Greenwich LifeSciences delays Form 10-K filing due to auditor coordination

Greenwich LifeSciences Inc. (NASDAQ: GLSI) announced that its Form 10-K filing for fiscal year 2025 remains under audit and has been delayed beyond the standard filing deadline.

The company stated that coordination between its current and former auditors has prevented timely filing, as both auditors must agree for the dual auditor filing to proceed. The Form 10-K includes both the 2025 audit by the new auditor and the 2024 audit previously completed by the former auditor.

Greenwich LifeSciences attributed the delays to accounts payable adjustments related to its Phase III clinical trial and increased patient enrollment in Europe during 2024 and 2025. The company said it provided filing information to auditors in February 2026 and did not contribute to the delays.

The company reported an unaudited cash balance of approximately $10.5 million as of March 31, 2026, which it described as an improvement over 2025 ending cash balances. Net cash used in operating activities for 2025 was approximately $9.9 million. The company stated it has retired over 75% of accounts payable for fiscal year 2025.

In its FLAMINGO-01 Phase III trial update, Greenwich LifeSciences reported that more than 1,300 patients have been screened at a current rate of approximately 800 patients per year. The 250-patient non-HLA-A*02 arm is fully enrolled, with all patients receiving GLSI-100 treatment.

The company reported a preliminary analysis showing approximately 70-80% reduction in recurrence rates after completion of the Primary Immunization Series in the non-HLA-A*02 arm, though it noted this data is preliminary and subject to change.

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