On November 9, 2017 Stemline Therapeutics, Inc. (Nasdaq: STML), a clinical-stage biopharmaceutical company developing novel therapeutics for difficult to treat cancers, reported financial results for the quarter ended September 30, 2017 (Press release, Stemline Therapeutics, NOV 9, 2017, View Source [SID1234521904]). The Company also reviewed recent clinical and regulatory events, and outlined key upcoming milestones:
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Pivotal Trial of SL-401 In Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
· 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) (Free ASH Whitepaper) Annual Meeting, being held December 9-12 in 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 (Free ASH Whitepaper) 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) (Free ESMO Whitepaper) 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 $79.9 million in cash, cash equivalents and investments, as compared to $93.2 million as of June 30, 2017, which reflects cash expenditures of $13.3 million for the quarter. The company ended the third quarter of 2017 with 25.3 million shares outstanding.
For the third quarter of 2017, Stemline had a net loss of $16.1 million, or $0.68 per share, compared with a net loss of $9.9 million, or $0.56 per share, for the same period in 2016.
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.