Announcement PDF Neurizon Therapeutics Limited ABN 35 094 006 023 www.neurizon.com Neurizon Granted Orphan Medicinal Product Designation for NUZ-001 in Europe 17 December 2024 – Melbourne, Australia: Neurizon Therapeutics Limited (ASX: NUZ & NUZOA) (“Neurizon” or “the Company”), a clinical-stage biotech company advancing treatments for neurodegenerative diseases, is pleased to announce it has received the official decision from the European Medicines Agency (EMA) granting Orphan Medicinal Product Designation (OMPD) for its lead drug candidate, NUZ-001, for the treatment of Amyotrophic Lateral Sclerosis (ALS). This follows the EMA’s positive opinion on the Company’s OMPD application, as previously announced on 11 November 2024. OMPD provides a robust framework of benefits, including reduced regulatory fees, free protocol assistance, and market exclusivity for 10 years in the EU 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. Dr. Michael Thurn, Managing Director and Chief Executive Officer of Neurizon Therapeutics, commented: “Securing Orphan Medicinal Product Designation from the European Commission is a significant achievement for Neurizon. Together with the positive preclinical results we’ve recently announced demonstrating its ability to reduce the aggregation of TAR DNA-binding protein 43, this milestone affirms the potential of NUZ-001 to address the substantial unmet medical needs of ALS patients. Not only does it bolster our position in Europe but also complements the Orphan Drug Designation previously granted by the U.S. Food and Drug Administration, providing global market exclusivity across key territories. “With this milestone, we are well-positioned to continue our efforts to advance NUZ-001 through the Phase 2/3 HEALEY ALS Platform Trial, commencing patient enrolment in early H1 CY2025. Our goal remains steadfast: to bring innovative treatments to patients battling ALS and create value for our shareholders.” Next Steps:  Advance preparations for the Phase 2/3 HEALEY ALS Platform Trial to support clinical validation of NUZ-001.  Continue strategic regulatory engagement with global agencies, including the EMA, TGA and the FDA. -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 Catherine Strong Sodali & Co catherine.strong@sodali.com +61 (0)406 759 268 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 NUZ-001’s potential 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. Level 4, 96-100 Albert Road, South Melbourne, VIC 3205 Tel: +61 3 9692 7222 Neurizon Therapeutics Limited ABN 35 094 006 023 www.neurizon.com 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 Level 4, 96-100 Albert Road, South Melbourne, VIC 3205 Tel: +61 3 9692 7222