• Developed liquid formulation of lead drug NUZ-001 for ALS patients
• Preclinical data supports NUZ-001's potential for neurodegenerative disorders
• Positive feedback from FDA on strategy to lift clinical hold on NUZ-001

Neurizon Therapeutics Limited, a clinical-stage biotech company focused on neurodegenerative diseases, provided its quarterly update for the period ended 30 June 2025. The company achieved several manufacturing, preclinical, clinical, and regulatory milestones for its lead drug candidate NUZ-001. Key highlights include the successful development of a liquid formulation of NUZ-001 to support ALS patients, promising preclinical data showing NUZ-001's potential for various neurodegenerative disorders, and positive feedback from the U.S. FDA on the company's strategy to lift the clinical hold on NUZ-001. Neurizon also made key executive appointments and continued its active engagement with the ALS community and industry through participation in conferences and events. Post quarter-end, the company executed a global license agreement with Elanco Animal Health for NUZ-001 and submitted a Clinical Hold Complete Response to the FDA, paving the way for the initiation of the HEALEY ALS Platform Trial in Q4 2025. Overall, the quarter's achievements have strengthened Neurizon's clinical, regulatory, and commercial foundations, positioning the company for an exciting next phase of growth and drug development.

Neurizon expects to commence participation in the HEALEY ALS Platform Trial in Q4 CY2025, pending FDA review of the submitted Clinical Hold Complete Response.

Neurizon remains committed to advancing the development of NUZ-001 as a potential treatment for ALS and other neurodegenerative disorders. The company is focused on optimizing the clinical development, enhancing the mechanistic understanding, and building strategic and commercial partnerships to deliver meaningful treatment options for patients.