Neurotech International Ltd Launches $4.5M Placement for Phase III Autism Trial

Neurotech launches ~$4.5m placement to fund NTI164 Phase III trial through to topline data

Neurotech International (ASX: NTI) has received binding commitments for a placement of approximately $4.5 million (before costs), issuing around 321.41 million new fully paid ordinary shares at $0.014 per share.

The clinical-stage biopharmaceutical company, focused on paediatric neurological disorders, expects the net proceeds, together with its existing cash, to fund it through to the topline data readout of the NTI164 Phase III trial in Autism Spectrum Disorder (ASD), known as the “Beyond Harmony” study.

That readout is anticipated to represent a significant milestone in the development pathway for NTI164, positioned by management as the next major value inflection point. The placement was managed by Taylor Collison Limited and Canary Capital Pty Ltd as Joint Lead Managers.

Placement structure and use of funds

The placement is structured across two tranches. Tranche 1 is to be issued under the company’s existing placement capacity, while Tranche 2 remains subject to shareholder approval at a future General Meeting. Investors should note that not all funds are unconditional.

According to the company, funds raised will be applied predominantly to the following:

• The Phase III double-blind, placebo-controlled clinical trial of NTI164 in children with ASD

• Regulatory activities

• General working capital

• Costs associated with the placement

Managing Director & CEO, Dr Anthony Filippis

“We are pleased to have secured support from new and existing shareholders, enabling Neurotech to progress NTI164 through its Phase 3 clinical program. This capital raising provides the Company with the cash runway to deliver the next major value inflection point for NTI164.”

What is NTI164 and why the Phase III trial matters

NTI164 is described by the company as a proprietary, multi-constituent, GMP-grade standardised formulation containing CBDA-rich extracts and select minor cannabinoids.

According to Neurotech, preclinical and earlier clinical findings have demonstrated the formulation’s potential to modulate neuroinflammatory signalling, immune dysregulation and upstream biological mechanisms implicated in neurodevelopmental disorders. In plain terms, it aims to influence the inflammatory and immune processes thought to contribute to conditions such as ASD.

The Phase II/III data underpinning the Beyond Harmony program now carries peer-reviewed validation of the Harmony Study, with results accepted for publication in Neurotherapeutics, the official journal of the American Society for Experimental Neurotherapeutics, providing independent scientific endorsement of the statistically significant outcomes reported across validated ASD measures.

Topline data is a significant milestone. A successful Phase III outcome is the gateway to potential regulatory approval, which is the key value driver for a clinical-stage biopharmaceutical company.

Track record behind the program

The company points to a body of completed clinical work supporting the Phase III study:

1. A completed Phase II/III randomised, double-blind, placebo-controlled ASD trial, which reported clinically meaningful and statistically significant benefits across a number of clinically-validated measures, alongside excellent safety.

2. Completed and reported Phase I/II trials in ASD, PANDAS/PANS (Paediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections and Paediatric Acute-Onset Neuropsychiatric Syndrome) and Rett Syndrome, with statistically significant and clinically meaningful results.

3. Human ethics committee clearance received for the Phase III ASD study.

Investment thesis and next steps

The core thesis is straightforward. Subject to completion of the placement, funding is expected to carry Neurotech to a single, high-impact catalyst, the topline Phase III data readout. The company states it remains focused on executing its global development strategy for NTI164, with the objective of addressing significant unmet needs in ASD.

The Beyond Harmony study is designed around a dual TGA and FDA regulatory pathway, with the single registrational trial structured to support market authorisation applications in both Australia and the United States, a cost-efficient approach that broadens the commercial upside of a successful topline readout.

The timeline below is indicative only and may vary, subject to the requirements of the ASX Listing Rules:

• Tranche 1 settlement: 13 August 2026

• Tranche 1 issue: 14 August 2026

• General Meeting to approve Tranche 2: in or around September 2026

• Tranche 2 settlement: in or around September 2026

• Tranche 2 issue: in or around September 2026

As Joint Lead Managers, Taylor Collison and Canary Capital will receive a 1% management fee and a 4% selling fee. Subject to shareholder approval, Neurotech has also agreed to issue Taylor Collison (or its nominees) 11.25 million unlisted options exercisable at $0.02 (expiring two years from issue) and 11.25 million unlisted options exercisable at $0.035 (expiring three years from issue).

Neurotech remains focused on progressing NTI164 towards potential regulatory approval and commercialisation. The company has explicitly cautioned that there is no guarantee the Phase 3 study will be successful or that NTI164 will receive regulatory approval, and investors are urged not to place undue reliance on forward-looking statements.

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