PRESS RELEASE

AS OF SCIENCE KNOWN THAT IT HAS SUBMITTED HIS RESPONSE TO DAY 120 QUESTIONS IN THE EMA REGULATORY REVIEW OF MASITINIB IN AMYOTROPHIC LATERAL SCLEROSIS AND CLARIFIES THE NEW HEALTH CANADA RESPONSE SCHEDULE

Paris, AApril 4 2023, 6 p.m

AB Science S.A (The “Pursue” – Euronext – FR0010557264 – AB) announces today an update on the timeline for the evaluation of its applications for conditional approval of masitinib by the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) and Health Canada in the treatment of amyotrophic lateral sclerosis ( AS).

As part of the ongoing EMA process, AB Science has submitted its responses to the Day 120 assessment of the process.

Because the EMA and Health Canada regulatory processes were occurring concurrently, and to ensure the best possible quality of responses in both processes, AB Science, in agreement with Health Canada, has extended Health Canada’s response time by 30 days. The new deadline for Health Canada to respond is April 12, 2023.

AB Science has received support from multiple ALS patient groups in Canada and Europe for conditional registration of masitinib in ALS.

Olivier Goy, Co-Founder and President of October, a European FinTech, said: “Masitinib is one of the most promising drugs in ALS that exists Only have been subject to the EMA conditional approval process. I strongly support drugs submitted for conditional approval, particularly when they have complementary mechanisms of action.“

Sabine Turgeman, Executive Director of ARSLA (Association pour la recherche sur la SLA) said: “Since 2004, the European regulation has provided a legal framework in Article 14-a of Regulation (EC) No. 726/2004 to support the conditional registration of medicinal products for incurable diseases if the final proof of efficacy is not yet fully available. Conditional Registration is the right way to speed up patient access to new treatments. We call on the EMA to set a maximum…