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 breast cancer study education network, to involve approximately 38 German sites in the study. Most of those sites have obtained 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, InvestingPro data shows that the company is still profitable, with EBITDA of -$10. 76 million over the past twelve months. GBG Forschungs GmbH, in combination with GBG, is identified as a leading organization for breast cancer studies worldwide.

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 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 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. The data in this article is based on a press. statement 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, has been ratified for the year ended December 31, 2024. A significant amendment to the Company’s 2019 inventory incentive plan was also approved, expanding the number of inventories reserved for issuance under the plan to 4,000,000 of the last 1,500,000 inventories.

The effects of those proposals reflect the company’s existing 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.

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