Stemline Therapeutics Reports Third Quarter 2017 Financial Results
Pivotal Trial of SL-401 In Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
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 9-12in Atlanta, GA.
Additional Clinical Trials – SL-401, SL-801, SL-701
- 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.
Third Quarter 2017 Financial Results Review
Stemline ended the third quarter of 2017 with
For the third quarter of 2017, Stemline had a net loss of
Research and development expense was
General and administrative expense was
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
|September 30, 2017
|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 $0.0001 par value, 53,750,000 shares authorized at
September 30, 2017 and 33,750,000 shares authorized at December 31,
2016. 25,271,907 shares issued and outstanding at September 30, 2017
and 19,219,223 shares issued and outstanding at December 31, 2016
|Additional paid-in capital||248,855,696||193,563,572|
|Accumulated other comprehensive loss||(87,683||)||(99,802||)|
|Total stockholders’ equity||66,244,151||57,723,085|
|Total liabilities and stockholders’ equity||$||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|
Source: Stemline Therapeutics, Inc.