Financial Position - The company reported significant losses and has never generated revenue from product sales, indicating a challenging financial position [23] - The company anticipates requiring substantial additional financing to pursue its business objectives, which may not be available on acceptable terms [23] - The company has a history of significant losses and has never generated revenue from product sales, indicating a need for substantial additional financing to pursue business objectives [23] - The company has limited operating history and may never achieve or maintain profitability, which poses a risk to investors [23] Regulatory Risks - The regulatory approval processes for product candidates are lengthy and inherently unpredictable, posing risks to commercialization [23] - The company is studying product candidates in combination with other therapies, exposing it to additional regulatory risks [23] - Clinical development involves a lengthy and expensive process with uncertain outcomes, and the company has limited experience in designing and implementing clinical trials [23] Compliance and Listing Standards - The company is currently not in compliance with the continued listing standards of the Nasdaq Global Select Market, risking delisting [30] - The company is currently not in compliance with the continued listing standards of the Nasdaq Global Select Market, which could lead to delisting if compliance is not regained [30] Competitive Position - The company has filed patent applications but has obtained only a small number of patents, which may affect its competitive position [30] - The company faces significant competition from other biotechnology and pharmaceutical companies, which may impact its market position [30] - The company has filed patent applications for its product candidates but has obtained only a small number of patents to date, which may affect its ability to compete [30] Operational Challenges - The company relies on third-party suppliers for key materials, and any disruption could harm its business operations [25] - The company relies on third-party suppliers for key materials in its manufacturing process, and any loss of these suppliers could harm its business [25] - The company may encounter difficulties in enrolling patients for clinical trials due to external factors, affecting its development timelines [23] - The company may face difficulties in enrolling patients in clinical trials due to external factors such as pandemics [23] - The company is dependent on its ability to advance product candidates through preclinical studies and clinical trials, which is uncertain [23]
NextCure(NXTC) - 2024 Q4 - Annual Report