• 5th patient with LCAT deficiency, also known as Norum disease, to be treated under Compassionate Access in Europe

Regulatory News:

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 provides an update on its activity, its revenue and its cash position for the 3rd quarter ended September 30, 2023.

The Company recorded consolidated revenue of €3,595 K for the first nine months of the year, after elimination of intra-group transactions. IRIS Pharma was the only company within the Group to generate revenue as of September 30, 2023, as the activity dedicated to the discovery and development of innovative therapies to improve the lives of patients did not generate any revenue over the first 9 months.

As of September 30, 2023, ABIONYX Pharma's cash position stood at €1.7 million. This cash position does not include the €3 million capital increase carried out by ABIONYX Pharma on October 6, 2023, or the reimbursement of IRIS Pharma's French Tax Credit (CIR) in the amount of €736 K, also in October 2023.

In September 2023, CER-001 vials were provided under compassionate access for a new patient in Italy with the rare kidney disease LCAT Deficiency which has no existing treatment. This is the fifth patient suffering from LCAT deficiency, also known as Norum disease, to be treated with CER-001 in Europe. The five patients suffering from this rare disease, which has a major impact on quality of life and on lifespan, represent very different stages in the evolution of the disease for which CER-001 may prove effective, whether the patients are transplanted or not, and whatever their age and severity of symptoms. ABIONYX is continuing its efforts to identify patients with this ultra-rare disease, support their treating physicians in seeking necessary approvals in their country/region, advising on appropriate treatment regimen to use and follow-up assessments to be performed, and providing CER-001 to them.

In the renal area, Phase 2 clinical data from the RACERS study in sepsis was selected for a Late-Breaking Clinical Results Poster presentation, at the American Society of Nephrology (ASN) Annual Meeting, which took place November 2-5, 2023, in Philadelphia, Pennsylvania. The full results of the RACERS study were published simultaneously and exclusively in the journal BMC Medicine (Nature Springer).

Two additional abstracts generated from ABIONYX-sponsored research programs were also accepted by the ASN for presentation at their 2023 Annual Meeting: an oral presentation on CER-001 treatment in ischemia reperfusion injury, and a poster on the action of CER-001 in "Brain Fog" associated with acute kidney injury. These preclinical results provide data that support exploring potential additional indications for CER-001 in future clinical studies.

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.

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

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