On May 10, 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 March 31, 2017 (Press release, Stemline Therapeutics, MAY 10, 2017, View Source [SID1234519066]). The company also reviewed clinical and regulatory events from the past quarter, and outlined key upcoming milestones:
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 $105.8 million in cash, cash equivalents and investments, as compared to $67.6 million as of December 31, 2016, which reflects a cash increase of $38.2 million for the quarter. The $38.2 million increase in cash represents the $48.2 million in net cash proceeds received from the company’s follow-on public offering during January 2017 offset by a $10.0 million cash burn for operating activities during the first quarter 2017. The company ended the first quarter of 2017 with 25.1 million shares outstanding.
For the first quarter of 2017, Stemline had a net loss of $14.6 million, or $0.67 per share, compared with a net loss of $9.0 million, or $0.51 per share, for the same period in 2016.
Research and development expenses were $9.6 million for the first quarter of 2017, which reflects an increase of $3.1 million, or 47%, compared with $6.5 million for the first quarter of 2016. The higher costs are primarily driven by an increase of $2.3 million in manufacturing development expenses to support our upcoming potential BLA filing for SL-401. The manufacturing development costs include process characterization and process development work relating to the manufacture of drug substance and drug product for SL-401. Additionally, we incurred an increase in costs due to higher compensation expense as a result of increased headcount. Partially offsetting these higher expenses was a decrease in clinical trial costs for SL-701 resulting from the study attaining full patient enrollment during 2016.
General and administrative expenses were $5.4 million for the first quarter of 2017, which reflects an increase of $2.5 million, or 87%, compared with $2.9 million for the first quarter of 2016. The increase in expense was attributable to higher legal and audit fees of $1.9 million as a result of the class action lawsuits filed against us arising from our January 2017 follow-on public offering. Additionally, the higher costs were driven by $0.5 million in commercial-related pre-launch expenses in support of preparing for a potential product launch of SL-401 in BPDCN if marketing approval from the FDA is received.
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