Stemline Therapeutics Reports Fourth Quarter 2019 Financial Results
- Net revenue for ELZONRIS® was
$11.8 million for the fourth quarter - Conference call and live webcast scheduled for
Monday, March 16 th, at8:00 AM ET
Fourth Quarter 2019 Financial Results Review
Net product revenue for ELZONRIS was
Stemline ended the fourth quarter with
Research and development expenses were
Selling, general and administrative expenses were
Corporate Highlights and Key Commercial and Clinical Milestones
BPDCN
$43.2 million in net revenues for ELZONRIS in 2019- IQVIA medical claims data identified approximately 534 unique patients in the
U.S. in 2018 with at least one claim of Blastic NK-Cell Lymphoma, a former name of BPDCN - Marketing Authorization Application (MAA) under review by
European Medicines Agency (EMA) for potential approval in the EU - Phase 1/2 trial of ELZONRIS in patients with BPDCN in the maintenance setting, post-stem cell transplant (SCT), open for enrollment
Chronic Myelomonocytic Leukemia (CMML)
- The CMML expansion cohort, Stage 3a, is open for enrollment of two patient populations: relapsed/refractory patients, and first-line, poor prognosis patients not expected to benefit from first line cytoreductive treatment
- Results from Stage 3a are expected to inform the design of the subsequent Stage 3b confirmatory cohort for potential registration
- We expect to provide updates from this trial in ~4Q20/1Q21
Myelofibrosis (MF)
- At ASH 2019, ELZONRIS data in patients with relapsed/refractory MF was the subject of an oral presentation
- In the MF clinical trial, ELZONRIS demonstrated efficacy (spleen size reductions and total symptom score [TSS] reductions) with a predictable and manageable safety profile, including in patients with poor prognostic factors, such as thrombocytopenia, CMML-type features/monocytosis, and clonal evolution
- The MF cohort of the ongoing trial has been expanded to include 20-25 additional patients
- We are evaluating relapsed/refractory patients and specific subsets of patients, including patients with monocytosis, thrombocytopenia, and CD123 positivity
- We expect to provide updates from this trial in ~4Q20/1Q21
Acute Myeloid Leukemia (AML)
- A Phase 1/2 trial of ELZONRIS in combination with other agents in patients with relapsed/refractory AML, treatment-naive AML unfit for chemotherapy, and high-risk myelodysplastic syndrome (MDS) is currently enrolling patients. CD123 expression levels are also being evaluated. We expect to provide updates later this year
Conference Call Information
The company will host a conference call and webcast on
The 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, and will be available live and for replay shortly after the event.
About ELZONRIS®
ELZONRIS® (tagraxofusp), a targeted therapy directed to CD123, is approved by the
ELZONRIS is also being evaluated in additional clinical trials in other CD123+ indications, including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), acute myeloid leukemia (AML), and others are planned, including a CD123+ all-comers trial.
About BPDCN
BPDCN, formerly blastic NK-cell lymphoma, is an aggressive hematologic malignancy, often with cutaneous manifestations, with historically poor outcomes. 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. The
About CD123
CD123 is a cell surface target expressed on a wide range of malignancies 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 multiple myeloma (MM), acute lymphoid leukemia (ALL), hairy cell leukemia (HCL), Hodgkin’s lymphoma (HL), and certain Non-Hodgkin’s lymphomas (NHL). In addition, CD123+ cells have been detected in the tumor microenvironment of several solid tumors as well as in certain autoimmune disorders including cutaneous lupus and scleroderma.
About
Forward-Looking Statements
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
Contact:
Investor Relations
Eleventh Floor
Tel: 646-502-2307
Email: investorrelations@stemline.com
Table 1.
