• Pilot Phase Finalised and Prepared for Data Unblinding
• Six Leading U.S. Autism Research Centers Added to Pivotal Study
• Clinical Trial Agreements Executed and Site Preparation Underway
• European ADHD Trial Progressing Toward Data Readout
• Strong Financial Position Maintained

During the September quarter, BlinkLab completed data collection and finalised preparations for unblinding of its U.S. autism pilot study, marking a key operational milestone ahead of the pivotal FDA 510(k) phase. The company also significantly expanded its U.S. site network, onboarding six of the nation's leading autism research and treatment institutions in addition to its existing partner. These sites will participate in BlinkLab's pivotal FDA trial, creating one of the most comprehensive multicenter networks in digital diagnostics for autism. While recruitment for the pivotal phase had not yet commenced, the quarter was instrumental in establishing full operational readiness, including budget negotiations, CTA execution, site-specific recruitment strategies, and clinical staff training program planning. BlinkLab's ADHD Dx 2 clinical program in Europe also advanced steadily, with recruitment across five sites remaining on track to deliver data from approximately 300 participants by year-end 2025. Financially, the company maintained a strong cash balance of A$7.232 million at 30 September 2025, providing a solid foundation to support pivotal-phase execution and ongoing regulatory activities.

• Site activation and clinical staff training across all U.S. pivotal sites in early 2026
• Delivery of the ADHD Dx 2 dataset
• Preparation of EU MDR technical documentation for autism diagnostic clearance in Europe
• Continued progress toward FDA 510(k) submission in 2H 2026