Core Viewpoint - Greenwich LifeSciences, Inc. is advancing its Phase III clinical trial, FLAMINGO-01, for GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences, while also updating on its cash burn rate and financing strategy [1][2]. Financial Updates - The Company raised more than its 2025 cash burn rate of approximately $9.5 million through its ATM financing, resulting in a year-end cash balance of approximately $6 million as of December 31, 2025 [2]. - As of January 23, 2026, the cash balance increased to approximately $12.5 million after raising about $7 million in the first three weeks of January 2026 [2]. - The current cash balance may cover the Company's cash needs for all of 2026, considering the projected increase in cash needs over the previous years [3]. Clinical Trial Progress - FLAMINGO-01 has screened over 1,000 patients, with a current screening rate of approximately 600 patients per year [4]. - The non-HLA-A*02 arm is fully enrolled, with 250 patients receiving GLSI-100, which represents a significant increase in treated patients compared to the Phase IIb trial [4]. - Preliminary analysis indicates an approximately 80% reduction in recurrence rates after the Primary Immunization Series (PIS) is completed, aligning with Phase IIb trial results [7]. Immunotherapy Details - GLSI-100 is designed to elicit a potent immune response, with the PIS involving six injections over the first six months, followed by five booster injections every six months [4][13]. - The safety profile and immune response trends in non-HLA-A*02 patients are similar to those observed in HLA-A*02 patients from the FLAMINGO-01 trial and the Phase IIb study [7]. Future Financing Strategy - The Company plans to continue using the ATM to sustain or grow its cash balance, potentially reducing the need for large financing in the near term [3]. - Continued use of the ATM may facilitate access to non-dilutive funding options, such as strategic partnerships or debt financing, to support FLAMINGO-01 and future commercial activities [3].

Core Insights - The recent update from Greenwich LifeSciences, Inc. (GLSI) focuses on manufacturing validation and regulatory progress rather than solely on clinical results [1] Company Overview - Greenwich LifeSciences has received FDA approval, indicating progress in its regulatory journey [1] Analyst Background - The analyst has a Master's degree in Cell Biology and extensive experience in drug discovery, which informs their investment analysis in the biotech sector [1] - The analyst has been active in the investment space for five years, with a focus on identifying promising biotechnology companies [1] Investment Focus - The analyst emphasizes evaluating the science behind drug candidates, competitive landscape, clinical trial design, and market opportunities while balancing financial fundamentals [1] - The goal is to provide insights that help investors understand both opportunities and risks in the biotech sector [1]

Core Insights - Biotech shares experienced significant movements in after-hours trading, with Sarepta Therapeutics leading due to anticipated trial data and other companies benefiting from recent clinical and regulatory updates [1] Company Summaries - Sarepta Therapeutics Inc. (SRPT) saw a surge of 9.65% to $23.17, driven by anticipation for a webcast on January 26, 2026, where three-year topline results from its Phase 3 trial of ELEVIDYS for Duchenne muscular dystrophy will be presented, potentially pivotal for its gene therapy program [2] - Fractyl Health, Inc. (GUTS) increased by 7.66% to $2.25, indicating speculative interest despite no new company news, suggesting momentum-driven trading [3] - Greenwich LifeSciences, Inc. (GLSI) advanced 2.08% to $26.00 following FDA approval of the first commercial lot of GP2 vials for the FLAMINGO-01 trial, marking a significant step in its commercialization efforts with the potential to prepare approximately 200,000 doses [4] - Anebulo Pharmaceuticals, Inc. (ANEB) rose 8.41% to $1.16, attracting buyers despite no new updates, reflecting investor interest [5] - OmniAb, Inc. (OABI) gained 4.59% to $2.05, similar to Anebulo, indicating broader investor interest in the biotech sector without fresh news [6] - Trevi Therapeutics, Inc. (TRVI) added 3.40% to $10.33 after publishing results from its Phase 2b CORAL trial in a peer-reviewed journal, enhancing credibility and investor enthusiasm [7] - AEON Biopharma, Inc. (AEON) edged up 1.80% to $1.13, confirming a meeting with the FDA and securing shareholder approval for financing transactions, simplifying its capital structure ahead of a second PIPE financing closing expected around January 27, 2026 [8]

