Stemline Therapeutics Reports First Quarter 2019 Financial Results
- Net revenue for ELZONRIS was
$5.05 millionfor the first quarter
- Conference call and live webcast scheduled for today at
8:00 AM ET
“Since ELZONRIS became commercially available in January, we have been very pleased with the progress we have made executing our launch plan,” stated
First Quarter 2019 Financial Results Review
Net revenue for ELZONRIS was
Stemline ended the first quarter with
Research and development expenses were
Selling, general and administrative expenses were
Recent Corporate Developments and Program Highlights
ELZONRIS™ (tagraxofusp) – Blastic plasmacytoid dendritic cell neoplasm (BPDCN)
- ELZONRIS was approved by the
FDAon December 21, 2018and commercially available for patients with BPDCN in the U.S. in January 2019.
New England Journal of Medicinepublished the pivotal trial results in its April 25th edition.
- We submitted a Marketing Authorization Application (MAA) to the
European Medicines Agency(EMA) in January 2019seeking marketing approval in Europe. The MAA was granted accelerated assessment and is currently under review.
ELZONRIS – Market Expansion Efforts
- We are conducting clinical trials to evaluate ELZONRIS in additional indications, including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), and acute myeloid leukemia (AML).
- Based on clinical results observed in patients with CMML and MF, we are evaluating next steps, including potential registrational pathways. For CMML, we intend to provide our registration-directed plans mid-year.
- We are also evaluating additional expansion opportunities, including maintenance therapy after stem cell transplant in patients with BPDCN.
- In parallel, we plan to expand our clinical efforts later this year and next into subsets of AML patients, including those enriched for CD123+ expression.
- We expect to provide periodic updates on these programs throughout this year and next at scientific conferences.
- ELZONRIS clinical trial data in CMML and MF have been selected for two poster presentations at the 2019
American Society of Clinical Oncology( ASCO) conference in June.
Other pipeline candidates
- We expect to provide periodic updates on our other product candidates, SL-701, SL-801, SL-901, and SL-1001, later this year.
Conference Call Information
Stemline will host a conference call and live webcast today at
The live webcast can be accessed via the company’s website (www.stemline.com), at the bottom of the “Investors & Media” section in the “News & Events” page. The webcast will be archived and made available for replay on the company’s website shortly after the event.
ELZONRIS (tagraxofusp-erzs), a CD123-directed cytotoxin, is approved by the
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, as well as other markers. For more information, please visit the BPDCN disease awareness website at www.bpdcninfo.com.
CD123 is a cell surface target expressed on a wide range of myeloid tumors including blastic plasmacytoid dendritic cell neoplasm (BPDCN), certain myeloproliferative neoplasms (MPNs) including chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF), acute myeloid leukemia (AML) (and potentially enriched in certain AML subsets), myelodysplastic syndrome (MDS), and chronic myeloid leukemia (CML). CD123 has also been reported on certain lymphoid malignancies including multiple myeloma (MM), acute lymphoid leukemia (ALL), hairy cell leukemia (HCL), Hodgkin’s lymphoma (HL), and certain Non-Hodgkin’s lymphomas (
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 U.S. launch and commercialization; the success of our MAA submission to the EMA and potential launch in
|March 31, 2019
|December 31, 2018|
|Cash and cash equivalents||$||24,014,510||$||9,443,667|
|Prepaid expenses and other current assets||3,120,926||2,952,996|
|Total current assets||133,940,812||63,058,852|
|Property and equipment, net||273,399||222,413|
|Right-of-use asset, net||1,738,680||—|
Liabilities and stockholders’ equity
|Accounts payable and accrued expenses||$||25,413,021||$||21,153,062|
|Right-of-use liability – current portion||1,023,678||—|
|Other current liabilities||6,021||65,862|
|Total current liabilities||26,442,720||21,218,924|
|Preferred stock $0.0001 par value, 5,000,000 shares authorized, none issued and outstanding at March 31, 2019 and December 31, 2018||—||—|
|Common stock $0.0001 par value, 53,750,000 shares authorized at March 31, 2019 and December 31, 2018. 43,576,081 shares issued and outstanding at March 31, 2019 and 31,943,186 shares issued and outstanding at December 31, 2018||4,358||3,194|
|Additional paid-in capital||425,410,295||331,343,484|
|Accumulated other comprehensive loss||(27,161||)||(56,559||)|
|Total stockholders’ equity||108,892,162||42,202,055|
Total liabilities and stockholders’ equity
|Three Months Ended March 31,|
|Product revenue, net||$||5,048,590||$||—|
Cost of goods sold
|Research and development||16,953,822||12,708,058|
|Selling, general and administrative||15,953,968||5,938,600|
|Total operating expenses||32,993,518||18,646,658|
Loss from operations
|Net loss before income taxes||(27,410,960||)||(18,416,753||)|
|Income tax benefit||3,694||—|
Net loss per common share:
|Basic and Diluted||$||(0.73||)||$||(0.69||)|
Weighted-average shares outstanding:
Basic and Diluted
Source: Stemline Therapeutics, Inc.