Abivax S.A. 6-K Filing

FAQ

Filing Documents

• abvx-20250930.htm (6-K) — 3955KB
• item991-pressreleaseq32025.htm (EX-99.1) — 61KB
• 0001956827-25-000035.txt ( ) — 18802KB
• abvx-20250930.xsd (EX-101.SCH) — 128KB
• abvx-20250930_cal.xml (EX-101.CAL) — 100KB
• abvx-20250930_def.xml (EX-101.DEF) — 534KB
• abvx-20250930_lab.xml (EX-101.LAB) — 866KB
• abvx-20250930_pre.xml (EX-101.PRE) — 735KB
• abvx-20250930_htm.xml (XML) — 4799KB

financial statements, copies of which are attached hereto as Exhibits 99.1 and 99.2, respectively, and incorporated

financial statements, copies of which are attached hereto as Exhibits 99.1 and 99.2, respectively, and incorporated herein by reference. Incorporation by Reference This Report on Form 6-K, including Exhibits 99.1 and 99.2, except for the quotes contained therein, shall be deemed to be incorporated by reference into the Registrant's registration statements on Form F-3 (File Nos. 333-283336 and 333-288884), and Form S-8 (File No. 333-286069) and to be part thereof from the date on which this Report is filed, to the extent not superseded by documents or reports subsequently filed. Exhibit Index Exhibit 99.1 Press release, dated December 15, 2025 Exhibit 99.2 Unaudited Interim Condensed Consolidated Financial Statements 3

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly. Abivax SA (Registrant) Date: December 15, 2025 /s/ Marc de Garidel Chief Executive Officer 4 Exhibit 99.2 Unaudited Interim Condensed Consolidated Financial Statements TABLE OF CONTENTS Page INTRODUCTION ................................................................................................................. 1 RISK FACTORS ................................................................................................................... 3 OPERATING RESULTS ........................................................................................................ 4 INDEX TO THE UNAUDITED INTERIM CONDENSED CONSOLIDATED FINANCIAL F-1 5 INTRODUCTION Unless otherwise indicated or the context otherwise requires, "Abivax," "the Company," "the Group," "we," "us" and "our" refer to Abivax SA and its consolidated subsidiary, taken as a whole. "Abivax" and the Abivax logo and other trademarks or service marks of Abivax SA appearing in this quarterly report are the property of Abivax SA. Solely for convenience, the trademarks, service marks and trade names referred to in this quarterly report are listed without the and symbols, but such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their right thereto. All other trademarks, trade names and service marks appearing in this quarterly report are the property of their respective owners. We do not intend to use or display other companies' trademarks and trade names to imply any relationship with, or endorsement or sponsorship of us by, any other companies. This quarterly report includes our unaudited interim condensed consolidated fina

RISK FACTORS

RISK FACTORS The Company's business faces significant risks. You should carefully consider all of the information set forth in this document and in the Company's other filings with the SEC, including the risk factors which the Company faces and which are faced by the Company's industry described in "Item 3.D—Risk Factors" of the Company's Annual Report on Form 20-F for the fiscal year ended December 31, 2024. Our risk factors have not changed materially from those described in our Annual Report on Form 20-F. Our business, financial condition or results of operations could be materially adversely affected by any of these risks. 8 OPERATING RESULTS Overview We are a clinical-stage biotechnology company focused on developing therapeutics that harness the body's natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases. Our lead drug candidate, obefazimod, is currently being evaluated in the following indications: Ulcerative colitis ("UC") : Phase 3 clinical trials for the treatment of adults with moderately to severely active UC are ongoing ("ABTECT"). On July 22, 2025, we announced the positive Phase 3 results of our ABTECT 8-week induction trials. Top-line results from the 44-week maintenance data read-out are expected during the second quarter of 2026. Crohn's disease ("CD") : On October 3, 2024, we announced the first patient was enrolled in our ENHANCE-CD Phase 2b clinical trial of obefazimod in patients with CD, and the 12-week induction data read-out is expected in second half of 2026. Combination therapy : In September 2024, we announced initial preclinical combination data of obefazimod combined with etrasimod in a mouse model of inflammatory bowel diseases (" IBD"). The results showed that treatment with the combination improved the response on body weight protection and Disease Activity Index and a synergistic and statistically significant reduction of several cytokines (TNFa, IL-17

View Full Filing

View this 6-K filing on SEC EDGAR