Core Viewpoint Greenwich LifeSciences, Inc. has made significant progress in its Phase III clinical trial, FLAMINGO-01, for GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences, with the FDA approving the first commercial lot of GP2 for use in the trial, which is a crucial step towards filing a Biological License Application (BLA) in the US. Group 1: Clinical Trial Updates - The first three commercial lots of GP2 were manufactured in 2023, capable of preparing approximately 200,000 doses [2] - The first commercial lot of GP2 vials has been approved for use in FLAMINGO-01 in the US [2][3] - More than 1,000 patients have been screened in FLAMINGO-01, with a current screening rate of approximately 600 patients per year [5] Group 2: Manufacturing and Regulatory Progress - The company plans to start using the new GP2 vials at all 40 US sites in the coming weeks [3] - The submission of commercial manufacturing data for three lots is critical for the BLA filing in the US and other countries [4] - At least two more lots of finished GP2 product will be manufactured to support clinical and manufacturing data review by the FDA [4] Group 3: Efficacy and Safety Data - Preliminary analysis shows an approximately 80% reduction in recurrence rates after the Primary Immunization Series (PIS) in the non-HLA-A*02 arm of FLAMINGO-01 [6] - The immune response and safety profile of non-HLA-A*02 patients are trending similarly to HLA-A*02 arms and the Phase IIb study [6] - The Phase IIb trial demonstrated an 80% or greater reduction in cancer recurrences in HER2/neu 3+ patients treated with GLSI-100 [8] Group 4: Future Plans and Market Potential - The company aims to conduct FLAMINGO-01 at 150 leading clinical sites in the US and Europe, facilitating a smooth transition to product launch if GLSI-100 is approved [5] - The trial is designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, with an interim analysis planned when at least 14 events have occurred [9] - The company is preparing to submit the same manufacturing data to regulatory agencies in Europe, the UK, and Canada [5]

Core Viewpoint - Shares of Greenwich LifeSciences Inc. (GLSI) have seen significant gains as the company advances its financing strategy and prepares to implement modifications to its phase III trial for the breast cancer immunotherapy GLSI-100, pending regulatory approval [1] Company Overview - GLSI-100 is a combination of GP2 peptide vaccine and GM-CSF, aimed at helping the immune system recognize and combat cancer cells expressing the HER2/neu protein, which is present in 75% of breast cancer cases [2] - The drug is targeted at high-risk breast cancer patients post-surgery and standard treatments [2] Clinical Trial Details - The ongoing phase 3 trial, FLAMINGO-01, involves HLA-A*02-positive and HER2/neu-positive breast cancer patients at high risk for recurrence, with about 500 patients planned for random assignment to receive either GLSI-100 or a placebo [3] - A preliminary analysis of the 250-patient open-label non-HLA-A*02 arm showed an approximately 80% reduction in recurrence rate [4] Planned Modifications to the Trial - The company plans to increase the study size to enhance statistical power and reduce risk, despite potentially fewer recurrences being anticipated [4] - Strategies include doubling or quadrupling the enrollment rate to increase patient-years in the study and maintain momentum at clinical sites [5] - The trial's projected completion date is December 31, 2026 [6] Industry Context - Breast cancer is the most common cancer among women in the U.S., with over 4 million survivors [7] - Major pharmaceutical companies like Roche, AstraZeneca, and Pfizer are actively involved in developing HER2-targeted therapies, shaping the breast cancer treatment landscape [9] Financing Strategy - As of September 30, 2025, the company held $3.81 million in cash and is utilizing an At-the-Market (ATM) offering strategy to manage cash efficiently and minimize shareholder dilution [10] - Between January 1, 2025, and September 30, 2025, the company completed ATM offerings, generating gross proceeds of $6.49 million from the sale of 621,674 shares at an average price of $10.44 per share [11] Insider Share Lock-Up - The Board of Directors has extended the lock-up period for shares held by directors, officers, and pre-IPO investors until September 30, 2026, approximately 72 months post-IPO [12] Stock Performance - GLSI shares began trading on the Nasdaq Capital Market at $5.75 on September 25, 2020, and reached a 52-week intraday high of $22.31 on December 26, 2025, closing at $20.68 [13]

