NTI164 Clinical Program Update

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 23 September 2021 NTI164 Clinical Program Update | Pivotal Paediatric Study in ASD  NTI is conducting the world’s first study using full - spectrum medicinal cannabis with less <0.3% THC (NTI164) in children with ASD.  The study is designed to vigorously assess the safety and efficacy of NTI164 in a dose escalation regime as well as assess the behaviour, focus and cognitive related parameters using internationally validated neuro - psychological tools – completed and assessed under the supervision of internationally accredited neuro - psychologists.  This is a pivotal study and will for m the foundation for follow up studies in therapies relating to the treatment of a wide range of neuro disorders.  An expanded pre - clinical program targeted at other neurological conditions where inflammation is a major contributing factor such as Multiple Sclerosis are progressing.  Several provisional patents relating to the novel neuro - regulatory and anti - inflammatory properties of the NTI/Dolce medicinal cannabis strains nearing finalisation. Neurotech International Limited (ASX: NTI) ("Neurotech" or "the Company") is pleased to provide an update on its Phase I/II open label clinical study in 20 children aged between 5 - 17 years with Autism Spectrum Disorder (ASD). The Study is being conducted u nder the guidance and supervision of Professor Michael Fahey, Head of Paediatric Neurology Monash Children’s Hospital. This is the first time in the world that full - spectrum <0.3% natural THC medicinal cannabis strains are being assessed in ASD. Neurotech is now in the process of mapping out P hase III – multi cohort registration studies in ASD to be conducted as a follow up study to the current P hase I/II study . The P hase III program is scheduled to commence in early calendar 2022 and, in addition to the p otential formal registration of NTI164 for paediatric ASD treatment, the company will also consider other Neuro - Orphan Diseases to provide urgent medical therapy for rarer neuro - disorders and accelerate the registration and development process by working u nder the FDA: Orphan Disease Development Category and TGA S pecial Access Scheme Category B . The c linical team are managing the complex COVID related situation which currently exists in Victoria by minimizing study disruptions caused by COVID imposed restr ictions and expanding the online medical data and study collection portal. The clinical team are providing patients and families with all the necessary additional support and there by minimi s ing patient hospital visits to manage potential risks. At this stage , anticipated initial reportable results should be available in November. Outside of minor COVID related delays, the study remains on schedule and progressing as planne d. Commenting on the Study, Professor Michael Fahey said : “This pivotal study is a world first and I am satisfied that we are progressing well given that the trial needs to be done in a rigorous and thorough way. I look forward to expanding this program multi - cohort registration studies in 2022. We are setting a plat form to assess other complex neurological disorders beyond ASD” 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 As the ASD P hase I/II study continues, NTI is pleased to report on additional progress in respect of the following: The Company continues to build its IP position over the novel neuro - regula tory and anti - inflammatory properties of the NTI/D olce medicinal cannabis strains. The Company is in the process of filing several provisional patents relating to the novel neuro - regulatory and anti - inflammatory properties of the NTI/D olce medicinal cannab is strains. NTI has also strengthened its preclinical program. Working in collaboration with RMIT and Monash University, NTI is progressing a series of preclinical investigations in Multiple Sclerosis and related progressive neuro - inflammatory disorders w ith results expected shortly. Additional studies are underway in respect of neuro inflammat ory conditions such as c oncussion, pain and cognitive enhancement. Neurotech’s Chairman, Mr Brian Leedman added: “We look forward to releasing the results of our Phase I/II clinical study in ASD and preparations are well underway for the commencement of our pivotal Phase III registration study. The imminent IP filings together with the expanded pre - clinical work on neuro - inflammation in particular, position Neu rotech as a class leading cannabinoid drug discovery company”. Authority This announcement has been authorised for release by the Board of Neurotec h International L imited . Further Information Brian Leedman Chairman [email protected] +61 (0)41 228 1780 Winton Willesee Non - Executive Director [email protected] +61 (0)41 066 7844 Media: Juliana Roadley IR Department [email protected] +61 (0)41 488 9863 About Neurotech Neurotech International Limited is a medical device and solutions company conducting clinical studies to assess the neuro - protective, anti - inflammatory and neuro - modulatory activities of our proprietary NTI/Dolce cannabis strains. Neurotech is also commer cialising 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 and Mente Autism please visit htt p:/ /www.neurotechinternational.com

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