Clinical Trial Failure Risk: Grace Therapeutics' product candidates may not achieve favorable results in clinical trials, leading to delays, increased costs, or complete termination of development.

Regulatory Approval Uncertainty Risk: Obtaining necessary regulatory approvals from agencies such as the FDA or EMA is a lengthy, expensive, and uncertain process, and failure to secure such approvals would prevent product commercialization.

Future Capital Requirements Risk: The company will require substantial additional capital to fund its operations and clinical development programs, and there is no guarantee that sufficient funding will be available on favorable terms, or at all, leading to potential delays or discontinuation of projects.