Final results confirm and build on interim BIRCH results in 23 ICH patients Primary safety endpoint met with no mortality observedEncouraging efficacy signals on all clinical and biomarker endpoints New adaptive pivotal Phase 2b/3 trial design meets EMA and FDA registration requirements – potentially upon positive Phase 2b dataPoster presentation at European Stroke Organisation Conference (ESOC) 2026 Gosselies, Belgium, 6 May 2026 (14:30 CET) – Bioxodes SA, a clinical stage biopharmaceutical company developing novel therapies for the prevention and treatment of thrombotic and inflammatory diseases, today announced positive final results from its Phase 2a clinical trial of its investigational therapy, BIOX-101, in 23 patients with intracerebral hemorrhage (ICH). The data and regulatory discussions support progression into a single pivotal adaptive Phase 2b/3 trial. The open-label randomized 3:1 Phase 2a proof-of-concept study showed favorable safety and tolerability, no mortality and no microhemorrhages at Day 7. Furthermore, encouraging signals were observed across multiple measures, including hemorrhage volume, edema growth, several key inflammation biomarkers, and a trend towards functional improvement in patients treated with BIOX-101 compared to standard of care (SoC). “These final BIRCH data are highly encouraging in a disease where there are no approved therapeutic options. The directional findings on hemorrhage volume, edema growth and functional recovery, together with a clean safety profile in patients who typically face very poor outcomes, provide a strong basis for advancing BIOX-101 into the planned pivotal adaptive Phase 2b/3 trial,” said Prof. Robin Lemmens, MD, PhD, Principal Investigator of the BIRCH trial and head of the stroke unit at University Hospitals Leuven. “These final clinical proof of concept results provide strong evidence supporting our biological therapeutic candidate’s mechanism of action as the first disease modifying breakthrough therapy for ICH patients. Recent discussions and feedback from regulators and our regulatory consultants in the U.S. and Europe have validated our new adaptive Phase 2b/3 pivotal trial design, which we will initiate upon accessing sufficient funding,” said Marc Dechamps, Chief Executive Officer at Bioxodes. “We believe that positive Phase 2b data could enable us to register BIOX-101 for accelerated approval around the end of 2029 and launch this breakthrough therapy towards the end of 2030 in the U.S. and in 2031 in Europe. We are in advanced discussions with both potential partners and investors and expect to have the resources required to advance this urgently needed candidate to patients without delay.” Among the findings disclosed at ESOC 2026: Reduced hemorrhage volume. At Day 3, hemorrhage volume in the BIOX-101 arm had decreased by 2.19 mL vs a 3.85 mL increase in the SoC arm. Limited edema growth. At Day 3, perihematomal edema (PHE) growth in the BIOX-101 arm was 6.44 mL, versus 10.46 mL in the SoC arm. This finding is critical, as growth in perihematomal edema (PHE) is a biomarker that has been shown to be associated with poor functional outcomes in patients with ICH1; PHE will serve as a key secondary endpoint in the planned pivotal trial.Fewer secondary lesions with BIOX-101. In patients treated with BIOX-101, 5.9% (1/17) showed secondary ischemic lesions on day 7, vs 16.7% (1/6) in the SoC arm.More stable inflammatory profile. BIOX-101 was associated with a more stable neutrophil-to-lymphocyte ratio over time compared with SoC, suggesting diminishing of the acute systemic inflammatory response following