Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage
biopharmaceutical company focused on the development and
commercialization of novel oncology therapeutics, today announced
preliminary net revenues for 2019, as well as outlined key BPDCN
market successes and upcoming commercial and clinical milestones.
Unaudited preliminary 2019 results include:
- $43.2 million in estimated ELZONRIS net revenues for the
year-ended December 31, 2019
- $11.8 million in estimated ELZONRIS net revenues for the fourth
quarter of 2019
The above financial information is based on preliminary
unaudited information, is subject to adjustment, and does not
present all information necessary for an understanding of the
Company’s full-year and fourth quarter financial results for 2019.
Stemline expects to report complete audited 2019 financial results
on or before March 16, 2020.
Robert Francomano, Chief Commercial Officer of Stemline, stated,
“We are very pleased with the solid uptake seen in the first year
of the ELZONRIS launch, as we continue to successfully create,
penetrate and grow a new market in BPDCN. Given the orphan nature
and unique features of this disease, we believe patient starts were
subject to significant quarterly variance – a phenomena that will
likely continue throughout 2020. We are actively implementing a
host of tactics to expand and further penetrate this emerging
market.”
Ivan Bergstein, CEO of Stemline, commented, “2019 was a
transformational year for Stemline as we launched ELZONRIS, the
first and only CD123 targeted agent and first agent ever approved
for patients with BPDCN. We continue to pursue growth opportunities
not only in BPDCN but also in a number of malignancies where
targeting CD123 could provide therapeutic benefit. We look forward
to data readouts in CMML, MF, and AML, including in patient subsets
with high CD123, later this year and on into next year. Given our
continued commercial and clinical progress, we look forward to a
productive 2020 and beyond.”
Corporate Highlights and Key Commercial and Clinical
Milestones
BPDCN
- $43.2 million in estimated, unaudited, net revenues for
ELZONRIS in 2019
- Marketing Authorization Application (MAA) under review by
European Medicines Agency (EMA) for potential approval in the
E.U.
- Phase 1/2 trial of ELZONRIS in patients with BPDCN in the
maintenance setting, post-stem cell transplant (SCT), has
regulatory authorization to proceed; targeting treatment of the
first patient in ~1Q20
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 is expected to inform the design of the
subsequent Stage 3b confirmatory cohort for potential
registration
- We expect to report initial data from this trial in ~4Q20
Myelofibrosis (MF)
- 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 report updated data from this trial in ~4Q20
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. We expect to provide data updates
later this year.
About ELZONRIS®
ELZONRIS® (tagraxofusp), 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 (MAA) 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 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) and acute myeloid leukemia (AML). Additional pipeline
candidates include: felezonexor (SL-801) (XPO1 inhibitor; Phase 1
in advanced solid tumor patients ongoing), SL-1001 (novel RET
kinase inhibitor, IND-enabling studies ongoing), SL-701
(immunotherapeutic; Phase 2 in glioblastoma patients completed),
and SL-901 (novel kinase inhibitor; prior abbreviated European
Phase 1, 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 risk that our
actual revenue for the fourth quarter and year ended December
31, 2019 may differ materially from our estimated results for
these periods as a result of the completion of year-end closing
procedures or the audit of our financial statements; 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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