Greenwich LifeSciences announced that its Phase III FLAMINGO‑01 trial has screened 1,000 patients, a key step toward the 1,500‑patient target needed for the study’s primary endpoint. The company reports an average screening rate of 150 patients per quarter across 140 active sites—40 in the United States and 100 in Europe—underscoring strong clinician and patient interest in the GLSI‑100 immunotherapy.
The FLAMINGO‑01 design enrolls approximately 500 HLA‑A*02 patients randomized to GLSI‑100 or placebo, plus up to 250 additional patients of other HLA types receiving GLSI‑100 in a third arm. The trial is powered to detect a hazard ratio of 0.3 with 28 events required for the primary analysis; an interim analysis is scheduled when 14 events have occurred. The 1,000‑patient milestone positions the study to reach that interim point sooner if enrollment continues at the current pace, giving the company flexibility for multiple interim looks and potentially shortening the overall development timeline.
Financially, Greenwich remains in a precarious position. The company reported a net loss of $4.15 million for Q3 2025, beating analyst expectations of a $4.32 million loss, but it has no revenue and disclosed substantial doubt about its ability to continue as a going concern. Cash balances of $3.81 million as of September 30, 2025, translate to roughly a 13‑month runway at current burn, a significant improvement over the less than one‑year runway reported earlier in the year. The milestone therefore carries heightened importance as a potential catalyst for new financing or a partnership that could extend the company’s survival horizon.
Regulatory context adds further weight to the screening achievement. GLSI‑100 received FDA Fast Track designation on September 10, 2025 for the HLA‑A02 patient population, a status that can accelerate review and approval. Phase IIb data, released earlier in the year, showed an 80 % or greater reduction in breast cancer recurrence over five years compared with placebo in HER2‑positive HLA‑A02 patients, providing encouraging efficacy signals that support the Phase III effort.
CEO Snehal Patel emphasized that the high screening pace offers “flexibility for multiple interim analyses and could accelerate the trial’s completion if enrollment continues at this rate.” He added that the milestone is a critical operational achievement that may help secure additional financing or a partnership before the trial’s outcome is known, thereby mitigating the company’s financial risk while advancing GLSI‑100 toward potential regulatory approval.
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