• Manufacture of 3 registration batches of NUZ-001 tablets completed ahead of schedule
• Manufacturing undertaken by Catalent, a leading global contract manufacturer
• Registration batches manufactured at a 1:10 scale of intended commercial production

Neurizon Therapeutics Limited (ASX: NUZ & NUZOA; OTCQB: NUZTF), a clinical-stage biotech company dedicated to advancing innovative treatments for neurodegenerative diseases, has announced the successful completion of manufacturing for three Good Manufacturing Practice (GMP) registration batches of its lead drug candidate NUZ-001. This marks a significant step forward in Neurizon's regulatory and operational readiness, enabling the supply of NUZ-001 for supplemental pivotal clinical trials, pending regulatory submissions, and future commercial sale opportunities. The registration batches were manufactured in partnership with Catalent Inc., a leading global contract development and manufacturing organization, utilizing full-scale commercial processes and equipment, and compliant with FDA and ICH guidelines. The batches were produced at a minimum 1:10 scale of the intended commercial production, supporting ICH long-term stability studies, NDA Module 3 (Quality), shelf-life, and providing validation of commercial-scale manufacturing. This milestone underscores the benefit of Neurizon's licensing deal with Elanco Animal Health, reducing supply chain risks, enabling scalability, and bringing NUZ-001 closer to regulatory approval and launch. Neurizon remains on track to commence enrolment in the HEALEY ALS Platform Trial in Q1 CY2026.

Neurizon remains confidently on track to commence patient enrolment in the HEALEY ALS Platform Trial early next year, a crucial step towards delivering NUZ-001 to patients with ALS and other severe neurodegenerative diseases.