Clinical Trial Failure Risk: Clinical trials for Edesa's drug candidates, including its lead asset EB0101, are inherently risky and may not demonstrate sufficient efficacy or safety, leading to development setbacks or termination.

Regulatory Approval Uncertainty Risk: Even if clinical trials are successful, Edesa may face challenges in obtaining timely and full regulatory approvals from health authorities like the FDA, which could delay or prevent market entry.

Capital & Funding Shortage Risk: Edesa is a clinical-stage company with significant operating expenses, and its ability to continue operations and fund development is contingent on raising additional capital, which may not be available on favorable terms or at all.