Clinical Trial Outcomes Risk: The success of CG Oncology's lead product candidate, cretostimogene, is highly uncertain, and future clinical trials may not achieve their primary endpoints, leading to significant delays or failure to obtain regulatory approval.

Regulatory Approval Risk: Even with positive clinical data, CG Oncology may fail to obtain necessary regulatory approvals from the FDA or other global health authorities for its product candidates, or approvals may be significantly delayed.

Commercialization and Market Adoption Risk: If approved, CG Oncology's product candidates may not achieve market acceptance or gain significant market share due to competition, unfavorable pricing, or lack of physician and patient adoption.