Neurizon Therapeutics Limited · ASX:NUZ
Neurizon Therapeutics — Investor Presentation (December 2025)
53 slides from Neurizon Therapeutics's investor presentation, Dec 23, 2025
Slide 1: Equity Raising Presentation
Not for release to US wire services or distribution in the United States Equity Raising Presentation 23 December 2025 ABN 35 094 006 023
Slide 2: Important notice and disclaimer
Important notice and disclaimer This following notice and disclaimer applies to this presentation and the information contained in it. You are The Company reserves the right to update, amend or supplement the information at any time in its absolute advised to read this carefully before reading or ma
Slide 3: Important notice and disclaimer
Important notice and disclaimer This presentation has been prepared without taking into account the objectives, financial or tax situation or needs of None of the Company or any of the other Limited Parties act, or are responsible, as a fiduciary to you, your directors, any person. Any references to
Slide 4: Important notice and disclaimer
Important notice and disclaimer Future performance and forward-looking statements Foreign jurisdictions This presentation may contain forward-looking statements about the Company, including reference to certain This presentation does not constitute or form a part of any offer or solicitation to purc
Slide 5: Important notice and disclaimer
Important notice and disclaimer Key investment risks There are a number of risks specific to the Offer, Neurizon and of a general nature which may affect the future operating and financial performance of Neurizon and the value of an investment in Neurizon. An investment in New Shares under the Offer
Slide 6: Our Vision
Our Vision To lead the development of neurodegenerative treatments towards a promising new horizon for patients.
Slide 7: Our Promise
Accelerating Patient Driving Hope and Access to Clinical Our Promise Innovative ALS Progress Treatment Unlocking the potential Delivering commercial of Neurizon to address readiness and high unmet need in stakeholder neurodegenerative value diseases
Slide 8: Neurizon & The Science Behind It
Neurizon & The Science Behind It
Slide 9: Corporate Overview
Corporate Overview Mid-stage biotechnology company targeting human neurodegenerative diseases Share Price Performance Capital Structure (AUD$) 18 December 2025 Current Share Price (NUZ/NUZOA) $0.11/ $0.02 Closing Price (AUD$) Volume (m) 52 Week Low / High (NUZ) $0. 096/ $0.175 0.50 6 No. of Shares (
Slide 10: Meet Our Board of Directors
Meet Our Board of Directors Sergio Duchini Dr Michael Thurn Dr Katie MacFarlane Marcus Hughes Chairman & Non-Executive Director Managing Director & Chief Executive Non-Executive Director Non-Executive Director Sergio serves as a Non-Executive Director Michael has over 25 years experience in technica
Slide 11: Meet Our Executive Team
Meet Our Executive Team Dr. Michael Thurn Dan O’Connell Dr Jeffrey M. Brown Sharon Tamir John Clark Managing Director & Chief Finance Officer Chief Scientific Advisor ALS Program Lead Chief Operating Officer Chief Executive Officer Dan has over 20 years of Dr Brown brings over two decades Sharon is
Slide 12: From Humble Beginnings
From Humble Beginnings Scientific reappraisal of an approved veterinary product uncovered a new pharmacology for neurodegenerative disease Potential Platform NUZ-001 Therapy for Neurodegenerative Antihelminth Phase 1 ALS POC Diseases Approved Anticancer Autophagy Activator Long-term safety and signa
Slide 13: Global License with Elanco
Global License with Elanco Exclusive global rights to Elanco’s data package and intellectual property LICENSE AGREEMENT1 SUPPLY AGREEMENT License Agreement: A foundational step in formalising Neurizon’s Supply Agreement: Agreed and planned next step in further expanding relationship with Elanco. Cri
Slide 14: NUZ-001: A Platform Molecule for Proteinopathy-Driven Diseases
NUZ-001: A Platform Molecule for Proteinopathy-Driven Diseases Impaired proteostasis contributes to the formation of intracellular inclusion bodies of misfolded proteins, 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 A
Slide 15: Our Strategic Progress
Our Strategic Progress Focus is on advancing ALS clinical program by commencing enrolment in the HEALEY ALS Platform Trial (Phase 2/3) Drug / Approved/ Next Major Partnerships & Licensing Indication Preclinical Phase 1 Phase 2 Phase 3 Dosage Form Marketed Catalysts Accelerated • HREC/IRB Approval Pi
Slide 16: Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis Urgent need for life-changing therapies Neurodegenerative disorder that primarily affects motor neurons, typically fatal within 2-5 years of symptom onset, with currently no disease modifying therapeutics on the market. This is in part due to the complexity of the disor
Slide 17: TDP-43 Aggregates are a Hallmark of ALS Pathology
TDP-43 Aggregates are a Hallmark of ALS Pathology Protein aggregates are cleared by multiple pathways including autophagy-lysosomal and ubiquitin-proteasome systems. Together these systems help to maintain proteostasis ALS Patient Population Spinal Cord Clearance of misfolded proteins in healthy mot
Slide 18: Phase 1 ALS MEND and Open Label Extension (OLE) Study Design
