Advicenne Provides an Update as its Operations Evolve

Regulatory News:

Advicenne (Euronext: ADVIC) (Paris:ADVIC) (BSE:ADVIC) provides an update on the overall progress of the Company.

In Europe, with the recent positive CHMP Opinion for our lead medicine ADV7103—Sibnayal, Advicenne should receive the EMA Marketing Authorization (MAA) for Sibnayal soon. The company is currently pursuing discussions with several partners for its commercialization in most countries of the European Community.

Meanwhile the clinical program in cystinuria in the EU is progressing. In spite of the hurdles encountered due to the ongoing COVID-19 crisis, the submission for Marketing Authorization is expected by late 2022.

Advicenne has been able to maintain a satisfactory level of activity, and the team has been doing a great job in all the aspects of the Sibnayal pre-launch, from market access to manufacturing and securement of the supply chain .

In the US, Advicenne Inc, Advicenne’s US affiliate, has made significant progress in building a team of highly qualified professionals. The pivotal Phase III ARENA trial of ADV7103 for distal Renal Tubular Acidosis (dRTA) is resuming. The submission for Marketing Authorization is expected in late 2022.

Meanwhile the launch of Ozalin by Primex under an exclusive license is progressing. Advicenne is confident in the continuous positive execution of the €40 million licensing deal signed in 2016.

Focus and streamlining, as well as effective cost management are practices put in place by the Company during these difficult times. The Company was able to secure €4.3 million of non-dilutive financing through a PGE (French state guaranteed loan) at the end of 2020.

Thanks to the positive evolution of the company a number of financing options are now open to secure the development of the Company in the mid term.

With the recent appointment of Peter Meeus as Chief Executive Officer of Advicenne (effective February 15, 2021), the Company will continue to develop strategies and operations to increase its footprint on rare kidney diseases.

“I am very pleased with the progress of the Company in the past year. Important milestones have been met, setting the ground for our new incoming CEO Peter Meeus whose great business experience in the industry will serve Advicenne extremely well to bring the company to its next stage of growth”, said Dr. David Horn Solomon, Chairman of the Board of Directors.