Third Quarter 2025 Business and Financial Results (Form 6-K)

Third Quarter 2025 Business and Financial Results

South San Francisco, California / November 14, 2025 / ACCESS NEWSWIRE / -- CASI Pharmaceuticals, Inc. (NASDAQ: CASI), a clinical-stage biopharmaceutical company focused on the development of CID-103, a potential best-in-class, anti-CD38 monoclonal antibody for patients with organ transplant rejection and autoimmune diseases, today reported business and financial results for the quarter ended September 30, 2025 (the "third quarter").

"We are focused on capitalizing and advancing our CID-103 clinical program in renal allograft antibody mediated rejection (AMR), first in the U.S. under an already approved IND, followed by China where a regulatory package has been accepted and is under review," said David Cory, CEO of CASI. "In addition, we look forward to presenting results of our ongoing Phase 1 dose-escalation study of CID-103 in chronic immune thrombocytopenia (ITP) at the American Society of Hematology (ASH) 2025 meeting on December 7."

Business Highlights

Program Updates and Upcoming Milestones

Corporate

Third Quarter 2025 Financial Highlights

CASI raised ~ $5.7M (after commissions) from at-the-market (ATM) facility during 3Q 2025.

As of September 30, 2025, CASI total shares outstanding was 20,548,273.

Revenues for the third quarter of 2025 were $3.1 million, a 60% decrease compared to $7.8 million in the same period last year. The decrease was mainly attributable to the Company's estimation of goods return for EVOMELA^®. In June 2025, the Company and China Resources Pharmaceutical Commercial Group International Trading Co., Ltd. ("CRPCGIT"), the Company's sole distributor for EVOMELA^®, entered into a modified distribution agreement, in which the Company allows CRPCGIT to return goods that are close to expiration dates and cannot be sold. The Company estimated the quantity of goods return in the future for the goods sold in this quarter, and the revenue with respect to the estimated quantity has not been recognized.

Cost of revenue for the third quarter of 2025 was $2.4 million, a 35% decrease compared to $3.7 million in the same period last year. The decrease was mainly attributable to decrease of royalty costs for EVOMELA^® which is in line with the decrease of revenues.

Research and development expenses for the third quarter of 2025 were $1.4 million, which is stable compared to $1.5 million in the same period last year.

General and administrative expenses for the third quarter of 2025 were $4.9 million, a 14% decrease compared to $5.7 million in the same period last year. In June 2025, CASI Pharmaceuticals (Wuxi) Co., Ltd., a Company's wholly owned subsidiary, started its production and certain costs in the amount of $0.9 million in relation to the GMP facilities were recorded into inventory instead of general and administrative expenses since then.

Selling and marketing expenses for the third quarter of 2025 were $4.6 million, a 6% decrease compared to $4.9 million in the same period last year.

Net loss for the third quarter of 2025 was $10.9 million, compared to $8.4 million in the same period last year. The increase in net loss was mainly attributable to the decrease in revenues.

As of September 30, 2025, cash and cash equivalents of the Company was $4.7 million, compared to $13.5 million as of December 31, 2024.

Further information regarding the Company, including its Quarterly Report for the third quarter, can be found at www.casipharmaceuticals.com.

Nasdaq Non-Compliance

On May 5, 2025, Nasdaq notified the Company that its market value of listed securities (MVLS) had fallen below the minimum requirement of $35 million for 30 consecutive trading days, and as a result, did not comply with Listing Rule 5550(b)(2). The Company was provided 180 calendar days, or until November 3, 2025, to regain compliance with this rule. On November 5, 2025, the Company received a delisting determination from Nasdaq, which was made as the Company did not regain compliance for the extended compliance standard period set by Nasdaq during such 180-calendar-day grace period that ended on November 3, 2025.

The Company has already appealed this determination and requested a hearing on the matter to present a detailed plan to Nasdaq to regain compliance, seeking a further extension of grace period to comply with the Nasdaq MVLS requirement. This appeal will stay the suspension of the Company's ordinary shares.

The Company remains committed to ensuring compliance and maintaining its Nasdaq listing.

About CASI Pharmaceuticals

CASI Pharmaceuticals, Inc. is a public biopharmaceutical company developing CID-103, an anti-CD38 monoclonal antibody for organ transplant rejection and autoimmune diseases.

CID-103 is a fully human IgG1, potentially best-in-class, clinical stage, anti-CD38 monoclonal antibody which targets a unique epitope and has demonstrated an encouraging pre-clinical efficacy and clinical safety profile compared to other anti-CD38 monoclonal antibodies, and for which CASI owns exclusive global rights. CASI received FDA IND clearance to conduct a Phase 1 study in renal allograft antibody-mediated rejection (AMR) in the U.S. and plans for first patient in first quarter of 2026. In parallel, CASI is actively recruiting and dosing patients in an ongoing Phase 1 study in immune thrombocytopenia (ITP). CASI plans to pursue multiple technologies for development of a stable, high concentration protein solution of CID-103 for subcutaneous injection.

More information on CASI is available at www.casipharmaceuticals.com.