Cerus (CERS) Study Update summary

European regulatory update

• CE Mark review for INTERCEPT RBCs in Europe concluded without approval due to insufficient impurity characterization data, despite satisfactory clinical, non-clinical, manufacturing, and quality modules.

• The Dutch Medicines Evaluation Board (CBG) found impurity data insufficient and limited further review cycles, leading to file closure.

• Differences in regulatory interpretation between CBG and FDA were noted, with FDA's similar concerns previously addressed successfully.

• The company is planning a new submission, leveraging recent positive U.S. clinical data and working with TÜV SÜD to identify the best path and competent authority.

• Positive U.S. Phase III RECIPE trial results may support a broader clinical indication in a future European submission.

US clinical program and BARDA partnership

• A new six-year BARDA contract provides up to $248 million to support U.S. development, regulatory submission, and commercialization of INTERCEPT RBCs.

• Initial BARDA funding of $32.1 million awarded, with further funding contingent on milestone achievement.

• Positive topline results from the U.S. Phase III RECIPE trial demonstrated non-inferiority and similar safety and efficacy outcomes for INTERCEPT RBCs in complex cardiac surgery patients.

• Enrollment in the ongoing REDS Phase III trial is progressing, with new sites including a key Turkish center now enrolling thalassemia patients.

• Results from ongoing trials will inform the planned modular PMA submission to the FDA.

Strategic, operational, and risk outlook

• The new BARDA contract, combined with the previous agreement, brings total potential BARDA funding to over $400 million.

• BARDA funding is time-based, subject to Congressional appropriations, and may be terminated at any time.

• No commercial revenue from the European red cell program was previously modeled, so the CE Mark outcome does not impact 2024 financial goals.

• The company remains committed to advancing INTERCEPT RBCs globally, leveraging new clinical data to strengthen future regulatory submissions.

• Commercialization and market acceptance depend on successful regulatory outcomes, product launch, and demonstrating safety, efficacy, and cost-effectiveness.