Abivax Announces Results of its June 6, 2025 Annual General Meeting PARIS, France, June 11, 2025, 10:00 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, held its annual general meeting of shareholders on June 6, 2025 (the “General Meeting”), ...

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].

Core Points - Abivax is advancing towards key operational milestones in 2025, including the ongoing Phase 3 ABTECT clinical program [3][7] - The Annual General Meeting is scheduled for June 6, 2025, in Paris, France [1][7] - The company aims to complete enrollment for induction trials in Q2 2025, with top-line data expected in Q3 2025 [3][7] - The CEO of Abivax, Marc de Garidel, expressed confidence in the company's long-term value, highlighting a personal investment of approximately 120,000 shares in Q1 2025 [4] Company Overview - Abivax is a clinical-stage biotechnology company focused on developing therapeutics for chronic inflammatory diseases [5] - The lead drug candidate, obefazimod (ABX464), is currently in Phase 3 trials for moderately to severely active ulcerative colitis [5]

Core Insights - Abivax has appointed Dr. Dominik Höchli to its Board of Directors, bringing extensive experience in immunology and biopharma, particularly from his 20-year tenure at AbbVie/Abbott [1][2][4] Company Overview - Abivax is a clinical-stage biotechnology company focused on developing therapeutics that stabilize the immune response in patients with chronic inflammatory diseases [5] - 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 [5] Leadership Experience - Dr. Höchli has over two decades of leadership experience in global biopharma, including roles as Vice President of Global Marketing for Immunology and Head of Global Medical Affairs at AbbVie [2][3] - He also served as Interim CEO of Catapult Therapeutics and is the founder of Abinode, a pharmaceutical strategy consulting firm [3] Strategic Importance - The appointment of Dr. Höchli is seen as pivotal for Abivax as it approaches key clinical and regulatory milestones for obefazimod, with a Phase 3 data readout for ulcerative colitis expected in Q3 2025 [2][4]

Financial Performance - The company reported net losses of €176.2 million, €147.7 million, and €60.7 million for the years ended December 31, 2024, 2023, and 2022, respectively[40]. - As of December 31, 2024, the company had accumulated tax losses of €609.4 million[40]. - The company has no approved products and has not generated any revenue from product sales to date[37]. - The company anticipates that research and development expenditures will substantially increase in 2025 due to ongoing clinical trials[48]. - The company faces substantial doubt about its ability to continue as a going concern without additional funding[46]. Funding and Financial Strategy - The company has existing cash and cash equivalents of €144.2 million as of December 31, 2024, and anticipates funding its cash flow requirements into the fourth quarter of 2025[47]. - The company plans to seek additional financing through public or private equity, debt financings, or collaborations, as it may never generate sufficient product revenue[49]. - The company entered into a framework subscription agreement allowing for up to €75 million in structured debt financing, all drawn as of the report date[65]. - The company has significant debt commitments that require compliance with operating covenants, with potential consequences for non-compliance[65]. Clinical Development and Regulatory Challenges - The company is focused on the timely and successful completion of clinical development for obefazimod, its lead drug candidate[39]. - The success of the drug candidates, particularly obefazimod, is uncertain and dependent on regulatory approval, which has not yet been obtained[83]. - The authorization process for drug candidates is lengthy, expensive, and uncertain, with no guarantee of success[85]. - Clinical trials may face delays due to difficulties in patient recruitment and regulatory requirements, impacting financial resources[78]. - Regulatory authorities may impose additional studies or requirements, potentially delaying or discontinuing product development[80]. Market and Competitive Landscape - The company faces intense downward pressure on healthcare costs, leading to high barriers for new product entry and potential changes in accepted pricing and reimbursement rates[103]. - The company faces competition from established pharmaceutical companies, which may impact the adoption and sales of its drug candidates[136]. - New market entrants and increased competition could adversely affect the company's financial position and growth outlook[166]. Intellectual Property Risks - The company faces risks related to potential misconduct by employees and third parties, which could lead to regulatory penalties[161]. - The company faces risks related to intellectual property rights, including potential challenges in maintaining patent protection and the possibility of competitors circumventing these rights[203]. - The patents protecting obefazimod's composition of matter are set to expire in 2030, and the patents for its methods of use will expire in 2035, posing a risk to its successful commercialization[224]. Operational and Compliance Challenges - The company has material weaknesses in its internal controls over financial reporting, which could adversely affect its financial reporting accuracy[55]. - The company may face challenges in maintaining adequate internal controls over financial reporting due to growth pressures and regulatory compliance requirements[62]. - Compliance with stringent regulatory standards (GLP, GCP) is critical; failure could lead to unreliable data and additional trials[151]. External Factors and Economic Conditions - Global economic conditions, including geopolitical developments and public health crises, could materially adversely impact demand for the company's drug candidates[137]. - The ongoing war between Ukraine and Russia has caused significant implications for the global economy, particularly affecting energy, raw materials, and food supply, leading to stock market volatility[201]. - The company has decided not to include Russia and Belarus in its global Phase 3 program for obefazimod due to the conflict, which may impact access to raw materials and logistics[201]. Cybersecurity and Data Risks - Cybersecurity threats pose risks to the company's sensitive data and information technology systems, potentially leading to operational disruptions and reputational harm[186]. - The reliance on third-party service providers introduces additional cybersecurity risks, as their security measures may not be adequate[190]. Human Resources and Organizational Challenges - The company’s growth strategy may be hindered by difficulties in managing expansion and recruiting qualified personnel, potentially affecting operational efficiency[129]. - Competition for hiring qualified personnel is intense, which may hinder the company's ability to achieve its objectives[159]. - The company faces challenges in recruiting, training, and retaining effective sales and marketing personnel, which may hinder product distribution and physician engagement[168].

