Risk Factors Update Summary

• Evolving FDA guidance may increase costs and delays in clinical trials, affecting recruitment and retention.
• The company heavily depends on the success of product pipeline, particularly APX3330, RYZUMVI, and PS.
• Increase in full-time employees from 10 to 17 may impact managing future development and expansion.
• The launch of RYZUMVI is anticipated in the first half of 2024.
• The company may face challenges in transitioning to commercial activities if APX3330 receives marketing approval.
• The company's profitability hinges on successful commercialization of product candidates and market acceptance.
• Pending U.S. patent applications may result in patents protecting technology or products.
• The company granted Viatris exclusive rights to commercialize RYZUMVI and PS in key global markets.
• The company's ability to commercialize APX3330 successfully depends on market acceptance and competition.
• Acquisition of rights to products may be challenging, impacting future growth and development.
• The company may face limitations in using pre-change NOLs and tax attributes due to ownership changes.
• Potential issuance of shares under ELOC arrangement could substantially increase outstanding shares.
• Environmental, social, and governance matters may require additional investments and new reporting processes.
• Market fluctuations could result in extreme price and volume fluctuations, impacting stock value.