Appendix 4E and 2026 Annual Report
Released
Released
Announcement PDF
Neurizon Therapeutics Limited
Appendix 4E
Preliminary final report
1. Company details
Name of entity: Neurizon Therapeutics Limited
ABN: 35 094 006 023
Reporting period: For the year ended 30 June 2026
Previous period: For the year ended 30 June 2025
2. Results for announcement to the market
$
Other income up 844.2% to 17,769,524
Loss from ordinary activities after tax attributable to the owners of
Neurizon Therapeutics Limited down 35.4% to (10,723,024)
Loss for the year attributable to the owners of Neurizon Therapeutics
Limited down 35.4% to (10,723,024)
Dividends
There were no dividends paid, recommended or declared during the current financial period.
Operating Results
The loss for the consolidated entity after providing for income tax amounted to $10,723,024 (30 June 2025: $16,593,619).
Financial Position
The net assets of the consolidated entity were $12,726,584 as at 30 June 2026 (30 June 2025: $2,820,571).
3. Net Tangible Asset
30 June 2026 30 June 2025
Cents Cents
Net tangible assets per ordinary security 1.67 0.57
4. Control gained over entities
Not applicable.
5. Loss of control over entities
Not applicable.
6. Dividends
Current period
There were no dividends paid, recommended or declared during the current financial period.
Previous period
There were no dividends paid, recommended or declared during the previous financial period.
7. Details of associates and joint venture entities
Not applicable.
Neurizon Therapeutics Limited
Appendix 4E
Preliminary final report
8. Foreign entities
Details of origin of accounting standards used in compiling the report:
All foreign entities are in compliance with International Financial Reporting Standards which is equivalent to Australian
Accounting Standards.
9. Audit qualification or review
The 30 June 2026 financial statements and accompanying notes for Neurizon Therapeutics Limited have been audited and
attached to the Appendix 4E. An unmodified opinion has been issued.
10. Attachments
Details of attachments (if any):
The Annual Report of Neurizon Therapeutics Limited for the year ended 30 June 2026 is attached.
11. Signed
Signed ___________________________ Date: 25 August 2026
Mr. Sergio Duchini
Interim Executive Chairman
2026
ANNUAL REPORT
Hope on
the Horizon
Contents
02 Company Snapshot
04 Chairman’s Letter
06 Key Highlights
0 Financial report
89 Corporate directory
Neurizon Therapeutics is a clinical-stage biotech company leading the
development of treatments towards a promising new horizon for people
living with neurodegenerative diseases.
Our lead investigational therapy, NUZ-001, is being evaluated in
the registrational Phase 2/3 HEALEY ALS Platform Trial for Amyotrophic
Lateral Sclerosis (ALS), with topline results due in late Q2 CY2027.
Our focus is resolute What’s on the horizon
Science-led.
Patient-driven.
Globally connected.
Neurizon Therapeutics Annual Report 2026 01
As a science-led, patient-driven and globally
connected biotechnology company, we combine
innovative research, disciplined clinical execution
and strategic partnerships to translate scientific
discoveries into meaningful outcomes for patients
while creating long-term value for all stakeholders.
Our goal is to develop disease-modifying therapies
that address the biological mechanisms underlying
neurodegeneration. Our lead investigational therapy
NUZ-001, is being evaluated in the registrational
Phase 2/3 HEALEY ALS Platform Trial for
Amyotrophic Lateral Sclerosis (ALS).
Following completion of enrolment of 250
participants into Phase 2/3 HEALEY ALS Platform
Trial, Neurizon's immediate focus is on disciplined
clinical execution as participants progress through
treatment and follow-up, with topline results due in
late Q2 CY2027.
In parallel, the Company is advancing regulatory
engagement, strengthening commercial readiness
and continuing to expand the scientific
understanding of NUZ-001.
