Abivax to Join CAC Mid 60 and SBF 120 Indices Following Euronext Paris Annual Review PARIS, France, September 12, 2025, 5:45 p.m. CEST – Abivax SA (Euronext Paris: FR0012333284 – ABVX / Nasdaq – ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to modulate the inflammatory response in patients with chronic inflammatory diseases, announces today that following the annual review of the Euronext Par ...

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].

Core Viewpoint - Abivax SA has resumed trading of its ordinary shares on Euronext Paris following a halt related to a public offering of American Depositary Shares [1][2]. Group 1: Company Overview - Abivax is a clinical-stage biotechnology company focused on developing therapeutics that modulate the immune response in patients with chronic inflammatory diseases [3]. - The company's lead drug candidate, obefazimod (ABX464), is currently in Phase 3 clinical trials for treating moderately to severely active ulcerative colitis [3]. Group 2: Trading Information - Trading of Abivax's ordinary shares was halted on July 24, 2025, at 9:00 a.m. CEST at the company's request to facilitate a public offering in the United States [2]. - The trading resumed at 3:30 p.m. CEST on the same day [1].

Core Viewpoint - Abivax SA has announced a public offering of American Depositary Shares (ADSs) priced at $64.00 per ADS, aiming to raise approximately $650 million to support its clinical development efforts [1][9][10]. Offering Details - The offering consists of 10,156,000 ADSs, each representing one ordinary share with a nominal value of €0.01 [1]. - The offering price reflects a 21.0% premium over the volume weighted average price of the ordinary shares on Euronext Paris over the last three trading sessions prior to pricing [2]. - The offering is managed by Leerink Partners, Piper Sandler & Co., and Guggenheim Securities, with LifeSci Capital as the lead manager [3]. Financial Proceeds - The gross proceeds from the offering are expected to be approximately $650 million, or €554 million, before deducting expenses [9]. - If the underwriters' option to purchase additional shares is fully exercised, total gross proceeds could reach approximately $747.5 million, or €637.5 million [10]. Use of Proceeds - The company plans to use the net proceeds to fund clinical development for its lead drug candidate, obefazimod, targeting ulcerative colitis and Crohn's disease, as well as for general corporate purposes [11][16]. - Specific allocations include approximately $140 million to $185 million for ulcerative colitis, and $30 million to $65 million for Crohn's disease [16]. Closing and Lock-up - The offering is expected to close on July 28, 2025, subject to customary conditions [6]. - Company board members and executive officers are subject to a 60-day lock-up period following the final prospectus supplement [13]. Dilution Impact - The issuance of ADSs will result in a dilution of approximately 16.0% of the company's share capital on a non-diluted basis, increasing to 18.4% if the underwriters' option is exercised [14]. Company Overview - Abivax is a clinical-stage biotechnology company focused on developing therapeutics that modulate the immune response in chronic inflammatory diseases, with its lead candidate currently in Phase 3 trials for ulcerative colitis [20].

Core Points - Abivax has announced a temporary trading halt of its ordinary shares on Euronext Paris at the company's request, effective from 9:00 a.m. CEST on July 24, 2025, due to a public offering of its American Depositary Shares in the United States [1][2] - The trading suspension is expected to last until a new communication is released by the company, with trading anticipated to resume at approximately 3:30 p.m. CEST on the same day [2] Company Overview - Abivax is a clinical-stage biotechnology company focused on developing therapeutics that utilize the body's natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases [2] - 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 [2]

Core Viewpoint - Abivax SA has announced the launch of a public offering of approximately $400 million, aimed at funding its clinical development and operational needs [1][10]. Group 1: Offering Details - The public offering will consist of American Depositary Shares (ADSs), each representing one ordinary share of the company, with a nominal value of €0.01 per share [1]. - The company plans to grant underwriters a 30-day option to purchase additional ADSs, up to 15% of the total number proposed to be sold [1]. - The offering price will be determined through a book-building process, and the final amount and terms will be announced after pricing [4][7]. Group 2: Use of Proceeds - The net proceeds from the offering are intended to be allocated as follows: approximately 23% for the development of obefazimod for Ulcerative Colitis, approximately 5% for Crohn's Disease, and about 72% for working capital and general corporate purposes [10][14]. Group 3: Company Background - Abivax is a clinical-stage biotechnology company focused on developing therapeutics that modulate the immune response in patients with chronic inflammatory diseases [18]. - The lead drug candidate, obefazimod (ABX464), is currently in Phase 3 clinical trials for the treatment of moderately to severely active ulcerative colitis [18]. Group 4: Financial Position - As of June 30, 2025, the company had cash and cash equivalents of $71.4 million, which is expected to finance its operating cash flow requirements into the fourth quarter of 2025 [9].

