27 May 2026

Highlights:

• Neurizon announces 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
• Increase in sample size driven by enrolment rate exceeding original expectations and the absence of a concurrent regimen during the expected recruitment period
• Regimen I expands from 160 to 240 participants to maintain statistical power for the primary endpoint aligned with the original trial assumptions
• The increased sample size allows more robust analysis of subgroups and biomarkers and ensures a fully powered study at topline results
• Based on current enrolment momentum, Neurizon anticipates that last participant dosing will now occur in Q2 CY2027 with topline results to be released Q3 CY2027, exceeding previous trial timeframe projection
• Expanded participant cohort cost is materially offset by a contribution  of philantrophic funds from the Sean M. Healey & AMG Center for ALS at Mass General Brigham
• As a result of diligent cost management and rapid recruitment, this change is expected to have no impact on Neurizon’s costs through to topline results and only a very modest increase in the total cost of completing the full trial
• Larger, consistent dataset expected to strengthen partnering and commercial positioning for NUZ-001
• 113 participants assigned and 74 dosed as of 22 May 2026, with 64 US clinical trial sites activated and 193 participants screened under the master protocol to date

Source: Neurizon