Half Yearly Report and Accounts

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Stock Blinklab Ltd (BB1.ASX)
Release Time 25 Feb 2026, 9:41 a.m.
Price Sensitive Yes
 BlinkLab Reports Interim Results for 2025
Key Points
  • Completed U.S. autism pilot study with strong diagnostic performance
  • Expanded clinical trial network in the U.S. and progressed ADHD program in Europe
  • Achieved key regulatory milestones in preparation for pivotal studies
Full Summary

During the half-year ended 31 December 2025, BlinkLab advanced from large-scale clinical validation into pivotal-stage regulatory execution across its autism and ADHD programs, while further strengthening its institutional network and scientific foundations. A major focus was the completion and analysis of the company's U.S. autism pilot study, which enrolled 485 children across diverse populations. The study demonstrated strong diagnostic performance of BlinkLab Dx 1 relative to gold-standard assessments, including in children with overlapping conditions like ADHD. The pilot data also enabled refinements to the company's machine learning models and pivotal study design. Regulatory engagement remained a key priority, with BlinkLab continuing formal interactions with the FDA to confirm the structure, endpoints and performance benchmarks of its proposed pivotal 510(k) study. In parallel, the company expanded and consolidated its U.S. clinical trial network. In Europe, BlinkLab progressed its ADHD clinical program, assessing 332 children using its smartphone-based platform. The half-year also included independent scientific validation of the company's core technology through publication in a leading peer-reviewed journal. BlinkLab's activities reflect a transition from exploratory validation into structured regulatory execution, positioning the company to move into the next phase of pivotal study initiation and broader platform expansion.

Outlook

BlinkLab is well-positioned to initiate its pivotal FDA study for its autism diagnostic platform in 2026, following the successful completion of its U.S. pilot study and ongoing regulatory alignment. The company will also continue to progress its ADHD program in Europe, leveraging its validated neurometric framework to expand its addressable market.