GLSI-100 / Greenwich LifeSci - LARVOL DELTA

Greenwich LifeSciences Announces Completion of Enrollment in the Open Label Arm of FLAMINGO-01 (The Manila Times) - "In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients are currently planned to be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types (non-HLA-A*02) are planned to be treated with GLSI-100 in a third open label arm."

Enrollment status • HER2 Positive Breast Cancer

Phase III study to evaluate the efficacy and safety of GLSI-100 (GP2 + GM-CSF) in breast cancer patients with residual disease or high-risk PCR after both neo-adjuvant and postoperative adjuvant anti-HER2 therapy, Flamingo-01 (SABCS 2025) - "After 1 year of trastuzumab-based therapy, 6 intradermal injections of GLSI-100 or placebo will be administered over the first 6 months and 5 subsequent boosters will be administered over the next 2.5 years. Email: Flamingo-01@greenwichlifesciences.com. Website: greenwichlifesciences.com."

Clinical • P3 data • Residual disease • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • CSF2 • HER-2 • HLA-A

Greenwich LifeSciences Provides Global Update on FLAMINGO-01… (GlobeNewswire) - "The Company has achieved a major milestone by screening over 1,000 patients in Flamingo-01, continuing its screening rate of approximately 150 patients per quarter or the equivalent of 600 patients per year in approximately 40 US sites and 100 EU sites for a total of 140 active sites. The Company is considering a strategy to continue enrolling in both the HLA-A*02 and non-HLA-A*02 arms until interim analyses are conducted and the appropriate size of each arm can be further assessed."

Trial status • HER2 Positive Breast Cancer

Greenwich LifeSciences Announces Addition of Austria to Flamingo-01 Clinical Trial (GlobeNewswire)

Trial status • HER2 Positive Breast Cancer

Greenwich LifeSciences Announces Expansion of Flamingo-01 Clinical Trial to Belgium (GlobeNewswire)

Trial status • HER2 Positive Breast Cancer

Greenwich LifeSciences Announces Addition of Portugal to Flamingo-01 Clinical Trial (GlobeNewswire) - "The Company's application to European regulators has been formally approved, adding Portugal as an approved country in FLAMINGO-01 in addition to Spain, France, Germany, Italy, Poland, Romania, Ireland, and the US."

Trial status • HER2 Positive Breast Cancer

Greenwich LifeSciences Announces Expansion of Flamingo-01 Clinical Trial to Ireland (GlobeNewswire) - "The Company's application to European regulators has been formally approved, adding Ireland as an approved country in FLAMINGO-01 in addition to Spain, France, Germany, Italy, Poland, Romania, and the US....FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer..."

Trial status • HER2 Positive Breast Cancer

Greenwich LifeSciences’ GLSI-100 Granted US FDA Fast Track Designation (GlobeNewswire) - "The designation specifically states that "GLSI-100 for the treatment of patients with HLA-A*02 genotype and HER2-positive breast cancer who have completed treatment with standard of care HER2/neu targeted therapy to improve invasive breast cancer free survival meets the criteria for Fast Track designation. The Fast Track designation for GLSI-100 may lead to earlier drug approval as the Company and the FDA can communicate more frequently to expedite the Biologic License Application (BLA) filing of the clinical and manufacturing data from FLAMINGO-01."

Evidence highlight • Fast track • HER2 Positive Breast Cancer • HER-2 • HLA-A

Greenwich LifeSciences Announces Expansion of Flamingo-01 into Romania (GlobeNewswire) - "The Company's application to expand Flamingo-01 into Romania has been formally approved by European regulators, thus adding Romanian sites to the approximately 150 approved sites in Spain, France, Germany, Italy, Poland and the US."

