Risk Factors Update Summary

• FDA may require more clinical studies for product candidates, increasing risk of delays or non-approval.
• Legislative changes may reduce coverage for drugs, impacting revenue. This could prevent marketing approval.
• Reliance on third parties for manufacturing and trials may lead to delays or insufficient quantities.
• Changes in U.S. trade policy could lead to increased costs for exporting products.
• Raised approximately $79.648 million from the sale of common stock in 2024.
• Failure to protect intellectual property could harm competitive position and result in lawsuits.
• Potential trade war could adversely affect world trade and economy, impacting product demand.
• Dilution risk for investors due to subsequent exercises of outstanding warrants.
• Need for additional financing to fund operations or face significant curtailment or discontinuation.
• Failure to regain compliance with Nasdaq listing requirements could lead to delisting.
• Broad discretion over fund use could impact business and financial condition.
• Loss of key personnel may impact handling of regulated substances and business strategy.
• Dependence on third-party contractors for manufacturing may lead to delays or interruptions.
• Uncertainties in patent protection and compliance may result in loss of rights or exclusivity.