On August 29, 2025 CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a clinical-stage biopharmaceutical company focused on developing innovative therapies for patients with organ transplant rejection and autoimmune diseases, reported business and financial results for the quarter ended June 30, 2025 (the "second quarter").
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We are focused on advancing our CID-103 program, a potentially best-in-class anti-CD38 monoclonal antibody," said David Cory, CEO of CASI. "We recently announced FDA clearance of our IND application for CID-103 in active and chronic active renal allograft antibody-mediated rejection (AMR). In parallel, our Phase 1/2 dose-escalation study of CID-103 in chronic immune thrombocytopenic purpura (ITP) is enrolling and dosing. We look forward to providing updates and guidance in the future regarding progress in the CID-103 clinical development program."
Business Highlights
Program Updates and Upcoming Milestones
CID-103 for Immune Thrombocytopenic Purpura (ITP)
Phase 1/2 dose-escalation study ongoing
CID-103 for Antibody-Mediated Rejection (AMR) for Renal Allografts
FDA clearance of IND application
Phase 1 study planned to initiate in the third quarter of 2025
Corporate
Appointed David Cory as Chief Executive Officer and Board Member
Entered Definitive Equity and Assets Transfer Agreement with Kaixin Pharmaceuticals Inc.
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 is subject to certain customary conditions, including the resolution of a judicial freeze on the Target Equity Interest involved in the Transaction issued in connection with a previously disclosed legal dispute of the Company with Juventas Cell Therapy Ltd. The arbitration proceedings related to this dispute are ongoing. 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.
Second Quarter 2025 Financial Highlights
Revenues for the second quarter of 2025 were $4.2 million, a 5% increase compared to $4.0 million in the same period last year.
Cost of revenue for the second quarter of 2025 was $2.1 million, an 11% increase compared to $1.9 million in the same period last year.
Research and development expenses for the second quarter of 2025 were $1.7 million, up 31% from $1.3 million in the same period last year. The increase is primarily for the development of CID-103, supporting the company’s focused pivot toward opportunities in organ transplant rejection and autoimmune indications.
General and administrative expenses for the second quarter of 2025 were $6.1 million, which is stable compared to $5.9 million in the same period last year.
Selling and marketing expenses for the second quarter of 2025 were $5.0 million, up 14% from $4.4 million in the same period last year. The increase is primarily due to increased marketing and promotion efforts in response to intensified competition from local melphalan generic products.
Share of net loss in an equity investee for the second quarter of 2025 were $2.2 million, representing the Company’s recognition of a $2.2 million investment loss in the equity interest in Precision Autoimmune Therapeutics.
Net loss for the second quarter of 2025 was $13.4 million, compared to $7.0 million in the same period last year.
As of June 30, 2025, we had cash and cash equivalents of $6.7 million, compared to $13.5 million as of December 31, 2024.
(Press release, CASI Pharmaceuticals, AUG 29, 2025, https://feeds.issuerdirect.com/news-release.html?newsid=7401342485027439&symbol=CASI [SID1234661704])