Trial status • HER2 Positive Breast Cancer

Phase III study to evaluate the efficacy and safety of GLSI-100 (GP2 + GM-CSF) in breast cancer patients with residual disease or high-risk PCR after both neo-adjuvant and postoperative adjuvant anti-HER2 therapy: Flamingo-01. (ASCO 2025) - P3 | "After 1 year of trastuzumab-based therapy, 6 intradermal injections of GLSI-100 or placebo will be administered over the first 6 months and 5 subsequent boosters will be administered over the next 2.5 years. Study Status: The study is actively recruiting and enrolling patients in the US and Europe at up to 150 sites. Contact Information: Greenwich LifeSciences, Inc., Stafford, TX; Email: Flamingo-01@greenwichlifesciences.com; Website: greenwichlifesciences.com"

Clinical • P3 data • Residual disease • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • CSF2 • HER-2 • HLA-A

Phase III study to evaluate the efficacy and safety of GLSI-100 (GP2 + GM-CSF) in breast cancer patients with residual disease or high-risk PCR after both neo-adjuvant and postoperative adjuvant anti-HER2 therapy, Flamingo-01 (ESMO-BC 2025) - P3 | "After 1 year of trastuzumab-based therapy, 6 intradermal injections of GLSI-100 or placebo will be administered over the first 6 months and 5 subsequent boosters will be administered over the next 2.5 years. The trial objectives are to: 1) Determine if GP2 therapy increases IBCFS, 2) Assess the safety profile of GP2, and 3) Monitor immunologic responses to treatment and assess relationship to efficacy and safety. The study is actively recruiting and enrolling patients in the US and Europe at up to 150 sites."

Clinical • P3 data • Residual disease • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • CSF2 • HER-2 • HLA-A

Greenwich LifeSciences Announces Positive Immune Response Data from FLAMINGO-01 Phase III Clinical Trial (GlobeNewswire) - P3 | N=750 | FLAMINGO-01 (NCT05232916) | Sponsor: Greenwich LifeSciences, Inc. | "The Company has analyzed the preliminary immune response data from FLAMINGO-01....The number of patients experiencing an immune response increased over time from baseline through the 4th to 6th month vaccinations in both HLA-A*02 and non-HLA-A*02 arms. In addition, a baseline immune response to GP2 is being observed before any treatment with GP2 in both HLA-A*02 and non-HLA-A*02 arms. This result suggests that GP2 is a natural antigen, that may have been part of an immune response in the patient during prior trastuzumab or other treatments."

P3 data • HER2 Positive Breast Cancer

Greenwich LifeSciences Provides Update on Open Label Safety Data from FLAMINGO-01 (GlobeNewswire) - P3 | N=750 | FLAMINGO-01 (NCT05232916) | Sponsor: Greenwich LifeSciences, Inc. | "The FLAMINGO-01 DSMB met twice in 2024, most recently in December 2024, and recommended to continue the study as is without modification. No serious adverse events related to GLSI-100 have been reported to date in FLAMINGO-01....A preliminary review of FLAMINGO-01 safety data in both the HLA-A*02 treated and placebo arms and the third open label arm with all other HLA types, shows that GP2 immunotherapy continues to be well-tolerated and that no safety signal for GP2 has yet to be identified across all arms of the study. Like the Phase IIb clinical trial, the most frequent adverse event is injection site reaction, which is also a sign of an immune response."

DSMB • P3 data • HER2 Positive Breast Cancer

Greenwich LifeSciences Provides Update on Open Label HLA Data from FLAMINGO-01 (GlobeNewswire) - P3 | N=750 | FLAMINGO-01 (NCT05232916) | Sponsor: Greenwich LifeSciences, Inc. | "A preliminary review of FLAMINGO-01 HLA data in both the HLA-A*02 treated and placebo arms and the third open label arm with all other HLA types, shows that approximately 46% of all screened patients have at least one HLA-A*02 allele from either parent.....The double HLA-A*02 prevalence, in patients who have received HLA-A*02 alleles from both parents, is about 8%. Because there are 2 HLA-A genes, one from each parent, the total of all prevalence percentages exceeds 100% and is less than 200% because of double HLA-A types. The HLA-A*03, HLA-A*24, and HLA-A*01 prevalences are about 20-25% for each allele. The HLA-A*11, HLA-A*68, HLA-A*29, and HLA-A*30 prevalences are about 9-12% for each allele."