Beyond ALS, Neurizon is building the scientific
foundation supporting the broader development of
NUZ-001 across neurodegenerative diseases,
including its potential to influence biological
pathways involved in maintaining cellular protein
homeostasis.
Company Snapshot
Lead Program: NUZ-001
Advancing a new frontier in neurodegenerative diseases
At Neurizon Therapeutics, we are redefining how neurodegenerative diseases are treated – by addressing
underlying biology, not just symptoms. Our goal is to transform the treatment of neurodegenerative diseases by
developing disease-modifying therapies that address the biological pathways underlying neuronal degeneration.
NUZ-001 is an orally available small molecule designed to support cellular protein homeostasis by enhancing
multiple intracellular protein clearance pathways involved in the management of misfolded and aggregated
proteins. Through its potential effects on autophagy and the ubiquitin-proteasome system, NUZ-001 is being
investigated for its ability to support the maintenance of neuronal protein balance, a biological process disrupted
across ALS and several other neurodegenerative diseases.
NUZ-001 is currently being evaluated in Regimen I of the Phase 2/3 HEALEY ALS Platform Trial as a potential
treatment for ALS, the most common form of motor neurone disease (MND).
Our Mechanism of Action
Indication
Amyotrophic Lateral
Sclerosis (ALS) – the most
common form of Motor
Neurone Disease (MND)
Mechanism of Action
NUZ-001 addresses disrupted
cellular protein homeostasis
through activation of multiple
protein clearance pathways
(autophagy and proteasomal
system) involved in managing
misfolded and aggregated proteins.
Trials
Phase 2/3 HEALEY ALS
Platform Trial
Recruitment completed with
250 participants enrolled in
less than 5 months
Topline results due in
late Q2 CY2027
Neurizon Therapeutics Annual Report 2026 02
FY2026 marked a defining year for Neurizon. The Company advanced NUZ-001 through late-stage clinical
development while strengthening its scientific, regulatory, operational and financial foundations.
These achievements reflect more than the successful delivery of individual milestones - they represent meaningful
progress toward achieving our ambition to develop disease-modifying therapies that have the potential to make a
meaningful difference for people living with neurodegenerative diseases.
Our strategic priorities provide the framework for achieving that ambition and guide every decision we make for
people living with ALS, partners and shareholders.
The HEALEY ALS Platform Trial represents the major step in Neurizon's mission to develop a potential
disease-modifying therapy for people living with ALS. As a global, adaptive registrational Phase 2/3 trial, it provides an
efficient and rigorous pathway to evaluate NUZ-001 while generating the clinical evidence needed to support future
regulatory and commercial opportunities.
NUZ-001 is currently being evaluated as Regimen I of the HEALEY ALS Platform Trial.
A clear strategic focus
Our strategic priorities
Delivering on our promise through advancing our clinical trial towards
topline results:
Neurizon Therapeutics Annual Report 2026 03
250
Participants
78
US Clinical Sites
3:1
Randomisation
NUZ-001 : Placebo
Topline Results
Due Late Q2 CY2027
TRIAL
INITIATION
FEBRUARY
2026
TRIAL
EXPANSION
MAY
2026
ENROLMENT
COMPLETED
JULY
2026
TRIAL
EXECUTION
EARLY
Q2 2027
DATABASE
LOCK
Q2
2027
TOPLINE
RESULTS
LATE
Q2 2027
ADAPTIVE
PLATFORM
COLLABORATIVE PATIENT
FOCUSED
The HEALEY ALS Platform Trial
– Regimen I – is a randomised,
double-blind, placebo-con-
trolled trial evaluating NUZ-001
in 250 participants with ALS
across 78 leading clinical sites
in the United States.
Allows efficient
evaluation and rapid
advancement of
promising therapies
Led by Healey & NEALS
with leading ALS
experts, researchers
and clinicians
Designed to accelerate
access to meaningful
treatments for people
living with ALS
Accelerating
Patient Hope
and Access to
Innovative ALS
Treatment
Driving
Clinical
Progress
Unlocking the
potential of
Neurizon to
address high
unmet need in
neurodegenerative
diseases
Delivering
commercial
readiness and
stakeholder
value
Dear fellow shareholders,
FY2026 was a defining year for Neurizon.
