Risk Factors Update Summary

• The company's ability to successfully commercialize OGSIVEO is crucial for revenue generation.
• Limited experience in commercial operations may lead to less successful sales and marketing efforts.
• Only one NDA was submitted to the FDA, for nirogacestat, granted regulatory approval on November 27, 2023.
• Dependence on third parties for manufacturing OGSIVEO and product candidates poses supply risks.
• An MAA was submitted to the EMA in 2024, granted priority review for nirogacestat.
• The company's lack of experience in commercializing products may hinder success in commercialization.
• Federal, state, and city net operating loss carryforwards increased from $368.5 million to $472.1 million.
• Approval of OGSIVEO by the FDA for desmoid tumors treatment is a significant milestone.
• Federal tax credits increased from $22.7 million to $33.5 million.
• The company's reliance on third parties for manufacturing may impact product supply and commercialization.
• Shares of common stock outstanding increased from 62.9 million to 73.4 million.
• The company's transition to commercial activities may face challenges in hiring and training qualified individuals.
• The number of restricted shares subject to future vesting decreased from 893.1 million to 713.8 million.