Investor Presentation

Phase I/II ASD 52 Week Results Investor Presentation Improving Lives Dr Tom Duthy Executive Director 17 March 2023 Disclaimer Purpose of presentation: This presentation (including this document, any related video or oral presentation, any question and answer session and any written or oral material discussed or distributed in relation to this presentation) has been prepared by Neurotech International Limited (ACN 610 205 402) (Neurotech or Company). It has been prepared for the sole purpose of providing general information on Neurotech and its business. Not an offer or solicitation: This presentation is not investment advice nor an offer to subscribe for securities or otherwise invest in Neurotech, and it should not be relied upon to make any investment decision. 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IMPORTANTINFORMATION 2 ASD 52 Week Phase I/II Results Neurotech Strategies Presentation Contents 3 Clinical Focus, Pipeline & Milestones Summary & Outlook Autism Spectrum Disorder (ASD) Goals 4 “The goals of treatment for ASD are to improve core deficits in social communication and social interactions and minimize the impact of restricted behaviours, with an overarching goal to help children develop greater functional skills and independence.” 1 1. Weitlauf AS, McPheeters ML, Peters B, et al. Therapies for Children With Autism Spectrum Disorder: Behavioural Interventions Update. Rockville (MD): Agency for Healthcare Research and Quality (US); 2014 Aug. (Comparative Effectiveness Review, No. 137.) Introduction. PREVALENCE OF ASD ~1 in 44 children in the US1 Current TreatmentMarket ASD is a serious neuro inflammatory developmental disorder that impairs the ability to communicate & interact Common symptoms; behavioural issues, agitation, repetitive movements, inability to focus & compulsive neurological patterns Clinical Trial Huge unmet medical need - patients need better treatment Current drugs have numerous side effects; weight gain, breast tissue development, nausea, dry mouth, anxiety, irritability, insomnia, stomach pain & movement disorders RISPERIDONE Approved 2006 (irritability label claim) 1. www.cdc.gov/ncbddd/autism/addm.html 2. https://www.fortunebusinessinsights.com/industry-reports/autism-spectrum-disorder-therapeutics-market-101207-CAGR-of-7-4.html Autism Spectrum Disorder (ASD) 5 2 TREATMENT MARKET SIZE US$1.85b Initial Focus of NTI164 – A full spectrum, oral cannabinoid biopharmaceutical product 1. The Australian, 25 October, 2022- https://www.afr.com/politics/federal/how-the-ndis-will-blow-out-to-50b-in-four-charts-20221019-p5br1c 2. https://www.uwa.edu.au/news/Article/2022/August/An-autism-minister-may-boost-support-and-coordination-But-governments-that-follow-SAs-lead-should-be-cautious 3. https://disabilityplanservices.com.au/blog/how-much-is-ndis-funding-for-autism/#:~:text=At%20Disability%20Plan%20Services%2C%20we,per%20year%20under%20the%20NDIS. 4. https://www.fortunebusinessinsights.com/industry-reports/autism-spectrum-disorder-therapeutics-market-101207-CAGR-of-7-4.html 5. Australian Bureau of Statistics. (2018). Autism in Australia. Retrieved from https://www.abs.gov.au/ausstats/[email protected]/mf/4428.0 ASD and the NDIS 6 • Prevalence of ASD in Australia est. 1 in 50 • 40-fold increase in 20 years5 The National Disability Insurance Scheme (NDIS) provides assistance to people with a disability, as well as their families and carers 34% ASD $35.5 Billion $6.1 Billion 34% of the 550,000 NDIS participants have ASD, 40% ≤ 14 years old (860,000 by 2030)2 Cost of NDIS in 2022, to increase to $52 billion by 2026, $100 billion by 20331 Implied annual cost of ASD to NDIS based on average ASD funding of $32,800 per annum e.g. physio, psychology, speech therapy, support workers3 There is a strong market need for an effective therapeutic intervention such as NTI164 to improve ASD symptoms & reduce healthcare costs NTI164 ASD Phase I/II - Trial Design The Program First in human Phase I/II ASD paediatric study Commenced