Core Viewpoint - Greenwich LifeSciences, Inc. has announced an extension of the lock-up period for shares owned by its directors, officers, and pre-IPO investors to September 30, 2026, to align interests with long-term investors and support the ongoing Phase III clinical trial, FLAMINGO-01, for its immunotherapy GLSI-100 aimed at preventing breast cancer recurrences [1][2] Group 1: Lock-Up Extension - The lock-up period for shares owned by directors, officers, and pre-IPO investors has been extended to approximately 72 months from the IPO date [1] - The Board of Directors retains the authority to modify the lock-up terms and implement a leak-out plan for share sales after the lock-up period [2] Group 2: FLAMINGO-01 Clinical Trial - FLAMINGO-01 is a Phase III clinical trial evaluating GLSI-100 in HER2 positive breast cancer patients, with over 1,000 patients screened and a current screening rate of about 600 patients per year [3][7] - The trial includes a fully enrolled non-HLA-A*02 arm with 250 patients receiving GLSI-100, which has shown a recurrence rate reduction similar to the Phase IIb trial results [3][6] - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis [7] Group 3: Clinical Data and Efficacy - Preliminary data from the FLAMINGO-01 trial indicates an approximately 80% reduction in recurrence rates after the Primary Immunization Series (PIS) [6] - The Phase IIb trial demonstrated an 80% or greater reduction in cancer recurrences among HER2/neu 3+ patients treated with GLSI-100 after 5 years of follow-up [5][11] - The immune response and safety profile in the non-HLA-A*02 arm are trending similarly to the HLA-A*02 arm and Phase IIb study results [6]

Core Viewpoint - Greenwich LifeSciences, Inc. is advancing its Phase III clinical trial, FLAMINGO-01, for GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences, with updates on clinical, financing, and partnering strategies [1][2]. Clinical Strategy - The FLAMINGO-01 clinical strategy is evolving to reduce risk and enhance marketing approval chances, supported by financing strategies and cost reduction activities [2] - Approximately 140 sites are currently enrolling patients, with plans to activate an additional 10 sites in 2026 and expand to more EU countries [2] - The study has shifted from principal investigator interest to patient-driven interest, with wait lists forming at certain sites [2] - Discussions are ongoing with clinical sites in the UK and Canada for potential study participation, pending regulatory approvals [2] Financing Strategy - The company is utilizing an At-The-Market (ATM) financing strategy to manage its burn rate, which was approximately $7 million annually in 2023 and 2024 [2] - The burn rate for the first three quarters of 2025 remains around $7 million, indicating a gradual increase but not substantial due to cost-saving initiatives [2] - The upfront costs of clinical expenses are expected to decrease after the initial six months of vaccinations, as booster shots will be administered every six months [2] Partnering Strategy - The company is actively attending partnering conferences to explore collaborations with larger pharmaceutical companies in the breast cancer drug market [2] - Patent filings for GLSI-100 are expected to strengthen its patent portfolio, enhancing its market position [2] FLAMINGO-01 Data Monitoring - The Data Safety Monitoring Board (DSMB) has recommended continuing the FLAMINGO-01 study without modifications, indicating confidence in the current trial design [3] - The Steering Committee has endorsed planned modifications to the study, pending regulatory approval [3] Open Label Phase III Data - Over 1,000 patients have been screened, with a current screening rate of approximately 600 patients per year [4] - The non-HLA-A*02 arm is fully enrolled with 250 patients, significantly increasing the treated patient data compared to the Phase IIb trial [4] - The Primary Immunization Series (PIS) consists of six initial injections followed by five booster injections every six months to maintain immune response [4] Preliminary Analysis - Preliminary analysis shows an approximately 80% reduction in recurrence rates in the non-HLA-A*02 arm after completing the PIS, aligning with Phase IIb trial results [7] - The immune response and safety profile in the non-HLA-A*02 patients are trending similarly to the HLA-A*02 arms of FLAMINGO-01 [7] About GLSI-100 - GLSI-100 is designed for HER2 positive breast cancer patients who have undergone surgery, with the trial led by Baylor College of Medicine and plans to expand to 150 sites globally [9] - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis [9]

