CASI Pharmaceuticals reported third‑quarter 2025 revenue of $3.1 million, a 60% decline from $7.8 million in the same period last year. The drop is largely attributable to a $1.2 million reduction in sales of EVOMELA®, the company’s anti‑CD38 antibody, after an estimated goods return adjustment. The company’s net loss widened to $10.9 million, up from $8.4 million in Q3 2024, reflecting the revenue shortfall and higher operating expenses associated with ongoing clinical development of CID‑103.
Cash on hand fell to $4.7 million at September 30, 2025, down from $13.5 million at the end of 2024. The liquidity squeeze is a key concern, as the company has received a Nasdaq delisting determination for failing to meet the minimum market‑value requirement. CASI has appealed the decision, but the threat underscores the urgency of improving cash flow and securing additional financing.
Management emphasized that the company remains focused on advancing CID‑103, its lead candidate for organ‑transplant rejection and autoimmune disease. CEO David Cory noted that the Phase 1 renal allograft antibody‑mediated rejection study has received FDA clearance and that preliminary data will be presented at ASH 2025. He also highlighted progress in China and the upcoming Phase 1 ITP study poster, underscoring the company’s commitment to clinical milestones despite the current financial headwinds.
The financial results also reflect a broader regulatory challenge: a clinical hold was placed on CID‑103 by the FDA in late 2024 for unspecified reasons. The hold delays the drug’s development timeline and adds uncertainty to the company’s future revenue prospects. Combined with the Nasdaq delisting threat, these factors have intensified investor concern about CASI’s short‑term viability.
In light of the revenue decline, widening loss, and liquidity constraints, the company’s outlook for the remainder of 2025 is cautious. Management has not provided new guidance, but the current data suggest that the company will need to prioritize cost control and secure additional capital to navigate the regulatory and listing challenges while continuing to push CID‑103 toward market approval.
The Q3 2025 results illustrate a company at a critical juncture: strong clinical progress is offset by significant financial and regulatory headwinds, and the path forward will depend on securing liquidity and resolving the FDA hold on its flagship product.
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