Financial Position - The company has cash on hand sufficient to fund operations for at least the next 12 months following the report date, based on existing cash as of December 31, 2022[26]. - Significant additional capital will be required to execute the long-term business plan, and failure to raise this capital could lead to delays or termination of development programs[26]. Product Development - The company is in the early stages of vaccine development with no products approved for commercial sale, which may impact future viability[25]. - The company depends entirely on a limited number of product candidates that are currently in preclinical development, with none having commenced clinical trials[27]. - Regulatory approval for clinical trials of vaccine candidates in children may require additional studies due to stricter requirements[34]. - The company relies on third parties for clinical trials and research, and their performance may not meet expectations[30]. - The company is dependent on licensed intellectual property, and losing these rights could hinder development and commercialization efforts[32]. Operational Risks - The ongoing COVID-19 pandemic may adversely affect the company's operations and clinical trials[29]. - The company may face substantial costs from product liability lawsuits, which could limit commercialization of product candidates[21]. - Failure to comply with healthcare regulations could result in significant enforcement actions, adversely affecting business operations and financial condition[33].
Blue Water Biotech(BWV) - 2022 Q4 - Annual Report