ICH.Trend towards functional improvement. At Day 90, 7 of 16 BIOX-101 patients achieved a modified Rankin Scale (mRS) score of 0–2, indicating functional independence, compared to 0 of 5 patients in the SoC arm.Clear target engagement. BIOX-101 demonstrated controlled exposure during 48-hour infusion (mean t½β: 31.45 h) with a fast and reversible antithrombotic effect lasting up to 72 hours, confirming inhibition of FXIa and FXIIa coagulation factors.Favorable safety. No mortality and no microhemorrhages at Day 7 were observed in either arm. Three SAEs in two BIOX-101 patients (11.8%) were considered unlikely drug-related or unrelated; three SAEs were observed in two SoC patients (33.3%)Poster presentation detailsAbstract title: BIRCH: A Phase IIa proof-of-concept study of BIOX-101 in spontaneous intracerebral haemorrhage Abstract number: ESOC2026LB16 Poster number: P143 Date and time: Wednesday, 6 May 2026, 13:00–14:00 CEST Location: Poster area, MECC Maastricht, the Netherlands.  About the BIRCH trial – BIRCH (NCT05970224) is a multicenter, open-label, randomized 3:1 Phase 2a proof-of-concept trial conducted at 8 stroke units in Belgium. The trial evaluated BIOX-101 administered as a 48-hour intravenous infusion within 24 hours of symptom onset in 23 patients with first-ever spontaneous ICH (5–60 mL hemorrhage volume) compared to standard of care. Bioxodes is currently planning a pivotal adaptive Phase 2b/3 trial with up to 500 patients with functional outcomes as primary endpoint 2. PHE volume will serve as a key secondary efficacy endpoint, following the results from the Phase 2a trial. The company is of the view that compelling Phase 2b interim efficacy data would be sufficient to support an accelerated approval pathway, and that BIOX-101 could be granted U.S. approval in late 2030, and 2031 in the EU. The company is actively engaged in a €70 million Series B fundraising to finance the trial, manufacturing, and registration of BIOX-101. 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 OFFICESBioPark Charleroi-Bruxelles Sud Rue Santos-Dumont, 16041 Gosselies, Belgium+32 496 59 03 54investment@bioxodes.comMEDIA RELATIONS, BELGIUMAlexandra Schiettekatte communication@bioxodes.com+32 476 65 04 38  INVESTOR RELATIONSGiovanni Ca’ ZorziCohesion Bureaugiovanni.cazorzi@cohesionbureau.comMEDIA RELATIONS, INTERNATIONALDouwe MiedemaCohesion Bureaudouwe.miedema@cohesionbureau.com 1 Peer-reviewed analysis in press, authors include members of Bioxodes’ Clinical Advisory Board2 Measured by the modified Ranking Scale (mRS), which gives a single score ranging from 1 to 6 reflecting a patient’s level of functional independence.
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20260506 Bioxodes PR ESOC data (final)

Gosselies, Belgium, 14 November 2025 (08:30 am CET) – Bioxodes SA, a clinical stage biopharmaceutical company developing novel therapies for the prevention and treatment of thrombotic and inflammatory diseases, has held a webcast on the breakthrough potential of its lead candidate BIOX101 to treat intracerebral hemorrhage (ICH) and discussed the data with Prof Dr Robin Lemmens, KU Leuven, the Principal Investigator of its Phase 2a BIRCH clinical trial. Prof Lemmens, a world-renowned stroke expert and head of the stroke unit at the University Hospital Leuven, underscored the urgent need to address the large unmet medical need in intracerebral hemorrhage, and provided his insights from the successful Phase 2a clinical study with BIOX-101. Bioxodes CEO Marc Dechamps presented the company’s strategy in bringing BIOX-101 to market, possibly as early as late 2030.

