BEIJING, June 26,
2024 /PRNewswire/ -- CASI Pharmaceuticals, Inc.
(Nasdaq: CASI) ("CASI" or the "Company"), a biopharmaceutical
company specializing in the development and commercialization of
innovative therapeutic and pharmaceutical products, announced today
that the Company is planning to submit an Investigational New Drug
("IND") application to the U.S. Food and Drug Administration
("FDA") for CID-103 for the treatment of antibody-mediated
rejection ("AMR") in kidney transplant recipients by the end of
2024. CID-103 is a fully human IgG1 anti-CD38 monoclonal antibody
recognizing a unique epitope that has demonstrated an encouraging
preclinical efficacy and safety profile compared to other anti-CD38
monoclonal antibodies. The Company believes that with the proceeds
from the previously announced private placement financing, together
with its existing cash and cash equivalents, it will have
sufficient capital to complete the Phase II clinical trial for
AMR.
CASI also announced that its board of directors (the "Board")
received a preliminary non-binding proposal letter (the "Proposal
Letter") dated June 21, 2024, from
Dr. Wei-Wu He, Chairman of the Board
and CEO of the Company, to acquire the entire business operations
of the Company in China and all
license-in, distribution and related rights in Asia (excluding Japan) related to all of the Company's
pipeline products, including but not limited to
EVOMELA®, FOLOTYN®, CNCT19, BI-1206,
CB-5339,CID-103 and Thiotepa, for an aggregate purchase price of
$40.0 million, which shall include
assumption of up to $20.0 million of
indebtedness of the Company (the "Proposed Transaction").
On June 25, the Board has formed a
special committee comprised solely of incumbent independent
directors (the "Special Committee") to evaluate the transaction
contemplated under the Proposal Letter and such other strategic and
business alternatives available to the Company in respect of the
Company's business operations in China.
The Board and the Special Committee caution the Company's
shareholders and others considering trading the Company's
securities that no decisions have been made with respect to the
Proposed Transaction or any alternative strategic option that the
Company may pursue. There can be no assurance that any definitive
offer will be received, that any definitive agreement will be
executed relating to the Proposed Transaction or that any other
transaction will be approved or consummated. The Company does not
undertake any obligation to provide any updates with respect to any
transaction, except as required under applicable law.
About CASI Pharmaceuticals
CASI Pharmaceuticals, Inc. is a biopharmaceutical company
focused on developing and commercializing innovative therapeutics
and pharmaceutical products in China, the United
States, and throughout the world. The Company is focused on
acquiring, developing, and commercializing products that augment
its hematology oncology therapeutic focus as well as other areas of
unmet medical need. The Company intends to execute its plan to
become a leader by launching medicines in the Greater China market, leveraging the Company's
China-based regulatory and
commercial competencies and its global drug development expertise.
The Company's operations in China
are conducted through its wholly owned subsidiary, CASI
Pharmaceuticals (China) Co., Ltd.,
located in Beijing, China.
Forward-Looking Statements
This announcement contains forward-looking statements. These
statements are made under the "safe harbor" provisions of the U.S.
Private Securities Litigation Reform Act of 1995. These
forward-looking statements can be identified by terminology such as
"will," "expects," "anticipates," "future," "intends," "plans,"
"believes," "estimates," "confident" and similar statements. Among
other things, the business outlook and quotations from management
in this announcement, as well as the Company's strategic and
operational plans, contain forward-looking statements. The Company
may also make written or oral forward-looking statements in its
periodic reports to the U.S. Securities and Exchange Commission
(the "SEC"), in in its annual report to shareholders, in press
releases and other written materials and in oral statements made by
its officers, directors or employees to third parties. Statements
that are not historical facts, including statements about the
Company's beliefs and expectations, are forward-looking statements.
Forward-looking statements involve inherent risks and
uncertainties. A number of factors could cause actual results to
differ materially from those contained in any forward-looking
statement, including but not limited to the following: the risk
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 possibility that we may be delisted from trading on The
Nasdaq Capital Market if we fail to satisfy applicable continued
listing standards; the volatility in the market price of our
ordinary shares; the risk of substantial dilution of existing
shareholders in future share issuances; the difficulty of executing
our business strategy on a global basis including China; our inability to enter into strategic
partnerships for the development, commercialization, manufacturing
and distribution of our proposed product candidates or future
candidates; legal or regulatory developments in China that adversely affect our ability to
operate 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, European
Medicines Agency, PRC National Medical Products Administration, 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 risks relating to the need for additional capital
and the uncertainty of securing additional funding on favorable
terms; the risks associated with our product candidates, and the
risks associated with our other early-stage products under
development; the risk that result in preclinical and clinical
models are not necessarily indicative of clinical results;
uncertainties relating to preclinical and clinical trials,
including delays to the commencement of such trials; our ability to
protect our intellectual property rights; the lack of success in
the clinical development of any of our products; and our dependence
on third parties; the risks related to our dependence on Juventas
to conduct the clinical development of and to partner with us to
co-market CNCT19; risks related to our dependence on Juventas to
ensure the patent protection and prosecution for CNCT19; risks
relating to the commercialization, if any, of our proposed products
(such as marketing, safety, regulatory, patent, product liability,
supply, competition and other risks); risks relating to interests
of our largest shareholder and our Chairman and CEO that differ
from our other shareholders; and risks related to the development
of a new manufacturing facility by CASI Pharmaceuticals (Wuxi) Co.,
Ltd. Further information regarding these and other risks is
included in the Company's filings with the SEC. All information
provided herein is as of the date of this announcement, and the
Company undertakes no obligation to update any forward-looking
statement, except as required under applicable law.
COMPANY CONTACT:
Rui Zhang
CASI Pharmaceuticals, Inc.
240.864.2643
ir@casipharmaceuticals.com
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