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Abivax SA (NASDAQ & Euronext: ABVX) is a clinical-stage biotechnology company headquartered in France, with operations in the United States. The company is dedicated to developing therapeutics that stabilize the immune response in patients suffering from chronic inflammatory diseases by leveraging the body's natural regulatory mechanisms. Abivax's flagship product, obefazimod (ABX464), is currently in Phase 3 clinical trials aimed at treating moderately to severely active ulcerative colitis (UC), a type of inflammatory bowel disease.
The company is also planning to initiate Phase 2b clinical trials for obefazimod in patients with Crohn's disease by Q3 2024. The initial clinical data has been promising, and Abivax is actively exploring potential combination therapies for UC. Recent achievements include the successful acceptance of four scientific abstracts on obefazimod for presentation at the 19th Congress of the European Crohn's and Colitis Organisation (ECCO) in February 2024. These presentations represent significant milestones in the company's quest to understand and treat ulcerative colitis more effectively.
Abivax operates with a strong focus on scientific innovation and has formed several key partnerships to advance its research and development efforts. The company recently added Troy Ignelzi, Dr. June Lee, and Ms. Camilla Soenderby to its Board of Directors, bringing on seasoned experts to guide its strategic and financial directions.
Abivax's mission is to harness cutting-edge biotechnology to develop treatments that may offer substantial improvements in the quality of life for patients suffering from chronic inflammatory conditions. For more information on the company, including the latest updates on their clinical trials and scientific symposia, visit their official website at www.abivax.com.
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.
Abivax SA, a clinical-stage biotechnology company, announced the results of its Ordinary and Extraordinary General Meeting held on May 30, 2024.
The shareholders approved all resolutions proposed by the Board, including the financial statements for 2023, the compensation policy for top executives, and delegations related to financial transactions.
New Board members, Mr. Troy Ignelzi, Dr. June Lee, and Ms. Camilla Soenderby, were ratified.
Details of the vote results can be accessed on the company's website.
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