Australian Microcap Investment Conference Presentation
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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
Australian Microcap Investment Conference presentation
11 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 presentation to be delivered at the 15th Annual Australian
Microcap Investment Conference, being held in Sydney, Australia on 11 May 2026.
The presentation will be delivered by Chief Operating Officer, Mr John Clark, and forms part of Neurizon’s ongoing
investor engagement activities aimed at increasing awareness of the Company’s clinical development programs,
strategic progress and upcoming milestones among Australian and international investors.
The Australian Microcap Investment Conference is one of Australia’s leading investment conferences focused on the
microcap sector, bringing together members of the investment community to hear directly from ASX-listed
companies with market capitalisations under A$300 million. Following its long-standing success in Melbourne, the
conference has expanded to Sydney in 2026.
The presentation provides an overview of Neurizon’s development activities for NUZ-001, including recent
recruitment progress in the HEALEY ALS Platform Trial, operational execution, and upcoming clinical and corporate
milestones.
The presentation slides are attached to this announcement.
-ENDS-
This announcement has been authorised for release by Sergio Duchini, Interim Executive Chairman on behalf of the
Board of Neurizon Therapeutics Limited.
For any questions, comments, or further information regarding Neurizon, please email enquiries@neurizon.com,
or contact:
Marketing & Corporate Affairs
Lidija Damjanovic
Marketing & Corporate Affairs
Email: lidija@neurizon.com
Phone: +61 (0) 425 700 504
Investor Relations
Henry Jordan
Six Degrees Investor Relations
Email: henry.jordan@sdir.com.au
Phone: +61 (0) 431 271 538
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
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
Neurizon Therapeutics
John Clark, Chief Operating Officer
Australian Microcap Investment Conference
May 2026, Sydney
A promising new horizon in
neurodegenerative diseases
Disclaimer
This disclaimer applies to this presentation and the information contained in it (This presentation has been
prepared by Neurizon Therapeutics Limited (ASX: NUZ) (the “Company”)). It does not purport to contain all the
information that a prospective investor may require in connection with any potential investment in the Company.
You should not treat the contents of this presentation, or any information provided in connection with it, as
financial advice, financial product advice or advice relating to legal, taxation or investment matters.
No representation or warranty (whether express or implied) is made by the Company or
any of its officers, advisers, agents or employees as to the accuracy, completeness or reasonableness of the
information, statements, opinions or matters (express or implied) arising out of, contained in or derived from this
presentation or provided in connection with it, or any omission from this presentation, nor as to the attainability
of any estimates, forecasts or projections set out in this presentation.
This presentation is provided expressly on the basis that you will carry out your own independent inquiries into
the matters contained in the presentation and make your own independent decisions about the affairs, financial
position or prospects of the Company.
The Company reserves the right to update, amend or supplement the information at any time in its absolute
discretion (without incurring any obligation to do so).
Neither the Company, nor its related bodies corporate, officers, their advisers, agents and employees accept any
responsibility or liability to you or to any other person or entity arising out of this presentation including pursuant
to the general law (whether for negligence, under statute or otherwise), or under the Australian Securities and
Investments Commission Act 2001, Corporations Act 2001, Competition and Consumer Act 2010 or any
corresponding provision of any Australian state or territory legislation (or the law of any similar legislation in any
other jurisdiction), or similar provision under any applicable law. Any such responsibility or liability is, to the
maximum extent permitted by law, expressly disclaimed and excluded.
Nothing in this material should be construed as either an offer to sell or a solicitation of an offer to buy or sell
securities. It does not include all available information and should not be used in isolation as a basis to invest in
the Company.
Australian Microcap Investment Conference 2
Future Matters
This presentation contains reference to certain intentions, expectations, future plans, strategy and prospects
of the Company. Those intentions, expectations, future plans, strategy and prospects may or may not be
achieved. They are based on certain assumptions, which may not be met or on which views may differ and
may be affected by known and unknown risks. The performance and operations
of the Company may be influenced by a number of factors, many of which are outside the control of the
Company. No representation or warranty, express or implied, is made by the Company, or any of its
directors, officers, employees, advisers or agents that any intentions, expectations or plans will be achieved
either totally or partially or that any particular rate of return will be achieved.
