Full Press Release Details
CASI PHARMACEUTICALS RECEIVES NASDAQ DEFICIENCY
NOTICE REGARDING MINIMUM MARKET VALUE REQUIREMENT
BEIJING, China (May 7, 2025) CASI Pharmaceuticals,
Inc. (Nasdaq: CASI, "CASI" or the "Company"), a Cayman incorporated biopharmaceutical company focused on developing
and commercializing innovative therapeutics and pharmaceutical products, today announced that it has received a notice (the "Notice")
from The Nasdaq Stock Market LLC ("Nasdaq") dated May 5, 2025 stating that the Company is not in compliance with the requirement
to maintain a minimum Market Value of Listed Securities ("MVLS") of $35 million as set forth under Nasdaq Listing Rule for
continued listing on The Nasdaq Capital Market.
Nasdaq Listing Rule 5550(b)(2) requires companies
to maintain a minimum MVLS of $35 million (the "MVLS Requirement"), and Nasdaq Listing Rule 5810(c)(3)(C) specifies that a
deficiency occurs if the MVLS falls below this threshold for 30 consecutive business days. Based on the Company's MVLS for the 30
consecutive business days from March 20, 2025, to May 2, 2025, the Company no longer meets this requirement. The Notice further states
that the Company also does not meet the alternative requirements under Nasdaq Listing Rules 5550(b)(1) and 5550(b)(3).
Pursuant to Nasdaq Listing Rule 5810(c)(3)(C),
the Company has a 180-calendar-day compliance period, which expires on November 3, 2025. If, during this period, the Company's MVLS
closes at or above $35 million for at least 10 consecutive business days, Nasdaq will notify the Company of its compliance, and the matter
If the Company is unable to regain compliance
with the applicable Nasdaq Listing Rules by the end of the compliance period, it will receive a written notice that its securities are
subject to delisting.
The Notice has no immediate effect on the listing
of the Company's securities and the Company's securities continue to trade on Nasdaq. The Company intends to take appropriate
actions within the specified period to regain compliance. However, there can be no assurance that the Company will be able to regain compliance
under the MVLS Requirement and other applicable Nasdaq Listing Rules.
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 focus on hematology
oncology therapeutics and therapeutics for organ transplant rejection and autoimmune disease, 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. More information
on CASI is available at www.casipharmaceuticals.com.
CASI 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 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: uncertainties related to the non-binding proposal to acquire the Company's certain
business operations in China; our recurring operating losses have raised substantial doubt regarding our ability to continue as a going
concern; 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
U.S. Food and Drug Administration, European Medicines Agency, PRC National Medical Products Administration, or other regulatory authorities;
our inability to receive approval for renewal of license of our existing products; 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 CNCT19 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; the risk related to the Company's ongoing development of and regulatory application for CID-103 with respect to the treatment
of antibody-mediated rejection for organ transplant and the license arrangements of CID-103; risks relating to interests of our largest
shareholder and our Chairman and CEO that differ from our other shareholders; risks related to the development of a new manufacturing
facility by CASI Pharmaceuticals (Wuxi) Co., Ltd. and risks related to our disagreement with Acrotech with respect to the termination
of agreements regarding EVOMELA . 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. We caution readers not to place undue reliance on any forward-looking
statements contained herein.
EVOMELA is proprietary
to Acrotech Biopharma Inc. and its affiliates. FOLOTYN is proprietary to Acrotech Biopharma Inc and its affiliates.
The Company is currently involved in disputes and legal proceedings related to certain pipeline products, including EVOMELA
and CNCT-19. Please refer to the Company's earlier SEC filing for further information.
CASI Pharmaceuticals, Inc.