Why Neurotech International (ASX:NTI) is reporting first patient dosed in its Phase 3 autism trial and A$5.2 million of closing cash

Sonal Goyal

28 October 2026 04:40 PM AEDT

Why Neurotech International (ASX:NTI) is reporting first patient dosed in its Phase 3 autism trial and A$5.2 million of closing cash

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Key Highlights

The first patient has been dosed in the Phase 3 Beyond Harmony trial of NTI164, with six sites initiated and up to 200 patients planned.
Closing cash was A$5.198 million, but estimated funding was 1.24 quarters and relies on a second placement tranche and a tax incentive refund.
Net operating cash outflow was A$4.189 million, and the company drew a A$3.15 million secured loan at 16 per cent annual interest.

Phase 3 trial under way

Neurotech International Limited (ASX:NTI) said in its quarterly report on 28 October 2026 that the first patient has been dosed in its Phase 3 "Beyond Harmony" trial of NTI164 in paediatric autism spectrum disorder, as announced on 21 September 2026. The company said six sites have been initiated across Victoria, Queensland, New South Wales, Tasmania and Western Australia. The trial is national, multi-centre, randomised, double-blind and placebo-controlled, with up to 200 patients and an adaptive design that allows pre-specified adjustments based on interim analysis.

The company said it had received more than 300 enquiries from parents and caregivers by the time of the September announcement, which management said supports its recruitment timeline.

Earlier data and regulatory steps

The Phase 3 follows the Harmony Phase II/III study in 54 children aged 2 to 17 with autism. The company said that study reported clinically meaningful, statistically significant results and a favourable safety profile, and was published in the journal Neurotherapeutics after independent peer review.

Neurotech also said the US Food and Drug Administration has cleared its investigational new drug application for NTI164. Any US study would be a population pharmacokinetic program, and the company said it would proceed only if Neurotech elects to start US clinical development. It is engaging with the Australian Therapeutic Goods Administration on aligning Australian and US regulatory strategy. In addition, the US Patent and Trademark Office issued notices of allowance for two applications, covering methods of reducing neuroinflammation using NTI164 and methods of treating autism.

Cash flow and funding

The Appendix 4C shows net cash used in operating activities of A$4.189 million for the quarter, of which research and development accounted for A$3.928 million. The company said total cash operating expenses were about A$4.1 million, compared with A$1.9 million in the June quarter, driven by one-off clinical trial initiation payments.

Financing cash flow was A$6.973 million, comprising A$4.107 million of equity proceeds less A$284,000 of costs, and A$3.15 million of borrowings. Closing cash at 30 September 2026 was A$5.198 million, up from A$2.414 million at the start of the quarter.

The equity raising was an August 2026 placement of about A$4.5 million before costs, priced at A$0.014 per share for about 321.4 million new shares, with Taylor Collison and Canary Capital as joint lead managers. The first tranche of about A$4.1 million has been received. A second tranche of about A$0.4 million is subject to shareholder approval, though the company said firm commitments have been received.

The borrowing is a A$3.15 million secured loan from Rockford RDF Pty Ltd as trustee for the Rockford RDF Unit Trust, announced on 15 July 2026. It is secured against anticipated refundable research and development tax incentive offsets for the 2026 and 2027 financial years, carries interest of 16 per cent a year plus a capitalised one per cent establishment fee, and matures on 31 December 2027, with an extension option.

Runway and risks

The report calculates estimated funding of 1.24 quarters, below the two-quarter threshold that triggers additional disclosure. In its responses, management said net outflows are expected to fall from the December quarter because the trial initiation payments were one-off, and that it expects the second placement tranche and a research and development tax incentive refund in the December quarter, net of the loan repayment. It said, based on its current plan and budget and subject to completing the placement, it expects to be funded through to the Phase 3 topline data readout.

That statement depends on items not yet received at the date of the report.

Next steps

The company listed continued recruitment, receipt of the second placement tranche, receipt of the tax incentive refund, lower operating outflows from the next quarter, aligning regulatory strategy with the Australian and US regulators, and discussions with potential strategic partners as its priorities. No trial results are available from the Phase 3 study yet.

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