Bioxodes BIOX-101 Phase 2a data show statistically significant reduction in perihematomal edema growth in intracerebral hemorrhage

• First disclosure of new imaging analyses and one-year functional outcome were presented at the World Stroke Congress today
• Change in normalized hemorrhage volume was significantly lower with BIOX-101 versus standard of care at 72 hours (LS mean difference: -27.4%; p=0.009772)
• Increase in normalized perihematomal edema (PHE) volume was significantly lower with BIOX-101 versus standard of care at 72 hours (LS mean difference: -79.1%; p=0.0098)
• PHE growth in the first 72 hours has been associated with death or dependence at 90 days after intracerebral hemorrhage
• A trend toward lower disability on the mRS (modified Rankin Scale) from Day 7 through Day 360 was observed
• Primary safety endpoint met: no deaths, zero treatment-related serious adverse events, no increased bleeding
• Bioxodes preparing a placebo-controlled global Phase 2b trial

Gosselies, Belgium, October 21, 2026 (8:30 a.m. CET) – Bioxodes SA, a clinical stage biopharmaceutical company developing novel therapies for the prevention and treatment of thrombotic and inflammatory diseases, today announced that exploratory analyses from the Phase 2a BIRCH trial showed significantly less hematoma expansion and perihematomal edema (PHE) growth at 72 hours with BIOX-101 compared with standard of care (p=0.0097 and p=0.0098, respectively). PHE is swelling that develops around the brain bleed; published patient-level data have linked greater early PHE growth with death or dependence at 90 days¹. ICH is the deadliest form of stroke and one for which no treatment is approved. The data were presented today in a Late-Breaking Science oral presentation at the 18th World Stroke Congress (WSC 2026) in Seoul, South Korea.

Safety was the primary objective of BIRCH. BIOX-101 was well tolerated, with no deaths and no serious or severe adverse events considered related to study treatment.

Dr. Dimitri Hemelsoet, Ghent University Hospital, presenting author said: “In BIRCH, BIOX-101 achieved target engagement and was well tolerated in patients treated within 24 hours of symptom onset. The reduction in hematoma expansion and PHE growth was consistent with the trajectory of inflammatory biomarkers and with functional outcomes assessed by the mRS through Day 360. These are very encouraging exploratory findings from such a small open-label study; their consistency across imaging, biomarker and functional endpoints support starting a larger, blinded trial.”

“PHE growth in the first 72 hours is a biomarker associated with death or long-term disability after ICH¹, which is why it will be a key endpoint in BIRCH 2. With zero treatment-related serious adverse events and no increased bleeding in patients treated within 24 hours of a brain hemorrhage, the BIRCH Data Monitoring Committee recommended keeping the same patient criteria and regimen in BIRCH 2, significantly de-risking success in the next trial,” said Dr. Hans Warrinnier, Chief Medical Officer of Bioxodes.

“There is no approved therapeutic to treat ICH or to prevent secondary damage following ICH; to our knowledge, this is the first time a therapeutic candidate has achieved statistically significant reductions in hematoma and PHE growth in patients with ICH. This new analysis of one-year follow-up data strengthens our case with partners and investors as we work to finance BIRCH 2, a placebo-controlled Phase 2b trial,” said Marc Dechamps, Chief Executive Officer of Bioxodes.

Dr. Dimitri Hemelsoet, neurologist at Ghent University Hospital, presented the data on behalf of the BIRCH investigators (Abstract 1056, Late Breaking Science Abstracts 02-ICH, Vascular Risk & Prevention). The full dataset, including the magnitude of the effects, the p-values and the one-year functional outcomes, is presented today for the first time; topline BIRCH results were first reported in May 2026.

BIRCH (NCT05970224) was a randomized (3:1), open-label Phase 2a proof-of-concept trial conducted at 8 stroke units in Belgium. It compared BIOX-101 added to standard of care (n=17) against standard of care alone (n=6) in 23 patients with first-ever spontaneous ICH of 5 to 60 mL. BIOX-101 was given as a 48-hour intravenous infusion started within 24 hours of symptom onset. Despite randomization, baseline hematoma and edema volumes were larger in the BIOX-101 group (mean 25.3 vs 14.1 mL and 22.1 vs 7.9 mL), so baseline-adjusted analyses provide the most informative comparison between groups.

