris, France.
In April 2020, the Company announced the formation of the Steering Committee for the REGAL study. The Steering Committee currently consists of three members: Dr. Hagop Kantarjian, MD, Professor and Chair of the Department of Leukemia at The University of Texas MD Anderson Cancer Center, and Principal Investigator at MD Anderson for the REGAL study and Chair of the REGAL Steering Committee; Dr. Javier Pinilla-Ibarz, MD, PhD, Director of Immunotherapy for Malignant Hematology at the H. Lee Moffitt Cancer Center and member of the SELLAS Scientific Advisory Board; and Dr. Moshe Yair Levy, MD, Director of Hematologic Malignancies at the Texas Oncology – Baylor Charles A. Sammons Cancer Center.
Initial data readout from the MPM IST is expected by the end of 2020; initial data from the Phase 1/2 basket study is expected in the first half of 2021; and the planned interim safety and futility analysis in the REGAL study is expected to occur by the end of 2021.
Recent Corporate Highlights
In July 2020, SELLAS announced a private placement priced at-the-market of 2,744,078 shares of its common stock and accompanying warrants to purchase an aggregate of up to 2,744,078 shares of common stock, at a combined purchase price of $3.335 per share and accompanying warrant, to certain institutional and accredited investors, with gross proceeds to the Company of approximately $9.2 million before deducting the placement agent fee and related offering expenses.
Second Quarter 2020 Financial Results
R&D Expenses: Research and development expenses were $2.3 million for the second quarter of 2020, as compared to $1.4 million for the second quarter of 2019. Research and development expenses for the first half of 2020 were $4.1 million, as compared to $3.2 million for the same period in 2019. The increases in research and development expenses during the second quarter and first half of 2020 compared to the same periods in 2019 were primarily due to clinical trial expenses incurred for the REGAL study commencing in 2020.
G&A Expense: General and administrative expenses were $2.0 million for the second quarter of 2020, as compared to $2.6 million for the second quarter of 2019. General and administrative expenses for the first half of 2020 were $4.2 million, as compared to $5.1 million for the same period in 2019. The decreases during the second quarter and first half of 2020 compared to the same periods in 2019 were primarily due a reduction in legal fees and personnel related expenses.
Net Loss: Net loss attributable to common stockholders was $4.4 million for the second quarter of 2020, or a basic and diluted loss per share attributable to common stockholders of $0.66, as compared to a net loss attributable to common stockholders of $4.1 million for the second quarter of 2019, or a basic and diluted loss per share attributable to common stockholders of $6.33. Net loss attributable to common stockholders was $8.6 million for the first half of 2020, or a basic and diluted loss per share attributable to common stockholders of $1.32, as compared to a net loss attributable to common stockholders of $9.1 million for the first half of 2019, or a basic and diluted loss per share attributable to common stockholders of $16.56.
Cash Position: As of June 30, 2020, cash and cash equivalents totaled approximately $3.3 million. Following the end of the quarter, on August 4, 2020, the Company received gross proceeds of approximately $9.2 million from the Company’s sale, through a private placement priced at-the-market, of shares of common stock and accompanying common stock warrants to purchase shares of common stock.