Presentation Materials - Licensing Agreement Webinar
Released
Released
Announcement PDF
Neurizon Therapeutics Limited
ABN 35 094 006 023
www.neurizon.com
Presentation Materials – Shareholder Webinar on Licensing Agreement
02 July 2025 – Melbourne, Australia: Neurizon® Therapeutics Limited (ASX: NUZ & NUZOA) (“Neurizon” or “the
Company”), a clinical-stage biotech company dedicated to advancing innovative treatments for neurodegenerative
diseases, is pleased to release the presentation slides accompanying today’s shareholder webinar, which will
provide an update on the Company’s recent strategic milestone — the global license agreement with Elanco Animal
Health.
The presentation provides an overview of:
Overview of the Global Licensing Agreement with Elanco
The significance of the agreement in accelerating regulatory and commercial readiness for NUZ-001
How this milestone strengthens Neurizon’s strategic position across clinical development, patient access,
and manufacturing
The Company’s forward strategy and key milestones
Presentation slides are available as an attachment to this announcement. The recording of the presentation will be
made available on Neurizon’s website at www.neurizon.com.
-ENDSThis announcement has been authorized for release by the Board of Neurizon Therapeutics Limited.
For further information, please contact:
Dr. Michael Thurn
Managing Director and Chief Execufive Officer
Neurizon Therapeufics Limited
enquiries@neurizon.com
+61 (3) 9692 7222
Lidija Damjanovic
Head of Markefing and Corporate Affairs
Neurizon Therapeufics Limited
lidija@neurizon.com
+61 (0) 425 700 504
Released through: Henry Jordan, Six Degrees Investor Relations, +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.
Neurizon Investor Hub
We encourage you to ufilise our Investor Hub for any enquiries regarding this
announcement or other aspects concerning Neurizon.
This plafform offers an opportunity to submit quesfions, share comments, and view
video summaries of key announcements.
To access Neurizon Investor Hub please scan the QR code or visit
hftps://investorhub.neurizon.com
Neurizon® is a registered trademark of Neurizon Therapeutics Limited
Suite 2, Level 11, 385 Bourke Street, Melbourne, VIC 3000 Tel: +61 3 9692 7222
Shaping the future of
neurodegenerative diseases
Elanco Licensing Agreement Webinar
02 July 2025
ASX: NUZ
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.
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.
Neurizon® is a registered trademark of Neurizon Therapeutics
Elanco Licensing Agreement Webinar, July 2025
2
Our vision is to lead the development of neurodegenerative
treatments towards a promising new horizon for patients
3
Our mission is to advance innovative, disease-modifying therapies that address the
underlying pathology and drivers of neurodegenerative conditions
Our success is underpinned by a clear strategic focus on:
Elanco Licensing Agreement Webinar, July 2025
4
NUZ-001: A Platform Molecule for Proteinopathy-Driven Diseases
Impaired proteostasis contributes to intracellular inclusion bodies of misfolded proteins is a hallmark of
neurodegenerative diseases
TDP-43
Amyloid beta
Tau
alpha Synuclein
mHTT
ALS/AD/PD/FTD/CTE
AD/PD
AD/PD/FTD/CTE/PSP
AD/PD
HD
NUZ-001 represents a mechanism-driven, disease-agnostic approach to treating
neurodegeneration by rebalancing proteostasis and reversing 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
Elanco Licensing Agreement Webinar, July 2025
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Our Strategic Progress
Our initial focus is on advancing clinical work on ALS, following acceptance into the HEALEY ALS Platform
Trial
Regulatory and Commercialisation Requirements for Realisation
• Access to animal safety data and manufacturing data critical to
• Access to manufacturing at scale critical to future
support future trials and potential regulatory approvals
commercialisation
FDA
Accelerated
approval
possible on
Phase 2 data
Elanco Licensing Agreement Webinar, July 2025
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Global License with Elanco
Exclusive global rights to Elanco’s data package and intellectual property
LICENSE AGREEMENT
SUPPLY AGREEMENT
License Agreement: A foundational step in formalising Neurizon’s
relationship with Elanco. Critical to future global regulatory approval and
commercialization.
