AB Science provides a summary of the live webcast held on March 4, 2024 giving an update on AB Science development

PRESS RELEASE

SUMMARY OF THE WEBCAST HELD ON MARCH 4, 2024 PROVIDING AN UPDATE ON AB SCIENCE DEVELOPMENT

Paris, March 7, 2024, 3pm CET

AB Science SA (Euronext - FR0010557264 - AB) is providing a summary of the live webcast held on March 4, 2024, giving an update on AB Science development.

The webcast presentation is available on the company’s website, in the section « Press Releases »: https://www.ab-science.com/news-and-media/press-releases/

The presentation covered four topics:

• Status of conditional approval application of masitinib in ALS with EMA and Health Canada
• Status of the masitinib platform clinical development program
• Status of masitinib licensing partnership
• Status of the microtubulin platform clinical development program
• Status of masitinib and AB8939 intellectual property
  
  

Status of conditional approval application of masitinib in ALS with EMA and Health Canada

• Regarding EMA, the application was filed in August 2022. An Oral Explanation was planned in January 2024, however, CHMP proposed that AB Science submit a written response to the List of Outstanding Issues at D195 of the procedure, instead of addressing these issues through the Oral Explanation, which is unusual. A decision is now expected by the end of Q2 2024.
• Regarding Health Canada, a Notice of Deficiency-Withdrawal (NOD/w) has been issued and AB Science intends to submit a Request for Reconsideration. This reconsideration process involves new assessors and offers the possibility to have an opinion from a panel of experts. A decision is now expected by the end of Q3/Q4 2024.

Of note, the press release dated 26 February 2024 incorrectly stated that Health Canada issued a Notice of Non Compliance – Withdrawal (NON/w) when the decision issued was in fact a Notice of Deficiency – Withdrawal (NOD-W).

The issuance of NOD-W or NON-W indicate different regulatory decisions. A NOD-W is issued if, during the scientific review of the response to a Notice of Deficiency (NOD), it is found that the submission/application remains deficient. On the other hand, a Notice of Non-Compliance Withdrawal is issued when, during the scientific review of the response to a Notice of Non-Compliance (NON), it is determined that the submission remains non-compliant.