Given the risks and uncertainties that may cause the Company’s actual future results, performance or
achievements to be materially different from those expected, planned or intended, recipients should not
place undue reliance on these intentions, expectations, future plans, strategy and prospects. The Company
does not warrant
or represent that the actual results, performance or achievements will be as expected, planned or intended.
US Disclosure
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.
To lead the development
of neurodegenerative
treatments towards a
promising new horizon
for patients.
Our Vision
Accelerating Patient
Access to Innovative ALS
Treatment
Our Promise
Driving
Clinical
Progress
Unlocking the potential
of Neurizon to address
high unmet need in
neurodegenerative
diseases
Delivering commercial
readiness and
stakeholder
value
5
Australian Microcap Investment Conference
Neurizon: From Scientific Origin to Clinical Momentum
A unique opportunity in neurodegenerative diseases
Well characterised drug Disease-modifying potential Strong foundation Late-stage clinical execution
1 2 3 4 5
DISCOVERY & FOUNDATION CLINICAL VALIDATION &
HEALEY SELECTION
2005 - 2013
TRANSLATION TO HUMAN DISEASE
2013 - 2021
NEURIZON FORMATION
& STRATEGY
2022 - 2023 2024 - 2025
CLINICAL EXECUTION
2026 - 2027
Monepantel – a proven
veterinary product with
extensive safety and
pharmacology data
From veterinary use to potential in
neurodegenerative diseases
Building a focused clinical-stage company
with the clear focus on
neurodegenerative diseases
NUZ-001 Phase 1 results show early signals
of efficacy in a small study with people living
with ALS/MND and drive inclusion into
HEALEY trial
Active execution of
Registrational Phase 2/3 HEALEY
ALS Platform Trial
NUZ-001 is a well-characterised molecule, with novel neurodegenerative biology, and is now
advancing through a registrational Phase 2/3 clinical program
NUZ-001: Potential application to range of neurodegenerative diseases
6
TDP-43
ALS/AD/PD/FTD/CTE
Amyloid beta
AD/PD
Tau
AD/PD/FTD/CTE/PSP
alpha Synuclein
AD/PD
NUZ-001 is a mechanism-driven, disease-agnostic approach to treating
neurodegeneration by rebalancing proteostasis and addressing core cellular
dysfunction.
AD = Alzheimer’s Disease; ALS = Amyotrophic Lateral Sclerosis; CTE = Chronic Traumatic Encephalopathy; FTD =
Frontotemporal Dementia; HD = Huntington Disease; PD = Parkinson’s Disease; PSP = Progressive Supranuclear Palsy
ALS is a current priority, but NUZ-001 has potential application to a range of neurodegenerative diseases.
mHTT
HD
Australian Microcap Investment Conference
New preclinical data show NUZ-001 increases activity of multiple protein clearance
pathways in neuronal models: autophagy and proteasomal systems.
Phase 1
Access to manufacturing at scale critical
to future commercialisation
Access to animal safety data and manufacturing data critical to
support future trials and potential regulatory approvals
Strongly Positioned with Regulatory and Commercialisation Requirements for Realisation
Derisked regulatory
approval process
Drug /
Dosage Form
NUZ-001
Oral Tablets
NUZ-001
Liquid and Oral
Tablets
Phase 2/3
HEALEY ALS
Platform
Trial
Phase 1
Amyotrophic
Lateral Sclerosis
(Motor Neurone Disease)
HEALEY ALS Platform Trial
Indication Preclinical Phase 2 Phase 3
Approved/
Marketed
Potential for
accelerated
approval based on
Phase 2/3 data
Registrational adaptive
Phase 2/3 clinical study
7
HEALEY Trial: Opportunity for accelerated approval
Initial focus is ALS, a rare disease with high unmet need and the possibility of accelerated approval on
Phase 2/3 data. Potential for broader application being developed through pre-clinical program.
