Neurotech Doubles Loss Amid Clinical Breakthroughs for NTI164

Financial Overview

Neurotech International Limited (ASX – NTI) released its preliminary final report for the year ended 30 June 2025, revealing a challenging financial year marked by a 23% decrease in revenues to $2.58 million and a doubling of its net loss to $10.6 million. The revenue decline primarily reflects a reduction in research and development grant income, which fell by approximately $2.44 million compared to the prior year. The company’s loss was further impacted by substantial research and development expenses totaling nearly $10 million, underscoring the high costs associated with advancing its clinical programs.

Clinical and Regulatory Progress

Despite the financial headwinds, Neurotech made notable strides in its flagship drug candidate, NTI164, a broad-spectrum cannabinoid therapy targeting paediatric neurological disorders. The company reported positive Phase II/III clinical trial results in Autism Spectrum Disorder (ASD), with statistically significant improvements in anxiety, depression, and mood. Long-term extension studies reaffirmed NTI164’s safety and sustained efficacy.

In Rett Syndrome, Neurotech’s Phase I/II trials demonstrated encouraging clinical improvements and an excellent safety profile, outperforming the only FDA-approved treatment in terms of tolerability. Importantly, NTI164 received orphan drug designation from both the US Food and Drug Administration and the European Commission, providing valuable regulatory incentives and market exclusivity prospects.

Further validation came from genomic and proteomic analyses in PANDAS/PANS patients, showing NTI164’s ability to reverse immune dysregulation, although the company deferred its orphan drug application in Europe pending additional data.

Strategic Leadership and Partnerships

February 2025 saw the appointment of Dr Anthony Filippis as Managing Director and CEO, bringing over 25 years of biotech leadership experience. Under his stewardship, Neurotech is pursuing a dual regulatory pathway with the Therapeutic Goods Administration in Australia and the FDA in the United States, while actively seeking strategic partnerships to accelerate NTI164’s commercialisation.

In line with this strategy, Neurotech entered a development agreement with RH Pharma, a European cannabis pharmaceutical leader, to scale up manufacturing of NTI164 under stringent global pharmaceutical standards. Additionally, the appointment of Dr Bonni Goldstein as Chief Medical Advisor in the US adds clinical and regulatory expertise to support the company’s expansion efforts.

Operational Focus and Future Outlook

Reflecting a sharpened focus on its core drug development, Neurotech has decided to liquidate its neurofeedback device subsidiaries due to minimal sales and limited market traction. This move will allow the company to concentrate resources on NTI164’s clinical and commercial advancement.

While the company’s cash reserves declined to $3 million from $11.6 million the previous year, the board remains confident in its ability to continue as a going concern, citing its capacity to raise capital and scale operations as needed. No dividends were declared, consistent with the company’s developmental stage.

Neurotech’s next steps include progressing regulatory submissions, expanding clinical trials, and pursuing licensing or partnership deals to unlock NTI164’s market potential. The company’s evolving leadership and strategic partnerships position it well to navigate the complex path toward commercialisation.