Additional $8.7 million funding to support advancement towards FDA registration and full-scale product commercialization
Cerus Corporation (Nasdaq: CERS) today 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.
“It has been an honor to partner with the DoD over the last several months as we have advanced development efforts for our LyoCryo product. We are gratified by the DoD’s decision to provide additional funding for this important project,” stated Dr. Laurence Corash, Cerus’ chief scientific officer and co-founder. “Massive hemorrhage in trauma remains a critical unmet need today, both in military and civilian settings. At Cerus, we are focused on enabling patient access to life-saving blood products when needed. LyoCryo is designed with the potential to deliver important clotting factors in a pathogen reduced, temperature stable format, thereby facilitating hemorrhage control on the battlefield as well as in other rural or remote settings, when time to transfusion is critical.”
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 today 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.
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.
Except for the historical statements contained herein, this press release contains forward-looking statements concerning Cerus’ products, prospects and expected results, including 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 and the sufficiency of that funding; and other statements that are not historical facts. 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 option’s 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 Cerus’ Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, filed with the SEC on May 4, 2023. Cerus disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.
Jessica Hanover – Vice President, Corporate Affairs