Stemline Therapeutics, Inc
. (Nasdaq: STML), a
commercial-stage biopharmaceutical company focused on discovering,
acquiring, developing and commercializing innovative oncology
therapeutics, today announced the pricing of an underwritten public
offering of 5,000,000 shares of its common stock at a price of
$15.25 per share, with expected gross proceeds to Stemline of
$76,250,000. Stemline has also granted the underwriters a 30-day
option to purchase up to 750,000 additional shares of its common
stock at the public offering price, less underwriting discounts and
commissions. The offering is expected to close on or about August
13, 2019, subject to customary closing conditions.
J.P. Morgan Securities LLC and Cowen and Company, LLC are acting
as joint book-running managers for the offering. Cantor Fitzgerald
& Co., Ladenburg Thalmann & Co. Inc. and H.C. Wainwright
& Co., LLC are acting as co-lead managers for the offering and
ThinkEquity, a division of Fordham Financial Management, Inc.,
A.G.P./Alliance Global Partners, and Aegis Capital Corp. are acting
as co-managers 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 chronic
myelomonocytic leukemia (CMML), myelofibrosis (MF), acute myeloid
leukemia (AML), and potentially other diseases such as certain
lymphomas; (iii) clinical development of additional pipeline
candidates (felezonexor (SL-801), SL-1001, SL-901 and SL-701); (iv)
research and development and regulatory activities; (v) potential
acquisitions and in-licensing; and (vi) 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 public offering of its common stock. The preliminary prospectus
supplement is available on the SEC's web site
at www.sec.gov. Copies of the final 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, or Cowen and
Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island
Avenue, Edgewood, New York 11717, Attn: Prospectus Department, or
by email at PostSaleManualRequests@broadridge.com.
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 CMML, MF, and 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 BPDCN,
certain myeloproliferative neoplasms (MPNs) including CMML and MF,
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 TherapeuticsStemline
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 BPDCN. In Europe, a MAA is
under review by the EMA. ELZONRIS is also being evaluated in
clinical trials in additional indications including CMML, MF and
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 Statements Some 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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