Over the past twelve months, the Company transitioned
into late-stage clinical development as NUZ-001
advanced into the registrational Phase 2/3 HEALEY ALS
Platform Trial. Alongside this clinical progress, we
strengthened the scientific, operational and financial
foundations of the business, positioning Neurizon for its
next phase of growth.
At the centre of this progress remains our commitment
to people living with ALS, the most common form of
Motor Neurone Disease (MND). ALS is a devastating
disease with an urgent need for more treatment options.
That urgency continues to guide how we prioritise our
activities and advance NUZ-001.
One of our principal objectives for FY2026 was clear –
advance NUZ-001 into the HEALEY ALS Platform Trial as
quickly and efficiently as possible. Following
constructive engagement with the US Food & Drug
Administration (FDA), the Company secured clearance
of its Investigational New Drug application, enabling
NUZ-001 to enter the HEALEY ALS Platform Trial as
Regimen I. These achievements represented the
culmination of years of scientific, clinical and regulatory
work and marked Neurizon's transition into late-stage
clinical development.
Our confidence in advancing NUZ-001 through
late-stage clinical development was further
strengthened by results from the 12-month Open-Label
Extension study of NUZ-001 in people living with ALS.
The study met its primary safety endpoint and provided
encouraging preliminary signals of efficacy, including
increased survival at the recommended Phase 2/3 dose
compared to matched, untreated controls. Pleasingly,
several participants continue to receive NUZ-001 to this
day, through the TGA’s Special Access Scheme.
With a regulatory pathway established, our focus shifted
rapidly to clinical execution. First participant dosing
commenced in February 2026 and recruitment
exceeded expectations from the outset.
Strong enrolment momentum provided an opportunity
to expand Regimen I from 160 to 240 participants,
strengthening the study. Importantly, through
philanthropic support from HEALEY and disciplined cost
management, this was achieved without increasing
Neurizon’s expected funding requirements.
Following year-end, enrolment of 250 participants was
completed in less than five months from first participant
dosing, making this the fastest enrolment achieved in
the history of the HEALEY ALS Platform Trial. Beyond the
significance of this milestone, it demonstrated the
quality of execution across the program and accelerated
the expected timing of topline efficacy and safety results
to late Q2 CY2027.
Clinical development is often defined by execution.
Completing enrolment at this pace, while increasing the
size of the study without increasing Neurizon's expected
funding requirement, represents an outstanding
achievement by everyone involved in the program. Our
immediate priority is now the disciplined execution of
the study through treatment completion, database lock
and topline readout.
While clinical execution remained our immediate priority,
we also strengthened the long-term scientific
foundation of NUZ-001. During the year, additional
preclinical studies expanded our understanding of its
mechanism of action, demonstrating activity across
multiple intracellular protein clearance pathways,
including autophagy and proteasomal activity, alongside
restoration of BDNF, preservation of STMN2 expression
and rebalancing of proteostasis. Together, these findings
further support NUZ-001's potential as a
disease-modifying therapy for ALS and reinforce its
broader potential across neurodegenerative diseases
characterised by impaired protein homeostasis. This
scientific progress was complemented by the grant of an
Australian patent extending protection through 2041.
Interim Executive
Chairman’s Le͵er
Sergio Duchini
Neurizon Therapeutics Annual Report 2026 04
While advancing the clinical program, we also
strengthened the operational foundations required to
support NUZ-001 through its next stage of development.
A key priority has been establishing a reliable
manufacturing and supply framework capable of
supporting ongoing clinical development, regulatory
activities and potential future commercialisation.