Core Insights - Greenwich LifeSciences Inc. reported a significant reduction in breast cancer recurrence rates in its Phase 3 trial FLAMINGO-01, with an approximately 80% reduction observed in the non-HLA-A*02 patient group [1][2] - The trial results are consistent with previous Phase 2b trial findings, where HLA-A*02 patients also showed up to an 80% reduction in recurrence rates compared to 20-50% reductions from other approved treatments [2] - The company has noted that the immune response and safety profile in non-HLA-A*02 patients are trending similarly to those in the HLA-A*02 group and the Phase 2b study [3] Trial Details - The Primary Immunization Series (PIS) consists of six GLSI-100 injections over the first six months, followed by five booster injections every six months to enhance long-term immune response [4] - In the non-HLA-A*02 data set, 250 patients received GLSI-100, which is five times the number treated in the Phase 2b trial, providing more robust recurrence rate data [4] Market Reaction - Following the announcement, GLSI stock increased by 8.76%, reaching $11.67 [5]

Core Insights - Greenwich LifeSciences, Inc. announced an approximately 80% reduction in breast cancer recurrence rates in the non-HLA-A*02 arm of its Phase III clinical trial, FLAMINGO-01 [1][4][7] Group 1: Clinical Trial Results - The open label non-HLA-A*02 arm of FLAMINGO-01 showed an 80% reduction in recurrence rates compared to historical data from the Katherine study, which reported recurrence rates of about 3.5-4% per year [4][5] - The trial included 250 non-HLA-A*02 patients, significantly larger than the approximately 50 patients in the Phase IIb trial, allowing for more robust data [4] - The immune response and safety profile in non-HLA-A*02 patients are trending similarly to those in the HLA-A*02 arms of FLAMINGO-01 and the Phase IIb study [2][7] Group 2: Immunization Series - The Primary Immunization Series (PIS) consists of 6 GLSI-100 injections over the first 6 months, followed by 5 booster injections every 6 months to enhance long-term immune response [3] - The data suggests that peak immunity is achieved after the completion of the PIS, leading to an 80% reduction in recurrence rates compared to the initial 6 months of vaccination [5] Group 3: Future Directions - The company plans to continue treating non-HLA-A*02 patients in a placebo-controlled manner within the study, with ongoing data analysis and potential updates [7] - FLAMINGO-01 is designed to evaluate the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients, with plans to expand to 150 clinical sites globally [9]

Core Viewpoint - Greenwich LifeSciences, Inc. has completed enrollment in the open label non-HLA-A*02 arm of its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences [1][5]. Group 1: Trial Details - The Phase III trial includes approximately 500 HLA-A*02 patients randomized to receive either GLSI-100 or a placebo, and up to 250 non-HLA-A*02 patients treated with GLSI-100 in an open label arm [2][7]. - The non-HLA-A*02 patient group represents about 55% of the total patient population in FLAMINGO-01 [2]. - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis, with an interim analysis planned after 14 events [7]. Group 2: Company Insights - The CEO highlighted that the non-HLA-A*02 patient population could potentially double the number of eligible patients for GLSI-100 treatment in the US and Europe to approximately 88,000 new patients annually, with a market potential of $8-10 billion per year [3][5]. - The company believes that patent claims related to the use of GLSI-100 in the non-HLA-A*02 population are not subject to any licensing or royalty payments, potentially extending patent protection beyond 2040 [3][5]. Group 3: Clinical Observations - Preliminary data suggests that the immune response and safety profile of non-HLA-A*02 patients are trending similarly to the HLA-A*02 arms, with previous studies showing breast cancer recurrences reduced by up to 80% [5][6]. - The company is actively seeking regulatory approval to continue randomized enrollment of new non-HLA-A*02 patients with a control arm [5].