临床试验进展 - 公司正处于临床三期试验阶段，正在评估GLSI-100免疫治疗预防乳腺癌复发的疗效[57] 财务状况 - 公司尚未产生任何收入，持续亏损，预计未来将继续大幅亏损[58][59] - 公司现金余额为722.49万美元，预计现有现金资源可维持公司未来12个月的计划运营[65] - 公司通过ATM协议和私募发行股票筹集了约4.26百万美元的资金[68][69][70] 研发投入 - 研发费用较上年同期增加67%，主要是由于临床和制造费用的增加[60] 会计政策变更 - 公司采用了FASB 2016-13号会计准则，该准则对公司财务报表和相关披露没有重大影响[74] - 公司将利用JOBS法案的豁免条款,延迟采用新的会计准则[76][77][78]

STAFFORD, Texas, Aug. 01, 2024 (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 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 ...

STAFFORD, Texas, Aug. 01, 2024 (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 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 ...

STAFFORD, Texas, June 26, 2024 (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 that it is set to join the Russell 2000 and Russell 3000 Indexes at the conclusion of the Russell indexes annual reconstitution, effective after the US markets open on July 1, 2024, according to a list o ...

STAFFORD, Texas, June 26, 2024 (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 that it is set to join the Russell 2000 and Russell 3000 Indexes at the conclusion of the Russell indexes annual reconstitution, effective after the US markets open on July 1, 2024, according to a list o ...

STAFFORD, Texas, June 14, 2024 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (NASDAQ:GLSI) (the "Company" or "Greenwich"), 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 that it has entered into a securities purchase agreement with its Chief Executive Officer, Snehal Patel, for the purchase and sale of 174,825 shares of its common stock at a purchase price ...

STAFFORD, Texas, June 14, 2024 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (NASDAQ:GLSI) (the "Company" or "Greenwich"), 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 that it has entered into a securities purchase agreement with its Chief Executive Officer, Snehal Patel, for the purchase and sale of 174,825 shares of its common stock at a purchase price ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 ☐ 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. (Exact Name of registrant as specified in its charter) Delaware 20-5473709 (State or other jurisdiction (I.R ...

公司融资和运营 - 公司需要融资以支持运营和产品开发[3] - 公司需要融资以支持运营和产品候选品的开发和商业化[3] 临床阶段挑战和风险 - 临床阶段生物制药公司面临着许多挑战，可能存在重大风险[4] - 公司面临激烈竞争，股价可能会大幅波动[10] 产品开发和监管 - 公司的产品开发计划可能无法发现所有可能的不良事件，未来的成功取决于产品候选药物的监管批准[8] - FDA对生物制品的监管[5] - FDA对生物制品上市前的审批流程[6] - FDA对生物制品上市后的监管[7] 产品市场接受度和竞争 - 公司的商业成功取决于当前和未来产品候选药物在市场中的接受度[9] - 竞争对手包括拥有更多财力和经验的大型制药公司，以及正在开发类似适应症产品的公司[5] 临床试验和产品效果 - GP2在临床试验中表现良好，没有与GLSI-100治疗相关的严重不良事件[1] - GP2 Phase III临床试验(Flamingo-01)正在美国招募中[3] - GP2 Phase IIb临床试验已完成，共有89名接受GP2 + GM-CSF治疗的患者[3] - GP2在HER2/neu 3+和HER2/neu 1-2+患者群中表现出良好的耐受性，主要不良事件为注射部位反应[1] 知识产权和合规 - 公司依赖第三方进行临床试验，如果第三方未能按时完成合同义务，可能无法及时获得监管批准[5] - 公司的未来成功取决于吸引、培养和留住关键人才，保持文化，确保董事会、管理层和更广泛员工队伍的多样性和包容性[1]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 ☐ 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. (Exact Name of registrant as specified in its charter) Delaware 20-5473709 (State or other jurisdiction ...