• Completed Phase 1 MEND trial and Open-Label Extension studies for lead drug NUZ-001
• Preparing to commence HEALEY ALS Platform Trial in Q4 2025
• Expanded potential of NUZ-001 as a platform therapy for multiple neurodegenerative diseases

Neurizon Therapeutics, formerly known as PharmAust Limited, has released its 2025 Annual Report, showcasing substantial operational progress and strategic evolution in its mission to deliver next-generation treatments for neurodegenerative diseases, with a primary focus on Amyotrophic Lateral Sclerosis (ALS), the most common form of Motor Neuron Disease (MND). The company's lead drug candidate, NUZ-001, made meaningful advances across manufacturing, preclinical, clinical, and regulatory fronts, validating the development strategy and reinforcing confidence in its potential to address the urgent unmet needs of the ALS/MND community. 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. Neurizon also executed a proactive and collaborative regulatory strategy to lift the U.S. FDA clinical hold on NUZ-001, completing additional preclinical studies, advancing an oral liquid formulation, and submitting a comprehensive Complete Response to the FDA. These efforts position the company to commence participation in the HEALEY ALS Platform Trial in the December quarter of 2025, pending FDA clearance. The 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. Neurizon also signed 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. The company remains committed to building trust and momentum across all stakeholder groups as it progresses, with a focus on securing FDA clearance, commencing the HEALEY ALS Platform Trial, and continuing to explore the potential of NUZ-001 beyond ALS/MND.

Neurizon's immediate priorities are securing FDA clearance to lift the clinical hold on NUZ-001, commencing the HEALEY ALS Platform Trial in Q4 2025, and continuing to explore the potential of NUZ-001 beyond ALS/MND, informed by emerging preclinical evidence of its broader neuroprotective mechanism. These steps are essential in the company's mission to deliver NUZ-001 as a potential first-in-class therapy and to maximize long-term value for patients, partners, and shareholders.