Our relationship with Elanco Animal Health has been
central to this strategy. During the year, we secured an
exclusive global licensing agreement providing access
to valuable manufacturing data and intellectual property,
followed by a long-term strategic supply agreement for
GMP monepantel, the active pharmaceutical ingredient
in NUZ-001.
Together, these agreements significantly strengthen our
manufacturing capability, reduce supply chain risk and
support the long-term development of the program.
Funding late-stage clinical development has been
another strategic priority. Throughout FY2026, the Board
adopted a disciplined capital management approach,
combining shareholder funding with government
incentives and flexible financing solutions to maximise
financial flexibility while minimising dilution.
During the year, we strengthened our capital position
through a combination of equity funding, non-dilutive
government support and the establishment of a $20
million convertible note facility. We also secured
eligibility under the Australian Government's R&D Tax
Incentive program, including an Advance and Overseas
Finding supporting eligible overseas expenditure
associated with the HEALEY program.
Following year-end, we further enhanced this strategy
through a non-dilutive R&D financing facility with Dare
Capital, enabling early access to anticipated R&D Tax
Incentive refunds while reducing reliance on alternative
funding sources. This reflects our continued focus on
directing capital toward activities that advance or de-risk
the clinical program while protecting long-term
shareholder value.
As Neurizon entered this next phase of development,
our governance evolved accordingly. During the year, I
assumed the role of Interim Executive Chair and we
welcomed Dr Ross Murdoch as Non-Executive Director.
Ross brings extensive global pharmaceutical and
biotechnology experience spanning neurodegenerative
diseases, clinical development and commercial strategy.
I would also like to acknowledge the valuable
contribution of Dr Michael Thurn, who retired from the
Board during the year.
As we enter FY2027, our priorities are clear. With
enrolment complete, our immediate focus is the
disciplined execution of Regimen I as participants
progress through treatment and follow-up phase ahead
of anticipated topline efficacy and safety results in late
Q2 CY2027.
Alongside the clinical program, we will continue
advancing regulatory engagement, strengthening the
scientific evidence supporting NUZ-001, maintaining
manufacturing readiness, progressing strategic
partnering activities and building the organisational
capability required for the Company's next phase of
development, including the appointment of a new Chief
Executive Officer. Our focus is not only on reaching the
next clinical milestone, but on ensuring Neurizon is well
positioned to realise the opportunities that may follow.
As we pursue these priorities, we remain mindful of the
people at the heart of our mission. I would like to
sincerely thank every participant and family who has
chosen to take part in Regimen I, together with the
investigators, research coordinators, clinical site teams
and the Sean M. Healey & AMG Center for ALS. Their
commitment has enabled the study to progress at an
exceptional pace and continues to advance the
development of potential new treatment options for this
devastating disease.
I would also like to thank my fellow Directors, our
employees, advisers and our scientific, clinical and
commercial collaborators for their dedication
throughout an exceptionally important year for Neurizon.
Finally, to our shareholders, thank you for your
continued confidence in Neurizon and our strategy.
FY2026 was a defining year in the Company's evolution.
We transitioned into late-stage clinical development,
strengthened the scientific, operational and financial
foundations of the business, and established a clear
path towards one of the most significant milestones in
our history. While clinical development is never without
risk, we enter FY2027 as a stronger and more mature
organisation with a disciplined strategy, a substantially
advanced clinical program and an unwavering
commitment to improving the lives of people living with
ALS. I look forward to updating you as we continue this
important journey together.
Yours sincerely,
Sergio Duchini
Interim Executive Chairman
Neurizon Therapeutics Limited
Neurizon Therapeutics Annual Report 2026 05
First Participant Dosed in
HEALEY ALS Trial
Executing a Registrational
Clinical Program
Strengthening the Scientific Foundation
of NUZ-001
Strengthening Capital and
Growth Foundations
Building Commercial Readiness
HEALEY ALS Trial Expanded
Regimen I Fully Enrolled
Key Highlights
FY2026 was a transformational year for Neurizon. The Company successfully completed enrolment in the registrational
Phase 2/3 HEALEY ALS Platform Trial, strengthened its capital position, advanced manufacturing and regulatory
readiness, and continued to build the scientific foundation supporting NUZ-001.
