NEW YORK, March 22, 2019 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) (“SELLAS” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, today reported financial results for the year ended December 31, 2018 and provided a business update.
“In February, we initiated a review of a wide range of strategic alternatives to maximize shareholder value, such as a sale of the Company, a merger, or a strategic investment or financing,” stated Dr. Angelos M. Stergiou, M.D., ScD h.c., President and Chief Executive Officer of SELLAS. “We are currently actively exploring these alternatives with the goal of identifying a plan that will enhance shareholder value while advancing our novel cancer immunotherapy clinical pipeline.”
2018 and Recent Business Highlights
Corporate Developments
Clinical Pipeline
Galinpepimut-S (GPS)
Nelipepimut-S (NPS)
Year End 2018 Financial Results
Cash Position: As of December 31, 2018, cash and cash equivalents were $5.3 million, compared to $2.3 million as of December 31, 2017. Net cash used in operating activities was $30.4 million for the year ended December 31, 2018, compared to $11.0 million for the year ended December 31, 2017. Net cash provided by financing activities was $23.1 million for the year ended December 31, 2018, primarily attributable to $31.5 million in net proceeds from the sale of equity securities, partially offset by $7.6 million in principal payments on previously outstanding debt. Net cash provided by financing activities for the year ended December 31, 2017 was $5.5 million, primarily attributable to $6 million in net proceeds from the sale of equity securities, partially offset by $0.5 million on previously outstanding long-term debt.
R&D Expenses: Research and development expenses were $8.8 million for the year ended December 31, 2018, as compared to $6.1 million for the year ended December 31, 2017. The $2.7 million increase was primarily due to increases in clinical and regulatory consulting and other clinical expenses related to startup costs for the Phase 1/2 basket trial of GPS in combination with pembrolizumab (Keytruda®) in multiple tumor types during 2018, and ongoing costs incurred related to the Phase 2b trial of NPS in combination with trastuzumab (Herceptin®). These increases were partially offset by decreases in compensation and benefits, including stock-based compensation, and manufacturing expenses.
G&A Expenses: General and administrative expenses were $12.8 million for the year ended December 31, 2018, as compared to $15.1 million for the year ended December 31, 2017. The $2.3 million decrease was primarily driven by a decrease in compensation and employee benefits, including stock-based compensation, and in banking and advisory fees partially offset by increases in outside services and public company costs, rebates and returns of former commercial products, and insurance premiums.
Net Loss: Net loss for the year ended December 31, 2018 was $27.7 million and loss attributable to common stockholders was $41.3 million, or a basic and diluted loss per share to common stockholders of $3.15, as compared to a net loss of $23.8 million and loss attributable to common stockholders of $24.4 million for the year ended December 31, 2017, or a basic and diluted loss per share to common stockholders of $10.44. Net loss and loss attributable to common stockholders for the year ended December 31, 2018 includes a $9.6 million one-time non-cash impairment charge of in-process research and development associated with the termination of a license agreement for anagrelide CR formulation (GALE-401).
Keytruda® and Herceptin® are registered trademarks of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA, and Genentech, Inc., respectively, and are not trademarks of SELLAS. The manufacturers of these brands are not affiliated with and do not endorse SELLAS or its products.
About SELLAS Life Sciences Group, Inc.
SELLAS is a clinical-stage biopharmaceutical company focused on novel cancer immunotherapeutics for a broad range of cancer indications. SELLAS’ lead product candidate, GPS, is licensed from Memorial Sloan Kettering Cancer Center and targets the Wilms Tumor 1 (WT1) protein, which is present in an array of tumor types. GPS has potential as a monotherapy or in combination to address a broad spectrum of hematologic malignancies and solid tumor indications. SELLAS has a Phase 3 clinical trial planned (pending funding availability) for GPS in AML and is also studying GPS in combination with pembrolizumab (Keytruda®) in multiple indications. SELLAS has received Orphan Drug designations for GPS from the FDA and the European Medicines Agency for AML, malignant pleural mesothelioma (MPM), and multiple myeloma (MM); GPS has also received Fast Track designation for AML, MPM and MM from the FDA. SELLAS’ second product candidate, NPS, is a HER2-directed cancer immunotherapy being investigated for the prevention of the recurrence of breast cancer after standard of care treatment in the adjuvant setting. NPS has received Fast Track status designation by FDA for the treatment of patients with early stage breast cancer with low to intermediate HER2 expression, otherwise known as HER2 1+ or 2+, which includes TNBC patients, following standard of care.
For more information on SELLAS, please visit www.sellaslifesciences.com.
Forward-Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, forward-looking statements can be identified by terminology such as “plan,” “expect,” “anticipate,” “may,” “might,” “will,” “should,” “project,” “believe,” “estimate,” “predict,” “potential,” “intend,” or “continue” and other words or terms of similar meaning. These statements include, without limitation, statements related to the Company’s plans to explore strategic alternatives, the potential outcome and benefits of a strategic transaction or a financing, the further development of GPS and NPS, including the timing of clinical results, the potential time to market for GPS and NPS, the potential results from a clinical trial and interactions with the U.S. Food and Drug Administration. These forward-looking statements are based on current plans, objectives, estimates, expectations and intentions, and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the Company’s ability to identify potential strategic and financial transactions and to complete any transactions it pursues, whether SELLAS will be able to realize the expected benefits from a strategic review or a strategic transaction, immune-oncology product development and clinical success thereof, the uncertainty of regulatory approval, the uncertainty of finding potential partners for product candidate development, and other risks and uncertainties affecting SELLAS and its development programs as set forth under the caption “Risk Factors” in SELLAS’ Annual Report on Form 10-K filed on March 22, 2019 and in its other SEC filings. Other risks and uncertainties of which SELLAS is not currently aware may also affect SELLAS’ forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof. SELLAS undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward-looking statements were made.
Investor Contact:
Will O’Connor
Stern Investor Relations, Inc.
212-362-1200
ir@sellaslife.com
Investor Relations
SELLAS Life Sciences Group, Inc.
917.438.4353
info@sellaslife.com