Abivax S.A.
ABVX, AAVXF · Pharmaceutical Preparations · EDGAR filings ↗
Grade
B73Well-capitalized clinical-stage biotech whose lead drug obefazimod posted positive Phase 3 UC induction data, materially de-risking the program.
Strengths
- Positive July 2025 Phase 3 induction readout (pooled 16.4% placebo-adjusted remission, no major safety signals) plus strong Phase 2b maintenance data
- Robust balance sheet: $607M cash (87th pct), 12.8-quarter runway, current ratio 8.7x
- Differentiated oral miR-124 MOA in a large IBD market
Risks
- No approved products or revenue; €336M FY2025 net loss and continuing cash burn
- Binary dependence on a single asset — Phase 3 maintenance and CD readouts still pending
- Older Phase 2 trial verdicts were inconclusive, so durability of confirmatory data is unproven
Notable findings
- No interest coverageInterest coverage -2.20 (cannot cover interest)
- Cash burnNegative free cash flow (-189.5M)
- Strong balance sheetStrong balance sheet — $607M cash & investments, ~13 quarters of runway
- Notable holderHeld by 4 notable fund(s): CITADEL ADVISORS LLC, FMR LLC, GOLDMAN SACHS GROUP INC +1 more (as of 2026-03-31)
- Trial readout soonUpcoming trial readout ~2026-04 — PHASE3 · Ulcerative Colitis
Key metrics
Return on equity
-73.8%
Return on assets
-57.5%
Interest coverage
-2.2×
Current ratio
8.7×
Free cash flow
-$190M
Tangible book value
$513M
Cash & investments
$607M
Cash runway
13q
Clinical trials
| Trial | Title | Phase | Status | Primary completion |
|---|---|---|---|---|
| NCT05177835 ↗ | Long-term Safety and Efficacy Profile of ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis Ulcerative Colitis | PHASE2 | Active Not Recruiting | 2028-03-01 |
| NCT06456593 ↗ | Efficacy and Safety of Obefazimod in Subjects With Moderately to Severely Active Crohn's Disease Moderately to Severely Active Crohn Disease | PHASE2 | Recruiting | 2026-12-01 |
| NCT07453784 ↗ | Study to Evaluate Pharmacokinetics, Relative Bioavailability, Palatability of Obefazimod Minitablet Formulation Healthy | PHASE1 | Recruiting | 2026-09-01 |
| NCT05535946 ↗ | ABTECT - Maintenance Ulcerative Colitis | PHASE3 | Active Not Recruiting | 2026-04-01 |
| NCT03897543 ↗ | ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma Carcinoma, Hepatocellular | PHASE1/PHASE2 | Recruiting | 2021-06-30 |
| NCT05507203 ↗ | ABTECT-1 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -1 Ulcerative Colitis | PHASE3 | Completed | 2025-06-24 |
| NCT05507216 ↗ | ABTECT-2 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -2 Ulcerative Colitis | PHASE3 | Completed | 2025-06-24 |
| NCT04023396 ↗ | Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative Colitis Ulcerative Colitis | PHASE2 | Completed | 2023-02-23 |
| NCT04049448 ↗ | Study Evaluating the Long-Term Safety and Efficacy of ABX464 in Patients With Moderate to Severe Rheumatoid Arthritis Rheumatoid Arthritis | PHASE2 | Completed | 2023-01-23 |
| NCT03905109 ↗ | Phase 2b/3 Study of ABX464 in Moderate to Severe Active Crohn's Disease Patients Crohn Disease | PHASE2/PHASE3 | Withdrawn | 2022-09-19 |
| NCT03368118 ↗ | Study Evaluating the Long-term Safety and Efficacy of ABX464 in Active Ulcerative Colitis Ulcerative Colitis | PHASE2 | Completed | 2022-07-12 |
| NCT05032560 ↗ | Safety and Pharmacokinetics Study in Healthy Japanese Volunteers Healthy Volunteers | PHASE1 | Completed | 2022-02-18 |
| NCT05121714 ↗ | Evaluation of the Potential CYP1A2-mediated Drug Drug Interaction Safety, and Tolerability of ABX464 Healthy | PHASE1 | Completed | 2021-05-18 |
| NCT03813199 ↗ | Study of Two Doses of ABX464 in Participants With Moderate to Severe Rheumatoid Arthritis Rheumatoid Arthritis | PHASE2 | Completed | 2021-04-27 |
| NCT03760003 ↗ | Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis Ulcerative Colitis | PHASE2 | Completed | 2021-04-01 |
| NCT04393038 ↗ | ABX464 in Treating Inflammation and Preventing Acute Respiratory Failure in Patients With COVID-19 COVID-19 | PHASE2/PHASE3 | Terminated | 2021-03-05 |
| NCT02990325 ↗ | A Safety, Pharmacokinetics, and Pharmacodynamics Study of ABX464 in HIV-1 Seronegative and Seropositive Adults HIV Infections, Health Volunteers | PHASE1/PHASE2 | Completed | 2018-12-27 |
| NCT03093259 ↗ | ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis Ulcerative Colitis | PHASE2 | Completed | 2018-07-25 |
| NCT02735863 ↗ | ABX464 in Fully Controlled HIV Infected Patients Treated With Boosted Protease Inhibitor Treatment HIV Infection | PHASE2 | Completed | 2017-08-30 |
| NCT02249988 ↗ | Clinical Efficacy of ABX203 Therapeutic Vaccine in HBeAg Negative Patients With Chronic Hepatitis B Chronic Hepatitis B | PHASE2/PHASE3 | Completed | 2016-12-01 |
Source: ClinicalTrials.gov (U.S. NIH) · active studies first.
Recent filings
| Form | Filed | Period | Accession |
|---|---|---|---|
| 20-F | 2026-03-23 | 2025-12-31 | 0001956827-26-000012 ↗ |
| 20-F | 2025-03-24 | 2024-12-31 | 0001956827-25-000010 ↗ |
| 20-F | 2024-04-05 | 2023-12-31 | 0001956827-24-000007 ↗ |