ROCKVILLE, Md., Aug. 14, 2018 /PRNewswire/ -- CASI
Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company
dedicated to the development and delivery of high quality,
cost-effective pharmaceutical products and innovative therapeutics
to patients in the U.S., China and
throughout the world, today reported financial results for the
second quarter and six months ended June 30,
2018 and provided a review of recent accomplishments and
anticipated upcoming milestones.
Ken K. Ren, Ph.D., CASI's Chief
Executive Officer, commented, "Our financial results for the second
quarter of 2018 are in line with our expectations. We have
made tremendous progress since the start of 2018 and remain
committed to working with the relevant regulatory authorities and
our strategic partners in the U.S. and in China to provide high quality, life-saving
medications to patients. We will continue to advance our current
product portfolio while evaluating additional opportunities to add
further medicines to our pipeline."
Second Quarter and Recent Business Highlights
China FDA (CFDA) import drug registration priority review of
EVOMELA® in progress – On April 26, 2018, the Center for Drug Evaluation
(CDE) of the China FDA held a Clinical Advisory Committee (the
"Advisory Committee") meeting to review the EVOMELA
application. CASI has recently received a series of standard
questions from the CFDA related to EVOMELA drug product production
which usually reflect the final stage of CFDA assessment before
approval based on the Import Drug Approval registration
pathway. CASI is working with Spectrum Pharmaceuticals and
its vendors from whom EVOMELA is in-licensed to address the
questions and submit the requested documents.
Preparation continues for EVOMELA®'s
commercial launch in China –
CASI is building an in-house marketing and sales team with key
members in place. The team is led by Thomas
Zhang who has a 20-year track record of commercialization of
multiple anti-cancer drugs in China for companies such as Roche and Johnson
& Johnson.
CFDA review in progress for
Marqibo® and Zevalin® –
CASI continues to work with the CFDA on advancing Marqibo's import
drug clinical trial application and anticipates that the regulatory
agency will complete its review within the next four to six months.
The import drug clinical trial application for ZEVALIN is
also in process with CFDA. The ZEVALIN antibody kit and the
radioactive Yttrium-90 component of the application require
separate submissions of which both are currently under technical
review by the CDE of CFDA and the quality confirmatory testing by
National Institute for Food and Drug Control (NIFDC) of CFDA as
part of the regulatory review process.
Company enters into strategic manufacturing agreement –
In June 2018, CASI entered into a
strategic and long-term contracting manufacturing agreement for the
manufacturing of entecavir and cilostazol. The partnership will
support CASI's plan to market and sell both products in
China, U.S. and worldwide
markets. Entecavir and cilostazol are part of the 29
abbreviated new drug applications (ANDAs) that were acquired from
Sandoz in January 2018.
CASI added to Russell
2000®, 3000® and
Microcap® Indexes – In July 2018, CASI announced that the company has
been added to the Russell 2000®,
3000® and Microcap® Indexes.
Second Quarter and First Half 2018 Financial Results
Cash Position: As of June 30,
2018, CASI had cash and cash equivalents of $66.2 million compared to $49.9 million as of March
31, 2018. This increase primarily reflects the
remaining gross proceeds of $20.7
million received in April 2018
related to CASI's $50 million private
placement announced in March 2018,
partially offset by costs related to operating expenses during the
quarter.
R&D Expenses: Research and development (R&D)
expenses for the three and six months ended June 30, 2018, were $1.7
million and $3.4 million,
respectively, compared to $1.7
million and $2.8 million for
the same periods in 2017. The increase in R&D expenses
primarily reflects personnel costs associated with the technology
transfer activities and regulatory support associated with the
recently acquired ANDA portfolio, offset by a decrease in costs
related to the timing of the CFDA regulatory process of CASI's
in-licensed U.S. FDA approved assets from Spectrum
Pharmaceuticals.
G&A Expenses: General and administrative
(G&A) expenses for the three and six months ended June 30, 2018, were $4.0 million and
$5.3 million, respectively, compared
to $0.7 million and $1.3 million for the same periods in 2017. The
increase in G&A over the prior year is primarily attributed to
non-cash stock-based compensation expense for the stock options
issued to the Company's Executive Chairman and an increase in
salary, benefits and recruitment expense in China, largely related to sales and marketing
efforts to prepare for the anticipated launch of the Company's
first commercial product in China,
as well as other G&A functions. There were also increased costs
associated with business development related to exploratory
acquisition activities, investor and public relations activities,
and an increase in legal and other professional services fees
during the 2018 period. G&A expenses include non-cash
stock-based compensation of $1.5
million and $1.6 million for
the three and six months ended June 30,
2018, respectively, compared to $0.1
million and $0.2 million in
the respective periods in 2017.
