ABTECT Phase 3 Data Safety Monitoring Board (DSMB) meeting on March 18, 2026 found no new safety signals; the analysis included 100% of patients randomized, with nearly 90% having completed the 44-week double blind maintenance trial
The Company's pivotal Phase 3 ABTECT maintenance trial evaluating obefazimod for moderately to severely active ulcerative colitis remains on track to report topline results in late Q2 2026
Abivax appointed Michael Nesrallah, MBA as Chief Commercial Officer, bringing extensive IBD leadership experience to support the Company's next phase of growth; other key senior leadership hires made in Regulatory Affairs and Research to support continued advancements of its programs
Cash, cash equivalents and short-term investments of €530.4M as of December 31, 2025; cash runway into Q4 2027
Abivax's Annual General Meeting ("AGM") to be held May 11, 2026, and the Company expects to report its first quarter 2026 financial results on May 25, 2026
PARIS, France, March 23, 2026, 9:05 PM CET, Abivax SA (PARIS:FR) ("Abivax" or the "Company"), 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, reported today its financial results for the full year ended December 31, 2025. The 2025 financial statements, approved by the Company's Board of Directors on March 19, 2026, have been audited by the Company's statutory auditors, and the financial reports will be filed with the French and U.S. securities regulatory authorities, respectively, on March 23, 2026.
Marc de Garidel, MBA, Chief Executive Officer of Abivax, commented: "With a strong financial foundation, we are well positioned to execute on our strategic priorities and prepare for the future. We are pleased with the recent DSMB safety update from our ABTECT maintenance trial and remain on track to report topline results from our ABTECT-UC maintenance trial in late Q2 2026. The addition of Michael Nesrallah as our new Chief Commercial Officer also marks an important step as we build toward potential commercialization and the next phase of growth. Together, these achievements reinforce our momentum and confidence in the path ahead."
Full Year 2025 Financial Highlights
Fundraise: On July 28, 2025, Abivax completed its underwritten public offering of 11,679,400 American Depositary Shares, each representing one ordinary share, EUR 0.01 nominal value per share, of the Company, in the United States. The net proceeds, after deducting underwriting commissions and offering expenses, were approximately $700.3 million, equivalent to approximately €597.2 million.
Cash Position and Runway: The Company had cash, cash equivalents and short-term investments of €530.4 million as of December 31, 2025, providing a projected cash runway into Q4 2027 based on current operating assumptions.
Debt: During the year Abivax settled all tranches of its debt with Kreos Capital VII(UK) Limited and Claret European Growth Capital Fund III SCSp as well as its senior convertible notes with Heights Capital Management.
R&D Expenses: Research and development ("R&D") expenses increased by €31.2 million to €177.8 million (70.9% of operating expenses) in 2025 compared to €146.5 million (79.0% of operating expenses) in 2024. This increase was predominantly driven by expenses related to:
A €13.0 million increase in transversal activities related to increased chemistry, manufacturing and controls ("CMC") and supply chain costs related to the progression of clinical trials and anticipation of future commercial launch; and
A €10.2 million increase related to the Company's Crohn's disease ("CD") clinical program, driven by the progression of Phase 2b clinical trials for obefazimod in CD; and
A €4.1 million increase related to new indications (including combination therapy) for obefazimod; and
A €1.6 million increase related to the Company's ulcerative colitis ("UC") clinical program, driven by the continuation of Phase 3 clinical trials for obefazimod in UC
96.5% of R&D expenses related to obefazimod in 2025 compared to 97.4% in 2024.
G&A Expenses: General and administrative ("G&A") expenses increased by €34.7 million to €67.7 million (27.0% of operating expenses) in 2025 compared to €32.9 million (17.8% of operating expenses) in 2024. This increase was primarily due to an increase in personnel costs of €33.4 million mainly explained by an increase in employer taxes and social contributions related to our AGA plans by €27.3 million resulting from the increase in the Company's share price during the second half of 2025.