Australian Microcap Investment Conference
NUZ-001
Preclinical Neurodegenerative
Diseases
Amyotrophic
Lateral Sclerosis
(Motor Neurone Disease)
Phase 1 ALS MEND Study and
Open Label Extension
Early Signals of Efficacy
-2.93 -1.65
-5
-4.5
-4
-3.5
-3
-2.5
-2
-1.5
-1
-0.5
0
PRO-ACT Matched Controls
(n=420) NUZ-001 (n=12)
Phase 1 Open Label Extension
Preliminary Efficacy ALSFRS-R and SVC
9
Treatment with NUZ-001 across combined Phase 1 and OLE studies slowed the progression of ALS in all patients by 31% for ALSFRS-R and 43% for SVC percent
predicted (PP) when compared to matched controls from the PRO-ACT historical database1
1. Atassi N, Berry J, Shui A, Zach N, Sherman A, Sinani E, Walker J, Katsovskiy I, Schoenfeld D, Cudkowicz M, Leitner M. The PRO-ACT database: design, initial analyses, and predictive features.
Neurology. 2014 Nov 4;83(19):1719-25. doi: 10.1212/WNL.0000000000000951.Epub 2014 Oct 8. PMID: 25298304; PMCID: PMC4239834
2. Forced vital capacity (FVC) was used when SVC was not collected
3. Matched on time since onset, baseline ALSFRS-R, pre-baseline slope, and disease onset location
Difference
1.27 points/month (p=0.078)
43%
Respiration – SVC PP2
-1.21 -0.83
-2
-1.8
-1.6
-1.4
-1.2
-1
-0.8
-0.6
-0.4
-0.2
0
PRO-ACT Matched Controls
(n=360) NUZ-001 (n=12)
ALSFRS-R
Slope
(points/month)
Motor Function – ALSFRS-R
Difference
0.37 points/month (p=0.145)
31%
3 3
Australian Microcap Investment Conference
VC
PP
Slope
(points/month)
Phase 1 Open Label Extension
Survival Probability Analysis
10
Compared to matched controls from the PRO-ACT database, treatment with NUZ-001 results in significantly longer survival of patients with ALS
(X2=10.95, p=0.00094) .
Analysis Method Log-Rank Test Cox Proportional Hazards Model
Dataset
Death Time
Imputation
χ2 p-value
Hazard
Ratio
95% CI p-value
Assumed
Survival
Leave out
Last Visit
10.9
5
11.9
8
0.00094
0.00054
0.298
0.287
(0.135, 0.659)
(0.131, 0.632)
0.0028
0.0019
Confirmed
Survival
Leave out
Last Visit
16.6
7
18.4
3
0.00004
0.00002
0.266
0.254
(0.126, 0.561)
(0.121, 0.534)
0.0005
0.0003
Hazard ratio of 0.298 (95% CI: (0.135, 0.659), p = 0.0028) suggests that treatment with NUZ-001 reduces the risk of death by 70.2%
Australian Microcap Investment Conference
11
Phase 1 Open Label Extension
Safety and Tolerability Summary
Study drug was shown to be safe and generally well tolerated during long-term administration in
the OLE, with no dose-limiting toxicities and no treatment-related deaths.
• No participants withdrew from study
• No serious adverse events related to study drug (Raised liver enzyme, Increased
hair growth, Dry mouth at night)
• No unexpected safety findings observed in the OLE compared with Phase 1 MEND
• 3 patients still receiving treatment under the TGA’s Special Access Scheme
Total (n) Related to Treatment (n)
Adverse Events 25 3
Serious Adverse Events 5 0
Australian Microcap Investment Conference
Registrational Phase 2/3
HEALEY ALS Platform Trial
HEALEY ALS Platform Trial Regimen ‘I’ for NUZ-001
13
Inclusion/Exclusion Criteria
36-week Double Blind Placebo
Controlled Period
36-week Active Treatment
Extension Period
3:1 Randomisation
n=160 participants
Primary Endpoint
• Change from baseline through Week 36 in disease severity,
measured by the ALSFRS-R total score and survival
Secondary Endpoints
• Change from baseline through Week 36 in secondary efficacy
measures (e.g., respiratory function via slow vital capacity (SVC))
• Survival through Week 36 (death or equivalent endpoint)
NUZ-001
10 mg/kg
Placebo
NUZ-001
10 mg/kg
Australian Microcap Investment Conference
14
‘Regimen-I’ HEALEY ALS Platform Trial Expected Key Milestones
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
Anticipated Trial Execution Updates
Site Activation Confirmation of additional clinical sites opened and recruitment underway
Enrolment Milestones Achieved Progress updates on patient recruitment (e.g., 50% enrolled, enrolment complete)
Completion Milestones Last Patient In (LPI) and Last Patient Last Visit (LPLV), with timing guidance for topline data release
Australian Microcap Investment Conference
Strong Recruitment Momentum
59 62
123 48
15
Activated Sites
Master Screening Dosed Participants
Regimen Assignment
Australian Microcap Investment Conference
Numbers referred to above are as of 5 May 2026.