Primary endpoint met, no drug-related serious adverse events Positive hematoma and edema volume evolutionRecruitment stopped early due to positive exploratory and efficacy outcomesPreparations underway to initiate Phase 2b study Gosselies, Belgium, 24 April 2025 (08:30 am CET) – Bioxodes SA, a clinical stage biopharmaceutical company developing novel therapies for the prevention and treatment of thrombotic and inflammatory diseases, today announces promising interim results from the BIRCH Phase 2a clinical trial of its lead asset, BIOX-101, to treat intracerebral hemorrhagic stroke (ICH). Interim analysis from the first 16 patients in the standard-of-care controlled, randomized trial showed that primary safety and secondary efficacy endpoints were met. The Data Monitoring Committee (DMC) identified no safety concerns related to changes in ICH volumes, serious adverse events, neurological outcomes, or mortality. Bioxodes will release a second interim report in the second half of 2025, and a final analysis of the study in 2026. The company has stopped recruitment for the trial, as it believes that adding more data would not alter the conclusions based on the available findings. Bioxodes will now start preparing the launch of a potentially registrational Phase 2b trial of BIOX-101 in ICH. “While preliminary, the data from this study all point in the right direction. This excellent result has given us the confidence to start the Phase 2b trial as soon as possible,” said Hans Warrinnier, Chief Medical Officer at Bioxodes. “Although hemorrhagic stroke often has debilitating consequences, it is a neglected disease, and the prospect of offering these patients hope is a strong motivating factor for our team.” “These encouraging results are an important milestone, which enables us to start looking ahead. We will now launch a Series B funding round, and start the CMC process required to produce sufficient BIOX-101 for the Phase 2b trial. This will take approximately a year to complete, so that we hope to start recruitment in the first half of 2027,” said Marc Dechamps, Chief Executive Officer at Bioxodes. No deaths have so far been recorded in the patient population, a surprisingly positive outcome, and no serious adverse events were attributed to treatment over the course of the trial. Treatment was well-tolerated, with no signs of increased bleeding. Data showed a consistent exposure to the drug during infusion, while pharmacodynamic data aligned well with pharmacokinetic findings. Imaging data suggested a favorable evolution of hematoma and edema volumes, while exploratory outcomes on inflammation biomarkers measurements were very encouraging. ICH is a devastating condition, which while accounting for only 13% of all cases of stroke, is behind 40% of all stroke-related deaths. There is currently no approved treatment, and many survivors are left with permanent or long-term disability. Bioxodes received Orphan Drug Designation for BIOX-101 in both the U.S. and in Europe in March 2025. The company is planning to file for PRIME status with the EMA later in 2025, and for Fast Track designation with the FDA later during development of the product. The planned Phase 2b trial could be sufficient to submit BIOX-101 for conditional marketing authorizations in the U.S. and Europe before 2030. BIOX-101 is a recombinant version of a small protein found in the saliva of the tick (Ixodes ricinus). It is designed to inhibit the harmful secondary effects of hemorrhagic stroke such as secondary ischemia, neuroinflammation and neuronal damage. The product exerts its anti-inflammatory effects by inhibiting activation of neutrophils and their release of extracellular DNA filaments (called NETs), which can cause excessive inflammation, exacerbating brain damage and disrupting the blood-brain barrier. Unlike currently marketed anticoagulants, BIOX-101 reduces clotting without increasing bleeding, by targeting Factors XIa and XIIa of the intrinsic coagulation pathway. Bioxodes is currently investigating the possibilities of a Phase 2 trial with BIOX-101 in acute ischemic stroke. 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 thromboinflammatory disease. BIOX-101’s unique mechanism of action is the foundation of an innovative pipeline of drug candidates for the prevention of (thrombo)inflammatory diseases. Worldwide, Bioxodes holds both granted and pending patents associated with BIOX-101. Bioxodes research is supported by the Walloon Region, and the company is registered in Belgium under number 825.151.779. HEAD OFFICES BioPark Charleroi-Bruxelles Sud Rue Santos-Dumont, 1 6041 Gosselies, Belgium+32 496 590354investment@bioxodes.com MEDIA RELATIONS, BELGIUMAlexandra Schiettekatte communication@bioxodes.com +32 476 65 04 38   MEDIA RELATIONS, INTERNATIONALDouwe Miedema Cohesion Bureau douwe.miedema@cohesionbureau.com INVESTOR RELATIONS Giovanni Ca’ Zorzi Cohesion Bureau giovanni.cazorzi@cohesionbureau.com    
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20250424 – Bioxodes PR interim results – final

