Greenwich LifeSciences(GLSI) - 2022 Q4 - Annual Report

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]