Core Insights - Abivax announced additional clinical data for obefazimod at the UEG Meeting, highlighting its efficacy in treating moderate-to-severely active ulcerative colitis [2][3] - The Phase 3 ABTECT trials demonstrated that obefazimod achieved clinically meaningful improvements across various patient subgroups, including those with prior inadequate responses to advanced therapies [4][7] Study Population - A total of 1272 patients were enrolled in the ABTECT trials, with approximately 60% having an endoscopic subscore of 3 [3] - About 47% of the total population had a prior inadequate response to advanced therapy, with 21% having failed to respond to a JAK inhibitor [3] Efficacy Results - The 50 mg dose of obefazimod showed clinically meaningful improvements in clinical remission, with a placebo-adjusted difference of 10% for patients with prior inadequate response (p=0.0009) and 22% for those without (p<0.0001) [4][7] - In participants without prior inadequate response, the 50 mg dose achieved a placebo-adjusted difference in clinical response of 28% (p<0.0001), while those with four or more prior inadequate responses showed a 29% difference (p=0.0242) [4][7] - The treatment also demonstrated a 34% improvement in clinical response for participants who previously failed JAK inhibitor therapy (p=0.0017) [4][7] Safety Profile - Obefazimod was well tolerated, with no new safety signals identified for both the 25 mg and 50 mg doses [4][7] Company Overview - Abivax is a clinical-stage biotechnology company focused on developing therapeutics that stabilize the immune response in patients with chronic inflammatory diseases [9]

Core Insights - Abivax announced results from the Phase 3 ABTECT 8-Week Induction Trials for obefazimod, aimed at treating moderate-to-severely active ulcerative colitis, during the UEG Meeting in Berlin [2][3] - The trials demonstrated significant clinical remission rates and safety data, highlighting the need for new therapies in this area [3][5] Group 1: Trial Results - A total of 1,272 patients were enrolled in the ABTECT 1 & 2 trials, with a pooled clinical remission rate of 16.4% (p<0.0001) at the 50 mg once-daily dose at Week 8 [3][5] - ABTECT-1 showed a placebo-adjusted clinical remission rate of 19.3% (p<0.0001), while ABTECT-2 demonstrated a rate of 13.4% (p=0.0001) at the same dosage [3][5] - All key secondary efficacy endpoints were met in both trials, indicating robust performance of obefazimod [5] Group 2: Safety Profile - No signals for serious, severe, or opportunistic infections or malignancies were observed in the trials [3][5] - The most commonly reported treatment-emergent adverse events (TEAEs) included headache (16% at 25 mg, 24.1% at 50 mg) and nausea (5% at 25 mg, 7.2% at 50 mg), with low discontinuation rates due to headaches [3][5] Group 3: Future Developments - Abivax plans to present a second late-breaking abstract on October 6, 2025, and will host a conference call to discuss the topline results [4][5] - The company is focused on developing therapeutics that stabilize the immune response in patients with chronic inflammatory diseases [2][6]

Core Insights - ABIVAX Société Anonyme is recognized as one of the 12 best performing healthcare stocks currently available for investment [1] - The company is focused on developing therapies for chronic inflammatory diseases, with its lead candidate, obefazimod, in advanced clinical trials [1] Group 1: Clinical Development - ABIVAX is a clinical-stage biotechnology company developing obefazimod, an oral miR-124 enhancer, which is currently in Phase 3 trials for ulcerative colitis (UC) and Phase 2b trials for Crohn's disease [1] - In July 2025, ABIVAX reported positive topline data from two Phase 3 induction trials in moderate to severe UC, showing a pooled clinical remission rate 16.4% higher than placebo, with the 50 mg dose achieving a 19.3% placebo-adjusted remission rate [3] - The company plans to submit U.S. and European regulatory applications in the second half of 2026 based on ongoing maintenance studies [3] Group 2: Upcoming Events - ABIVAX announced it will present late-breaking data from the ABTECT Phase 3 induction trials at the United European Gastroenterology (UEG) Congress in Berlin on October 6, 2025 [2] - The presentation will focus on eight-week efficacy results of obefazimod, including outcomes in patients who previously did not respond to advanced therapies [2] - An investor call and symposium on new treatment mechanisms for UC will be hosted alongside the congress [2] Group 3: Financial Position - To support its late-stage programs, ABIVAX strengthened its financial position with a $650 million (€554 million) public offering in July 2025 [4] - This funding extends the company's cash runway into the fourth quarter of 2027, enhancing investor confidence as it advances obefazimod toward potential approval and commercialization [4]

Core Insights - Abivax announced the acceptance of an additional late-breaking abstract for its lead drug candidate, obefazimod, to be presented at the 2025 United European Gastroenterology Congress, highlighting its significance in treating moderately to severely active ulcerative colitis [1][2] Group 1: Presentation Details - The late-breaking abstract titled "EFFICACY AND SAFETY OF OBEFAZIMOD IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS" will be presented on October 5, 2025, at 5 PM CEST [1] - The presentation will include results from two Phase 3 randomized, double-blind, placebo-controlled, 8-week induction trials (ABTECT-1 & 2) [1][3] Group 2: Clinical Significance - The results from the ABTECT Phase 3 induction trials demonstrate statistically significant and clinically meaningful activity, along with an impressive safety and tolerability profile for obefazimod [2] - These findings are seen as crucial steps towards providing a novel, first-in-class oral treatment option for patients with ulcerative colitis [2] Group 3: Company Overview - Abivax is a clinical-stage biotechnology company focused on developing therapies that stabilize the immune response in patients with chronic inflammatory diseases [5] - The company is based in France and the United States, with obefazimod currently in Phase 3 clinical trials for ulcerative colitis [5]

