• Ongoing communication with US FDA regarding IND application for NUZ-001
• Formal request for advice on two short-term PK studies to lift clinical hold
• Proactively commencing PK studies to generate additional animal exposure data

Neurizon Therapeutics Limited (ASX: NUZ) has been in communication with the US Food and Drug Administration (FDA) regarding the clinical hold on its Investigational New Drug (IND) application for NUZ-001, its lead drug candidate for the treatment of ALS. The company has submitted a formal request for advice detailing two short-term, low-cost pharmacokinetic (PK) studies necessary to lift the clinical hold. These PK studies are expected to provide additional animal exposure data specifically requested by the FDA, which will be used to assess the adequacy of systemic exposure to NUZ-001. The FDA has indicated it will provide a formal response within the next 60 days. Neurizon has decided to proactively commence the PK studies, which are anticipated to take around four months from start to completion. The initiative, expected to cost between AUD$400,000 to AUD$600,000, highlights the company's proactive approach to lifting the clinical hold and facilitating the entry of NUZ-001 into the HEALEY ALS Platform Trial in the second half of 2025. The extra PK data generated from these studies will also support the ongoing clinical development of NUZ-001 and future regulatory approval applications.

The timely execution of these studies will allow NUZ-001 entry into the HEALEY ALS Platform Trial during the second half of CY2025.