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Bioxodes raises €2.7 million from existing investors in Series A extension Interim data from BIRCH intracerebral hemorrhage (ICH) Phase 2a trial in Q1 2025 Recruitment of up to 16 additional patients continues in BIRCH BIOX-101 Phase IIb ICH study preparations ongoing, to start upon close of Series B 12 February 2025 – 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 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. The content above comes from the network. if any infringement, please contact us to modify.

GOSSELIES, Belgium I December 19, 2024 I Bioxodes SA, a clinical stage biopharmaceutical company developing novel therapies for the prevention and treatment of thrombotic and inflammatory diseases, has enrolled the first 16 of 32 patients in the open-label, randomized and controlled Phase 2a clinical trial of its lead asset BIOX-101 in patients with intracerebral hemorrhagic stroke (ICH). Treatment of the first 16 patients will trigger an interim analysis, according to the trial protocol. Data of these patients will be available for investors under condition of confidentiality, as is already the case with currently available patient data. BIOX-101 is a proprietary novel therapeutic candidate, a peptide which Bioxodes has developed from a protein discovered in tick saliva. “We’ve reached a crucial point in the development of BIOX-101, which we believe can save lives, and improve quality of life, by preventing the harmful secondary damage in patients hit by intracerebral hemorrhagic stroke, a devastating condition for which there is no currently available treatment. I am looking forward to the full interim analysis report from the first 16 patients in March of next year,” said Marc Dechamps, Chief Executive Officer at Bioxodes. The BIRCH trial will enroll a total of 32 patients, with 24 receiving BIOX-101, and 8 standard-of-care treatment. In the study, BIOX-101 is administered intravenously within the first hours from onset. It is being conducted in 10 stroke units in Belgium, led by Prof Robin Lemmens, a world-leading stroke authority and head of clinic at the University Hospital Leuven. Only 13% of strokes are classified as ICH, yet these account for 40% of all stroke-related deaths, leaving many survivors with permanent or long-term disability. Standard of care consists largely of monitoring and stabilizing patients, without using anticoagulant medication, which can worsen bleeding. ICH is an orphan disease in U.S. and Europe. Drugs developed for orphan indications often have relatively rapid and cost-effective paths to market compared to drugs for other indications. Bioxodes filed for orphan drug status in the U.S. and Europe this month, which could lead to a response from regulatory agencies in both territories in the first quarter of 2025. At the same time, the company is preparing to ramp up production of BIOX-101 for a potential registrational international Phase 2b trial, for which it plans to start recruitment in the first quarter of 2027. BIOX-101, developed from a protein found in the saliva of the tick 1 , is designed to reduce the harmful secondary brain injuries that occur after a hemorrhagic stroke. It works by preventing blood clot formation without increasing the risk of further bleeding. Moreover, it prevents the acute neuroinflammatory events associated with ICH, by inhibiting the activation of neutrophils, a type of white blood cell that often act as the first responders of the inflammatory system. BIOX-101 is also in early development as a platform for a series of other indications, including ischemic stroke and other thrombo-inflammatory diseases. 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. SOURCE: Bioxodes