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LONDON, UK / ACCESSWIRE / March 24, 2017 / Active Wall St. blog coverage looks at the headline from Stemline Therapeutics, Inc. (NASDAQ: STML) as the Company announced on March 23, 2017, that enrolment of Stage 3 in the SL-401 pivotal trial in blastic plasmacytoid dendritic cell neoplasm (BPDCN) has been completed. The Company also reviewed key milestones for the SL-401 program over the coming year. Stemline is a clinical stage biopharmaceutical Company developing novel therapeutics for oncology indications of unmet medical need. Register with us now for your free membership and blog access at:
One of Stemline Therapeutics' competitors within the Biotechnology space, Jazz Pharmaceuticals PLC (NYSE: JAZZ), reported on February 28, 2017, its financial results for the full year and the fourth quarter of 2016 and provided financial guidance for 2017. AWS will be initiating a research report on Jazz Pharma in the coming days.
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Stage 3 Enrollment
Stemline has completed enrolment of the Stage 3 cohort of the SL-401 pivotal trial in BPDCN. The Company has enrolled 13 first-line BPDCN patients for the Stage III trials. The Company stated that the statistical analysis will be based on evaluable first-line patients. The registration pathway was as per its agreement with the U.S. Food and Drug Administration (FDA). Based on the data outcome of the trial, Stemline plans to use the results generated to support the potential filing of a Biologics License Application (BLA) for full approval in first-line BPDCN, and is targeting possible BLA filing in H2 2017.
For the Stage III multicenter, pivotal trial Stemline has enrolled 47 BPDCN patients at seven centers in the US. The 47 BPDCN patients were comprised of 32 first-line patients and 15 relapsed/refractory patients dosed at 12 ug/kg/day. Stemline plans to provide a clinical update on patients enrolled in Stages 1 and 2 at a medical conference around mid-year, with top-line data from Stage 3 expected in H2 2017. Stemline plans to continue to enroll both first-line and relapsed/refractory BPDCN patients under the current protocol. SL-401 received Breakthrough Therapy Designation (BTD) by the FDA in August 2016.
BLA Preparation and Pre-Commercial Activities
Stemline announced that its clinical, preclinical, manufacturing, and regulatory teams are working toward a timely and comprehensive potential BLA filing. Ongoing efforts include compiling the necessary supportive data and assembling the BLA modules, including clinical, clinical pharmacology, non-clinical, and CMC (chemistry, manufacturing, and controls). In parallel, the Company's commercial team is working to define the BPDCN market landscape, including factors related to patient flow, market access and pricing considerations, all with an eye toward setting the stage for a successful launch of SL-401, if approved.
Other Trial Updates
Stemline is performing additional Phase 2 trials with SL-401 and is enrolling patients with other malignancies including high-risk myeloproliferative neoplasms (MPN) and acute myeloid leukemia (AML) in remission with minimal residual disease (MRD). A Phase 1/2 trial of SL-401 in combination with pomalidomide is enrolling patients with relapsed/refractory multiple myeloma. The Company also has a Phase 1 dose escalation trial and is enrolling patients with advanced tumors with SL-801, a novel oral small molecule reversible inhibitor of XPO1. A Phase 2 trial with SL-701, an immunotherapy designed to activate the immune system to attack tumors has completed dosing and patients with second-line glioblastoma are being followed for survival.
On March 16, 2017, Stemline announced that for Q4 FY16 it had a net loss of $10.0 million, or $0.56 per share, compared with a net loss of $10.2 million, or $0.58 per share, for Q4 FY15. The Company's Research and development expenses were $7.3 million for Q4 FY16, which reflects a drop of 8%, compared with $7.9 million for Q4 FY15.
Stemline ended Q4 FY16 with $67.6 million in cash, cash equivalents, and investments compared to $74.3 million as of September 30, 2016, which reflects a cash burn of $6.7 million for the reported quarter. Subsequent to year end 2016, Stemline completed a follow-on public offering during January 2017 raising $48.2 million in net cash proceeds bringing total cash, cash equivalents, and investments to approximately $110.0 million as of March 16, 2017.
At the closing bell, on Thursday, March 23, 2017, Stemline Therapeutics' stock dropped 5.03%, ending the trading session at $8.50. A total volume of 365.52 thousand shares were traded at the end of the day. In the last month and previous twelve months, shares of the Company have surged 27.82% and 83.98%, respectively. At Thursday's closing price, the stock's net capitalization stands at $212.93 million.
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