Quarterly Activities Report and Appendix 4C for the Period Ended 31 December 2024

BlinkLab Limited (ASX:BB1) (“BlinkLab”, or the “Company”) an innovative digital healthcare company leveraging smartphones, computer vision, Artificial Intelligence (“AI”), and Machine Learning (“ML”) to diagnose neurodevelopmental conditions such as autism and ADHD, is pleased to release its Appendix 4C and Quarterly Activity Report for the period ended 31 December 2024 (the “Quarter”).

Highlights

• BlinkLab initiated its FDA registrational study, which aims to revolutionise the diagnostics and care for autism, making it more accessible and reliable.
  • The initial phase will recruit up to 100 participants (children aged between 2-11 years old), with the main study recruiting up to 1,000 subjects.
  • Four clinical sites have been selected, with six additional sites to be added; the sites are spread across the US to ensure diversity of the population.
  • Final results are expected by the end of CY 2025 and will be used for the 510(k) Food and Drug Administration (“FDA”) approval.
• BlinkLab received positive feedback from a Pre-Submission meeting with the US Federal Drug Administration (“FDA”) regarding the regulatory pathway for BlinkLab Dx 1 diagnostic app.
• Final results from the pivotal autism study (announced in November of 2024) bolster confidence that BlinkLab Dx 1 will surpass the accuracy parameters that are required for regulatory approval in the upcoming FDA registration trial.
• BlinkLab and Monash University have partnered on the large-scale Monash Autism-ADHD Genetics and Neurodevelopment (“MAGNET”) study, which aims to conduct deep phenotyping in children on the autism spectrum, with ADHD, or both. The study will also work towards further improvements to BlinkLab’s Machine Learning (“ML”) algorithm to better distinguish between autism- and ADHD-specific clinical features.
• As at 31 December 2024, the Company had a cash balance of A$4.4 million.

Following the positive outcome from the recent FDA pre-submission meeting, as well as positive final data from the pivotal preliminary study (ASX Announcement 19 November 2024), BlinkLab is confident in the success of its registrational study, as well as the subsequent 510(k) regulatory approval for our first diagnostic tool for autism, called “Blinklab Dx 1”.

US FDA Registrational Study in Autism Now Underway

The FDA registrational study program will consist of a pilot study, followed by the primary study. The pilot study will recruit up to 100 participants (children aged between 2-11 years) and will continue into a registrational study, which will be conducted with up to 1,000 subjects across ten clinical sites in the US. The pilot study will be used to train the investigators and personnel at clinical sites, as well as to test the procedures of subject screening and data collection. These steps are part of BlinkLab’s considered strategy for mitigating risk leading up to the main FDA study and are aimed at ensuring the highest quality of data and diagnostic accuracy of the BlinkLab tests.

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