The offer and sale of the foregoing shares were made by Greenwich in a private placement under Section 4(a) (2) of the Securities Act of 1933, as amended (the "Act"), and/or Regulation D promulgated thereunder, and such securities have not been registered under the Act or applicable state securities laws. Accordingly, such securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act ...

Company Contact Snehal Patel Investor Relations Office: (832) 819-3232 Email: info@greenwichlifesciences.com Investor & Public Relations Contact for Greenwich LifeSciences Dave Gentry RedChip Companies Inc. Office: 1-800-RED CHIP (733 2447) Email: dave@redchip.com 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 GLS ...

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) (State or other jurisdiction of incorporation or orga ...

Financial Performance and Losses - The company has incurred substantial losses since inception and anticipates continuing to incur significant losses for the foreseeable future[30]. - The company has incurred substantial losses since inception and anticipates continuing to incur significant and increasing losses for the foreseeable future[30]. Financing and Capital Requirements - The company requires significant additional financing to fund operations and complete product development, with potential delays or reductions in programs if capital is not raised[30]. - The company requires significant additional financing to fund operations and complete the development and commercialization of its product candidate[30]. Clinical Trials and Patient Enrollment - The company faces challenges in enrolling patients for clinical trials due to the limited number of patients with the diseases being studied[31]. - The company may face difficulties in enrolling patients for clinical trials due to the limited number of patients with the diseases being studied[31]. - The company relies on third parties for preclinical studies and clinical trials, and any failure by these parties could delay regulatory approval[36]. - The company relies on third parties for conducting preclinical studies and clinical trials, and any failure by these parties could delay regulatory approval[36]. - The company may encounter substantial costs and delays in the testing and approval process for its product candidates[57]. Dependency on Technologies and Market Acceptance - The company is dependent on licensed technologies, and losing these rights could harm product development capabilities[37]. - The company is dependent on licensed technologies, and losing these rights could harm its ability to develop new products[37]. - Market acceptance of the company's product candidates is crucial for commercial success, and inadequate reimbursement from payors could negatively impact business[38][39]. - The commercial success of the company depends on achieving significant market acceptance of its current and future product candidates[38]. Stockholder Returns and Dividends - The company does not intend to pay cash dividends, with returns to stockholders limited to potential increases in share price[49]. - The company does not intend to pay cash dividends on its common stock, limiting returns to stockholders to potential increases in share price[49]. Regulatory and Compliance Risks - The company must maintain compliance with Nasdaq listing standards to avoid delisting, which could adversely affect stockholder value[54]. - The company is classified as an "emerging growth company," allowing it to utilize reduced disclosure requirements, which may affect investor attractiveness[50]. - The company is classified as an "emerging growth company," allowing it to take advantage of reduced disclosure requirements[50]. Stock Price Volatility and Litigation Risks - The company may face significant stock price volatility, particularly related to clinical trials and product approvals, which could lead to litigation risks[51]. - The company may face risks related to securities class action litigation, particularly associated with stock price volatility during clinical trials[51].

Financial Performance - The company reported net losses of approximately $6.1 million for the nine months ended September 30, 2023, compared to $5.0 million for the same period in 2022, reflecting an increase in clinical expenses [39]. - The company has not generated any revenue to date and expects to continue incurring significant expenses as it develops its drug pipeline [39]. - The company incurred net cash used in operating activities of $4.32 million for the nine months ended September 30, 2023, compared to $4.03 million for the same period in 2022 [48]. - The company has a cumulative net loss from operations since its inception in 2006 and will continue to incur net losses for the foreseeable future [45]. Research and Development - Research and development expenses increased by $1.35 million, or 34%, to $5.37 million for the nine months ended September 30, 2023, primarily due to increased clinical expenses [43]. - Research and development expenses increased by $434,674, or 25%, to $2.16 million for the three months ended September 30, 2023, compared to $1.72 million for the same period in 2022 [41]. - The company is conducting a Phase III clinical trial, Flamingo-01, to evaluate the safety and efficacy of GLSI-100 in HER2/neu positive patients [38]. Cash Position and Funding - As of September 30, 2023, the company's cash totaled $9.14 million, down from $13.47 million as of December 31, 2022 [46]. - The company expects to require additional capital to meet long-term operating requirements and plans to raise funds through equity and/or debt securities [46]. General and Administrative Expenses - General and administrative expenses decreased by $1,815 to $1.13 million for the nine months ended September 30, 2023, from $1.13 million for the same period in 2022 [44].

