ROCKVILLE, Md., Nov. 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
third quarter and nine months ended September 30, 2018 and provided a review of
recent accomplishments and anticipated upcoming milestones.
Ken K. Ren, Ph.D., CASI's Chief
Executive Officer, commented, "CASI made substantial progress in
the third quarter. We continue working with relevant
regulatory authorities and our strategic partners in the U.S. and
in China to advance EVOMELA,
MARQIBO, and ZEVALIN closer to the finish line in terms of CFDA
approval and are making solid progress on all fronts. Our recent
appointments of George Chi as Chief
Financial Officer and Larry Zhang as
President of CASI's Beijing
operations further underscore our commitment to bringing
high-quality, cost-effective pharmaceutical products and innovative
therapeutics to the market, and enables us to significantly ramp up
our commercial preparatory activities. We recently acquired a U.S.
FDA-approved ANDA for HBV from Laurus Labs Limited and continue to
pursue opportunities to further augment our pipeline in conjunction
with our broader mission."
Third Quarter and Recent Business Highlights
September Financing – During September, CASI
received gross proceeds of approximately $37.5 million from a private placement of shares
of common stock and warrants to purchase common stock to new and
existing shareholders. The net proceeds will be used to
support commercial activities, ongoing business development and for
general working capital purposes.
New Executive Appointments: Chief Financial Officer and
President of CASI China – On September
28, CASI announced the appointment of George Chi as Chief Financial Officer to oversee
the company's expanding fiduciary responsibilities as it gears up
for commercialization in China and
to lead the company's financial strategy and affairs. On
October 2, the company announced the
appointment of Larry Zhang as
President of CASI (Beijing)
Pharmaceuticals Co., Ltd., the China operating subsidiary of CASI
Pharmaceuticals, Inc. Mr. Zhang is overseeing operations in
China as CASI prepares for
commercial activities.
Acquired U.S. FDA-approved abbreviated new drug application
(ANDA) from Laurus Labs Limited – On October 23, CASI announced that it had acquired
tenofovir disoproxil fumarate (TDF), indicated for the treatment of
hepatitis B virus (HBV), from Laurus Labs Limited. The
aggregate purchase price for the ANDA was $3
million, with an upfront payment of $700,000 and $2.3
million to be paid upon completion of certain
milestones. The acquisition of TDF is consistent with the
company's mission to commercialize U.S. FDA approved drugs in
China.
China FDA (CFDA) import drug registration priority review of
EVOMELA® in progress – CASI has 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 has established a core in-house marketing and sales team led
by Thomas Zhang, who possesses a
20-year track record of commercializing oncology drugs in
China for Roche and Johnson &
Johnson.
CFDA review in progress for
Marqibo® and Zevalin® –
CASI continues to make good progress with the CFDA toward advancing
Marqibo's and ZEVALIN's import drug clinical trial
applications. The ZEVALIN antibody kit and the radioactive
Yttrium-90 component of the application require separate
submissions; both are currently under technical review by the
Center for Drug Evaluation of the CFDA and the quality confirmatory
testing by National Institute for Food and Drug Control (NIFDC) of
the CFDA as part of the regulatory review process.
Third Quarter and First Nine Months 2018 Financial
Results
Cash Position: As of September
30, CASI had cash and cash equivalents of $98.9 million compared to $66.2 million as of June
30, 2018. This increase primarily reflects the gross
proceeds of $37.5 million received in
September 2018 related to CASI's
$48.5 million private placement
announced in September 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 nine months ended September 30, 2018, were $1.8 million and $5.2
million, respectively, compared to $1.0 million and $3.7
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 services
associated with the recently acquired ANDA portfolio, as well as
increased costs associated with the Company's internal preclinical
activities in China.
G&A Expenses: General and administrative
(G&A) expenses for the three and nine months ended September 30, 2018, were $6.9 million and
$12.3 million, respectively, compared
to $0.6 million and $2.0 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 $1.6
million and $3.3 million for
the three and nine months ended September
30, 2018, respectively, compared to $0.1 million and $0.3
million in the respective periods in 2017.
Net Loss: The Company reported a net loss attributable to
common shareholders for the three and nine months ended
September 30, 2018 of ($8.8) million, or ($0.10) per share, and ($18.2) million, or ($0.22) per share, respectively, compared to
($1.6) million, or ($0.03) per share, and ($5.7) million, or ($0.10) per share for the same periods in 2017.
The larger net loss for both periods 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 related to
exploratory acquisition efforts and investor relations activities,
higher professional service fees, and administrative fees
associated with the Company's September
2018 financing.
Further information regarding the Company, including its
Quarterly Report on Form 10-Q for the quarter ended September 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 from Sandoz, and recently acquired an HBV ANDA
from Laurus Labs. 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
Juliette
Bogus
410.980.5687
juliettebogus@presscommpr.com
|
(Financial Table Follows)
CASI
Pharmaceuticals, Inc.
|
SUMMARY OF
OPERATING RESULTS
|
|
Three Months
Ended
September
30,
|
|
|
|
|
|
2018
|
|
2017
|
Total
revenues
|
$
-
|
|
$
-
|
|
|
|
|
Research and
development
|
$
1,806,222
|
|
$
970,989
|
|
|
|
|
General and
administrative
|
$
6,904,800
|
|
$
625,878
|
|
|
|
|
Net loss
|
$
(8,756,311)
|
|
$
(1,613,523)
|
|
|
|
|
Net loss per share
attributable to common shareholders
(basic and diluted)
|
$
(0.10)
|
|
$
(0.03)
|
|
|
|
|
Weight average number
of
shares outstanding
(basic and diluted)
|
86,953,611
|
|
60,196,574
|
|
|
|
|
Cash and cash
equivalents
|
$
98,867,087
|
|
$
21,640,068
|
Nine Months
Ended
|
September
30,
|
|
|
2018
|
|
2017
|
Total
revenues
|
$
-
|
|
$
-
|
|
|
|
|
Research and
development
|
$
5,232,925
|
|
$
3,747,683
|
|
|
|
|
General and
administrative
|
$
12,250,269
|
|
$
1,961,463
|
|
|
|
|
Acquired in-process
research and development
|
$
686,998
|
|
$
-
|
|
|
|
|
Net loss
|
$
(18,207,005)
|
|
$
(5,722,287)
|
|
|
|
|
Net loss per share
attributable to
common shareholders
(basic and diluted)
|
$
(0.22)
|
|
$
(0.10)
|
|
|
|
|
Weighted average
number of
shares outstanding
(basic and diluted)
|
81,457,085
|
|
60,196,574
|
|
|
|
|
Cash and cash
equivalents
|
$
98,867,087
|
|
$
21,640,068
|
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SOURCE CASI Pharmaceuticals, Inc.