Risk Factors Update Summary

• The company may require substantial additional financing to achieve goals, potentially impacting commercialization activities.
• Increased borrowing capacity from $100 million to $260 million through loan agreements with Hercules.
• Added potential impairment to business operations due to insurance inadequacy, impacting capital sufficiency.
• The approval and successful commercialization of VOQUEZNA for the treatment of erosive GERD in Q4 2023 is critical.
• Delay in FDA approval for VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK until November 2023.
• Increased scrutiny and enforcement actions related to data protection laws, necessitating significant resources.
• The company's ability to generate revenue and achieve profitability is highly dependent on the success of vonoprazan.
• Expansion of the organization with a substantial increase in employees in 2023 for commercialization preparation.
• Enhanced privacy and security obligations under new California CPRA, with additional consumer rights processes.
• Extension of NCE exclusivity for VOQUEZNA until May 3, 2032, potentially affecting competition timeline.
• Potential impact on business and financial condition due to loss of patent protection or non-compliance with privacy laws.
• Increased cybersecurity risks due to remote work, leading to heightened vulnerabilities and potential disruptions.
• Changes in U.S. tax law affecting federal net operating loss carryforwards and potential ownership changes.