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STAFFORD, Texas - Greenwich LifeSciences, Inc. (NASDAQ:GLSI), a $165 million market cap biotechnology company currently trading at $12.01, announced Tuesday it is building an internal clinical trial management team to oversee its Phase III FLAMINGO-01 trial, reducing reliance on external Clinical Research Organizations (CROs). According to InvestingPro analysis, the stock appears overvalued at current levels.
The biopharmaceutical company, which is evaluating GLSI-100 immunotherapy for breast cancer recurrence prevention, has begun hiring staff to manage operations for the trial. According to a company press release, this strategy aims to reduce costs and increase efficiency as the trial expands to more sites and countries. This cost-reduction initiative comes as the company reports an EBITDA of -$18.14 million in the last twelve months, with InvestingPro data showing weak gross profit margins.
"Although our experience with an external CRO has been successful, the ability to reduce our costs and improve our efficiency by bringing in dedicated staff and contractors is quite appealing," said Jaye Thompson, VP at Greenwich LifeSciences.
The company plans to continue using select vendors while developing internal capabilities to potentially conduct multiple trials simultaneously. This includes possibly expanding the current FLAMINGO-01 study or developing other drug candidates.
CEO Snehal Patel stated the new approach "will reduce our baseline burn rate, while improving the quality of the data collected and the management and monitoring of each site."
FLAMINGO-01 is designed to evaluate GLSI-100 in HER2-positive breast cancer patients who completed trastuzumab-based treatment. The trial includes U.S. and European clinical sites with plans to expand to 150 sites globally. Approximately 500 HLA-A02 patients will be randomized to receive either GLSI-100 or placebo, with up to 250 patients of other HLA types receiving GLSI-100 in a third arm.
Greenwich LifeSciences is focused on developing GP2, a peptide immunotherapy aimed at preventing breast cancer recurrences in patients who have undergone surgery. With a beta of 3.16 and a healthy current ratio of 1.85, the company maintains financial flexibility despite its development-stage status. InvestingPro subscribers can access 4 additional ProTips and comprehensive financial metrics to better evaluate GLSI’s investment potential.
In other recent news, Greenwich LifeSciences has announced the expansion of its Phase III FLAMINGO-01 clinical trial into Romania. This trial is focused on evaluating GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences. The expansion adds Romania to the list of approximately 150 approved sites across Europe and the United States. This development comes after the company received regulatory approval to proceed with the trial in Romania. The decision to include Romania is notable, given that 12,861 new breast cancer cases were diagnosed in the country in 2022. This expansion is part of Greenwich LifeSciences’ broader strategy to enhance its research and development efforts in the field of breast cancer treatment.
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