Stemline Therapeutics, Inc. (Nasdaq:STML), a
commercial -stage biopharmaceutical company focused on discovering,
acquiring, developing and commercializing innovative oncology
therapeutics, today announced that it intends to offer and sell,
subject to market conditions, 5,000,000 shares of its common stock
in an underwritten public offering. All of the shares to be sold in
the offering will be offered by Stemline. In addition, Stemline
intends to grant the underwriters a 30-day option to purchase up to
an additional 750,000 shares of its common stock offered in the
public offering.
J.P. Morgan Securities LLC is acting as book-running manager for
the offering.
Stemline intends to use the net proceeds from this offering for
(i) commercial activities of ELZONRIS® (tagraxofusp; SL-401), (ii)
clinical trials for additional indications including CMML, MF, AML,
and potentially other diseases such as certain lymphomas; (ii)
clinical development of additional pipeline candidates (felezonexor
(SL-801), SL-1001, SL-901 and SL-701); (iii) research and
development and regulatory activities; (iv) potential acquisitions
and in-licensing; and (v) other general corporate purposes.
Stemline has filed a preliminary prospectus supplement to its
shelf registration statement on Form S-3 (File No. 333-230341) with
the U.S. Securities and Exchange Commission (“SEC”) for the
proposed public offering of its common stock. The offering will be
made only by means of a prospectus and a prospectus supplement,
which will be available on the SEC's web site at www.sec.gov.
Copies of the preliminary prospectus supplement and the
accompanying prospectus relating to these securities may also be
obtained, when available, by contacting J.P. Morgan Securities
LLC, c/o Broadridge Financial Solutions, 1155 Long Island
Avenue, Edgewood, New York 11717, Telephone: (866)
803-9204.
The offering of these securities is being made under an
effective shelf registration statement on file with the SEC. This
press release shall not constitute an offer to sell or the
solicitation of an offer to buy nor shall there be any sale of
these securities in any state or jurisdiction in which such offer,
solicitation or sale would be unlawful prior to registration or
qualification under the securities laws of any such state or
jurisdiction.
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 (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 CD123 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 (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 (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).
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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