Successful Completion of Preclinical MS Studies

A SX Announcement Neurotech International Ltd Suit e 5 CPC, 1 45 Stirling Highway Nedl ands, Western Aust ralia 6009 T: +61 (8) 9389 3130 E: [email protected] W: neurotechinternation al.com ABN : 73 610 205 402 ASX: NTI 1 o f 4 22 Octo ber 2021 Successful completion of preclinical Multiple Sclerosis studies using NTI164  P reclinical studies confirm that NTI164 can significantly suppress the expression of key MS bio markers, IL - 12 and TNF - alpha in human derived microglial cells  NT I 164 has shown to be more effective than CBD alone and CBD / THC by up to 2.5 times  MS t herap ies market size is valued at over $4 0 Billion USD globally and estimated to grow at 6 . 3 % per annum *  Results provide a uniq ue opportunity for the development and c o mmerciali s ati o n of potential human ther ap y for the management of MS Neurotech International Limited (ASX: NTI) ("Neurotech" or "the Company") is p leased to announce that it has s uccessfully complete d preclinical studies assessing t he effect s of NTI164 , i ts proprieta r y medical cannabis strain, against Cytokines in Multiple Sclerosis (MS) models. The studies were performed in collaboration with RMIT University and Monash University . Results ha ve c onfirmed the potent ant i - inflammatory and neu ro - regulat o r y activity of t he NTI 164 , specif ically:  NTI 16 4 reduced the inflammatory cytokine I L - 12 by 44%, su bstantially out performing CBD alone (15% reduction) and CBD / THC in combination ( 19% reduction)  NTI 16 4 reduced the inflammatory cytokine TNF - alph a by 4 2 %, out p erforming C BD alone ( 29 % re ducti on) and CBD / THC in combination ( 25 % reduction) The preclinical studies demonstrate d that NTI 16 4 strain can suppress the expression of key MS markers, IL - 12 and TNF - alph a , in human derived microglial cell s . T hese studies a r e an expan sion of the earlier f ind ings (refer ASX An n ouncement 25 M a y 2021) i n which NTI 164 significantly suppr esse d the expression of COX - 2 inhibition in human derived microglial cells . Cytokines play an imp ortant role in the neuroinfl ammator y respons es . Cy tokines regulate the body's response to disease and in fection, as well as mediate normal cellular processes in our body . ** MS is a progressive inflammatory disease characterised by the l oss of myelin sheath which results in complex n euro - infl amma tor y s ym ptoms such as spa sti city, los s of movement and pai n . Immune system dysregulation is believed to be a major underlying mechanism for MS and disease progression. IL - 12 and TNF - alpha are both elevated in MS patients and are thought to p lay a major role i n t he pat hology. Mul tiple Sclerosis – substantial mar ket wi th many unmet need s The global MS therapi es market w as val ued a t over $40 Billi on USD in 20 21 and is p rojected to reach $ 4 8 Billion USD by 2026 * . Current therapies in the trea tment of MS include steroid based medicines, disease - mo difying therap ies an d more re cently anti body - based thera p ies. Neurotech International Ltd Suit e 5 CPC, 1 45 Stirling Highway Nedl and s, Western Aust ralia 6009 T: +61 (8) 9389 3130 E: [email protected] W: neurotechinternation al.com ABN : 73 610 205 402 ASX: NTI Sativ ex TM is the only medicinal cannabis - based FDA approved product for the trea tment of MS ** * . The Comp any has as sessed s imilar form ulations in these pre c linical models , 1:1 CBD / THC mixture s . R esults hav e shown t hat NTI164 is significantly more effe ctive in suppr essi ng key biomarkers versus CBD / THC formulation . Recent p atent filing s by NTI will also allow the Company t o ass ess combination formulation opti o ns with NTI 16 4 and proven MS therapi es to i mprove treatment efficacy and reduce s id e effects. This s tr ong pre clinical data further s uppo r t s the potent anti - in flamma tory properties of NTI164 and broadens the potenti al applications to now include MS in add i tion to Au tism Spec t rum Disor der (ASD) . Neur otec h ’s Chairman, Mr Brian Leed man said : “ These are very exciting dev elopment s an d more importantly re - co nfirm the potency and the un iqueness of our low THC me di c inal cannabis stra ins. Current therap ies have ma n y unwanted side e ffects , so to have the opportunit y to dev elo p na t urally derived low THC stra ins is a gre at commercia l opportunity for our Company . Our Company remains comm itted to the development of a solid port folio for the expansion of application and u se o f NT I strains beyon d Au tism . ” Authori ty This anno uncement has been authorised for release by the Board of Neurotech International Limi ted. Further Information Brian Leedman Chairman b.leedman@neurotechint ernational.com +61 (0)41 228 178 0 Wi n ton Will esee Non - Executive Dir ector winton@a zc.com.au +6 1 (0)41 066 7844 Media: Juliana Roadley IR Depa rtment j [email protected] om.au +61 (0)41 488 9863 About Neurotech Neurotech International Limited is a medical device and solutions