BlinkLab (ASX: BB1) has conducted an oversubscribed A$17.5 million placement at A$0.65 per share to fund trials for its autism diagnostic aid (Dx1) and advance US ADHD clinical studies.
The placement issued 26,923,077 new fully-paid ordinary shares, with directors committing to A$200K worth of shares.
The proceeds will be primarily directed towards completing pivotal FDA 510(k) clearance trials for its autism diagnostic aid (Dx1) and accelerating CE marking and EU MDR processes for Dx1 in Europe.
The funds will also launch and advance BlinkLab's US ADHD program using its Dx2 platform, including initiating the FDA 510(k) trial process for ADHD.
Additionally, working capital will support ongoing operations, platform development, and extending the company's patent portfolio.
Morocco Program Validation and Expansion
In a significant development, BlinkLab's Dx1 has been selected for Morocco's nationwide, government-funded autism screening initiative.
This program, commencing in April 2026, will see early autism screening start at 18 months of age across outpatient and hospital settings in Morocco.
The Moroccan government and the Foundation Mohammed V for Solidarity will fund all program-related costs, including clinical rollout and implementation, with BlinkLab retaining ownership of the data generated by the program and expecting no material capital expenditure.
This real-world deployment is considered to complement the company's ongoing FDA registrational trials, with commercial terms for Morocco to be revisited after any future FDA clearance.
Autism Dx1 FDA Pathway Progress
BlinkLab's FDA 510(k) pivotal validation program for Dx1 has commenced, with the first participant successfully enrolled and completing initial testing.
This double-blinded, multi-centre study is designed to generate pivotal clinical and usability evidence for a targeted FDA submission by end-2026.
Prior pilot data for Dx1 has reportedly exceeded FDA-agreed performance thresholds, indicating the diagnostic aid is approaching late-stage regulatory and commercial readiness.
The study is being led and conducted by IQVIA-MCRA to ensure adherence to protocols and data quality standards.
The recently secured capital will also initiate the FDA 510(k) trial process for ADHD using BlinkLab's Dx2 platform, expanding the company's diagnostic pipeline beyond autism and leveraging its existing smartphone-based platform infrastructure for the US clinical program expansion into ADHD.
