Neurizon Therapeutics (ASX:NUZ) has entered the second half of financial year 2026 in an acceleration phase, advancing its lead drug candidate while strengthening the financial and strategic foundations needed to bring it into late-stage development.
For the six months to 31 December 2025, the company reported a reduced net loss of $5.5 million, an improvement on the prior corresponding period, alongside a sharp rise in other income largely driven by research and development incentives. Net assets also increased significantly, reflecting capital raising activity and funding support that helped stabilise the balance sheet as clinical development intensified.
Operationally, the period was defined by progress around NUZ-001, the company’s investigational therapy for amyotrophic lateral sclerosis, the most common form of motor neurone disease. Neurizon focused on preparing the drug for participation in the HEALEY ALS Platform Trial, a global adaptive study designed to test multiple therapies more efficiently than traditional standalone trials. The company expects that inclusion in this framework will accelerate data generation while reducing both cost and development risk.
Regulatory momentum also improved. After earlier questions from the US Food and Drug Administration, Neurizon successfully addressed the agency’s requests for additional data, leading to acceptance of its Investigational New Drug application and clearing the path for further clinical evaluation. At the same time, patients in the company’s open-label extension study continued treatment, with results suggesting favourable long-term safety and tolerability and early signals supporting dose selection for later-stage trials.
A major strategic step came through a global licensing agreement with Elanco, which granted Neurizon worldwide rights to monepantel, the active ingredient in NUZ-001. The deal also provided access to extensive nonclinical safety and manufacturing data, resources that management believes will reduce development timelines and strengthen the program’s regulatory footing across multiple jurisdictions. The agreement is structured around milestone payments and royalties, aligning costs with future progress and commercial outcomes.
Alongside scientific and regulatory work, the company moved to secure its longer-term commercial position. An Australian patent granted during the period extended intellectual property protection for NUZ-001 through 2041 across several neurodegenerative diseases, reinforcing its potential as a platform therapy rather than a single indication product. Manufacturing preparation also advanced, with work focused on scaling drug production and ensuring supply readiness for future clinical dosing and registration requirements.
Funding remained a central priority as development costs rose. During the half year, Neurizon completed placements, secured a convertible note facility and accessed government support programs, including the R&D Tax Incentive and an Advance and Overseas Finding that enables rebates on eligible international research expenditure. Post period, the company also completed an entitlement offer and received a substantial tax rebate payment, further strengthening liquidity as it enters what management describes as a pivotal stage for the NUZ-001 program.