• FDA lifted clinical hold on NUZ-001 IND, clearing path for clinical development
• NUZ-001 granted clearance to enter HEALEY ALS Platform Trial as Regimen I
• Successful production of 3 registration batches of NUZ-001 tablets

Neurizon Therapeutics Limited (ASX: NUZ) reported significant regulatory, clinical, and corporate milestones during the quarter, positioning the company for late-stage clinical development of its lead asset, NUZ-001. The US FDA lifted the clinical hold on NUZ-001's Investigational New Drug (IND) application, clearing the pathway for progression into advanced clinical trials. This was followed by FDA clearance for NUZ-001 to enter the HEALEY ALS Platform Trial, with NUZ-001 confirmed as Regimen I. Neurizon also completed GMP tablet registration batches for NUZ-001, strengthening manufacturing readiness ahead of regulatory submissions. The company was granted an Australian patent covering NUZ-001 across multiple neurodegenerative indications, extending IP protection to 2041. Strategically, Neurizon further strengthened its relationship with Elanco Animal Health. To fund the HEALEY ALS Platform Trial, Neurizon executed a comprehensive funding package, including a placement, convertible note facility, and a pro rata entitlement offer, providing full funding certainty. The company maintained strong engagement with the ALS community and continued its capital markets expansion, including trading on the OTCQB Venture Market in the US.

Neurizon has secured sufficient funding to complete the pivotal registration-adaptive Phase 2/3 HEALEY ALS Platform Trial for its lead asset NUZ-001.

Neurizon is well positioned to execute on its clinical strategy, deepen strategic partnerships, and progress toward accelerated regulatory pathways for NUZ-001, with the goal of delivering meaningful progress for people living with ALS and other neurodegenerative diseases, and long-term value for shareholders.