Stemline Therapeutics to Host Conference Call on First Quarter 2019 Financial Results on May 10, 2019
May 08 2019 - 7:00AM
Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage
biopharmaceutical company focused on the development and
commercialization of novel oncology therapeutics, announced today
that the company will host a conference call and live webcast on
Friday, May 10, 2019 at 8:00 a.m. ET to report its first quarter
2019 financial results and other business highlights.
The conference call can be accessed by dialing 1-800-667-5617
(domestic) or 1-334-323-0509 (international) and referring to
conference ID 2090827. 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.
About ELZONRIS™ ELZONRIS (tagraxofusp-erzs), a
CD123-directed cytotoxin, 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 (MMA) is under review
by the European Medicines Agency (EMA). ELZONRIS is also being
evaluated in additional clinical trials in other indications
including chronic myelomonocytic leukemia (CMML), myelofibrosis
(MF) and acute myeloid leukemia (AML).
About BPDCN 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.
About CD123CD123 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 (NHL). In addition, CD123 has
been detected on some solid tumors as well as 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 or
older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN).
In Europe, a marketing authorization application (MMA) 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) and acute myeloid leukemia (AML). Additional pipeline
candidates include: SL-701 (immunotherapeutic; Phase 2 in
glioblastoma patients completed), SL-801 (XPO1 inhibitor; Phase 1
in advanced solid tumor patients ongoing), SL-901 (novel kinase
inhibitor; prior abbreviated European Phase 1, IND-enabling studies
ongoing), and SL-1001 (novel RET kinase inhibitor, IND-enabling
studies pending). 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
ELZONRIS U.S. commercial launch, the success of our MAA submission
to the EMA and potential commercial launch of ELZONRIS in Europe;
the success and timing of our clinical trials and preclinical
studies for our products and product candidates, including ELZONRIS
in additional indications, 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 products 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 payers) 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 products and product
candidates; delays, interruptions, or failures in the manufacture
and supply of our products 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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