Risk Factors Update Summary

• The company received a milestone payment of $10.0 million in Q1 2024 and expects an upfront payment of $12.0 million in Q1 2023.
• The company may face delays and significant expenses if the Los Angeles facility is not approved for commercial manufacturing.
• Cash, cash equivalents, and marketable securities decreased from approximately $41 million to $39 million.
• The company may need to raise additional funds through various means to meet needs.
• Dispute with CSMC over overdue payment obligations may lead to termination of the license agreement.
• The FDA may not approve manufacturing facilities for commercial products, impacting viability.
• The company faces risks related to product liability and potential product and environmental liability.
• FDA draft guidance E6 (R3) may impact clinical trial data standards and require further studies.
• The company may not be able to satisfy obligations under licensing agreements, affecting financials.
• Risks related to competitive factors include potential delays in regulatory approval compared to competitors.
• Increase in shares available for future issuance under incentive plans by 1,557,416 shares.
• Market and economic conditions may adversely affect the industry, causing a decline in stock price.
• Failure to satisfy Nasdaq listing requirements may lead to delisting, affecting market price and liquidity.
• Potential securities class action litigation or litigation by individual stockholders may be costly.