co m pany conducting clinical studies to assess the neuro - protectiv e, anti - inflammatory and neuro - modulatory activities of our proprietary NTI/Dolce cannabis strains. Neurotech is also commercialising Mente, the world’s first home therapy that is clinically p r oven 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 http://www.neurotechinternational.com *https://www.prnewswire.com/news - re l eases/multiple - sclerosis - drugs - market - size - worth -- 42 - 46 - billion - globally - by - 2028 - at - 6 - 3 - cagr - verified - market - research - 301352043.html **https://pubmed.ncbi.nlm.nih.gov/30447707/ ***https://mstrust.org.uk/a - z/sativex - nabiximols # I mpaired interleukin - 12 prod u ction in multiple sclerosis patients C Rohowsky - Kochan 1 , D Molinaro, A Choudhry, M Kahn, S D Cook https://pubmed.ncbi.nlm.nih.gov/10516776/ Neurotech International Ltd Suit e 5 CPC, 1 45 Stirling Highway Nedl and s, Western Aust ralia 6009 T: +61 (8) 9389 3130 E: [email protected] W: neurotechinternation al.com ABN : 73 610 205 402 ASX: NTI Resu lts Summary Treatment Cytokine Results Expressed as: Average +/ - Standard D eviation (SD) Statistical Sig n ificance Reductio n Compared to Contro l Alone Control: Interleukin and Inter f eron Activation IL - 12 TNF - alpha 99.91 +/ - 12.88 N = 8 NTI 164 IL - 12 TN F - alpha 56.30 +/ - 18.24 N=8 58.28 +/ - 15.08 N=8 44% re duction , P=0.0001 42% reduc tion, P<0.0001 CB D alone IL - 12 T NF - alpha 84.40 +/ - 6.54 N =8 71. 1 3 +/ - 12.81 N =8 15% reduction, P=0.008 29 % reduction , P=0.0005 CBD / THC (1:1) IL - 12 TNF - alpha 80.77 +/ - 12. 23 N=8 74.49 +/ - 14 .30 N=8 19% reduction, P=0 .008 25% reduction, P=0.01 Assay details:  S t udies were carried out using Multiplex Quantitation System. The system allows for the accurate me asurement of these neuro - markers levels. Measureme nts are done via fluoresce nce and expressed as F1 values.  Positive controls: Interleukin and Interferon acti v ity at 100%.  R esults are compared to positive control expressed as 100% activation and CB , CBD | THC where applicable Signi ficance between NTI1 64 versus CBD al one and C BD / T HC combination s (1:1) NT I 164 IL - 12 P=0.0011 versus CBD alone 44% versus 15% (n=8) Highly signific ant NTI 164 TNF - alpha P=0.0 5 75 versus CBD alone 4 2 % versus 29% (n=8) Signific ant NTI 164 IL - 12 P= 0.00 69 versus CBD / T HC combination 44% vers us 19% (n=8) Highly significant NTI 164 TNF - alpha P= 0.0446 versus CBD / THC combination 42 % versus 25% (n=8) Positive trend Neurotech International Ltd Suit e 5 CPC, 1 45 Stirling Highway Nedl and s, Western Aust ralia 6009 T: +61 (8) 9389 3130 E: [email protected] W: neurotechinternation al.com ABN : 73 610 205 402 ASX: NTI Key F ind ings Preclinical stu dies focused on the key cytokines involved in MS and vari ou s inflammatory disea se states : Cytokine A ctivity/Function I L - 12 (MS biomarker) Plays an important role in immune re gu lation/ important role in MS progression. IL - 12 is a cytokine that plays a key role in the pathogenesis of M S . # Pub lished data and s tudies demonstrate that blocki ng this C ytoki ne via a neutrali z ing antibody causes dramatic improvement s in animal models o f the disease, and multiple human trials found the antibody to be safe and effective in humans. Cytokine Activi ty/Function TNF - a lpha (MS biomarker ) Plays an i mportant role in dys regulation o f acute inflammation involved in MS onse t.  NTI 16 4 is stat is tically more potent in suppressing the key cytokines (biomarkers) : IL - 12 an d TNF - alpha when compared C BD alone and CBD / THC (1 :1) mix tur e  Results ar e very encouraging and recon firm the potent p roperties of the NT I 164 strains in modul ating inflammatory p ro cesses in neurological disorders where inflammation induced by immun e resp onses in dysregula ted.  These preclinical studies ha ve succ essfully paved t he way forward to the furthe r exp anding our k nowledge base and the potential applicat ion of our unique st ra ins in the treatment of neuro - anti - inflammatory disorders. Backgroun d What i s MS? It is a chronic, typically progressive disease involving damag e to the sheaths of nerve ce lls i n the brain and spinal cord, whose symptoms may incl ude numbness, impairment o f speech and of muscular coordination, blurred vision, and severe fati gue, c hronic pain, blindness. CBD has assisted man y patie nts with their o verall pain management and i mprov ed quality o f life ( reference: https://msra.org.au/m e dicinal - cannabis - ms/). A cc ording to MS Research Australia a review of up to 600 patients with M S who took medicinal cannabis felt that their spasti city wa s reduced and fe lt that their pain related t o spa sticity and sleep disturbance were also improved. Th e study participants were a ble to complete a walking task faster, but not all objective measurem ents o f spasticity were improved . ( reference: https:/ /msra.o rg.au/medicinal - cannabis - ms/ )

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