Clinical Trial Failure or Delays: The success of Nuvation Bio's product candidates depends heavily on positive results from extensive and costly clinical trials, which may not achieve their primary endpoints, face unexpected safety issues, or experience significant delays.

Regulatory Approval Uncertainty: Nuvation Bio operates in a highly regulated industry, and its product candidates require rigorous review and approval from regulatory authorities, such as the FDA, which may not grant approval on a timely basis, or at all, even if clinical trials are successful.

Significant Capital Requirements and Funding Needs: Developing new pharmaceutical products is an extremely capital-intensive process, and Nuvation Bio will require substantial additional funding in the future to complete development and potential commercialization, which may not be available on favorable terms or at all.