ROCKVILLE, Md., Nov. 14, 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, today
reported financial results for the three and nine months ended
September 30, 2017.
As of September 30, 2017, CASI had
cash and cash equivalents of approximately $21.6 million.
CASI reported a net loss for the third quarter of 2017 of
($1.6 million), or ($0.03) per share. This compares with a net loss
of ($1.7 million), or ($0.03) per share, for the same period last year.
For the first nine months of 2017, the Company reported a net loss
of ($5.7 million), or ($0.10) per share as compared to a net loss of
($6.8 million), or ($0.15) per share for the first nine months of
2016. The smaller net loss for the nine-month period in 2017 can be
attributed to a decrease in non-cash compensation expense
associated with the timing of stock option issuances and a decrease
in clinical costs associated with the ENMD-2076 fibrolamellar
trial, offset by an increase in R&D costs related to the
advancement of EVOMELA®, MARQIBO®, and
ZEVALIN® with the China Food and Drug Administration
(CFDA) and an increase in costs related to our internal preclinical
program.
Ken K. Ren, Ph.D., CASI's Chief
Executive Officer, stated, "I am pleased with our third quarter
financial results. In October, we announced a $23.8 million registered direct offering, funds
raised from which will be used to advance our internal pipeline and
support our business development in-license activities. With
respect to existing in-licensed assets, we continue to advance
EVOMELA®, MARQIBO®, and
ZEVALIN® for the China
market. EVOMELA® has been granted priority review by the
CFDA, which we believe will accelerate its approval for the
treatment of patients with multiple myeloma. We look forward to
providing further updates on these in-licensed assets as well as on
our internal pipeline
candidates."
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
|
(Financial Table Attached)
CASI
PHARMACEUTICALS, INC.
SUMMARY OF
OPERATING RESULTS
|
Three Months Ended
September 30,
|
|
|
2017
|
2016
|
Total
revenues
|
$
|
-
|
$
|
-
|
|
|
|
Research and
development
|
$
|
970,989
|
$
|
1,013,929
|
|
|
|
General and
administrative
|
$
|
625,878
|
$
|
676,927
|
|
|
|
Net loss
|
$
|
(1,613,523)
|
$
|
(1,693,492)
|
Net loss per share
attributable to
common shareholders
(basic and diluted)
|
$
|
(0.03)
|
$
|
(0.03)
|
|
|
|
Weighted average
number of
shares outstanding
(basic and diluted)
|
|
60,196,574
|
|
49,227,983
|
|
|
|
Cash and cash
equivalents
|
$
|
21,640,068
|
$
|
24,137,329
|
|
Nine Months Ended
September 30,
|
|
|
2017
|
2016
|
Total
revenues
|
$
|
-
|
$
|
-
|
|
|
|
Research and
development
|
$
|
3,747,683
|
$
|
3,395,362
|
|
|
|
General and
administrative
|
$
|
1,961,463
|
$
|
3,356,804
|
|
|
|
Net loss
|
$
|
(5,722,287)
|
$
|
(6,779,728)
|
Net loss per share
attributable to
common shareholders
(basic and diluted)
|
$
|
(0.10)
|
$
|
(0.15)
|
|
|
|
Weighted average
number of
shares outstanding
(basic and diluted)
|
|
60,196,574
|
|
44,132,599
|
|
|
|
Cash and cash
equivalents
|
$
|
21,640,068
|
$
|
24,137,329
|
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SOURCE CASI Pharmaceuticals, Inc.