ABIONYX Pharma

Earnings Release • Feb 4, 2021

Press Release

ABIONYX Pharma provides an update on its cash position and the start of its clinical activities in Q4 2020

• Cash and cash equivalents of €9.2 million as of December 31, 2020
• Initiation of a fully-funded Phase 2a clinical trial with CBVF¹ for CER-001 in patients with sepsis at high risk of developing acute renal injury
• Positive therapeutic signals found in ATUn in France and Italy for ultra-rare kidney disease
• Positive preclinical results published in the journal Metabolism demonstrating that CER-001 improves renal function

Toulouse, FRANCE, Lakeland MI, UNITED-STATES, February 4, 2021, 6:00 pm CET ABIONYX Pharma (FR0012616852 - ABNX - PEA PME eligible), a new generation biotech company dedicated to the discovery and development of innovative therapies for patients, today announced that cash and cash equivalents totaled €9.2 million as of December 31, 2020.

As ABIONYX Pharma's activities are dedicated to the discovery and development of innovative therapies to improve patients' lives, the company has not generated any revenues for the year 2020.

The company notes that with a cash position of more than 9 million euros and the fully-funded phase 2 study in collaboration with CBVF*, no dilutive financial instruments or debt have been necessary to put in place.

In terms of business activity, the last quarter of 2020 was intense and marked by the start of clinical trials with the launch of a phase 2a clinical study for CER-001, named RACERS, in patients with sepsis at high risk of developing acute renal injury, in partnership with the University of Bari, as announced last December 23rd.

This study, launched with the important input and support of Italian Key Opinion Leaders from the University of Bari, follows the finding of positive therapeutic signals from compassionate use of CER-001 under nominative ATUs in France and Italy in ultra-rare kidney disease, as announced on November 25, 2020. These positive signals were in line with the positive preclinical results announced in the journal Metabolism on December 15, showing that CER-001 improves renal function.

¹ CBVF: Consorzio per Valutazioni Biologiche e Farmacologiche, i.e. the Italian Consortium for Biological and Pharmacological Evaluations, which provides scientific, methodological and regulatory support to European entities and companies interested in innovation in the pharmaceutical and biotechnology fields.

Thus, all preclinical results and clinical signals predict potential efficacy of CER-001 in renal diseases and a potentially disease-modifying effect on the progression of the inflammatory cascade in sepsis. This marks a repositioning of CER-001 in severe renal diseases, which have not had a breakthrough innovation for a long time. The company is awaiting further preclinical and clinical results.

Next press release: Annual results, February 25, 2021

About ABIONYX Pharma

ABIONYX Pharma is a new generation biotech company dedicated to the discovery and development of innovative therapies for patients. The biotech assets inherited from CERENIS Therapeutics constitute a rich portfolio of valuable programs for the treatment of metabolic diseases as well as with a HDL targeted drug delivery platform.

Contacts:

NewCap Investor relations Louis-Victor Delouvrier abionyx@newcap.eu +33 (0)1 44 71 98 53

NewCap Media relations Nicolas Merigeau abionyx@newcap.eu +33 (0)1 44 71 94 98