Stemline Therapeutics to Host Conference Call on Fourth Quarter 2019 Financial Results on March 16, 2020
March 11 2020 - 4:05PM
Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage
biopharmaceutical company focused on the development and
commercialization of novel oncology therapeutics, today announced
that the company will host a conference call and webcast on Monday,
March 16, 2020 at 8:00 a.m. ET to report its fourth quarter 2019
financial results and other business highlights.
The conference call can be accessed by dialing
1-800-367-2403 (domestic) or 1-334-777-6978 (international) and
referring to conference ID 7728185. 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 U.S. Food and Drug Administration (FDA) and
commercially available in the U.S. for the treatment of adult and
pediatric patients, two years or older, with blastic plasmacytoid
dendritic cell neoplasm (BPDCN). For full prescribing information
in the U.S., visit www.ELZONRIS.com. In Europe, a marketing
authorization application (MAA) is under review by the European
Medicines Agency (EMA).
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 World
Health Organization (WHO) termed this disease “BPDCN” in 2008;
previous names included blastic NK cell lymphoma and agranular
CD4+/CD56+ hematodermic neoplasm. For more information, please
visit the BPDCN disease awareness website at www.bpdcninfo.com.
About CD123CD123 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 Stemline Therapeutics
Stemline Therapeutics, Inc. is a commercial-stage biopharmaceutical
company focused on the development and commercialization of novel
oncology therapeutics. ELZONRIS® (tagraxofusp), a targeted
therapy directed to CD123, is FDA-approved and commercially
available in the U.S. for the treatment of adult and pediatric
patients, two years and older, with blastic plasmacytoid dendritic
cell neoplasm (BPDCN). In Europe, a marketing authorization
application (MAA) is under review by the European Medicines Agency
(EMA). ELZONRIS is also being evaluated in clinical trials in
additional indications including chronic myelomonocytic leukemia
(CMML), myelofibrosis (MF) acute myeloid leukemia (AML), and
additional trials and indications are planned. Additional pipeline
candidates include: felezonexor (SL-801) (XPO1 inhibitor; Phase 1
in advanced solid tumor patients ongoing) and SL-1001 (RET kinase
inhibitor, IND-enabling studies ongoing). For more information,
please visit the company’s website at www.stemline.com.
Forward-Looking StatementsSome
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 Europe; the success
and timing of our clinical trials and preclinical studies for our
product and product candidates, including ELZONRIS in additional
indications and our other pipeline 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 FDA, EMA, or other ex-U.S. national
drug authority ultimately does not agree with our data, find our
data supportive of approval, or approve any of our product
candidates; the possibility that results of clinical trials are not
predictive of safety and efficacy results of our product candidates
in broader patient populations or of our products if approved; our
plans to develop and commercialize our product candidates,
including, but not limited to delays in arranging satisfactory
manufacturing capabilities and establishing commercial
infrastructure for ELZONRIS; product efficacy or safety concerns
resulting in product recalls or regulatory action; the risk that
estimates regarding the number of patients with the diseases that
our product and product candidates may treat are inaccurate;
inadequate market penetration of our products; our products not
gaining acceptance among patients (and providers or third party
payors) for certain indications (due to cost or otherwise); the
risk that third party payors (including governmental agencies) will
not reimburse for the use of ELZONRIS at acceptable rates or at
all; the company’s ability to produce, maintain or increase sales
of ELZONRIS; the company’s ability to develop and/or commercialize
ELZONRIS; the adequacy of our pharmacovigilance and drug safety
reporting processes; our available cash and investments; our
ability to obtain and maintain intellectual property protection for
our product and product candidates; delays, interruptions, or
failures in the manufacture and supply of our product and product
candidates; the performance of third-party businesses, including,
but not limited to, manufacturers, clinical research organizations,
clinical trial sponsors and clinical trial investigators; and other
risk factors identified from time to time in our reports filed with
the SEC. Any forward-looking statements set forth in this press
release speak only as of the date of this press release. We do not
intend to update any of these forward-looking statements to reflect
events or circumstances that occur after the date hereof.
Contact: Investor
RelationsStemline Therapeutics, Inc.750 Lexington AvenueEleventh
FloorNew York, NY 10022Tel: 646-502-2307Email:
investorrelations@stemline.com
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