• Bellberry HREC approves Neurizon's Phase 1 formulation study for NUZ-001 oral liquid
• Oral liquid formulation developed to improve treatment accessibility and continuity for ALS patients
• Study designed to generate data to support clinical, regulatory and commercial development of NUZ-001

Neurizon Therapeutics Limited (ASX: NUZ) has announced that the Bellberry Human Research Ethics Committee (HREC) has approved the company's Phase 1 formulation study supporting the development of the NUZ-001 oral liquid formulation. This represents a further milestone in the development of NUZ-001 for ALS. The oral liquid formulation was developed to improve treatment accessibility, administration flexibility and continuity of treatment for people living with ALS, particularly as swallowing difficulties progress during the course of the disease. The study will enrol 32 healthy volunteers in Australia in a randomised, four-arm Phase 1 clinical trial evaluating NUZ-001 oral liquid and tablet formulations under fed and fasted conditions. The study is designed to generate pharmacokinetic, safety and tolerability data, alongside exploratory biomarker and palatability data, to support formulation development and the broader clinical and regulatory development program for NUZ-001. Interim Executive Chairman Sergio Duchini commented that the oral liquid formulation was developed in direct response to the practical challenges faced by people living with ALS, and that the advancement of the oral liquid formulation reflects Neurizon's broader strategy to support long-term treatment accessibility and expand the potential utility of NUZ-001 across different stages of disease progression.

The study initiation is targeted for Q3 CY2026, with study completion anticipated in Q4 CY2026, subject to completion of remaining operational and site initiation activities.