Stemline Therapeutics Reports Second Quarter 2017 Financial Results

August 8, 2017 at 7:00 AM EDT

NEW YORK, Aug. 08, 2017 (GLOBE NEWSWIRE) -- Stemline Therapeutics, Inc. (Nasdaq:STML), a clinical-stage biopharmaceutical company developing novel therapeutics for difficult to treat cancers, announced today financial results for the quarter ended June 30, 2017. The Company also reviewed recent clinical and regulatory events, and outlined key upcoming milestones:

SL-401 In Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

  • The SL-401 pivotal Phase 2 trial enrolled 45 BPDCN patients in Stages 1, 2 and 3. Stage 3 was prospectively designed to support potential registration.

  • During the quarter, we presented updated data from Stages 1 and 2 of the Phase 2 trial at the 22ndCongress of the European Hematology Association (EHA) in Madrid, Spain.

  • Analysis of Phase 2 data, inclusive of Stage 3, is ongoing and we remain on track to announce top-line results in 2H17. We are also targeting a medical conference to present more detailed results later this year.

  • To ensure ongoing patient access to SL-401, we are enrolling both first-line and relapsed/refractory BPDCN patients in an additional cohort.

  • Depending on the data from the trial, we plan to use the results generated, along with other relevant data, to support the filing of a Biologics License Application (BLA) for approval in BPDCN. We continue to anticipate a possible BLA filing could begin in 4Q17 or 1Q18.

Additional Clinical Trials 

  • Clinical trials evaluating SL-401 are ongoing in additional indications including certain myeloproliferative neoplasms (MPN), acute myeloid leukemia (AML), and multiple myeloma, as a single agent or in combination with other agents. We expect to provide updates on these studies later this year and into next year.

  • SL-801, a novel XPO1 inhibitor, is being evaluated in a Phase 1 trial of patients with advanced solid tumors. SL-701 has completed dosing in a Phase 2 trial of patients with second-line glioblastoma. We are targeting medical conferences for updates on both of these studies later this year.

Second Quarter 2017 Financial Results Review
Stemline ended the second quarter of 2017 with $93.2 million in cash, cash equivalents and investments, as compared to $105.8 million as of March 31, 2017, which reflects a use of cash of $12.6 million for the quarter. The company ended the second quarter of 2017 with 25.2 million shares outstanding.

For the second quarter of 2017, Stemline had a net loss of $15.5 million, or $0.66 per share, compared with a net loss of $9.3 million, or $0.52 per share, for the same period in 2016.

Research and development expenses were $11.5 million for the second quarter of 2017, which reflects an increase of $4.6 million, or 67%, compared with $6.9 million for the second quarter of 2016. The higher costs are primarily driven by an increase of $2.1 million in manufacturing expenses to support our potential BLA filing for SL-401. We also incurred $1.2 million in higher costs for regulatory support of our potential BLA filing for SL-401. Additionally, we incurred higher compensation expense as a result of increased headcount.

General and administrative expenses were $4.5 million for the second quarter of 2017, which reflects an increase of $1.6 million, or 57%, compared with $2.9 million for the second quarter of 2016. The increase in expense was primarily attributable to $0.7 million in pre-launch expenses in support of a potential commercialization of SL-401 in BPDCN, if marketing approval from the FDA is granted. The increase in costs was also driven by $0.4 million in higher legal expense as a result of the class action lawsuit, as well as a $0.3 million increase in non-cash stock-based compensation expense.

About Stemline Therapeutics
Stemline Therapeutics, Inc. is a clinical stage biopharmaceutical company developing novel therapeutics for difficult to treat cancers. SL-401 is a targeted therapy directed to the interleukin-3 receptor (CD123), a cell surface receptor overexpressed on BPDCN and a variety of other hematologic cancers. SL-401 was granted Breakthrough Therapy Designation (BTD) for the treatment of patients with BPDCN. A pivotal Phase 2 trial with SL-401 in BPDCN has completed enrollment in Stages 1, 2 and 3 of the trial; to ensure ongoing patient access to SL-401, an additional cohort, Stage 4, is enrolling. Additional Phase 1/2 trials are assessing SL-401 in patients with other malignancies including myeloproliferative neoplasms (MPN) (focused on chronic myelomonocytic leukemia [CMML] and myelofibrosis [MF]), acute myeloid leukemia (AML), and multiple myeloma, as a single agent or in combination with other agents. SL-801, a novel oral small molecule reversible inhibitor of XPO1, is enrolling patients with advanced solid tumors in a Phase 1 trial. SL-701, an immunotherapeutic, has completed dosing of patients with second-line glioblastoma in a Phase 2 trial and patients are being followed for outcomes including survival.

