CASI Pharmaceuticals says 2025 Form 20-F is late, expects going-concern doubt

What the notice says

CASI Pharmaceuticals, Inc. (CASIF) filed a notification of late filing on Form 12b-25, known as an NT 20-F, dated April 21, 2026. It covers the fiscal year ended December 31, 2025. The company says it cannot file its Form 20-F within the prescribed period without unreasonable effort or expense, because its U.S. GAAP financial statements are not yet available. It expects to file the Form 20-F once those statements become available.

The form's extension provision, which the notice points to, allows a late annual report to be filed on or before the fifteenth calendar day after the prescribed due date. The notice does not give a date for the filing. It is signed by Wei-Wu He, chairman of the board, and gives a principal executive office in Beijing, at 1701-1702, China Central Office Tower 1, No. 81 Jianguo Road, Chaoyang District.

The notice also answers two questions on the form. It lists Larry Zhang as the contact person. The company says it has filed all other periodic reports required in the preceding 12 months. It also says it does not anticipate a significant change in results of operations from the prior fiscal year. The notice gives no figure for that expected result and no explanation of it.

The going-concern warning

The notice says management anticipates that the Form 20-F will disclose "there remains substantial doubt" about the company's ability to continue as a going concern. In plain terms, that is doubt about whether the company can keep operating. The word "remains" points to an earlier warning, but the notice does not say which report first carried it.

The warning is based, the notice says, on currently available information. The notice gives no cash balance, no loss figure and no description of the company's funding. Nor does it say what steps management has taken or plans to take to address the doubt. The notice gives the warning and the reason for the delay, but none of the numbers behind either.

The company's most recent annual report on file before this notice covered 2024. The part of it available here deals mainly with Cayman Islands, PRC and U.S. federal tax treatment of holders of its ordinary shares. It says substantially all of the company's operations are based in the PRC, that substantially all of its finance and human resources managers work there, and that over 50% of its board members habitually reside there. The company says it is not currently treated as a PRC resident enterprise by the Chinese tax authority, but that the rules for determining a "de facto management body" are unclear. That matters because a resident-enterprise finding could change how foreign investors are taxed. The report does not say how the 2025 position compares with 2024, and the notice does not supply that comparison.

The audit and the review

The notice's forward-looking statements name two risks. The first is "changes to our anticipated financial results as a result of our independent registered public accounting firm completing its audit." The second is the ability of the company and its auditors "to confirm information or data identified in the review." The notice does not describe the review, say who carried it out, or say what it identified.

The forward-looking statements also name the company's ability to file future periodic reports on time as a risk. That risk sits alongside the answer that all other reports for the past year were filed. The 20-F is the one report that is late.

What the notice leaves open

The notice gives no filing date, no audit timetable and no explanation of why the financial statements are not yet available. It does not say whether the audit has begun, whether the auditor has raised concerns about the data it is checking, or whether the company expects to meet the fifteen-day extension. The form does not require the company to state its cash position.

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