Etrasimod Arginine

Abivax presents third quarter 2024 key financial information PARIS, France, November 14, 2024, 10:00 p.m. CET – 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 its key financial information for the quarter ended September 30, 2024. Abivax provided the following updates on its business and operational goals in press releases published: On July 15, 2024 press release titled “Abivax provides operational and key program update”On August 6, 2024 press release titled “Abivax Announces ABTECT Phase 3 Trial Achieves Key Enrollment Milestone”On September 9, 2024 press release titled “Abivax presents first-half 2024 financial results”On September 25, 2024 press release titled “Abivax Provides Update on Ulcerative Colitis (UC) Combination Therapy Program Strategy and Announces Early Preclinical Combination Data of Obefazimod and Etrasimod in Inflammatory Bowel Disease (IBD) Mouse Model”On October 3, 2024 press releases titled “Abivax Reports Positive Interim Efficacy and Safety Analysis of Once-Daily 25mg Obefazimod in Moderate to Severe Ulcerative Colitis Patients After 2-Years of Open-Label Maintenance” and “Abivax Announces First Patient Enrolled in ENHANCE-CD, the Phase 2b Trial of Obefazimod in Crohn’s Disease”On October 7, 2024 press release titled “Abivax Congratulates Victor Ambros and Gary Ruvkun on Their Nobel Prize for the Discovery of microRNA and its Role in Post-Transcriptional Gene Regulation” Third Quarter 2024 Financial Highlights Preliminary Results(Consolidated, unaudited results) Cash and Cash Equivalents: Abivax had cash and cash equivalents of EUR 180.5 million as of September 30, 2024. Based on the current operating plan and financial projections, the Company expects to be able to fund its operations into Q4 2025. Principal Debt Outstanding: Abivax had total principal debt outstanding of EUR 106.3 million as of September 30, 2024, compared to EUR 108.4 million as of June 30, 2024. Principal Debt Outstanding* in millions of euros 30/09/202430/06/2024 Change Debt Facility Kreos/Claret Financing 75.075.0 0.0Heights Convertible Notes 26.328.4 -2.1BPI Conditional Advances 2.52.5 0.0State Guaranteed Loan - “PGE” 2.52.5 0.0 Total Principal Debt Outstanding 106.3108.4 -2.1 *Principal debt consists of principal cash owed for each respective instrument, excluding impact of fair-value adjustments and/or derivatives. The preliminary financial data included in this press release has been prepared by, and is the responsibility of, Abivax's management. PricewaterhouseCoopers Audit has not audited, reviewed, examined, compiled, nor applied agreed-upon procedures with respect to the preliminary financial data. Accordingly, PricewaterhouseCoopers Audit does not express an opinion or any other form of assurance with respect thereto. ***** About Abivax Abivax is a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases. Based in France and the United States, Abivax’s lead drug candidate, obefazimod (ABX464), is in Phase 3 clinical trials for the treatment of moderately to severely active ulcerative colitis. More information on the Company is available at www.abivax.com. Follow us on LinkedIn and on X, formerly Twitter, @ABIVAX. Contacts: Abivax Investor RelationsPatrick Malloypatrick.malloy@abivax.com+1 847 987 4878 FORWARD-LOOKING STATEMENTS This press release contains forward-looking statements, forecasts and estimates, including those relating to the Company’s business and financial objectives. Words such as “expect,” “plan,” “project” and variations of such words and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements concerning or implying Abivax’s cash runway and other statements that are not historical fact. Although Abivax’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks, contingencies and uncertainties, many of which are difficult to predict and generally beyond the control of Abivax, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. A description of these risks, contingencies and uncertainties can be found in the documents filed by the Company with the French Autorité des Marchés Financiers pursuant to its legal obligations including its universal registration document (Document d’Enregistrement Universel) and in its Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on April 5, 2024 under the caption “Risk Factors.” These risks, contingencies and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug candidate, as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, and the availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements. Special consideration should be given to the potential hurdles of clinical and pharmaceutical development including further assessment by the Company and regulatory agencies and IRBs/ethics committees following the assessment of preclinical, pharmacokinetic, carcinogenicity, toxicity, CMC and clinical data. Furthermore, these forward-looking statements, forecasts and estimates are made only as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Abivax disclaims any obligation to update these forward-looking statements, forecasts or estimates to reflect any subsequent changes that the Company becomes aware of, except as required by law. Information about pharmaceutical products (including products currently in development) that is included in this press release is not intended to constitute an advertisement. This press release is for information purposes only, and the information contained herein does not constitute either an offer to sell, or the solicitation of an offer to purchase or subscribe for securities of the Company in any jurisdiction. Similarly, it does not give and should not be treated as giving investment advice. It has no connection with the investment objectives, financial situation or specific needs of any recipient. It should not be regarded by recipients as a substitute for exercise of their own judgment. All opinions expressed herein are subject to change without notice. The distribution of this document may be restricted by law in certain jurisdictions. Persons into whose possession this document comes are required to inform themselves about and to observe any such restrictions.

