Shares of Greenwich LifeSciences Inc. (GLSI) have been on a tear over the past ten days as the clinical-stage biotech pushes ahead with its financing strategy and prepares to implement risk-reducing modifications to the phase III trial of its investigational breast cancer immunotherapy, GLSI-100, upon the regulatory go-ahead.GLSI-100 is a combination of GP2 peptide vaccine and GM-CSF, an immune system booster, which is designed to help the body recognize and fight cancer cells that express the HER2/neu pro ...

STAFFORD, Texas, Dec. 29, 2025 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating Fast Track designated GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced that its Board of Directors has extended the lock-up of the shares owned by the Company's directors, officers, and existing pre-IPO investors to September 30, 2026 which is approxi ...

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]

Greenwich LifeSciences Inc. (NASDAQ:GLSI) stock is trading higher on Monday, with a session volume of 2.804 million compared to the average volume of 81.85 thousand, as per data from Benzinga Pro.Greenwich LifeSciences on Monday said its Phase 3 trial FLAMINGO-01, evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, showed an approximately 80% recurrence rate reduction in the 220-patient open-label non-HLA-A*02 arm of FLAMINGO-01.The observation is trending similarly to the Phase 2b t ...

STAFFORD, Texas, Dec. 15, 2025 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced an approximately 80% recurrence rate reduction in the open label non-HLA-A*02 arm of FLAMINGO-01. A preliminary analysis of recurrence rates by two methods to estimate the reduction in recurrence rate s ...

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].

Core Viewpoint - Greenwich LifeSciences, Inc. is making significant progress in its Phase III clinical trial, FLAMINGO-01, aimed at evaluating GLSI-100, an immunotherapy for preventing breast cancer recurrences [1][2]. Group 1: FLAMINGO-01 Progress - The company has screened over 1,000 patients in the FLAMINGO-01 trial, maintaining a screening rate of approximately 150 patients per quarter, equating to 600 patients annually across 140 active sites [2][3]. - The company is considering a strategy to continue enrolling patients in both HLA-A*02 and non-HLA-A*02 arms until interim analyses are conducted [2]. Group 2: Clinical Trial Details - FLAMINGO-01 is designed to evaluate the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients who have residual disease or high-risk pathologic complete response after surgery [4]. - The trial will randomize approximately 500 HLA-A*02 patients to receive either GLSI-100 or a placebo, with an additional arm for up to 250 patients of other HLA types [4]. - An interim analysis for superiority and futility will be conducted after at least 14 events have occurred, with the trial designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival [4]. Group 3: Company Overview - Greenwich LifeSciences is focused on developing GP2, an immunotherapy aimed at preventing breast cancer recurrences in patients post-surgery [6]. - The company is actively expanding its clinical trial sites, with plans to open up to 150 sites globally [4].

Financial Performance - The company reported net losses of approximately $15.8 million and $8.9 million for the years ended December 31, 2024 and 2023, respectively, and $11.4 million and $7.7 million for the nine months ended September 30, 2025 and 2024, respectively [51]. - The company incurred net losses of $11,435,485 and $7,748,590 during the nine-month periods ended September 30, 2025 and 2024, respectively [59]. Expenses - Research and development expenses increased by $1,229,536 or 54%, to $3,521,576 for the three months ended September 30, 2025, compared to $2,292,040 for the same period in 2024 [53]. - General and administrative expenses rose by $216,055, or 49%, to $653,066 for the three months ended September 30, 2025, from $437,011 for the same period in 2024 [54]. - For the nine months ended September 30, 2025, research and development expenses increased by $2,836,178, or 42%, to $9,630,604 from $6,794,426 for the same period in 2024 [55]. - General and administrative expenses for the nine months ended September 30, 2025, increased by $739,093, or 65%, to $1,872,323 from $1,133,230 for the same period in 2024 [56]. Cash Position - As of September 30, 2025, the company's cash totaled $3,806,978, down from $4,091,990 as of December 31, 2024 [58]. - Net cash used in operating activities was $6,738,796 for the nine months ended September 30, 2025, compared to $5,414,337 for the same period in 2024 [60]. Capital Raising - The company completed At The Market ("ATM") offerings resulting in gross proceeds of $6,492,994 from the issuance of 621,674 shares at an average price of $10.44 per share between January 1, 2025, and September 30, 2025 [64]. Clinical Trials - The company plans to expand its Phase III clinical trial, Flamingo-01, into Europe with plans to open up to 150 sites globally [50].

Market Trends - The Santa Claus Rally is anticipated as a familiar market trend, historically resulting in stock increases 80% of the time during this period since 1972 [1] - This year's rally is expected to be accompanied by volatility due to factors such as AI speculation, a weakening labor market, and record-low consumer sentiment [2] Labor Market and Layoffs - October saw over 150,000 layoffs, the highest figure in 20 years, impacting companies including Amazon, which laid off 14,000 corporate employees [2] Stock Market Performance - The tech-heavy Nasdaq Index fell 5% recently, indicating cracks in the bull market, with Amazon shares dropping 6% [3] Investment Opportunities - Utz Brands Inc. (UTZ) is highlighted as an attractive investment, trading at 13 times forward earnings, significantly lower than its long-term average, with a profit outlook of 5% growth this year and 15% next year [12] - Greenwich LifeSciences Inc. (GLSI) is noted for its potential in cancer immunotherapy, with recent insider buying and FDA Fast Track designation, despite a 33% decline in shares due to short selling [15][19] - Matador Resources Co. (MTDR) is recognized for its strong insider buying activity and attractive cost structure, trading at a low valuation compared to peers, with a 4% dividend yield [22][25][26] Insider Buying as a Bullish Signal - Insider buying is considered a strong bullish signal, with examples of significant gains following such activity in companies like Longeveron Inc. and Nuvation Bio Inc. [14][27] Upcoming Events - A Profit Surge Event is scheduled, where insights on market volatility and trading opportunities will be shared [7][28]

Core Insights - Greenwich LifeSciences, Inc. is expanding its Phase III clinical trial FLAMINGO-01 to Austria, which is aimed at evaluating GLSI-100, an immunotherapy for preventing breast cancer recurrences [1][2] Company Overview - Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on developing GP2, an immunotherapy targeting breast cancer recurrences in patients post-surgery [6] - The company has initiated the FLAMINGO-01 trial, which is designed to assess the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients [4][6] Clinical Trial Details - FLAMINGO-01 is a Phase III trial that includes sites in the US and Europe, with plans to expand to 150 sites globally [4] - The trial will randomize approximately 500 HLA-A*02 patients to receive either GLSI-100 or a placebo, with an additional arm for up to 250 patients of other HLA types [4] - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis [4] Market Context - In Austria, breast cancer is the most common cancer among women, accounting for about 28% of all female cancers, with 6,070 new cases diagnosed in 2022 [3] - Breast cancer was the leading cause of cancer-related deaths in women in Austria, with 1,789 deaths reported in 2022 [3] Collaboration and Expansion - The company is collaborating with principal investigators at Ordensklinikum Linz in Upper Austria, with plans to activate this site within the year and explore additional sites in Vienna and Salzburg [4]