ROCKVILLE, Md., Aug. 14, 2017 /PRNewswire/ -- CASI
Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company
dedicated to innovative therapeutics addressing cancer and other
unmet medical needs, today reported financial results for the three
and six months ended June 30,
2017.
As of June 30, 2017, CASI had cash
and cash equivalents of approximately $23.4
million.
CASI reported a net loss for the second quarter of 2017 of
($2.4 million), or ($0.04) per share. This compares to a net loss of
($3.3 million), or ($0.08) per share, for the same period last year.
For the six months ended June 30,
2017, the Company reported a net loss of ($4.1 million), or ($0.07) per share, compared to a net loss of
($5.1 million), or ($0.12) per share, for the same period in
2016. The smaller net loss for the three and six month
periods in 2017 can be attributed to a decrease in non-cash
compensation expense associated with the timing of stock option
issuances, offset by an increase in costs related to the China Food
and Drug Administration (CFDA) regulatory process of our
in-licensed U.S. Food and Drug Administration (FDA) approved assets
from Spectrum Pharmaceuticals.
Ken K. Ren, Ph.D., CASI's Chief
Executive Officer, stated, "We continue to effectively manage
our expenses and are pleased to end the quarter with a strong cash
position. For the balance of 2017, we will continue to
advance MARQIBO®, ZEVALIN® and
EVOMELA® closer towards marketing approval in
China, evaluate our maturing
clinical data and determine the next steps for ENMD-2076, while at
the same time continue our business development activities to
further expand our pipeline."
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) our lead proprietary drug candidate, ENMD-2076, in
multiple Phase 2 clinical trials, (2) MARQIBO®,
ZEVALIN® and EVOMELA®, all FDA approved drugs
in-licensed from Spectrum Pharmaceuticals, Inc. for China regional rights, and currently in
various stages in the regulatory process for market approval in
China, and (3) proprietary
early-stage candidates in preclinical development. 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.
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.
MARQIBO®, EVOMELA® 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
June
30,
|
|
2017
|
|
2016
|
|
|
|
|
Research and
development
|
$
1,727,407
|
|
$
1,362,676
|
General and
administrative
|
$
691,422
|
|
$
1,914,802
|
Net loss
|
$
(2,408,582)
|
|
$
(3,291,870)
|
Net loss per share
attributable to
common shareholders
(basic and diluted)
|
$
(0.04)
|
|
$
(0.08)
|
Weighted average
number of
shares outstanding
(basic and diluted)
|
60,196,574
|
|
42,906,781
|
Cash and cash
equivalents
|
$
23,360,529
|
|
$
18,534,467
|
|
|
|
|
Six Months
Ended
June
30,
|
|
|
2017
|
|
2016
|
|
|
|
|
Research and
development
|
$
2,776,694
|
|
$
2,381,433
|
General and
administrative
|
$
1,335,585
|
|
$
2,679,877
|
Net loss
|
$
(4,108,764)
|
|
$
(5,086,236)
|
Net loss per share
attributable to
common shareholders
(basic and diluted)
|
$
(0.07)
|
|
$
(0.12)
|
Weighted average
number of
shares outstanding
(basic and diluted)
|
60,196,574
|
|
41,556,911
|
Cash and cash
equivalents
|
$
23,360,529
|
|
$
18,534,467
|
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SOURCE CASI Pharmaceuticals, Inc.