Gold prices edge higher on raised Fed rate cut hopes
On Monday, H.C. Wainwright analyst Yi Chen increased the price target on Greenwich LifeSciences (NASDAQ:GLSI) shares to $39.00, up from the previous $38.00, while maintaining a Buy rating. Currently trading at $8.95, the stock shows significant upside potential according to analyst targets. The adjustment follows Greenwich LifeSciences’ announcement of positive immune response data from their ongoing Phase 3 FLAMINGO-01 trial, evaluating GLSI-100 in breast cancer patients. According to InvestingPro data, the stock has experienced high volatility with a beta of 3.38, making it particularly sensitive to market movements.
The trial, which involves the therapeutic vaccine GLSI-100 (GP2 and GM-CSF), demonstrated an increasing number of patients showing an immune response over time, from the initial baseline through the 4th to 6th month of vaccinations. These responses were noted in both HLA-A02 and non-HLA-A02 patient arms. A baseline immune response to GP2 was also detected prior to any treatment, indicating that GP2 could be a natural antigen.
These findings mirror the immune response trends observed in the earlier Phase 2b trial, which only included HLA-A02 patients. The ongoing FLAMINGO-01 study remains blinded, and the reported immune response data is preliminary, based on patients enrolled thus far. While the company’s research progresses, InvestingPro analysis reveals strong liquidity with a current ratio of 2.62, indicating the company’s ability to fund ongoing operations. Get access to 5 more exclusive ProTips and comprehensive financial metrics with InvestingPro.
In light of the positive preliminary data, Greenwich LifeSciences is contemplating the addition of a randomized placebo arm for non-HLA-A02 patients. This change could potentially convert the current open-label third arm into a second Phase 3 pivotal trial. Such an expansion would approximately double the pool of patients eligible for GP2 treatment, potentially reaching around 88,000 new patients annually in the U.S. and Europe.
Chen expressed optimism regarding the preliminary immune response data, suggesting it could indicate promising outcomes for future data readouts. While H.C. Wainwright estimates a market value of $554 million, the current market capitalization stands at $118.8 million, with the stock down about 33% over the past six months. The firm maintains its Buy rating and updated 12-month price target of $39 per share. Investors seeking deeper insights into Greenwich LifeSciences’ valuation metrics and growth potential can access comprehensive analysis through InvestingPro’s advanced financial tools and exclusive features.
In other recent news, Greenwich LifeSciences has reported significant progress in its Phase III FLAMINGO-01 clinical trial, which evaluates the immunotherapy GLSI-100 for preventing breast cancer recurrences. The trial has shown promising preliminary safety data, with no serious adverse events related to the drug, leading the Data Safety Monitoring Board to recommend the continuation of the study without modifications. The company has also expanded the non-HLA-A02 arm of the trial to 250 patients, with approvals from both EU and US regulators, which could lead to separate Phase III trials and multiple marketing approval pathways. Additionally, the trial has achieved its highest screening rate, exceeding 150 patients per quarter, and plans to activate more sites globally.
The trial’s preliminary HLA data indicates that 46% of screened patients possess at least one HLA-A02 allele, supporting the sample size estimates and interim analysis plans. Greenwich LifeSciences is also exploring subgroup analyses based on various HLA-A combinations to inform commercial development strategies. The Phase IIb trial showed an 80% or greater reduction in metastatic breast cancer recurrence rate, with GLSI-100 being well-tolerated, suggesting potential treatment applications beyond the HER2/neu 3+ over-expressors. CEO Snehal Patel expressed satisfaction with the trial’s progress and the potential for analyzing immune response data to improve study conduct and design.
The FLAMINGO-01 trial, led by Baylor College of Medicine, involves approximately 500 patients with the HLA-A02 allele and an additional 250 patients of other HLA types in an open label arm. The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, with an interim analysis planned after 14 of the required 28 events have occurred. The company is also developing its manufacturing and regulatory strategy for GLSI-100 in the US and Europe, aiming for commercialization based on positive Phase IIb results.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.