Regulatory Approval Challenges: CytoDyn faces significant hurdles in obtaining regulatory approvals for its drug candidates, particularly Leronlimab, which has experienced past delays and rejections from health authorities like the FDA.

Financial Liquidity and Funding Concerns: The company has historically operated at a net loss and requires substantial additional capital to fund ongoing operations, clinical trials, and potential commercialization, leading to potential dilutive financing or solvency issues.

Clinical Trial Efficacy and Safety Doubts: The primary asset, Leronlimab, has not consistently demonstrated statistically significant efficacy in all targeted indications, raising concerns about its clinical utility and the ability to meet trial endpoints.