Abivax provides business and operational update

• ABTECT Phase 3 Global Clinical Trial Enrollment Progressing as Planned; Induction and Maintenance Data Readouts Expected in Q1 2025 and Q1 2026, Respectively
• Durability of Efficacy Results with No New Safety Signals Observed in Step-Down Dosing from 50 mg to 25 mg for Approximately the Third and Fifth Year of Open-Label Maintenance Treatment with Obefazimod in Ulcerative Colitis (“UC”) Patients
• Prioritizing the Goal of Expanding the Global IP Position of Obefazimod Beyond 2035 up to 2039
• Expansion of U.S. Operations Commences with Focus on Potential Future Commercialization of Obefazimod in the U.S. Inflammatory Bowel Disease (“IBD”) Market
• Multi-Pronged Strategy to Support Financial Stability through Q2 2024 (with possible extension to Q4 2024 with drawdown of all debt facilities) with Catalysts Expected into 2026 and Operational Excellence Reinforced with Strengthened Management Team and Additional Board Members

PARIS, France, September 7, 2023 – 08:00 a.m. (CEST) – Abivax SA (Euronext Paris: FR0012333284 – ABVX) (“Abivax” or the “Company”) today announced updated business and operational goals along with changes to Abivax’s overall strategy, focused on preparing Abivax for the potential commercialization of its investigational lead asset, obefazimod, in IBD.

Marc de Garidel, Chief Executive Officer of Abivax, says: “With our strategic roadmap in place, we are ready to move Abivax into its next chapter by strengthening our position within the U.S. We are working to extend patent protection for obefazimod and have brought on an experienced leadership team to help prepare obefazimod for commercialization in the U.S. Furthermore, we are in the process of executing a multi-pronged strategy to secure our future business and financial objectives.”

Didier Blondel, Chief Financial Officer of Abivax, continues: “In 2023, we have successfully executed two financing rounds in equity and debt with top-tier investors, which we believe indicates investor confidence and belief in the potential of obefazimod. Moving forward, we intend to look for opportunities to further extend our operating capital, allowing us to deliver on our clinical development goals.”

BUSINESS AND OPERATIONAL UPDATE
Strategic priorities

• Advance Obefazimod—Establish obefazimod as a potential first-line advanced therapy for the treatment of IBD. This goal is based on (i) robust Phase 2a and 2b clinical trial data in patients with moderately to severely active UC, as well as (ii) obefazimod’s novel mechanism of action that was demonstrated to enhance the expression of miR-124, a natural regulator of the inflammatory response. Initiation of the Phase 2a clinical trial in Crohn’s disease (“CD”) is expected in 2024 and evaluation of potential combination therapy opportunities in UC is ongoing.
• Optimize Opportunity in IBD in the Near Term with Phase 3 Data Beginning in 2025—Overcome limitations of currently available treatments for UC to establish obefazimod as a differentiated treatment option with the goal of providing convenient oral administration, safety, tolerability, and durable efficacy.
• Leverage Library of miR-124 Enhancers—Explore and expand development options of obefazimod in other inflammatory conditions and continue R&D work to identify additional drug candidates from Abivax’s proprietary small molecule library that includes additional miR-124 enhancers.

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