Core Insights - Abivax announced positive topline results from its Phase 3 ABTECT-1 and ABTECT-2 trials for obefazimod, a first-in-class oral miR-124 enhancer, in patients with moderately to severely active ulcerative colitis [2][3][4] Study Details - The ABTECT-1 and ABTECT-2 trials were global, multicenter, randomized, double-blind, placebo-controlled studies assessing once-daily oral administration of obefazimod at 25 mg or 50 mg doses [4][5] - A total of 1,275 patients were enrolled from over 600 clinical trial sites across 36 countries, making it one of the largest Phase 3 ulcerative colitis trials conducted [4][5][6] Efficacy Results - The 50 mg once-daily dose of obefazimod achieved a pooled placebo-adjusted clinical remission rate of 16.4% (p<0.0001) at Week 8 [5][7] - Individually, the 50 mg dose showed a remission rate of 19.3% (p<0.0001) in ABTECT-1 and 13.4% (p=0.0001) in ABTECT-2 [5][7] - The 25 mg dose achieved a placebo-adjusted remission rate of 21.4% in ABTECT-1, while in ABTECT-2 it did not reach statistical significance but indicated a strong clinical response [8] Safety Profile - Obefazimod demonstrated a favorable safety profile with no new safety signals observed, and the treatment was generally well tolerated across both dose groups [9][10] - Treatment Emergent Adverse Events (TEAEs) were reported in 59.4% of patients receiving the 50 mg dose in ABTECT-1 and 61.0% in ABTECT-2 [10][11] Future Plans - The ongoing ABTECT Maintenance Trial is expected to report topline results in Q2 2026, which will support regulatory filings globally [12][16] - Pending successful results from the maintenance trial, Abivax plans to submit a New Drug Application to the FDA and a Marketing Authorization Application to the EMA in the second half of 2026 [3][16]

Group 1 - The core focus of Abivax is on developing therapeutics that modulate the inflammatory response in patients with chronic inflammatory diseases [1][3] - The annual general meeting of shareholders was held on June 6, 2025, chaired by Sylvie Grégoire [1][2] - All resolutions proposed by the Board were adopted, including the financial statements for the 2024 financial year and the compensation policy for key executives [2] Group 2 - Sylvie Grégoire was ratified as Chairman, and Dominik Höchli, MD, was appointed as a Board member [2] - Abivax's lead drug candidate, obefazimod (ABX464), is currently in Phase 3 clinical trials for treating moderately to severely active ulcerative colitis [3]

Core Viewpoint - Abivax SA reported its financial results for the first quarter of 2025, highlighting a decrease in total operating income and an increase in operating loss, primarily driven by rising research and development expenses [2][3][7]. Financial Highlights - Total operating income for Q1 2025 was €1.0 million, down from €1.2 million in Q1 2024, reflecting a decrease of €0.2 million [3][7]. - Total operating expenses increased, with research and development costs rising to €39.3 million from €35.7 million, an increase of €3.6 million [3][7]. - The operating loss for the quarter was €47.2 million, compared to €44.7 million in the same period last year, marking an increase of €2.5 million [3][7]. - The net loss for the period was €52.4 million, up from €42.9 million in Q1 2024, indicating a rise of €9.5 million [3][7]. Balance Sheet Overview - As of March 31, 2025, the net financial position was €18.5 million, a decrease of €34.9 million from €53.4 million at the end of 2024 [3][5]. - Cash and cash equivalents stood at €103.6 million, down from €144.2 million at the end of 2024, reflecting a decrease of €40.6 million [5][7]. - Total assets decreased to €166.9 million from €205.2 million, a reduction of €38.3 million [5]. Research and Development Focus - R&D expenses increased significantly, with a €3.0 million (736%) rise related to the Crohn's Disease clinical program, driven by the progression of Phase 2b clinical trials for obefazimod [7]. - A €2.7 million (78%) increase in transversal activities was noted, attributed to the expansion of the R&D headcount and new equity awards [7]. - There was a decrease of €1.3 million (-4%) in expenses related to the Ulcerative Colitis clinical program as Phase 3 trials reached full enrollment [7]. Operational Updates - Abivax is focused on developing therapeutics for chronic inflammatory diseases, with its lead drug candidate, obefazimod, currently in Phase 3 clinical trials for ulcerative colitis [2][8]. - The company anticipates being able to finance its operating cash flow requirements into the fourth quarter of 2025 based on current funds and operating assumptions [6].