Clinical Trial Outcomes: Clinical trials for drug candidates are inherently uncertain, and positive results in early stages may not be replicated in later, larger trials, potentially leading to significant delays or discontinuation of development programs.

Regulatory Approval Hurdles: Drug candidates require extensive regulatory review and approval from agencies like the FDA, which is a complex, lengthy, and unpredictable process, and failure to obtain such approvals would prevent commercialization.

Funding and Capital Needs: Compugen operates in a capital-intensive industry and requires significant funding to continue its research and development activities, and its ability to raise additional capital on favorable terms in the future is not guaranteed.