ROCKVILLE, Md., May 15, 2019 /PRNewswire/ -- CASI
Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. pharmaceutical company
with a platform to develop and accelerate the launch of innovative
therapeutics and pharmaceutical products in China, the U.S., and throughout the world,
today reported financial results for the first quarter 2019 and
provided a review of recent accomplishments and anticipated
upcoming milestones.
Wei-Wu He, Ph.D., CASI's Chairman
and Chief Executive Officer, commented, "We have made good progress
in the first quarter of 2019. Most recently, we announced that we
acquired exclusive worldwide rights to a novel anti-CD38 monoclonal
antibody (CID-103). Preclinical data suggests an enhanced safety
and efficacy profile against a broad array of hematological
malignancies expressing CD38, making CID-103 an excellent strategic
fit amid our broader oncology platform. We look forward to
announcing progress in this program as well as across other key
programs in our pipeline."
First Quarter and Recent Business Highlights
Acquired worldwide rights to CID-103, a novel anti-CD38
monoclonal antibody – On April 17,
2019, CASI acquired worldwide rights to CID-103, a
novel anti-CD38 monoclonal antibody. CID-103 is a human
monoclonal antibody targeting a specific epitope of the CD38 cell
surface antigen. It is at the IND/IMPD submission stage of
development with Phase 1 trials expected in late 2019 or early
2020. The addition of CID-103 compliments the Company's oncology
pipeline and allows the Company to provide more treatment options
to patients in the future.
Entered into distribution agreement with China distribution partner for
EVOMELA® (melphalan hydrochloride for injection) –
In March 2019, the Company entered
into an exclusive distribution agreement with China Resources
Guokang Pharmaceuticals Co., Ltd., (CRGK) to be the
Company's exclusive distributor in China for EVOMELA®. CASI will
maintain responsibility for direct marketing and sales.
Received National Medical Products Administration (NMPA)
Clinical Trial Application (CTA) Approvals – In
February and March 2019, CASI
announced key NMPA clinical trial approvals (CTA) to conduct
confirmatory registration trials for both
ZEVALIN® and MARQIBO®,
respectively. ZEVALIN® is indicated for
relapsed or refractory, low-grade or follicular B-cell
non-Hodgkin's lymphoma and MARQIBO® is indicated
for Philadelphia
chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in
second or greater relapse or whose disease has progressed following
two or more anti-leukemia therapies. The Company is working toward
getting the trials started in China.
Chairman Wei-Wu He, Ph.D.
expanded role to include Chief Executive Officer – On
April 2, 2019, CASI appointed its
Chairman of the Board of Directors as the Company's Chief Executive
Officer. Dr. He served on CASI's Board of Directors since
2012. Dr. He has a very successful career building companies
from early stage to revenue and profitability stages and most
recently was the CEO of OriGene Technologies which he co-founded
and built into a profitable life science company; OriGene
ultimately merged with a publicly traded Chinese company in
2018.
Financial Results for the Quarter ended March 31,
2019
Cash Position: As of March 31,
2019, CASI had cash and cash equivalents of $99.7 million.
R&D Expenses: R&D expenses for the quarter
ended March 31, 2019 were $2.6 million compared to
$1.7 million in 2018, an
increase of $0.9 million. The
increase in R&D expenses primarily reflects costs associated
with regulatory, consulting and manufacturing related services,
primarily associated with our acquired ANDAs in 2018, as well as an
increase in facility costs due to new lease space in China, as well as an increase in personnel
costs due to growth in the number of employees.
G&A Expenses: G&A expenses for the quarter
ended March 31, 2019 were $5.7 million compared to
$1.3 million in 2018. The
increase of $4.4 million in G&A
over the prior year primarily reflects an increase of $1.6 million in non-cash stock compensation
expense largely attributed to stock options issued to the Company's
Chairman and also the President of CASI China, an increase in
salary, benefits and recruitment expense, as well as facilities
costs primarily in China, 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 professional
services fees, including audit and legal services during the 2019
period.
Net Loss: The Company reported a net loss of
($8.2 million), or ($0.09) per share, for the quarter ended
March 31, 2019. This compares
with a net loss of ($3.6 million), or
($0.05) per share for the first
quarter of 2018. The larger net loss for both periods is
primarily due to the increase in non-cash stock-based compensation
expense during the 2019 period, costs associated with the
manufacturing and regulatory support for our ANDA portfolio, and
increased costs associated with G&A functions, including
employment costs for sales and marketing efforts, as well as
increased facilities cost in China
and higher professional service fees.
Further information regarding the Company, including its
Quarterly Report on Form 10-Q for the quarter ended March 31, 2019, can be found at
www.casipharmaceuticals.com.
About CASI Pharmaceuticals
CASI Pharmaceuticals is a U.S. pharmaceutical company with a
platform to develop and accelerate the launch of pharmaceutical
products and innovative therapeutics in China, the U.S., and throughout the
world. CASI's product pipeline features (i) CID-103, an
anti-CD38 monoclonal antibody being developed for the treatment of
hematological cancers; (ii) China
regional rights to three U.S. Food and Drug Administration
(FDA)-approved drugs (EVOMELA®) (melphalan hydrochloride
for injection) approved by China's
National Medical Products Administration (NMPA) for marketing,
ZEVALIN® (ibritumomab tiuxetan) and MARQIBO®
(vincristine sulfate LIPOSOME injection) approved by NMPA for
registration confirmatory trials in China; and (iii) a portfolio of FDA-approved
and pending abbreviated new drug applications (ANDAs). CASI
has offices in Rockville, Maryland
and a wholly owned subsidiary in Beijing,
China through which substantially all of our operations are
conducted. 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: the difficulty of
executing our business strategy in China; 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
FDA, NMPA, or other regulatory 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 CID-103 and our
product candidates; risks associated with CID-103 and our other
early-stage products under development; risks 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
Acrotech Biopharma LLC 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
|
(Financial Table Follows)
CASI
Pharmaceuticals, Inc.
|
SUMMARY OF
OPERATING RESULTS
|
|
Three Months Ended
March 31,
|
|
|
|
|
|
2019
|
|
2018
|
Total
Revenues
|
$
-
|
|
$
-
|
Research &
development
|
$
2,614,657
|
|
$
1,697,232
|
General &
administrative
|
$
5,709,687
|
|
$
1,303,122
|
Acquired in-process
research and development
|
$
-
|
|
$
686,998
|
Net loss
|
$(8,159,262)
|
|
$(3,590,910)
|
Net loss per share
attributable to common shareholders
(basic and diluted)
|
$
(0.09)
|
|
$
(0.05)
|
Weight average number
of shares outstanding (basic and
diluted)
|
95,649,773
|
|
71,215,000
|
Cash and cash
equivalents
|
$99,733,620
|
|
$49,887,600
|
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SOURCE CASI Pharmaceuticals, Inc.