Stemline Therapeutics Reports Fourth Quarter 2017 Financial Results
SL-401 in Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
December 2017, we presented detailed data from the pivotal trial at the 2017 American Society of Hematology(ASH) 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, 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:
• 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) 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
For the fourth quarter of 2017, Stemline had a net loss of
Research and development expenses were
General and administrative expenses were
Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The factors that could cause our actual results to differ materially include: the intended use of proceeds from the offering; the success and timing of our clinical trials and preclinical studies for our product candidates, including site initiation, institutional review board approval, scientific review committee approval, patient accrual, safety, tolerability and efficacy data observed, and input from regulatory authorities including the risk that the
|December 31, 2017||December 31, 2016|
|Cash and cash equivalents||$||4,795,098||$||10,316,064|
|Prepaid expenses and other current assets||469,067||290,747|
|Total current assets||52,188,777||47,169,711|
|Property and equipment, net||136,672||22,531|
Liabilities and stockholders’ equity
|Accounts payable and accrued expenses||$||19,742,087||$||9,284,514|
|Current portion of deferred grant revenue||—||898,199|
|Other current liabilities||96,826||71,100|
|Total current liabilities||19,838,913||10,253,813|
|Commitments and contingencies|
|Preferred stock $0.0001 par value, 5,000,000 shares authorized, none issued and outstanding at December 31, 2017 and 2016||—||—|
|Common stock $0.0001 par value, 53,750,000 shares authorized at December 31, 2017 and 33,750,000 shares authorized at December 31, 2016.
25,313,595 shares issued and outstanding at December 31, 2017 and 19,219,223 shares issued and outstanding at December 31, 2016
|Additional paid-in capital||251,489,546||193,563,572|
|Accumulated other comprehensive loss||(145,958||)||(99,802||)|
|Total stockholders’ equity||47,070,429||57,723,085|
Total liabilities and stockholders’ equity
|Three Months Ended December 31,||Twelve Months Ended December 31,|
|Research and development||16,725,380||7,284,262||50,242,386||27,869,921|
|General and administrative||5,213,353||3,142,260||19,214,207||12,056,890|
|Total operating expenses||21,938,733||10,426,522||69,456,593||39,926,811|
|Loss from operations||(21,938,733||)||(10,127,121||)||(68,558,394||)||(38,885,457||)|
|Other (expense) income||(3,145||)||(299||)||(6,330||)||11,438|
Net loss before income taxes
|Income tax (expense) benefit||—||(10,282||)||—||25,296|
|Net loss per common share:|
|Basic and Diluted||$||(0.93||)||$||(0.56||)||$||(2.94||)||$||(2.15||)|
|Weighted-average shares outstanding:
Basic and Diluted
Source: Stemline Therapeutics, Inc.