Financial Performance - Total operating income increased by EUR 7.9 million to EUR 12.5 million in FY 2024 compared to EUR 4.6 million in FY 2023[10] - Net loss for the period was EUR 176.2 million in FY 2024, compared to EUR 147.8 million in FY 2023, reflecting an increase of EUR 28.4 million[8] - The company reported a financial loss of EUR 3.3 million in FY 2024, significantly improved from EUR 20.4 million in FY 2023[8] Research and Development - Research and development (R&D) expenses rose by EUR 43.3 million to EUR 146.5 million in FY 2024, primarily due to the Phase 3 clinical trials for obefazimod[10] - The company expects full enrollment in the Phase 3 ABTECT trial for ulcerative colitis in Q2 2025, with top-line results anticipated in Q3 2025[5] Cash and Financial Position - Cash balance as of December 31, 2024, was EUR 144.2 million, providing a cash runway into Q4 2025[5] - Financial liabilities increased to EUR 114.0 million in FY 2024 from EUR 77.0 million in FY 2023[8] - The company plans to finance its operating cash flow requirements into Q4 2025, including expected reimbursement of EUR 5.7 million in research tax credits[11] Employee and Administrative Expenses - Total number of employees increased to 69 as of December 31, 2024, from 61 as of December 31, 2023[10] - General and administrative expenses increased by EUR 10.5 million to EUR 32.9 million in FY 2024, driven by increased headcount and legal fees[10]

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].

Group 1 - Abivax SA Sponsored ADR (ABVX) shares have increased by 29.5% over the past four weeks, closing at $7.60, with a mean price target of $35 indicating a potential upside of 360.5% [1] - The average of seven short-term price targets ranges from a low of $12 to a high of $50, with a standard deviation of $14.12, suggesting a potential increase of 57.9% to 557.9% from the current price [2] - Analysts show strong agreement in revising earnings estimates higher, with the Zacks Consensus Estimate increasing by 10.2% over the last 30 days, indicating positive earnings prospects for ABVX [10][11] Group 2 - The Zacks Rank for ABVX is 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates, which supports the stock's potential upside [11] - While price targets are often viewed skeptically, the direction implied by these targets can serve as a useful guide for potential price movements [12]

Core Insights - Abivax will host a Key Opinion Leader (KOL) webcast on March 17, 2025, featuring Dr. David Rubin discussing the treatment landscape for ulcerative colitis and the ABTECT Phase 3 trial of obefazimod [1][2] Event Details - The webcast is scheduled for March 17, 2025, at 9:00 a.m. EDT (2:00 p.m. CET) and will be conducted virtually [4] - Registration for the event can be completed through a provided link [4] Company Overview - Abivax is a clinical-stage biotechnology company focused on developing therapies for chronic inflammatory diseases, with its lead drug candidate obefazimod (ABX464) currently in Phase 3 trials for ulcerative colitis [5]