Risk Factors Update Summary

• CMS will negotiate drug prices for select drugs starting in 2026 and 2028, potentially decreasing revenue.
• Implementing changes to internal controls may incur substantial costs and distract employees.
• Added risks related to potential significant cost increases or shortages in platinum / etoposide or topotecan chemotherapy products, impacting COSELA sales.
• Increased need for substantial additional funding, with net losses of $147 million in 2022.
• Medicare Part D benefit design changes in 2025, capping out-of-pocket spending at $2,000.
• Risks from a hybrid workforce include security vulnerabilities, limited technology access, and intellectual property risks.
• Failure to comply with regulations may impact clinical trials and commercial supply, affecting product availability.
• Increased privacy laws in various states and countries may lead to compliance challenges and increased costs.
• Cybersecurity risks pose threats to confidential information, potentially disrupting operations and causing financial loss.
• Expansion of workforce locations may lead to compliance challenges with local laws and intellectual property risks.
• Changes in patent laws may impact the breadth of intellectual property protection and ability to commercialize products.
• Regulatory changes and legal challenges may affect the company's ability to compete effectively in the marketplace.
• State legislation on healthcare costs may impact profitability and commercialization efforts.
• Expanded risks related to failure in drug development, including the potential impact on commercialization efforts.
• Political uncertainty and climate change regulations may negatively affect business operations and financial performance.
• Challenges in obtaining and enforcing intellectual property protection may hinder successful commercialization efforts.
• Legislative proposals aim to expand product offerings, potentially impacting financial results.
• Added risks related to delays or difficulties in clinical trials, potentially affecting COSELA development and approval.
• Enhanced risks related to compliance with healthcare laws and regulations, with potential penalties and impacts on operations.
• Increased expenses for ongoing activities, including commercialization and larger-scale clinical trials, leading to higher capital requirements.
• Added risks related to potential delays or reductions in commercialization efforts, impacting revenue generation and profitability.