Press Release

ABIONYX Pharma is scaling up its operations after securing the resources needed to achieve its goals and is embarking on a new cycle of value creation in the treatment of severe inflammation and sepsis

• All resolutions submitted for a vote at today’s Combined General Meeting were approved
• Launch of the largest pivotal clinical trial for CER-001 in sepsis, the 3rd cause of death worldwide
• Progress in regulatory and manufacturing phases toward approval of CER-001 for LCAT deficiency
• Financial visibility through the end of 2028 following the raising of up to €33 million
• Focus on leveraging and optimizing a unique scientific apoA-I platform

Toulouse, FRANCE, Fullerton, UNITED STATES, June 30, 2026, 6:00 p.m. CEST – ABIONYX Pharma (FR0012616852 – ABNX – eligible for the PEA PME program), a next-generation biopharmaceutical company developing innovative therapies for sepsis and critical care based on a proprietary apoA-I-based technology platform, today provided an update on the Combined General Meeting held at the company’s headquarters and the new phase of development beginning on June 30, 2026.

At the Combined General Meeting, all resolutions presented by the Board of Directors were adopted. ABIONYX Pharma thanks all shareholders who were present, represented, or voted by mail for their commitment and support during this General Meeting. The minutes of the General Meeting, as well as the voting results by resolution, will be available on the Company’s website in the “General Meetings” section.

Having secured the necessary resources for the development of its priority programs through a recent strategic financing transaction, the Company is entering a phase in which value creation will rely primarily on clinical execution, the quality of the data generated, and the progressive monetization of its scientific platform.

Financial Resources to Support All Strategic Objectives

Following the success of its recently completed financing round, the Company has secured funding totaling up to €33 million. This strengthened financial position provides a solid foundation for pursuing all of the Company’s strategic objectives and allows it to fully focus its resources on the development of its priority programs:

• the clinical development of CER-001 for sepsis; initiation of a pivotal Phase 2b clinical trial by the end of 2026, with the first results expected in the first half of 2028,
• market access for CER-001 in LCAT deficiency; validation of the production of two GMP batches in 2027 for submission of a marketing authorization application to the EMA by early 2028,
• the development of new scientific, technological, and industrial partnerships.

A Strategy Fully Focused on Execution

The Board of Directors and management remain fully focused on executing the strategy, and the priority for the coming quarters will be the rigorous execution of the announced programs, with particular attention paid to:

• adherence to clinical and GMP production timelines for sepsis and LCAT deficiency;
• generating clinical data establishing CER-001 as the new standard of care for sepsis and LCAT deficiency;
• leveraging and optimizing its recombinant apoA-I-based technology platform;
• preparing for the next regulatory steps; and
• continuing to maintain rigorous financial management in support of its growth ambitions.

A High Potential Scientific Platform

For more than two decades, ABIONYX has been developing in-depth knowledge of apoA-I and its role in inflammatory and metabolic mechanisms. The data from its research and development programs now constitute a scientific asset designed to support the clinical development of CER-001, strengthen scientific collaborations, and open up new avenues for development.

In this context, ABIONYX will actively pursue collaborations with academic, industrial, and technology partners to accelerate the commercialization of this platform.

A Long-Term Ambition

Beyond its current developments, ABIONYX is pursuing a clear vision: to become a leading player in treatments targeting severe inflammatory diseases, rare diseases, and conditions in which apoA-I can play a decisive therapeutic role.

Next financial press release:
• Cash position and update on Q2 2026 activity, August 27, 2026

About ABIONYX Pharma

ABIONYX Pharma is a next-generation biopharmaceutical company focused on sepsis and critical care, developing breakthrough biotherapies for serious conditions for which there are no effective treatments. Through its proprietary apoA-I-based technology platform, ABIONYX Pharma designs innovative biologics and next-generation HDL carriersthat target the immune-inflammatory dysregulation at the core of sepsis and other severe diseases. Driven by recognized scientific expertise, a differentiated pipeline, and an expanding global clinical network, ABIONYX Pharma aims to redefine therapeutic standards for sepsis and become a key player in intensive care.

Contacts:

ABIONYX Pharma
infos@abionyx.com

Disclaimer:

The statements contained in this document may constitute “forward-looking statements.” These statements include all matters that are not historical facts and can generally, but not always, be identified by the use of words such as “believes,” “expects,” “should,” “anticipates,” “intends,” “estimates,” “is expected to,” “will continue,” “may,” “is likely to,” “forecasts,” or similar expressions, including their variations and negative forms or comparable terms.

Forward-looking statements are not guarantees of future performance; they involve a number of known and unknown risks, uncertainties, and other factors, and ABIONYX Pharma’s actual operating results, financial condition, and the development of the sector in which it operates may differ materially from those indicated or suggested in the forward-looking statements contained in this document. Furthermore, even if ABIONYX Pharma’s operating results and financial condition, as well as developments in the sector in which it operates, are consistent with the forward-looking statements contained in this document, such results or developments are not necessarily indicative of results or developments in subsequent periods. ABIONYX Pharma does not undertake to publicly update or revise any forward-looking statements that may be made in this document, whether as a result of new information, future events, or otherwise.