Announcement PDF Neurizon Therapeutics Limited / Appendix 4E 1. Company details Name of entity: Neurizon Therapeutics Limited (Formerly known as PharmAust Limited) ABN: Reporting period: Previous period: 35 094 006 023 For the year ended 30 June 2025 For the year ended 30 June 2024 2. Results for announcement to the market $ Other income up 117.3% to 1,882,037 Loss from ordinary activities after tax attributable to the owners of Neurizon Therapeutics Limited up 116.3% to (16,593,619) Loss for the year attributable to the owners of Neurizon Therapeutics Limited up 116.3% to (16,593,619) 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 $16,593,619 (30 June 2024: $7,673,153). Financial Position The net assets of the consolidated entity were $2,820,571 as at 30 June 2025 (30 June 2024: $10,228,243). 3. Net Tangible Asset Net tangible assets per ordinary security 30 June 2025 Cents 30 June 2024 Cents 0.57 2.30 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. i Neurizon Therapeutics Limited / Appendix 4E 7. Details of associates and joint venture entities Not Applicable 8. Foreign entities Details of origin of accounting standards used in compiling the report: All foreign entities are in compliance with IFRS which is equivalent to Australian Accounting Standards. 9. Audit qualification or review The 30 June 2025 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 2025 is attached. 11. Signed Signed ___________________________ Sergio Duchini Chairman ii Date: 25 August 2025 2025 Annual Report Hope on the Horizon Contents 02 Company Snapshot 04 Chairman’s Letter 06 Key Highlights 07 MD & CEO Letter 08 Financial report 70 Corporate directory Science‑led. Patient‑driven. Globally connected. Neurizon Therapeutics is a clinical‑stage biopharmaceutical company leading the development of neurodegenerative disease treatments towards a promising new horizon for patients. Our focus is resolute What’s on the horizon At Neurizon, everything we do is guided by our mission: to bring forward next‑generation treatments that make a real difference in the lives of patients and their loved ones living with neurodegenerative diseases. With strong global partnerships and a clear clinical pathway, we are building momentum toward regulatory milestones and long‑term value creation. Our goal is to create hope by delivering meaningful progress for people living with neurodegenerative diseases, and to advance innovative, disease‑modifying therapies that address the underlying pathology and drivers of neurodegenerative diseases like Amyotrophic Lateral Sclerosis (ALS), the major form of Motor Neurone Disease (MND), Huntington’s Disease (HD), and others. We are building more than a biotech company – we are creating a patient‑centered organisation grounded in scientific credibility, transparency, and authentic partnership with the communities we serve. Neurizon Therapeutics Annual Report 2025 In the coming months, our priority is to open our Investigational New Drug (IND) application with the U.S. FDA for NUZ‑001, enabling us to commence the HEALEY ALS Platform Trial in Q4 CY2025. This marks an important inflection point in our journey – bringing us closer to delivering a much‑needed, disease‑modifying therapy to people living with ALS/MND. Beyond ALS/MND, we are exploring the broader potential of NUZ‑001 as a platform therapy for multiple neurodegenerative diseases that share common pathological drivers. We continue to strengthen our preclinical and clinical data packages to support this expanded potential, while advancing regulatory strategies such as Fast Track Designation to accelerate development timelines. 01 Company Snapshot Reimagining Treatment for ALS/MND and Neurodegenerative Diseases At Neurizon Therapeutics, we are redefining how neurodegenerative diseases are treated – by addressing their root causes, not just symptoms. Our lead investigational therapy, NUZ‑001, is a novel, orally available small molecule designed to restore neuronal health by enhancing the brain’s innate protein clearance systems. NUZ‑001 targets shared pathological mechanisms – including TDP‑43 protein aggregation, impaired autophagy, and STMN2 loss – with the potential to serve as a platform therapy across multiple neurodegenerative diseases. Early preclinical data in ALS/MND and Huntington’s disease support our belief in the broad therapeutic applicability of NUZ‑001. NUZ‑001 Mechanism of Action Stressor TDP‑43 TDP‑43 Aggregation Stathmin‑2 Lead Program: NUZ‑001 Indication: Amyotrophic Lateral Sclerosis (ALS) – the most common form of Motor Neurone Disease (MND) Mechanism of Action: NUZ‑001 targets shared pathological mechanisms – including TDP‑43 protein aggregation, impaired