Stemline Therapeutics Reports Fourth Quarter 2018 Financial Results
ELZONRIS™ (tagraxofusp) – US Approval and Commercial Launch
- ELZONRIS was
FDA-approved on December 21, 2018for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients, two years and older.
- ELZONRIS has been commercially available in the U.S. since the end of
January 2019, and patients are currently being treated with ELZONRIS in the commercial setting.
- A Marketing Authorization Application (MAA) for ELZONRIS seeking marketing approval in
Europewas submitted to, and subsequently validated by, the European Medicines Agency(EMA) in January 2019. The MAA has been granted accelerated assessment and is currently under review.
ELZONRIS – Market Expansion Efforts
- ELZONRIS is being evaluated in clinical trials in additional indications, including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), and acute myeloid leukemia (AML).
- Based on the clinical results observed in CMML and MF thus far, we are evaluating potential registrational pathways in these indications. For CMML, we intend to discuss registration-directed plans with the
- We are also working towards expansion opportunities within the BPDCN universe, including maintenance therapy after stem cell transplant.
- In parallel, we plan to expand our clinical efforts later this year and next into subsets of AML patients enriched for CD123+ expression.
- We expect to provide periodic updates on these initiatives throughout this year and next at scientific conferences.
December 2018, ELZONRIS data were selected for four presentations at the 2018 American Society of Hematology(ASH) conference. Presentations included results of the BPDCN pivotal trial, delivered via oral presentation, and updated clinical trial data in patients with CMML and MF.
- Additionally, we had an active clinical, medical affairs and pre-commercial presence at ASH focused on BPDCN disease awareness.
October 2018, 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. We expect to provide further updates at upcoming conferences.
November 2018, data from the Phase 2 trial of SL-701 in patients with second-line glioblastoma (GBM) were delivered via oral presentation at the 23rd Annual Meeting of the Society of Neuro-Oncology(SNO). We expect to provide further updates on this program later this year.
- SL-901 is a novel kinase inhibitor that was evaluated in an abbreviated Phase 1 trial of solid tumor patients in
Europe. Neither a dose limiting toxicity nor maximum tolerated dose was identified, and there was one partial response (PR) in a patient with advanced non-small cell lung cancer. We plan to re-initiate a Phase 1 study by early 2020.
March 2019, we announced the in-licensing of SL-1001, a novel, selective RET kinase inhibitor that demonstrated potent preclinical in vitro and in vivo activity. We expect to begin IND-enabling studies this year, with a Phase 1 clinical trial targeted for 2020.
Fourth Quarter 2018 Financial Results Review
Stemline ended the fourth quarter of 2018 with
For the fourth quarter of 2018, Stemline had a net loss of
Research and development expenses were
General and administrative expenses were
BPDCN is an aggressive hematologic malignancy with historically poor outcomes and an area of unmet medical need. BPDCN typically presents in the bone marrow and/or skin and may also involve lymph nodes and viscera. The BPDCN cell of origin is the plasmacytoid dendritic cell (pDC) precursor. The diagnosis of BPDCN is based on the immunophenotypic diagnostic triad of CD123, CD4, and CD56, and other markers. For more information, please visit the BPDCN disease awareness website at www.bpdcninfo.com.
ELZONRIS (tagraxofusp), a CD123-directed cytotoxin, was approved by the
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 of our MAA submission to the EMA; 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, 2018||December 31, 2017|
|Cash and cash equivalents||$||9,443,667||$||4,795,098|
|Prepaid expenses and other current assets||2,952,996||469,067|
|Total current assets||63,058,852||52,188,777|
|Property and equipment, net||222,413||136,672|
|Liabilities and stockholders’ equity|
|Accounts payable and accrued expenses||$||21,153,062||$||19,742,087|
|Other current liabilities||65,862||96,826|
|Total current liabilities||21,218,924||19,838,913|
|Commitments and contingencies|
|Preferred stock $0.0001 par value, 5,000,000 shares authorized, none issued and outstanding at December 31, 2018 and 2017||—||—|
|Common stock $0.0001 par value, 53,750,000 shares authorized at December 31, 2018 and December 31, 2017. 31,943,186 shares issued and outstanding at December 31, 2018 and 25,313,595 shares issued and outstanding at December 31, 2017||3,194||2,531|
|Additional paid-in capital||331,343,484||251,489,546|
|Accumulated other comprehensive loss||(56,559||)||(145,958||)|
|Total stockholders’ equity||42,202,055||47,070,429|
|Total liabilities and stockholders’ equity||$||63,493,570||$||67,006,168|
|Three Months Ended December 31,||Twelve Months Ended December 31,|
|Research and development||12,074,872||16,725,380||47,725,019||50,242,386|
|General and administrative||14,853,116||5,213,353||39,061,667||19,214,207|
|Total operating expenses||26,927,988||21,938,733||86,786,686||69,456,593|
|Loss from operations||(26,927,988||)||(21,938,733||)||(86,286,686||)||(68,558,394||)|
|Net loss per common share:|
|Basic and Diluted||$||(0.92||)||$||(0.93||)||$||(2.99||)||$||(2.94||)|
|Weighted-average shares outstanding:|
|Basic and Diluted||29,085,767||23,517,007||28,388,901||23,056,928|
Source: Stemline Therapeutics, Inc.