Neurizon Expands ALS Trial to 240 Patients With Faster Results and No Extra Cost

Neurizon expands Regimen I to 240 participants as recruitment momentum accelerates

In its 28 May 2026 investor webinar, Neurizon Therapeutics (ASX: NUZ) presented the strategic rationale for expanding Regimen I of the HEALEY ALS Platform Trial from 160 to 240 participants, with management confirming no change to funding requirements. The expansion was driven by enrolment rates exceeding original expectations, and the company outlined an accelerated path to topline results ahead of prior guidance.

NUZ-001 is Neurizon’s lead drug candidate for ALS (amyotrophic lateral sclerosis), the most common form of motor neurone disease. For investors, the headline message from the webinar was straightforward: a larger trial, faster results, and the same financial envelope.

What the expanded cohort means for the trial

From 160 to 240 — what changed and why

The original Regimen I design enrolled 160 participants under a 3:1 randomisation ratio, allocating 120 to the active arm and 40 to placebo. The expanded design scales that proportionally to 240 participants total, with 180 active and 60 placebo, while preserving the same 3:1 randomisation structure.

According to the 28 May 2026 webinar presentation, the expansion was driven by three operational factors: enrolment rates exceeding original expectations, rapid U.S. site activation and strong operational execution across the Sean M. Healey & AMG Center for ALS network, and the absence of a concurrent regimen during the expected recruitment window.

The presentation emphasised that this represents an opportunity to generate a larger and more informative dataset under the same inclusion criteria, capitalising on current recruitment momentum while maintaining trial continuity.

Key Takeaway — May 2026 Webinar Presentation

“Neurizon announced an expansion to the size of Regimen I intended to support a larger and more informative dataset, with accelerated time to topline readout and no change in funding requirements.”

Why a larger dataset strengthens the investment case

The webinar presentation outlined three strategic benefits of the expanded cohort:

1. Stronger Dataset: The expanded design maintains statistical power aligned with the original assumptions, enables subgroups of lower prevalence to be studied, and supports additional biomarker and translational insights relevant to ALS and broader neurodegenerative diseases.

2. Improved Regulatory Credibility: The larger cohort removes reliance on placebo data from concurrent regimens, strengthens the interpretability of the primary endpoint analysis, and supports future expedited regulatory pathway discussions, including Fast Track Designation, Breakthrough Designation, Priority Review and Accelerated Approval, where appropriate.

3. Commercial Advantage: A larger, more informative dataset generated under the same inclusion criteria optimises partnering opportunities and broader strategic positioning for NUZ-001.

For investors unfamiliar with clinical trial design, a platform trial tests multiple treatments simultaneously within a shared infrastructure, reducing costs and improving efficiency. When enrolment momentum supports a cohort increase, as it does here, it reflects strong operational execution rather than a modification driven by trial difficulty.

Recruitment numbers and accelerated timelines

Trial recruitment as of 22 May 2026

The presentation provided a snapshot of recruitment progress across the HEALEY network, as of 22 May 2026:

• 64 activated sites
• 193 participants in master screening
• 113 participants at regimen assignment
• 74 participants dosed

These figures underpin the confidence behind the expansion decision, demonstrating that the operational infrastructure is executing ahead of original expectations.

Timelines now ahead of previous projections

Based on current enrolment momentum, the presentation detailed accelerated timelines across the four milestones where the schedule has shifted:

Topline results are now anticipated in early Q3 CY2027, ahead of prior guidance, with the last participant dosing expected in Q2 CY2027. The presentation noted these projections are based on current enrolment momentum and are subject to that momentum continuing.

Financial picture and what comes next

No change to funding requirements

Management confirmed that the expansion carries no change to expected costs through to topline readout. The presentation outlined a three-part cost offset structure:

• Focused cost management and accelerated enrolment pace support no change to the expected cost profile to topline readout.
• Philanthropic contribution from the Sean M. Healey & AMG Center for ALS is materially offsetting the modest increase in total study completion costs.
• Australian Federal Government’s R&D Tax Incentive cash rebate provides a further offset against the modest increase in total trial costs.

The investor-facing framing from the webinar was clear: the expanded cohort delivers a larger, more informative trial dataset with a faster path to topline results and within the same financial envelope previously communicated.

Upcoming milestones to watch

The presentation outlined a series of milestones across the near and medium term.

Near-term, in Q2 CY2026:

• PMDA Regulatory Consultation
• Preclinical Updates
• Commercial Supply Agreement with Elanco

Looking into Q3/Q4 CY2026 and beyond:

• EMA Protocol Advice opinion
• PMDA General Consultation
• Liquid Formulation PK Study
• HEALEY tablet supply secured through completion
• HEALEY trial enrolment complete
• CEO appointment
• Participation at partnering and scientific conferences

On an ongoing basis through CY2026, the company outlined continued work to broaden its pipeline to other neurodegenerative diseases, expand partnerships with patient associations, and progress targeted engagement with potential strategic partners.

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