autophagy, and STMN2 loss Trials: Successfully completed Phase 1 MEND trial and Open‑Label Extension studies in Australia TDP-43 NUZ‑001 and NUZ‑001 Sulfone dose‑dependent reduces the aggregation of TDP‑43 and helps restore functional activity in M337V Motor Neurons derived from hiPSCs in co‑cultured in response to a stressor. TDP‑43 Lysosome Autophagy Investigating the effects of NUZ‑001 and NUZ‑001 Sulfone on autophagic flux and their ability to restore STMN2 loss in M337V Motor Neurons derived from hiPSCs in co‑cultured in response to a stressor. TPD‑43 = Transactive response DNA‑binding protein 43 hiPSCs = human induced Pluripotent Stem Cells STMN2 = Stathmin‑2 02 Preparing to commence participation in the HEALEY ALS Platform Trial in Q4 CY2025, pending the FDA clearance Patient Impact: 420,000+ affected by ALS alone Differen­ tiation: Strong signals of safety, tolerability and survival benefit data from Phase 1 and Open-Label Extension Studies. Every 90 minutes, someone is diagnosed and someone passes away from ALS Multi‑targeted mechanism addressing core ALS/MND disease pathology Potential to serve as a platform therapy across multiple neurodegenerative diseases Expedited U.S. method‑of‑use patent for NUZ‑001 in ALS/MND and other neurodegenerative diseases valid until 2041 De‑risked regulatory pathways enabling accelerated commercial readiness for NUZ‑001 Neurizon Therapeutics Annual Report 2025 A Clear Strategic Focus Neurizon’s FY25 activities were shaped by a clear, patient‑driven strategy designed to deliver maximum clinical, commercial, and patient impact. Underpinning our decisions is a long‑term mission: to deliver next‑generation treatments that make a real difference in the lives of people affected by neurodegenerative diseases. Our three pillars of progress 1 Advancing patient access This year, we moved closer to making NUZ‑001 available to those who need it most. We completed our Phase 1 and Open‑Label Extension studies, secured Orphan Drug Designation in the U.S., and started preparations for Australia’s Special Access Scheme. Each step brings us closer to delivering an innovative therapy to patients and families facing the urgent reality of ALS/MND. 2 3 Accelerating hope We are on the cusp of joining the HEALEY ALS Platform Trial – one of the most innovative ALS/MND research collaborations in the world. With Pharmacokinetic studies completed, Clinical Hold Complete Response submitted to the FDA, and our Regimen Specific Appendix finalised, we are ready to move quickly once the IND is opened. For patients who cannot afford to wait, every day we save matters. Unlocking potential ALS/MND is just the beginning. This year, new preclinical findings reinforced the potential of NUZ‑001 as a platform therapy across multiple neurodegenerative diseases by targeting shared disease drivers such as TDP‑43 aggregation, impaired autophagy, and STMN2 loss. By expanding the reach of our science, we aim to bring hope to even more patients living with devastating, neurodegenerative diseases. Partnership Ecosystem Research and Clinical Manufacturing and Development Advocacy and Patient Communities • • Ncardia • • • • • • NEALS Consortium • • • • Massachusetts General Hospital Berry Consultants Elanco Animal Health Catalent MND Australia FightMND I AM ALS ALS Association University of Queensland Tessara Therapeutics Neurizon Therapeutics Annual Report 2025 03 Chairman’s Letter Dear fellow shareholders, I am pleased to present Neurizon Therapeutics Limited’s 2025 Annual Report, which highlights significant momentum in our mission to advance the delivery of science-led neurodegenerative disease treatments. At the core of our purpose is an unchanging reality – neurodegenerative diseases are far-reaching and debilitating, and those affected do not have time to wait. For this reason, the Company approached the year with considerable urgency, achieving multiple milestones. These included key advancements in our regulatory and clinical development strategy, preclinical work which deepened the level of scientific confidence for our treatment portfolio, and ongoing preparations for late-stage development to establish commercial readiness for NUZ-001, our lead asset currently anchored in the treatment of Amyotrophic Lateral Sclerosis (ALS), the most common form of Motor Neurone Disease (MND). The strength of our clinical foundation and increased level of scientific confidence is best evidenced through the successful completion of our Phase I trial and Open-Label Extension study using NUZ-001, leaving the company well-positioned to participate in the HEALEY ALS Platform Trial in Q4 this year. This platform will provide a globally recognised, patient-centric and capital-efficient pathway to the delivery of Phase 2 data – the next key step in our clinical development pathway, prior to broader commercialisation opportunities. Our clinical program was complemented by the consistent delivery of strong preclinical results throughout the year. These detailed work programs allowed Neurizon to advance our understanding of the NUZ-001 compound’s mechanism of action, identified a number of potential biomarkers to support patient stratification and response monitoring, and progressed on our objective to expand the indication expansion beyond ALS/MND to include other neurogenerative diseases. 