NEW YORK, March 14, 2016 (GLOBE NEWSWIRE) -- Stemline Therapeutics, Inc. (Nasdaq:STML) today reported financial results for the quarter ended December 31, 2015.
Ivan Bergstein, M.D., Stemline’s Chief Executive Officer, commented, “During the fourth quarter, we made significant progress across all three of our development programs. Key achievements included 1) generating and presenting data from our ongoing Phase 2 trial of SL-401 in blastic plasmacytoid dendritic cell neoplasm (BPDCN) which we have designed to support potential registration, 2) treating our first patient in the second stage of our Phase 2 program of SL-701 in advanced brain cancer, and 3) the opening of our IND for SL-801 on schedule. At the American Society of Hematology (ASH) meeting in December, we presented very strong data from our ongoing SL-401 trial in BPDCN, demonstrating a high overall response rate in BPDCN, with multiple complete responses. We are also very pleased with the pace of enrollment in BPDCN, and note that we are tracking in-line with our expectations. We look forward to sharing key clinical and regulatory updates on SL-401 throughout this year.”
Dr. Bergstein continued, “We continue to evaluate SL-401 in several additional malignancies that overexpress IL-3R. Specifically, we have single agent trials enrolling AML patients with minimal residual disease and patients with advanced high-risk myeloproliferative neoplasms. We also expect our first clinical studies that combine SL-401 with other therapies will begin this year.”
Dr. Bergstein concluded, “Our other pipeline candidates, SL-701 and SL-801, continue to advance. Our SL-701 trial is currently enrolling patients and we expect updates from this program in the second half of the year. The SL-801 IND is open, and we are on track to treat our first patient this quarter. With our strong cash position, we believe we have sufficient financial resources to achieve significant clinical and regulatory milestones this year and beyond.”
Fourth Quarter 2015 Financial Results Review
Stemline ended the fourth quarter of 2015 with $97.5 million in cash, cash equivalents and investments, as compared to $104.0 million as of September 30, 2015, which reflects a cash burn of $6.5 million for the quarter. The company ended the fourth quarter of 2015 with 18.2 million shares outstanding.
For the fourth quarter of 2015, Stemline had a net loss of $10.2 million, or $0.58 per share, compared with a net loss of $6.9 million, or $0.53 per share, for the same period in 2014. The net loss for full year 2015 was $37.2 million, or $2.15 per share, as compared with a net loss of $28.8 million, or $2.23 per share, in the prior year.
Research and development expenses were $7.9 million for the fourth quarter of 2015, which reflects an increase of $2.8 million, or 56%, compared with $5.1 million for the fourth quarter of 2014. The increase in expenses during the current quarter was primarily attributable to the ramp up in our clinical trial activities for SL-401 and SL-801.
General and administrative expenses were $2.6 million for the fourth quarter of 2015, which reflects an increase of $0.6 million, or 30%, compared with $2.0 million for the fourth quarter of 2014. The increase in expenses during the current quarter was primarily attributable to an increase in compensation expense relating to administrative employees.
About Stemline Therapeutics
Stemline Therapeutics, Inc. is a clinical stage biopharmaceutical company developing novel oncology therapeutics. Stemline is developing three product candidates, SL-401, SL-701, and SL-801. A potentially pivotal Phase 2 trial with SL-401 is currently enrolling patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). Data from the initial stage of this ongoing trial demonstrated high overall response rates, with multiple complete responses (CRs) and patients bridged to transplant. Patients continue to be followed for overall response, progression free survival (PFS) and overall survival (OS), and new patients are also enrolling into the study. Clinical studies with SL-401 are also enrolling patients with additional malignancies including acute myeloid leukemia (AML) in CR with minimal residual disease (MRD) and high-risk myeloproliferative neoplasms (MPN). A clinical study with SL-701, an immunotherapy designed to activate the immune system to attack tumors, is currently enrolling adult patients with second-line glioblastoma multiforme (GBM). SL-801, a novel oral small molecule reversible inhibitor of XPO1, has an open IND and is being advanced into clinical trials in patients with advanced solid cancers. For more information about Stemline Therapeutics, visit www.stemline.com.
