Abivax S.A. Stock Price, News & Analysis

Abivax (Euronext: FR0012333284 – ABVX / Nasdaq: ABVX), a clinical-stage biotechnology company focused on developing therapies for chronic inflammatory diseases, has announced its 2025 financial communications calendar. The schedule includes:

- March 24, 2025: 2024 Annual Business and Financial Report, Universal Registration Document, and Annual Report on Form 20-F
- June 2, 2025: 2025 Q1 Financial Results
- June 6, 2025: Annual General Meeting in Paris
- August 11, 2025: 2025 Half-Year Business and Financial Report
- December 15, 2025: 2025 Q3 Financial Results

All financial reports will be released after US market closure and will include corresponding regulatory filings for both Euronext and US markets.

Abivax (ABVX) announced the presentation of seven scientific abstracts focusing on obefazimod, its lead drug candidate for treating moderately to severely active ulcerative colitis (UC), at the upcoming European Crohn's and Colitis Organization's 20th Annual Congress in Berlin (February 19-22, 2025).

The presentations include one oral presentation on the efficacy and safety of dose de-escalation from 50mg to 25mg QD of obefazimod maintenance treatment, and six poster presentations covering various aspects including histologic outcomes, integrated safety summary, health-related quality of life, long-term efficacy and safety after dose de-escalation, treatment patterns, and synergistic reduction of inflammatory cytokines.

The presentations will feature research from prominent medical experts, including Prof. Silvio Danese, Prof. Séverine Vermeire, and Prof. Parambir S. Dulai, among others.

Abivax (ABVX) has reached a significant milestone in its Phase 3 ABTECT trial for obefazimod, enrolling 1,003 out of 1,224 targeted participants (82%) for treating moderately to severely active ulcerative colitis. The company expects to complete enrollment in Q2 2025, with top-line results for the 8-week induction trial anticipated in Q3 2025.

The 44-week maintenance data is expected in Q2 2026, followed by NDA submission in H2 2026 if successful. The blinded baseline characteristics align with the pre-specified target population and are consistent with the Phase 2b UC trial. The company confirms its cash runway extends through the ABTECT induction trial readout and into Q4 2025, with no additional financing needed.

The trial's safety profile shows no new safety signals under the oversight of the independent Data Monitoring Committee. Obefazimod is being developed as a potentially first-in-class oral treatment option for UC patients.

Abivax announced that Dr. Philippe Pouletty, representative of Truffle Capital, will resign as director effective December 31, 2024. Dr. Pouletty, who served as Chairman of the Board from the company's inception in December 2013 until August 2022, is stepping down due to his recent appointment as Chairman and acting CEO of a French listed biotechnology company in plastics recycling. As CEO of Truffle Capital, he was instrumental in founding Abivax and developing obefazimod, the company's lead drug candidate currently in Phase 3 clinical trials for ulcerative colitis. The Board will initiate a search for a new director to support Abivax's late-stage pipeline development in IBD.

Abivax has announced the implementation of a 3-year At-The-Market (ATM) Program on Nasdaq, allowing the company to issue and sell American Depositary Shares (ADS) with aggregate gross sales proceeds of up to $150 million. Each ADS represents one ordinary share. The program will be effective until November 19, 2027, with Piper Sandler acting as sales agent. The company plans to use the net proceeds for clinical programs on obefazimod, working capital, and general corporate purposes. The maximum potential dilution is approximately 39.5% based on existing share capital as of October 31, 2024.

Abivax reported its Q3 2024 financial highlights, showing cash and cash equivalents of EUR 180.5 million as of September 30, 2024. The company expects this to fund operations into Q4 2025. Total principal debt outstanding decreased to EUR 106.3 million from EUR 108.4 million in Q2 2024. The debt structure includes EUR 75.0 million in Kreos/Claret financing, EUR 26.3 million in Heights convertible notes, and EUR 5.0 million in BPI advances and state-guaranteed loans.

Abivax has appointed Mark Stenhouse as Board Observer and Advisor. Stenhouse brings over 30 years of biopharma industry experience, most recently serving as COO of Prometheus Biosciences, which was acquired by Merck for $10.8 billion in 2023. Previously, he spent 25+ years at AbbVie, where he led U.S. Immunology as Vice President, overseeing HUMIRA® sales and marketing teams. The appointment aims to support Abivax's progress toward commercialization of obefazimod and strengthen its pipeline, leveraging Stenhouse's extensive experience in gastroenterology and immunology.

Abivax has announced the enrollment of the first patient in its Phase 2b ENHANCE-CD trial for obefazimod in Crohn's disease. The trial aims to evaluate the efficacy and safety of obefazimod, an oral, once-daily treatment, in adults with moderately to severely active Crohn's disease. The study is designed as a multicenter, double-blind, randomized, placebo-controlled trial.

The trial consists of three phases: a 12-Week Induction Phase, a 40-Week Maintenance Phase, and a 48-Week Extension Phase. It will assess obefazimod's performance compared to placebo in patients who have shown inadequate response to conventional and/or advanced therapies. The primary objective of the Extension Phase is to evaluate the long-term safety and tolerability of obefazimod.

Abivax (ABVX) has reported positive interim efficacy and safety results for obefazimod in treating moderate to severe Ulcerative Colitis (UC) patients. The open-label maintenance study evaluated patients who received a reduced dose of 25mg once daily for up to two additional years after completing previous Phase 2a and 2b studies.

Key findings include:

• Maintenance of clinical remission at weeks 48 (84%) and 96 (87%)
• High symptomatic remission rates at weeks 48 (91%) and 96 (92%)
• Consistent safety profile with no new safety signals
• Efficacy and safety demonstrated for up to six years of treatment

The study involved 130 patients, with 113 evaluated at 48 weeks and 74 at 96 weeks. Patient retention rates were high, with only 12% discontinuing in the first year and 5% in the second year.