Risk Factors Update Summary

• The UK's exit from the EU requires a separate marketing authorization application, impacting market access.
• FDA granted Breakthrough Therapy Designation for QINLOCK for the treatment of GIST.
• Cash, cash equivalents, and marketable securities increased from $339 million in 2022 to $352.9 million in 2023.
• Geographic expansion of QINLOCK in key European markets extended to 2024.
• Failure to maintain orphan drug exclusivity for ripretinib could affect market exclusivity.
• Net losses decreased from $194.9 million in 2022 to $178.9 million in 2023.
• Plan to provide access to QINLOCK to fourth-line GIST patients in additional countries.
• FDA Reauthorization Act of 2017 may not effectively protect products from competition.
• Accumulated deficit decreased from $1.4 billion in 2022 to $1.2 billion in 2023.
• Initiation of the pivotal Phase 3 INSIGHT study of QINLOCK versus [specific mutations] in 2023.
• Plans to initiate the Phase 3 INSIGHT study of QINLOCK in August 2023.
• Opening of the first sites for enrollment in the Phase 3 INSIGHT study of QINLOCK.
• Increased focus on artificial intelligence integration and associated risks.
• Potential impact of exchange rate fluctuations on financial results and operations.