P3 data • HER2 Positive Breast Cancer

Greenwich LifeSciences Approved to Add Additional Sites to FLAMINGO-01 in Europe (GlobeNewswire) - "The Company's application to add an additional 11 sites in Spain, Germany, and Poland has been formally approved by EMA. The academic networks participating in each country are Geicam (Spain), Unicancer (France), GBG (Germany), GIM (Italy), and a network of Polish sites. With this additional approval, regulators have cleared the way to activate approximately 110-115 sites in Europe. Based on the interest of principal investigators at additional sites, the Company plans to submit applications to EMA regulators to add 5-10 additional sites in Ireland, Romania, and potentially other countries in Europe....'In 2024, we activated sites in all 5 countries in Europe, which represent a large population similar to that of the US. We visited these sites to train the study team, doctors, pharmacists, and nurses and hope to complete the activation of the last sites in the coming quarters in 2025'."

Trial status • HER2 Positive Breast Cancer

Greenwich LifeSciences Announces Activation of Flamingo-01 in Poland (GlobeNewswire) - "The Company is collaborating with Dr. Piotr Wysocki, who is leading one of the largest academic and private breast cancer research networks in Poland, where 9 to 11 sites have agreed to participate in FLAMINGO-01. These sites were approved by Polish authorities, which has led to site initiation visits and the treatment of the first patient in Poland in 2024."

Trial status • HER2 Positive Breast Cancer

Greenwich LifeSciences Announces Additions of Harvard and Johns Hopkins to Flamingo-01 (GlobeNewswire) - "Greenwich LifeSciences, Inc...today announced the initiation of new clinical sites in the US. Both Harvard University and Johns Hopkins University sites were recently added as participating sites in FLAMINGO-01 in the US..."

Trial status • Breast Cancer

Greenwich LifeSciences Provides Update on Commercial Manufacturing (GlobeNewswire) - "In addition to the submission of the Phase III clinical data, submitting commercial manufacturing data will be critical to the filing of a Biological License Application (BLA) for GLSI-100 in the US and for regulatory filings in other countries.....'We have now manufactured GP2 vials that can be stored in preparation for commercial launch or used in clinical trials. We will be manufacturing at least two more lots of finished GP2 product. Our plan is to complete these activities in parallel to conducting FLAMINGO-01 so that both clinical and manufacturing data are available for review by the biologics division of the FDA prior to potentially being granted a marketing license with up to 12 years of market exclusivity based on current law'."

Commercial • HER2 Positive Breast Cancer

Greenwich LifeSciences Announces Partnership with GBG in Germany for Flamingo-01 (GlobeNewswire) - "Greenwich LifeSciences, Inc...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 initiation of clinical sites in Germany. The Company has partnered with GBG (German Breast Group), the largest academic breast cancer research network in Germany, where approximately 38 sites have agreed to participate in FLAMINGO-01. Most of the sites have been approved by German authorities which has led to start-up activity in 2024, and the remaining sites are currently under review."

Trial status • HER2 Positive Breast Cancer

Phase III study to evaluate the efficacy and safety of GLSI-100 (GP2 + GM-CSF) in breast cancer patients with residual disease or high-risk PCR after both neo-adjuvant and postoperative adjuvant anti-HER2 therapy, Flamingo-01 (SABCS 2024) - "After 1 year of trastuzumab-based therapy, 6 intradermal injections of GLSI-100 or placebo will be administered over the first 6 months and 5 subsequent boosters will be administered over the next 2.5 years. Trial Objectives: The trial objectives are to: 1) Determine if GP2 therapy increases IBCFS, 2) Assess the safety profile of GP2, and 3) Monitor immunologic responses to treatment and assess relationship to efficacy and safety. Study Status: The study is actively recruiting and enrolling patients in the US and Europe at up to 150 sites."