Together, these achievements reinforce the strength of Neurizon's science and position the Company to pursue
significant clinical, scientific and commercial opportunities in the years ahead.
Completed enrolment of 250
participants across 78 U.S. sites in less
than five months, becoming the fastest
enrolment in HEALEY ALS Platform Trial
and accelerating anticipated topline
results to late Q2 CY2027.
First participant dosed in Regimen I of
the registrational Phase 2/3 HEALEY
ALS Platform Trial, marking the
commencement of late-stage clinical
development.
Long-Term Supply Agreement
with Elanco
Secured long-term manufacturing and
supply agreement securing access to
GMP monepantel for continued clinical
development and potential future
commercialisation of NUZ-001.
Intellectual Property Strengthened
Secured NEURIZON® trademark protection
across priority global markets and
Australian patent protection for NUZ-001
through 2041.
Protein Homeostasis
Mechanism Expanded
Demonstrated activity across multiple
intracellular protein clearance
pathways, further supporting its
differentiated mechanism addressing
disrupted protein homeostasis.
Multi-Pathway Clearance
Activity Demonstrated
Generated evidence of activity across
autophagy and the ubiquitin-proteasome
system, supporting the management of
misfolded and aggregated proteins.
Platform Potential Reinforced
Generated additional scientific
evidence supporting the broader
potential of NUZ-001 across
neurodegenerative diseases.
Strengthened Capital Position
Raised approximately $20.8 million
through equity raises, supporting
continued execution through key
clinical milestones.
Access to Non-Dilutive Funding
Strengthened non-dilutive funding
position by securing the Australian
Government's R&D Tax Incentive and
establishing an R&D financing facility
providing early access to the FY2026
incentive.
Expanded the participant cohort from
160 to 250, while maintaining the original
statistical power and funding through
topline results.
Neurizon Therapeutics Annual Report 2026 06
2026
ANNUAL REPORT
Financial
Report
10
8
9
40
2
3
78
80
81
89
86
Contents
Directors' report
Auditor's independence declaration
Consolidated Statement of profit or loss
and other comprehensive income
Consolidated Statement of financial position
Consolidated Statement of changes in equity
Consolidated Statement of cash flows
Notes to the financial statements
Consolidated entity disclosure statement
Directors' declaration
Independent auditor's report to the members
of Neurizon Therapeutics Limited
Shareholder information
Corporate directory
Directors’
Report
01
For the year ended 30 June 2026
Annual Report 2026
Neurizon Therapeutics Limited
Directors' report
30 June 2026
The directors present their report, together with the financial statements, on the consolidated entity (referred to
hereafter as the 'consolidated entity' or 'Group') consisting of Neurizon Therapeutics Limited (referred to hereafter
as the 'Company' or 'parent entity' or 'Neurizon') and the entities it controlled at the end of, or during, the year ended
30 June 2026.
Directors
The following persons were directors of Neurizon Therapeutics Limited during the whole of the financial year and up
to the date of this report, unless otherwise stated:
Mr. Sergio Duchini Interim Executive Chairman (transitioned from Non-
Executive Chairman on 16 March 2026)
Mr. Marcus Hughes Non-Executive Director
Dr. Katie MacFarlane Non-Executive Director
Dr. Ross Murdoch Non-Executive Director (appointed on 8 May 2026)
Dr. Michael Thurn Managing Director and Chief Executive Officer (resigned
on 16 March 2026); Non-Executive Director (retired on 8
May 2026)
Principal activities
The principal continuing activities constituted by Neurizon Therapeutics Limited and the entities it controlled during
the year were to develop its own intellectual property for the treatment of neurological diseases.
Dividends
There were no dividends paid, recommended or declared during the current or previous financial year.
