Risk Factors Update Summary

• Management now evaluates substantial doubt about the company's ability to continue beyond one year due to ongoing significant operating losses and lack of committed revenue sources. This may impact future operations significantly.
• The company's ability to raise additional capital may be adversely affected by global economic conditions and disruptions in financial markets, potentially impacting financial stability.
• The company's federal and state net operating loss carryforwards increased from $300 million to $322 million, potentially affecting future tax liabilities and financial performance.
• The research and development tax credit carryforwards increased from $6 million to $9 million, indicating potential tax benefits and improved financial position.
• The orphan drug tax credit carryforwards increased from $40 million to $42 million, potentially enhancing tax advantages and financial flexibility.
• The company's ability to obtain product revenue in future periods may be impacted by the early-stage development status of its drug candidates, posing challenges to future commercial success.
• The company's lack of experience in FDA approval processes may pose risks, especially if interpretations of trial data differ, potentially leading to regulatory challenges.