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Share Name | Share Symbol | Market | Type |
---|---|---|---|
SELLAS Life Sciences Group Inc | NASDAQ:SLS | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-0.03 | -2.22% | 1.32 | 0.80 | 1.33 | 1.37 | 1.29 | 1.36 | 786,873 | 05:00:11 |
“In recent months, we have made clinical advancements across our pipeline of novel cancer peptide vaccines, particularly with our program for galinpepimut-S (GPS) in combination with anti-PD-1 therapies where we believe these treatments may be synergistic, ,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “As we look forward, we anticipate the following key milestones during the remainder of the year: (i) initiation of our Phase 3 registrational study of GPS in patients with acute myeloid leukemia (AML), (ii) first patient dosed in the investigator-sponsored study of GPS in combination with nivolumab in patients with malignant pleural mesothelioma (MPM), and (iii) initial clinical data from our Phase 2 trial of nelipepimut-S (NPS) in ductal carcinoma in situ (DCIS). Additionally, in the first quarter of 2020, initial clinical data is expected from our Phase 1/2 basket study of GPS in combination with KEYTRUDA® (pembrolizumab).”
Dr. Stergiou added, “Importantly, with our recent follow-on offering, we strengthened our balance sheet in order to support our clinical development programs through what we believe will be value-creating inflection points. We look forward to hosting our first R&D Investor Day in November where we will present our GPS immunotherapy programs in greater detail, particularly the Phase 3 AML study, and key opinion leaders will discuss the current treatments of solid tumors and hematologic malignancies and the potential role of GPS in treating these devastating diseases.”
Recent Pipeline Highlights
Recent Corporate Highlights
R&D Investor Day Scheduled
The Company will host its first R&D Investor Day in New York, NY on Friday, November 15, 2019. The agenda includes updates regarding the GPS Phase 3 AML clinical trial and Phase 1/2 basket study in combination with pembrolizumab, and scientific discussions from key opinion leaders in cancer immunotherapeutics, including Dr. Hagop M. Kantarjian, MD, Professor and Chair of the Department of Leukemia at the University of Texas MD Anderson Cancer Center, and principal investigator of the Phase 3 AML clinical trial.
Second Quarter 2019 Financial Results
Cash Position: As of June 30, 2019, cash and cash equivalents totaled approximately $12.8 million, which includes the net proceeds of approximately $13.4 million from the Company’s underwritten public offering of shares of common stock and pre-funded warrants and accompanying common stock warrants to purchase shares of common stock consummated in June 2019.
R&D Expenses: Research and development expenses were $1.4 million for the second quarter of 2019, as compared to $1.6 million for the second quarter of 2018. The $0.2 million decrease was primarily attributable to a $0.5 million decrease in personnel related expenses due to reduced headcount and a $0.3 million decrease in outsourced clinical and regulatory consulting services. These decreases were partially offset by a $0.5 million increase in clinical trial expenses related to the Company’s ongoing basket trial of GPS in combination with pembrolizumab and a $0.1 million increase in licensing fees. Research and development expenses for the six months ended June 30, 2019 were $3.2 million, as compared to $3.4 million for the same period in 2018. The decrease of $0.2 million was primarily attributable to a $0.8 million decrease in personnel related expenses resulting from reduced headcount, partially offset by a $0.3 million increase in clinical trial expenses for the GPS basket trial and an increase of $0.3 million in licensing fees.
G&A Expense: General and administrative expenses were $2.6 million for the second quarter of 2019, as compared to $4.9 million for the second quarter of 2018. The $2.3 million decrease was primarily due to a $1.3 million decrease in legal fees, a $0.4 million decrease in public company costs, a $0.3 million decrease in personnel related expenses due to reduced headcount and a $0.3 million decrease in other expenses. General and administrative expenses for the first half of 2019 were $5.1 million, as compared to $8.8 million for the six months ended June 30, 2018. The $3.7 million decrease during the period was primarily related to a $1.8 million decrease in legal fees, a $0.5 million decrease in public company costs, a $0.4 million decrease in accounting and audit fees, a $0.3 million decrease in personnel related expenses due to reduced headcount, a $0.3 million decrease in outsourced consulting fees and a $0.4 million decrease in other expenses.
Net Loss: Net loss attributable to common stockholders was $4.1 million for the second quarter of 2019, or a basic and diluted loss per share attributable to common stockholders of $0.13, as compared to a net loss attributable to common stockholders of $8.5 million for the second quarter of 2018, or a basic and diluted loss per share attributable to common stockholders of $1.26. Net loss attributable to common stockholders was $9.1 million for the six months ended June 30, 2019, or a basic and diluted loss per share attributable to common stockholders of $0.33, as compared to a net loss attributable to common stockholders of $18.5 million for the six months ended June 30, 2018, or a basic and diluted loss per share attributable to common stockholders of $2.89.
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 WT1 protein, which is present in an array of tumor types. 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.
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 for further development of GPS and NPS, including the timing of clinical results. 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 immune-oncology product development and clinical success thereof, the uncertainty of regulatory approval, 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 Contacts:Will O’ConnorStern Investor Relations, Inc.212-362-1200ir@sellaslife.com
Investors RelationsSELLAS Life Sciences Group, Inc. 917.438.4353info@sellaslife.com
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