Key Highlights

  • Neurotech International Limited (ASX:NTI) shares rose 5.56% to $0.019 at 12:04 pm during the trading session on 23 October 2026.
  • In its announcement dated 21 September 2026, the company said the first patient was dosed in the Phase 3 Beyond Harmony study of NTI164 in autism.
  • The study plans to enrol up to 200 patients across six Australian sites, and the company reported more than 300 enquiries from parents and caregivers.

Neurotech International Limited (ASX:NTI) shares rose 5.56% to $0.019 during the trading session on 23 October 2026, as at 12:04 pm, while the S&P/ASX 200 stood at 8,762.60, down 0.35% (30.60 points). The company is a clinical-stage biopharmaceutical business focused predominantly on paediatric neurological disorders, developing an oral cannabinoid therapy called NTI164. In an ASX announcement dated 21 September 2026, it reported that the first patient had been dosed in its Phase 3 Beyond Harmony study in Autism Spectrum Disorder (ASD).

First Patient Dosed in Phase 3 Beyond Harmony Study

In its announcement dated 21 September 2026, Neurotech said all sites had been initiated and the first patient had been dosed in its pivotal Phase 3 Beyond Harmony clinical study of NTI164 in children with ASD. The company said dosing formally commences the study and advances NTI164 into pivotal Phase 3 development.

Beyond Harmony is a national, multi-centre, randomised, double-blind, placebo-controlled study with six sites across Australia, spread across Victoria, Queensland, New South Wales, Tasmania and Western Australia. It is designed to evaluate the efficacy, safety and tolerability of NTI164 and will assess behavioural and functional outcomes aligned with regulatory guidance.

Adaptive Design and Recruitment Interest

The 21 September 2026 announcement stated that up to 200 patients are planned for enrolment under an adaptive trial design. The company said the design allows pre-specified modifications based on interim analyses.

Neurotech also reported that, following recent media coverage of the upcoming trial, it had received more than 300 enquiries from parents and caregivers seeking information about potential participation. The company said this level of interest gave it confidence in its ability to recruit the required number of participants within the planned recruitment timeframe.

Earlier HARMONY Study and FDA Clearance

The company said Beyond Harmony builds on its earlier HARMONY Phase II/III study, a 54-patient, randomised, double-blind, placebo-controlled trial of NTI164 in children aged two to 17 years with ASD. According to the announcement dated 21 September 2026, that study generated clinically meaningful and statistically significant results across a range of validated measures.

Neurotech noted that these data formed part of the clinical evidence presented in its recently cleared Investigational New Drug application with the US FDA. The results have also been published in Neurotherapeutics following independent peer review.

About the Company and Business Overview

Neurotech International Limited (ASX:NTI) is a clinical-stage biopharmaceutical development company based at Suite 102, Level 1, 55 Collins Street, Melbourne, Victoria. Its lead program is NTI164, described as a proprietary, multi-constituent, GMP-grade standardised formulation containing CBDA-rich extracts and select minor cannabinoids.

The company says preclinical and earlier clinical findings show its potential to modulate neuroinflammatory signalling and immune dysregulation. Beyond ASD, Neurotech has completed and reported Phase I/II trials in ASD and in Paediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections (PANDAS) and Paediatric Acute-Onset Neuropsychiatric Syndrome (PANS), together with Rett Syndrome. It has also received human ethics committee clearance for a Phase I/II clinical trial in spastic cerebral palsy.

Related Sector Context

Neurotech operates in clinical-stage biopharmaceutical development, a part of the healthcare sector in which companies typically progress from preclinical work through Phase I, II and III trials before seeking regulatory registration. Companies at this stage generally have no product revenue.

At 12:04 pm on 23 October 2026, the S&P/ASX 200 stood at 8,762.60, down 0.35%, while Neurotech shares moved 5.56% higher to $0.019. A small clinical-stage company priced at $0.019 can behave differently from the broader market.

Risks to Weigh In

Clinical development carries inherent uncertainty. Beyond Harmony has only just commenced, and the company has stated that it plans to recruit up to 200 patients under an adaptive design. Results and recruitment pace may differ from earlier findings, and the HARMONY study involved 54 patients.

Regulatory outcomes are a further uncertainty. The company's stated objective is regulatory registration and commercialisation of NTI164, which depends on trial results and review by regulators.

As a clinical-stage company, Neurotech is subject to the funding requirements of ongoing trials. The announcement did not provide funding details for Beyond Harmony.

Catalysts on Watch

The announcement of 21 September 2026 points to several items that may be updated in future. These include recruitment of up to 200 patients across six Australian sites, any modifications arising from interim analyses, and steps following the cleared US FDA Investigational New Drug application.

Neurotech also holds human ethics committee clearance for a Phase I/II trial in spastic cerebral palsy.

Where Things Stand

At 12:04 pm on 23 October 2026, Neurotech shares were up 5.56% at $0.019 while the S&P/ASX 200 was down 0.35% at 8,762.60. The company's most recent update, dated 21 September 2026, reported the first patient dosed in the Phase 3 Beyond Harmony study of NTI164, with up to 200 patients planned across six Australian sites.