Clinical Trial Failure Risk: The development of new pharmaceutical products is inherently uncertain, and Aptorum Group's drug candidates may fail to demonstrate efficacy or safety in clinical trials, leading to significant delays or discontinuation.

Regulatory Approval Uncertainty: Even if clinical trials are successful, there is no guarantee that Aptorum Group will receive the necessary regulatory approvals from health authorities like the FDA or EMA, which could prevent or significantly delay market entry.

Funding and Liquidity Concerns: As a clinical-stage company with no product revenue, Aptorum Group has significant cash burn and will require substantial additional financing in the future, which may not be available on acceptable terms or at all, leading to potential operational limitations or dilution.