Risk Factors Update Summary

• Net losses decreased from $136.6 million to $126.6 million, with an accumulated deficit increasing to $571.8 million.
• Litigation challenging FDA approval of mifepristone may impact new drug development and distribution.
• Strategic reorganization in November 2023 may result in delays or unrealized efficiencies, impacting financial condition.
• Changes in regulatory landscape due to Brexit and EU pharmaceutical legislation review may impact market authorization timelines.
• FDA, EMA, and other regulatory authorities enforce laws prohibiting off-label promotion, leading to significant liability.
• Funding estimate extended from the second half of 2025 to 2027, potentially requiring earlier additional funding.
• Collaboration with Moderna for ctLNP delivery system and iqDNA platform may impact future commercialization efforts.
• Potential impact of FDA and Congress changes on orphan drug regulations could affect business profitability and operations.
• New laws and regulations introduce privacy obligations, requiring additional compliance mechanisms and processes.
• Federal NOLs increased from $328.2 million to $353.0 million, state NOLs increased from $326.5 million to $360.8 million.
• The IRA requires drug manufacturers to engage in price negotiations with Medicare, impacting pricing strategies.
• The IRA subjects drug manufacturers to penalties for non-compliance with pricing regulations.
• The IRA may lead to civil monetary penalties and excise taxes for failing to comply with pricing legislation.
• Litigation involving provisions of the IRA may continue, with unpredictable and uncertain results.