Release Details

• Oral presentation of Phase 2b, 96-week, open-label, maintenance efficacy and safety in obefazimod-treated patients with moderately to severely active ulcerative colitis (UC)
• Moderated poster presentation highlighting correlation of pharmacokinetic (PK) parameters with enhanced expression of a single microRNA, miR-124, in blood of obefazimod-treated UC patients
• Poster presentation on long-term enhanced expression of miR-124 in blood and rectal tissue of obefazimod-treated UC patients

PARIS, France, October 2, 2023 – 06:00 p.m. (CEST) – Abivax SA (Euronext Paris: FR0012333284 – ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to modulate the immune response in patients with chronic inflammatory diseases, today announced that three scientific abstracts on its lead drug candidate, obefazimod, will be presented during the United European Gastroenterology (UEG) Week meeting, October 14-17, 2023, in Copenhagen, Denmark.

“We continue to be encouraged by the emerging clinical profile of obefazimod based on the 96-week efficacy and safety data from our Phase 2b open-label maintenance study,” said Sheldon Sloan, M.D., M. Bioethics, Chief Medical Officer of Abivax. “With the presentation of this new data and the underlying novel mechanism of action, obefazimod has the potential to advance the treatment paradigm for people living with ulcerative colitis.”

For more information on the Abivax clinical program and company updates, please visit Abivax’s UEG booth at C2-32 or see the conference program at the UEG website.

Obefazimod data to be presented

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About Obefazimod

Obefazimod, Abivax’s lead investigational drug candidate, is an oral small molecule that enhances the expression of a single microRNA, miR-124. Phase 2 clinical trials in patients with UC have generated positive efficacy and safety data, resulting in the initiation of a pivotal global Phase 3 clinical trial program (ABTECT Program), with first patients enrolled in the U.S. in October 2022. Initiation of a Phase 2a clinical trial in Crohn’s disease is expected in Q1 2024, and exploration of potential combination therapy opportunities in UC is ongoing.

About Abivax

Abivax is a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to modulate the immune response in patients with chronic inflammatory diseases. Based in France and the U.S., Abivax’s lead drug candidate, obefazimod (ABX464), is in Phase 3 clinical trials for the treatment of moderately to severely active ulcerative colitis. More information on the Company is available at www.abivax.com. Follow us on X, formerly Twitter, @ABIVAX.

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FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements, forecasts and estimates, including those relating to the Company’s business and financial objectives. Words such as “continue,” “could,” “expect,” “goal,” “intend,” “objective,” ”will” and variations of such words and similar expressions are intended to identify forward-looking statements. Although Abivax’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks, contingencies and uncertainties, many of which are difficult to predict and generally beyond the control of Abivax, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. A description of these risks, contingencies and uncertainties can be found in the documents filed by the Company with the French Autorité des Marchés Financiers pursuant to its legal obligations including its universal registration document (Document d’Enregistrement Universel). These risks, contingencies and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug candidate, as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates. Special consideration should be given to the potential hurdles of clinical and pharmaceutical development including further assessment by the company and regulatory agencies and IRBs/ethics committees following the assessment of preclinical, pharmacokinetic, carcinogenicity, toxicity, CMC and clinical data. Furthermore, these forward-looking statements, forecasts and estimates are only as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Abivax disclaims any obligation to update these forward-looking statements, forecasts or estimates to reflect any subsequent changes that the Company becomes aware of, except as required by law. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement. This press release is for information purposes only, and the information contained herein does not constitute either an offer to sell, or the solicitation of an offer to purchase or subscribe securities of the Company in any jurisdiction. Similarly, it does not give and should not be treated as giving investment advice. It has no connection with the investment objectives, financial situation or specific needs of any recipient. It should not be regarded by recipients as a substitute for exercise of their own judgment. All opinions expressed herein are subject to change without notice. The distribution of this document may be restricted by law in certain jurisdictions. Persons into whose possession this document comes are required to inform themselves about and to observe any such restrictions.