Greenwich LifeSciences expands trial sites in Germany

STAFFORD, Texas - Greenwich LifeSciences, Inc. (NASDAQ:GLSI), a clinical-stage biopharmaceutical company valued at $161 million, has announced the initiation of clinical sites in Germany for its Phase III trial, FLAMINGO-01. This trial is designed to evaluate the efficacy of GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences. According to InvestingPro data, the stock has experienced significant volatility, with a 32% gain over the past year despite recent pullbacks. Current analysis suggests the stock is trading above its 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+ high-risk breast cancer patients who have not achieved a pathologic complete response (pCR) and those pCR patients at high risk of relapse. The trial has already seen the first patient from Germany randomized and treated as of October 2024.

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.

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 other recent news, Greenwich LifeSciences held its Annual Meeting of Stockholders, where key decisions were made that will shape the company's future. The meeting saw the re-election of all five director nominees, 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 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.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.