Clinical Trial Failure Risk: Portage Biotech's drug candidates are in various stages of preclinical and clinical development. There is a high risk that these candidates may not demonstrate the necessary efficacy or safety in human trials, leading to program termination and significant financial loss for the company.

Regulatory Approval Uncertainty: Even if clinical trials are successful, obtaining marketing approval from regulatory authorities such as the FDA or EMA is a lengthy, complex, and uncertain process. There is no guarantee that any of Portage's drug candidates will receive the required approvals.

Funding and Capital Needs: As a clinical-stage biotechnology company, Portage Biotech requires substantial additional capital to fund its research and development activities, including ongoing and future clinical trials. Failure to secure adequate funding could lead to delays, curtailment, or abandonment of its development programs.