04 Sergio Duchini Non-Executive Chairman Neurizon Therapeutics Limited These efforts not only enhanced the commercial potential of our lead program but also laid the groundwork for future clinical opportunities in related neurodegenerative diseases. Commercial readiness remained a key area of focus during the period, and the Company delivered a defining achievement post year-end through a strategic licensing agreement with Elanco Animal Health (Elanco). Announced in early July, this agreement provides Neurizon with exclusive global rights to the active compound in NUZ-001, along with access to an extensive package of non-clinical data and manufacturing intellectual property supporting its ongoing development. From a regulatory standpoint, the Company executed to a high standard in its engagement with the US Food and Drug Administration (FDA) after our lead asset was placed on a clinical hold in January. Under the leadership of Managing Director and CEO, Dr Michael Thurn, Neurizon approached these discussions with urgency and integrity, delivering two expedited pharmacokinetic studies ahead of schedule and within budget. These efforts culminated in an important milestone in July, when the FDA issued a written endorsement of the Company’s strategy, which positions Neurizon to advance our clinical and commercialisation pathway for NUZ-001 for the second half of this year. Concurrently, Neurizon continued its transition to later-stage development and during this process, built further trust with patients, clinicians and other key stakeholders. Alongside this, our organisation grew in size and capability, with talented personnel now in place to manage global clinical execution, regulatory interactions, and manufacturing scale-up in quick succession. Neurizon Therapeutics Annual Report 2025 We are continually inspired by the courage, resilience, and determination of the ALS/MND patient and carer community. Their lived experience brings urgency to our mission and clarity to our purpose. This would not be possible if it were not for Dr Michael Thurn’s clarity, integrity, and tireless commitment to our vision. I would also like to thank the executive team for building operational strength while preserving our values-led and patient-focused culture. We are continually inspired by the courage, resilience, and determination of the ALS/MND patient and carer community. Their lived experience brings urgency to our mission and clarity to our purpose. It is their strength that fuels our commitment to scientific progress and reminds us why our work matters. Every step we take toward delivering a therapy is driven by the hope of making a meaningful difference in their lives. I would also like to extend my thanks and acknowledgement to my fellow Directors, for their expertise, strategic guidance, collaborative spirit and commitment to advancing our mission. Neurizon Therapeutics Annual Report 2025 To our investors and key stakeholders – thank you. Your continued support and belief in our science have enabled this progress. We do not take your support for granted. Together, we will advance next-generation treatments for ALS/MND and other neurodegenerative diseases – offering hope in an area of profound unmet need. Yours sincerely, Sergio Duchini Non-Executive Chairman Neurizon Therapeutics Limited 05 Key Highlights This year, Neurizon advanced on multiple fronts – from clinical and regulatory achievements to strategic partnerships and patient‑focused innovations. We strengthened the foundation for the global development of NUZ-001, secured pathways to accelerate FDA approval, and delivered progress across science, manufacturing, intellectual property, and community engagement. Together, we are moving closer to making treatments a reality for people living with ALS/MND and other neurodegenerative diseases. Rebrand to Neurizon Therapeutics A new identity that reflects our patient-centric mission and unwavering focus on advancing next-generation treatments for neurodegenerative diseases. Orphan Medicinal Product Designation (EMA) Granted Orphan Medicinal Product Designation by the EMA for NUZ-001 in ALS, providing 10 years of market exclusivity in Europe upon the approval and reinforcing global regulatory and commercial positioning. Grant of “Method of Use” Patent until 2041 Expedited grant of ‘method of use’ patent for NUZ‑001 by the United States Patent & Trademark Office (USPTO). US patent protection for NUZ‑001 and structurally related compounds for neurodegenerative diseases/cancer now extends to 2041. Global Licence Agreement with Elanco Exclusive global licence agreement with Elanco Animal Health (NYSE:ELAN) for the rights to the active pharma ingredient in NUZ‑001, aiding commercialisation pathway provides Neurizon with access to Elanco’s comprehensive data set to support future regulatory submissions. Inclusion in the HEALEY ALS Platform Trial Lead asset, NUZ‑001, selected for inclusion in the HEALEY ALS Platform Trial across +70 clinical sites in the US. Provides framework for independent validation of the potential of NUZ‑001 as a treatment for ALS/MND and accelerates the path to FDA approval. Completion of Phase 1 MEND and Open Label Extension Studies The top line study results for 10-patient group – who all completed the earlier Phase 1 MEND Study – further demonstrate the long-term safety and efficacy signals of the treatment of ALS/MND with NUZ-001, building on interim findings that confirmed robust survival and functional benefits. Development of Oral Liquid Formulation of NUZ‑001 Successful development of a new oral liquid formulation of NUZ‑001 for the treatment of ALS/MND, designed to support patients with all stages of ALS/MND, particularly those with swallowing. Developed as part of Neurizon’s patient‑centric innovation strategy, the liquid form enhances continuation of treatment, ease of administration, and overall treatment experience for patients with ALS. Preclinical Advances Supporting Platform Potential Preclinical studies strengthened the scientific foundation for NUZ‑001 as a platform therapy beyond ALS/MND, demonstrating brain penetration, significant reduction of TDP‑43 aggregation, restoration of neuronal survival factors, and protection against multiple pathways of neurodegeneration. These findings, showcased at leading international conferences, reinforce NUZ‑001’s potential to address a broad range of neurodegenerative diseases. 06 Neurizon Therapeutics Annual Report 2025 MD & CEO Letter This past year marked a period of substantial operational progress and strategic evolution for Neurizon Therapeutics, as we advanced our mission to deliver next‑generation treatments that make a real difference in the lives of people affected by neurodegenerative diseases – with a primary focus on Amyotrophic Lateral Sclerosis (ALS), the most common form of Motor Neuron Disease (MND). Our lead drug candidate, NUZ‑001, made meaningful advances across manufacturing, preclinical, clinical, and regulatory fronts – validating our development strategy and reinforcing confidence in its potential to address the urgent unmet needs of the ALS/MND community. Importantly, topline results from the Open-Label Extension (OLE) study demonstrated long-term safety and efficacy signals, further supporting the potential of NUZ-001 as a disease-modifying therapy. In the second half of the year, we focused on executing a proactive and collaborative regulatory strategy to lift the U.S. FDA clinical hold on NUZ‑001. We completed additional preclinical studies, advanced an oral liquid formulation to enhance patient access, refined our Regimen Specific Appendix for the HEALEY ALS Platform Trial, and submitted a comprehensive Complete Response to the FDA shortly after year‑end. These efforts position us to commence participation in the HEALEY Trial in the December quarter, pending FDA clearance. Our development pathway was further strengthened by the grant of an expedited U.S. method‑of‑use patent for NUZ‑001, securing protection for its use in ALS and other neurodegenerative diseases through to 2041. Post year‑end, we further de‑risked our program by signing an exclusive global licence agreement with Elanco Animal Health for NUZ‑001, ensuring ongoing access to pivotal animal safety data and securing long‑term supply at scale to support near‑term regulatory and commercial activities. Positive written feedback from the FDA on our IND strategy reinforces the clarity of our pathway to commencing the regimen in the HEALEY ALS Platform Trial and progressing toward potential accelerated regulatory approval. Dr Michael Thurn Managing Director & Chief Executive Officer These achievements reflect Neurizon’s unwavering commitment not only to scientific excellence but also to