Abivax S.A. Stock Price, News & Analysis

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.

Abivax announced that three scientific abstracts on its lead drug candidate, obefazimod, will be presented at the United European Gastroenterology (UEG) Week meeting in Vienna, Austria, from October 12-15, 2024. The presentations will focus on obefazimod's efficacy and safety in treating ulcerative colitis (UC).

The presentations include:

• An oral presentation by Prof. Bruce E. Sands on the efficacy and safety of obefazimod at week 48 in UC patients who were non-responders at week 8 of the Phase 2b induction trial.
• Two moderated poster presentations: one by Prof. Séverine Vermeire on corticosteroid-free efficacy and safety at weeks 48 and 96, and another by Prof. Britta Siegmund on the impact of obefazimod on histologic and endoscopic outcomes at week 8.

Abivax's Chief Medical Officer, Fabio Cataldi, MD, expressed optimism about obefazimod's potential to advance the treatment paradigm for UC as a once-daily oral therapy.

Abivax has announced initial preclinical combination data of obefazimod and etrasimod in an inflammatory bowel disease (IBD) mouse model. The company is conducting studies with multiple oral and injectable therapies, with additional data expected in Q4 2024. The preclinical evaluation showed improved body weight protection and Disease Activity Index, with a synergistic and statistically significant reduction of several cytokines compared to individual treatments.

Abivax aims to develop a fixed-dose combination therapy for ulcerative colitis (UC) patients, targeting best-in-disease state induction and maintenance efficacy. The company believes obefazimod's safety and efficacy profile makes it an attractive candidate for combination with other mechanisms of action. Abivax plans to select a candidate in 2025 and develop a fixed-dose combination for clinical development.

Abivax SA (ABVX) has released its first-half 2024 financial results, highlighting a cash balance of EUR 222.3M as of June 30, 2024, with a cash runway extending into Q4 2025. The company reported an increased operating loss of EUR 80.0M, up from EUR 37.3M in the same period of 2023. This increase was primarily driven by higher R&D expenses, which rose to EUR 64.7M, mainly due to the progression of Phase 3 clinical trials for obefazimod in Ulcerative Colitis. Sales and marketing expenses increased to EUR 4.2M, while general and administrative costs rose to EUR 17.9M. The company's net loss for the period was EUR 81.6M, compared to EUR 52.0M in H1 2023. Abivax also completed drawdowns of tranches B and C of the Kreos/Claret financing, each for EUR 25M.