CER-001

TOULOUSE, France & LAKELAND, Mich.--(BUSINESS WIRE)-- Access here the full press release ABIONYX Pharma, (FR0012616852 – ABNX – PEA PME eligible), a new generation biotech company dedicated to the discovery and development of innovative therapies based on the world’s only natural recombinant apoA-I, today acknowledges that the Phase 3 AEGIS-II study evaluating the efficacy and safety of CSL Behring’s human-plasma-derived apoA-I, CSL112, compared to placebo in reducing the risk of major adverse cardiovascular events (MACE) in patients following an acute myocardial infarction (AMI), did not meet its primary efficacy endpoint of MACE reduction at 90 days. About CER-001 CER-001 is a novel engineered recombinant human apoA-I that was designed to mimic the structural and functional biological properties of natural, nascent HDL, also known as pre-β HDL, and has been shown to perform all steps of the Reverse Lipid Transport pathway (RLT), the only natural pathway responsible for lipid elimination. Administered CER-001 particles increase transient apoA-I and the number of HDL particles and promote the elimination of trapped cholesterol and lipids in tissues in the absence of LCAT enzyme for example, but also the elimination of bacterial lipid endotoxin (LPS) in the case of sepsis. HDL particles are then recognized by the liver, leading to the elimination of these transported lipids via a process called Reverse Lipid Transport (RLT). About ABIONYX Pharma ABIONYX Pharma is a next-generation biotech company focused on developing innovative medicines in diseases where there is no effective or existing treatment, even the rarest ones. The company expedites the development of novel therapeutics through an extensive expertise in lipid science and a differentiated apoA-I -based technology platform. ABIONYX Pharma is committed to radically improving treatment outcomes in sepsis and critical care. View source version on businesswire.com: Contacts NewCap Investor relations Nicolas Fossiez Louis-Victor Delouvrier abionyx@newcap.eu +33 (0)1 44 71 98 53 NewCap Media relations Arthur Rouillé abionyx@newcap.eu +33 (0)1 44 71 00 15 Source: ABIONYX Pharma View this news release online at:

CER-001 showed robust efficacy in sepsis demonstrating statistically significant sustained reduction in endotoxins (LPS) and consequent decreases in inflammatory cytokines and markers of endothelial dysfunction Data showed a reduced severity of AKI, a trend for decreased mortality and shorter ICU stay CER-001 shows promise as a therapeutic strategy for sepsis management, improving outcomes and mitigating inflammation and organ damage with the potential to save lives Simultaneous publication of data from translational sepsis research project, including the RACERS study, exclusively in BMC Medicine (Nature Springer) TOULOUSE, France & LAKELAND, Mich.--(BUSINESS WIRE)-- ABIONYX Pharma, (FR0012616852 - ABNX - PEA PME eligible), a new generation biotech company dedicated to the discovery and development of innovative therapies based on the world's only recombinant human apoA-1, today announced the full results of the RACERS Phase 2 clinical trial of CER-001, an apoA-1-based therapy for the treatment of sepsis, in a late-breaking clinical trial poster presentation at the American Society of Nephrology (ASN) Kidney Week 2023. Key Points from the RACERS Data: CER-001 rapidly and significantly eliminated endotoxins, and the result was maintained (p<0.05 on days 3, 6 and 9), whereas even by day 9, patients on standard care alone showed no decreases in endotoxin levels relative to baseline. Mortality for all patients at 30 days was 6.7% for the CER-001 group and 20.0% for patients treated with standard care alone. This represents a Relative Risk Reduction (RRR) of 65%. Among critical care patients, mortality rates were 14.7% compared to 50.0% for patients on standard care (RRR=71%). ICU patients treated with CER-001 were discharged earlier than patients receiving standard care, with an average ICU stay 5 days shorter than that of patients on standard care. Access here the full press release About ABIONYX Pharma ABIONYX Pharma is a new generation biotech company that aims to contribute to health through innovative therapies in indications where there is no effective or existing treatment, even the rarest ones. Thanks to its partners in research, medicine, biopharmaceuticals and shareholding, the company innovates on a daily basis to propose drugs for the treatment of renal and ophthalmological diseases, or new apoA-I vectors used for targeted drug delivery.