Greenwich LifeSciences(GLSI) - 2023 Q4 - Annual Report

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].