Cerus (CERS) Study Update summary

European regulatory update

• CE Mark review for INTERCEPT RBCs in Europe concluded without product approval due to concerns about impurity characterization in the final transfused red cells, raised by the Dutch Medicines Evaluation Board (CBG-MEB), and insufficient data on the impurity profile of the active pharmaceutical ingredient.

• The notified body TÜV SÜD found the major sections of the regulatory filing, including clinical, non-clinical, manufacturing, and quality modules, satisfactory, but the competent authority had unresolved theoretical risk concerns.

• CBG's concerns were not based on clinical or non-clinical data signals but on their interpretation of risk and impurity data.

• The company is assessing strategies for a new regulatory submission, planning to update modules with new data (including RECIPE trial results), and may leverage recent U.S. trial data for a broader clinical indication.

• The process will leverage previous work, focusing on updates rather than a full restart, with timelines to be clarified after further discussions.

U.S. clinical program and BARDA partnership

• Secured a new six-year BARDA contract worth up to $248 million to support development, regulatory submission, and commercialization activities for the INTERCEPT RBC system, with initial funding of $32.1 million and further funding contingent on milestones.

• Positive top-line results from the U.S. phase III RECIPE trial showed INTERCEPT RBCs were non-inferior to conventional red cells in complex cardiac surgery patients, meeting primary and safety endpoints.

• Patients receiving pathogen-reduced red cells required about 10% less hemoglobin, and adverse event rates were similar between groups.

• Enrollment continues in the REDS phase III trial for acute and chronic anemia, with new sites including a key Turkish center now enrolling at an encouraging pace; results will inform the planned modular PMA submission to the FDA.

• No clinically significant hemolysis was observed from treatment-emergent antibodies in the test group.

Strategic, operational, and risk outlook

• The new BARDA contract brings total partnership value to over $400 million, supporting both regulatory and commercial advancement.

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

• The company is working closely with TÜV SÜD to determine the optimal path for European resubmission and competent authority selection.

• Expanded use of INTERCEPT Fibrinogen Complex is generating increased clinical interest and case studies at major medical meetings.

• Regulatory approval in both the U.S. and Europe is subject to risks, including potential requirements for additional clinical data, possible delays in study completion, BARDA funding being subject to Congressional appropriations, and challenges in supply chain, safety, efficacy, and market acceptance.