Clinical Trial Failure Risk: The success of Qualigen's therapeutic candidates, particularly AS1411, is highly dependent on positive outcomes from ongoing and future clinical trials, and any setbacks or failures could severely impact their development and value.

Regulatory Approval Uncertainty: Even with successful clinical trials, there is no guarantee that Qualigen will obtain the necessary regulatory approvals from agencies like the FDA for their drug candidates, which is a lengthy and uncertain process.

Insufficient Funding and Liquidity Risk: Qualigen has a history of operating losses and may require significant additional capital to fund its research, development, and commercialization efforts, potentially leading to further dilution for existing shareholders or an inability to continue operations.