Neurotech’s Focused Strategy Raises Questions on Future Funding and Trials

Positive Human Pharmacokinetics Validate NTI164

Neurotech International Limited (ASX – NTI) has delivered promising results from its first-in-human pharmacokinetic (PK) study of NTI164, a proprietary CBDA-rich cannabinoid formulation targeting pediatric neurological disorders. Conducted in healthy adult volunteers, the study demonstrated rapid and predictable absorption of CBDA, with peak plasma levels reached within 2 to 4 hours and steady-state concentrations achieved by Day 3. Importantly, THC exposure remained negligible, preserving the non-intoxicating profile essential for pediatric use.

The study also revealed a consistent CBDA to CBD plasma ratio of approximately 16 – 1, indicating minimal conversion and supporting the drug’s targeted mechanism of action. These findings, combined with earlier preclinical toxicology studies showing excellent tolerability in animal models, provide a robust safety and pharmacokinetic foundation for advancing NTI164’s clinical development.

Clinical Progress in Rett Syndrome and Broader Pediatric Disorders

Neurotech’s clinical momentum was further bolstered by presentations at the International Rett Syndrome Foundation Annual Scientific Meeting in Boston, where Phase I/II trial data for NTI164 were shared. The open-label study, recently published in the Journal of Paediatrics and Child Health, reported that NTI164 was well tolerated and produced meaningful clinical improvements across neurological, behavioral, and functional domains relevant to Rett Syndrome.

These results reinforce NTI164’s potential as a therapeutic option for a range of pediatric neurological and inflammatory brain disorders, including autism spectrum disorder (ASD) and PANDAS/PANS, where Neurotech has also reported positive clinical outcomes in earlier trials.

Strategic Regulatory and Corporate Developments

On the regulatory front, Neurotech is advancing dual pathways with the Australian Therapeutic Goods Administration (TGA) and the US Food and Drug Administration (FDA). The company has initiated formal engagement with the FDA in preparation for an Investigational New Drug (IND) application expected in the 2026 fiscal year, marking a critical step toward international clinical development and commercialization.

Complementing these efforts, Neurotech appointed Dr. Bonni Goldstein as Chief Medical Advisor USA. Dr. Goldstein brings over 25 years of clinical experience in pediatric cannabinoid therapy and is recognized as a leading expert in the field. Her role will be pivotal in navigating the complex US regulatory environment and fostering engagement with clinicians, caregivers, and advocacy groups.

In a strategic move to concentrate resources on NTI164, Neurotech has placed its neurofeedback device subsidiaries, AAT Medical Ltd and AAT Research Ltd, into voluntary liquidation. This divestment underscores the company’s commitment to advancing its core biopharmaceutical pipeline.

Financial Position and Outlook

During the quarter ending 30 June 2025, Neurotech recorded operating cash outflows of $2.6 million, primarily driven by research and development activities. The company closed the period with $3 million in cash and cash equivalents and expects to receive an R&D tax incentive refund of approximately $3 million in the coming quarter, which should bolster its liquidity.

Looking ahead, Neurotech anticipates a reduction in operating expenses in the next quarter due to the completion of toxicity studies and cultivation activities. The company’s financial discipline and strategic focus position it well to sustain its clinical and regulatory programs.