Investment Potential
Placement & Entitlement Offer
• Raised ~A$7.1 million under the
Placement, through issue of New
Shares at A$0.08 per New Share for
the HEALEY ALS Platform Trial
• 2-for-5 Entitlement Offer at A$0.08
per New Share, which raised a total
of A$8.5 million through the
entitlement offer (January 2026) and
the shortfall placement (April 2026).
Research & Development
(R&D) Tax Rebate
• Neurizon’s Advance and
Overseas Finding (AOF) provides
a cash rebate for foreign R&D
spend
• Cash rebate of at least 43.5% on
HEALEY spend
• AOF is binding on Australian Tax
Office and AusIndustry -
providing an important, non-
dilutive source of funds
Convertible Note Facility
• Convertible Note Facility for up
to A$20 million with Obsidian
Global GP, LLC
• Initial draw of A$5 million
completed in February 2026
• Committed facility - option but
no obligation to use remaining
A$15 million in the facility
• Includes trading restrictions to
protect shareholder and
optionholder interests
Neurizon’s funding strategy has been developed with a focus on protecting shareholders’ interests through flexible funding
instruments and minimising dilution. This includes the ability to finance the company’s R&D rebate receivables and the ability to
displace the convertible note facility, if appropriate to do so.
17
HEALEY: Funding secured
Strong shareholder support has secured adequate funding for HEALEY ALS Platform trial1
1 See ASX: NUZ - Equity Raising Presentation (23 December 2025), including details of funding strategy and identified risks.
Australian Microcap Investment Conference
18
ALS: High Unmet Need with Significant Value Potential
A serious, rapidly progressive disease with limited treatment options.
Meaningful innovation in ALS can create value for people living with ALS and the market.
~30,000+
people living with ALS in
the U.S only.1
Rapid progression
Median survival often 2–5
years from diagnosis²
High unmet need
Limited treatment options.
Need remains for therapies
addressing underlying
disease biology.
Aims to inhibit TDP-
43 aggregation and
restore proteostasis
(NUZ-001
mechanism of
action).
Addresses key ALS
pathology
Entered Phase 2/3
HEALEY ALS
Platform Trial.
Clinical-
stage
program
Exploring relevance in
other neurodegenerative
diseases with shared
pathology.
Multi-
Indication
potential
Convenient, scalable
formulation with the
potential for broad
patient access.
Oral
administration
NUZ-001
Investigational oral
therapy
Designed to address
key disease biology in
97% of people living
with ALS
WHY NUZ-001 IS RELEVANT
THE NEED IN ALS COMMERCIAL VALUE POTENTIAL
ALS market has demonstrated
significant strategic value
Multiple large-value transactions and
licensing deals in recent years.
Strong interest in differentiated therapies,
particularly with oral or disease-modifying
potential.
Appeared safe and generally well-tolerated
with signals of efficacy in exploratory studies
1. The ALS Association; www.als.org; accessed April 2026
2. Chio A, et al Prognostic factors in ALS: a critical review. Amyotroph Lateral Scler. 2009;10(5-6);310-323
Potential value drivers for Neurizon
Regulatory milestones
Partnership and licensing optionality
Pipeline expansion into HD and other
neurodegenerative diseases
Australian Microcap Investment Conference
ALS: High Unmet Need with Significant Value Potential
Australian Microcap Investment Conference 19
Multiple large-value transactions and deals in recent years
Key ALS Value Reference Point: Shionogi – RADICAVA US$2.5B Transaction
(April 2026)1
Transaction: Shionogi acquired global rights to RADICAVA (IV edaravone) and RADICAVA ORS
(oral edaravone) from Tanabe Pharma.
Deal value: US$2.5 billion upfront (lump sum), with potential additional royalties on future
sales (subject to conditions).
