Full Press Release Details
CASI PHARMACEUTICALS ANNOUNCES
FIRST QUARTER 2025 BUSINESS AND FINANCIAL RESULTS
BEIJING, China (May 16, 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 reported business and financial results for the quarter
ended March 31, 2025.
Dr. Wei-Wu He, Ph.D., CASI's Chairman and Chief
Executive Officer, commented, "We remained focused on advancing the development of our lead program, CID-103. We dosed the initial
patient in the third cohort at the target dose of 300mg in our Phase 1/2 dose-escalation study evaluating the safety, tolerability, and
preliminary efficacy of CID-103 in adults with chronic immune thrombocytopenia (ITP). Simultaneously, we continue to work toward resolving
the FDA clinical hold on our renal allograft antibody-mediated rejection (AMR) program."
Divestiture of Assets in China
On May 12, 2025, the Company announced that it
had entered into a definitive Equity and Assets Transfer Agreement (the "Equity and Assets Transfer Agreement") with Kaixin
Pharmaceuticals Inc., a Cayman Islands incorporated entity wholly-owned by Dr. Wei-Wu He ("Kaixin Pharmaceuticals") and two
direct wholly-owned subsidiaries of the Company in China (the "Target Companies"), pursuant to which the Company will sell
and transfer, and Kaixin Pharmaceuticals will purchase and acquire, 100% equity interests in both Target Companies (the "Target
Equity Interest"), and all licensing rights, distribution rights, supply arrangements and related rights related to BI-1206 (in
China), CID-103 (in Asia excluding Japan) and Thiotepa (in China excluding Hong Kong, Macau and Taiwan) (the "Target Pipeline Products")
for an aggregate purchase price of $20.0 million, which shall include assumption of up to $20.0 million of indebtedness of the Company
(the "Transaction"). The closing of the Transaction shall be subject to certain customary conditions, including the resolution
of a certain judicial freeze on Target Equity Interest involved in the Transaction issued in connection with a certain ongoing legal dispute
of the Company. The Company and Kaixin Pharmaceuticals plan to enter into certain novation and/or assignment agreements with relevant
licensors to effect the transfer of rights related to the Target Pipeline Products, which is expected to be completed concurrently with
the transfer of the Target Equity Interest.
After the closing of the Transaction, the Company
expects to retain the rights related to CID-103 (in Japan and non-Asian regions), EVOMELA , FOLOTYN , CNCT19
and CB-5339. The Company believes this transaction marks a pivotal moment for CASI, underscoring its commitment to sharpening its strategic
focus on core priorities and adapting to dynamic market conditions. By concentrating resources on the advancement of CID-103, CASI expects
to be well positioned to deliver long-term value for both patients and shareholders.
First Quarter 2025 Financial Highlights
Revenues for the first quarter of 2025 were $6.2
million, an 82% increase compared to $3.4 million in the same period last year. This strong quarterly growth reflects the successful execution
of our commercial strategy implemented in the second half of 2024.
Research and development expenses for the first
quarter of 2025 were $1.9 million, down 24% from $2.5 million in the same period last year. The decline primarily reflects annual regulatory
filing fees for our generic portfolio that was fully paid in the prior-year quarter. We ceased incurring this expense after we sold our
generic portfolio in the second quarter of 2024.
General and administrative expenses for the first
quarter of 2025 were $7.7 million, representing a 60% increase from $4.8 million in the same period last year. The increase was mainly
attributable to legal fees in relation to our current arbitration with Juventas and dispute with Acrotech.
Net loss for the first quarter of 2025 was $10.8
million, a 14% increase compared to $9.5 million in the same period last year. The expanding of net loss was mainly attributed to the
incurrence of legal fees mentioned above.
As of March 31, 2025, we had cash and cash equivalents
of $10.9 million, a 19% decrease compared to $13.5 million as of December 31, 2024.
Further information regarding the Company, including
its Quarterly Report for the quarter ended March 31, 2025, can be found at www.casipharmaceuticals.com.
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 possibility that the Transaction will not occur
as planned if events arise that result in the termination of the Equity and Assets Transfer Agreement, or if one or more of the
various closing conditions to the Transaction are not satisfied or waived; the possibility that our plan with respect to our
business operations after the consummation of the Transaction can be implemented successfully; 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
EVOMELA is proprietary
to Acrotech Biopharma Inc. and its affiliates. FOLOTYN is proprietary to Acrotech Biopharma Inc and its affiliates.