Washington, D.C. 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION For the quarterly period ended June 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) (State or other jurisdiction (I.R.S. Employer of incor ...

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, 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) (State or other jurisdiction of incorporation or orga ...

Financial Losses and Funding - The company has incurred substantial losses since inception and anticipates continuing to incur significant losses for the foreseeable future[16] - The company needs significant additional financing to fund operations and complete the development of its product candidate[16] - The company must raise substantial additional capital to fund operations, which could delay or reduce product development programs[16] - The company requires significant additional financing to fund operations and complete product candidate development and commercialization[16] Clinical Trials and Regulatory Approval - The success, cost, and timing of clinical trials are critical factors for the company's future[11] - The company relies on third parties for conducting preclinical studies and clinical trials, which poses risks to obtaining regulatory approval[23] - The results of preclinical studies or earlier clinical trials may not predict future results, and regulatory approval is uncertain[18] - The company’s future success is dependent on obtaining regulatory approval for its product candidate[21] Market Acceptance and Competition - Market acceptance of the product candidate is essential for commercial success, with significant competition in the industry[25] - The commercial success of the company depends on achieving significant market acceptance among healthcare providers and payors[25] - The company may face substantial competition, which could hinder its ability to successfully commercialize products[26] Operational Risks - The company faces substantial risks related to intellectual property rights, including potential infringement claims[11] - The company has limited manufacturing and distribution capabilities, relying on third parties, which could affect supply and costs[22] - The company relies on third parties for manufacturing, sales, marketing, and distribution, which introduces risks that could increase costs and limit supply[22] - The potential impact of health epidemics, such as the coronavirus pandemic, on business operations and clinical trials is a significant concern[11] Patient Enrollment Challenges - The company faces challenges in enrolling patients for clinical trials due to the limited number of patients with the targeted diseases[17] Stock Price Volatility - The price of the company's common stock may fluctuate significantly due to stockholder control over a substantial number of shares[27]

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, 2022 ☐ 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) (State or other jurisdiction of incorporation or ...

Financial Performance - The company reported net losses of approximately $4.6 million and $1.9 million for the years ended December 31, 2021 and 2020, respectively, and $2.7 million and $1.3 million for the six months ended June 30, 2022 and 2021, respectively [40]. - The increase in net losses for the six months ended June 30, 2022, was primarily due to increased cash compensation, clinical, and manufacturing expenses [48]. Research and Development - Research and development expenses increased by $1,455,560, or 174%, to $2,294,071 for the six months ended June 30, 2022, compared to $838,511 for the same period in 2021 [44]. - The company commenced the Flamingo-01 Phase III clinical trial to evaluate the safety and efficacy of GLSI-100 in HER2/neu positive patients [39]. - The combination of GP2 + GM-CSF (GLSI-100) showed no recurrences in patients treated in a Phase IIb clinical trial after a median follow-up of 5 years [38]. Operating Expenses - General and administrative expenses decreased by $47,101, or 9%, to $468,439 for the six months ended June 30, 2022, from $515,540 for the same period in 2021 [45]. - Net cash used in operating activities was $2,480,163 for the six months ended June 30, 2022, compared to $1,132,589 for the same period in 2021 [49]. Cash Position and Funding - As of June 30, 2022, the company's cash totaled $17,187,890, down from $27,204,269 as of December 31, 2021 [47]. - The company expects to require additional capital to meet long-term operating requirements and plans to raise funds through equity and/or debt securities [47]. - The company has not generated any revenue to date and expects to continue incurring significant expenses as it develops its pipeline and prepares for commercialization [41].