BlinkLab Expands into Therapy Evaluation for Neurodevelopmental Conditions with Erasmus MC

Highlights

• Therapy Evaluation Partnership with Leading European Medical Centre: BlinkLab has entered into a research agreement with Erasmus University Medical Centre Rotterdam, a leading European medical research institution.
• Neurodevelopmental Relevance Including Autism: The program focuses on a rare disorder associated with neurodevelopmental and behavioural symptoms, including autism. BlinkLab’s novel neurometric technology will be used to provide objective measures of patient responses to treatment, an outcome that has not been possible previously.
• Beyond Diagnostics: The collaboration supports BlinkLab’s expansion from diagnostic assessment into therapy evaluation, treatment monitoring and future digital endpoints for pharmaceutical and interventional studies.

BlinkLab Limited (ASX:BB1) is pleased to announce that it has entered into an academic research agreement with Erasmus University Medical C enter (Erasmus MC), a world-renowned medical research institution in The Netherlands. The project is designed to investigate treatment-related changes in behavioural and neurodevelopmental function in patients with Activated PI3K Delta Syndrome (APDS), a rare inborn error of immunity that is increasingly recognised as being associated with neurodevelopmental conditions, including autism.

Commenting on the research agreement, Dr Henk-Jan Boele, Managing Director and CEO ofBlinkLab, stated:

“This is a very exciting step for BlinkLab because it will further unlock the full potential of our technology. From the start, our ambition has been to build a platform that is useful not only for diagnostic support, but also for formalising objective measurement in therapeutic and treatment studies. As more drug development moves into biologically defined neurodevelopmental conditions, BlinkLab aims to be at the forefront of therapy evaluation, treatment monitoring and digital endpoints. Aleksandra and I have worked together successfully over many years through projects connected to Erasmus MC and Princeton University, so it is especially rewarding to take this nextstep together.”

Also commenting on the agreement, Dr. Aleksandra Badura, Principal Investigator at Erasmus MC on the project, stated:

“I am very much looking forward to collaborating with BlinkLab on this study. APDS is not only an immunological disorder, but one that can also affect neurodevelopmental and behavioural function, including domains relevant to autism. Combining our clinical and translational expertise with BlinkLab’s scalable neurometric technology opens up a promising way to study treatment effects more objectively over time.”

Strategic Significance of the Research

The collaboration represents a strategically important expansion of BlinkLab’s platform into rare disease, neurodevelopmental medicine and therapy evaluation. APDS is a rare inborn error of immunity associated not only with immune dysfunction, but also with reported neurodevelopmental and behavioural symptoms, including autism. To date, these manifestations have rarely been studied using objective, scalable tools that can be deployed repeatedly over time.

Importantly, the study evaluates behavioural and neurodevelopmental function before and during treatment with a selective PI3Kδ inhibitor, a pathway-targeted therapy in APDS. This creates an opportunity to quantify therapy response longitudinally, explore treatment-related digital biomarkers, and establish a framework for future interventional studies in biologically defined neurodevelopmental disorders.

This is strategically important for BlinkLab because it moves the Company beyond diagnostics alone and into therapy evaluation. Over time, the Company believes its reflex-based and broader sensorimotor neurometric platform can support pharmaceutical companies and academic groups seeking objective, remote and repeatable endpoints for clinical development programs. That broader direction is consistent with BlinkLab’s longstanding platform ambition. Since listing, the Company has described its neurometric platform within a wider digital diagnostic and therapy landscape across multiple neurodevelopmental conditions, and this Erasmus MC collaboration is an important step toward formalising that opportunity in real-world therapeutic research.

Growing Regulatory and Pharmaceutical Relevance

Recent regulatory developments also underline why this area matters. The FDA has already approved a selective PI3Kδ inhibitor for APDS¹, demonstrating that targeted therapies are reaching rare, biologically defined patient populations. More broadly, recent FDA action involving leucovorin in cerebral folate deficiency² with autistic features highlights the increasing regulatory attention being given to conditions that sit at the intersection of biology, neurodevelopment and behaviour. As more targeted therapies emerge for neurodevelopmental conditions and related syndromes, there is a growing need for tools that can help identify patient subgroups, quantify behavioural function, and monitor treatment response over time. BlinkLab believes its smartphone-based neurometric approach is well positioned to support that future and to push the Company’s technology toward its full potential.

While the Company’s primary regulatory focus remains its autism and ADHD diagnostic programs, this collaboration highlights the broader applicability of its platform as a scalable, objective neurobehavioural measurement system not only for diagnostic purposes but also across multiple therapeutic areas.

About Erasmus University Medical Center

Erasmus University Medical Center is the largest university medical centre in The Netherlands, based in Rotterdam and affiliated with the broader Erasmus University Rotterdam, and is one ofEurope’s leading academic institutions for health and life sciences research. Erasmus MC is widely recognised for translational medicine, clinical research integration, and specialised work across immunology, neuroscience and precision medicine. The Department of Neuroscience at Erasmus MC brings together multidisciplinary teams across fundamental neuroscience, neurology, psychiatry and neurorehabilitation. This makes it a strong environment for collaborative projects that connect biological mechanisms with objective behavioural measurement and future treatment evaluation.

This announcement has been authorised for release by the Board of BlinkLab Limited.

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References

1. LINK: https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-treatment-activated-phosphoinositide-3-kinase-delta-syndrome
2. LINK: https://www.fda.gov/news-events/press-announcements/fda-takes-action-make-treatment-available-autism-symptoms