Risk Factors Update Summary

• Expanded clinical trials for product candidates, including zipalertinib, may require additional approvals and substantial delays.
• Addition of 23 full-time employees and 2 consultants, increasing total employees from 62 to 85.
• Changes in Medicaid Drug Rebate Program calculations and Medicare Part D coverage gap discounts may impact revenue.
• Healthcare cost containment measures could reduce demand for product candidates and limit pricing flexibility.
• Increased focus on regulatory approvals and maintaining INDs and CTAs for current and future product candidates.
• Increase in federal NOL carryforwards from $42 million to $54 million, and state NOL carryforwards from $27.1 million to $56 million.
• Uncertainty in obtaining coverage and reimbursement for product candidates, impacting commercialization and profitability.
• Legislative and regulatory reforms affecting healthcare services may limit coverage and reimbursement for newly approved drugs.
• Potential dilution risk due to the need for substantial additional funding for product development.
• Federal NOLs of $5.8 million generated prior to 2018, which will begin to expire at various dates through 2037.
• The amended bylaws now include a "Federal Forum Provision" in addition to the existing provision.
• State NOL carryforwards beginning to expire in 2031, with federal and state R&D tax credit carryforwards detailed.
• Failure to resolve litigation on a timely basis may negatively impact the company's stock price.
• Potential additional $130 million milestone payment related to the sale of equity interest in Cullinan Pearl.
• The company's stock price and trading volume could decline if analysts do not cover its securities.
• Increase in total voting stock from 63% to 53.8%, based on outstanding shares as of December 31, 2023.
• Mention of potential sanctions against Chinese CMOs, WuXi AppTec and WuXi Biologics, by U.S. lawmakers.