Abivax S.A.

Abivax SA operates in the clinical-stage biotechnology industry, focusing on developing therapeutics that harness the body's natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases. The company's initial focus is on inflammatory bowel diseases, chronic conditions involving inflammation of the gastrointestinal tract, of which the two most common forms are ulcerative colitis and Crohn's disease. The estimated market opportunity for UC was approximately $9.2 billion in worldwide sales in 2025 and is expected to reach $21.8 billion in worldwide sales in 2032 ¹. In the United States, UC sales were approximately $6.0 billion in 2025 and are expected to reach $14.9 billion by 2032 ². The estimated market opportunity for CD was approximately $15.2 billion in worldwide sales in 2025 and is expected to reach $19.4 billion in worldwide sales in 2032 ³. In 2025, approximately $10.5 billion of sales were generated from the United States for CD ⁴. From 2020 to 2025, U.S. advanced therapy usage has increased by approximately 96% from approximately 138,000 advanced therapy patients in 2020 to approximately 271,000 advanced therapy patients in 2025 ⁵. The company currently estimates that approximately 300,000 moderate-to-severe UC patients in the United States, out of an estimated 500,000 patients, are on conventional therapy or steroids only ⁶. The company currently estimates that there are approximately 480,000 moderate-to-severe CD patients in the United States, out of an estimated 800,000 patients ⁷.

The biotechnology and pharmaceutical industries are highly competitive and subject to significant and rapid technological change. Primary competitors in the chronic inflammatory disease field include AbbVie, Eli Lilly, Johnson & Johnson, Pfizer and Takeda, with Merck, Roche, and Teva/Sanofi identified as potential future competitors based on recent acquisitions of TL1A molecules. The company believes its lead drug candidate, obefazimod, is differentiated from competing approaches for the treatment of IBD via its novel mechanism of action, which was demonstrated to specifically enhance the expression of a single micro-RNA, miR-124, which plays a critical role in the regulation of the inflammatory response. The company believes that obefazimod is the only small molecule drug candidate in clinical development with a mechanism of action that was demonstrated to specifically enhance the expression of a single micro-RNA. The company holds worldwide rights to obefazimod.

The company is a clinical-stage biopharmaceutical company with no approved products and has not generated any revenue from product sales to date. The majority of its operating income has been derived from reliance on research collaborations unrelated to obefazimod. The company's ability to generate revenue from product sales depends heavily on the successful development and commercialization of obefazimod, as other programs in its preclinical portfolio are still in earlier stages of development. The company does not anticipate generating revenue from product sales for the next several years, if ever.

The company's lead drug candidate, obefazimod, is an oral small molecule drug candidate in clinical development for the treatment of moderately to severely active UC and CD. Obefazimod is currently in Phase 3 clinical development for the treatment of moderately to severely active UC. The company is continuing to develop obefazimod for the treatment of CD and is evaluating potential combination therapy opportunities in IBD. In parallel, the company is strengthening its development portfolio by generating follow-on compounds based on its miR-124 platform and assessing external early drug candidates in IBD. The company has launched a research and development program to generate new potential drug candidates to strengthen its intellectual property portfolio on the miR-124 platform and to identify additional drug candidates from its proprietary small molecule library that includes additional miR-124 enhancers. The company expects to announce an obefazimod follow-on candidate selection in 2026.