in May 2021 at Monash Children’s Hospital led by A/Prof. Michael Fahey Open label – single group 14 patients from 8 to 17yo, Level II and III Autism Spectrum Disorder Dose regime assessments 5mg/kg, 10mg/kg, 15mg/kg and 20mg/kg of NTI164 (initial 4 weeks) Maximum tolerated dose daily through to 52 weeks ~7,000 Assessment points over 52 weeks, daily oral treatment 7 28 Day Data Released 8 July 2022 20 Week Data Released 26 October 2022 52 Week Data Released 17 March 2023 NTI164 ASD Phase I/II – Safety (52 week Data) NTI164 Safety Effects Maintained Over 52 Weeks 8 Conclusion: NTI164 longer term (chronic) administration now established with an excellent safety profile and minimal patient-specific side-effects: safety data will be collected beyond 52 weeks for at least six additional months No serious adverse events recorded Across all doses Only 1 patient on Risperidone at enrollment (not considered a pref. standard of care) Adverse events were tolerated and manageable mild nausea, abdominal pain Normal blood chemistry, normal kidney and liver function and vital signs A total of 11 patients evaluable at 52 weeks (12 pts. at 20 weeks) NTI164 ASD Phase I/II – Efficacy (52 week Data) Summary Outcome Measures 9 Clinical Interpretation • Statistical significance (p<0.05): • Study was never statistically powered for any efficacy measures (safety was primary endpoint) • Highly significant results for the most clinically important measures: • Severity of illness • Adaptive behaviour • Social responsiveness • Consistent improvements across multiple standard clinical measures at 52 weeks versus baseline do not support a placebo effect Sub-Domain Scale 20 Weeks P-value (Paired T-Test) 52 Weeks P-value (Paired T-Test) Severity of illness CGI-S 0.005 0.032 Global improvement CGI-S n/a* n/a* Therapeutic effect CGI-S n/a* n/a* Adaptive behaviour composite (Total) Vineland-3 0.0005 0.028 Communication Vineland-3 0.002 0.0001 Daily living skills Vineland-3 0.019 0.005 Socialisation Vineland-3 0.014 0.118 Social responsive scale – Total SRS-2 0.012 0.049 Social awareness SRS-2 0.596 0.421 Social cognition SRS-2 0.028 0.105 Social communication SRS-2 0.019 0.216 Social motivation SRS-2 0.118 0.005 Restricted interest and repetitive behaviour SRS-2 0.009 0.109 Social communication and interaction SRS-2 0.029 0.081 Anxiety scale for children - Child's total ASC-ASD-C 0.025 NM Performance anxiety ASC-ASD-C 0.364 NM Anxious arousal ASC-ASD-C 0.12 NM Separation anxiety ASC-ASD-C 0.025 NM Uncertainty ASC-ASD-C 0.033 NM Anxiety scale for children - Parent's total ASC-ASD-P 0.034 NM Performance anxiety ASC-ASD-P 0.07 NM Anxious arousal ASC-ASD-P 0.333 NM Separation anxiety ASC-ASD-P 0.025 NM Uncertainty ASC-ASD-P 0.066 NM Sleep disturbances scale for children - Total SDSC 0.016 NM Disorders of initiating and maintaining sleep SDSC 0.01 NM Sleep breathing disorders SDSC 0.047 NM Sleep-wake transition disorders SDSC 0.094 NM Anxiety, depression and mood scale – Total ADAMS 0.001 NM * t-test cannot be performed due to different measurement scale used at baseline; NM – not measured NTI164 ASD Phase I/II – Efficacy (52 Week Data) CGI-Severity of illness1 (p = 0.03) 10 Clinical Interpretation • NTI164 treatment is associated with a significant reduction in disease severity (1.3 scale change, 30% improvement) • ~40% of subjects markedly or severely ill at baseline – 0% from week 4 onwards 1. Clinical Global Impression (CGI)- is a physician/observer-rated scale synthesizing the clinician’s impression of the global state of an individual & frequently employed in clinical trials for neuropsychiatric disorders. Baseline and 28 day data as previously reported has been normalised to exclude those two patients who did not complete 20 weeks of daily NTI164 treatment and one patient at 52 weeks. The CGI is a 3-item observer- rated scale that measures illness severity, global improvement and therapeutic effect. 