ABIONYX Pharma: Gross Cash Position and Business Update for the First Half Of 2021

• Gross cash position of €4.8 million at June 30, 2021
• Recording of the company’s first sales figures during the period
• Launch of the Phase 2a clinical trial, RACERS, evaluating CER-001 in the prevention of Acute Kidney Injury in ICU patients with septicemia
• Receipt of positive opinion from EMA within the framework of the Orphan Drug Designation process for CER-001 for the rare disease LCAT Deficiency

TOULOUSE, France & LAKELAND, Mich.–(BUSINESS WIRE)–Regulatory News:

ABIONYX Pharma (FR0012616852 – ABNX – PEA PME eligible), a next-generation biotech company dedicated to the discovery and development of innovative therapies, announces today its gross cash position for the first half of the year ending June 30, 2021 and reviews the highlights of the period.

Cash position

Cash and cash equivalents amounted to €4.8 million at June 30, 2021, compared with €7.3 million at March 31, 2021. This change is explained, on the one hand, by the Covid-19 crisis that affected the company’s activity, requiring it to make an up-front purchase of raw materials necessary for the production of its CER-001 bio product and, on the other hand, by expenses related to the restarting of R&D activities, notably in ophthalmology, incurred in the first half of 2021.

Recording of the company’s first sales figures

ABIONYX Pharma also 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, following positive results obtained in March 2021 in the treatment of LCAT deficiency, an ultra-rare renal disease, in a patient in France.

Highlights of the period and outlook

Launch of the Phase 2a clinical trial, RACERS, evaluating CER-001 in the prevention of Acute Kidney Injury in ICU patients with septicemia

RACERS is a randomized Phase 2a, open-label, placebo-controlled, parallel group study evaluating the safety and efficacy of intravenously administered CER-001 in ICU patients with sepsis at high risk for AKI based on their Sequential Organ Failure Assessment (SOFA score). A total of 20 patients will be randomized to receive 8 doses of CER-001 or placebo over 6 days. The primary endpoint of the study will be the onset and severity of AKI according to KDIGO criteria as well as safety and tolerability of the dosage regimens in order to select the optimal dose of CER-001.The clinical study is partnered with the University of Bari and the Consorzio per Valutazioni Biologiche e Farmacologiche (CBVF) and is already fully funded.

Outlook

During the second half of 2021, ABIONYX Pharma intends to pursue the clinical and operational development of CER-001, whose entire value chain is now under the Company’s full control thanks to its strategic production agreement. CER-001 is one of the most advanced biomedicines in France and ABIONYX Pharma is considering a marketing application for LCAT deficiency as soon as possible, following receipt of a positive opinion from EMA within the framework of the Orphan Drug Designation process for CER-001 for the rare disease LCAT Deficiency.

Next financial communication: 2021 Half-year results, Thursday September 9, 2021

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

Louis-Victor Delouvrier

[email protected]
+33 (0)1 44 71 98 53

NewCap
Media relations

Nicolas Merigeau

[email protected]
+33 (0)1 44 71 94 98