Regulatory News:

ABIONYX Pharma, (FR0012616852 – ABNX – eligible PEA PME), a next-generation biopharma company pioneering a new therapeutic era in sepsis and critical care through its proprietary apoA-I–based technology platform, and SEBIA, a global player in specialized biological diagnostics, today announced an exclusive global strategic partnership in sepsis.

New tests for early diagnosis and monitoring of sepsis treatment

This partnership will enable the validation of new infectious and metabolic diagnostic tests that allow for earlier and more accurate identification of the severity of sepsis, enabling faster treatment and dynamic monitoring of treatment efficacy, including ABIONYX Pharma's recombinant apoA-I.

A global partnership based on scientific excellence and technological complementarity

Under this agreement, SEBIA will draw on its unique expertise in preparative analytical chemistry for blood samples and in the development and validation of methods for separating proteins, lipoproteins, and glycoproteins. ABIONYX Pharma, for its part, will contribute its expertise in lipid biology and clinical studies, and its in-depth understanding of sepsis acquired through its recombinant biomedicine in phase 2b/3.

The two companies have established a Joint Steering Committee to jointly oversee the program, from initial analytical validations to regulatory approvals.

A confidentiality framework necessary for exclusive cooperation

Discussions between the two companies, which began several months ago, have led to an extensive and exclusive cooperation agreement. The financial terms, technical milestones, and deployment conditions remain confidential.

A major medical and economic challenge

Every year, sepsis affects more than 50 million people. Despite advances in intensive care, the mortality rate can exceed 30% in severe cases. Early detection remains one of the most difficult challenges in modern medicine: the signs are diffuse, and the progression is often sudden and severe. The current lack of reliable and rapid diagnostic tools often leads to critical delays in treatment. Every minute counts when it comes to sepsis—this devastating inflammatory syndrome kills more than 11 million people worldwide each year.

By combining biotherapy and diagnostics, ABIONYX Pharma and SEBIA are laying the foundations for an integrated approach to sepsis management that can improve survival rates, reduce hospital stays, and optimize healthcare costs. The global market for sepsis diagnostics is estimated to be worth more than $1.5 billion by 2030, with annual growth of close to 9%. The two companies' shared ambition is clear: to make this innovation a global benchmark in emergency diagnostics.

About SEBIA : www.sebia.com

Founded in 1967, Sebia is one of the world's leading suppliers of equipment and reagents for clinical protein electrophoresis, a technology used for in vitro diagnostic testing. Its systems analyze proteins to screen for and monitor various diseases and conditions, primarily in oncology (multiple myeloma) and metabolic disorders such as diabetes, but also in hemoglobinopathies and rare diseases. Following the acquisition of Orgentec, Corgenix, Arotec in 2021, and Zeus Scientific in 2022, Sebia now develops and markets innovative solutions for the diagnosis of autoimmunity. Based in Lisses, France, the company is present in more than 120 countries.

About ABIONYX Pharma : www.abionyx.com

ABIONYX Pharma is a next-generation biopharma company pioneering a new therapeutic era in sepsis and critical care through breakthrough biotherapies that address life-threatening conditions with no effective treatments. Leveraging its proprietary apoA-I–based technology platform, ABIONYX Pharma develops innovative biologics and HDL-derived vectors that target the immune and inflammatory dysregulation underlying sepsis and other severe diseases. With a strong scientific foundation and a growing network of global clinical partners, ABIONYX Pharma aims to redefine the standard of care in sepsis and to bring critical care solutions to patients worldwide.

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