Appendix 4D - Half-year Financial Report - 31 December 2025
| Stock | NUZ.ASX (NUZ.ASX) |
|---|---|
| Release Time | 25 Feb 2026, 9:51 a.m. |
| Price Sensitive | Yes |
Neurizon Therapeutics Reports H1 2025 Results
- Exclusive global licensing agreement with Elanco for monepantel (NUZ-001)
- FDA clears IND for NUZ-001 in ALS, enabling participation in HEALEY ALS Platform Trial
- Positive top-line results from Phase 1 Open-Label Extension study of NUZ-001
Neurizon Therapeutics Limited reported its financial results for the half-year ended 31 December 2025. The company continued to advance its lead drug candidate, NUZ-001, toward late-stage clinical evaluation for the treatment of Amyotrophic Lateral Sclerosis (ALS). Key highlights include: Execution of an exclusive global licensing agreement with Elanco Animal Health, securing worldwide rights to monepantel (NUZ-001) and access to extensive non-clinical safety and manufacturing data; Acceptance of Neurizon's Investigational New Drug (IND) application for NUZ-001 by the U.S. FDA after successfully addressing the clinical hold, enabling participation in the HEALEY ALS Platform Trial; Positive top-line results from the Phase 1 Open-Label Extension study, indicating a favourable long-term safety and tolerability profile for NUZ-001, with exploratory signals of efficacy and survival; Manufacturing and supply chain readiness progress to support clinical dosing requirements and late-stage development; Granting of an Australian patent for NUZ-001, extending protection through to May 2041 across ALS and multiple neurodegenerative indications; Securing of Advance & Overseas Finding from AusIndustry, enabling cash rebates on eligible overseas R&D including the HEALEY Trial; Strengthening of the balance sheet and funding position through capital raises, a convertible note facility, and disciplined cost management.
Neurizon's focus is now on execution, progressing toward first patient dosing in the HEALEY ALS Platform Trial and ensuring NUZ-001 is delivered within a robust and well-established clinical trial framework. Participation in HEALEY provides an efficient and capital-effective pathway to late-stage clinical evaluation and reflects the strength of the underlying science supporting the program.