Net Loss: The Company reported a net loss attributable to
common shareholders for the three and six months ended June 30, 2018 of ($5.9)
million, or ($0.07) per share,
and ($9.5) million, or ($0.12) per share, respectively, compared to
($2.4) million, or ($0.04) per share, and ($4.1) million, or ($0.07) per share for the same periods in 2017.
The larger net loss is primarily due to the non-cash stock-based
compensation expense for stock options issued to the Company's
Executive Chairman, costs associated with the technology transfer
activities and regulatory support for our ANDA portfolio, the
write-off of approximately $0.7
million in January 2018 due to
acquired in-process R&D primarily related to ANDAs not approved
by the FDA, and increased costs associated with G&A functions,
including employment costs for sales and marketing efforts,
increased business development and investor relations activities,
as well as other professional service fees.
Further information regarding the Company, including its
Quarterly Report on Form 10-Q for the quarter ended June 30, 2018, can be found at
www.casipharmaceuticals.com.
About CASI Pharmaceuticals, Inc.
CASI Pharmaceuticals (NASDAQ: CASI) is a U.S.-based
biopharmaceutical company dedicated to the development and delivery
of high quality, cost-effective pharmaceutical products and
innovative therapeutics to patients in the U.S., China and throughout the world. CASI's product
pipeline features three U.S. Food and Drug Administration
(FDA)-approved drugs in-licensed from Spectrum Pharmaceuticals,
Inc. for China regional rights.
These are currently in various stages in the regulatory process for
market approval in China. The
Company also acquired a portfolio of 25 FDA-approved abbreviated
new drug applications (ANDAs), and four pipeline ANDAs that are
pending FDA approval. 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.
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: risks relating to interests of our
largest stockholders that differ from our other stockholders; the
difficulty of executing our business strategy in China; the risk that we will not be able to
effectively select, register and commercialize products from our
recently acquired portfolio of abbreviated new drug applications
(ANDAs); our lack of experience in manufacturing products and
uncertainty about our resources and capabilities to do so on a
clinical or commercial scale; risks relating to the
commercialization, if any, of our products and proposed products
(such as marketing, safety, regulatory, patent, product liability,
supply, competition and other risks); 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; the volatility in the
market price of our common stock; 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; 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; and our
dependence on third parties. 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:
Solebury
Trout
Jennifer
Porcelli
646.378.2962
jporcelli@troutgroup.com
Brennan
Doyle
617.221.9005
BDoyle@troutgroup.com
|
MEDIA
CONTACT:
PressComm PR,
LLC
Jamie
Lacey-Moreira
410.299.3310
jamielacey@presscommpr.com
|
(Financial Table Follows)
CASI
Pharmaceuticals, Inc.
|
SUMMARY OF
OPERATING RESULTS
|
|
Three Months Ended
June 30,
|
|
|
|
|
|
2018
|
|
2017
|
Total
Revenues
|
$
-
|
|
$
-
|
Research &
Development
|
$
1,729,470
|
|
$
1,727,407
|
General &
Administrative
|
$
4,042,347
|
|
$
691,422
|
Net loss
|
$(5,859,783)
|
|
$(2,408,582)
|
Net loss per share
attributable to common shareholders
(basic and diluted)
|
$
(0.07)
|
|
$
(0.04)
|
Weight average number
of shares outstanding
(basic and diluted)
|
86,029,692
|
|
60,196,574
|
Cash and cash
equivalents
|
$66,215,678
|
|
$23,360,529
|
|
Six Months
Ended June 30,
|
|
|
|
2018
|
|
2017
|
|
|
|
|
Research &
Development
|
$
3,426,703
|
|
$
2,776,694
|
General &
Administrative
|
$
5,345,469
|
|
$
1,335,585
|
Acquired in-process
Research & development
|
$
686,998
|
|
$
-
|
|
|
|
|
Net loss
|
$
(9,450,694)
|
|
$
(4,108,764)
|
Net loss per share
attributable to
common shareholders
(basic and diluted)
|
$
(0.12)
|
|
$
(0.07)
|
Weighted average
number of
shares outstanding
(basic and diluted)
|
78,663,271
|
|
60,196,574
|
Cash and cash
equivalents
|
$
66,215,678
|
|
$
23,360,529
|
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SOURCE CASI Pharmaceuticals, Inc.