- On October 31, 2017, we announced that the pivotal trial of SL-401 in blastic plasmacytoid dendritic cell neoplasm (BPDCN) met its primary endpoint.
- We anticipate that a Biologics License Application (BLA) submission could begin in the fourth quarter of 2017 or first quarter of 2018.
- We plan to have detailed data on this trial presented at the upcoming 2017 American Society of Hematology (ASH) Annual Meeting, being held December 9-12 in Atlanta, GA.
- SL-401 is also being evaluated in ongoing Phase 1/2 trials in additional indications including certain myeloproliferative neoplasms (MPN) (chronic myelomonocytic leukemia [CMML] and myelofibrosis [MF]), acute myeloid leukemia (AML), and multiple myeloma, as a single agent or in combination with other agents. We expect to provide updates on some of these studies at ASH and on into next year.
- SL-801 Phase 1 results in patients with advanced solid tumors were the subject of a presentation at the European Society of Medical Oncology (ESMO) Annual Congress in September. Dose escalation is ongoing, and the trial is currently enrolling patients in the eighth dosing cohort.
- SL-701 has completed dosing in a Phase 2 trial of patients with second-line glioblastoma. We plan to provide an update on the trial at the upcoming Society for Neuro-Oncology (SNO) meeting in November.
Research and development expense was $12.4 million for the quarter ended September 30, 2017, compared with $7.2 million for the quarter ended September 30, 2016, representing an increase of $5.2 million. The higher costs are primarily driven by an increase of $2.4 million in manufacturing expenses to support our upcoming potential BLA filing for SL-401. We also incurred $2.1 million in higher regulatory costs to support our potential BLA filing for SL-401.General and administrative expense was $4.2 million for the quarter ended September 30, 2017, compared with $3.2 million for the quarter ended September 30, 2016, representing an increase of $1.0 million. The increase in expense was primarily attributable to $0.6 million in higher legal expenses. Additionally, the higher costs were due to $0.2 million of pre-launch expenses in support of a potential commercialization of SL-401 in BPDCN, if marketing approval from the FDA is received. About Stemline Therapeutics Stemline Therapeutics, Inc. is a clinical stage biopharmaceutical company developing novel therapeutics for difficult to treat cancers. Stemline is developing three clinical stage product candidates: SL-401, SL-801, and SL-701. SL-401 is a targeted therapy directed to the interleukin-3 receptor (CD123), a cell surface receptor expressed on a variety of malignancies including blastic plasmacytoid dendritic cell neoplasm (BPDCN), a highly aggressive, lethal malignancy of unmet medical need, with no approved therapies. SL-401 was granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of patients with BPDCN. A pivotal Phase 2 trial with SL-401 in BPDCN has completed enrollment. An additional cohort is currently enrolling BPDCN patients to ensure continued access to SL-401. Additional Phase 1/2 trials with SL-401, including as a single agent or in combination with other agents, are ongoing 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. A Phase 1 trial of SL-801, a novel oral small molecule reversible XPO1 inhibitor, is enrolling patients with advanced solid tumors. Results presented at the European Society of Medical Oncology (ESMO) Annual Congress in September 2017 included dose escalation data of SL-801 through 6 dosing cohorts without dose limiting toxicity. The ideal therapeutic dose of SL-801 has not yet been determined and dose escalation/schedule optimization continues. A Phase 2 trial of SL-701, an immunotherapeutic, has completed dosing of patients with second-line glioblastoma and patients are being followed for outcomes including survival. Forward-Looking StatementsSome 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 agree with our data, find our data supportive of approval, or 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. ContactInvestor RelationsStemline Therapeutics, Inc.750 Lexington AvenueEleventh FloorNew York, NY 10022Tel: 646-502-2307Email: firstname.lastname@example.org
Table 1. Stemline Therapeutics, Inc. - Balance Sheets
|September 30, 2017 (Unaudited)||December 31, 2016|
|Cash and cash equivalents||$||10,265,356||$||10,316,064|
|Prepaid expenses and other current assets||598,356||290,747|
|Total current assets||66,123,635||47,169,711|
|Property and equipment, net||145,968||22,531|
|Liabilities and stockholders' equity|
|Accounts payable and accrued expenses||$||14,368,329||$||9,284,514|
|Current portion of deferred grant revenue||—||898,199|
|Other current liabilities||96,827||71,100|
|Total current liabilities||14,465,156||10,253,813|
|Preferred stock $0.0001 par value, 5,000,000 shares authorized, none issued and outstanding at September 30, 2017 and December 31, 2016||—||—|
|Common stock $0.0001 par value, 53,750,000 shares authorized at September 30, 2017 and 33,750,000 shares authorized at December 31, 2016. 25,271,907 shares issued and outstanding at September 30, 2017 and 19,219,223 shares issued and outstanding at December 31, 2016||2,527||1,922|
|Additional paid-in capital||248,855,696||193,563,572|
|Accumulated other comprehensive loss||(87,683||)||(99,802||)|
|Total stockholders' equity||66,244,151||57,723,085|
|Total liabilities and stockholders' equity||$||80,830,340||$||68,119,098|
|Three Months Ended September 30,||Nine Months Ended September 30,|
|Research and development||12,417,652||7,176,960||33,517,006||20,585,659|
|General and administrative||4,152,449||3,187,869||14,000,854||8,914,630|
|Total operating expenses||16,570,101||10,364,829||47,517,860||29,500,289|
|Loss from operations||(16,270,704||)||(10,065,428||)||(46,619,661||)||(28,758,336||)|
|Net loss before income taxes||(16,056,147||)||(9,932,044||)||(46,079,093||)||(28,329,487||)|
|Income tax benefit||—||8,822||—||35,578|
|Net loss per common share:|
|Basic and Diluted||$||(0.68||)||$||(0.56||)||$||(2.01||)||$||(1.59||)|
|Weighted-average shares outstanding:|
|Basic and Diluted||23,464,505||17,831,022||22,901,883||17,777,675|