• FDA has completed review and cleared NUZ-001 regimen for HEALEY ALS Platform Trial
• NUZ-001 is officially Regimen I in the HEALEY ALS Platform Trial
• Next steps include obtaining IRB approval, site initiations, and clinical start-up activities ahead of patient enrollment in early 2026

Neurizon Therapeutics Limited (ASX: NUZ & NUZOA; OTCQB: NUZTF) has announced that the Sean M. Healey & AMG Center for ALS at Mass General Brigham has received clearance from the US Food and Drug Administration (FDA) to proceed with Neurizon's NUZ-001 regimen in the HEALEY ALS Platform Trial (ClinicalTrial.gov identifier: NCT04297683) following completion of the FDA's 30-day review. NUZ-001 is officially Regimen I in the trial. The FDA's acceptance of the protocol amendment allows the commencement of clinical activities under the Sean M. Healey & AMG Center for ALS Investigational New Drug (IND). It represents another significant regulatory milestone for Neurizon, enabling the Company and the HEALEY ALS Platform Trial team to progress to the next operational phases, including Institutional Review Board (IRB) submissions and approvals, activation of clinical trial sites, and initiation of study start-up activities. The first patients are expected to be enrolled early in 2026. The HEALEY ALS Platform Trial is a multicenter, double-blind, placebo-controlled, adaptive trial for ALS created in partnership with the Network of Excellence for ALS (NEALS). The goal of the HEALEY ALS Platform Trial is to accelerate the development of potential new ALS therapies. NUZ-001 is in development for treating amyotrophic lateral sclerosis (ALS) and aims to address key pathological mechanisms, including TDP-43 protein aggregation and impaired autophagy, which are central features across multiple neurodegenerative diseases.

Neurizon remains dedicated to developing novel, disease-modifying therapies for ALS and other serious neurodegenerative diseases, leveraging international collaborations and world-leading clinical platforms to accelerate clinical progress.