• Lead drug candidate NUZ-001 accepted into prestigious HEALEY ALS Platform Trial
• Positive interim results from Open-Label Extension study show NUZ-001 slowed disease progression and increased survival in ALS patients
• Achieved key regulatory milestones including EMA SME status and Orphan Medicinal Product Designation

Neurizon Therapeutics Limited (formerly PharmAust Limited) reported its Appendix 4D and Half-Year Financial Report for the period ended 31 December 2024. The company delivered on several key objectives to advance its lead drug candidate NUZ-001 in the treatment of neurodegenerative diseases, particularly Motor Neurone Disease (MND) / Amyotrophic Lateral Sclerosis (ALS). Highlights include NUZ-001's acceptance into the prestigious HEALEY ALS Platform Trial, which provides an accelerated pathway for clinical development. The company also reported positive interim results from its Open-Label Extension (OLE) study, showing NUZ-001 reduced the rate of ALS functional decline by 43.2%, significantly increased survival, and reduced the risk of death by 80.3% compared to historical controls. Neurizon achieved important regulatory milestones, including being granted Small and Medium-Sized Enterprise (SME) status by the European Medicines Agency (EMA) and securing Orphan Medicinal Product Designation for NUZ-001 from the EMA. These developments have laid a strong foundation for Neurizon as it progresses its clinical trial pipeline and the advancement of innovative treatments for ALS/MND.

Neurizon remains committed to delivering innovative therapies to patients in need and looks forward to the promising developments ahead as it progresses toward pivotal clinical trials for NUZ-001 in the treatment of ALS and other neurodegenerative diseases.