Phase 1 ALS MEND and Open Label Extension (OLE) Study Design The Phase 1 MEND Study was an open-label, multicentre study involving 12 patients with ALS that commenced in October 2022 and provided patients with ongoing access to NUZ-001 through a compassionate-use program and later a 12-month open-la
Slide 19: Phase 1 Open Label Extension
Phase 1 Open Label Extension Safety and Tolerability Summary Study drug was well tolerated during long-term administration in the OLE, with no dose- limiting toxicities and no treatment-related deaths. Total (n) Related to Treatment (n) Adverse Events 25 3 Serious Adverse Events 5 0 • No participant
Slide 20: Phase 1 Open Label Extension: Preliminary Efficacy
Phase 1 Open Label Extension Preliminary Efficacy ALSFRS-R and SVC 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 dat
Slide 21: Phase 1 Open Label Extension: Survival Probability Analysis
Phase 1 Open Label Extension Survival Probability Analysis Compared to matched controls from the PRO-ACT, treatment with NUZ-001 resulted in a significantly (X2=13.75, p=0.00021) longer survival of patients with ALS > Doubled Life Expectancy (X2=13.75, p=0.00021) Reduced risk of 76.7% death Hazard r
Slide 22: Demonstrating Meaningful Progress: FY 2026 Milestones
Demonstrating Meaningful Progress: FY 2026 Milestones Executed NUZ-001 IND First Preliminary Australian Global License Opened, clearing registration R&D Funding Patent Agreement the path to batch of received granted for with Elanco HEALEY NUZ-001 NUZ-001 – Expiry 2041 PACTALS & NEALS Successfully ra
Slide 23: Entering The Next Phase Of Value Creation: HEALEY ALS Platform Trial
Entering The Next Phase Of Value Creation: HEALEY ALS Platform Trial
Slide 24: HEALEY ALS Platform Trial
HEALEY ALS Platform Trial NUZ-001 selected for entry into the HEALEY ALS Platform Trial HEALEY ALS Platform Trial is a competitive process led by a group of expert ALS scientists and members of the Healey Science Advisory Committee HEALEY ALS Platform Trial Design Innovative Trial Structure FDA appr
Slide 25: HEALEY ALS Platform Trial Regimen 'I' for NUZ-001
HEALEY ALS Platform Trial Regimen ‘I’ for NUZ-001 36-week Double blind Placebo 36-week Active Treatment Screening Period Controlled Period Extension Period NUZ-001 10 mg/kg Biomarkers DNA ALSFRS-R 3:1 Randomization NUZ-001 n=160 patients 10 mg/kg Placebo Primary Endpoint • Change from baseline throu
Slide 26: Regimen-I HEALEY ALS Platform Trial Expected Key Milestones
‘Regimen-I’ HEALEY ALS Platform Trial Expected Key Milestones IND Amendment Submission Q4 2025 1 Platform Trial IND submitted to regulatory authorities FDA Clearance FDA cleared NUZ-001 entry accepted 2 Q4 2025 NUZ-001 for entry into HEALEY ALS Platform First Patient Screened Q1 2026 3 First patient
Slide 27: Accelerated & Streamlined Path to NDA and Launch
Accelerated & Streamlined Path to NDA and Launch Elanco License Agreement Sample 1 • Strengthens NDA readiness MODULE 1 Elanco License • Reduces development cost Text Admin Agreement • Supports accelerated timeline & launch readiness Sample 2 MODULE 2 • Comprehensive non- • Complete API GMP document
Slide 28: Potential Near-Term Milestones
Potential Near-Term Milestones • HEALEY ALS Platform Trial– Site Activation • 43 J.P. Morgan Annual Healthcare Conference rd • Australian R&D Refund (net of R&D funding) • HEALEY ALS Platform Trial – First Patient Dosed • Additional Preclinical Updates • Additional Preclinical Updates • FDA Fast Tra
Slide 29: HEALEY Funding Strategy
HEALEY Funding Strategy Focused on flexibly and efficiently securing adequate funding for the HEALEY ALS Platform Trial Neurizon’s strategy is to efficiently secure adequate funding for the HEALEY ALS Platform Trial, to enable the Company to commit to it1. The strategy is focused on protecting share
Slide 30: The Offer
The Offer
Slide 31: Offer Overview
Offer Overview Offer Structure Up to ~A$24.2 million via the issue of up to ~303.4 million new fully paid ordinary shares in the Company (“New Shares”) comprising: • an ~A$7.1 million placement via the issue of ~89.1 million New Shares to certain eligible institutional, sophisticated or professional
Slide 32: Sources & Use of Funds
Sources & Use of Funds Neurizon is focused on efficiently delivering an outcome from the HEALEY ALS Platform Trial, including significantly reducing spend on non-core costs. The below table, excluding any funds raised from the Entitlement Offer, shows the sources and uses of funds to the expected to
Slide 33: Indicative Timetable
Indicative Timetable1 Trading Halt Friday, 19 December 2025 Trading Halt Lifted and Return to Trading on the ASX, Announce Results of Placement, Announce Entitlement Tuesday, 23 December 2025 Offer Entitlement Offer ‘Ex’ Date Monday, 29 December 2025 Entitlement Offer Record Date Tuesday, 30 Decembe
Slide 34: Convertible Note Facility
Convertible Note Facility
Slide 35: Convertible Note Facility
Convertible Note Facility Neurizon has executed an agreement with Obsidian Global GP, LLC (“Obsidian”) to establish a convertible note facility which will provide committed convertible note funding enabling drawdowns up to an aggregate of A$20 million1 over two years from date of first purchase2 (“C
Slide 36: Convertible Note Facility – Key Terms
