ABIONYX Pharma

Financial Highlights and Business Review for the First Quarter Of 2021

Regulatory News:

ABIONYX Pharma (FR0012616852 - ABNX - PEA PME eligible) (Paris:ABNX), a new generation biotech company dedicated to the discovery and development of innovative therapies for patients, publishes its financial information for the first quarter ended March 31, 2021 and reviews its operational achievements made during the period.

• Recording of the company's first sales figures

Following positive results in the treatment of an ultra-rare renal disease in a patient in France, which led to the postponement of dialysis and the reduction of corneal lipid deposits, resulting in improved vision, ABIONYX Pharma recorded its first sales of €26,650 excluding VAT for the period, corresponding to the supply of CER-001 for the treatment of a patient for one month in the context of a new ATUn.

Since the exclusive publication of the positive results of the first French ATUn in the scientific journal "Annals of Internal Medicine" last March, the company has been approached by several nephrologists around the world to supply CER-001 under ATUn programs. Given the stock of CER-001 available, the company will not be able to fulfill all requests at this time, but remains more dedicated than ever to the development of innovative therapies for patients without effective or existing treatment.

• Gross cash position of €7.3 million as of March 31, 2021

As announced last October, the company, which no longer has sufficient stocks of product to meet all possible new ATU requests, is facing significant supply tensions in the context of COVID-19. The company intends to secure the purchase of raw materials for its supply chain in the context of the relocation of its production to France. Consequently, the company has purchased these materials, which explains the decrease in cash and cash equivalents, which amounted to €7.3 million as of March 31, 2021.

• Structural and operational developments during the period

Over the past quarter, ABIONYX Pharma has reorganized the biomanufacturing of its recombinant bio‑HDL mimetic, through the conclusion of a strategic partnership with GTP Biologics (Fareva Group) and V-Nano (VBI Therapeutics Group), specialized in the production and formulation of biological nanomedicines. The company will thus benefit from the innovative technological approach of GTP Biologics and V-Nano to ensure the success of its complex, high value-added biomanufacturing in France.

Lastly, the Company is still waiting for the start of the new Phase 2a clinical trial for CER-001, called RACERS, in sepsis at high risk of developing acute kidney injury, in partnership with the University of Bari. The Company is also awaiting further preclinical and clinical results.

• Combined General Meeting of June 11, 2021

Given the current sanitary crisis, the General Meeting will be held in closed session and will be broadcasted via the company's website. Shareholders will be invited to exercise their rights by voting by mail or by giving a proxy to the Chairman. The preparatory documents for this CGM will be made available to the company's shareholders in accordance with the procedures and within the time limits provided for by the applicable legal and regulatory provisions. The documents relating to this CGM referred to in Article R.22-10-23 of the French Commercial Code will be available on the company's website (www.abionyx.com).

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.

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