Clinical Trial Failure Risk: Clinical trials for Atossa's drug candidates may not achieve desired endpoints or may encounter unforeseen safety issues, leading to project termination and significant financial losses, as success in early trials does not guarantee success in later stages.

Regulatory Approval Uncertainty Risk: Obtaining regulatory approvals from agencies like the FDA is a highly complex, lengthy, and uncertain process; Atossa may fail to secure necessary marketing authorizations for any of its drug candidates, delaying or preventing commercialization.

Significant Capital Needs Risk: As a clinical-stage company with no revenue-generating products, Atossa relies heavily on its ability to raise additional capital, and future financing may not be available on favorable terms or at all, leading to dilution or an inability to continue operations.