Risk Factors Update Summary

• Potential safety concerns or adverse events in clinical trials could lead to termination, delays, or additional costs.
• Lack of redundant supply arrangements poses a risk of significant delays and costs in engaging new suppliers.
• The company must attract and retain highly skilled employees to manage growth effectively.
• Addition of "and uncertainties" to risk disclosure. This change emphasizes broader risk coverage.
• Increased legal risks due to potential intellectual property disputes, including challenges and infringement claims.
• Increasingly, third-party payors are challenging drug prices, impacting demand and reimbursement levels significantly.
• Monumental statutory damages could result from potential commandeering under the Defense Production Act of 1950.
• Dependence on a limited number of suppliers, including sole suppliers, poses risks to the manufacturing process.
• Approval delays for new suppliers could lead to shortages of drug substance or product candidates.
• Failure to retain key personnel could disrupt operations and delay business plans.
• Failure to obtain profitable reimbursement rates may adversely affect operating results and ability to raise capital.
• Inclusion of "audited consolidated financial statements" enhances transparency for investors.
• Failure to achieve effective internal control over financial reporting could lead to sanctions and investigations.
• Potential adverse effects from security incidents, system disruptions, data loss, cyberattacks, and related costs.
• International operations expose the company to various risks, including regulatory and financial challenges.
• Competition from other products may impact market acceptance, pricing, and commercial success of TOUR006.
• Disease outbreaks could disrupt operations, delay regulatory approvals, and impact clinical trial results.
• Regulatory changes in pricing and reimbursement globally could delay or limit commercial launch of products.
• Expanded risks include dependence on third parties for development, manufacturing, and commercialization.
• Material weaknesses in internal controls may result in future misstatements in financial statements.
• Heightened risks from evolving online and offline threats, including ransomware attacks and data breaches.
• Limited ability to develop or commercialize clinical trials due to key personnel additions or departures.
• Potential future tax laws could impact business, with a 15% minimum tax on book income.
• Transitioning manufacturing facilities to the U.S. may result in delays and impact product comparability.
• Intense competition for qualified personnel may hinder successful research and development.
• Unfavorable economic conditions may negatively affect financial results and operations.
• Executive severance and change in control plans could lead to significant financial harm.
• Changes in financial accounting standards may lead to unexpected revenue fluctuations affecting financial position.
• Anticipated growth in employees and operations may pose challenges in managing growth effectively.
• Complex and changing privacy and data security laws globally, requiring significant resources for compliance.
• Failure of CDMOs to perform obligations could lead to significant delays in clinical trials.
• Failure to identify new product candidates may adversely affect business operations and prospects.
• Challenges in negotiating BD arrangements may delay development and commercialization efforts.
• Market acceptance factors include efficacy, safety, pricing, patient population, and regulatory approvals.
• Risks related to data privacy and security obligations, including potential fines, penalties, and regulatory actions.
• Challenges in addressing and complying with evolving data privacy expectations and obligations, impacting business operations.
• Insufficient funds may hinder further development and commercialization of product candidates.
• Increased scrutiny and potential restrictions on cross-border transfers of personal data, affecting operations and compliance efforts.
• Competition risks could impact sales and pricing, especially if competitors develop and commercialize products faster.