ROCKVILLE, Md., Oct. 13, 2017 /PRNewswire/ -- CASI
Pharmaceuticals, Inc. (the "Company") (Nasdaq: CASI), a
biopharmaceutical company dedicated to the acquisition, development
and commercialization of innovative therapeutics addressing cancer
and other unmet medical needs for the global market with a
commercial focus on China,
announced that it has entered into definitive agreements with
certain institutional and accredited investors, including existing
shareholders, to purchase approximately $23.8 million of securities in a registered
direct offering. CASI expects to receive net proceeds of
approximately $23.3 million after
deducting agent's fees and other offering expenses.
CASI has agreed to sell an aggregate of approximately 7,951,868
shares of its common stock and warrants to purchase shares of its
common stock. Each unit, consisting of one share of common
stock and a warrant to purchase 0.2 share of common stock will be
sold for a purchase price of $3.00. The warrants will become exercisable
six months after the issuance date and have a term of 2.5 years and
an exercise price equal to $3.75. The offering is expected to close on
or about October 17, 2017, subject to
satisfaction of customary closing conditions.
Dr. Wei-Wu He, the Company's
Chairman, stated, 'We are pleased with the return of our investors
and the positive momentum of our Company. We intend to use
the net proceeds to support our business development activities and
drive the Company's continued growth. We also are pleased with the
China FDA's recent public guidance that in its efforts to
accelerate approvals for imported drugs, it plans to accept data
from clinical trials outside of China. We believe this could potentially
accelerate our pipeline of U.S. approved drugs that are currently
under China FDA review, namely EVOMELA®, which has been
granted priority review; and MARQIBO® and
ZEVALIN®. We look forward to accelerating these
medicines to the second largest pharmaceutical market, and will
continue to add on to our pipeline."
HC Wainwright acted as exclusive placement agent in this
transaction. A shelf registration statement containing a
prospectus relating to the shares of common stock and warrants to
be issued in this transaction (and the shares of common stock
issuable upon exercise of the warrants) has been filed with the
Securities and Exchange Commission (the "SEC") and declared
effective on October 15, 2015.
A prospectus supplement relating to the offering will be filed by
CASI with the SEC. Copies of the prospectus and prospectus
supplement and accompanying prospectuses may be obtained directly
from. This announcement is neither an offer to sell nor a
solicitation of an offer to buy any securities of CASI. No
offer, solicitation or sale will be made in any jurisdiction in
which such offer, solicitation or sale is unlawful.
About CASI Pharmaceuticals, Inc.
CASI is a U.S. based, late-stage biopharmaceutical company
focused on the acquisition, development and commercialization of
innovative therapeutics addressing cancer and other unmet medical
needs for the global market with a focus on commercialization in
China. CASI's product pipeline
features (1) EVOMELA®, MARQIBO® and
ZEVALIN®, all U.S. Food and Drug Administration (FDA)
approved drugs in-licensed from Spectrum Pharmaceuticals, Inc. for
China regional rights, and
currently in various stages in the regulatory and clinical process
for market approval in China, (2)
CASI-001 and CASI-002, proprietary preclinical candidates in
immune-oncology, and (3) our proprietary drug candidate, ENMD-2076,
ongoing in one Phase 2 clinical study. CASI is headquartered
in Rockville, Maryland and has a
wholly owned subsidiary and R&D operations in Beijing, China. More information on CASI is
available at www.casipharmaceuticals.com and in CASI's filings with
the U.S. Securities and Exchange Commission.
CASI's China rights to
EVOMELA® (melphalan) for Injection, MARQIBO®
(vinCRIStine sulfate LIPOSOME injection) and ZEVALIN®
(ibritumomab tiuxetan) were previously licensed from its partner
Spectrum Pharmaceuticals, Inc. Based on the U.S. FDA's
approval of these three licensed products, CASI is pursuing the
Import Drug registration path for approval in China.
Forward Looking Statements
This news release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act with
respect to the outlook for expectations for future financial or
business performance, strategies, expectations and goals.
Forward looking statements are subject to numerous assumptions,
risks and uncertainties, which change over time. Forward-looking
statements speak only as of the date they are made, and no duty to
update forward-looking statements is assumed. Actual results
could differ materially from those currently anticipated due to a
number of factors, including: that we may be unable to continue as
a going concern as a result of our inability to raise sufficient
capital for our operational needs; the volatility in the market
price of our common stock; risks relating to interests of our
largest stockholders that differ from our other stockholders; the
risk of substantial dilution of existing stockholders in future
stock issuances, the difficulty of executing our business strategy
in China; our inability to predict
when or if our product candidates will be approved for marketing by
the China Food and Drug Administration authorities; our inability
to enter into strategic partnerships for the development,
commercialization, manufacturing and distribution of our proposed
product candidates or future candidates; risks relating to the need
for additional capital and the uncertainty of securing additional
funding on favorable terms; risks associated with our product
candidates; risks associated with any early-stage products under
development; the risk that results in preclinical and early
clinical models are not necessarily indicative of later clinical
results; uncertainties relating to preclinical and clinical trials,
including delays to the commencement of such trials; the lack of
success in the clinical development of any of our products;
dependence on third parties; and risks relating to the
commercialization, if any, of our proposed products (such as
marketing, safety, regulatory, patent, product liability, supply,
competition and other risks). Such factors, among others,
could have a material adverse effect upon our business, results of
operations and financial condition. We caution readers not to
place undue reliance on any forward-looking statements, which only
speak as of the date made. Additional information about the factors
and risks that could affect our business, financial condition and
results of operations, are contained in our filings with the U.S.
Securities and Exchange Commission, which are available at
www.sec.gov.
EVOMELA®, MARQIBO® and
ZEVALIN® are proprietary to Spectrum
Pharmaceuticals, Inc. and its affiliates.
COMPANY
CONTACT:
CASI Pharmaceuticals,
Inc.
240.864.2643
ir@casipharmaceuticals.com
|
INVESTOR
CONTACT:
Torrey Hills
Capital
Jim
Macdonald
858.456.7300
jm@sdthc.com
|
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SOURCE CASI Pharmaceuticals, Inc.