Clinical Development Failure: The success of Engene's product candidates depends heavily on positive outcomes from ongoing and future clinical trials, which are inherently uncertain and prone to delays or failure, potentially halting product development.

Regulatory Approval Risks: Even with positive clinical trial data, there is no guarantee that regulatory authorities will grant approval for Engene's product candidates, which is essential for commercialization and market entry.

Capital Funding Requirements: Engene is likely to incur significant research, development, and operational expenses, requiring substantial additional capital that may not be available on favorable terms or at all, potentially leading to funding shortfalls or equity dilution.