$9.1 million funding to support manufacturing scale-up and defining pathway for FDA registration for DoD and civilian use

Cerus Corporation (Nasdaq: CERS) today announced that it has been awarded a $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. With this project and the associated funding, Cerus and DoD will collaborate to bring a product to patients that addresses a critical unmet need for early treatment of traumatic bleeding.

“We are pleased to partner with the DoD in support of our development efforts for our LyoCryo product,” stated Dr. Laurence Corash, Cerus’ chief scientific officer and co-founder. “We believe a product with the ability to deliver important clotting factors in a pathogen reduced, temperature stable format will be an important tool that can be used on the battlefield as well as in rural clinics and other remote areas. In life-threatening bleeding events, minutes matter, and we hope to bring yet another solution to the market that will help ensure immediate availability and contribute to improved patient outcomes.”

This product builds upon the INTERCEPT Blood System for Cryoprecipitation, which is used to make INTERCEPT Fibrinogen Complex, with the goal of creating a product that can be applicable for both DoD and civilian use. Since 2019, Cerus has been working to develop a lyophilized, pathogen reduced cryoprecipitate product and has advanced this program through several important development milestones, including product feasibility. Today’s announcement and the associated funding will support the scale-up of manufacturing technology for the LyoCryo product and developing preliminary data to support a U.S. Food & Drug Administration (FDA) submission for regulatory review.

ABOUT CERUS

Cerus Corporation is dedicated solely to safeguarding the world’s blood supply and aims to become the preeminent global blood products company. Headquartered in Concord, California, the company develops and supplies vital technologies and pathogen-protected blood components to blood centers, hospitals, and ultimately patients who rely on safe blood. The INTERCEPT Blood System for platelets and plasma is available globally and remains the only pathogen reduction system with both CE mark and FDA approval for these two blood components. The INTERCEPT red blood cell system is under regulatory review in Europe, and in late-stage clinical development in the US. Also in the US, the INTERCEPT Blood System for Cryoprecipitation is approved for the production of INTERCEPT Fibrinogen Complex, a therapeutic product for the treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency. For more information about Cerus, visit www.cerus.com and follow us on LinkedIn.

INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation.

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