Cerus Corporation Announces Follow-On Award of U.S. Department of Defense Funding for Development of Pathogen Reduced, Lyophilized Cryoprecipitate

Cerus Corporation announced that it has been awarded an additional $8.7 million contract amendment to the original $9.1 million contract by the U.S. Department of Defense (DoD) Industrial Base Analysis and Sustainment (IBAS) program for the development of pathogen reduced, lyophilized cryoprecipitate (“LyoCryo”) to treat bleeding due to trauma. Cerus' LyoCryo product is being designed for shelf stability, rapid availability, and portability, enabling administration to patients in remote environments with the aim of increasing survival from traumatic injury bleeding. Optimizing survival and recovery of military personnel with combat-related injury is a priority for the Army's Combat Casualty Care Research Program.

For civilians, trauma with massive bleeding is the leading cause of death for people under the age of 45 years in the U.S. The “Golden Hour” is the critical time a bleeding patient must be resuscitated with blood transfusion to enhance survival, yet conventional blood products are not feasible for use in far-forward austere combat environments or at the point of injury. This additional funding will support the joint work by Cerus and the DoD to make a novel product accessible to patients in order to address a critical unmet need for early treatment of traumatic bleeding. LyoCryo builds upon the INTERCEPT Blood System for Cryoprecipitation, which is used to produce INTERCEPT Fibrinogen Complex.

LyoCryo is designed for both DoD and civilian use. Since receiving the initial DoD funding award in November 2022, Cerus has met with the U.S. Food & Drug Administration (FDA) to define the regulatory pathway for LyoCryo, including potential clinical trial design, successfully scaled-up the lyophilization process, and provided prototype materials for evaluation to the DoD. The additional funding announced will support implementation of manufacturing processes required by the FDA, continued scale-up of manufacturing technology for the LyoCryo product, and development of data to support a submission to the FDA for regulatory review.