Washington, D.C. 20549 UNITED STATES SECURITIES AND EXCHANGE COMMISSION ☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to COMMISSION FILE NUMBER 001-39555 GREENWICH LIFESCIENCES, INC. Form 10-Q (Exact Name of registrant as specified in its charter) (Mark One) (Address of principal executive offices) (Zip Code) ( ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from to Commission File Number: 001-39555 GREENWICH LIFESCIENCES, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation ...

STAFFORD, Texas, April 03, 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 provided the following global update on FLAMINGO-01. Flamingo-01 Progress to Date & Future Plans The Company recently confirmed that the preliminary HLA prevalence, safety, and immune response data in FLAMINGO-01 ...

STAFFORD, Texas, April 02, 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 the following update on FLAMINGO-01 open label immune response data. FLAMINGO-01 Immune Response Data Summary The Company has analyzed the preliminary immune response data from FLAMINGO-01. Immune respo ...

Core Viewpoint - Greenwich LifeSciences, Inc. has extended the lock-up period for shares owned by its directors, officers, and pre-IPO investors to March 31, 2026, which is approximately 66 months post-IPO, restricting their ability to sell shares during this time [1] Group 1: Company Overview - Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on developing GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences in patients who have undergone surgery [4] - 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 [2] Group 2: Clinical Trial Details - FLAMINGO-01 is designed to include 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 3: Market Context - In the U.S., one in eight women will develop invasive breast cancer, with around 300,000 new cases and 4 million survivors annually [3] - HER2 protein is expressed in approximately 75% of breast cancers, highlighting the potential market for therapies targeting this receptor [3]

Core Viewpoint - Greenwich LifeSciences, Inc. is progressing with its Phase III clinical trial FLAMINGO-01, evaluating GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences, with preliminary safety data indicating a well-tolerated profile and no serious adverse events reported to date [1][2][9]. Group 1: FLAMINGO-01 Trial Updates - The Data Safety Monitoring Board (DSMB) recommended continuing the FLAMINGO-01 study without modifications after two meetings in 2024, with no serious adverse events related to GLSI-100 reported [2][6]. - 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 [10]. Group 2: Phase IIb Safety Data - In the Phase IIb clinical trial, 46 HER2/neu 3+ patients treated with GLSI-100 showed an 80% or greater reduction in cancer recurrences over five years, compared to a 20-50% reduction with other approved products [3][6]. - The Phase IIb safety data indicated that GLSI-100 was well tolerated, with no serious adverse events reported, and the most common adverse events were mild or moderate injection site reactions, accounting for approximately 70% of reported events [4][7]. Group 3: Immunotherapy Insights - Full immunization in the Primary Immunization Series (PIS) elicited a potent immune response, with booster injections prolonging this response for longer-term protection [4]. - Preliminary safety data from FLAMINGO-01 suggests that GP2 immunotherapy continues to be well-tolerated, with no safety signals identified across all study arms [6][9]. Group 4: Future Directions - The company anticipates analyzing immune response data and comparing preliminary results from FLAMINGO-01 to Phase IIb data, with potential presentations at future scientific conferences [9]. - 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 once 14 events have occurred [10].

Core Insights - Greenwich LifeSciences, Inc. is conducting a Phase III clinical trial, FLAMINGO-01, to evaluate GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences [1][13] - Preliminary analysis of open label HLA data indicates that approximately 46% of screened patients possess at least one HLA-A*02 allele [2][11] - The trial includes a third open label arm for patients without the HLA-A*02 allele, which has been expanded from 100 to 250 patients [7] Trial Design and Patient Population - FLAMINGO-01 is a prospective, randomized, double-blinded, multi-center study with approximately 500 patients with the HLA-A*02 allele randomized to receive GLSI-100 or placebo [5][6] - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis [13] - The patient population is stratified to balance treated and placebo arms, with a focus on major screening criteria [5] HLA Data Analysis - The open label arm investigates the safety and efficacy of GLSI-100 in patients lacking the HLA-A*02 allele, with potential for immune response conclusions [3][10] - CEO Snehal Patel noted that the 46% prevalence of HLA-A*02 aligns with expectations and supports sample size estimates [4] - The prevalence of double HLA-A*02 alleles is about 8%, with various other HLA types also prevalent among the screened patients [11] Ethnic and Racial Prevalence - Among self-reported White patients, approximately 50% have at least one HLA-A*02 allele, with 10% having double alleles [11] - In Hispanic or Latino populations, 50% have at least one HLA-A*02 allele, with 7% having double alleles [11] - For Black or African-American patients, about 40% have at least one HLA-A*02 allele, while Asian patients show a prevalence of 17% [11] Future Directions - The company is interested in analyzing immune response and efficacy across various HLA types, which may inform commercial development strategies [4][10] - A central laboratory is sequencing DNA to determine HLA types, potentially identifying other alleles that may associate with therapeutic effects [10]

