Stemline Therapeutics Reports Third Quarter 2018 Financial Results
ELZONRIS – Potential Approval and Pre-Commercial Activities
FDAaccepted, for filing, the Company’s Biologics License Application (BLA) for ELZONRISTM (tagraxofusp; SL-401) for the treatment of patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). The FDAalso granted Priority Review for the BLA and set a target action date of February 21, 2019, under the Prescription Drug User Fee Act (PDUFA).
- In preparation for potential US approval, we continue to build out our pre-launch activities. These efforts include ramping up our disease awareness campaign targeting key stakeholders including hematologist-oncologists, dermatologists, and pathologists.
- During the quarter, we conducted meetings with our assigned Rapporteurs and the
European Medicines Agency(EMA). Based on feedback from these meetings, we plan to submit a Marketing Authorization Application (MAA) to the EMA for ELZONRIS in the first quarter of 2019 seeking marketing approval in Europe.
ELZONRIS – Market Expansion Efforts
- ELZONRIS is being evaluated in clinical trials in additional indications, with a focus on chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF).
- Based on the clinical results observed in CMML and MF thus far, we are finalizing registrational plans in these indications. We plan to seek regulatory advice in early 2019 with the goal of initiating pivotal trials, or cohorts, to follow. Ahead of this, the ongoing trial continues to enroll CMML and MF patients, and periodic updates at upcoming conferences will be provided.
- At the upcoming
American Society of Hematology(ASH) conference in December, ELZONRIS data were selected for four presentations, including an oral presentation. Presentations include results of the BPDCN pivotal trial and updated clinical trial data in patients with chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF).
- Additionally, we expect to have a robust clinical, medical affairs and pre-commercial presence at ASH, including hosting an investor/analyst event on
- In October, data from the ongoing Phase 1 trial of SL-801 in patients with advanced solid tumors were presented at the European Society of Medical Oncology (
ESMO) Annual Congress 2018.
- Patient enrollment and dose escalation continues. We expect to provide further updates at upcoming conferences.
- In October, data from the Phase 2 trial of SL-701 in patients with second-line glioblastoma (GBM) were delivered via oral presentation at the European Society of Medical Oncology (
ESMO) Annual Congress 2018.
- Discussions around next steps to unlock potential value from the program are ongoing, and we expect to provide further updates at upcoming conferences.
Third Quarter 2018 Financial Results Review
Stemline ended the third quarter of 2018 with
Research and development expenses were
General and administrative expenses were
Please visit the BPDCN disease awareness booth (#205) at ASH 2018, and the BPDCN disease awareness website at www.bpdcninfo.com.
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 success and timing of our BLA submission to the
|September 30, 2018
|December 31, 2017|
|Cash and cash equivalents||$||11,677,741||$||4,795,098|
|Prepaid expenses and other current assets||1,996,235||469,067|
|Total current assets||80,530,475||52,188,777|
|Property and equipment, net||221,820||136,672|
Liabilities and stockholders’ equity
|Accounts payable and accrued expenses||$||17,202,090||$||19,742,087|
|Other current liabilities||133,170||96,826|
|Total current liabilities||17,335,260||19,838,913|
|Commitments and Contingencies
|Preferred stock $0.0001 par value, 5,000,000 shares authorized, none issued and outstanding at September 30, 2018 and December 31, 2017||—||—|
|Common stock $0.0001 par value, 53,750,000 shares authorized at September 30, 2018 and December 31, 2017. 31,671,552 shares issued and outstanding at September 30, 2018 and 25,313,595 shares issued and outstanding at December 31, 2017||3,167||2,531|
|Additional paid-in capital||326,084,695||251,489,546|
|Accumulated other comprehensive loss||(96,546||)||(145,958||)|
|Total stockholders’ equity||63,538,166||47,070,429|
|Total liabilities and stockholders’ equity||$||80,964,600||$||67,006,168|
|Three Months Ended September 30,||Nine Months Ended September 30,|
|Research and development||11,758,025||12,417,652||35,650,147||33,517,006|
|General and administrative||9,647,336||4,152,449||24,208,551||14,000,854|
|Total operating expenses||21,405,361||16,570,101||59,858,698||47,517,860|
|Loss from operations||(21,405,361||)||(16,270,704||)||(59,358,698||)||(46,619,661||)|
|Net loss per common share:|
|Basic and Diluted||$||(0.73||)||$||(0.68||)||$||(2.07||)||$||(2.01||)|
|Weighted-average shares outstanding:
Basic and Diluted
Source: Stemline Therapeutics, Inc.