NTI granted HREC Approval for PANDAS/PANS Trial Extension

ASX Announcement Neurotech International Ltd Suite 5 CPC, 145 Stirling Highway Nedlands, Western Australia 6009 T: +61 (8) 9389 3130 E: [email protected] W: neurotechinternational.com ABN: 73 610 205 402 ASX: NTI 1 of 2 30 May 2023 Neurotech Granted HREC Approval for PANDAS/PANS Trial Extension Neurotech International Limited (ASX: NTI) (“Neurotech” or “the Company”) , a clinical -stage biopharmaceutical development company focused predominately on paediatric neurological disorders, today announces Human Research Ethics Committee (HREC) approval to extend the current Phase I/II clinical trial of NTI164 in children diagnosed with Paediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections (PANDAS) and Paediatric Acute- Onset Neuropsychiatric Syndrome (PANS ) to allow children to continue to receive treatment when they turn 18 years of age. The trial completed recruitment of 15 paediatric pat ients in early May 2023 , with clinical results anticipated in Q3 CY2023. Dr Thomas Duthy, Executive Director of Neurotech said “This HREC approval gives Neurotech utmost flexibility to treat our important PANDAS/PANS patients if they elect to continue daily oral NTI164 dosing beyond their 12-week treatment phase and into the fifty-four (54) weeks extension phase of the trial. Our study investigators and parents requested the protocol change to allow a patient who turns 18 years of age while on NTI164 treatment to remain compliant with the approved study protocol . The previous HREC approval received in January 2023 allowed PANDAS/PANS patients who were aged 1- 17 years of age to participate in the trial. This new approval extends that to 20 years of age. ” Authority This announcement has been authorised for release by the Board of Neurotech International Limited. Investors: Dr Thomas Duthy Executive Director [email protected] +61 (0)402 493 727 About Neurotech Neurotech International Limited (ASX:NTI) is a clinical -stage biopharmaceutical development company focused predominately on paediatric neurological disorders. Neurotech has completed a Phase I/II clinical trial in Autism Spectrum Disorder (ASD), which dem onstrated excellent safety and efficacy results at 28 days, 20 weeks and 52 weeks of treatment with NTI164. The Company commenced Phase II/III randomised, double -blind, placebo -controlled clinical trial in ASD in Q4 CY2022. Neurotech is also conducting add itional Phase I/II trials in Paediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections (PANDAS) and Paediatric Acute- Onset Neuropsychiatric Syndrome (PANS), collectively PANDAS/PANS, along with Rett Syndrome and Cerebral Palsy during CY2023. Neurotech is also commercialising Mente, the world’s first home therapy that is clinically proven to increase engagement and improve relaxation in autistic children with elevated Delta band brain activity. For more information about Neurotech please visit http://www.neurotechinternational.com. Neurotech International Ltd Suite 5 CPC, 145 Stirling Highway Nedlands, Western Australia 6009 T: +61 (8) 9389 3130 E: [email protected] W: neurotechinternational.com ABN: 73 610 205 402 ASX: NTI 2 of 2 About NTI164 NTI164 is a proprietary drug formulation derived from a unique cannabis strain with low THC (M<0.3%) and a novel combination of cannabinoids including CBDA, CBC, CBDP, CBDB and CBN. NTI164 has been exclusively licenced for neurological applications globally. Pre -clinical studies have demonstrated a potent anti -proliferative, anti -oxidative, anti -inflammatory and neuro -protective effects in human neuronal and microglial cells. NTI164 is being developed as a therapeutic drug product for a range of neurological disorders in children where neuroinflammation is involved. About PANS/PANDAS Paediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections (PANDAS) and Paediatric Acute -Onset Neuropsychiatric Syndrome (PANS) , collectively PANDAS/PANS, is a clinical diagnosis given to children who have a dramatic (typically within one day) onset of neuropsychiatric symptoms including Obsessive-Compulsive Disorder (OCD) and/or restrictive eating. Children may exhibit repetitive tic movements, become moody, irritable/aggressive and anxious and have difficulty with schoolwork. The cause of PANS is unknown in the majority of cases; however, the disorder is hypothesised to be triggered by infections, metabolic disturbances, and other inflammatory reactions. PANDAS is considered a subset of PANS. About Neurotech PANDAS/PANS Phase I/II Clinical Trial NTIPANS1 is a single-arm, open-label, Phase I/II clinical trial that will recruit 15 paediatric patients with a clinical diagnosis of moderate to severe PANDAS/PANS to determine the efficacy and safety of orally administered NTI164 in these patients. The primary endpoints of the trial are the change from baseline at twelve (12) weeks for the Revised Children’s Anxiety and Depression Scale-Parent-rated (RCADS-P) score and Clinical Global Impression (CGI) of severity (CGI -S) and improvement (CGI -I). Secondary clinical endpoints include other gold-standard, validated assessment tools : Yale Global Tic Severity Scale (YGTSS), Children’s Yale-Brown Obsessive-Compulsive Scale, Conners Scale and EQ-5D-Y. Other secondary endpoints will examine the Safety and Tolerability of orally administered NTI164 (at 5,10,15 and 20 mg/kg/day). The trial intends to enrol children at two centres within Australia; the Children’s Hospital at Westmead and the Paediatric Neurology Unit at Monash Medical Centre. The Phase I/II clinical trial has been registered on the Australian New Zealand Clinical Trials Registry (ANZ CTR) under registration number: ACTRN12622001419752 or visit: https://www.anzctr.org.au

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