the people who inspire our work – those living with ALS/MND, their families, and carers. This year, we deepened our community engagement through fundraising events, scientific conference participation, and sponsorship of MND Australia’s landmark economic burden report “Every Moment Matters”. We remain committed to building trust and momentum across all stakeholder groups as we progress. Looking ahead, our immediate priorities are: • • Securing FDA clearance to lift the clinical hold. • Continuing to explore the potential of NUZ‑001 beyond ALS/MND, informed by emerging preclinical evidence of its broader neuroprotective mechanism. Commencing the HEALEY ALS Platform Trial in Q4 CY2025. These steps are essential in our mission to deliver NUZ‑001 as a potential first‑in‑class therapy and to maximise long‑term value for patients, partners, and shareholders. None of this would be possible without the extraordinary dedication of our team. I extend my sincere thanks to our staff, scientific collaborators, clinical partners, and Board. To our shareholders – thank you for your continued trust and belief in our vision. We look forward to sharing further progress as we work to bring forward a new horizon in neurodegenerative disease treatment. Yours Sincerely, Dr Michael Thurn Managing Director and Chief Executive Officer Neurizon Therapeutics Annual Report 2025 07 Contents 09 Directors’ report 35 Consolidated Statement of cash flows 19 Remuneration report (audited) 36 Notes to the financial statements 31 Auditor’s independence declaration 60 Consolidated entity disclosure statement 32 Consolidated Statement of profit or loss and other comprehensive income 61 Directors’ declaration 33 62 Independent auditor’s report Consolidated Statement of financial position 66 Shareholder information 34 Consolidated Statement of changes in equity 70 Corporate directory 08 Neurizon Therapeutics Limited / Directors’ report 30 June 2025 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 2025. 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 Dr Michael Thurn Mr Marcus Hughes Dr Katie MacFarlane Non-Executive Chairman Managing Director and Chief Executive Officer Non-Executive Director Non-Executive Director Principal activities The principal activity of Neurizon Therapeutics Limited and the entities it controlled during the year was the development of its own drug discovery 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 $16,593,619 (30 June 2024: $7,673,153). Neurizon Therapeutics Limited (“Neurizon” or “the Company”), is a 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), which is the most common form of Motor Neurone Disease (MND). Neurizon’s business strategy is to accelerate patient access to effective ALS/MND therapies while exploring the potential of NUZ-001 for broader neurodegenerative applications. In FY2025, Neurizon achieved significant progress across intellectual property, manufacturing, preclinical, clinical, and regulatory activities. These milestones were accompanied by a strategic repositioning of the Company, a sharpened focus on bringing NUZ-001 to market for ALS/ MND, and key management appointments to strengthen commercialisation capability. Strategic Repositioning and Company Name Change: In October 2024, shareholders approved a name change from PharmAust Limited to Neurizon Therapeutics Limited, reflecting a commitment to neurodegenerative disease research. The Company’s new name was subsequently registered with the Australian Securities and Investments Commission (ASIC). Following this, Neurizon refined its development strategy to align to three key pillars: Pillar 1 – Advancing patient access to innovative ALS/MND treatments Pillar 2 – Advancing hope by partnering with the world’s leading neurologists at Mass General’s HEALEY ALS Platform Trial Pillar 3 - Unlocking the potential of NUZ-001 to treat the range of neurodegenerative diseases Clinical, Regulatory Progress and Preclinical scientific development: During the period, Neurizon’s clinical development pathway was led by advancements in its preparations for participation in the HEALEY ALS Platform Trial, where NUZ-001 was selected for inclusion based on Phase 1 MEND study results. In September 2024, the Company completed a pre-submission meeting with the European Medicines Agency (EMA) and the Committee for Orphan Medicinal Products (COMP) and submitted a request for Orphan Medicinal Product Designation (OMPD) for NUZ-001 for the treatment of ALS/MND. A positive opinion on this was received shortly thereafter, with the designation being officially granted in December 2024. OMPD provides a robust framework of benefits, including reduced regulatory fees, free protocol