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 has been admitted to the CAC Mid 60 and SBF 120 indices on Euronext Paris, enhancing its visibility and accessibility to institutional investors and index-linked funds [1][2][3]. Group 1: Company Overview - Abivax is a clinical-stage biotechnology company focused on developing therapeutics that modulate the inflammatory response in patients with chronic inflammatory diseases [1][4]. - The company's lead drug candidate, obefazimod (ABX464), is currently in Phase 3 clinical trials for the treatment of moderately to severely active ulcerative colitis [4]. Group 2: Market Impact - Inclusion in the CAC Mid 60 and SBF 120 indices is expected to broaden Abivax's investor base and enhance its market presence [2]. - The decision to include Abivax in these indices reflects the financial markets' confidence in the company's strategic vision and execution capabilities [3].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Abivax SA (Exact name of Registrant as specified in its charter and translation of Registrant's name into English) 7-11 boulevard Haussmann 75009 Paris, France (Address of principal executive offices) Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40- F. Form 20-F ☒ Form 40-F ☐ 1 On September 8, 2025, Abivax SA (the "Registrant") announced its financial results as of and ...

Core Viewpoint - Abivax SA reported a significant decline in total operating income and an increase in operating loss for the first half of 2025, highlighting challenges in its financial performance while continuing to advance its clinical programs [2][3][5]. Financial Highlights - Total operating income for the first half of 2025 was €2.1 million, down from €6.8 million in the same period of 2024, representing a decrease of €4.7 million [3][5]. - Total operating expenses increased, with research and development (R&D) costs rising to €77.9 million from €64.7 million, an increase of €13.2 million [3][5]. - The operating loss for the first half of 2025 was €93.7 million, compared to €80.0 million in the first half of 2024, reflecting an increase of €13.7 million [3][5]. Cash Position - As of June 30, 2025, the company's net financial position was €(20.2) million, a decrease of €73.6 million from €53.4 million at the end of 2024 [3][5]. - Available cash and cash equivalents decreased to €60.9 million from €144.2 million, a reduction of €83.3 million [3][5]. Recent Developments - On July 28, 2025, Abivax completed a public offering that raised approximately $747.5 million (about €637.5 million) before expenses, which is expected to support its financial needs [5][6]. - The company anticipates that its existing cash and the proceeds from the public offering will fund its operations into the fourth quarter of 2027 [7]. Clinical Programs - Abivax's lead drug candidate, obefazimod, is currently in Phase 3 clinical trials for the treatment of moderately to severely active ulcerative colitis, indicating ongoing commitment to its therapeutic development [8].

Core Viewpoint - Abivax SA has successfully closed a public offering of 11,679,400 American Depositary Shares (ADSs), raising approximately $747.5 million, which will support its operations and clinical trials through 2027 [1][2]. Group 1: Offering Details - The public offering included the full exercise of the underwriters' option, resulting in gross proceeds of approximately $747.5 million, or €637.5 million, before expenses [1]. - Estimated net proceeds from the offering, after deducting underwriting commissions and expenses, are approximately $700.3 million, equivalent to €597.2 million [1]. - The offering was managed by Leerink Partners, Piper Sandler & Co., and Guggenheim Securities, with LifeSci Capital as the lead manager [3]. Group 2: Financial Outlook - The company anticipates that the net proceeds, along with existing cash and cash equivalents, will finance operations into the fourth quarter of 2027, providing a 12-month cash runway post-NDA submission for Ulcerative Colitis, contingent on positive Phase 3 trial results [2]. Group 3: Company Overview - Abivax is a clinical-stage biotechnology company focused on developing therapeutics that modulate the immune response for chronic inflammatory diseases, with its lead drug candidate, obefazimod (ABX464), currently in Phase 3 trials for ulcerative colitis [5].

Core Viewpoint - Abivax SA has successfully completed an offering of American Depositary Shares (ADSs), raising gross proceeds of approximately $747.5 million (€637.5 million) following the full exercise of the underwriters' option to purchase additional ADSs [1][2]. Group 1: Offering Details - The offering included a total of 11,679,400 ADSs, with gross proceeds of approximately $747.5 million (€637.5 million) and estimated net proceeds of around $700.3 million (€597.2 million) after deducting underwriting commissions and offering expenses [2]. - The offering price for the additional ADSs was set at $64.00 per ADS, which corresponds to €54.58 per ordinary share, reflecting a premium of 21.0% over the volume weighted average price of the ordinary shares in the preceding trading sessions [4]. Group 2: Use of Proceeds - The company intends to apply the net proceeds from the sale of the additional ADSs on a pro rata basis to the uses identified in the base offering [3]. Group 3: Company Overview - Abivax is a clinical-stage biotechnology company focused on developing therapeutics that modulate the immune response in patients with chronic inflammatory diseases, with its lead drug candidate, obefazimod (ABX464), currently in Phase 3 clinical trials for ulcerative colitis [7].