Core Insights - Abivax has provided its corporate outlook for 2026, emphasizing advancements in its clinical trials and therapeutic pipeline, particularly for obefazimod in treating ulcerative colitis (UC) and Crohn's disease (CD) [2][3][4] Market Opportunity - The ulcerative colitis market is projected to grow significantly, with sales expected to increase from $9.2 billion in 2025 to $21.2 billion by 2032, driven by advanced therapies and innovative mechanisms of action [4] - Market research indicates that obefazimod may become a market leader in UC, potentially outperforming existing therapies and new entrants [5] Clinical Trial Updates - The ABTECT Phase 3 maintenance trial for obefazimod has shown no new safety signals, with over 80% of participants completing the trial [8][9] - Topline results from the ABTECT Phase 3 maintenance trial are anticipated in late Q2 2026, with a subsequent US regulatory filing planned for late 2026 [8][10] - The ENHANCE-CD Phase 2b trial for obefazimod in moderate-to-severely active Crohn's disease is ongoing, with results expected in late 2026 [12] Pipeline Advancement - Obefazimod is noted for its first-in-class mechanism of action, targeting inflammation and showing potential anti-fibrotic effects in Crohn's disease [11] - The company plans to share detailed results, including 22 abstracts, at the 2026 European Crohn's and Colitis Organization Annual Meeting [11] - Ongoing studies are evaluating obefazimod in combination with other agents, with a lead combination candidate expected to be selected by year-end 2026 [13][14] Financial Outlook - The company has secured funding that is expected to support operations into Q4 2027, allowing for the completion of key clinical trials and potential NDA filing [15]

Core Insights - Abivax reported a significant increase in net loss for the nine months ending September 30, 2025, amounting to EUR 254.1 million, compared to EUR 136.9 million for the same period in 2024, reflecting a rise of EUR 117.3 million [3][5][10] Financial Performance - Total operating income decreased to EUR 4.1 million for the nine months ended September 30, 2025, down from EUR 8.1 million in 2024, a decline of EUR 4.0 million [3][5] - Total operating expenses rose to EUR 178.5 million, with research and development costs increasing by EUR 25.4 million to EUR 133.4 million, primarily due to costs associated with clinical programs for ulcerative colitis and Crohn's disease [3][5][6] - Operating loss increased by EUR 44.2 million to EUR 174.4 million for the nine months ending September 30, 2025, compared to EUR 130.2 million in 2024 [3][5] Cash Position - Cash and cash equivalents as of September 30, 2025, were EUR 589.7 million, a substantial increase from EUR 144.2 million as of December 31, 2024, primarily due to net proceeds from a public offering [5][8] - The company expects its cash runway to extend into Q4 2027 based on its current cash position [10] Shareholder Equity and Financial Position - Total assets increased to EUR 652.1 million as of September 30, 2025, compared to EUR 205.2 million at the end of 2024, reflecting a growth of EUR 446.8 million [5] - Total shareholders' equity rose to EUR 511.2 million from EUR 40.6 million, an increase of EUR 470.7 million [5] Operational Updates - Abivax has been actively presenting updates on its clinical trials, including late-breaking presentations at the 2025 United European Gastroenterology (UEG) Meeting, highlighting the progress of its lead drug candidate, obefazimod [4][10] - The company has made significant advancements in its clinical programs, particularly in ulcerative colitis and Crohn's disease, which are reflected in the increased R&D expenses [3][5][6]

Company Overview - Evommune, a biotechnology company, focuses on chronic inflammatory diseases [1] Financial Highlights - Evommune raised $150 million in an initial public offering (IPO) [1]

Core Insights - Abivax announced the presentation of a late-breaking abstract for its lead drug candidate, obefazimod, at the United European Gastroenterology Congress, highlighting its potential as a new treatment for moderately to severely active ulcerative colitis [2][3] Company Overview - Abivax is a clinical-stage biotechnology company focused on developing innovative therapies for chronic inflammatory diseases, with obefazimod (ABX464) currently in Phase 3 clinical trials for ulcerative colitis [10] Upcoming Events - The late-breaking abstract titled "EFFICACY OF OBEFAZIMOD IN ABTECT PHASE 3 INDUCTION TRIALS: RESULTS OF 8-WEEK THERAPY IN SUBSETS OF PATIENTS WITH AND WITHOUT PRIOR INADEQUATE RESPONSE TO ADVANCED THERAPIES" will be presented on October 6, 2025, at 10 AM CET [7] - Abivax management will hold an analyst and investor call on October 6 at 3 PM CET to discuss the data [8] - A symposium titled "From Evolution to Revolution: New Mechanisms in Ulcerative Colitis" will take place on October 6 from 5:30 PM to 6:30 PM CET [8]

Core Viewpoint - Abivax reported its full-year financial results for 2024, highlighting significant clinical progress and a strong cash position that supports its ongoing clinical trials and operational needs [2][3]. Financial Highlights - Total operating income for FY 2024 was EUR 12.5 million, an increase of EUR 7.9 million from EUR 4.6 million in FY 2023 [5]. - Research and Development (R&D) costs rose to EUR 146.5 million, up EUR 43.3 million from EUR 103.2 million in the previous year, primarily due to increased expenses related to the Phase 3 clinical trials for obefazimod [5][8]. - The net loss for the period was EUR 176.2 million, compared to EUR 147.8 million in FY 2023, reflecting higher operational expenditures [5][8]. - The cash balance as of December 31, 2024, was EUR 144.2 million, down from EUR 261.0 million in 2023, providing a cash runway into Q4 2025 [6][9]. Upcoming Milestones - Full enrollment in the Phase 3 ABTECT trial for obefazimod is expected in Q2 2025, with top-line results anticipated in Q3 2025 [6][7]. - Completion of the 44-week maintenance trial is projected for Q2 2026, with top-line results expected in the same quarter [7]. Operational Insights - The total number of employees increased to 69 as of December 31, 2024, from 61 in the previous year, indicating organizational growth [8]. - General and Administrative (G&A) expenses rose to EUR 32.9 million, up EUR 10.5 million from EUR 22.4 million in 2023, driven by increased headcount and legal fees associated with being a dual-listed company [8][12].