assistance, and market exclusivity for 10 years in the European Union upon product approval. During this exclusivity period, similar medicinal products will not be eligible for marketing authorisation in the same indication, offering a substantial commercial advantage for NUZ-001. In December 2024, after submitting an Investigational New Drug (IND) application for NUZ-001, the US Food and Drug Administration (FDA) placed the IND on Clinical Hold in January 2025, which led to the Company actioning a number of initiatives to address the regulator’s concern and enable ongoing commercialisation of NUZ-001. During the second half of the financial year, Neurizon continued to engage directly with the FDA and directed workstreams to generate robust scientific evidence to support the broad therapeutic potential of NUZ-001. 09 Neurizon Therapeutics Limited / Directors’ report 30 June 2025 Preclinical studies conducted during the period demonstrated that both NUZ-001 and its major active metabolite, NUZ-001 Sulfone, effectively penetrate the brain and reduce the aggregation of TDP-43, a protein linked to ALS/MND and other neurodegenerative diseases. These studies showed that it was possible to deliver therapeutic levels of NUZ-001 and its major active metabolite to the central nervous system. Further research indicated that NUZ-001 may act through multiple pharmacological mechanisms, providing further justification for its development as a platform therapy for multiple neurodegenerative conditions. In a zebrafish model of Huntington’s disease, NUZ-001 restored Brain Derived Neurotrophic Factor (BDNF), a neuronal growth and survival factor typically reduced in the disease, highlighting the therapeutic potential of NUZ-001. Collaborative efforts with the University of Queensland revealed that NUZ-001 improved the survival of motor neurons exposed to TDP-43 toxicity without altering autophagy markers, suggesting alternate protective mechanisms. These findings were showcased at the AD/PD 2025 International Conference in Vienna, alongside new data from Tessara Therapeutics. Using the RealBrain® 3D human micro-tissue model, Tessara demonstrated that NUZ-001 improved neuronal viability and connectivity and offered partial protection against ferroptosis, a form of cell death implicated in neurodegeneration. Additional preclinical validation conducted with Ncardia confirmed that NUZ-001 and its sulfone metabolite reduced TDP-43 aggregation by ~50–55% and rescued electrophysiological dysfunction in human iPSC-derived motor neurons, further supporting its disease-modifying potential. These results build upon earlier preclinical work, including in vitro studies using induced pluripotent stem cell (iPSC)-derived motor neurons, which confirmed the ability of NUZ-001 to prevent TDP-43 aggregation and improve electrophysiological dysfunction. Collectively, these findings provide a strong scientific rationale for continued clinical development, which remains a key area of focus. Prior to the end of the period, Neurizon received positive written feedback on its strategy to resolve the FDA’s Clinical Hold. Subsequently, a comprehensive Clinical Hold Complete Response (CHCR) was submitted post-balance date, representing a significant step towards reactivation of the IND and inclusion in the HEALEY trial. In August, the FDA advised that, due to agency-wide restructuring and resourcing constraints, the review period has been extended, with a decision now expected by 3 October 2025. While this delay is beyond the standard statutory timeframe, it does not reflect the quality or completeness of Neurizon’s submission. In the meantime, the company is actively engaging with leading key opinion leaders, the HEALEY ALS Platform Trial team, and patient associations to explore opportunities to expedite review, reflecting the urgency of advancing access to potential treatments for people living with ALS/MND. Alongside the steps taken to lift the Clinical Hold, Neurizon continued to make significant strides across NUZ-001’s clinical program. Most recently, the Company reached a major milestone with the final patient completing the 12-month Open Label Extension (OLE) study. Interim data from the study confirmed that NUZ-001 remains well-tolerated and continues to show promising signals in extending life expectancy in patients with ALS/MND. The top line results have been released on August 20, further demonstrating the long-term safety and efficacy signals of the treatment of ALS/MND with NUZ-001, building on interim findings that confirmed robust survival and functional benefits. The OLE study was an open-label, safety, tolerability, and preliminary efficacy study of NUZ-001 in 10