What went well
- New long-term durability data reinforced obefazimod's profile: a three-year interim analysis of Study 108 (open-label extension) showed that of 130 patients de-escalated from 50 mg to 25 mg once-daily after 2-4 years of prior treatment, 68% (88/130) were in clinical remission at Week 144 and 80% (104/130) completed 144 weeks, with patients treated for up to seven years and no new safety signals.
- The pivotal ABTECT-UC Phase 3 maintenance trial remained on track to report topline results in late Q2 2026, with a Q4 2026 NDA submission still targeted.
- Abivax simplified its capital structure by agreeing (May 2026) to repurchase and cancel its September 2022 royalty certificates for $90 million ($45 million cash plus a $45 million interest-free vendor loan reinvested in ADSs), materially reducing the royalty overhang; CFO Didier Blondel framed it as strengthening the balance sheet on attractive terms.
- G&A costs fell EUR 1.7 million to EUR 6.3 million as the first-quarter share-price decline reversed EUR 3.5 million of AGA-related employer charges - the flip side of 2025's share-price-driven cost inflation.
- The quarter delivered a EUR 8.0 million net financial gain (versus a EUR 5.2 million loss a year earlier), and the company held EUR 491.6 million of cash, equivalents and short-term investments with a runway into Q4 2027.
What went wrong
- R&D expense rose EUR 10.2 million to EUR 49.5 million (86.0% of operating expenses), driven by EUR 8.0 million for new indications/combination therapy, EUR 2.0 million of CMC/supply-chain costs and EUR 2.0 million for the Crohn's Phase 2b program (partly offset by a EUR 4.0 million decline in UC Phase 3 spend as those trials near completion).
- Operating loss widened to EUR 56.2 million (from EUR 47.2 million a year earlier) as spending scaled toward potential commercialization.
- Operating cash outflow increased to EUR 50.5 million (from EUR 33.3 million in Q1 2025).
- Cash, equivalents and short-term investments declined to EUR 491.6 million at March 31, 2026 (from EUR 530.4 million at year-end 2025), and total shareholders' equity fell to EUR 429.6 million.
- S&M costs rose to EUR 1.7 million (from EUR 0.9 million) on early U.S. commercial-preparation spend - an investment, but a growing cash cost ahead of any revenue.
Guidance Changes
| Metric | Period | Current guidance |
|---|---|---|
| ABTECT Phase 3 maintenance topline | late Q2 2026 | On track for late Q2 2026 |
| Half-year 2026 financial results | 2026 | To be reported September 21, 2026 |
| Phase 2b induction trial for Crohn's disease | Q4 2026 | Topline expected Q4 2026 |
| NDA submission (obefazimod in UC) | Q4 2026 | Targeted Q4 2026, subject to positive data |
| Cash runway | from Mar 31, 2026 | Unchanged into Q4 2027, including after the royalty-certificate repurchase (EUR 491.6M cash, equivalents & short-term investments) |
Performance Breakdown
| Metric | YoY | Note |
|---|---|---|
| R&D costs (Q1) | EUR 49.5M (+EUR 10.2M) | New indications/combination (+EUR 8.0M), CMC/supply chain (+EUR 2.0M), Crohn's Phase 2b (+EUR 2.0M), less a EUR 4.0M decline in UC Phase 3 as trials near completion. |
| G&A costs (Q1) | EUR 6.3M (-EUR 1.7M) | EUR 3.5M lower AGA-related employer taxes/social contributions from the Q1 2026 share-price decline, partly offset by EUR 1.4M higher professional fees. |
| S&M costs (Q1) | EUR 1.7M (+EUR 0.9M) | Early U.S. commercialization-preparation spend for obefazimod. |
| Operating loss (Q1) | EUR 56.2M (vs EUR 47.2M) | Higher R&D and S&M, partly offset by lower G&A; operating income EUR 1.3M. |
| Net financial gain/(loss) (Q1) | EUR 8.0M gain (vs EUR 5.2M loss) | Favorable non-cash/FX movements versus prior year. |
| Net loss (Q1) | EUR 48.5M (vs EUR 52.4M) | Wider operating loss offset by the EUR 8.0M financial gain. |
| Cash, equivalents & short-term investments | EUR 491.6M at Mar 31, 2026 | Down from EUR 530.4M at year-end 2025 on EUR 50.5M operating use. |
Earnings Call Themes & Trends
| Topic | Previous mention | Current period | Trend |
|---|---|---|---|
| Durability of response (Study 108) | - | Up to seven years of obefazimod treatment with 68% clinical remission at Week 144 after de-escalation to 25 mg and no new safety signals, supporting a durable-maintenance positioning. | — |
| Capital-structure clean-up | Structured debt retired in 2025 | May 2026 agreement to repurchase/cancel the 2022 royalty certificates for $90M, reducing royalty overhang with cash runway unchanged. | — |
| Commercial ramp | CCO hired | S&M and infrastructure spend rising as the company builds U.S. launch capabilities ahead of the ABTECT maintenance readout. | — |
More on Abivax S.A.
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