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