• Significant advancements made for pending participation in the HEALEY ALS Platform Trial
• 100kgs of NUZ-001 successfully manufactured under Good Manufacturing Practice (GMP)
• NUZ-001 'method of use' patent for neurodegenerative diseases granted by the USPTO, extending protection to 2039

Neurizon Therapeutics Limited, a clinical-stage biotech company dedicated to advancing treatments for neurodegenerative diseases, has provided its Appendix 4C and Quarterly Activities Report for the period ended 31 March 2025. The report highlights significant advancements in preparing for participation in the HEALEY ALS Platform Trial, including the successful manufacture of 100kgs of NUZ-001 under Good Manufacturing Practice (GMP) and the initiation of a GMP manufacturing campaign with Catalent to produce three validation batches of NUZ-001 tablets. Additionally, the company reported updates to the HEALEY ALS Platform Trial's Master Protocol, including the confirmation of slow vital capacity (SVC) as a valuable secondary endpoint. A major strategic milestone was the expedited grant of Neurizon's 'method of use' patent for its lead amyotrophic lateral sclerosis (ALS) drug candidate, NUZ-001, by the United States Patent & Trademark Office (USPTO), extending the patent protection runway to 2039. The company continued to engage with the US Food and Drug Administration (FDA) to advance the Investigational New Drug (IND) application for NUZ-001, initiating two short-term, low-cost pharmacokinetic (PK) studies to address the FDA's clinical hold concern. Neurizon also maintained its industry engagement, participating in key global events and nurturing crucial global collaborations, while reinforcing its commitment to raising ALS awareness through direct participation in community events and collaborations with patient advocacy groups.

Neurizon is well-positioned for the upcoming quarters, with a focus on updating investors on positive results and outcomes on its near-term objectives, driven by its ongoing engagement with the FDA and future participation in the HEALEY ALS Platform Trial.