Abivax SA American Depositary Shares - ABVX STOCK NEWS

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.

Abivax (ABVX) has reached a significant milestone in its Phase 3 ABTECT trial for obefazimod, a treatment for moderately to severely active ulcerative colitis (UC). The trial has surpassed 600 enrolled patients, keeping it on track to achieve full enrollment by early Q1 2025. This progress aligns with the company's expectations and reflects similar baseline characteristics and trends observed in the earlier Phase 2b trial.

The ABTECT trial is a important step in Abivax's development of therapeutics that aim to stabilize the immune response in chronic inflammatory diseases. The company's approach focuses on harnessing the body's natural regulatory mechanisms. With this enrollment milestone, Abivax reaffirms its timeline for the trial's completion, potentially bringing obefazimod closer to market for UC patients.

Abivax SA (ABVX) provided an update on its key clinical programs and leadership changes. The Phase 3 ABTECT trial for obefazimod in ulcerative colitis is on track to complete enrollment in early Q1 2025, with top-line results expected in early Q2 2025. The company is making progress on its pre-clinical combination therapy program. Sylvie Grégoire has been named Chair of Abivax's Board of Directors, while Dr. Fabio Cataldi and Dr. David Zhang have been appointed as Chief Medical Officer and Chief Strategy Officer, respectively.

Abivax's cash position allows for runway into Q4 2025, covering the ABTECT 8-week induction top-line results. The company is focusing on R&D while streamlining G&A expenses. The Phase 2b ENHANCE-CD trial for Crohn's disease is planned to start enrollment in September 2024.