FDA Lifts Clinical Hold on NUZ-001

• U.S. FDA lifts the Clinical Hold on NUZ-001, Neurizon's lead investigational therapy for ALS
• Clears the way for entry into the HEALEY ALS Platform Trial expected to commence in Q4 CY2025
• IND supported by robust preclinical safety data and comprehensive manufacturing and quality information from the previously signed Elanco licensing agreement

Neurizon Therapeutics Limited (ASX: NUZ & NUZOA), a clinical-stage biotech company dedicated to advancing innovative treatments for neurodegenerative diseases, is pleased to announce that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on its lead investigational drug, NUZ-001. This decision marks a pivotal regulatory milestone for Neurizon and the ALS community, clearing the way for Phase 2/3 development of NUZ-001 as part of the HEALEY ALS Platform Trial, expected to commence Q4 CY2025. The IND for NUZ-001 is supported by robust preclinical safety data and comprehensive manufacturing and quality information from the previously signed Elanco licensing agreement, which enhances confidence in the platform's readiness for clinical development and reinforces its potential as a therapeutic platform with broad applicability, offering both strategic flexibility and long-term commercial value. Neurizon is now partnering with the HEALEY ALS Platform Trial team to take the next critical steps in advancing NUZ-001, supported by compelling TDP-43 preclinical data and encouraging survival outcomes from the Open-Label Extension (OLE) study in ALS patients.

Neurizon anticipates Mass General Hospital (MGH) filing a protocol amendment to their IND for the HEALEY ALS Platform Trial to incorporate Neurizon's specific protocol regimen early in the coming weeks. Neurizon expects to initiate patient enrollment in the HEALEY ALS Platform Trial in Q4 CY2025.