On March 16, 2018 Stemline Therapeutics, Inc. (Nasdaq: STML), a clinical-stage biopharmaceutical company developing novel oncology therapeutics, reported that financial results for the quarter ended December 31, 2017 (Press release, Stemline Therapeutics, MAR 16, 2018, View Source [SID1234524840]). The Company also reviewed recent clinical and regulatory events, and outlined key upcoming milestones:
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
SL-401 in Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
In December 2017, we presented detailed data from the pivotal trial at the 2017 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Atlanta, GA.
Based on these trial results and other data, we expect to complete submission of a rolling Biologics License Application (BLA) in the first half of 2018.
· Also at ASH (Free ASH Whitepaper), we launched our BPDCN disease awareness campaign which is designed to build awareness of BPDCN and CD123.
Later this year, we anticipate feedback from the European Medicines Agency (EMA) regarding a potential regulatory filing.
Additional Clinical Trials
SL-401 is also being evaluated in clinical trials in additional indications including myeloproliferative neoplasms (MPN) focused on chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF), acute myeloid leukemia (AML), and multiple myeloma.
We presented data from the ongoing SL-401 MPN trial at ASH (Free ASH Whitepaper):
In relapsed/refractory CMML (n=11), 71% (5/7) of patients with baseline splenomegaly had a >50% reduction in spleen size by physical examination. One relapsed/refractory CMML patient had a complete response (CR), comprised of a bone marrow complete response (BMCR) and a 100% spleen reduction (5 to 0 cm, or not palpable).
In relapsed/refractory MF (n=12), 50% (5/10) of patients with baseline splenomegaly had spleen reductions of >25% (range: 29-100%) by physical exam, including 3 patients (30%) with spleen reductions >35%. Notably, 2 of these 3 patients had baseline thrombocytopenia prior to administration of SL-401: 1 patient with platelets <100K/microliter and 1 patient with platelets <50K/microliter.
· Most common treatment-related adverse events (TRAEs) included hypoalbuminemia (33%), thrombocytopenia (33%), and fatigue (29%). Capillary leak was reported in 24% (5/21) evaluable patients: 4 cases were grades 1-2 and 1 case was grade 3. Most common TRAEs (grade 3 or higher) included thrombocytopenia (24%) and anemia (19%).
· Patient enrollment and follow-up is ongoing in this trial. We believe SL-401’s favorable tolerability and preliminary signs of activity support continued development and evaluation of possible registration-directed trial designs. Updates relating to this trial, and further plans for these indications, are expected later this year.
· SL-801: the Phase 1 trial in patients with advanced solid tumors is ongoing. Preliminary data were presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress in 2017.
No dose limiting toxicity or maximum tolerated dose has been reached. Dose escalation is ongoing and we are currently enrolling patients in the ninth dosing cohort.
· SL-701: the Phase 2 trial in patients with second-line glioblastoma has been completed. Data were presented at the Society for Neuro-Oncology (SNO) annual meeting in November 2017. SL-701 was well-tolerated and demonstrated evidence of activity, with immunostimulants, as a single agent and in combination with bevacizumab including several major responses and long-term survivors. Data are being analyzed and we expect to provide next steps for the program later this year.
Fourth Quarter 2017 Financial Results Review
Stemline ended the fourth quarter of 2017 with $66.2 million in cash, cash equivalents and investments, as compared to $79.9 million as of September 30, 2017, which reflects cash expenditures of $13.7 million for the quarter. Subsequent to year-end 2017, Stemline completed a follow-on public offering during January 2018 raising $55.5 million in net cash proceeds bringing total cash, cash equivalents and investments as of March 16, 2018 to approximately $106.8 million.
For the fourth quarter of 2017, Stemline had a net loss of $21.7 million, or $0.93 per share, compared with a net loss of $10.0 million, or $0.56 per share, for the same period in 2016.
Research and development expenses were $16.7 million for the fourth quarter of 2017, which reflects an increase of $9.4 million compared with $7.3 million for the fourth quarter of 2016. The higher costs are primarily due to an increase in manufacturing and regulatory expenses in support of our BLA filing and potential commercialization of SL-401. In addition, the higher costs are attributable to increased headcount relating to the build out of various functions, including regulatory and commercial, in support of our BLA filing and potential launch.
General and administrative expenses were $5.2 million for the fourth quarter of 2017, which reflects an increase of $2.1 million compared with $3.1 million for the fourth quarter of 2016. The increase in costs was primarily attributable to pre-launch expenses in support of the potential commercialization of SL-401, if marketing approval from the FDA is obtained, legal expenses, and compensation costs.