• Neurizon receives Orphan Medicinal Product Designation (OMPD) from the European Medicines Agency for its lead drug candidate, NUZ-001, to treat Amyotrophic Lateral Sclerosis (ALS)
• OMPD provides regulatory benefits including reduced fees, free protocol assistance, and 10-year market exclusivity in the EU upon product approval
• This milestone, along with positive preclinical results, affirms the potential of NUZ-001 to address the unmet medical needs of ALS patients

Neurizon Therapeutics Limited (ASX: NUZ & NUZOA), a clinical-stage biotech company advancing treatments for neurodegenerative diseases, 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 that securing OMPD from the European Commission is a significant achievement for the company, affirming the potential of NUZ-001 to address the substantial unmet medical needs of ALS patients. This milestone, along with the positive preclinical results recently announced demonstrating NUZ-001's ability to reduce the aggregation of TAR DNA-binding protein 43, complements the Orphan Drug Designation previously granted by the U.S. Food and Drug Administration, providing global market exclusivity across key territories. Neurizon is now well-positioned to continue its efforts to advance NUZ-001 through the Phase 2/3 HEALEY ALS Platform Trial, commencing patient enrolment in early H1 CY2025.

Neurizon is well-positioned to continue its efforts to advance NUZ-001 through the Phase 2/3 HEALEY ALS Platform Trial, commencing patient enrolment in early H1 CY2025. The company's goal remains to bring innovative treatments to patients battling ALS and create value for its shareholders.