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Greenwich LifeSciences Stock Surges Following Clinical Trial Update

Greenwich LifeSciences, Inc. (NASDAQ:GLSI) experienced a notable increase in its stock price on Friday, rising by 16.21% to reach $19.99. This uptick occurred despite the absence of new announcements from the company to clarify the surge. The stock’s movement follows a corporate update earlier this week, detailing advancements in the company’s Phase 3 FLAMINGO-01 clinical trial and efforts to optimize business operations.

Progress in Clinical Trials and Patient Demand

During the recent update, Greenwich LifeSciences highlighted growing interest in GLSI-100, an immunotherapy designed to prevent breast cancer recurrence. The company reported that approximately 140 active sites are currently enrolling patients in the FLAMINGO-01 study, with plans to activate an additional 10 approved sites in 2026. Furthermore, Greenwich aims to expand into more countries within the European Union, responding to a marked increase in patient-driven demand.

Notably, some trial sites are reportedly experiencing waitlists, indicating a robust interest among potential participants. To enhance trial quality and reduce costs, Greenwich LifeSciences is implementing operational changes, such as transitioning more clinical trial operations in-house and discontinuing the use of a contract research organization for both U.S. and global trial management.

Financial Overview and Future Prospects

The company’s management emphasized a disciplined approach to cash management. Greenwich LifeSciences has been using its at-the-market facility judiciously to align expenditures with its cash burn, which has averaged about $7 million annually in recent years. Although net losses increased due to non-cash stock-based compensation, operational cash usage remained relatively low.

In the first three quarters of 2025, the burn rate was consistent with prior years, supported by a streamlined structure and effective cost-saving measures. The Data Safety Monitoring Board for the FLAMINGO-01 trial convened twice in 2025, most recently in December, and recommended that the study continue without any modifications.

The Steering Committee, during a meeting at the San Antonio Breast Cancer Symposium (SABCS) in 2025, endorsed proposed protocol modifications pending regulatory approval. These adjustments include expanding the study size, increasing enrollment rates, and employing interim analyses to potentially refine study parameters.

As of the latest report, Greenwich LifeSciences stock is trading at a new 52-week high, according to data from Benzinga Pro. The company’s progress in clinical trials and efforts to optimize operations suggest a promising outlook as it seeks to establish partnerships and enhance its position in the competitive biotech landscape.

The rise in share price reflects both investor confidence and the growing interest in innovative treatments for breast cancer, underscoring the significance of clinical advancements in the biotechnology sector.

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