ABIONYX Pharma

Business and Financial Review • Dec 18, 2023

Press Release

ABIONYX Pharma successfully manufactures a third batch of recombinant human apoA-I CER-001 using a new, innovative and robust industrial bioprocess

• Complete success of industrial biomanufacturing of CER-001, one of the most advanced biomedicines
• Preparation of biomanufacturing requiring 3 consecutive batches for Marketing Authorization

Toulouse, FRANCE, Lakeland MI, USA, December 18, 2023, 6:00 p.m. CET – 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, announces the successful completion of a third batch for the GMP (Good Manufacturing Practice) industrial biomanufacturing of CER-001 using the latest innovative and robust method.

ABIONYX successfully manufactured a third batch of CER-001 under GMP conditions, using the new innovative and robust industrial process. ABIONYX thus confirms that its new production line, based on an innovative and efficient approach, is ready to bring the only recombinant apoA-I protein to market. All stages of the biomanufacturing process are geared to increasing production yields and serving target markets such as kidney disease, sepsis and ophthalmology.

Thanks to the successful production of this third batch, the new manufacturing process has been confirmed, paving the way for biomanufacturing, which will require the completion of 3 consecutive GMP pilot batches at the level of performance required for the future commercial exploitation of CER-001.

ABIONYX Pharma points out that its reference shareholders Domundi, Cyrille Tupin and Luc Demarre, have not sold any shares, nor have all the shareholders who subscribed to the last capital increase last October. Finally, as indicated last October at the time of the capital increase, the Company's financial visibility is now extended to Q1 2025, without drawing on the equity-linked financing facility.

Next financial release: Cash position and activity update for Q4 2023, February 29, 2024

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 HDL vectors used for targeted drug delivery.

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