On August 4, 2016 Stemline Therapeutics, Inc. (Nasdaq:STML) reported financial results for the quarter ended June 30, 2016 (Press release, Stemline Therapeutics, AUG 4, 2016, View Source [SID:1234514305]). Clinical highlights and milestones include:

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SL-401 in blastic plasmacytoid dendritic cell neoplasm (BPDCN)

Oral presentations of Phase 2 clinical trial results of SL-401 in patients with BPDCN delivered at annual meetings of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and the European Hematology Association (EHA) (Free EHA Whitepaper).
SL-401 efficacy and safety data continue to be positive with increasing treatment duration, drug exposure, and patient enrollment.
As of July 2016, 29 BPDCN patients have received SL-401, including 26 adults (16 first-line and 10 relapsed/refractory) and 3 pediatric compassionate use patients.
SL-401 continues to maintain high overall response rates (ORR) in both first-line (>90% ORR) and relapsed/refractory adult BPDCN (>50% ORR). Notably, a relapsed/refractory BPDCN patient was recently bridged to stem cell transplant (SCT) following a major response to SL-401.
Response duration, progression free and overall survival data continue to mature and trend favorably. Multiple patients remain progression free after receiving ongoing SL-401 treatment (up to 12+ months [16+ cycles], ongoing) or experiencing a major response on SL-401 and proceeding to SCT (up to 16+ months, ongoing).
Further clinical and regulatory updates expected this year.
SL-401 in additional malignancies

Completed lead-in, dose escalation stage of Phase 2 trial in patients with acute myeloid leukemia (AML) in remission with high relapse risk including minimal residual disease (MRD). There were no unexpected side effects and no dose limiting toxicities. The expansion stage is currently enrolling MRD+ AML patients at 12 ug/kg.
Patients are currently enrolling in the lead-in, dose escalation stage of a Phase 2 trial in advanced, high risk myeloproliferative neoplasms (MPN). The first two dosing cohorts have been cleared with no unexpected side effects and no dose limiting toxicities. Patients are currently enrolling in the third dosing cohort, 12 ug/kg.
Patients are currently enrolling in a Phase 1/2 trial in relapsed or refractory multiple myeloma with SL-401 in combination with pomalidomide and dexamethasone (POM+DEX); the first combination trial of SL-401 with another agent. No unexpected side effects and no dose limiting toxicities have been observed with the combination to date. Enrollment continues.
Further clinical updates expected later this year from these trials.
SL-701

Phase 2 trial of SL-701 in combination with bevacizumab in adult patients with second-line GBM currently enrolling patients.
Trial updates expected later this year.
SL-801

Phase 1 trial of SL-801 in patients with advanced solid tumors currently enrolling. The first and second dosing cohorts have cleared, and the third cohort is currently enrolling.
Trial updates expected later this year and on into next year.
Ivan Bergstein, M.D., Stemline’s Chief Executive Officer, commented, "We are making substantial progress across our entire clinical pipeline this year. A key highlight of the quarter was the high profile oral presentations of positive results from our ongoing Phase 2 potentially pivotal trial of SL-401 in BPDCN at both the ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) annual meetings." Dr. Bergstein continued, "The efficacy and safety data from this trial continue to be strong with increasing treatment duration and patient exposure. We look forward to additional clinical and regulatory updates this year, including more clarity around our registration pathway and timeline."

Dr. Bergstein concluded, "As we continue to build upon our compelling data in BPDCN, we also look forward to further updates later this year regarding our multiple enrolling trials with SL-401 in additional hematologic cancers, SL-701 in brain cancer, and SL-801 in advanced solid tumors. Importantly, our strong cash position provides us with the resources to reach important milestones across all of our programs this year and beyond."

Second Quarter 2016 Financial Results Review
Stemline ended the second quarter of 2016 with $81.2 million in cash, cash equivalents and investments, as compared to $87.8 million as of March 31, 2016, which reflects a cash burn of $6.6 million for the quarter.

For the second quarter of 2016, Stemline had a net loss of $9.3 million, or $0.52 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 $6.9 million for the second quarter of 2016, which reflects a decrease of $1.3 million, or 16%, compared with $8.2 million for the second quarter of 2015. The lower expenses year over year were primarily attributable to an increase in costs in the prior year relating to clinical site startup expenses and initiation of clinical trial activities.

General and administrative expenses were $2.9 million for the second quarter of 2016, which reflects an increase of $0.7 million, or 33%, compared with $2.2 million for the second quarter of 2015. The increase in expense year over year was primarily attributable to higher non-cash stock based compensation and payroll costs relating to employees.