Stemline Therapeutics Reports First Quarter 2017 Financial Results
SL-401 In Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
- During the quarter, we announced completion of enrollment in the Stage 3 cohort of the Phase 2 trial. Stage 3 enrolled 13 patients, and statistical analysis will be conducted on evaluable first-line BPDCN patients.
- Depending on the data from the trial, we plan to use the results generated, along with other relevant data, to support the potential filing of a Biologics License Application (BLA) for approval in BPDCN. A possible BLA filing could begin in 4Q17 or 1Q18.
- To ensure ongoing patient access to SL-401, we are enrolling both first-line and relapsed/refractory BPDCN patients under the current protocol in a Stage 4 cohort.
- We plan to provide an update on Stage 1 and 2 patients mid-year at an upcoming hematology-focused medical conference and on Stage 3 patients in the second half of the year.
Additional Clinical Trials
- Clinical trials evaluating SL-401 are ongoing in additional indications including certain myeloproliferative neoplasms (MPN), acute myeloid leukemia (AML) in complete remission with minimal residual disease, and relapsed/refractory multiple myeloma, and we expect to provide updates on these studies later this year and into next year.
- SL-801 is being evaluated in a Phase 1 dose escalation trial of advanced solid tumor patients, and we recently opened the sixth dosing cohort. SL-701 has completed dosing in a Phase 2 trial in second-line glioblastoma. Updates from both of these studies are expected later this year and into next year.
First Quarter 2017 Financial Results Review
Stemline ended the first quarter of 2017 with
For the first quarter of 2017, Stemline had a net loss of
Research and development expenses were
General and administrative expenses were
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
|March 31, 2017
|December 31, 2016|
|Cash and cash equivalents||$||57,129,787||$||10,316,064|
|Prepaid expenses and other current assets||516,510||290,747|
|Total current assets||90,171,109||47,169,711|
|Furniture and fixtures, net||21,579||22,531|
|Liabilities and stockholders’ equity|
|Accounts payable and accrued expenses||$||12,535,261||$||9,284,514|
|Current portion of deferred revenue||598,798||898,199|
|Other current liabilities||71,100||71,100|
|Total current liabilities||13,205,159||10,253,813|
|Preferred stock $0.0001 par value, 5,000,000 shares authorized, none issued and outstanding at March 31, 2017 and December 31, 2016||—||—|
|Common stock $0.0001 par value, 33,750,000 shares authorized at March 31, 2017 and December 31, 2016, 25,096,214 shares issued and outstanding at March 31, 2017 and 19,219,223 shares issued and outstanding at December 31, 2016||2,510||1,922|
|Additional paid-in capital||244,319,102||193,563,572|
|Accumulated other comprehensive loss||(92,192||)||(99,802||)|
|Total stockholders’ equity||93,216,114||57,723,085|
|Total liabilities and stockholders’ equity||$||106,545,698||$||68,119,098|
|Three Months Ended March 31,|
|Research and development||9,620,324||6,532,730|
|General and administrative||5,367,775||2,866,122|
|Total operating expenses||14,988,099||9,398,852|
Loss from operations
|Net loss per common share:|
|Basic and Diluted||$||(0.67||)||$||(0.51||)|
|Weighted-average shares outstanding:
Basic and Diluted
Contact Investor Relations
Stemline Therapeutics, Inc. 750 Lexington AvenueEleventh Floor New York, NY10022 Tel: 646-502-2307 Email: email@example.com