Risk Factors Update Summary

• New U.S. state laws and federal regulations could impact business operations and data security.
• Orphan Drug Designation can lead to exclusivity for 7 years if first FDA approval is granted.
• The company plans to pursue key objectives for 2024, including completing the U.S. IND for PMN310 and initiating a Phase 1a clinical study.
• The company aims to advance an additional proprietary antibody into preclinical development.
• FTC imposing stringent requirements on sensitive personal information collection and disclosure.
• Pediatric exclusivity adds 6 months to existing exclusivity periods and patent terms.
• Marketing exclusivity provisions under the FD&C Act can delay submission or approval of certain applications.
• GDPR and UK GDPR impose strict requirements on data processing, potentially leading to fines.
• The company is conducting further preclinical studies to support pipeline candidates, with an emphasis on product validation and development for the amyloid vaccine program.
• The Inflation Reduction Act exempts orphan drugs from the Medicare drug price negotiation program.
• Introduction of UK Data Protection and Digital Information Bill may alter UK data protection regime.
• The EU's AI Act imposes obligations on AI systems, potentially increasing costs and compliance efforts.
• The Affordable Care Act subjected biologic products to potential competition by lower-cost biosimilars.
• Changes in U.S. federal laws may affect reimbursement, pricing, and commercialization of products.
• The FDA strictly regulates marketing, labeling, advertising, and promotion of products placed on the market.
• Potential adverse effects on business due to disruptions at regulatory authorities like the FDA.
• Failure to comply with statutory and regulatory requirements can lead to legal or regulatory action.