Risk Factors Update Summary

• Failure to secure appropriate reimbursement price or positive health technology assessment may adversely affect business.
• The "Windsor Framework" replaces the Northern Ireland Protocol, impacting medicinal products compliance by January 1, 2025.
• Addition of IND applications for product candidates, including foreign applications, may cause delays.
• Becoming a large accelerated filer increases costs and demands on management significantly.
• Becoming a large accelerated filer and no longer a smaller reporting company increases costs and demands.
• Expanded cybersecurity risks include misappropriation, leakage, and reputational harm, with increasing threats over time.
• In January 2023, FDA clearance was received for PLN-101095, a dual inhibitor for solid tumors.
• Commencing development of biological products, including a new product candidate, is significant.
• Increase in full-time employees from 124 to 158 may affect operations and growth management.
• Phase 2a INTEGRIS-PSC trial data is expected to be released in late 2024.
• Changes in FDA trial requirements, such as informed consent guidance, may impact enrollment.
• Change from Phase 1a to Phase 1 clinical trials for lead product candidate bexotegrast.
• No prior cybersecurity incidents materially affected operations, but future threats could damage credibility.
• The Phase 2b trial BEACON-IPF was initiated in August 2023, enrolling approximately 270 patients.
• Geopolitical events like the Russian invasion of Ukraine and the Israel-Hamas conflict pose risks.
• Potential impact of new EU legislation on orphan drug designation and market access.
• PLN-101325, a monoclonal antibody for muscular dystrophies, is expected to file for first-in-human studies.
• Rising inflation and interest rates pose uncertainties affecting the company's financial outlook.
• The company has increased full-time employees from 124 to 158, including those with Ph.D. or M.D. degrees.