云顶新耀（HKEX 1952.HK）是一家专注于创新药研发、临床开发、制造和商业化的生物制药公司，今日宣布伊曲莫德（VELSIPITY®）治疗中重度活动性溃疡性结肠炎（UC）的亚洲多中心Ⅲ期临床研究ES101002的完整诱导期数据在第32届欧洲消化疾病周（UEGW 2024）以口头报告形式公布。UEGW 2024于2024年10月12日-15日期间在奥地利维也纳举行，是全球消化系统疾病领域最具影响力和权威性的学术会议之一。 在今年的“炎症性肠病治疗中的小分子药物”专场，汇集了全球顶级的炎症性肠病(IBD)治疗领域专家，其中包括Bruce E. Sands, Raphaël Laoun, Britta Siegmund, Séverine Vermeire, Geert R. D Haens, Sebastian Zeissig, James O. Linsay, Peter Irving, Ailsa L Hart等世界知名专家。在会上，云顶新耀与参会的专家共同分享了伊曲莫德亚太研究的诱导期结果。 ES101002研究是迄今为止在亚洲中重度活动性溃疡性结肠炎患者中完成的最大规模的III期临床研究。诱导期研究结果显示，伊曲莫德治疗组的所有主要和关键次要疗效目标均达到具有统计学意义和临床显著性的改善：与安慰剂组相比的临床缓解率、内镜改善率和临床应答率的治疗差异分别达到 20.4%、28.6%和32.0% （ P值均<0.0001）。深度愈合与疾病的长期控制、减少复发、降低并发症和以及提高生活治疗密切相关。接受伊曲莫德治疗的患者在粘膜愈合(P<0.0001)和内镜恢复正常（P=0.0003）方面均达到了具有临床意义和统计学显著性的改善。 ES101002研究维持期的顶线结果已经于今年7月发布。经过维持期治疗后，与安慰剂组相比，伊曲莫德组同样达到了主要和所有次要疗效终点 （P均<0.0001）。维持期研究结果计划在近期的学术会议上发表。 罗永庆 云顶新耀首席执行官 很高兴看到伊曲莫德的完整诱导期研究数据取得具有临床意义和统计学显著性的积极结果。到2030年，中国的溃疡性结肠炎患者人数预计将达到约100万人，超过2019年患者人数的一倍以上，存在迫切且巨大的未被满足的临床需求。在“港澳药械通”政策支持下，伊曲莫德正式获得“粤港澳大湾区内地临床急需进口港澳药品批件”批准，进入大湾区，成为云顶新耀第三款商业化新药。今年我们将在中国大陆地区递交伊曲莫德的新药上市许可申请，扩大可及性，造福更多患者。 伊曲莫德亚太临床试验牵头研究者、世界胃肠病学会常务理事、亚太消化病学会秘书长兼常务理事、中华医学会消化病学分会副主任委员、中国人民解放军第四军医大学附属西京医院吴开春教授表示：“ES101002研究的分析结果表明，与安慰剂相比，患者接受伊曲莫德2mg治疗显示出更大改善，这种新一代S1P调节剂通过口服、每日一次的治疗方案，可快速起效，达到临床缓解，并显示其对于深度愈合的积极作用，显著提高了内镜恢复正常和粘膜愈合的患者比例。