Risk Factors Update Summary

• Outside the United States, many EU Member States may adopt cost-containing measures, impacting reimbursement.
• Started testing one product candidate in clinical trials, outcomes are uncertain. This change might result in delays in product development.
• The EU's Regulation No 2021/2282 on HTA may affect pricing and reimbursement status from January 2025.
• Commenced first Phase 1 clinical trial but not completed any clinical trials. This may impact future commercialization plans.
• Reliance on third parties for manufacturing and clinical trials. Delays or failures in third-party operations could impact product development.
• Increased emphasis on financial condition and capital requirements. Failure to raise additional funds may impact operations and development timelines.
• Changes in U.S. legislation may impact Medicare pricing and rebate rules, subject to ongoing litigation.
• Increased focus on ESG practices and sustainability concerns. Failure to meet evolving ESG standards could harm reputation.
• Enhanced focus on intellectual property protection. Competitors may infringe patents, leading to legal challenges and potential business impact.
• Expansion of compliance requirements related to healthcare laws and regulations. Non-compliance could lead to penalties and impact business operations.
• Proposed legislative changes may control drug costs for Medicare and Medicaid beneficiaries.
• New state data privacy laws, like the CCPA, provide individuals with rights concerning personal information.
• The EU GDPR and UK GDPR impose strict requirements for processing personal information, with significant penalties.
• Generative AI technologies subject to privacy laws may result in compliance costs and legal actions.