Greenwich Lifesciences Inc Stock Price, News & Analysis

Greenwich LifeSciences (Nasdaq: GLSI), a clinical-stage biopharmaceutical company, announced plans to build its internal clinical trial management team for the Phase III FLAMINGO-01 trial of GLSI-100, an immunotherapy for breast cancer recurrence prevention.

The company aims to reduce dependency on Clinical Research Organizations (CROs) by hiring dedicated internal staff, which is expected to lower costs and increase efficiency in managing clinical trial operations. This strategic shift will enable Greenwich to handle multiple trials simultaneously, including potential expansion of HLA-A*02 patient trials and development of other in-licensed drug candidates.

Greenwich LifeSciences (NASDAQ:GLSI) has received regulatory approval to expand its Phase III clinical trial, FLAMINGO-01, into Romania. The trial, which evaluates GLSI-100 immunotherapy for breast cancer recurrence prevention, will now include Romanian sites in addition to approximately 150 approved sites across Spain, France, Germany, Italy, Poland, and the US.

Dr. Nicoleta Antone, Head of Breast Cancer Centre at the Chiricuta Institute of Oncology, will serve as the national principal investigator in Romania. The expansion targets a significant market, as Romania reported 12,861 new breast cancer cases in 2022, representing 28% of all female cancers, with 3,877 deaths recorded that year.

Greenwich LifeSciences (NASDAQ:GLSI), a clinical-stage biopharmaceutical company developing GLSI-100 immunotherapy for breast cancer recurrence prevention, has announced updates regarding recent CEO interviews and corporate events. The company has made available several key interviews on its website, including appearances on Bloomberg TV, a fireside chat at the Noble Virtual Conference, and an interview on the Charles Schwab Network.

The company has maintained an active presence at major industry events, presenting their Flamingo-01 trial data through posters at multiple conferences including the San Antonio Breast Cancer Symposium, ESMO Breast Conference, and ASCO. GLSI has also participated in several investor conferences including the BIO CEO & Investor Conference, H.C. Wainwright BioConnect, and the Jefferies Global Healthcare Conference.

Greenwich LifeSciences (NASDAQ: GLSI) has provided an update on its Phase III FLAMINGO-01 clinical trial evaluating GLSI-100, an immunotherapy for breast cancer recurrence prevention. The company reported positive preliminary data trends in both HLA-A*02 and non-HLA-A*02 arms, with the latter being expanded to 250 patients in 2024.

The trial achieved its highest screening rate in Q1 2025, processing over 150 patients per quarter across 117 active sites (40 US and 77 EU locations). The company plans to activate 30 additional EU sites in 2025, with potential for 10 more, bringing the total to over 150 sites globally.

The trial has garnered participation from prominent US teaching hospitals including Yale, Johns Hopkins, and Harvard, along with major European academic networks in Spain (GEICAM), France (UCGB), Germany (GBG), and Italy (GIM). The company is also developing manufacturing and regulatory strategies for both US and European markets.

Greenwich LifeSciences (NASDAQ: GLSI) has reported positive preliminary immune response data from its FLAMINGO-01 Phase III clinical trial evaluating GLSI-100, an immunotherapy for breast cancer recurrence prevention. The data shows increasing immune responses over time in both HLA-A*02 and non-HLA-A*02 patient arms.

Key findings include baseline immune response to GP2 before treatment and increasing response with vaccinations through months 4-6, consistent with Phase IIb trial results. The company has filed patent claims for non-HLA-A*02 patients, potentially doubling eligible patients to 88,000 annually in the US and Europe, with market potential of $8-10 billion per year.

Previous Phase IIb trial demonstrated an 80% or greater reduction in cancer recurrences over 5 years in HER2/neu 3+ patients treated with GLSI-100. The company is considering adding a randomized placebo arm for non-HLA-A*02 patients, effectively creating a second pivotal Phase III trial.

Greenwich LifeSciences (NASDAQ: GLSI) has announced an extension of the lock-up period for shares owned by company directors, officers, and pre-IPO investors until March 31, 2026. This extension represents approximately 66 months from the company's IPO date.

During this lock-up period, these insiders will be restricted from selling their common stock holdings unless modified by the Board of Directors. After the lock-up expiration, daily and periodic trading restrictions will still apply to these shares, subject to Board modification.

The company is currently conducting the Phase III FLAMINGO-01 clinical trial of GLSI-100, an immunotherapy designed to prevent breast cancer recurrences.

Greenwich LifeSciences (NASDAQ: GLSI) has provided an update on the safety data from its Phase III FLAMINGO-01 clinical trial evaluating GLSI-100, an immunotherapy for breast cancer recurrence prevention. The Data Safety Monitoring Board (DSMB) met twice in 2024 and recommended continuing the study without modifications, with no serious adverse events reported.

The update includes comparison with Phase IIb trial results, which showed an 80% or greater reduction in cancer recurrences in HER2/neu 3+ patients treated with GLSI-100. The Phase IIb trial, involving 96 patients across 16 sites, demonstrated no serious adverse events and a well-tolerated safety profile.

Preliminary FLAMINGO-01 safety data analysis shows GP2 immunotherapy continues to be well-tolerated across all study arms, with injection site reactions being the most frequent adverse event. The safety profile is trending similarly to the Phase IIb study, requiring no protocol modifications.

Greenwich LifeSciences (NASDAQ: GLSI) has provided an update on the open label HLA data from its Phase III FLAMINGO-01 trial, which evaluates GLSI-100 immunotherapy for breast cancer recurrence prevention. The analysis reveals that 46% of screened patients have at least one HLA-A*02 allele, meeting the expected 40-50% prevalence rate and supporting sample size estimates for the trial.

The study includes three arms: two blinded arms for HLA-A*02 patients (treatment vs. placebo) and an expanded open-label arm for non-HLA-A*02 patients, recently increased from 100 to 250 participants. Notably, 8% of patients have received HLA-A*02 alleles from both parents, which could potentially lead to greater immune response and efficacy. The trial's design allows for analysis of various HLA combinations and their prevalence across different racial and ethnic groups, which may inform future commercial development strategies.

Greenwich LifeSciences (NASDAQ: GLSI) has received EMA approval to add 11 new clinical trial sites in Spain, Germany, and Poland for its Phase III FLAMINGO-01 trial, which evaluates GLSI-100 immunotherapy for breast cancer recurrence prevention. The expansion involves academic networks including Geicam (Spain), Unicancer (France), GBG (Germany), GIM (Italy), and Polish sites, bringing the total approved European sites to approximately 110-115.

The company plans to submit applications for an additional 5-10 sites in Ireland, Romania, and potentially other European countries. Currently, GLSI has activated approximately 100 sites globally that are screening patients, with notable increased patient screening activity in the second half of 2024. The company completed site activations across five European countries in 2024, including team training for study personnel.