Risk Factors Update Summary

• Successful commercialization of HEPLISAV-B in the United States and Germany will require significant resources and time.
• Failure to comply with regulatory requirements could prevent commercialization of products and impact financial condition.
• Uncertainty in protecting intellectual property rights globally due to evolving laws and limited patent protection.
• We have expanded our field sales force to generate significant sales momentum.
• Failure to timely conduct a pregnancy registry study may expose additional safety concerns.
• Potential impact of changes in U.S. and foreign patent laws on diminishing patent value.
• We did not recognize revenue for CpG 1018 adjuvant for the year ended December 31, 2023.
• We may face uncertainty regarding coverage, pricing, and reimbursement in the European Union and Great Britain.
• Introduction of a new unitary patent system in Europe affecting European patents.
• Legislative actions in the EU and the UK may propose cost-containing measures affecting healthcare costs.