Bioxodes raises €2.7 million from existing investors in Series A extensionInterim data from BIRCH intracerebral hemorrhage (ICH) Phase 2a trial in Q1 2025Recruitment of up to 16 additional patients continues in BIRCH BIOX-101 Phase IIb ICH study preparations ongoing, to start upon close of Series B Gosselies (Belgium), 12 February 2025 (08:30 am CET) – Bioxodes SA, a clinical stage biopharmaceutical company developing novel therapies for the prevention and treatment of thrombotic and inflammatory diseases, has raised €2.7 million from existing investors in an extension of its Series A funding round, now totaling about €15 million. The proceeds will allow the company to deliver full results from BIRCH, its Phase 2a trial of BIOX-101 to treat intracerebral hemorrhage (ICH), an orphan disease with no currently approved therapeutic intervention, and prepare for the launch of a potentially registrational Phase 2b trial of BIOX-101 for ICH. “The Series A extension is an important financial commitment from our existing investors, and an invaluable sign of confidence in the future of Bioxodes,” said Marc Dechamps, Chief Executive Officer at Bioxodes. “We are at a crucial moment in the development of BIOX-101, a first-in-class therapeutic to treat the devastating effects of intracerebral hemorrhagic stroke, a high unmet medical need. In the first half of this year, we will update investors about a number of crucial milestones, including the strengthening of our top management, interim results from the BIRCH Phase 2a study, a decision about the Orphan Drug Designation of BIOX-101, and our Series B funding round.” Recruitment for the randomized, open-label BIRCH trial is continuing after Bioxodes enrolled the first 16 patients in December. Bioxodes is planning to present an interim analysis of these patients when the data become available. Bioxodes is also expecting an imminent response from U.S. and EU regulators about its Orphan Drug Designation for BIOX-101, which it applied for in the fourth quarter of 2024. ICH is classified as an orphan disease in U.S. and Europe; drugs developed for orphan indications can have relatively rapid and cost-effective paths to market compared to other drugs. For example, the Phase 2b trial of BIOX-101 could be sufficient to register the product for marketing authorization before the end of this decade. At the same time, Bioxodes is working to ramp up production of BIOX-101 for a potential registrational international Phase 2b trial, which it plans to launch early next year, with recruitment expected to start in the first quarter of 2027. The Chemistry, Manufacturing and Controls (CMC) required to generate BIOX-101 for Phase 2b will take approximately a year to complete. Bioxodes is launching a series B funding round of about 50 million in Q2 2025, to support CMC and clinical development for BIOX-101, as well as to develop the drug candidate for additional indications including ischemic stroke and undisclosed thrombo-inflammatory diseases. In addition, Bioxodes will research other novel options to treat thrombotic and inflammatory diseases. BIOX-101 is synthesized based on a small protein found in the saliva of the tick1. It is designed to reduce the harmful secondary brain injuries that occur after a hemorrhagic stroke. BIOX-101 has demonstrated striking benefits in preclinical proof-of-concept studies, including the prevention of blood clot formation, as well as a reduction in detrimental neuroinflammation after an ICH. Unlike anticoagulants currently marketed to prevent blood clot formation, BIOX-101 reduces clotting without increasing the risk of bleeding. BIOX-101 also inhibits the activation of neutrophils and their release of extracellular DNA filaments (called NETs), which can cause excessive inflammation, exacerbating brain damage and disrupting the blood-brain barrier About Bioxodes Bioxodes is a clinical stage biopharmaceutical company developing novel therapies for the prevention and treatment of thrombotic and inflammatory diseases. Since its founding in 2013, Bioxodes has developed its lead asset BIOX-101, a first-in-class drug candidate aimed at patients with thrombo-inflammatory disease. BIOX-101’s unique mechanism of action is the foundation of an innovative pipeline of drug candidates for the prevention of (thrombo-)inflammatory diseases. Worldwide, Bioxodes holds both granted and pending patents associated with BIOX-101. Bioxodes research is supported by the Walloon Region, and the company is registered in Belgium under number 825.151.779. For more information please visit www.bioxodes.com or contact: HEAD OFFICES BioPark Charleroi-Bruxelles Sud Rue Santos-Dumont, 1 6041 Gosselies, Belgium+32 496 590354investment@bioxodes.com MEDIA RELATIONSAlexandra Schiettekatte communication@bioxodes.com +32 476 65 04 38   COHESION BUREAU EU MEDIA RELATIONSSophie Baumont sophie.baumont@cohesionbureau.com INVESTOR RELATIONS Giovanni Ca’ Zorzi giovanni.cazorzi@cohesionbureau.com     1 Ixodes ricinus
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20250211 – Bioxodes PR Series A extension – final