Webinar presentation - Regimen I expands to 240 participants
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Neurizon Therapeutics Limited
ABN 35 094 006 023
www.neurizon.com
Suite 2, Level 11, 385 Bourke Street, Melbourne, VIC 3000 Tel: +61 3 9692 7222
Webinar presentation - Regimen I expands to 240 participants
28 May 2026 – Melbourne Australia: Neurizon® Therapeutics Limited (ASX: NUZ & NUZOA; OTCQB: NUZTF)
("Neurizon" or "the Company"), a clinical-stage biotech company dedicated to advancing innovative treatments for
neurodegenerative diseases, is pleased to provide the following presentation which will be used in the Company’s
webinar scheduled for 4:00pm AEST (2:00pm AWST) on Thursday, 28 May 2026.
The webinar will provide additional details regarding the recently announced expansion of Regimen I in the HEALEY
ALS Platform Trial from 160 to 240 participants, including the strategic rationale for the expanded cohort, ongoing
recruitment momentum across the HEALEY network, accelerated timelines to topline results, no change in financial
implications and the broader strategic significance for the NUZ-001 program and Neurizon’s future regulatory and
commercial positioning.
Registration details are provided below. Participants are encouraged to submit questions in advance during the
registration process or via company email to enquiries@neurizon.com.
Registration Link: https://bit.ly/NUZ-001
Date: 28 May 2026
Time: 4:00pm AEST
-ENDS-
This announcement has been authorised for release by Sergio Duchini, Interim Executive Chair, on behalf of the
Board of Neurizon Therapeutics Limited.
For further information, please contact:
Neurizon Therapeutics
Lidija Damjanovic
Marketing & Corporate Affairs
Email: lidija@neurizon.com
Phone: +61 (0) 425 700 504
Australia Investor Relations
Henry Jordan
Six Degrees Investor Relations
Email: henry.jordan@sdir.com.au
Phone: +61 (0) 431 271 538
About Neurizon Therapeutics Limited
Neurizon Therapeutics Limited (ASX: NUZ) is a clinical-stage biotechnology company dedicated to advancing
treatments for neurodegenerative diseases. Neurizon is developing its lead drug candidate, NUZ-001, for the
treatment of ALS, which is the most common form of motor neurone disease. Neurizon’s strategy is to accelerate
access to effective ALS treatments for patients while exploring the potential of NUZ-001 for broader
neurodegenerative applications. Through international collaborations and rigorous clinical programs, Neurizon is
dedicated to creating new horizons for patients and families impacted by complex neural disorders. NUZ-001 is an
investigational product and is not approved for commercial use in any jurisdiction.
Neurizon Investor Hub
We encourage you to utilise our Investor Hub for any enquiries regarding this
announcement or other aspects concerning Neurizon.
This platform offers an opportunity to submit questions, share comments, and
view video summaries of key announcements.
To access Neurizon Investor Hub please scan the QR code or visit
https://investorhub.neurizon.com
Neurizon® is a registered trademark of Neurizon Therapeutics Limited
ABN 35 094 006 023
HEALEY ALS Platform
Trial Regimen I Sample
Size Expansion
MAY 2026
Disclaimer
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Regimen I Sample Size Expansion 2
Future Matters
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prospects of the Company. Those intentions, expectations, future plans, strategy and prospects may or
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Company does not warrant
or represent that the actual results, performance or achievements will be as expected, planned or
intended.
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This document does not constitute any part of any offer to sell, or the solicitation of an offer to buy, any
securities in the United States or to, or for the account or benefit of any “US person” as defined in
Regulation S under the US Securities Act of 1993 (“Securities Act”). The Company’s shares have not
been, and will not be, registered under the Securities Act or the securities laws of any state or other
jurisdiction of the United States, and may not be offered or sold in the United States or to any US person
without being so registered or pursuant to an exemption from registration including an exemption for
qualified institutional buyers.
Agenda • Key takeaways
• Recruitment momentum and execution update
• HEALEY platform dynamics and rationale for
expansion
• Regimen I Timeline
• Financial considerations
• Future milestones
• Q&A
Regimen I Sample Size Expansion 3
Key Takeaways
Increase in Neurizon’s Regimen I sample size driven by the enrolment rate exceeding original
expectations and the absence of a concurrent regimen during the expected recruitment period.
Revised design preserves the original statistical assumptions underpinning the primary endpoint
analysis and supports more robust subgroup and biomarker analysis.
Larger and more informative dataset generated under the same inclusion criteria strengthens future
regulatory discussions, partnering opportunities and commercial positioning.
Funding requirements remain unchanged. A modest increase anticipated in total study completion costs
to be offset by Philanthropic funding support from the Sean M. Healey & AMG Center for ALS.
Based on current enrolment momentum, Neurizon anticipates last participant dosing in Q2 CY2027 with
topline results expected in early Q3 CY2027, ahead of previous expectations.
