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]

Core Viewpoint - Greenwich LifeSciences, Inc. is expanding its Phase III clinical trial, FLAMINGO-01, to Belgium, which aims to evaluate GLSI-100, an immunotherapy for preventing breast cancer recurrences [1][2]. Group 1: Clinical Trial Expansion - The FLAMINGO-01 trial has received formal approval from European regulators to include Belgium, adding to its existing sites in Spain, France, Germany, Italy, Poland, Romania, Ireland, Portugal, and the US [2]. - The trial is led by Baylor College of Medicine and plans to open up to 150 sites globally, with a focus on university-based hospitals and academic networks [5]. Group 2: Breast Cancer Statistics in Belgium - In 2022, Belgium reported 11,366 new cases of breast cancer, making it the most common cancer among women, accounting for approximately 33% of all female cancers [3]. - Breast cancer was the leading cause of cancer-related deaths in women in Belgium, with 2,324 deaths recorded in 2022 [3]. Group 3: Principal Investigator and Collaboration - The company is collaborating with Dr. Patrick Neven, a prominent figure in breast oncology, who will serve as the national principal investigator for FLAMINGO-01 in Belgium [4]. - Dr. Neven has extensive experience in clinical trials and has published over 300 peer-reviewed papers, contributing significantly to breast cancer research [4]. Group 4: Trial Design and Objectives - FLAMINGO-01 is designed to evaluate the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients who have completed neoadjuvant and postoperative adjuvant trastuzumab-based treatment [5]. - 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 [5].

Core Insights - Greenwich LifeSciences, Inc. is expanding its Phase III clinical trial, FLAMINGO-01, to Portugal, focusing on GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences [1][2] Group 1: Clinical Trial Expansion - The FLAMINGO-01 trial has received formal approval from European regulators to include Portugal, joining other countries such as Spain, France, Germany, Italy, Poland, Romania, Ireland, and the US [2] - The trial is designed to evaluate the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients who have completed neoadjuvant and postoperative adjuvant trastuzumab-based treatment [5] Group 2: Breast Cancer Statistics in Portugal - In 2022, there were 9,065 new cases of breast cancer diagnosed in Portugal, making it the most common cancer among women, accounting for approximately 30% of all cancers in this demographic [3] - Breast cancer was the leading cause of cancer-related deaths in women in Portugal, with 2,211 deaths reported in 2022 [3] Group 3: Principal Investigator and Collaboration - Dr. Luís António Marques da Costa has been appointed as the national principal investigator for FLAMINGO-01 in Portugal, bringing extensive experience in oncology and clinical trials [4] - The CEO of Greenwich LifeSciences expressed enthusiasm for collaborating with Dr. Costa and his team, indicating ongoing efforts to activate clinical trial sites in Lisbon and other regions of Portugal [5] Group 4: Trial Design and Objectives - FLAMINGO-01 aims to 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 [5] - The trial is designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis, with an interim analysis planned once 14 events have occurred [5]

Core Viewpoint - Greenwich LifeSciences, Inc. is expanding its Phase III clinical trial FLAMINGO-01 to Ireland, which aims to evaluate 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 designed to prevent breast cancer recurrences in patients who have previously undergone surgery [7][8]. Clinical Trial Details - FLAMINGO-01 (NCT05232916) is a Phase III clinical trial assessing the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery [5]. - The trial is led by Baylor College of Medicine and includes clinical sites in the US and Europe, with plans to open up to 150 sites globally [5]. - Approximately 500 HLA-A*02 patients will be randomized to receive GLSI-100 or placebo, with an additional 250 patients of other HLA types treated with GLSI-100 [5]. - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis [5]. Expansion to Ireland - The application to European regulators for including Ireland in the FLAMINGO-01 trial has been formally approved, adding to existing sites in Spain, France, Germany, Italy, Poland, Romania, and the US [2]. - Dr. Janice Walshe will serve as the national principal investigator in Ireland, collaborating with Cancer Trials Ireland to provide access to novel agents for Irish women affected by breast cancer [4]. Breast Cancer Statistics - In 2022, Ireland reported 3,723 new cases of breast cancer, making it the most common cancer diagnosed in women, accounting for approximately 30% of all cancers in women [3]. - Breast cancer is the second leading cause of cancer-related deaths among women in Ireland, with 883 deaths recorded in 2022 [3].

Group 1 - Greenwich LifeSciences (NASDAQ:GLSI) experienced a ~32% increase in premarket trading following the U.S. FDA's Fast Track designation for its lead asset GLSI-100, aimed at treating a specific subset of breast cancer patients [4] - The Fast Track status granted by the FDA is significant as it facilitates the development and expedites the review of drugs intended to treat serious conditions and fill an unmet medical need [4] - GLSI-100 is positioned to potentially improve treatment options for breast cancer patients, indicating a positive outlook for the company's future performance in the oncology sector [4]

Core Viewpoint - Greenwich LifeSciences, Inc. has received Fast Track designation from the FDA for its immunotherapy GLSI-100, aimed at preventing breast cancer recurrences in HLA-A*02 positive patients who have completed standard HER2/neu targeted therapy [1][2] Company Overview - Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on developing GP2, an immunotherapy designed to prevent breast cancer recurrences in patients post-surgery [9][11] - The company is currently conducting a Phase III clinical trial named FLAMINGO-01, which evaluates the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients [7][11] Fast Track Designation - The Fast Track designation allows for more frequent communication between the FDA and the company, potentially leading to earlier drug approval and the ability to submit parts of the Biologic License Application (BLA) as they are completed [2][5] - The designation is granted to drugs that address serious conditions and fill unmet medical needs, with GLSI-100 showing potential to improve invasive breast cancer-free survival [2][4] Clinical Trial Details - FLAMINGO-01 is designed to include approximately 500 HLA-A*02 patients randomized to receive GLSI-100 or placebo, with an interim analysis planned after 14 events of invasive breast cancer [7] - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, providing 80% power if the annual event rate in placebo-treated subjects is 2.4% or greater [7] Previous Clinical Data - In a Phase IIb trial, GLSI-100 demonstrated an 80% or greater reduction in cancer recurrences over five years in HER2/neu 3+ patients, with no serious adverse events reported [6][10] - The immunotherapy was well tolerated, and booster injections every six months prolonged the immune response, indicating a strong safety profile [6][10]

Core Viewpoint - Greenwich LifeSciences, Inc. has announced the initiation of company-sponsored equity research coverage by Noble Capital Markets, focusing on its Phase III clinical trial, FLAMINGO-01, which evaluates GLSI-100 as an immunotherapy for preventing breast cancer recurrences [1] Group 1: Clinical Trial Details - FLAMINGO-01 is a Phase III clinical trial assessing the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients with residual disease or high-risk pathologic complete response after surgery [2] - The trial will involve approximately 500 HLA-A*02 patients randomized to receive either GLSI-100 or a placebo, with an additional arm for up to 250 patients of other HLA types receiving GLSI-100 [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 [2] Group 2: Company Overview - Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on developing GP2, an immunotherapy aimed at preventing breast cancer recurrences in patients post-surgery [4] - GP2 is a 9 amino acid transmembrane peptide derived from the HER2 protein, which is expressed in 75% of breast cancers at varying levels [4] - The company is actively conducting the FLAMINGO-01 trial, with plans to expand to 150 clinical sites globally [2][4] Group 3: Breast Cancer Statistics - One in eight U.S. women will develop invasive breast cancer in their lifetime, with around 300,000 new cases and 4 million survivors annually [3] - HER2 protein is expressed in 75% of breast cancers, indicating its significance in treatment strategies [3][4]