Neurotech International (ASX: NTI) has secured Human Research Ethics Committee (HREC) approval to commence its pivotal Phase 3 clinical study for NTI164 in Autism Spectrum Disorder (ASD) Levels 2 and 3, a significant step toward potential TGA and FDA submissions.
This approval allows for the initiation of study activities, including site activation and recruitment.
The study’s design is specifically intended to support future regulatory submissions to the Therapeutic Goods Administration (TGA) in Australia and the Food and Drug Administration (FDA) in the United States.
Prior studies with NTI164 in ASD demonstrated statistically significant and clinically meaningful improvements across various symptom domains and caregiver quality of life.
The Phase 3 study will be led by Professor Michael Fahey, working with a network of satellite clinical sites. Initiation activities are now set to commence.
Annual Report Highlights NTI164 Progress
Neurotech International's FY25 annual report confirmed NTI164 as the central asset in its pipeline.
The report highlighted positive clinical signals across several indications, including ASD, Rett Syndrome, and PANDAS/PANS.
Key strategic moves included a development agreement with RH Pharma to scale up manufacturing and ensure global supply.
Additionally, the company undertook the divestment of its Mente device subsidiaries to reallocate capital and focus resources on NTI164 development.
For the 2025 financial year, the group posted a net loss of US$10.6 million and received a US$2.44 million R&D tax incentive.
Recent Capital Raising Supports Development
In December 2025, Neurotech International announced binding commitments for a capital raising of approximately A$4 million.
This placement involved the issue of 285,976,909 new shares at an issue price of A$0.014 per share.
The funds raised are specifically earmarked to advance NTI164 through non-clinical toxicology work, support registration-enabling clinical programs, and facilitate regulatory submissions.
This capital injection aims to provide essential runway for the continued advancement of NTI164 and its regulatory pathway.
Financial Context: Losses and Funding
Neurotech International remains a loss-making business, with annual losses widening to US$10.6 million in FY25.
Despite these losses, the company has actively pursued funding to support its development pipeline.
In November 2025, Neurotech received an A$4.73 million R&D tax incentive refund for FY2025, which was allocated to clinical development and general working capital.
The recent A$4 million placement also bolstered capital, though it resulted in significant equity dilution for existing shareholders.
Outlook and Risks
The HREC approval for the NTI164 Phase 3 ASD study is a critical milestone.
While positive, the company faces ongoing risks including clinical trial success, regulatory hurdles, and financial execution, with a continued dependence on future milestones and partnerships to unlock value.