此次完整积极数据的公布，再次在循证证据上证明伊曲莫德治疗中重度活动性溃疡性结肠炎具有良好的疗效和安全性，相信伊曲莫德可以为更多患者带来新希望。” ES101002研究是基于一项在亚洲地区开展的伊曲莫德的多中心、随机、双盲、安慰剂对照III期研究。这项研究是迄今为止完成的最大规模的亚洲中重度溃疡性结肠炎的III期注册临床研究，总计 340名中重度活动性溃疡性结肠炎患者随机接受伊曲莫德或安慰剂治疗。在12周诱导治疗期内，既往对至少一种常规治疗、生物制剂或Janus激酶（JAK）抑制剂治疗失败或不耐受的溃疡性结肠炎患者，每日一次服用2mg伊曲莫德或安慰剂治疗。 伊曲莫德于去年10月和今年2月先后在美国和欧盟获得新药上市批准，并成为欧盟首个且唯一获批用于16岁及以上患者的新一代口服治疗溃疡性结肠炎药物，也是目前唯一在全球Ⅲ期临床试验中证实对孤立性直肠炎有疗效的药物。 作为云顶新耀自身免疫性疾病领域的重磅产品，伊曲莫德于今年上半年陆续在中国澳门、新加坡获得新药上市批准。此外，云顶新耀也已在中国香港递交了伊曲莫德的新药上市许可申请。在“港澳药械通”政策的支持下，伊曲莫德已在近期正式获批进入大湾区，可以在中山大学附属第一医院、佛山复星禅诚医院两家大湾区药械通政策指定的医疗机构先行使用，成为云顶新耀第三款商业化新药。 关于伊曲莫德（VELSIPITY®, etrasimod） 伊曲莫德（VELSIPITY®，etrasimod）是一种每日一次口服的高选择性鞘氨醇-1-磷酸（S1P）受体调节剂，采用优化的药理学设计，与S1P受体1、4和5结合。伊曲莫德目前已在美国、欧盟、加拿大、澳大利亚、英国、瑞士、以色列以及中国澳门和新加坡获得新药上市批准。 关于云顶新耀 云顶新耀是一家专注于创新药和疫苗研发、临床开发、制造和商业化的生物制药公司，致力于满足亚洲市场尚未满足的医疗需求。云顶新耀的管理团队在中国及全球领先制药企业从事过高质量研发、临床开发、药政事务、化学制造与控制（CMC）、业务发展和商业化运营，拥有深厚的专长和丰富的经验。云顶新耀已打造多款疾病首创或者同类最佳的药物组合，公司的治疗领域包括肾科疾病、感染性和传染性疾病、自身免疫性疾病。有关更多信息，请访问公司网站：www.everestmedicines.com。 前瞻性声明 本新闻稿所发布的信息中可能会包含某些前瞻性表述，乃基于本公司或管理层在做出表述时对公司业务运营情况及财务状况的现有看法、相信、和现有预期，可能会使用“将”、“预期”、“预测”、“期望”、“打算”、“计划”、“相信”、“预估”、“确信”及其他类似词语进行表述。这些前瞻性表述并非对未来业绩的保证，会受到风险、不确定性及其他因素的影响，有些乃超出本公司的控制范围，难以预计。因此，受我们的业务、竞争环境、政治、经济、法律和社会情况的未来变化及发展等各种因素及假设的影响，实际结果可能会与前瞻性表述所含资料有较大差别。本公司及各附属公司、各位董事、管理人员、顾问及代理未曾且概不承担更新该稿件所载前瞻性表述以反映在本新闻稿发布日后最新信息、未来项目或情形的任何义务，除非法律要求。