STAFFORD, Texas – Greenwich LifeSciences, Inc. (NASDAQ: GLSI), a $161 million clinical-stage biopharmaceutical company, announced the opening of clinical sites in Germany for its Phase III trial, FLAMINGO-01. This trial aims to compare the effectiveness of GLSI-100, an immunotherapy aimed at preventing breast cancer recurrence. According to data from InvestingPro, the stock has seen significant volatility, with a 32% gain from last year despite recent setbacks. Current research suggests that inventory is quoted above fair value.
The company has partnered with the German Breast Group (GBG), Germany’s largest academic breast cancer research network, to involve approximately 38 German sites in the study. Most of these sites have received approval from German authorities, with the rest under review. While the company’s current ratio of 6.91 indicates strong liquidity to fund its operations, InvestingPro data shows the company is not yet profitable, with an EBITDA of -$10.76 million in the last twelve months. The GBG Forschungs GmbH, associated with GBG, is recognized as a leading organization in breast cancer research globally.
FLAMINGO-01 focuses on HER2+ breast cancer patients at increased risk of relapse who have achieved a pathologic complete reaction (pCR) and pCR patients at increased risk of relapse. The trial has already detected the first German patient randomized and treated in October 2024.
Dr. Sibylle Loibl, a member of the FLAMINGO-01 Steering Committee and a renowned figure in breast cancer research, expressed optimism about the collaboration and its potential impact on understanding and preventing breast cancer recurrences.
Professor Marcus Schmidt, National Principal Investigator from Germany, highlighted the importance of the FLAMINGO-01 trial in advancing the future of immunotherapies in the treatment of breast cancer. Jaye Thompson, Vice President of Clinical Affairs and Regulatory Authorities, and Snehal Patel, Chief Executive Officer of Greenwich LifeSciences, highlighted the importance of the collaboration with GBG and the opportunity it represents for patient access to the trial in Europe.
The FLAMINGO-01 trial, led by Baylor College of Medicine, includes clinical centers in the United States and plans to expand to 150 centers worldwide. The study aims to compare GLSI-100 in preventing recurrence in patients with HER2 positive breast cancer who have completed trastuzumab-based treatment. With the stock lately trading at $12. 26, analysts have a bullish outlook with a value target of $38. dollars. Discover more detailed monetary metrics and 7 other exclusive ProTips by subscribing to InvestingPro. The trial will randomize approximately 500 patients with HLA-A02 to GLSI-100 or placebo, with an additional group treating up to 250 patients of other HLA types with GLSI-100.
The GBG clinical sites are listed on clinicaltrials.gov, providing information on the majority of participating clinical sites. This expansion into Germany is part of Greenwich LifeSciences’ broader effort to reduce metastatic breast cancer through scientific advancements. The information in this article is based on a press release statement from Greenwich LifeSciences, Inc.
In addition, Greenwich LifeSciences held its annual shareholders meeting, where key decisions were made that will shape the long term of the company. The five nominated directors were re-elected at the meeting, namely, David McWilliams, Snehal S. Patel, Eric Rothe, F. Joseph Daugherty, M. D. and Kenneth Hallock. These administrators will serve on the Board until the 2025 Annual Meeting or until their successors are elected.
The Company’s independent registered public accounting firm, RBSM, LLP, has been ratified for the fiscal year ending December 31, 2024. A significant amendment to the Company’s 2019 Stock Incentive Plan was also approved, which expands the number of shares reserved for plan issuance to 4,000,000 of the final 1,500,000 shares.
The effects of those proposals reflect the company’s current leadership and strategic initiatives for shareholders. Although it is not currently profitable, analysts at InvestingPro have set an ambitious value target of $38 for Greenwich LifeSciences. These are the recent developments of the company.
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