Stemline Therapeutics Announces Proposed Public Offering of Common Stock
January 14 2019 - 4:35PM
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, 6,600,000 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 990,000 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)
including clinical trials for additional indications including
CMML, MF and other diseases; (ii) clinical development of SL‑801,
SL‑701 and potentially SL-901; (iii) research and development
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. 333-219794) 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 Stemline Therapeutics Stemline
Therapeutics, Inc. is a biopharmaceutical company focused on the
development and commercialization of novel oncology therapeutics.
In December 2018, the FDA approved ELZONRIS, a targeted therapy
directed to CD123, for the treatment of adult and pediatric
patients, two years or older, with blastic plasmacytoid dendritic
cell neoplasm (BPDCN). In November 2018, the European Medicines
Agency (EMA) granted accelerated assessment to the marketing
authorization application (MAA) of ELZONRIS for the treatment of
patients with BPDCN, which was submitted to the EMA in January
2019. ELZONRIS is also being evaluated in clinical trials in
additional indications including chronic myelomonocytic leukemia
(CMML), myelofibrosis (MF) and others. Additional Stemline clinical
candidates include SL-801, a novel oral small molecule reversible
inhibitor of XPO1, which is currently in a Phase 1 trial of
patients with advanced solid tumors and recent data was presented
at the 2018 European Society of Medical Oncology (ESMO) annual
conference; and SL-701, an immunotherapeutic which has completed a
Phase 2 trial in patients with second-line glioblastoma and recent
data were presented at the 2018 Society for Neuro-Oncology (SNO)
annual conference.
About ELZONRIS™ ELZONRIS
(tagraxofusp), a CD123-directed cytotoxin, was approved by the Food
and Drug Administration (FDA) on December 21, 2018 for the
treatment of adult and pediatric patients, two years and older,
with blastic plasmacytoid dendritic cell neoplasm (BPDCN). In
November 2018, the European Medicines Agency (EMA) granted ELZONRIS
accelerated assessment to the marketing authorization application
(MAA), which was submitted to the EMA in January 2019. ELZONRIS is
also being evaluated in additional clinical trials in other
indications including chronic myelomonocytic leukemia (CMML),
myelofibrosis (MF) and other CD123 positive diseases.
About BPDCN BPDCN is an aggressive hematologic
malignancy with historically poor outcomes and an area of unmet
medical need. The BPDCN cell of origin is the plasmacytoid
dendritic cell (pDC) precursor. BPDCN typically presents in the
bone marrow and/or skin and may also involve lymph nodes and
viscera. The diagnosis of BPDCN is based on the immunophenotypic
diagnostic triad of CD123, CD4, and CD56. For more information,
please visit the BPDCN disease awareness website at
www.bpdcninfo.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 and timing
of our MAA submission to the EMA CHMP; the success and timing of
our clinical trials and preclinical studies for our product
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 products and product candidates may treat are
inaccurate; 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 maintain or
increase sales of ELZONRIS; the company’s ability to develop and
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:Investors:Investor
RelationsStemline Therapeutics, Inc.750 Lexington AvenueEleventh
FloorNew York, NY 10022Tel: 646-502-2307Email:
investorrelations@stemline.com
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