Cerus Corporation Announces Additional Department of Defense Award to Advance Care for Major Hemorrhage in Traumatic Injury

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.

“We are privileged to extend our collaboration with the DoD to gain additional insights on how the immediate availability of IFC can potentially benefit trauma patients with earlier fibrinogen transfusion compared to conventional frozen CRYO-AHF. We believe this study will support and build upon the current broad clinical adoption of IFC by U.S. hospitals,” said Dr. Laurence Corash, Cerus’ founder and chief scientific officer. “In addition, we expect the results of the CRYO-FIRST study could provide critical information about how best to treat acute trauma patients with fibrinogen deficiency and could be directly relevant to future use of LyoIFC.”

“We believe LyoIFC represents a next generation product that could help enable the provision of fibrinogen to severely bleeding patients for early treatment pre-hospital and during medical evacuations of wounded warfighters at or near the point of injury as well as at forward surgical hospitals,” continued Dr.Corash. “Hemorrhage is a leading cause of preventable death in trauma patients and by providing fibrinogen as early as possible in the treatment cycle, we believe it could improve survival.”

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.

Study Design for CRYO-FIRST

The study is designed to compare two FDA approved blood components (IFC versus CRYO-AHF) for the treatment of trauma associated hemorrhagic shock, and it incorporates point of care testing. It will be a two-cohort, 320 patient study using hospital cluster randomized treatment blocks for trauma associated hemorrhagic shock. Patients must be admitted to hospital in less than 60 minutes from trauma injury, have an admission fibrinogen < 200 mg/dL (low fibrinogen also called hypofibrinogenemia) determined by point of care testing. During IFC treatment blocks, patients will receive IFC within 60 minutes of hospital admission. During conventional treatment blocks, patients will receive CRYO-AHF when ordered.

The expected primary objectives are as follows: 1) Determine the ability of IFC to increase low plasma fibrinogen concentration in trauma patients; 2) Characterize the safety of IFC in patients with hypofibrinogenemia, including sub-analyses in patients with blunt versus penetrating trauma; and 3) Determine the proportion of trauma associated hemorrhagic shock patients admitted with hypofibrinogenemia as determined by rapid point of care testing. These outcomes will provide important information about patient response to IFC and the safety of IFC when administered to patients with hypofibrinogenemia resulting from trauma. In addition, data will be important in the design of a future study for registration of LyoIFC. Measured outcomes will include: plasma fibrinogen concentration, time to bleeding control, early and late mortality, length of ICU and hospital stay, and adverse events.

Initial patient enrollment is targeted for the first half of 2026.

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. In the U.S., the INTERCEPT Blood System for Cryoprecipitation is approved for the production of Pathogen Reduced Cryoprecipitated Fibrinogen Complex (commonly referred to as INTERCEPT Fibrinogen Complex), a therapeutic product for the treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency. The INTERCEPT red blood cell system is under regulatory review in Europe, and in late-stage clinical development in the U.S. 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.

Forward-Looking Statements

Except for the historical statements contained herein, this press release contains forward-looking statements concerning Cerus’ expectations with respect to receipt of funding under the amended DoD contract; Cerus’ expectations with respect to activities that will or may be funded under the amended DoD contract, the sufficiency of that funding, and the timing of those activities; and other statements that are not historical fact. Actual results could differ materially from these forward-looking statements as a result of certain factors, including, without limitation risks associated with; the uncertain and time-consuming development and regulatory process, including the risks related to the uncertain clinical trials and regulatory processes that must be completed to obtain regulatory approval of LyoCryo in a timely manner or at all; risks that anticipated clinical trials may not be initiated on the anticipated timing or at all, or if initiated, may be extended, delayed, suspended or terminated, including as result of safety concerns; risks associated with the uncertain nature of DoD’s funding over which Cerus has no control as well as actions of Congress and governmental agencies that may adversely affect the availability of funding under Cerus’ amended DoD agreement and/or the DoD’s exercise of any potential options under the amended contract, such that the anticipated activities that Cerus expects to conduct with the funds available from DoD may be delayed or halted; risks related to future opportunities and plans, including the uncertainty of Cerus’ future capital requirements and its future revenues and other financial performance and results; as well as other risks detailed in Cerus’ filings with the Securities and Exchange Commission, including under the heading “Risk Factors” in Cerus’ Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC on May 1, 2025. Cerus disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.

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