US FDA Rare Pediatric Disease Designation in Rett syndrome

ASX Announcement Neurotech International Ltd Suite 102 / Level 1, 55 Collins Street, Melbourne, VIC 3000 T : 03 9498 3132 E: [email protected] W: neurotechinternational.com ABN: 73 610 205 402 ASX: NTI 1 of 2 8 October 202 5 US FDA Rare P ediatric Disease Designation for NTI164 in Rett s yndrome Highlights  This mi lestone recognition from the FDA complements the existing Orphan Drug Designation for NTI164 in Rett s yndrome  Provides access to FDA support, tax incentives and seven years of market exclusivity if approved  Neurotech continues to advanc e its regulatory and partnering strategy Neurotech International Limited (ASX: NTI) (“Neurotech” or “the Company”) , a clinical - stage biopharmaceutical company focused on paediatric neurological disorders, is pleased to announce that the US Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) for its lead drug candidate, NTI164, for the treatment of Rett s yndrome. This important regulatory milestone complements the Orphan Drug Designation previously granted by the FDA for NTI164 in Rett syndrome, further strengthening Neurotech’s position in developing novel therapies for rare and underserved neurological disorders. The RPDD program recogni s es promising therapies being developed for conditions that affect fewer than 200,000 people in the United States. This designation helps facilitate the development of innovative treatments by providing regulatory support, including enhanced FDA guidance du ring the drug development process and potential priority review. When pair ing RPDD with Orphan Drug Designation, sponsors may also benefit from financial incentives such as tax credits for clinical testing, exemption from certain FDA fees, and seven years of US market exclusivity if the therapy is approved. The designation received from the FDA was based on its finding that Rett syndrome is a serious or life - threatening disease , and that Rett syndrome meets the definition of “rare disease or condition” at section 526 of the FD&C Act. Dr Anthony Filippis, Chief Executive Officer and Managing Director of Neurotech, said: “The granting of Rare Pediatric Disease Designation by the FDA marks another major milestone for NTI164 and underscores its therapeutic potential for Rett syndrome. Combined with the existing Orphan Drug Designation, this recognition reinforces the significance of our program and our co mmitment to developing much - needed treatments for children and families affected by these challenging conditions.” NTI164 is a unique anti - inflammatory and neuroprotective compound derived from a proprietary Cannabis sativa strain with a distinct profile of cannabinoids. It is currently being evaluated in multiple clinical programs targeting neurodevelopmental disorders . For further information contact us via [email protected] Neurotech International Ltd Suite 102 / Level 1, 55 Collins Street, Melbourne, VIC 3000 T : 03 9498 3132 E: [email protected] W: neurotechinternational.com ABN: 73 610 205 402 ASX: NTI 2 of 2 About Neurotech Neurotech International Limited (ASX:NTI) is a clinical - stage biopharmaceutical development company focused predomina n tly on paediatric neurological disorders with a broad - spectrum oral cannabinoid drug therapy called NTI164 . Neurotech has completed a Phase II/III randomised, double - blind, placebo - controlled clinical trial in Autism Spectrum Disorder (ASD) with clinically meaningful and statistically significant benefits reported across a number of clinically - validated measur es and excellent safety. In addition, Neurotech has completed and reporte d statistically significant and clinically meaningful Phase I/II trials in ASD and Paediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections (PANDAS) and Paediatric Acute - Onset Neuropsychiatric Syndrome (PANS), collectively PANDAS/PANS along with Rett Syndrome. Neurotech has received human ethics committee clearance for a Phase I/II clinical trial in spastic cerebral palsy. For more information about Neurotech please visit http://www.neurotechinternational.com .

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