Brainomix AI Technology Reveals Efficacy of Novel Neuroprotective Drug Candidate in Severe Acute Ischemic Stroke Patients

• Brainomix 360 Stroke imaging was utilized to improve and standardize the grading of baseline stroke severity, prior to treatment in patients enrolled in Argenica Therapeutic’s Phase II study of neuroprotective ARG-007
• Brainomix AI core lab uses regulatory cleared stroke technology, alongside its foundation-model-powered imaging pipeline for clinical trials, to provide robust baseline phenotyping and efficacy analysis
• The Brainomix AI-enabled analysis demonstrated efficacy of Argenica’s ARG-007 in severe stroke patients
• Findings from the analysis will inform future clinical development and patient selection to advance treatment options for patients with severe acute ischemic stroke

CHICAGO and OXFORD, England, Dec. 18, 2025 /PRNewswire/ — Brainomix, a global leader and pioneer of AI-powered imaging biomarkers for stroke and lung fibrosis, today announced results from its partnership with Argenica Therapeutics (ASX: AGN) for imaging and clinical data analysis of the Phase II trial evaluating ARG-007, a neuroprotective agent for acute ischemic stroke. Analysis using Brainomix 360 Stroke, an FDA-cleared and CE-marked AI-imaging platform, confirmed statistically significant and clinically meaningful efficacy of ARG-007 in severe acute ischemic stroke patients through accurate and standardized quantification of digital imaging biomarkers, including e-ASPECTS which allowed for improved stratification of patients.

The analysis addressed a fundamental challenge in stroke clinical trials: variability in baseline stroke severity assessment. By applying standardized, objective AI imaging biomarkers to the trial data, Brainomix 360 Stroke confirmed that patients with larger infarcts (brain tissue death) at presentation experienced statistically significant improvements in neurological function at 24 hours and disability outcomes at 90 days when treated with ARG-007 compared with placebo. Brainomix also showed that these patients demonstrated significantly smaller final infarct volumes, a key hallmark of neuroprotection.

“This collaboration highlights the value of proactively incorporating AI-enabled precision imaging in clinical trial design and analysis of stroke research,” said Dr. Michalis Papadakis, CEO and co-founder of Brainomix. “Clinical trials in stroke rely heavily on accurate baseline assessments and manual scoring methods, which can introduce variability that obscures true treatment effects. Our Brainomix 360 Stroke platform provides standardized, objective measurements that help identify responsive patient populations with greater precision and, ultimately, accelerate the path to effective therapies for stroke patients. For ARG-007, by standardizing stroke assessment, AI removed variability and exposed a treatment effect that was previously hidden.”

Dr. Liz Dallimore, CEO and Managing Director of Argenica Therapeutics, added, “We are excited by the outcomes of this analysis from Brainomix. Their expertise and AI-enhanced imaging platform allowed us to gain deeper insights from our clinical trial data, providing greater clarity around treatment effects and enabling more detailed exploration of key biomarkers, and show that ARG-007 delivers real benefit where it is needed most, in patients with the largest, most disabling strokes.

“With AI, we can now design a next-phase study of ARG-007 using precision medicine principles, selecting patients based on objectively measured brain injury and maximizing the chance of meaningful recovery.”

About Brainomix 360 Stroke
Brainomix 360 Stroke is the world’s first fully automated AI imaging platform, specifically designed for acute stroke assessment across every stage of the patient pathway, facilitating more confident treatment and transfer decisions for patients in all hospitals, regardless of local resources or expertise. By integrating advanced algorithms for NCCT, CTA, CTP, and MRI, Brainomix 360 Stroke enables faster, more accurate diagnosis and empowers clinicians to make informed decisions that improve patient outcomes.

About Brainomix AI Core Lab
Brainomix AI core lab uses its regulatory cleared products, alongside next generation imaging and clinical analytics, to inform the interpretation of clinical trial data and provide insights from routinely collected trial imaging. Through improved baseline phenotyping and detailed analysis of imaging endpoints, including Brainomix’s next generation foundation model analysis, the AI core lab provides critical insights into therapeutic efficacy, safety and mechanisms of action at all stages of clinical development.

About Brainomix
Brainomix is a global pioneer in AI medical imaging, working with life science partners to support the clinical development novel therapeutics, as well as enabling precision medicine for better treatment decisions in stroke and lung fibrosis. Its flagship product, Brainomix 360 Stroke, is the world’s first fully automated AI-imaging platform, designed for acute stroke assessment at all points of the patient pathway, facilitating more confident treatment and transfer decisions for patients in all hospitals, regardless of local resources or expertise. Brainomix 360 e-Lung technology applies AI-driven CT biomarkers to identify, monitor, and predict disease progression in pulmonary fibrosis. Founded as a spinout from the University of Oxford, Brainomix has offices in the UK, Ireland and the USA, and operations in more than 20 countries.

To learn more about Brainomix and its technology visit www.brainomix.com, and follow us on Twitter, LinkedIn and Facebook.

About Argenica Therapeutics

Argenica Therapeutics (ASX: AGN)  is a Perth-based biotechnology company developing innovative neuroprotective therapies to protect brain cells following stroke, traumatic brain injury, and other neurological conditions. Its lead drug candidate, ARG-007, is a novel neuroprotective peptide designed to limit brain tissue damage and improve recovery outcomes. ARG-007 has demonstrated efficacy in preclinical stroke, traumatic brain injury, and hypoxic-ischaemic encephalopathy models, and has completed Phase 1 and Phase 2 clinical trials in humans and is currently advancing toward a more targeted Phase 2b trial informed by the new AI analysis findings.

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SOURCE Brainomix