• Positive 8-month interim results from OLE Study
• Positive preclinical data on NUZ-001
• IND submission to support HEALEY ALS Platform Trial
• Orphan Medicinal Product Designation granted by EMA
• Name change to Neurizon Therapeutics

Neurizon Therapeutics Limited (ASX: NUZ), 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 December 2024. During the quarter, the company achieved key regulatory milestones, reported encouraging clinical trial outcomes, and strengthened its corporate identity through strategic rebranding. The company reported positive 8-month interim results from its Open-Label Extension (OLE) study, which continued to demonstrate encouraging results in slowing disease progression and increasing the life expectancy of patients with ALS. Neurizon also presented compelling preclinical data on NUZ-001's unique mechanism of action in preventing the aggregation of TAR DNA-binding protein 43 (TDP-43), a key pathological feature of ALS. The company received Orphan Medicinal Product Designation from the EMA for NUZ-001 for the treatment of ALS and submitted an IND application to the FDA to support the inclusion of NUZ-001 in the HEALEY ALS Platform Trial. Following shareholder approval, the company rebranded to Neurizon Therapeutics Limited, reflecting its commitment to pioneering advancements in the treatment of neurodegenerative diseases. The company also received two R&D tax rebates totaling $1,537,836 and issued Tranche 2 Placement Shares to certain related parties, raising $885,000.

Neurizon Therapeutics remains dedicated to delivering innovative therapies to patients in need and is enthusiastic about the progress it anticipates in the coming months, as it advances toward pivotal clinical trials for NUZ-001 in ALS.