• Focus of the Services activity on the Biotech's preclinical studies in ophthalmology
  • Manufacturing of a new batch of CER-001 under GMP conditions using a new innovative and robust industrial bioprocess
  • Cash position of €2.9 million as of March 31, 2023

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 natural recombinant ApoA-I, today provides an update on its activity and cash position as of March 31, 2023.

ABIONYX Pharma recorded consolidated quarterly revenue of €1,09 million after elimination of intra-group transactions. IRIS Pharma recorded quarterly revenue of €1,17 million. The Company did not generate any revenue in the quarter from its business dedicated to the discovery and development of innovative therapies to improve the lives of patients. The consolidated revenue reflects the decision of the biotech to focus its Services activity on preclinical studies of CER-001 in ophthalmology in order to enter the clinical phase as soon as possible.

As of March 31, 2023, the Company had cash of close to €3 million available, taking into account the expenses for the manufacturing of the new batch of CER-001 carried out under GMP conditions, using a new innovative and robust industrial process as part of an innovative and efficient approach to access the Apotherapy market, based on the only recombinant human ApoA-I protein. This cash flow is before the receipt of the upcoming Research Tax Credit of an estimated amount of 1.5 million euros.

The Company published its strategy in ophthalmology this quarter. Given the strong development dynamics of the ophthalmology activities, ABIONYX Pharma has decided to separate these specific activities, and plans to transfer its ophthalmology biotech activities to IRIS Pharma Holding (IPH), renamed APOGEYE Pharma, in order to more clearly valorize the Apotherapy and Biovectorization activities in ophthalmology.

In the renal area, the Company reported promising results from the 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 awaiting a future scientific publication of the clinical results of RACERS.

Finally, the Company continues to receive new Compassionate Access Authorization (CAA) requests for bio-HDL (CER-001) from several hospitals around the world.

Next financial press release : Cash position and activity update for Q2 2023, August 17, 2023

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.

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

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

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