Partnership with SHANK2 Autism Foundation in the United States

Highlights

• Precision Neurogenetics Collaboration: BlinkLab has entered a new partnership with U.S.-based SHANK2 Autism Foundation; a non-profit organisation aiming to improve awareness and research infrastructure for rare neurodevelopmental conditions caused by mutations or deletions in the SHANK2 gene.‍
• Genetic Neurodevelopmental Condition Focus: Partnering with the SHANK2 Foundation gives BlinkLab access to a genetically defined patient population, enabling the company to validate its digital biomarkers in a biologically well-characterised neurodevelopmental disorder. This collaboration will help demonstrate how BlinkLab’s technology can support precision diagnostics and future clinical trial endpoints in rare neurological diseases.‍
• Favourable Regulatory FDA Developments in Autism-Related Disorders: Recent FDA approval of leucovorin for a rare genetic disorder with autistic features highlights growing regulatory focus on biologically defined neurodevelopmental conditions, supporting demand for precision diagnostics and digital biomarkers.
  

BlinkLab Limited (ASX:BB1) (“BlinkLab” or the “Company”) is pleased to announce that it has entered into a new partnership with the SHANK2 Foundation (the “Foundation”), a U.S.-based not-for-profit organisation with a focus on advocacy, awareness, the creation of research infrastructure, as well as data collection and assistance with phenotyping studies on SHANK2-related neurodevelopmental disorders. The SHANK2 gene plays a critical role in how brain cells form and maintain synaptic connections involved in learning, memory and behaviour. Mutations in SHANK2 disrupt these neural signalling pathways and are strongly associated with autism and other neurodevelopmental disorders, often leading to developmental delays, communication difficulties and sensory processing challenges. Because SHANK2-related disorders arise from a well-defined genetic cause, they provide an important model for studying the biological basis of autism and related conditions like cognitive impairment, developmental delay and epilepsy.

Strategic Importance of the Collaboration

The collaboration with the SHANK2 Foundation supports BlinkLab’s strategy to expand its digital neurodiagnostic platform into genetically defined neurodevelopmental disorders and rare disease research. Genetically defined conditions provide well-characterised patient populations that can strengthen digital biomarker validation and support the development of more precise digital phenotyping approaches.

BlinkLab’s collaboration with the SHANK2 Foundation provides access to genetically confirmed patient populations. SHANK2-related disorders are genetically defined, creating a biologically characterised cohort that can be used to evaluate BlinkLab’s digital behavioral biomarkers. Studying genetically defined disorders may also improve biomarker validation. Because these patient groups are molecularly defined, they may provide a stronger signal-to-noise ratio, enabling cleaner datasets that support the development of artificial intelligence and machine-learning models. The collaboration accelerates research and data generation. Through engagement with patient registries, families, and specialist researchers connected to the SHANK2 Foundation, BlinkLab can support efficient data collection and collaborative research initiatives.

Genetically defined disorders are also highly relevant from a regulatory perspective. For regulators such as the U.S. Food and Drug Administration (FDA), these populations provide attractive settings for biomarker validation and the development of exploratory digital endpoints. If BlinkLab demonstrates measurable digital signatures in individuals with SHANK2 mutations, the technology may support future clinical trial applications, including digital endpoints, patient stratification tools, and treatment monitoring platforms. The initiative also supports BlinkLab’s broader strategy to expand its platform beyond autism screening into additional neurodevelopmental and neurological conditions.

Finally, these capabilities may significantly broaden the commercial opportunities for BlinkLab’s technology. This includes the potential to support pharmaceutical and biotechnology companies developing therapies for rare neurodevelopmental and synaptic disorders.

BlinkLab’s Managing Director and CEO, Dr Henk-Jan Boele, stated:

“It’s a great honor to work with Ben Hutz and the SHANK2 Foundation. The first children have already been successfully tested, and we are deeply grateful to the SHANK2 children and families worldwide participating in this important study. In the autism field, it is essential to work with well-defined patient groups, since establishing ground truth in autism research can be challenging due to misdiagnosis, heterogeneous populations, and diagnostic uncertainty. This collaboration provides important external validation of the usefulness of our smartphone-based neurometric assessments. In collaboration with the SCANNER consortium, and through my role as Assistant Professor at Erasmus MC, we will also test mouse models carrying the exact same SHANK2 mutation to evaluate treatment effectiveness.”

Growing Regulatory Focus on Targeted Therapies in Autism and Neurodevelopmental Disorders

Recent regulatory developments highlight the increasing focus from regulators and industry on advancing targeted therapies and diagnostics in the autism and neurodevelopmental disorder space. In March 2026, the U.S. Food and Drug Administration approved leucovorin (folinic acid) for the treatment of cerebral folate transport deficiency associated with FOLR1 gene mutations, a rare genetic disorder that can present with developmental delays and autistic features. While the approval is limited to this specific genetic condition, it reflects a broader shift toward identifying biologically defined patient subgroups and developing precision approaches to neurodevelopmental disorders.

As more targeted therapies emerge, there is growing demand for objective tools capable of identifying patient subtypes, supporting clinical trials and monitoring treatment responses. BlinkLab’s collaboration with the SHANK2 Foundation positions the Company within this evolving ecosystem and may enable the Company to benefit from an increasingly favourable regulatory and clinical landscape, where digital biomarkers and precision diagnostic tools are expected to play an important role in supporting therapeutic development and future commercial partnerships in neurodevelopmental medicine.

About The SHANK2 Foundation

The SHANK2 Foundation is a non-profit rare disease advocacy and research enablement organisation working to improve the quality of life for individuals experiencing or associated with SHANK2-related disorders and variants, including carriers, families, researchers, clinicians, and industry partners. The Foundation supports research efforts concerning the SHANK2 gene, including the development of treatments and raising awareness about SHANK2 and its role in Intellectual Disability (IDD) and autism. The SHANK2 Data Collection Program is a patient data repository accessible to researchers studying the pathology of disease-causing SHANK2 variants.

As part of their commitment to supporting treatment development, the Foundation offers an Innovation Award to support early-stage studies aimed at advancing novel research or therapeutic strategies for SHANK2-related disorders.

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