Supply Agreement: Agreed and planned next step in further expanding
formalisation of Neurizon’s relationship with Elanco.
License: An exclusive global licensing agreement providing worldwide rights
to utilise Elanco’s intellectual property for the treatment, palliation,
prevention, or cure of neurodegenerative diseases in humans.
Indicative Terms: Nominal upfront fee with additional approval and sale
milestones1 and tiered single digit royalty on sales.
Status: License Agreement outlines key terms for the conclusion of a
Supply Agreement, including duration and price. Supply Agreement
expected to be finalised prior to the end of CY2025.
Expected Outcome: Supply Agreement expected to provide access to a
long-term, scalable source of GMP-compliant monepantel, the active
pharmaceutical ingredient in NUZ-001.
Clear pathway for accelerated global commercialization and a de-risking of global regulatory approval
1 Refer to the ASX announcement dated 02 July 2025
Elanco Licensing Agreement Webinar, July 2025
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Accelerated & Streamlined Path to NDA and Launch
Elanco Licensing Agreement
Module 1
Administrative
Module 2
Summary
Documents
Fast Track Designation
allows for rolling submission
of completed modules
Module 3
Quality
Module 4
Non-Clinical
Module 5
Clinical
01 Comprehensive non-clinical safety
License Agreement
package
02 Complete API GMP documentation of
• Strengthens NDA readiness
• Reduces development cost
• Supports accelerated timeline
& launch readiness
the manufacturing process for the FDA
03 Improves alignment with FDA module
expectations
04 De-risked regulatory approval process
Elanco Licensing Agreement Webinar, July 2025
8
FDA Review
Progressing Toward Clinical Hold Resolution: PK Studies in Progress /
Complete Response on Track
Regulatory Support
PK Studies
•
•
•
•
•
The FDA continues to review our strategy to address the clinical hold
Neurizon remains engaged and responsive to agency requests
Two pharmacokinetic studies placed at leading CRO
Studies ahead of schedule; treatment phase complete
Study reports expected in July CY2025
Next Steps
Momentum
•
•
•
Complete response package for clinical hold progressing as planned
Clinical hold clearance expected following completion of PK studies
Progressing startup activities towards HEALEY ALS Platform Trial
inclusion and broader clinical advancement
PK Studies
Initiated
PK Studies
Completion
FDA Submission
& Hold Lift
HEALEY Trial
First Patient In
Top Line Results
Expected
April CY2025
June CY2025
July/August
CY2025
H2 CY2025
H1 CY2027
Note: Timelines indicative and subject to regulatory and operational variation
Commercialisation
Readiness
CY2028
Elanco Licensing Agreement Webinar, July 2025
9
Investment credentials for NUZ-001
De-risked clinical program for a rare neurodegenerative disease positioned for near-term
regulatory approval and launch
Well-characterized Drug
✓
• Oral bioavailable
• Crosses the Blood Brain Barrier
• “Rediscovered” veterinary drug
Restores Proteostasis
✓
✓
• Promising Phase 1 data
• Accepted into HEALEY ALS Platform Trial
• Access to extensive data and IP
• Supply Agreement
Near-term Regulatory
Strategy
✓
• Targets the underlying
pathology – protein
aggregation
• Multiple indications possible
Clinical POC
Strategic Agreements
•
FDA accelerated approval possible
• Multiple regulatory designations
• High deal flow for neurology assets
✓
✓
Strong IP Position
• Patent protection out to 2039
• World class team assembled to maximise
IP
Elanco Licensing Agreement Webinar, July 2025
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Thank You
Registered Address:
Suite 2, Level 11, 385 Bourke Street
Melbourne VIC 3000 Australia
+61 (3) 9692 7222
enquiries@neurizon.com
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