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STAFFORD, Texas - Greenwich LifeSciences, Inc. (NASDAQ:GLSI), a clinical-stage biopharmaceutical company with a market capitalization of $122.9 million, has provided an update on its Phase III clinical trial, FLAMINGO-01, which evaluates GLSI-100, an immunotherapy for preventing breast cancer recurrences. The company’s stock, currently trading at $9.35, has experienced significant volatility with a beta of 3.32. According to InvestingPro analysis, the stock is trading near its 52-week low, presenting an interesting case for investors following clinical-stage biotech companies.
The company has observed expected trends in preliminary HLA prevalence, safety, and immune response data from the trial’s participants. The non-HLA-A02 arm was expanded to 250 patients in 2024, with approvals from both EU and US regulators. This expansion could potentially lead to a separate Phase III trial and multiple marketing approval pathways for GLSI-100. While the company maintains a strong liquidity position with a current ratio of 6.91, InvestingPro data reveals the company is not yet profitable, with a negative EBITDA of $10.76 million in the last twelve months.
In the first quarter of 2025, Greenwich LifeSciences achieved its highest screening rate, exceeding 150 patients per quarter. This rate represents a significant increase in patient engagement across 117 active sites in the US and EU. The company plans to activate an additional 30 sites in the EU this year, with the possibility of expanding to more than 150 sites globally.
Prominent teaching hospitals and oncology networks in the US and Europe are participating in the trial. The US network includes institutions such as Yale, Johns Hopkins, Harvard, and Baylor College of Medicine, which is the lead site. In Europe, the trial has expanded into five countries, with leading oncology networks like GEICAM in Spain, Unicancer in France, and GBG Forschungs GmbH in Germany taking part.
The FLAMINGO-01 Steering Committee includes key opinion leaders from the US and the largest breast oncology networks in Germany, France, and Spain. Their expertise and the involvement of prestigious sites contribute to the validation of GLSI-100’s promise.
CEO Snehal Patel expressed optimism about the high level of interest in the FLAMINGO-01 trial and the momentum it has created in patient awareness. Patel also discussed the company’s focus on analyzing the open label data from the trial, which may lead to future publications and improvements in the study’s conduct and design.
Greenwich LifeSciences is simultaneously developing its manufacturing and regulatory strategy for GLSI-100 in the US and Europe, aiming to replicate the positive results from the Phase IIb trial and prepare for commercialization. With the next earnings report due on May 19, 2025, investors tracking this development can access additional insights and 8 more exclusive ProTips through InvestingPro, including detailed analysis of the company’s financial health and market position.
The FLAMINGO-01 trial (NCT05232916) is designed to test the efficacy and safety of GLSI-100 in patients with HER2 positive breast cancer who are at high risk following surgery and trastuzumab-based treatments. For more information on participating in the trial, interested patients can visit clinicaltrials.gov.
This article is based on a press release statement and aims to provide an unbiased overview of Greenwich LifeSciences’ ongoing clinical trial and its developments.
In other recent news, Greenwich LifeSciences has reported positive safety data from its Phase III FLAMINGO-01 clinical trial for GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences. The Data Safety Monitoring Board recommended the continuation of the study without modifications, as no serious adverse events related to GLSI-100 were observed. The trial, which is being conducted by Baylor College of Medicine, is expanding globally, including new clinical sites in Germany in partnership with the German Breast Group. This expansion aims to involve approximately 38 German sites, with most already approved by authorities. Additionally, Greenwich LifeSciences has commenced analysis on open label HLA data from the trial, noting that 46% of screened patients possess at least one HLA-A02 allele. This aligns with the company’s expectations for trial sample sizes and interim analysis. The trial also includes a third open label arm for patients without the HLA-A02 allele, recently expanded to 250 patients. CEO Snehal Patel highlighted the potential for greater immune response in patients with HLA-A02 alleles from both parents. These developments reflect Greenwich LifeSciences’ ongoing efforts to advance breast cancer treatment through scientific research.
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