On August 14, 2026 CASI Pharmaceuticals, Inc. (OTCQB:CASIF), a clinical-stage biopharmaceutical company developing CID-103, an anti-CD38 monoclonal antibody, for patients with antibody-mediated rejection (AMR) in organ transplant and various autoimmune diseases, reported business and financial results for the first half year ended June 30, 2026.
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"We remained focused on advancing the development of our lead program, CID-103," said Dr. Wei-Wu He, Executive Chairman and Principal Executive Officer of CASI. "We dosed the first patient in the Phase 1/2 trial evaluating the safety and tolerability of CID-103 in adult patients with active and chronic active renal allograft antibody-mediated rejection (AMR) in China. We also completed the enrollment of Part A (the dose-escalation part) of our ongoing Phase 1/2 study in immune thrombocytopenia (ITP), with the maximum tested dose of 1,200 mg."
Business Highlights
Program Updates and Upcoming Milestones
CID-103 for Antibody-Mediated Rejection (AMR) for Renal Allografts
Approval of clinical trial application by China NMPA for Phase 1/2 study
First patient dosed in Phase 1/2 study in China
CID-103 for Immune Thrombocytopenia (ITP)
Completed enrollment in Part A, the dose-escalation part, of the ongoing Phase 1/2 study, with the maximum tested dose of 1,200 mg
Corporate
Completed $15 million convertible note financing pursuant to certain convertible note purchase agreement with ETP Global III Fund LP, a partnership controlled by Dr. Wei-Wu He
Dr. Wei-Wu He, Ph.D., assumed the role of the Company’s principal executive officer while continuing to serve as Executive Chairman
Subsequent to quarter-end, received a favorable final award in the Juventas arbitration, pursuant to which the tribunal rejected all of Juventas’s allegations of breach, determined that Juventas had wrongfully terminated the relevant agreements, and awarded the Company amounts totaling well over RMB 100 million
Entered into a Settlement Agreement with Acrotech Biopharma Inc., pursuant to which the prior purported termination of the EVOMELA license and related agreements was rescinded and the agreements remain in full force and effect, subject to certain revisions
Ordinary shares began to be quoted for trading on the OTCQB market under the ticker CASIF
First Half 2026 Financial Highlights
Revenues for the first half of 2026 were $9.8 million, representing a 5.8% decrease compared to $10.4 million in the same period last year. The decline in revenue was primarily attributable to the product transition from EVOMELA to the locally manufactured MAFALAN, which remains in its market‑expansion phase.
Cost of revenue for the first half of 2026 was $2.2 million, representing a 53.2% decrease compared to $4.7 million in the same period last year. The decrease was mainly attributable to lower unit cost for MAFALAN than that of EVOMELA.
Research and development expenses for the first half of 2026 were $2.3 million, representing a 37.8% decrease compared to $3.7 million in the same period last year. The decrease was mainly attributable to decreased clinical studies costs for our pipeline products, as well as decreased labor cost.
General and administrative expenses for the first half of 2026 were $14.3 million, representing a 3.6% increase compared to $13.8 million in the same period last year. The increase was mainly attributable to increased legal fees, partially offset by decreased labor cost.
Selling and marketing expenses for the first half of 2026 were $7.5 million, representing an 18.5% decrease compared to $9.2 million in the same period last year. The decrease was mainly attributable to decreased labor cost and decreased travel and conference fees.
Net loss for the first half of 2026 was $20.0 million, compared to $24.1 million in the same period last year.
As of June 30, 2026, cash and cash equivalents of the Company was $3.8 million, compared to $5.6 million as of December 31, 2025.
As of June 30, 2026, total outstanding shares of the Company were 20,555,873.
Nasdaq Delisting and OTCQB Quotation
On February 23, 2026, the Company received a determination letter from the Hearings Panel of The Nasdaq Stock Market notifying the Company that the Panel had determined to delist the Company’s securities due to the Company’s failure to satisfy Nasdaq’s continued listing requirements. As a result, trading in the Company’s securities was suspended at the opening of business on February 26, 2026. On June 23, 2026, Nasdaq filed Form 25 in relation to such delisting decision.
On April 14, 2026, the Company’s ordinary shares began to be quoted for trading on the OTCQB market under the ticker CASIF.