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, gaining 32% over the past year despite recent pullbacks. Current research suggests that inventory is trading above its fair value.
The company partnered with the German Breast Group (GBG), Germany’s largest university network for breast cancer studies, to involve approximately 38 German sites in the study. Most of those sites have gained approval from German authorities, while the others are under review. The company’s existing ratio of 6. 91 indicates strong liquidity to fund its operations, data from InvestingPro shows that the company is still profitable, with EBITDA of -$10. 76 million in the trailing twelve months. GBG Forschungs GmbH, in collaboration with GBG, is recognized as a leading organization in the study of breast cancer worldwide.
FLAMINGO-01 focuses on HER2 breast cancer patients with a higher threat of relapse who have achieved a pathological complete reaction (pCR) and pCR patients with a higher risk of relapse. In October 2024, the first German patient was already randomized and treated in the trial.
Dr. Sibylle Loibl, who is part of the FLAMINGO-01 Steering Committee and a renowned figure in breast cancer research, expressed optimism regarding the collaboration and its potential impact on understanding and preventing breast cancer recurrences.
Professor Marcus Schmidt, the national Principal Investigator for Germany, emphasized the importance of the FLAMINGO-01 trial in advancing the potential of immunotherapies in breast cancer care. Jaye Thompson, VP of Clinical and Regulatory Affairs, and Snehal Patel, CEO of Greenwich LifeSciences, both highlighted the significance of the collaboration with GBG and the opportunity it presents for patient access to the trial in Europe.
The FLAMINGO-01 trial, led by Baylor College of Medicine, includes US clinical sites and plans to expand to 150 sites globally. The study aims to evaluate GLSI-100 in preventing recurrence among HER2-positive breast cancer patients who have completed trastuzumab-based treatment. With the stock currently trading at $12.26, analysts maintain a bullish outlook with a price target of $38. Discover more detailed financial metrics and 7 additional exclusive ProTips by subscribing to InvestingPro. The trial will randomize approximately 500 HLA-A02 patients to GLSI-100 or placebo, with an additional arm treating up to 250 patients of other HLA types with GLSI-100.
GBG clinical sites are indexed on Clinicaltrials. gov and provide data on most clinical sites. This expansion into Germany is part of Greenwich LifeSciences’ broader efforts to reduce metastatic breast cancer through clinical advances. Data in this article is based on a press release from Greenwich LifeSciences, Inc.
In addition, Greenwich LifeSciences held its annual shareholder meeting, where key decisions were made that will shape the company’s long-term. 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 directors will serve on the Board until the 2025 Annual Meeting or until their successors are elected.
The Company’s independent and 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 the issuance of the plan to 4,000,000 of the last 1,500,000 shares.
The outcomes of these proposals reflect the shareholders’ support for the company’s current leadership and strategic initiatives. Despite not currently being profitable, analysts from InvestingPro have set an ambitious price target of $38 for Greenwich LifeSciences. These are the recent developments for the company.
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