How Neurotech Halved Losses While Advancing NTI164’s Autism and Rett Trials

Financial turnaround amid ongoing investment

Neurotech International Limited (ASX: NTI) has reported a striking improvement in its financial results for the half-year ended 31 December 2025, cutting its net loss by 91% to $696,501 from $7.44 million in the prior corresponding period. This turnaround was underpinned by a doubling of revenues to $4.74 million, primarily from research and development grants, reflecting the company’s intensified focus on advancing its clinical programs.

Despite the reduced loss, Neurotech remains in a development phase, investing heavily in its lead drug candidate NTI164, a broad-spectrum oral cannabinoid therapy targeting paediatric neurological disorders. The company’s cash reserves more than doubled to $6.34 million, bolstered by a $4 million capital raising and a $4.7 million R&D tax incentive refund, providing a stronger runway for ongoing clinical and regulatory activities.

Clinical and regulatory milestones accelerate

NTI164 continues to be the focal point of Neurotech’s pipeline, with significant progress across multiple indications. The company secured Human Research Ethics Committee approval to commence its pivotal Phase 3 clinical trial in Autism Spectrum Disorder (ASD) Levels 2 and 3, a critical step towards regulatory submissions in Australia and the United States. This trial, branded Beyond Harmony, aims to generate robust data to support market authorisation and commercialisation strategies.

In parallel, NTI164 received the U.S. Food and Drug Administration’s Rare Pediatric Disease Designation for Rett syndrome, complementing existing Orphan Drug Designations in the U.S. and Europe. This designation offers regulatory incentives including priority review and market exclusivity, enhancing the therapy’s commercial potential.

Further clinical validation came through the publication of positive Phase I/II trial data in peer-reviewed journals for both Rett syndrome and Paediatric Acute-Onset Neuropsychiatric Syndrome (PANS)/Paediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections (PANDAS). These studies demonstrated statistically significant improvements in neurological and behavioural symptoms, alongside mechanistic insights into NTI164’s modulation of neuroinflammation and epigenetic pathways.

Strategic collaborations and safety data reinforce development

Neurotech also announced a research collaboration with the University of Sydney to deepen understanding of NTI164’s effects in Rett syndrome using advanced human neuronal models. This partnership aims to elucidate the drug’s impact on disease mechanisms associated with MECP2 deficiency, a hallmark of Rett syndrome.

Complementing these efforts, the company reported positive results from a 90-day Good Laboratory Practice (GLP) repeat-dose oral toxicity study in Beagle dogs. The study confirmed NTI164’s favourable safety and tolerability profile at doses significantly exceeding those used in human trials, supporting long-term dosing potential and regulatory submissions.

Capital raising and outlook

To fund these ambitious clinical and regulatory programs, Neurotech completed a placement raising approximately $4 million, with shares issued to institutional and sophisticated investors. The company’s directors also committed to participate in the upcoming tranche, signalling confidence in the development pathway. The strengthened cash position, combined with ongoing R&D tax incentives, provides a solid foundation for the next phases of clinical development.

While the company acknowledges material uncertainty related to its going concern status, the board remains confident in its ability to secure further funding and scale operations as needed. The coming months will be pivotal as Neurotech initiates its Phase 3 ASD trial and advances regulatory submissions, setting the stage for potential market entry in key jurisdictions.