 

Key data presented at WSC 2026:

• Hematoma growth: In an exploratory adjusted analysis, at 72 hours, normalized hematoma volume remained essentially stable with BIOX-101 (-1.9% from baseline), compared with a 25.5% increase with standard of care (p=0.0097). By Day 10, mean normalized hematoma volume in the BIOX-101 group was 34.2% below baseline.
• Perihematomal edema (PHE): In an exploratory adjusted analysis, at 72 hours, PHE increased by 49.7% with BIOX-101, compared with 128.8% with standard of care (p=0.0098). At Day 10, the mean PHE increases from baseline were 137.7% with BIOX-101 and 213.0% with standard of care. In a published meta-analysis of individual participant data, higher PHE growth within 24 and 72 hours of ICH onset was independently associated with death or dependence at 90 days¹.
• Inflammation: the neutrophil-to-lymphocyte ratio followed a more favorable trajectory with BIOX-101, and a nucleosome-based NETosis biomarker (Nu CitH3R8/Nu.H3.1 ratio) showed a favorable pattern during the infusion period. These exploratory findings are consistent with the mechanism of BIOX-101 on neutrophil-driven inflammation.
• Functional outcome: a shift toward lower disability categories on the mRS appeared early with BIOX-101 and remained visible at each assessment through Day 360, despite the larger baseline bleeds in this group.
• Safety: there were no deaths, no study discontinuations due to treatment-related adverse events and zero treatment-related serious or severe adverse events. Serious adverse events, all considered unrelated to study treatment, occurred in 3 of 17 BIOX-101 patients (17.6%) and 2 of 6 standard-of-care patients (33.3%). Treatment-related events were all mild or moderate; the most frequent was prolonged aPTT (3 of 17 patients), consistent with the pharmacology of BIOX-101. No secondary hemorrhages were observed on Day 7 MRI in either group.
• Target engagement: the aPTT ratio was maintained at the 2.5 target from 3 to 48 hours and returned to 1.09 at Day 7. Mean inhibition of factor XI and factor XII procoagulant activity from 3 to 48 hours was 62% and 81%, showing rapid and reversible engagement of both targets.

The full dataset presented at WSC 2026 is available on the Bioxodes website.

Next step: BIRCH 2

Bioxodes is preparing BIRCH 2, a randomized, double-blind, placebo-controlled global Phase 2b trial of BIOX-101 in about 230 ICH patients. The planned primary endpoint is PHE volume at 72 hours adjusted for baseline; functional outcome on the mRS at Day 90 and Day 180 and all-cause mortality are planned secondary endpoints. The trial will use the same patient criteria and the same regimen as BIRCH, as recommended by the independent Data Monitoring Committee (DMC). The company is in discussions with potential partners and investors to finance the study.

KOL event and investor webcast

Bioxodes plans to host a KOL event and investor webcast following the presentation. Details will be announced in a separate communication.

Bioxodes SA (www.bioxodes.com) is a clinical stage biopharmaceutical company developing novel therapies for the prevention and treatment of thrombotic and inflammatory diseases. The company’s lead asset, BIOX-101, is a first-in-class drug candidate being developed to treat intracerebral hemorrhage (ICH), the deadliest and most disabling form of stroke, for which no approved therapy exists. BIOX-101’s unique dual mechanism of action has the potential to address a broad range of thromboinflammatory diseases beyond ICH. Worldwide, Bioxodes holds both granted and pending patents associated with BIOX-101. Bioxodes’ research is supported by the Walloon Region (SPW Recherche), and the company is registered in Belgium under number 825.151.779.

For further information, please contact:

HEAD OFFICES BioPark Charleroi-Bruxelles Sud Rue Santos-Dumont, 1 6041 Gosselies, Belgium +32 496 59 03 54 investment@bioxodes.com	MEDIA RELATIONS, BELGIUM Alexandra Schiettekatte communication@bioxodes.com +32 476 65 04 38
INVESTOR RELATIONS AND INTERATIONAL MEDIA RELATIONS Giovanni Ca’ Zorzi Cohesion Bureau giovanni.cazorzi@cohesionbureau.com

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¹ Samarasekera N, et al. Perihematomal Edema and Functional Outcome After Intracerebral Hemorrhage: A Meta-Analysis of Individual Participant Data. Stroke. 2026;57(5):1310-1324. doi:10.1161/STROKEAHA.125.053991

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