Timing: Announced 22 December 2025 and completed in early April 2026
Asset profile: A commercial, revenue-generating ALS therapy franchise with both IV and oral
formulations already in market.
Strategic rationale: Strengthened Shionogi’s rare disease commercial platform (especially US),
adding established programs/teams and readiness to launch additional rare disease
treatments.
Other Recent ALS Deals
Eli Lilly entered neurodegenerative disease collaborations with
Alchemab2 (2025; reported up to US$415M) and QurAlis3 (2024;
US$45M upfront plus potential milestones).
Eli Lilly and Verge Genomics4 entered an ALS discovery
collaboration in 2021. Public reports described potential
transaction economics of approximately US$694M.
Ferrer: Prilenia and Ferrer announced a strategic collaboration
and licensing agreement relating to pridopidine in 2025.5
1. Shionogi press release, 22 December 2025; transaction completion announced April
2026.
2. Alchemab Therapeutics press release, 6 May 2025
3. QurAlis press release, 3 June 2024
4. Fierce Biotech, 6 January 2021
5. Prilenia Therapeutics press release, 28 April 2025
2: mTOR pathway-related diseases
NUZ-001: Strong portfolio protection
2035 2040
2030
2025
2015 2020
Patent Families for monepantel
1: Human kinase inhibitor
3: Combinatorial treatments
4: API repurposing protection
5: Neurodegenerative diseases
What is protected:
• Key analogues of monepantel
• Optimised dosing, formulation and combo strategies
• Monepantel use in neurodegenerative and mTOR-related diseases
Protected Jurisdictions:
1. AU, CA, CN, EU, CH, HK, JP, SK, USA
2. AU, CA, CN, EU, CH, HK, JP, SK, USA
3. AU, CA, CN, EU, CH, HK, JP, SK, USA
4. AU, EU, CH, JP, USA
5. AU, USA; Pending: CA, EU, HK, JP
20
Australian Microcap Investment Conference
In addition to patent protection, NUZ-001 has US Orphan Drug Designation (ODD) and European Orphan
Medicinal Product Designation (OMPD) providing 7 and 10 years of market exclusivity, respectively.
21
FDA
EMA
PMDA
Orphan Drug Designation
Type C Meeting
Q2
2024
Q3
2026
HEALEY Topline
Results
H2 2027
Orphan Drug
Designation
Q4
2024
Scientific Protocol Advice Meeting
Q3
2026
General
Consultation
Q2
2026
ODD Application
H2
2026
JNDA Application
H2
2028
MAA Submission
H1
2028
NDA Submission
H1
2028
IND Clearance
Q3
2025
NUZ-001 Regulatory Strategy for ALS Market Access
Australian Microcap Investment Conference
Demonstrating Meaningful Progress
Successfully raised
$7.1m through a
share placement
22
Executed Global
License
Agreement with
Elanco
Regimen “I”
commenced in the
HEALEY ALS
Platform Trial
Successful
manufacture of
three registration
batches of NUZ-001
Received ~$6m
cash rebate from
R&D Tax Incentive
for FY2025
Promising
exploratory top-
line results from
Phase 1 and OLE
study
R&D Tax
Incentive Advance
& Overseas Finding
Approval
Raised $5.88m
through Entitlement
Offer to Eligible
Shareholders
Australian
Patent granted
for NUZ-001 –
Expiry 2041
Established a
$20m strategic
con note facility
with Obsidian
Secured registered
trademark
protection for
NEURIZON®
Australian Microcap Investment Conference
Strengthened
preclinical data and
understanding of the
MOA of
NUZ-001
23
What Comes Next in Our Growth Strategy
Australian Microcap Investment Conference
Potential Value Outcomes:
Our Focus Areas:
Ongoing clinical execution
Continued data generation
Progressing the Regulatory Pathway
Further strengthening of
scientific insight
Partnership expansion and opportunities
Clinical de-risking driving higher
probability of success
High-quality data generating
long-term value
Sustainable value creation for
shareholders
Stronger partnerships creating scale and
reach
Regulatory progress unlocking future
milestones and optionality
Q&A
Registered Address:
Suite 2, Level 11, 385 Bourke Street
Melbourne, VIC 3000 Australia
+61 (3) 9692 7222
enquiries@neurizon.com
THANK YOU
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