DAYBUE receives marketing authorization in Canada

1 of 2 Neuren (NEU) – ASX Announcement 17 October 2024 DAYBUE™ (trofinetide) receives marketing authorization in Canada Highlights: • Acadia Pharmaceuticals announces Health Canada approval of DAYBUE™ (trofinetide) for the treatment of Rett syndrome in adult and pediatric patients two years of age and older under the Priority Review process • First and only approved treatment for Rett syndrome in Canada • Potential sales in Canada will be added to US sales for calculation of Neuren’s royalties and sales milestone payments Melbourne, Australia: Neuren Pharmaceuticals (ASX: NEU) today announced that its partner Acadia Pharmaceuticals (NASDAQ: ACAD) received Health Canada approval of DAYBUE™ (trofinetide) for the treatment of Rett syndrome in adult and pediatric patients two years of age and older under the Priority Review process. This makes it the first and only drug approved in Canada for the treatment of Rett syndrome. In Canada, prevalence of Rett syndrome is estimated to be 600 to 900 patients.1 In Canada, DAYBUE is indicated for the treatment of Rett syndrome in adults and pediatric patients two years of age and older and weighing at least 9 kg. For further details please refer to Acadia’s announcement https://acadia.com/media/news- releases/acadia-pharmaceuticals-announces-health-canada-approval-of-daybue-trofinetide-for-the- treatment-of-rett-syndrome/ Neuren CEO Jon Pilcher commented: “We are excited to see this first approval outside the United States, which is a significant milestone in the ongoing program to expand access to DAYBUE.” Canada is included as part of the North America region under Neuren’s agreement with Acadia. Potential sales in Canada will be added to US sales for calculation of Neuren’s royalties and sales milestone payments. Tiered Royalty Rates (% of net sales)2 Annual Net Sales Rates ≤US$250m 10% >US$250m, ≤US$500m 12% >US$500m, ≤US$750m 14% >US$750m 15% Sales Milestones payments Net Sales in one calendar year US$m ≥US$250m 50 ≥US$500m 50 ≥US$750m 100 ≥US$1bn 150 1 Acadia estimates 2 Royalty rates payable on the portion of annual net sales that fall within the applicable range. Each sales milestone payment is payable once only. 2 of 2 About Neuren Neuren is developing new drug therapies to treat multiple serious neurological disorders that emerge in early childhood and have no or limited approved treatment options. Recognising the urgent unmet need, all programs have been granted “orphan drug” designation in the United States. Orphan drug designation provides incentives to encourage development of therapies for rare and serious diseases. DAYBUE™ (trofinetide) is approved by the US Food and Drug Administration (FDA) for the treatment of Rett syndrome in adult and pediatric patients two years of age and older. Neuren has granted an exclusive worldwide licence to Acadia Pharmaceuticals Inc. for the development and commercialisation of trofinetide. Neuren’s second drug candidate, NNZ-2591, is in Phase 2 development for multiple neurodevelopmental disorders, with positive results achieved in Phase 2 clinical trials in Phelan-McDermid syndrome, Pitt Hopkins syndrome and Angelman syndrome. Contact: [email protected] Jon Pilcher, CEO: +61 438 422 271 ASX Listing Rules information This announcement was authorized to be given to the ASX by the board of directors of Neuren Pharmaceuticals Limited, Suite 201, 697 Burke Road, Camberwell, VIC 3124 Forward-looking Statements This announcement contains forward-looking statements that are subject to risks and uncertainties. Such statements involve known and unknown risks and important factors that may cause the actual results, performance or achievements of Neuren to be materially different from the statements in this announcement.

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