On 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, reported business and financial results for the quarter ended March 31, 2025 (Press release, CASI Pharmaceuticals, MAY 16, 2025, View Source [SID1234654341]).
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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.