Risk Factors Update Summary

• The company may incur additional losses if unable to generate sufficient revenue from approved products.
• Inclusion of specific financial penalties for non-compliance with pricing programs, emphasizing financial risks.
• Addition of "if approved" to product candidate references, emphasizing regulatory dependency. This change highlights the criticality of regulatory approval.
• Increased full-time employees from 262 to 384, impacting operational costs and scalability.
• Mention of potential regulatory challenges and uncertainties due to global privacy and data security requirements.
• Inclusion of the need for additional clinical trials for new indications, indicating increased development complexity.
• Limited history of recognizing revenue from product sales, with net losses of $198.4 million in 2023.
• Introduction of risks related to the development and commercialization of new product candidates, emphasizing the importance of successful trials and approvals.
• The company may require substantial additional funding for financial needs and product development.
• Net operating loss carryforwards increased from $203 million to $269 million, affecting tax liabilities.
• The company's financial results will be highly dependent on the continued successful launch and commercial sales.
• Introduction of artificial intelligence risks, highlighting potential security threats and regulatory uncertainties.
• Expansion of privacy laws discussion to include various states, indicating increased compliance complexity.
• The company may not achieve or maintain long-term sustainable profitability without successful commercialization.
• Ownership changes may limit utilization of NOLs and tax credits, impacting future taxable income.
• Research and development tax credit carryforwards rose from $4.6 million to $8.8 million.
• The market acceptance of products depends on various factors, including efficacy, safety, and market conditions.
• Potential release of valuation allowance on deferred tax assets subject to profitability and growth.
• Compliance with Nasdaq's continued listing requirements may impact stock price and trading volume.
• The company's ability to generate revenue and remain profitable depends on successful product commercialization.
• Securities class action litigation risk due to stock price volatility and past lawsuits.