Risk Factors Update Summary

• Added therapy for treating pain in patients suffering from PDN and NSBP.
• The company must comply with evolving data privacy laws, with potential significant costs.
• Increased net losses from $92.2 million in 2021 to $131.4 million in 2023.
• Failure to comply with regulations around artificial intelligence could lead to increased expenses.
• Accumulated deficit increased from $607 million in 2022 to $699 million in 2023.
• New regulations in the EU may impact the operation and cost of the company's learning platforms.
• Federal NOLs increased from $538 million to $543 million, with state NOLs increasing from $300 million to $337 million.
• Changes in laws and regulations may require significant compliance costs, affecting financials.
• Proposed rule to amend the Quality System Regulation to align with ISO standards.
• Failure to comply with foreign regulations could harm the company's business operations.
• New regulatory regime introduced for EU-US data privacy framework.
• The company faces risks related to the evolving regulatory framework for machine learning technology.
• Increased focus on compliance with EU, EU Member State, and UK privacy laws on cookies and tracking technologies.
• Increased litigation in various jurisdictions poses a risk to the company's use of artificial intelligence.