Cerus Corporation Announces Follow-on Award of U.S. Department of Defense Funding for Development of Pathogen Reduced, Lyophilized Cryoprecipitate
05 Junio 2023 - 7:30AM
Business Wire
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.
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.
Forward-Looking Statements
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20230605005325/en/
Jessica Hanover – Vice President, Corporate Affairs Cerus
Corporation 925-288-6137
Cerus (NASDAQ:CERS)
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