A French biotechnology company developing once-daily oral medicines for chronic inflammatory diseases, led by its drug candidate obefazimod for ulcerative colitis and Crohn's disease. It was founded in Paris in 2013 by immunologist Philippe Pouletty, who brought together three French biotech firms to build it. The name hints at its surprising start: obefazimod was first researched as an anti-HIV compound, and its anti-inflammatory powers were discovered by accident along the way.
20-F · Fiscal year ended Dec 31, 2025 · SEC filing ↗
Abivax's Phase 3 ulcerative colitis trials met their primary endpoint, but the net loss widened 91% to €336.1M.
Obefazimod cleared its pivotal test. The Phase 3 ABTECT induction trials in ulcerative colitis met the primary endpoint with a pooled 16.4% placebo-adjusted clinical remission rate, while the net loss widened 91% to €336.1M, driven by a €65.9M non-cash on convertible notes and warrants. A €607.2M Nasdaq offering extended the cash runway into Q4 2027, past the planned .
Key takeaways
The Phase 3 ABTECT induction trials for obefazimod in moderately to severely active ulcerative colitis met the primary endpoint, showing a pooled 16.4% placebo-adjusted clinical remission rate at week 8 with no major safety concerns.
The net loss widened 91% to €336.1M, primarily from a €65.9M non-cash on convertible notes and warrants, a €27.3M increase in employer taxes on , and higher R&D spending.
R&D expenses rose 21% to €177.8M, driven by the progression of the Phase 3 ulcerative colitis program and the Phase 2b Crohn's disease trial (ENHANCE-CD), which was initiated in Q4 2024.
General and administrative expenses rose 105% to €67.7M, mainly from a €27.3M increase in employer taxes on .
The company raised gross proceeds of €607.2M in a July 2025 Nasdaq offering, ending the year with €516.7M in cash and equivalents, which management expects to fund operations into Q4 2027.
A of €5.8M was recognized for the first time, driven by a taxable temporary difference arising from royalty certificates.
What changed
The top-line induction data from the Phase 3 ABTECT trials, previously expected in Q1 2025 and then Q3 2025, was reported and met the primary endpoint, resolving the central clinical catalyst flagged in prior filings.
The going-concern risk flagged in FY 2024, when cash of €144.2M funded operations only into Q4 2025, was addressed by a €607.2M Nasdaq offering in July 2025, extending the cash runway into Q4 2027.
The net loss widened from €176.2M to €336.1M, but the increase was largely driven by a non-cash €65.9M on convertible notes and warrants, rather than a proportional increase in operating spending.
What to watch
Top-line induction data from the Phase 2b ENHANCE-CD trial in Crohn's disease, expected in Q4 2026.
Selection of a follow-on miR-124 enhancer candidate, planned for 2026.
Progress toward the planned for obefazimod in ulcerative colitis, now within the cash runway.
Remediation progress on the material weaknesses in internal controls over financial reporting.
Section summaries
Quantitative and Qualitative Disclosures About Market Risk
The company faces foreign currency and credit risk, does not use derivatives for hedging, and reports a €2.0M sensitivity to a 10% adverse USD/EUR move.
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The company does not use for hedging and holds financial instruments only to finance ongoing business, not for speculation.
Foreign currency exchange risk arises from commercial transactions in non-functional currencies, with no recurring hedging mechanism in place.
In 2025, 9% of total operating expenses (€21.7M out of €250.6M) were incurred in foreign currencies, up from 7% in 2024.
The material weaknesses in internal controls over financial reporting, identified in prior years, remained unremediated as of December 31, 2025.
A hypothetical 10% adverse change in the USD/EUR exchange rate would have resulted in an estimated foreign exchange loss of approximately €2.0M in 2025.
Credit risk on cash and cash equivalents is deemed not significant due to the quality of counterparty financial institutions, though €92.5M in bank deposits exceeded insured limits as of December 31, 2025.
Credit risk on other and advances to is considered minimal.
A clinical-stage biotech with no approved products faces material risks from ongoing losses, internal control weaknesses, and heavy dependence on lead candidate obefazimod.
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The company has never generated product , reported a €336.1M net loss in 2025, and expects losses to continue as it funds the development of obefazimod.
Management has identified material weaknesses in internal controls over financial reporting related to risk assessment, control activities, information/communication, and monitoring, which remain unremediated as of December 31, 2025.
The business is heavily dependent on the success of obefazimod, its lead drug candidate, and any failure, delay, or inability to obtain regulatory approval would materially harm the company.
The company relies on a small number of third-party suppliers and manufacturers, including single-source suppliers, with no long-term supply agreements, creating significant supply chain risk.
The company faces intense competition from large pharmaceutical companies in the inflammatory disease market, and its novel miR-124 mechanism has no approved precedent, making its commercial outlook uncertain.
As a French company with a U.S. listing, investors face risks from dual-market trading, potential tax treatment, and limited ability to enforce U.S. judgments.
Abivax is a clinical-stage biotech developing obefazimod, a first-in-class oral small molecule for chronic inflammatory diseases, initially targeting ulcerative colitis and Crohn’s disease.
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The lead candidate obefazimod enhances miR-124 to stabilize the immune response without broad immunosuppression, potentially differentiating it from existing therapies.
Phase 3 ABTECT induction trials in moderately to severely active UC met the primary endpoint, showing a pooled 16.4% rate at week 8 with no major safety concerns.
A Phase 2b trial in Crohn’s disease (ENHANCE-CD) was initiated in Q4 2024, with top-line induction data expected in Q4 2026.
The company is evaluating obefazimod in combination therapies and plans to select a follow-on miR-124 enhancer candidate in 2026.
Abivax holds worldwide rights to obefazimod and intends to retain them, while opportunistically pursuing strategic partnerships for certain geographies.
The estimated worldwide UC market was $9.2 billion in 2025, growing to a projected $21.8 billion by 2032, with oral agents expected to gain significant share.
Net loss widened 91% to €336.1M in FY2025, driven by higher R&D and G&A expenses, partly offset by a €607.2M July 2025 Nasdaq offering.
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Total operating expenses rose 35% to €250.6M, with R&D up 21% to €177.8M on Phase 3 UC and Phase 2b CD trial progression, and G&A up 105% to €67.7M mainly from a €27.3M increase in employer taxes on .
Other fell 63% to €4.6M due to a €4.1M drop in subsidies and a €3.6M decline in research tax credits (CIR), partly offset by €1.5M in depositary service fees.
Financial loss surged to €84.2M from €3.3M, primarily from €65.9M in losses on convertible notes and warrants, €13.4M in FX losses, and €17.2M in royalty certificate interest.
Cash used in operations was €161.1M; the company ended the year with €516.7M in cash and equivalents, and expects its cash runway to fund operations into Q4 2027, past the planned NDA submission for obefazimod in UC.
A deferred tax charge of €5.8M was recognized for the first time, driven by a taxable temporary difference arising from royalty certificates.