Cerus Awarded Addl $7.2M Contract Amendment By U.S. Dod IBAS Program For Development Of Lyophilized Pathogen Reduced, Cryoprecipitated Fibrinogen Complex To Treat Bleeding Due To Trauma

Additional Funding to Support Randomized Study Evaluating Earlier Access to INTERCEPT Fibrinogen Complex in Trauma Associated Hemorrhagic Shock Patients

Cerus Corporation (NASDAQ:CERS) announced today that it has been awarded an additional $7.2 million contract amendment by the U.S. Department of Defense (DoD) Industrial Base Analysis and Sustainment (IBAS) program for the development of lyophilized Pathogen Reduced, Cryoprecipitated Fibrinogen Complex (commonly referred to as INTERCEPT Fibrinogen Complex, or IFC, and, as lyophilized, LyoIFC) to treat bleeding due to trauma. This additional award is additive to the approximately $18 million currently provided for under Cerus' contract with the DoD to develop a manufacturing capability to provide a room-temperature, shelf-stable LyoIFC for use in austere military environments where refrigeration is limited or not feasible to improve the care of both military and civilian patients with traumatic injury.

The additional funding will support CRYO-FIRST, a randomized study comparing the use of pre-thawed IFC to conventional cryoprecipitated antihemophilic factor (CRYO-AHF) in trauma associated hemorrhagic shock patients.

Since receiving the initial DoD funding award in November 2022 for the development of LyoIFC, Cerus has met with the U.S. Food & Drug Administration (FDA) to discuss the regulatory pathway for LyoIFC, successfully scaled-up the pathogen reduction and lyophilization processes, and provided prototype materials for evaluation to the DoD.