Cerus Corporation Announces Positive Topline Results from Phase 3 RedeS Trial of the INTERCEPT Blood System for Red Blood Cells

• Met primary efficacy endpoint demonstrating non-inferiority of INTERCEPT Red Blood Cells (RBCs) to conventional RBCs by adjusted hemoglobin increment
• Primary safety endpoints:

• No statistically significant difference in related treatment-emergent adverse events (TEAEs) between treatment and control arms
• No evidence of hemolysis or clinical impact detected in treatment-emergent, low titer, transient antibodies, which were observed in RedeS, consistent with Cerus’ prior ReCePI study

CONCORD, Calif.--(BUSINESS WIRE)--Cerus Corporation (Nasdaq: CERS) today announced positive topline results from the Phase 3 RedeS (NCT03037164) trial.

“Over the past decade, pathogen reduction technology has become an integral component of the blood safety toolkit. The topline results from the RedeS study reinforce the potential to extend this established paradigm to red blood cell transfusions,” said Ross M. Fasano, MD, Professor of Pathology & Laboratory Medicine and Hematology at Emory University, and RedeS study site investigator at Grady Memorial Hospital.

RedeS Topline Results

The primary efficacy endpoint was met, demonstrating non-inferiority for INTERCEPT RBCs compared to conventional RBCs, as measured by adjusted hemoglobin increment, a commonly used measure of RBC transfusion effectiveness¹. On a modified intent to treat (mITT) basis:

• Adjusted hemoglobin increment was 1.996 g/dL (N=195) in the INTERCEPT arm compared with 2.050 g/dL (N=199) in the control arm, for an estimated difference of -0.054 g/dL (95% CI, -0.210 to 0.103).
• The lower bound of the 95% confidence interval was above the prespecified non-inferiority margin of −0.32 g/dL, demonstrating non-inferiority (p=0.004).

The study was designed with two prespecified primary safety endpoints.

• The proportion of subjects with any TEAEs (possibly, probably or definitely) related to a study RBC transfusion was 3.4% (n=9) in the INTERCEPT arm (N=267) compared with 2.5% (n=7) in the control arm (N=276), with no statistically significant difference between treatment arms (p=0.634).
• As in Cerus’ prior ReCePI study, treatment-emergent, low titer, transient INTERCEPT-specific antibodies were detected in RedeS without evidence of hemolysis or clinical impact. The proportion of subjects with INTERCEPT RBC-specific antibodies was 2.2% (n=6) in the INTERCEPT arm (N=267), compared with zero in the control arm (N=276) (p<0.013). The six INTERCEPT RBC-specific antibodies observed in the treatment arm were included in the TEAE safety endpoint.

Full study results, including secondary endpoints, are expected to be submitted to a peer-reviewed scientific journal as well as presented at upcoming scientific meetings.

“Today, we took another important step toward extending pathogen reduction to red blood cells. The topline RedeS results provide additional evidence on the performance of INTERCEPT-treated red blood cells in patients requiring transfusion support and complement the earlier results from the STARS, SPARC, and ReCePI clinical studies,” said Dr. Richard Benjamin, Cerus’ chief medical officer. “Our sincere thanks go to the patients, investigators and blood centers whose participation made this study possible.”

Cerus has ongoing studies to further evaluate the nature of INTERCEPT RBC specific antibodies observed in clinical studies.

Development of the INTERCEPT Blood System for Red Blood Cells has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Center for Biomedical Advanced Research and Development Authority (BARDA), under contract numbers HHSO100201600009C and 75A50124C00046.

The U.S. Food and Drug Administration (FDA) has not yet reviewed the final RedeS clinical study report, and its assessment of the study findings and the overall benefit-risk profile may differ from Cerus’ assessment.

The INTERCEPT Blood System for Red Blood Cells remains investigational in the United States and has not been approved by the FDA. These results do not establish regulatory approval or the timing of any potential approval.

Conference Call and Webcast

The Company will host a conference call at 4:30 P.M. ET this afternoon, during which management will discuss its third-quarter 2026 financial results, the RedeS topline results, and provide a general business overview and outlook. To listen to the live webcast, please visit the Investor Relations page of the Cerus website at http://www.cerus.com/ir.

A replay will be available on Cerus’ website approximately three hours after the call through November 23, 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.

1. Roubinian NH, Plimier C, Woo JP, et al. Effect of donor, component, and recipient characteristics on hemoglobin increments following red blood cell transfusion. Blood. 2019;134(13):1003-1013. doi:10.1182/blood.2019000773

Cerus, INTERCEPT, and the Cerus logo 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 relating to: the potential of the INTERCEPT Blood System for Red Blood Cells, including Cerus potentially making pathogen reduction available for RBCs; the significance and potential implications of the topline results from the RedeS clinical trial; Cerus’ expectations regarding completion of the full analysis of the RedeS data, including secondary endpoints, and publication and presentation of the full study results; Cerus’ ongoing evaluation of INTERCEPT RBC-specific antibodies observed in clinical studies; Cerus’ plans for further clinical and regulatory activities relating to INTERCEPT RBCs; the potential timing, scope and outcome of future interactions with the FDA and other regulatory authorities; Cerus’ ability to advance the INTERCEPT Blood System for Red Blood Cells toward regulatory submissions and potential approvals in the United States, Europe and other jurisdictions; 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 clinical development and regulatory review processes, including the risks that (a) Cerus may not complete a full analysis of the RedeS data or publish and present the full study results in a timely manner or at all, (b) the topline RedeS results reported herein and related findings and conclusions may change following completion of the full analysis of the study data, including secondary endpoints, (c) the full RedeS results may differ from or not support the conclusions suggested by the topline results, (d) additional analyses, clinical studies or other data may be required to support regulatory submissions or approvals for INTERCEPT RBCs, (e) Cerus and the FDA or other regulatory authorities may reach different conclusions regarding the RedeS results, INTERCEPT RBC-specific antibodies, the overall benefit-risk profile of INTERCEPT RBCs or the clinical or regulatory requirements necessary to support approval, (f) Cerus may be unable to complete planned clinical, regulatory or development activities in a timely manner or at all, (g) any regulatory submission for INTERCEPT RBCs may be delayed, may not be accepted for review, or may not be approved in a timely manner or at all, and (h) Cerus may be unable to obtain or maintain regulatory approvals for INTERCEPT RBCs in the United States, Europe or other jurisdictions; risks related to product safety and efficacy, including the occurrence, persistence or potential clinical significance of antibody reactivity to INTERCEPT RBCs; risks related to Cerus’ ability to demonstrate to the transfusion medicine community and other health care constituencies that pathogen reduction is safe, effective and economical; risks associated with Cerus’ ability to maintain an effective and secure manufacturing and supply chain and comply with applicable regulatory requirements; risks associated with macroeconomic, geopolitical and financial market developments; Cerus’ need for additional funding; and other risks detailed in Cerus’ filings with the Securities and Exchange Commission, including under the heading “Risk Factors” in Cerus’ Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 2, 2026, and Cerus’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2026. Cerus disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.