Regulatory Approval Uncertainty: Mainz Biomed's lead product, ColoAlert, requires further regulatory approvals (e.g., FDA) for broader market access, and there is no guarantee these will be obtained in a timely manner or at all, which could significantly delay or prevent commercialization.

Commercialization and Market Adoption Challenges: Even if approved, there is no assurance that ColoAlert will achieve significant market acceptance or compete effectively against established screening methods and other emerging technologies, impacting revenue generation.

Significant Funding Requirements: The company operates at a net loss and will require substantial additional financing to fund ongoing clinical trials, regulatory processes, commercial launch, and operations, which may not be available on favorable terms or at all, leading to potential dilution or cessation of operations.