Neurotech Advances NTI164 with FDA IND Clearance and Patent Progress

FDA Clears IND Submission for NTI164

Neurotech International (ASX:NTI) has received clearance from the US Food and Drug Administration for its Investigational New Drug (IND) application for NTI164, its broad-spectrum oral cannabinoid therapy targeting paediatric neurological disorders. The FDA’s sign-off comes after reviewing Neurotech’s nonclinical, chemistry, manufacturing and controls, and clinical protocol data, raising no objections to the US trial proceeding as designed.

This regulatory milestone unlocks a US pharmacokinetic study that will complement Neurotech’s ongoing Australian Phase 3 "Beyond Harmony" trial in children with autism spectrum disorder (ASD). The company is aligning its US and Australian regulatory strategies to build a unified global development pathway for NTI164, aiming to generate clinical data that supports submissions across multiple jurisdictions.

Strengthening Intellectual Property with Patent Allowances

Further bolstering its position, Neurotech secured Notices of Allowance from the United States Patent and Trademark Office for two key patent applications related to NTI164. One patent covers methods of reducing neuroinflammation using NTI164, while the other specifically addresses methods of treating ASD. Once granted, these patents are expected to extend Neurotech’s intellectual property protection through to 2042, reinforcing the company’s competitive moat as it advances through Phase 3 clinical development.

Expansion of Authorised Prescriber Program

Neurotech’s Authorised Prescriber (AP) program, which provides real-world access to NTI164, expanded to seven clinical sites nationally during the quarter, up from six previously. Demand remains robust, with over 200 patients referred and awaiting clinical review. This program not only supports patient access but also builds a longitudinal safety and tolerability dataset in a real-world setting, complementing the registrational clinical program. Pricing is set to cover supply costs plus a modest margin, ensuring the program remains cost-neutral to the company.

Financial Position and Funding Update

Neurotech recorded total cash operating expenses of approximately $1.9 million for the quarter, down from $2.2 million in the prior period. Research and development costs accounted for $1.7 million, primarily driven by IND-enabling preclinical programs and ongoing clinical trial activities. The company ended the quarter with $2.4 million in cash and equivalents, down from $4.3 million.

Subsequent to quarter-end, Neurotech secured a $3.15 million loan backed by its anticipated refundable R&D tax incentives for FY2026 and FY2027, providing additional runway to support its Phase 3 autism trials and general operations. The company is currently in a trading halt pending a capital raising announcement, reflecting ongoing efforts to strengthen its funding position.

Engagement with Stakeholders and Investors

In May, Neurotech hosted an Advocacy Day that brought together families, clinicians, shareholders, and other stakeholders to discuss the impact of NTI164. The event featured clinical updates from Principal Investigator Professor Michael Fahey and personal testimonials from parents of children with ASD receiving NTI164. The company also presented at investor conferences in Hong Kong and on the Gold Coast, highlighting the significant opportunity ahead for its paediatric neurological disorder pipeline.