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 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 patients with highest-threat HER2 breast cancer who have experienced a pathologic complete reaction (pCR) and pCR patients with a high risk of relapse. The trial has already seen the first German patient randomized and treated in 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, 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 and Regulatory Affairs, and Snehal Patel, Chief Executive Officer of Greenwich LifeSciences, highlighted the importance of the collaboration with GBG and the opportunity it presents for patient access to controls 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 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 existing leadership and strategic initiatives of the company’s shareholders. Although currently unprofitable, analysts at InvestingPro have set an ambitious value target of $38 for Greenwich LifeSciences. These are the latest developments of the company.
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