Welcome to our dedicated page for Cerus news (Ticker: CERS), a resource for investors and traders seeking the latest updates and insights on Cerus stock.
Cerus Corporation develops and supplies blood-safety technologies and pathogen-protected blood components for blood centers and hospitals. Its recurring news centers on the INTERCEPT Blood System for platelets and plasma, the U.S. INTERCEPT Blood System for Cryoprecipitation used to produce INTERCEPT Fibrinogen Complex, and the company’s red blood cell pathogen-reduction program.
Company updates commonly cover product revenue, gross margin trends, revenue guidance, government contract activity, international supply agreements, clinical studies involving pathogen-inactivated platelets, regulatory and pipeline developments, healthcare conference participation, and governance changes. Commercial disclosures often emphasize demand for INTERCEPT Fibrinogen Complex and adoption of pathogen inactivation technologies by blood establishments in the United States, Europe and other markets.
Cerus Corporation (Nasdaq: CERS) has secured an additional $7.2 million contract amendment from the U.S. Department of Defense (DoD) to advance the development of lyophilized INTERCEPT Fibrinogen Complex (LyoIFC) for treating trauma-related bleeding. This supplements their existing $18 million DoD contract for developing room-temperature, shelf-stable LyoIFC.
The new funding will support the CRYO-FIRST study, a 320-patient randomized trial comparing pre-thawed IFC to conventional cryoprecipitated antihemophilic factor in trauma patients with hemorrhagic shock. The study aims to evaluate the effectiveness of early fibrinogen administration in trauma patients and will begin enrollment in early 2026.
Since receiving initial DoD funding in November 2022, Cerus has achieved key milestones including FDA pathway discussions, successful process scale-up, and prototype delivery to the DoD.
Cerus Corporation (Nasdaq: CERS) announced progress in its European regulatory review for the INTERCEPT Red Blood Cells (RBC) system. The company's Notified Body, TÜV-SÜD, has completed reviewing the clinical module of the CE Mark submission and transferred information to the Czech Republic's State Institute for Drug Control (SÚKL).
The clinical module includes positive results from the U.S. Phase 3 ReCePI trial, expanding the CE Mark submission to cover all patient indications for RBC transfusion. SÚKL will now review the API module before TÜV-SÜD conducts manufacturing facility audits for final CE Mark decision.
Cerus Corporation (CERS) will present clinical data for its INTERCEPT Blood System at the 35th Regional International Society of Blood Transfusion Congress in Milan from May 31 to June 4, 2025. The presentations will highlight data on the system's applications for platelets, plasma, cryoprecipitated fibrinogen complex, and red blood cells.
Key presentations include positive results from the Phase 3 ReCePI study in red blood cells, INTERCEPT treated cold stored platelets, and effective inactivation of California encephalitis virus. The event features a Cerus-sponsored symposium focusing on INTERCEPT's impact on adverse events, platelet use, and inventory management in France, along with its safety in neonates.
Multiple oral and poster presentations will cover topics including cold-stored platelet concentrates, reduced hemoglobin use in cardiac surgery, and pathogen reduction effectiveness.
Cerus (CERS) has scheduled the release of its first quarter 2025 financial results for Thursday, May 1, 2025, after market close. The company will host a conference call and webcast at 4:30 P.M. ET on the same day to discuss financial performance and provide business updates.
Management will present detailed financial results and offer a general business overview and outlook during the call. A replay of the event will be accessible on Cerus' website until May 22, 2025.
Cerus (CERS) has received CE mark approval for its next-generation LED-based illumination device (INT200) for the INTERCEPT Blood System for platelets and plasma under the EU Medical Device Regulation (MDR). This approval enables Cerus to market the INT200 throughout the European Union and regions recognizing CE mark certification.
The INT200 represents a significant upgrade featuring enhanced physical design and new software interface while maintaining compatibility with existing processing sets. This approval completes the authorization of the INTERCEPT Blood System for both platelets and plasma within the EU MDR framework, following the 2023 CE mark approvals of INTERCEPT processing sets.
The CE mark represents the first regulatory approval for Cerus' next-generation illuminator, with additional regulatory submissions planned over coming years. The INT200 will serve as the foundation for geographic expansion and future growth of the INTERCEPT business.
Cerus (CERS) reported strong financial results for full-year and Q4 2024. Full-year product revenue reached $180.3 million, up 15% year-over-year, while Q4 product revenue was $50.8 million, a 9% increase. The company achieved significant financial improvements, including a 40% reduction in GAAP net loss to $20.9 million and positive non-GAAP adjusted EBITDA of $5.7 million for 2024.
Notable achievements include four consecutive quarters of positive operating cash flows, totaling $11.4 million for the year, a $55 million improvement from 2023. The INTERCEPT Fibrinogen Complex (IFC) product showed strong growth, with full-year revenue of $9.2 million, up 42% from the previous year.
The company reiterated its 2025 product revenue guidance of $194-200 million, including $12-15 million for IFC, projecting 8-11% growth from 2024.