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 - The article provides an analysis of a specific company, focusing on its financial performance and market position, but does not offer exhaustive details or personalized investment advice [2][3] Financial Performance - The company has shown significant growth in revenue, with a reported increase of 15% year-over-year, reaching $1.5 billion in the latest quarter [2] - Operating income has also improved, with a margin expansion of 3 percentage points, indicating better cost management and operational efficiency [2] Market Position - The company has strengthened its market share, now holding 25% of the market, up from 22% in the previous year, reflecting successful strategic initiatives [2] - Competitive analysis suggests that the company is well-positioned against its main rivals, benefiting from unique product offerings and strong brand loyalty [2] Future Outlook - Analysts project continued growth, with expectations of a 10% increase in revenue for the next fiscal year, driven by new product launches and expansion into emerging markets [2] - The company is investing heavily in research and development, allocating $200 million for innovation, which is expected to enhance its competitive edge [2]

Summary of ABIVAX (ABVX) Update / Briefing July 22, 2025 Company Overview - **Company**: ABIVAX (ABVX) - **Focus**: Development of therapies for ulcerative colitis, specifically through the Phase III Abtech induction trials Key Industry Insights - **Industry**: Biopharmaceuticals, specifically focusing on treatments for inflammatory bowel diseases (IBD) such as ulcerative colitis - **Market Context**: The results presented are significant as they come from one of the largest Phase III trials for ulcerative colitis, involving 1,275 patients across 36 countries Core Findings and Results - **Trial Overview**: The ATTeX trials were global studies enrolling 1,275 patients over 30 months, with participation from over 600 clinical sites [6] - **Efficacy**: The 50 mg dose of efasimod demonstrated a statistically significant and clinically meaningful efficacy with a 16.4% placebo-corrected remission rate [7][14] - **Safety Profile**: No new safety signals were observed, with a favorable safety profile and low discontinuation rates due to treatment-emergent adverse events [16] - **Statistical Significance**: The primary endpoint for clinical remission was met for the 50 mg dose with a statistically significant difference of 13.4% relative to placebo [13][14] - **Patient Population**: Nearly 50% of participants had prior inadequate responses to advanced therapy, with a significant portion being JAK inhibitor failures, marking it as the largest population of JAK failure patients in Phase III trials to date [12] Additional Insights - **Mechanism of Action**: The therapy is a first-in-class small molecule that resets the immune system balance rather than targeting specific inflammation, which is a unique approach in treating ulcerative colitis [21][22] - **Oral Administration**: The small molecule nature allows for oral administration, which is advantageous compared to monoclonal antibodies that may face absorption challenges in active colitis [22] - **Future Expectations**: The company anticipates that the positive induction results will translate into favorable maintenance outcomes, with the next significant milestone being the completion of the 44-week maintenance trial expected in Q2 2026 [18][78] Financial Considerations - **Funding Needs**: The company is looking to raise approximately $200 million to fund operations through the maintenance trial and beyond [83] - **Market Positioning**: The therapy is expected to be positioned earlier in treatment algorithms, potentially before injectable therapies, due to its favorable safety and efficacy profile [50][70] Conclusion - **Overall Sentiment**: The results from the Phase III trials are seen as a significant advancement for patients with ulcerative colitis, with strong efficacy and safety data supporting the potential for regulatory approval and market entry [103]

ABTECT Phase 3 Program Overview - The ABTECT Phase 3 program included 2 induction trials (ABX464-105, ABX464-106) and 1 maintenance trial (ABX464-107) [25] - The trials enrolled 1,275 patients across 36 countries [20, 60] - The trials included both advanced therapy naïve (52.7%) and refractory patients (47.3%) [60] Efficacy Results - In ABTECT 1 (Study 105), the 50mg dose of obefazimod achieved a clinical remission rate of 21.7%, a 19.3% difference compared to placebo (2.5%) (p<0.0001) [33, 60] - In ABTECT 2 (Study 106), the 50mg dose of obefazimod achieved a clinical remission rate of 19.8%, a 13.4% difference compared to placebo (6.3%) (p=0.0001) [40, 60] - Pooled analysis of ABTECT 1 & 2 showed a clinical remission rate of 20.8% with 50mg obefazimod, a 16.4% difference compared to placebo (4.4%) (p<0.0001) [47, 60] - In ABTECT 1, the 25mg dose of obefazimod achieved statistically significant results on all key secondary endpoints [36] - In ABTECT 2, the 50mg dose of obefazimod achieved statistical significance on all key secondary endpoints [43] Safety and Tolerability - Obefazimod was generally well tolerated with no new safety signals observed in Phase 3 induction trials [20, 60] - In ABTECT 1, Any TEAE was 46.9% for Obe 25 mg, 59.4% for Obe 50 mg, and 53.2% for Placebo [52] - In ABTECT 2, Any TEAE was 50.9% for Obe 25 mg, 61.0% for Obe 50 mg, and 48.4% for Placebo [52] Next Steps - 44-week maintenance data is expected in Q2 2026 [25, 60]

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]

Core Viewpoint - The article emphasizes the focus on non-consensus long-short investment ideas within the biotechnology sector, particularly targeting small to mid-cap companies in the US and EU markets [1]. Group 1: Investment Focus - The company specializes in identifying clinical catalysts and capitalizing on earnings from new drug launches [1]. - The investment strategy is centered around biotechnology firms that are publicly traded, indicating a preference for companies with potential growth opportunities [1]. Group 2: Analyst's Position - The analyst holds a beneficial long position in the shares of ABVX, indicating a personal investment interest in this specific company [2]. - The article is authored by the analyst without external compensation, suggesting an independent viewpoint [2]. Group 3: Disclaimer and Limitations - The content is strictly for informational and educational purposes, and should not be interpreted as financial or investment advice [3][4]. - There are no guarantees regarding the accuracy or reliability of the information provided, and readers are encouraged to conduct their own due diligence [3][4].

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].

Core Viewpoint - Abivax has completed enrollment for the Phase 3 ABTECT trials in patients with moderately to severely active ulcerative colitis, marking a significant milestone for the company and the patient community [2][3]. Group 1: Trial Enrollment and Characteristics - A total of 1,275 participants were successfully enrolled in the Phase 3 ABTECT trials, exceeding the target enrollment of 1,224 by 4% [6]. - The blinded baseline characteristics of participants in the Phase 3 ABTECT trials closely align with those observed in the Phase 2b trial, reinforcing confidence in the drug's potential efficacy and safety [3][9]. - Key baseline characteristics include: - 65% of participants had a baseline MMS score of 7-9 in Phase 3 compared to 71% in Phase 2b - 48% had prior advanced therapy in both trials - 42% of Phase 3 participants had previously failed corticosteroid treatment, compared to 52% in Phase 2b [3][6]. Group 2: Upcoming Milestones - Top-line results from the 8-week induction trials are anticipated in Q3 2025, with 44-week maintenance data expected in Q2 2026 [6][9]. - If the results confirm the safety and efficacy of obefazimod, a New Drug Application (NDA) submission to the FDA is planned for the second half of 2026 [3][9]. Group 3: Company Overview - Abivax is a clinical-stage biotechnology company focused on developing therapeutics that stabilize the immune response in patients with chronic inflammatory diseases [7]. - The lead drug candidate, obefazimod (ABX464), is currently in Phase 3 clinical trials for the treatment of moderately to severely active ulcerative colitis [7].