Neurotech International (ASX: NTI) has reported a year of significant clinical achievements, regulatory recognition, and corporate renewal as it advances its proprietary cannabinoid therapy, NTI164, for paediatric neurological disorders.
The company’s flagship therapy, NTI164, a broad-spectrum oral cannabinoid, continued to show promise across several clinical programs. In Autism Spectrum Disorder, Neurotech’s Phase II/III Harmony Study met all primary and key secondary endpoints, including statistically significant improvements in anxiety, depression, and mood. Extension data reaffirmed NTI164’s excellent safety and sustained clinical benefit, with some patients now receiving more than three years of continuous treatment.
In Rett Syndrome, NTI164 has also delivered encouraging outcomes. Data from Phase I/II and extension studies showed functional improvements across multiple domains, with no serious adverse events reported. Regulatory progress was underlined by orphan drug designation from both the FDA and the European Commission. In Australia, the Therapeutic Goods Administration also determined that NTI164 is eligible for provisional designation, potentially enabling earlier patient access.
Work in PANDAS/PANS added further validation. Genomic and proteomic analyses showed NTI164 could reverse immune dysregulation in affected children, consistent with its proposed mechanism of action. While the FDA deferred a decision on orphan designation for this indication, it accepted Neurotech’s scientific rationale, and the company will continue development while assembling further supporting data.
Meanwhile, Neurotech announced results from its first-in-human pharmacokinetics study. The findings confirmed that NTI164 is rapidly absorbed, maintains sustained plasma concentrations, and demonstrates predictable dosing with excellent tolerability. Management said this outcome derisks late-stage clinical development and supports the drug’s suitability for long-term use in paediatric settings.
To ensure manufacturing scale-up and quality, Neurotech signed a development agreement with RH Pharma, a subsidiary of European Cannabis Company, to produce NTI164 to global pharmaceutical standards. The company also deepened its clinical expertise with the appointment of Dr Bonni Goldstein, a leading US authority on cannabinoid medicine, as Chief Medical Advisor.
Corporate renewal also defined the year. In February 2025, Neurotech appointed Dr Anthony Filippis as Managing Director and CEO. With more than 25 years’ experience in sector leadership, partnering, and capital markets, Dr Filippis brings the commercial acumen required to steer the company into its next growth phase. “We now have the clinical data, regulatory momentum, and leadership to deliver NTI164 to patients globally,” Chairman Mark Davies said.
The company also made the strategic decision to divest its Mente neurofeedback device subsidiaries, placing them into voluntary liquidation, to focus entirely on the development and commercialisation of NTI164.
Neurotech reported a net loss of $10.6 million for the financial year 2025, compared to $5.1 million the prior year, with research and development costs accounting for nearly $10 million. Revenue fell to $2.6 million, primarily due to lower R&D grant income. Year-end cash reserves stood at $3 million. The board acknowledged the need for additional capital to support operations but said it remains confident in the company’s ability to raise funds and advance its clinical and regulatory agenda.
Looking ahead, Neurotech’s strategy centres on a dual regulatory pathway in Australia and the US. In Australia, the company is exploring expedited approval options with the TGA, while in the US, preparations are underway for an Investigational New Drug application to the FDA, scheduled for the 2026 financial year. The company also intends to deepen engagement with potential partners to support commercialisation.
“FY25 was a turning point,” Davies said. “With a strong clinical package, regulatory recognition, and an experienced team, Neurotech is well-positioned to accelerate NTI164 and deliver meaningful benefits to patients and families.”