Convertible Note Facility – Key Terms Matter Detail Matter Detail Convertible Note The Company may create and issue convertible notes convertible into Shares (“Convertible Notes”). The Investor agrees to subscribe Interest No interest is payable on the Convertible Notes. Facility for the Convertible
Slide 37: Convertible Note Facility – Key Terms
Convertible Note Facility – Key Terms Matter Detail Matter Detail Conditions Conditions precedent in respect of each transaction contemplated in the Convertible Note Facility include: Events of • the Convertible Note Facility or a transaction contemplated by such agreement has become, or is claimed
Slide 38: Convertible Note Facility – Key Terms
Convertible Note Facility – Key Terms Matter Detail Effect of event • Upon the occurrence of an event of default or potential event of default, the Investor may, by notice to the of default Company, postpone any subsequent conversion, for such time as it continues (or a shorter period of time, in (c
Slide 39: Risks
Risks
Slide 40: Risks
Risks This section describes some of the potential risks associated with an investment in the Group. An investment in the Group is subject to risks specific to the Group and its business and is also subject to general risks. Each of these risks could, if they eventuate, have a material adverse impac
Slide 41: Risks: Offer and Funding Specific Risks
Risks Offer and Funding Specific Risks Dilution risks of Offer Shareholders will be diluted by the issue of New Shares under the Placement. As the Entitlement Offer is non-renounceable, entitlement rights under the Entitlement Offer cannot be traded on ASX or otherwise transferred. Eligible sharehol
Slide 42: Risks
Risks Research & Development (R&D) tax incentive risk The Company may claim the R&D tax incentive by the Australian Government to support its ongoing research and development activities. Whilst the Company is not aware of any reason why it would not be eligible to receive the R&D tax incentive rebat
Slide 43: Risks: Company Specific Risks
Risks Company Specific Risks Clinical development risk The Company's lead product candidate, NUZ-001, is undergoing further clinical trials for the treatment of human neurodegenerative diseases (including as a proposed participant of the HEALEY ALS Platform Trial for Phase 2/3 studies). Clinical tri
Slide 44: Risks
Risks Regulatory risk The development and commercialisation of NUZ-001 is subject to extensive regulation by regulatory authorities and institutions (including clinics and hospitals) across multiple jurisdictions. Obtaining regulatory approval is a lengthy, costly, and uncertain process. Even with p
Slide 45: Risks
Risks Competition risk The biotechnology and pharmaceutical industries are highly competitive and subject to rapid and significant technological change, both in Australia and internationally. There are no guarantees about the Company’s ability to successfully compete. The Company's products will com
Slide 46: Risks
Risks Intellectual property risk The Company’s success is partly dependent on its ability to secure and maintain intellectual property rights, including patents, trademarks, trade secrets, and other proprietary information over NUZ-001 and other products it develops in the future, and to enforce suc
Slide 47: Risks
Risks Reliance on key personnel (continued) Given the nature of the Company’s activities, its ability to continue the development of NUZ-001 and other drug candidates in the future is dependent on its ability to attract and maintain appropriately qualified personnel either within the Company or thro
Slide 48: Risks
Risks IT system failure and cyber security risk Any information technology (“IT”) system is potentially vulnerable to interruption and/or damage from a number of sources, including but not limited to computer viruses, cyber security attacks and other security breaches, power, systems, internet and d
Slide 49: Risks: General Risks
Risks General Risks Nature of Investment Potential investors should consider that an investment in the Company is speculative and should consult their professional advisers before deciding whether to apply for securities pursuant to this presentation. General economic conditions Factors such as infl
Slide 50: Risks
Risks Tax risk The acquisition and disposal of Shares will have tax consequences, which will differ depending on the individual financial affairs of each investor. All potential investors in the Shares are urged to obtain independent financial advice about the consequences of acquiring Shares from a
Slide 51: International Offer Restrictions
International Offer Restrictions
Slide 52: International Offer Restrictions
International Offer Restrictions This presentation does not constitute an offer of New Shares of the Company in any jurisdiction in which it would be unlawful. In particular, this presentation may not be distributed to any person, and the New Shares may not be offered or sold, in any country outside
Slide 53: International Offer Restrictions
International Offer Restrictions United Kingdom Neither this presentation nor any other presentation relating to the offer has been delivered for approval to the Financial Conduct Authority in the United Kingdom and no prospectus (within the meaning of section 85 of the Financial Services and Market
Neurizon Therapeutics — Investor Presentation (December 2025) on 6ix