Neurizon in great financial shape to advance development of key ALS drug

• Neurizon secures $5m institutional placement and overseas R&D tax incentive advance for NUZ-001 development
• Australian Advance and Overseas Finding award validates development pathway for NUZ-001
• Funds to support entry into the Healey ALS Platform Trial and investigate its potential across related neurodegenerative diseases

Special Report: Neurizon Therapeutics is entering a position of financial strength to advance its innovative treatments for neurodegenerative diseases after securing firm support for a $5m institutional placement and an R&D tax incentive advance.

The company was awarded an Advance and Overseas Finding from AusIndustry for eligible overseas research and development expenditure during the 2025, 2026 and 2027 financial years for its lead candidate NUZ-001 drug treatment for amyotrophic lateral sclerosis (ALS) – a major form of motor neurone disease.

Securing this award covers all of Neurizon Therapeutics’ (ASX:NUZ) development costs in ALS and other neurodegenerative diseases – spanning pre-clinical, manufacturing, regulatory and clinical programs, including the HEALEY ALS Platform Trial.

This means that in addition to eligible Australian R&D expenditure, the company’s planned overseas R&D expenditure is now eligible for a 43.5% cash rebate.

It is also a clear validation of its development pathway for NUZ-001.

NUZ expects to receive a R&D tax rebate of about $5.6m for FY2025, though it anticipates receiving a net amount of about $4.1m in the fourth quarter of the 2025 calendar year due to the need to pay off a $1.5n loan from Radium Capital it had secured against the refund.

“This Advance and Overseas Finding is a strong validation of Neurizon’s development pathway for NUZ-001, our lead candidate in ALS and related neurodegenerative diseases,” chief financial officer Dan O’Connell said. 

“It directly supports our ability to execute pivotal clinical trials and enhances investor confidence by providing a substantial, nondilutive funding stream. 

“Importantly, it enables us to accelerate timelines while reducing risk, ensuring we can keep momentum in bringing NUZ-001 closer to patients who urgently need new treatment options.”

Listen: Michael Thurn chats with Tim Boreham

In a previous instalment of Health Kick, host Tim Boreham chatted to Neurizon’s Michael Thurn for an update on the company’s ALS program and its lead candidate, NUZ-001.

Strongly supported placement

NUZ’s financial position is further supported by new and existing institutional investors providing firm commitments for a $5m share placement priced at 12c per share – a 18.9% discount to the five-day volume weighted average price of 14.8c.

Proving the company’s board and management are aligned with its success, they will subscribe for $200,000 worth of shares under the placement though $130,000 of this is subject to shareholder approval.

Funds from the placement are earmarked for its NUZ-001 drug candidate’s planned entry into entry the Healey ALS Platform Trial in Q4 CY2025 pending US Food and Drug Administration approval for its investigational new drug application.

The trial is also pending manufacturing of second and third GMP registration batches, regulatory filings, and pre-clinical initiatives aimed at expanding the potential of NUZ-001 across other neurodegenerative diseases.

“We are delighted by the strong support from both new and existing institutional investors. Importantly, this raise positions Neurizon to advance the development of NUZ001 in ALS and expand its potential across related neurodegenerative diseases,” non-executive chairman Sergio Duchini said.

“This Placement strengthens our balance sheet as we prepare for the pivotal Phase 2/3 HEALEY ALS Platform Trial and allows us to continue expanding the potential of NUZ-001 through our pre-clinical program.”

NUZ-001 is being developed for the treatment of ALS and is designed to target key pathological mechanisms such as TDP-43 protein aggregation and impaired autophagy, which are common features across multiple neurodegenerative diseases.

It has demonstrated favourable oral bioavailability, central nervous system (CNS) penetration and a strong safety profile in preclinical and phase I studies, supporting its continued development.

This article was developed in collaboration with Neurizon Therapeutics, a Stockhead advertiser at the time of publishing. 

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.