Risk Factors Update Summary

• Identified substantial doubt about obtaining additional capital to continue as a going concern. This may result in significant operational reductions or cessation.
• Healthcare legislative reform may adversely affect business. Starting in 2023, a manufacturer must pay a rebate to the federal government for drugs covered by Medicare Parts B or D.
• Inflation may materially increase costs, potentially outpacing expectations, leading to the need for additional capital.
• Expanded collaboration risks with partners, including potential loss of valuable rights and resources.
• Regulatory approval risks include delays, additional expenses, and ongoing compliance requirements.
• The Inflation Reduction Act of 2022 introduces new drug pricing regulations impacting the biopharmaceutical industry.
• Increased need for additional funding due to historical losses and limited operating history. Accumulated deficit of $452.8 million as of December 31, 2023.
• Manufacturing difficulties may limit supply, affecting clinical trials. Costs of commercial manufacturing increased by 46%.
• The European Union's new unitary patent system introduces uncertainty and potential litigation risks.
• Breakthrough therapy designation may not expedite approval, with no guarantee of faster development.
• Clinical trials are costly and risky; failure to demonstrate safety and efficacy could harm operations.
• Increased competition risks due to potential obsolescence of biologic candidates by competitors' products.
• Reverse Stock Split implemented at a ratio of 1-for-15, affecting liquidity and potentially decreasing stock value.
• Enrollment challenges may delay or prevent clinical trials, impacting commercial prospects.
• Market acceptance challenges may arise, impacting revenue generation and commercial viability.
• Risks related to ownership of common stock, including dilution from issuance of additional shares.
• Increased complexity and uncertainty in European patent laws may impact patent protection strategies.
• Dependence on information technology and cybersecurity risks could compromise sensitive data and operations.
• Risks related to reliance on third parties for clinical trials and manufacturing, including potential delays and supply chain disruptions.