Clinical Trial Failure: BriaCell's success depends on the successful outcome of its clinical trials. There is no guarantee that its lead drug candidates will demonstrate sufficient efficacy or safety, meet primary endpoints, or progress through clinical development phases, which could lead to significant delays or termination of programs.

Regulatory Approval Uncertainty: Even with positive clinical trial results, obtaining marketing authorization from regulatory bodies like the FDA or Health Canada is a complex, lengthy, and uncertain process. There is no assurance that BriaCell's product candidates will receive necessary approvals, or that such approvals will be granted within anticipated timelines.

Funding and Capital Needs: BriaCell is a clinical-stage company with no revenue from product sales and requires substantial additional capital to fund its research, development, clinical trials, and potential commercialization activities. Inability to raise sufficient funds on acceptable terms could severely impact operations, delay development, or force the company to curtail or cease operations.