Review of operations
The loss for the consolidated entity after providing for income tax amounted to $10,723,024 (30 June 2025:
$16,593,619).
Neurizon Therapeutics Limited (“Neurizon” or “the Company”), is a late clinical-stage biotech company
dedicated to advancing treatments for neurodegenerative diseases. Neurizon is focused on developing its
lead drug candidate, NUZ-001, for the treatment of Amyotrophic Lateral Sclerosis (ALS), the most common
form of Motor Neurone Disease (MND).
During FY2026, Neurizon delivered transformational progress through a series of regulatory, clinical,
manufacturing, intellectual property, corporate and funding milestones, culminating in NUZ-001’s entry into
the pivotal Phase 2/3 HEALEY ALS Platform Trial. These achievements were delivered alongside continued
execution against the Company’s four strategic pillars – advancing patient access to innovative ALS/MND
treatments, driving clinical progress, unlocking the potential of NUZ-001 to treat the range of
neurodegenerative diseases and delivering commercial readiness and stakeholder value.
Neurizon Therapeutics Annual Report 2026 10
Neurizon Therapeutics Limited
Directors' report
30 June 2026
Clinical, Regulatory Progress and Preclinical Scientific Development
Neurizon’s clinical and regulatory pathway was defined by the resolution of the FDA’s clinical hold on the NUZ-
001 Investigational New Drug (IND) application and the Company’s subsequent entry into the HEALEY ALS
Platform Trial.
In late July 2025, the Company submitted a comprehensive Clinical Hold Complete Response (CHCR) to the US
Food & Drug Administration (FDA), incorporating new data from two 28-day bridging pharmacokinetic studies
in rats and dogs requested by the regulator to assess the adequacy of systemic exposure to NUZ-001. While
the FDA’s review was delayed in August 2025 due to agency-wide resourcing constraints, the Company
received positive written guidance confirming its proposed strategy was appropriate, and in early October 2025
the FDA formally accepted the CHCR and lifted the clinical hold on the NUZ-001 IND. This represented a defining
regulatory milestone for the Company, clearing the path for NUZ-001’s entry into the HEALEY ALS Platform Trial
and providing a strong regulatory foundation to unlock the molecule’s platform potential across other
neurodegenerative diseases.
In August 2025, Neurizon reported positive topline results from the Open-Label Extension (OLE) study of NUZ-
001, which met its primary endpoint, confirming that long-term treatment was safe and well-tolerated. Based on
a study population of 12 participants, preliminary efficacy analysis against matched historical controls from the
PRO-ACT database showed a significant survival benefit (76.7% reduction in risk of death, HR=0.233,
p=0.0013), an estimated median survival extension of approximately 16 months, and a slowing of functional and
respiratory decline of 31% (p=0.145) and 43% (p=0.078) respectively. While the small sample size warrants
caution in interpreting these preliminary findings, the results reinforced the rationale for advancing NUZ-001
into the pivotal HEALEY ALS Platform Trial.
In December 2025, following completion of the FDA’s 30-day review of the associated protocol amendment,
NUZ-001 was formally cleared for inclusion in the HEALEY ALS Platform Trial and confirmed as Regimen I –
representing official entry into the world’s leading adaptive Phase 2/3 ALS clinical development platform. The
HEALEY ALS Platform Trial, conducted by the Sean M. Healey & AMG Center for ALS at Mass General Brigham
in partnership with the Network for Excellence in ALS (NEALS), is a multicentre, double-blind, placebo-controlled
study evaluating multiple investigational ALS therapies concurrently under a shared master protocol across 78
clinical sites in the United States.
Following Institutional Review Board (IRB) approvals and clinical site activations, first participant dosing in
Regimen I was achieved in February 2026.