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 13,561,712 | $ | 9,443,667 | |||
Short-term investments | 150,869,056 | 50,662,189 | |||||
Accounts receivable, net | 15,120,229 | — | |||||
Inventories, net | 1,151,373 | — | |||||
Prepaid expenses and other current assets | 4,459,127 | 2,952,996 | |||||
Total current assets | 185,161,497 | 63,058,852 | |||||
Property and equipment, net | 191,158 | 222,413 | |||||
Operating lease right-of-use assets | 1,317,598 | — | |||||
Other assets | 308,751 | 212,305 | |||||
Total assets | $ | 186,979,004 | $ | 63,493,570 | |||
Liabilities and stockholders’ equity | |||||||
Current liabilities: | |||||||
Accounts payable and accrued expenses | $ | 21,952,048 | $ | 21,153,062 | |||
Operating lease liabilities – current portion | 1,169,764 | — | |||||
Other current liabilities | 10,125 | 65,862 | |||||
Total current liabilities | 23,131,937 | 21,218,924 | |||||
Operating lease liabilities | 226,306 | — | |||||
Other liabilities | 4,370 | 72,591 | |||||
Total liabilities | 23,362,613 | 21,291,515 | |||||
Commitments and contingencies | |||||||
Stockholders’ equity: | |||||||
Preferred stock |
— | — | |||||
Common stock |
5,035 | 3,194 | |||||
Additional paid-in capital | 529,488,474 | 331,343,484 | |||||
Accumulated other comprehensive income (loss) | 28,171 | (56,559 | ) | ||||
Accumulated deficit | (365,905,289 | ) | (289,088,064 | ) | |||
Total stockholders’ equity | 163,616,391 | 42,202,055 | |||||
Total liabilities and stockholders’ equity | $ | 186,979,004 | $ | 63,493,570 |
Table 2.
Three Months Ended |
Twelve Months Ended |
|||||||||||||||
2019 |
2018 |
2019 |
2018 |
|||||||||||||
Revenues: | ||||||||||||||||
Product revenue, net | $ | 11,828,984 | $ | — | $ | 43,216,862 | $ | — | ||||||||
Income: | ||||||||||||||||
Grant income | — | — | — | 500,000 | ||||||||||||
Operating expenses: | ||||||||||||||||
Cost of goods sold | 3,152,779 | — | 4,893,339 | — | ||||||||||||
Research and development | 10,546,987 | 12,074,872 | 50,724,411 | 47,725,019 | ||||||||||||
Selling, general and administrative | 16,476,470 | 14,853,116 | 66,846,633 | 39,061,667 | ||||||||||||
Total operating expenses | 30,176,236 | 26,927,988 | 122,464,383 | 86,786,686 | ||||||||||||
Loss from operations | (18,347,252 | ) | (26,927,988 | ) | (79,247,521 | ) | (86,286,686 | ) | ||||||||
Other expense, net | (44,087 | ) | (3,608 | ) | (47,697 | ) | (7,505 | ) | ||||||||
Interest expense | (33,920 | ) | (321 | ) | (34,706 6 | ) | (794 | ) | ||||||||
Interest income | 784,255 | 297,003 | 2,538,273 | 1,270,620 | ||||||||||||
Net loss before income taxes | $ | (17,641,004 | ) | $ | (26,634,914 | ) | $ | (76,791,651 | ) | $ | (85,024,365 | ) | ||||
Income tax expense | (39,021 | ) | — | (25,574 | ) | — | ||||||||||
Net loss | $ | (17,680,025 | ) | $ | (26,634,914 | ) | $ | (76,817,225 | ) | $ | (85,024,365 | ) | ||||
Net loss per common share: | ||||||||||||||||
Basic and Diluted | $ | (0.38 | ) | $ | (0.92 | ) | $ | (1.83 | ) | $ | (2.99 | ) | ||||
Weighted-average shares outstanding: | ||||||||||||||||
Basic and Diluted | 46,851,498 | 29,085,767 | 42,091,027 | 28,388,901 | ||||||||||||
Source: Stemline Therapeutics, Inc.