Key Highlights

  • The first patient was dosed on 21 September 2026 in the Phase 3 Beyond Harmony trial, with all six Australian sites initiated and up to 200 patients planned.
  • The FDA cleared the Investigational New Drug submission for NTI164, and the USPTO issued Notices of Allowance for two US patent applications.
  • Neurotech raised funds through a placement of about A$4.5 million at A$0.014 per share and a A$3.15 million loan secured against R&D tax incentive offsets.
  • Cash and cash equivalents rose to about A$5.2 million from A$2.4 million, after operating outflows of about A$4.1 million.

Neurotech International Limited (ASX:NTI) dosed the first patient in its pivotal Phase 3 Beyond Harmony trial of NTI164 in children with autism spectrum disorder during the September 2026 quarter, moving the paediatric neurological drug candidate into late-stage development. The quarter also brought US Food and Drug Administration clearance of the company's Investigational New Drug submission, two US patent Notices of Allowance, peer-reviewed publication of earlier trial results, and funding of about A$7.65 million from a placement and a loan.

Beyond Harmony Moves Into Dosing

Neurotech announced on 21 September 2026 that the first patient had been dosed in Beyond Harmony, a national, multi-centre, randomised, double-blind, placebo-controlled study. All six sites across Victoria, Queensland, New South Wales, Tasmania and Western Australia have been initiated. The trial is expected to enrol up to 200 patients under an adaptive design that allows pre-specified adjustments based on interim analyses. It will assess behavioural and functional outcomes with a focus on core autism symptoms, while also examining neuroinflammatory pathways.

More than 300 enquiries from parents and caregivers had been received following media coverage by the time of the announcement, which the company said gave it confidence in recruiting within its planned timeframe. The trial builds on the 54-patient Phase II/III Harmony study of children aged two to 17, which reported clinically meaningful and statistically significant results across validated measures and a favourable safety profile. Its results were published in Neurotherapeutics after independent peer review.

FDA Clearance and Patent Allowances

The FDA cleared Neurotech's Investigational New Drug submission for NTI164, which included chemistry, manufacturing and controls, non-clinical and clinical information. If the company elects to begin US development, the study under the cleared IND would comprise a population pharmacokinetic program designed to complement Beyond Harmony by supporting dose characterisation. Neurotech is also engaging with the Australian Therapeutic Goods Administration to align its Australian and US regulatory strategies.

The USPTO issued Notices of Allowance for applications No. 18/698,605 and No. 19/335,945, both titled Compositions and Methods for Treating Neurological Disorders. The allowed claims of the first cover methods of reducing neuroinflammation using NTI164, while those of the second are directed to methods of treating autism spectrum disorder.

Funding and Cash Flow

In August, Neurotech secured binding commitments for a placement of about A$4.5 million before costs, comprising roughly 321.4 million new shares at A$0.014 each. About A$4.1 million falls under existing placement capacity and about A$0.4 million is subject to shareholder approval, with Taylor Collison and Canary Capital as Joint Lead Managers. The company also drew A$3.15 million from a secured loan with Rockford RDF Pty Ltd, backed by anticipated refundable R&D tax incentive offsets for FY2026 and FY2027. The loan carries a 16% annual interest rate and a 1% capitalised establishment fee, and matures on 31 December 2027, subject to an extension option.

Cash operating expenses were about A$4.1 million, up from A$1.9 million in the prior quarter. Research and development accounted for about A$3.9 million, driven by IND-enabling preclinical and toxicology work and Phase 3 preparation, while advertising, staff, administrative and corporate costs were about A$0.2 million. Financing inflows totalled A$6.97 million, including A$4.1 million of equity proceeds and A$3.15 million of borrowings, less A$284,000 of transaction costs. Cash and cash equivalents closed at about A$5.2 million, compared with A$2.4 million at the end of the previous quarter. Payments to related parties totalled A$299,000.

Where the Quarter Leaves Neurotech

Neurotech entered the Phase 3 stage of NTI164 development, holds FDA IND clearance and two allowed US patent claims, and lifted its cash balance to about A$5.2 million. Based on its current clinical development plan and budget, the company anticipates being fully funded through to the top-line data readout of the Phase 3 trial.