In May 2026, Regimen I was expanded from 160 to 240 participants to maintain the trial’s original statistical
power, in the absence of a concurrent regimen. Importantly, the expansion was achieved with no change to
Neurizon’s funding requirement through to topline readout, in part as a result of philanthropic funding from the
Sean M. Healey & AMG Center for ALS. Subsequent to year end, on 17 July 2026, the Company advised that
Regimen I had completed enrolment in under five months from first participant dosing, with a total of 250
participants. This marked the fastest site activation and enrolment of any regimen in HEALEY’s history, with
topline efficacy and safety results now anticipated in late Q2 CY2027.
Neurizon Therapeutics Annual Report 2026 11
Neurizon Therapeutics Limited
Directors' report
30 June 2026
Alongside strong clinical progress, Neurizon continued to build the scientific evidence base for NUZ-001 as a
potential platform therapy for other neurodegenerative diseases and to better understand the mechanism of
action. In October 2025, the Company presented preclinical and trial-methodology research at the NEALS
Annual Meeting, highlighting NUZ-001’s brain penetration and reduction of TDP-43 aggregation. In March 2026,
new preclinical data presented at the American Society for Experimental NeuroTherapeutics (ASENT) Annual
Meeting demonstrated NUZ-001’s activity in Huntington’s disease models, including restoration of Brain-Derived
Neurotrophic Factor (BDNF) levels, reduced apoptosis and enhanced autophagic markers in human neuronal
systems. This was followed by delivery of additional data showing NUZ-001 activated the ubiquitin proteasome
pathway – a complementary protein clearance mechanism to autophagy – reinforcing the Company’s hypothesis
of a differentiated, multi-pathway approach to restoring protein homeostasis in neurodegenerative disease. In
June 2026, at the BIO International Convention, Neurizon presented additional mechanism-of-action data
demonstrating preservation of STMN2 expression in motor neurons and rebalancing of proteostasis across
neuronal models, further differentiating NUZ-001’s mechanism of action.
Manufacturing Process
Neurizon made significant progress in de-risking NUZ-001’s manufacturing and supply pathway during the
period. Having procured 100 kilograms of GMP-manufactured NUZ-001 and launched a manufacturing
campaign with Catalent in the prior year, the Company completed production of three GMP registration batches
of NUZ-001 tablets during the December 2025 quarter, using full-scale commercial processes compliant with
FDA and ICH requirements. Produced at a one-tenth commercial scale, these batches will underpin long-term
stability studies, shelf-life determination and the Chemistry, Manufacturing and Controls (CMC) module of
Neurizon’s planned New Drug Application (NDA) with the FDA.
This manufacturing progress was supported by Neurizon’s global licensing agreement with Elanco Animal
Health (Elanco), executed on 1 July 2025, which provided the Company with exclusive access to the group’s
comprehensive package of non-clinical animal safety and GMP manufacturing data for monepantel, the active
pharmaceutical ingredient in NUZ-001. Building on this agreement, in November 2025, Elanco's appointment of
Ms Justine Conway (previously Elanco’s Head of Business Development) as a Board Observer to Neurizon and
in December 2025 Elanco participated in an equity placement undertaken by Neurizon, becoming one of the
Company’s top five shareholders. Further, in June 2026, Neurizon executed a long-term, strategic supply
agreement with Elanco, securing GMP-compliant supply of human health specification GMP monepantel over
an initial five-year term. The license agreement and long-term supply agreement, materially reduce Neurizon’s
manufacturing and supply-chain risk and strengthen the Company’s commercial and regulatory readiness.
Strengthened Intellectual Property (IP) Portfolio
Neurizon further strengthened its global IP position during the period. In October 2025, the Company was
granted an Australian patent covering NUZ-001 for the treatment of neurodegenerative diseases, including
ALS/MND, Alzheimer’s disease, Huntington’s disease and Parkinson’s disease, providing protection through to
May 2041 and complementing the expedited US method of use patent granted in the prior year.
Neurizon also completed registered trademark protection for the NEURIZON® brand across all priority global
commercial markets, including t
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