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, institutional review board approval, scientific review committee approval, patient accrual, safety, tolerability and efficacy data observed, and input from regulatory authorities including the risk that the FDA or other ex-U.S. national drug authority ultimately does not approve any of our product candidates; our plans to develop and commercialize our product candidates; market acceptance of our products; reimbursement available for our products; 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

      June 30, 2017
    December 31, 2016  
Current assets:              
Cash and cash equivalents     $ 8,549,890     $ 10,316,064  
Short-term investments     55,536,100     36,562,900  
Prepaid expenses and other current assets     471,880     290,747  
Total current assets     64,557,870     47,169,711  
Furniture and fixtures, net     45,773     22,531  
Long-term investments     29,157,603     20,714,551  
Other Assets     212,305     212,305  
Total assets     $ 93,973,551     $ 68,119,098  

Liabilities and stockholders’ equity
Current liabilities:              
Accounts payable and accrued expenses     $ 13,523,018     $ 9,284,514  
Current portion of deferred grant revenue       299,397       898,199  
Other current liabilities       71,100       71,100  
Total current liabilities     13,893,515     10,253,813  
Other liabilities     106,650     142,200  
Total liabilities     14,000,165     10,396,013  
Stockholders’ equity:              
Preferred stock $0.0001 par value, 5,000,000 shares authorized, none issued and outstanding at June 30, 2017 and December 31, 2016          
Common stock $0.0001 par value, 53,750,000 shares authorized at June 30, 2017 and 33,750,000 shares authorized at December 31, 2016. 25,180,024 shares issued and outstanding at June 30, 2017 and 19,219,223 shares issued and outstanding at December 31, 2016     2,518     1,922  
Additional paid-in capital     246,562,007     193,563,572  
Accumulated other comprehensive loss     (120,897 )   (99,802 )
Accumulated deficit     (166,470,242 )   (135,742,607 )
Total stockholders’ equity     79,973,386     57,723,085  
Total liabilities and stockholders’ equity     $ 93,973,551     $ 68,119,098  

Table 2. Stemline Therapeutics, Inc. - Statements of Operations (Unaudited)

  Three Months Ended June 30,       Six Months Ended June 30,  
    2017         2016         2017         2016  
Grant revenue $ 299,401       $ 236,901       $ 598,802       $ 442,552  

Operating expenses:
Research and development   11,479,030         6,875,970         21,099,354         13,408,700  
General and administrative   4,480,630         2,860,639         9,848,406         5,726,761  
Total operating expenses   15,959,660         9,736,609         30,947,760         19,135,461  
Loss from operations   (15,660,259 )       (9,499,708 )       (30,348,958 )       (18,692,909 )
Other income           10,359                 10,359  
Interest income   203,323         140,450         326,012         285,107  
Net loss before income taxes   (15,456,936 )       (9,348,899 )       (30,022,946 )       (18,397,443 )
Income tax benefit           26,756                 26,756  

Net loss
$ (15,456,936 )     $ (9,322,143 )     $ (30,022,946 )     $ (18,370,687 )
Net loss per common share:                            
Basic and Diluted $ (0.66 )     $ (0.52 )     $ (1.33 )     $ (1.03 )
Weighted-average shares outstanding:


Basic and Diluted
  23,412,409         17,785,406         22,615,909         17,750,709  

Investor Relations
Stemline Therapeutics, Inc.750 Lexington Avenue
Eleventh Floor
New York, NY 10022
Tel: 646-502-2307

Primary Logo

Stemline Therapeutics