Forward-Looking Statements
Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The factors that could cause our actual results to differ materially include: the success and timing of our clinical trials and preclinical studies for our product candidates, including site initiation, internal review board approval, scientific review committee approval, patient accrual, safety, tolerability and efficacy data observed, and input from regulatory authorities; our plans to develop and commercialize our product candidates; our available cash and investments; our ability to obtain and maintain intellectual property protection for our product candidates; our ability to manufacture; the performance of third-party manufacturers, clinical research organizations, clinical trial sponsors and clinical trial investigators; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not intend to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.
Table 1. Stemline Therapeutics, Inc. - Balance Sheets
| December 31, 2015 | December 31, 2014 | ||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 13,376,196 | $ | 25,007,217 | |||
| Short-term investments | 32,663,245 | 28,976,147 | |||||
| Prepaid expenses and other current assets | 651,889 | 1,636,808 | |||||
| Total current assets | 46,691,330 | 55,620,172 | |||||
| Furniture and fixtures, net | 95,661 | 230,000 | |||||
| Long-term investments | 51,428,632 | 4,644,820 | |||||
| Total assets | $ | 98,215,623 | $ | 60,494,992 | |||
| Liabilities and stockholders’ equity | |||||||
| Current liabilities: | |||||||
| Accounts payable and accrued expenses | $ | 9,455,477 | $ | 4,473,842 | |||
| Total current liabilities | 9,455,477 | 4,473,842 | |||||
| Deferred grant revenue | 616,949 | 607,999 | |||||
| Other liabilities | 31,241 | — | |||||
| Total liabilities | 10,103,667 | 5,081,841 | |||||
| Stockholders’ equity: | |||||||
| Preferred stock $0.0001 par value, 5,000,000 shares authorized, none issued and outstanding at December 31, 2015 and 2014 | — | — | |||||
| Common stock $0.0001 par value, 33,750,000 shares authorized at December 31, 2015 and 2014, 18,235,020 shares issued and outstanding at December 31, 2015 and 13,285,232 shares issued and outstanding at December 31, 2014 | 1,825 | 1,329 | |||||
| Additional paid-in capital | 185,703,423 | 115,604,563 | |||||
| Accumulated other comprehensive income (loss) | (153,690 | ) | 3,000 | ||||
| Accumulated deficit | (97,439,602 | ) | (60,195,741 | ) | |||
| Total stockholders’ equity | 88,111,956 | 55,413,151 | |||||
| Total liabilities and stockholders’ equity | $ | 98,215,623 | $ | 60,494,992 | |||
Table 2. Stemline Therapeutics, Inc. - Statements of Operations
| Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||||||||||||||
| 2015 | 2014 | 2015 | 2014 | |||||||||||||||||
| Revenues: | ||||||||||||||||||||
| Grant revenue | $ | 205,651 | $ | 121,429 | $ | 654,160 | $ | 335,287 | ||||||||||||
| Operating expenses: | ||||||||||||||||||||
| Research and development | 7,882,933 | 5,053,862 | 29,458,676 | 21,240,599 | ||||||||||||||||
| General and administrative | 2,631,148 | 2,030,044 | 8,828,843 | 8,084,580 | ||||||||||||||||
| Total operating expenses | 10,514,081 | 7,083,906 | 38,287,519 | 29,325,179 | ||||||||||||||||
| Loss from operations | (10,308,430 | ) | (6,962,477 | ) | (37,633,359 | ) | (28,989,892 | ) | ||||||||||||
| Other income | — | 164 | 1,609 | 3,607 | ||||||||||||||||
| Interest income | 128,824 | 30,119 | 387,889 | 156,310 | ||||||||||||||||
| Net loss | $ | (10,179,606 | ) | $ | (6,932,194 | ) | $ | (37,243,861 | ) | $ | (28,829,975 | ) | ||||||||
| Net loss per common share: | ||||||||||||||||||||
| Basic and Diluted | $ | (0.58 | ) | $ | (0.53 | ) | $ | (2.15 | ) | $ | (2.23 | ) | ||||||||
| Weighted-average shares outstanding: | ||||||||||||||||||||
| Basic and Diluted | 17,562,559 | 12,980,135 | 17,289,021 | 12,936,741 | ||||||||||||||||