On March 16, 2017 Stemline Therapeutics, Inc. (Nasdaq: STML), a clinical-stage biopharmaceutical company developing novel therapeutics for oncology indications of unmet medical need, reported financial results for the quarter ended December 31, 2016 (Filing, Q4/Annual, Stemline Therapeutics, 2016, MAR 17, 2017, View Source [SID1234518191]). The company also reviewed clinical and regulatory events from the past quarter, and outlined key upcoming milestones: Schedule your 30 min Free 1stOncology Demo!
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SL-401 In Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
· SL-401 Phase 2 clinical trial results in patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) delivered as an oral presentation at the 2016 American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting.
· After receipt of breakthrough therapy designation in 3Q16, Stemline had a successful meeting with the U.S. Food and Drug Administration (FDA) resulting in a defined registration pathway for possible full approval in first-line BPDCN.
· Stemline is currently enrolling patients in a new cohort (Stage 3) that is expected to enroll approximately 8-12 first-line BPDCN patients.
· Completion of enrollment of the Stage 3 cohort expected this quarter. We plan to provide clinical results from this cohort in the second half of this year.
Additional Clinical Trials
· SL-401 is being clinically evaluated in several additional indications including certain high-risk myeloproliferative neoplasms (MPN), acute myeloid leukemia (AML) in complete remission with minimal residual disease, and with relapsed/refractory multiple myeloma. SL-801 is being evaluated in a Phase 1 dose escalation trial of advanced solid tumor patients. SL-701 has completed dosing in a Phase 2 trial in second-line glioblastoma. Updates from these studies are expected this year.
Fourth Quarter 2016 Financial Results Review
Stemline ended the fourth quarter of 2016 with $67.6 million in cash, cash equivalents and investments, as compared to $74.3 million as of September 30, 2016, which reflects a cash burn of $6.7 million for the 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.
For the fourth quarter of 2016, Stemline 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 the same period in 2015.
Research and development expenses were $7.3 million for the fourth quarter of 2016, which reflects a decrease of $0.6 million, or 8%, compared with $7.9 million for the fourth quarter of 2015. The lower costs reflect a one-time payroll-related expense in 2015 partially offset by higher non-cash stock based compensation expense in 2016.
General and administrative expenses were $3.1 million for the fourth quarter of 2016, which reflects an increase of $0.5 million, or 19%, compared with $2.6 million for the fourth quarter of 2015. The increase in costs was primarily attributable to higher non-cash stock based compensation expense and the commencement of building infrastructure to support a potential commercial launch of SL-401 for BPDCN.