Regimen I Sample Size Expansion 4
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.
Strong Phase 2/3 ALS Trial Recruitment Momentum
64 113
193 74
Activated Sites
Master Screening Dosed Participants
Regimen Assignment
Numbers referred to above are as of 22 May 2026.
5
Regimen I Sample Size Expansion
Regimen I Sample Size Expansion
Expansion of Regimen I sample from 160 to 240 participants
6
6
Original Design:
• n=160 participants
• 3:1 Randomisation
Expanded Design:
• n=240 participants
• 3:1 Randomisation
Expansion Driven by:
• Enrolment rates exceeding original expectations
• Rapid U.S. site activation and strong operational execution across the Sean M. Healey & AMG Center for ALS network
• Absence of a start of a concurrent regimen during the expected recruitment window
• Opportunity to generate a larger and more informative dataset under the same inclusion criteria
• Potential to strengthen future regulatory, partnering, and commercial positioning
• Ability to capitalise on current recruitment momentum while maintaining trial continuity and efficiency
• 180 Active
• 60 Placebo
• 120 Active
• 40 Placebo
Why Expansion to 240 Matters?
7
• Maintains statistical power aligned
with the original assumptions
• Allows subgroups of lower
prevalence to be studied
• Supports additional biomarker and
translational insights relevant to ALS
and broader neurodegenerative
diseases
Stronger Dataset Improved Regulatory Credibility Improves Commercial Positioning
• Stronger Evidence: Generates a
larger, more informative dataset to
support future regulatory
interactions
• Faster Execution: Accelerates time-
to-topline by delivering a fully
powered dataset earlier through
rapid enrolment rate
• Commercial Advantage: Optimises
partnering and broader strategic
positioning for NUZ-001
Regimen I Sample Size Expansion
• Clinically meaningful benefit with
ability to detect effect size
maintained
• Removes reliance on placebo data
from concurrent regimens
• Strengthens interpretability of the
primary endpoint analysis
• Supports future expedited regulatory
pathway discussions, including Fast
Track Designation, Breakthrough
Designation, Priority Review and
Accelerated Approval, where
appropriate
‘Regimen-I’ Trial execution timelines exceed previous projections
Enrollment
Complete
Q3-Q4 2026
First Patient
Dosed
160 patients
enrolled in the
trial
First patient
screened for
eligibility
Last Patient
Dosed
Q1 2026
First Patient
Screened
Q2-Q3 2027
Last participant
receives
final dose
Database
Lock
Q3 2027
Clinical trial
database locked
for analysis
Topline Data
Released
Topline results
of the trial
announced
Q3 2027
First participant
dosed in
Regimen I
Platform Trial IND
submitted to
regulatory
authorities
Q4 2025
IND Amendment
Submission
NUZ-001
entry
accepted
Q4 2025
FDA
Clearance
Q1 2026
5 6 7 8
NOW
Q3 2026
NOW
Q2 2027
NOW
Q2 2027
NOW
EARLY Q3 2027
Expanded cohort to 240 participants
Based on current enrolment rate, Neurizon
anticipates accelerated trial timeline projection
8
Regimen I Sample Size Expansion
Financial Considerations
Accelerated time to topline readout with no change in funding
requirements
9
Cost Management &
Accelerated Trial Timeline
Focused cost management and fast
enrolment support no change to expected
costs to topline read out
Philanthropic Contribution
from HEALEY
R&D Tax Incentive
Accelerating ALS research through collaboration and cost efficiency
Regimen I Sample Size Expansion
Additional cost being materially offset by
meaningful contribution of philanthropic
funds from the Sean M. Healey & AMG
Center for ALS
Modest increase in cost of full trial to be
further offset by Australian Federal
Government’s R&D Tax Incentive cash rebate
Key Progress and Upcoming Milestones
10
Q3-
Q4
CY
2026
ONGOING EFFORTS
ü Work to broaden pipeline to other
neurodegenerative diseases
ü Partnership expansion opportunities with
patient associations
ü Targeted engagement with
potential strategic partners
Q2
• Preclinical updates
• HEALEY enrollment updates
• CEO Appointment
• VIC and QLD shareholder briefing events
• HEALEY tablet supply secured through
completion
• Liquid Formulation PK Study
• EMA Protocol Advice opinion
• PMDA General Consultation
• HEALEY Trial enrollment complete
• Participation at partnering and scientific
conferences
Preclinical
Updates
Commercial Supply
Agreement with Elanco
HEALEY Regimen I
update
Ethics Approval for
Liquid Formulation PK
Study
EMA Scientific
Advice preparation
PMDA Regulatory
Consultation
Regimen I Sample Size Expansion
Shareholder events
in NSW & WA
Data Strengthening
MOA Understanding
Upcoming Milestones in Q2
Key Progress in Q2 Upcoming Milestones Q3/Q4
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