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 over last year despite recent setbacks. Current research suggests that inventory is trading above its fair value.
The company partnered with the German Breast Group (GBG), Germany’s largest breast cancer educational network, to involve approximately 38 German sites in the study. Most of those sites have gained approval from German authorities and the rest are currently under review. While the company’s current 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 combination with GBG, is identified as a leading global breast cancer research organization.
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 of 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 and regulatory affairs, and Snehal Patel, CEO of Greenwich LifeSciences, highlighted the importance of the collaboration with GBG and the opportunity it presents for patient access to screening in Europe.
The FLAMINGO-01 trial, led through Baylor College of Medicine, includes clinical sites in the United States and plans to expand to 150 sites worldwide. The study aims to compare GLSI-100 in preventing recurrence in patients with HER2 positive breast cancer who have completed treatment with trastuzumab. With shares recently trading at $12. 26, analysts have a bullish outlook with a price target of $38. Discover more detailed money 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, and an additional group will treat up to 250 patients of other HLA types with GLSI-100.
GBG clinical sites are indexed in 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 advancements. The data in this article is based on a news release from Greenwich LifeSciences, Inc.
In addition, Greenwich LifeSciences held its annual shareholders’ meeting, where key decisions were made that will shape the future of the company. The assembly saw the re-election of five trustee candidates, 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 registered public accounting firm, RBSM, LLP, was ratified for the fiscal year ending December 31, 2024. A significant amendment to the company’s 2019 Equity Incentive Plan was also approved, increasing the number of shares reserved for issuance under the plan to 4,000,000 from the previous 1,500,000 shares.
The effects of those proposals reflect shareholders for the company’s existing leadership and strategic initiatives. Although it is not currently profitable, analysts at InvestingPro have set an ambitious value target of $38 for Greenwich LifeSciences. These are the latest developments from the company.
This article was generated with the support of AI and reviewed by an editor. For more information consult our General Terms and Conditions.