• FDA lifts clinical hold on NUZ-001 IND, clearing path for HEALEY ALS Platform Trial
• Positive 12-month open-label extension study results show safety and survival benefit
• Secures global licensing agreement with Elanco for non-clinical and manufacturing data

Neurizon Therapeutics Limited (ASX: NUZ & NUZOA; OTCQB: NUZTF) has reported significant advancements across its regulatory, clinical, and commercial activities for its lead drug candidate NUZ-001 for the treatment of Amyotrophic Lateral Sclerosis (ALS). Key highlights include the FDA lifting the clinical hold on the NUZ-001 Investigational New Drug (IND) application, positive results from a 12-month open-label extension study, and the execution of an exclusive global licensing agreement with Elanco Animal Health. The FDA's acceptance of Neurizon's Clinical Hold Complete Response and the subsequent lifting of the clinical hold clears the path for the company to accelerate NUZ-001's development through entry into the HEALEY ALS Platform Trial. The open-label extension study met its primary safety endpoint and showed preliminary signs of efficacy, including a significant survival benefit compared to historical controls. Neurizon also secured access to Elanco's extensive non-clinical animal safety and manufacturing data, strengthening the regulatory submission package and reducing the timeline to potential approval. The company further strengthened its balance sheet through a $5.2 million capital raise and a $1.5 million loan, as well as securing an Advance and Overseas Finding from AusIndustry for eligible overseas R&D expenditure. Neurizon remains focused on expanding its global presence, advancing awareness, and engaging with the broader scientific and patient communities as it progresses NUZ-001 towards regulatory approval for ALS.

Neurizon expects to receive approximately $5.6 million in Q2 FY2026 from the Australian R&D Tax Incentive scheme, of which $1.5 million has been advanced via a secured loan.

Neurizon is focused on advancing NUZ-001 through the HEALEY ALS Platform Trial, with plans to submit the protocol amendment to the FDA, complete GMP registration batches, and activate trial sites in the coming quarters. The company is also pursuing preclinical work to broaden its pipeline to other neurodegenerative diseases and exploring partnership opportunities with patient associations and potential strategic partners.