In July 2025, the company announced top-line data from the two ABTECT induction trials. Overall, 1,275 patients were randomized and 1,272 patients were treated in ABTECT-1 (N=636) and ABTECT-2 (N=636) ⁸. In the pooled analysis of ABTECT trials, a significantly higher proportion of patients receiving obefazimod 50 mg (20.8%) or obefazimod 25 mg (17.6%) versus placebo (4.4%) achieved clinical remission (obefazimod 50 mg-placebo difference: 16.4%, p<0.0001; obefazimod 25 mg-placebo difference: 13.2%, p<0.0001) ⁹. A significantly higher proportion of patients receiving obefazimod 50 mg (ABTECT-1: 21.7%, ABTECT-2: 19.8%) versus placebo (2.5% and 6.3%) achieved clinical remission (obefazimod 50 mg-placebo difference: ABTECT-1: 19.3%, p<0.0001; ABTECT-2: 13.4%, p=0.0001) ¹⁰. In ABTECT-1, a significantly higher proportion of patients receiving obefazimod 25 mg versus placebo achieved clinical remission (obefazimod 25 mg -placebo difference: 21.4%, p<0.0001) ¹¹. As of the data cutoff date (September 30, 2025), 1,372 patients have received obefazimod in all completed and ongoing clinical trials across all indications, including 324 patients for longer than one year ¹². Additionally, 1,163 patients have received only blinded obefazimod or placebo in the ABTECT program or Phase 2b clinical trial in CD ¹³. The company expects to report top-line data from its Phase 3 ABTECT maintenance trial in late second quarter of 2026. Subject to positive data, the company currently expects to submit its NDA with the FDA in the fourth quarter of 2026. The company also initiated a Phase 2b clinical trial in patients with CD in the fourth quarter of 2024, with a planned top-line induction data read-out in the fourth quarter of 2026.

For the years ended December 31, 2025, 2024 and 2023, the company reported net losses of €336.1 million, €176.2 million, and €147.7 million, respectively ¹⁴. As of December 31, 2025, the company carried forward accumulated tax losses of €912.9 million ¹⁵. The company has devoted most of its financial resources to research and development, including its clinical and preclinical development activities. The company expects to continue to incur significant expenses and operating losses for the foreseeable future and does not anticipate achieving profitability in the future unless it obtains the regulatory approvals necessary to commercialize obefazimod and any additional drug candidates.

The company expects to report top-line data from its Phase 3 ABTECT maintenance trial in late second quarter of 2026. Subject to positive data, the company currently expects to submit its NDA with the FDA in the fourth quarter of 2026. The company also expects to announce Phase 2b induction trial top-line results for CD in the fourth quarter of 2026. The company expects to announce an obefazimod follow-on candidate selection in 2026. Additional preclinical data to support decision-making on a combination agent is expected in 2026.

The company is advancing obefazimod through pivotal clinical trials to establish it as a potential preferred advanced therapy for IBD. The company believes that the strength of the induction data generated in July 2025 in its Phase 3 clinical trials, with a pooled 16.4% placebo-adjusted clinical remission rate after 8 weeks of treatment, and a highly differentiated placebo adjusted clinical response rate across all lines of bio-naïve and bio-refractory patients, including JAK resistant patients, with no major safety concerns, uniquely positions obefazimod as a potential highly competitive advanced therapy choice for moderately to severely active UC, if approved ¹⁶. The company also believes that the strength of the maintenance data demonstrated in its Phase 2b trial (as evidenced by a clinical remission rate of 53%, clinical response rate of 73% and no new adverse safety signals observed from its two-year Phase 2b open label maintenance trial), should they be confirmed in its ongoing Phase 3 maintenance trial, could further position obefazimod as a potential treatment of choice for all UC patient treatment lines ¹⁷.

The company is leveraging its library of miR-124 enhancers to expand its pipeline in chronic inflammatory diseases. Based on the mechanistic concept of obefazimod, the company has launched a research and development program to generate new potential drug candidates to strengthen its intellectual property portfolio on the miR-124 platform and to identify additional drug candidates from its proprietary small molecule library that includes additional miR-124 enhancers. The company expects to announce an obefazimod follow-on candidate selection in 2026. The company may also consider R&D portfolio additions anytime, with compounds resulting from external scientific and medical partnerships in chronic inflammatory diseases at preclinical or clinical stage.

The company is evaluating potential combination therapy in IBD with obefazimod. In September 2024, the company announced initial preclinical combination data of obefazimod combined with etrasimod in a mouse model of IBD. The results showed that treatment with the combination improved the response on body weight protection and Disease Activity Index, and a synergistic and statistically significant reduction of several cytokines (TNFa, IL-17, IL-6, IFNg) in the blood compared to each drug alone. The company is also investigating potential synergies with agents resulting from several other MOAs (a4b7, IL-23, PDE-4 and ahR). Additional preclinical data to support decision-making on a combination agent, which would also be based on an evaluation of induction and maintenance data from the Phase 3 clinical trials, is expected in 2026.

The company intends to retain worldwide development and commercialization rights for obefazimod. For certain geographies, the company may opportunistically enter into strategic partnerships to accelerate development activities in order to realize the commercial potential of obefazimod as well as other assets in its pipeline. In connection with any potential strategic partnership, the company plans to pursue and receive upfront funding, milestone payments and future royalties for these agreements.

The company expects to continue to incur significant expenses and operating losses for the foreseeable future. The company anticipates that its expenses will increase substantially if, and as, it timely and successfully completes clinical development of obefazimod, seeks and maintains regulatory and marketing approvals, continues preclinical and clinical development of its drug candidates, expands the scope of its current clinical trials, begins new clinical trials, develops, scales and validates commercial manufacturing capabilities, establishes a sales, marketing and distribution infrastructure, seeks to discover, identify and validate additional drug candidates, acquires or in-licenses other drug candidates and technologies, makes milestone, royalty or other payments under in-license or collaboration agreements, obtains, maintains, protects, enforces and expands its intellectual property portfolio, attracts new and retains existing skilled personnel, and continues its operations as a U.S. public company.

The company faces significant operational risks as a result of doing business internationally, such as fluctuations in foreign currency exchange rates, differing payor reimbursement regimes, potential changes to accounting standards, reduced protection of intellectual property rights in certain countries, difficulties in attracting and retaining qualified personnel, restrictions imposed by local labor practices and laws, rapid changes in global government, economic and political policies and conditions, and tariffs, trade protection measures, import or export licensing requirements, trade embargoes and other trade barriers. The company does not hedge its currency exposure and therefore incurs currency transaction risk whenever it enters into either a purchase or sale transaction using a currency other than the Euro.

The company is heavily dependent on the success of its drug candidates, in particular obefazimod, and cannot be certain that obefazimod or any of its other current or future drug candidates will receive regulatory approval. The company currently has no drug candidates approved for marketing. The company's ability to generate revenue related to sales, if any, will in the near future depend entirely on the successful development and regulatory approval of obefazimod. Clinical failure can occur at any stage of clinical development, and the results of earlier clinical trials as well as data from any interim analysis of ongoing trials are not necessarily predictive of future results. The company may experience setbacks that could delay or prevent regulatory approval of its drug candidates or its ability to commercialize any products.

The company is a clinical-stage company with a limited operating history and no approved products and no historical product revenues, which makes it difficult to assess future prospects and financial results. The company has incurred considerable losses historically, with net losses of €336.1 million, €176.2 million, and €147.7 million for the years ended December 31, 2025, 2024 and 2023, respectively ¹⁸. As of December 31, 2025, the company carried forward accumulated tax losses of €912.9 million ¹⁹. The company is heavily dependent on the success of its drug candidates, in particular obefazimod, and cannot be certain that obefazimod or any of its other current or future drug candidates will receive regulatory approval. Clinical failure can occur at any stage of clinical development, and the results of earlier clinical trials are not necessarily predictive of future results. There are material weaknesses in the company's internal controls over financial reporting, specifically related to a lack of design and implementation of effective risk assessment process, formal, documented and implemented processes, controls and review procedures, sufficient processes to identify, capture and communicate information necessary to support the functioning of internal controls over financial reporting, and process to identify, maintain, and develop all control activities, due to a lack of sufficient number of professionals with an appropriate level of internal control knowledge, training and experience. These material weaknesses continue to exist as of December 31, 2025 ²⁰.

Management's message emphasizes the company's focus on developing and commercializing obefazimod for the treatment of IBD, starting with moderately to severely active UC and CD. The key strategic priorities emphasized for the period ahead include advancing obefazimod through pivotal clinical trials and establishing it as a potential preferred advanced therapy for IBD, leveraging the library of miR-124 enhancers to expand the pipeline in chronic inflammatory diseases, evaluating potential combination therapy in IBD with obefazimod, and opportunistically evaluating strategic partnerships to maximize the value of obefazimod and the therapeutic pipeline. Management expects to report top-line data from the Phase 3 ABTECT maintenance trial in late second quarter of 2026 and, subject to positive data, currently expects to submit an NDA with the FDA in the fourth quarter of 2026. Management also expects to announce Phase 2b induction trial top-line results for CD in the fourth quarter of 2026 and an obefazimod follow-on candidate selection in 2026.