Sales and Marketing Expenses: Sales and marketing ("S&M") expenses decreased by €0.8 million to €5.2 million (2.1% of operating expenses) in 2025 compared to €6.0 million (3.2% of operating expenses) in 2024. The decrease is explained by one-time costs of €1.8 million incurred in 2024 for the Company's corporate re-branding, offset by an increase in personnel costs of €1.6 million, of which €0.8 million relate to an increase in employer taxes and social contributions related to our AGAs resulting from the increase in the Company's share price during the second half of 2025.
Data Safety Monitoring Board (DSMB) Update for ABTECT Phase 3 Trials
On March 18, 2026, the independent Data Safety Monitoring Board ("DSMB") completed a safety review of the ongoing Phase 3 ABTECT-UC maintenance trial and reported no new safety signals. Nearly 90% of enrolled participants have completed the 44-week treatment period. This positive update supports the continued advancement of the program as the Company remains on track to report topline results from its ABTECT-UC maintenance trials in late Q2 2026.
Board of Directors Update
On March 19, 2026, Sofinnova Partners, represented by Dr. Kinam Hong, stepped down from the Company's Board of Directors. The Company thanks Sofinnova and Dr. Hong for their long-standing commitment, leadership, and partnership over the years.
Key Management Updates
To support its next phase of growth and continued advancement of its development programs, the Company has strengthened its leadership team with the appointment of Michael Nesrallah as its Chief Commercial Officer, Keith Fournier, PhD, as Senior Vice President of Global Regulatory Affairs, and Maurus de la Rosa, PhD, as its Senior Vice President of Research. These additions further enhance the Company's commercial, regulatory and scientific capabilities as the Company continues to execute its business priorities.
Michael Nesrallah, MBA, Chief Commercial Officer of Abivax, added: "Abivax is entering an exciting new chapter, and I'm thrilled to be joining the Company at such a pivotal moment. We have a meaningful opportunity ahead to further strengthen our commercial capabilities to prepare for the successful launch of obefazimod, if approved, which has the potential to truly make a difference for patients. I look forward to working with the team to help drive the Company's continued growth and long-term success."
Michael Nesrallah, MBA - Chief Commercial OfficerMr. Nesrallah will lead global commercial strategy and launch preparation as the Company advances toward potential regulatory approval and market entry for obefazimod, bringing more than 20 years of global biopharmaceutical leadership experience with deep expertise in gastroenterology and immunology. Prior to joining Abivax, he held several senior leadership roles at Takeda, including Vice President and U.S. Franchise Head for its inflammatory bowel disease business, where he drove significant growth for Entyvio while expanding treatment access for patients. He also served as General Manager for Belgium and Luxembourg and later established and led Takeda's International Marketing & Commercial Excellence organization, building integrated commercial capabilities across more than 60 countries to support launch readiness and portfolio growth. Earlier in his career, Mr. Nesrallah held commercial leadership roles at Novartis and began his career at McKinsey & Company. He holds an MBA from the Richard Ivey School of Business and a Bachelor of Science in Biochemistry from the University of Ottawa.
Keith Fournier, PhD - Senior Vice President, Global Regulatory AffairsDr. Keith Fournier is an experienced regulatory affairs executive with extensive expertise in global regulatory strategy and lifecycle management. Most recently, he served as Vice President, Global Regulatory Affairs, at EMD Serono, where he led regulatory planning and agency interactions across key therapeutic areas, supporting product development, approvals and post-marketing activities. He also held senior regulatory roles at AbbVie, where he led global regulatory strategy across multiple programs. He brings deep experience navigating complex global regulatory environments to advance innovative therapies. He holds a PhD in Pharmacology from the University of Pennsylvania, as well as a Bachelor of Science in Biology and a Bachelor of Arts in Economics from Duke University.
Maurus de la Rosa, PhD - Senior Vice President, ResearchDr. Maurus de la Rosa is a seasoned immunologist with more than 15 years of experience in immunomodulation and drug development across multiple programs, modalities, and development stages. He brings extensive expertise in immunology ...