Core Viewpoint - Greenwich LifeSciences, Inc. is advancing its Phase III clinical trial, FLAMINGO-01, to evaluate GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences, with recent updates on HLA data indicating a 46% prevalence of the HLA-A*02 allele among screened patients [1][12]. Group 1: Trial Design and Patient Population - FLAMINGO-01 is a prospective, randomized, double-blinded, multi-center study designed to assess the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients [5][12]. - Approximately 500 patients with the HLA-A*02 allele will be randomized to receive GLSI-100 or a placebo, while an additional 250 patients without the HLA-A*02 allele will be enrolled in an open label arm [6][13]. - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis [13]. Group 2: HLA Data Insights - Preliminary analysis shows that about 46% of all screened patients possess at least one HLA-A*02 allele, aligning with the expected prevalence of 40-50% [2][4]. - The prevalence of double HLA-A*02 alleles, where patients receive the allele from both parents, is approximately 8% [12]. - The trial will also explore various HLA-A types and their combinations to assess immune response and clinical outcomes, potentially informing commercial development strategies [4][11]. Group 3: Ethnic and Racial Prevalence - Among self-reported White patients, approximately 50% have at least one HLA-A*02 allele, with 10% having double HLA-A*02 alleles [12]. - In Hispanic or Latino patients, the prevalence of at least one HLA-A*02 allele is also around 50%, with 7% having double alleles [12]. - For Black or African-American patients, about 40% have at least one HLA-A*02 allele, while the prevalence in Asian patients is approximately 17% [12].

Core Viewpoint - Greenwich LifeSciences, Inc. is expanding its Phase III clinical trial, FLAMINGO-01, into Europe to evaluate GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences [1][4]. Group 1: Clinical Trial Expansion - The European Medicines Agency (EMA) has approved the addition of 11 sites in Spain, Germany, and Poland, allowing for approximately 110-115 activated sites in Europe [2]. - The company plans to submit applications to EMA for adding 5-10 additional sites in Ireland, Romania, and potentially other European countries based on interest from principal investigators [3]. Group 2: Trial Details - FLAMINGO-01 is designed to assess 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 [5]. - The trial will include 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 [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]. Group 3: Company Overview - Greenwich LifeSciences is focused on developing GP2, an immunotherapy targeting breast cancer recurrences in patients post-surgery, with a significant portion of breast cancers expressing the HER2 protein [7].

Core Viewpoint - Greenwich LifeSciences, Inc. is expanding its Phase III clinical trial, FLAMINGO-01, into Europe to evaluate GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences [1][4]. Clinical Trial Expansion - The European Medicines Agency (EMA) has approved the addition of 11 sites in Spain, Germany, and Poland, allowing for approximately 110-115 activated sites in Europe [2]. - The company plans to submit applications to add 5-10 more sites in Ireland, Romania, and potentially other European countries based on interest from principal investigators [3]. Global Site Activation - In 2024, the company activated sites in all five European countries, which have a population comparable to the U.S. [4]. - Currently, there are about 100 activated sites globally that are screening patients, with a significant increase in patient screening observed in the second half of 2024 [4]. Trial Details - FLAMINGO-01 (NCT05232916) is designed to assess 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 [5]. - The trial will randomize approximately 500 HLA-A*02 patients to receive either GLSI-100 or a 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]. Company Overview - Greenwich LifeSciences focuses on developing GP2, an immunotherapy to prevent breast cancer recurrences in patients post-surgery [7]. - The company is actively engaged in clinical trials and aims to expand its global presence with plans to open up to 150 sites worldwide [5][7].