Clinical • P3 data • Residual disease • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • CSF2 • HER-2 • HLA-A

Greenwich LifeSciences Provides Update on Expansion of Flamingo-01 into Spain (GlobeNewswire) - "Greenwich LifeSciences...announced the following update of the expansion of clinical sites into Spain. As previously announced, the Company has partnered with GEICAM, the largest academic breast cancer research network in Spain, where 38 hospitals have agreed to participate in FLAMINGO-01. To date, approximately 30 out of 38 sites have conducted site initiation visits (SIVs). An SIV is followed by site activation, HLA type screening, and study treatment. To date approximately 19 sites have been activated. Multiples sites have begun screening patients for HLA type and have started treating patients. The Company has visited and trained in-person at approximately 26 out of the 38 sites to ensure optimal treatment at each site. In the coming months, GEICAM hopes to complete the remaining SIVs and the Company hopes to visit the remaining sites."

Trial status • HER2 Positive Breast Cancer

Phase III study to evaluate the efficacy and safety of GLSI-100 (GP2 + GM-CSF) in patients with breast cancer with residual disease or high-risk PCR after both neo-adjuvant and postoperative adjuvant anti-HER2 therapy: Flamingo-01. (ASCO 2024) - P3 | "After 1 year of trastuzumab-based therapy, 6 intradermal injections of GLSI-100 or placebo will be administered over the first 6 months and 5 subsequent boosters will be administered over the next 2.5 years for a total of 11 injections over 3 years. Study status: The study has been initiated at a number of sites in the US. The study is also expected to be opened in Spain, France, Germany, Italy, and Poland."

Clinical • P3 data • Residual disease • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • CSF2 • HER-2 • HLA-A

Greenwich LifeSciences Partners with GEICAM in Spain & Conducts First Site Initiation Visits in Europe (GlobeNewswire) - "Greenwich LifeSciences, Inc...announced the initiation of the first clinical sites in Europe in collaboration with GEICAM in Spain. The Company has partnered with GEICAM, the largest academic breast cancer research network in Spain, where 38 hospitals have agreed to participate in FLAMINGO-01. These sites were recently approved by Spanish authorities, which led to site initiation visits and training of the first sites this past week."

Licensing / partnership • Trial status • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Greenwich LifeSciences Flamingo-01 Phase III Clinical Trial Approved to Expand into Five Largest European Countries (GlobeNewswire) - "Greenwich LifeSciences, Inc...provided the following update on the expansion of the clinical trial into Europe. The Company's application to expand Flamingo-01 into Europe has been formally approved by Spain, France, Germany, Italy, and Poland. The academic networks participating in each country are Geicam (Spain), Unicancer (France), GBG (Germany), GIM (Italy), and a network of Polish sites. With this final approval, regulators have cleared the way to activate 105 sites as soon as site contracts and site initiation visits are completed. Site initiation visits have been scheduled as early as the week of March 4, 2024."

Trial status • Breast Cancer • Oncology • Solid Tumor

Greenwich LifeSciences Flamingo-01 Manufacturing & Protocol Accepted by European Regulators (GlobeNewswire) - "The Company's application to expand Flamingo-01 into Europe has been reviewed by European Medicines Agency (EMA) through EMA's Clinical Trials Information System (CTIS). The Company was informed that the manufacturing, non-clinical, clinical, statistical, and regulatory sections of its application are acceptable and the regulators' requests for information have been addressed. The regulators have thus approved the clinical trial, marking a major milestone for the Company....The 5 individual countries in Europe will now make a final determination, and if acceptable, they will allow the first group of approximately 105 sites in Europe to begin initiation and activation. Once an individual site has been activated patients can be screened and enrolled."

European regulatory • Trial status • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor