Greenwich LifeSciences Reports $15.8 Million Net Loss for Fiscal Year 2024

Greenwich LifeSciences, Inc. has reported significant financial losses for the fiscal year ending December 31, 2024, with a net loss of $15.8 million, up from $8.9 million in 2023. The company's total cash reserves decreased to $4.1 million from $7.0 million over the same period. The increase in losses is attributed primarily to heightened clinical expenses associated with the ongoing Phase III clinical trial, Flamingo-01, which evaluates GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences. The company has not yet generated any revenue, as it remains focused on the development of its product candidate.

In terms of operational developments, Greenwich LifeSciences is expanding its clinical trial efforts into Europe, planning to open up to 150 sites globally for the Flamingo-01 trial. The trial is designed to assess the safety and efficacy of GLSI-100 in HER2/neu positive patients who have completed standard treatments. The company has also reported a significant increase in research and development expenses, which rose by approximately 68% to $12.95 million, driven by costs related to the Phase III trial and a one-time options grant to employees and management.

The company’s workforce remains small, with only eight employees as of April 2025, which has contributed to challenges in maintaining adequate internal controls over financial reporting. Greenwich LifeSciences has acknowledged material weaknesses in its internal controls due to limited personnel and insufficient written policies. The company is actively working on a remediation plan to address these issues.

Looking ahead, Greenwich LifeSciences anticipates needing substantial additional financing to support its operations and complete the development of GLSI-100. The company plans to raise capital through equity and debt offerings, although it faces uncertainty regarding the timing and success of these efforts. The management has indicated that the future financial performance will depend heavily on the successful completion of clinical trials and the ability to secure regulatory approvals, which are critical for any potential commercialization of its product candidate.

Overall, Greenwich LifeSciences is navigating a challenging landscape as it seeks to advance its clinical programs while managing financial constraints and operational risks. The company remains focused on its goal of bringing GLSI-100 to market, but it acknowledges the significant hurdles that lie ahead in terms of funding, regulatory approval, and market acceptance.