Financial Performance - The company has incurred significant net losses since inception and does not generate any revenue, anticipating continued substantial net losses for the foreseeable future [20]. - As of December 31, 2021, the company estimates it has sufficient cash to fund operations into the second quarter of 2023, but will require significant additional capital to execute its long-term business plan [21]. Product Development - The company is in the early stages of vaccine development with no products approved for commercial sale, making it difficult to evaluate its success and future viability [19]. - The company depends entirely on a limited number of product candidates that are in preclinical development, with none having commenced clinical trials [23]. - The marketing approval process by the FDA is lengthy and unpredictable, and failure to obtain approval for product candidates could substantially harm the business [24]. Operational Risks - The ongoing COVID-19 pandemic may adversely affect the company's operations and clinical trials [27]. - The company relies on third parties for conducting clinical trials and research, which may not perform satisfactorily [27]. - The company may face significant costs from product liability lawsuits, which could limit commercialization of its product candidates [20]. Market Conditions - The market price of the company's common stock has been extremely volatile, and stockholders could lose all or part of their investment [34]. - The company is classified as an "emerging growth company," allowing it to take advantage of reduced regulatory and reporting requirements [766].
Blue Water Biotech(BWV) - 2021 Q4 - Annual Report