4.3 3.6 3.4 3.4 3.2 3.0 3.0 Baseline Week 4 Week 8 Week 12 Week 20 Week 32 Week 52 Mean Severity of Illness 1 2 3 4 5 6 7 Severity of illness Scale (CGI-S) Baseline Week 4 Week 20 Week 32 Week 52 NTI164 ASD Phase I/II – Efficacy (52 week Data) CGI-Global improvement 1 11 1. Clinical Global Impression (CGI) - is a physician/observer-rated scale synthesizing the clinician’s impression of the global state of an individual & frequently employed in clinical trials for neuropsychiatric disorders. Baseline and 28 day data as previously reported has been normalised to exclude those patients who did not complete 20-52 weeks of daily NTI164 treatment. The CGI is a 3-item observer-rated scale that measures illness severity, global improvement and therapeutic effect. Clinical Interpretation • 100% of active patients showed improvement after 20 weeks of daily treatment with NTI164 • After 52 weeks of daily treatment with NTI164, 90% of active patients (n=10) had a global improvement of Much improved and 10% (n=1) had a score of Very much improved. 9% 18% 27% 9% 82% 64% 82% 100% 90% 9% 10% 0% 20% 40% 60% 80% 100% Week 4 Week 8 Week 12 Week 20 Week 52 Percentage of Active Patients 1. Very much improved 2. Much improved 3. Minimally improved 4. No change NTI164 ASD Phase I/II – Efficacy (52 week Data) CGI-Therapeutic Effect1 12 Clinical Interpretation • After 52 weeks of daily NTI164 treatment, 10% of active patients demonstrated the highest possible efficacy index of 1: Marked therapeutic effect – Vast improvement. Complete or nearly complete remission of all symptoms. 90% of patients had an efficacy index of either 5 or 6: Moderate therapeutic effect – Decided improvement. Partial remission of symptoms. 1. Clinical Global Impression (CGI) - is a physician/observer-rated scale synthesizing the clinician’s impression of the global state of an individual & frequently employed in clinical trials for neuropsychiatric disorders. Baseline and 28 day data as previously reported has been normalised to exclude those patients who did not complete 20-54 weeks of daily NTI164 treatment. The CGI is a 3-item observer-rated scale that measures illness severity, global improvement and therapeutic effect. 9% 18% 9% 82% 64% 55% 27% 90% 18% 9% 36% 73% 10% 0% 20% 40% 60% 80% 100% Week 4 Week 8 Week 12 Week 20 Week 52 Percentage of Active Patients Marked (1-2) Moderate (5-7) Minimal (9-10) Unchanged or worse (13) Marked - Vast improvement. Complete or nearly complete remission of all symptoms. Moderate - Decided improvement. Partial remission of symptoms. Minimal - Slight improvement. Doesn't alter status of care of patient. NTI164 ASD Phase I/II – Efficacy (52 week Data) Vineland™-31 13 1. Vineland™-3 is internationally recognised as a leading instrument for supporting the diagnosis of intellectual and developmental disabilities in ASD; specifically adaptive behaviour. Adaptive functioning, which are skills people need to function independently at home, at school and in the community is an important factor in predicting long-term outcomes for people with ASD. Improving adaptive abilities in patients is therefore a desirable treatment goal. The adaptive behaviour composite consists of (a) communication, (b) daily living skills & (c) socialisation. Clinical Interpretation • Adaptive behaviour improvement is a treatment goal in ASD • Highly significant improvements in composite outcome AND individual domains of communication, daily living at 20 weeks continued through to 52 week endpoint Standardised measure of adaptive behaviour (3 month+ measure) Norm-based: adaptive functioning compared to others of same age Excellent test, re-test reliability & between rater (clinician, parent) Vineland-3 Domain P-value (Paired T-Test) 20 weeks P-value (Paired T-Test) 52 weeks Adaptive behaviour composite 0.0005 0.0278 Communication 0.002 0.0001 Daily living skills 0.019 0.0050 Socialisation 0.014 0.118 NTI164 ASD Phase I/II – Efficacy (20 week Data) 14 Clinical Interpretation • At 20 weeks of daily treatment with NTI164, the study achieved strong overall statistical significance for social responsiveness (p=0.012). This positive change remained statistically significant at 52 weeks (p=0.049) • NTI164 targets social skills: beneficial for social functioning and social anxiety symptoms SRS™-21 1. Social Responsiveness Scale (SRS™-2) is internationally recognised as a leading instrument (65 items) for identifying the presence and severity of social impairment within the Autism spectrum and differentiates it from that which occurs in other disorders. The SRS-2 total score is the most reliable measure for social deficits related to ASD. SRS-2 is distinct from other measures in that it provides a continuous measure of social ability (from impaired to above average) instead of a categorical yes/no identification of ASD impairments. High scores are associated with more severe social impairments. SRS-2 is a valid and reliable quantitative measure of core ASD symptoms related to social impairment. SRS-2 Domain P-value (Paired T-Test) 20 weeks P-value (Paired T-Test) 52 weeks Total 0.012 0.049 Social awareness 0.596 0.421 Social cognition 0.028 0.105 Social communication 0.019 0.216 Social motivation 0.118 0.005 Restricted interest and repetitive behaviour 0.009 0.109 Social communication and interaction 0.029 0.081 Children with autism spectrum disorder have difficulty with social interaction behaviours, including establishing and maintaining relationships, reciprocating social interaction, and communicating with others. SRS-2 is a validated measurement tool of assessing these factors NTI164 ASD Phase I/II – Conclusions 15 • Continued excellent durability of results at 52 weeks, with clinical benefits showing a significant improvement across a large number of clinically validated assessments versus baseline (Day 0) • Any significant change over time for measures of CGI-S, Vineland™-3 and SRS™-2 are considered clinically meaningful: NTI164 showed sig. improvement for all measures at 52 weeks v baseline • NTI164 is a patient ‘enabling’ drug with non-drug behavioural therapies, by improving daily living and allowing children to integrate into society via significant improvements in socialisation & anxiety versus ‘restrictive’ prescription of Risperidone (prevention of aggression, irritability) Professor Michael Fahey – Lead Investigator “We continue to see benefits in these ASD patients through daily oral treatment with NTI164 over 52 weeks. Our standardised ASD scales relating to global improvement, severity of illness, socialisation and adaptive behaviour, continued to show a clinically meaningful and statistically significant difference from baseline measures with no serious adverse events recorded and clean pathology results. Importantly, there was no evidence that prolonged use of NTI164 in these patients can lead to any form of therapeutic tolerance as measured by a slow reversion of symptoms through extended use. This is particularly pleasing and highlights chronic administration of NTI164 is required to achieve significant improvements in clinical outcome measures. We certainly look forward to the next phase of this exciting development opportunity in ASD.” Neurotech: Strategies, Pipeline, Milestones, Outlook 16 Neurotech Four Core Strategies 17 Focus on Partnering with Key Opinion Leaders / Clinicians Focus on Paediatric Patients Focus On Drug Product Development Focus On Rare Neurological Disorders with Neuroinflammation Strategic Focus Offers Significant Value Upside 18 Focus on Paediatric Patients Focus On Rare Neurological Disorders with Neuroinflammation Focus on Partnering with Key Opinion Leaders / Clinicians Focus on Drug Product Development • Often overlooked by big pharma • Can be unencumbered drug therapy markets (no standard of care, no approved treatments) • Lack of clinical trials that may compete for patients • Ability to leverage significant regulatory levers at FDA & EMA: orphan designation, breakthrough status, fast-track, priority review • Literature well-established for cannabinoids / extracts on inflammatory processes • NTI164 shown strong pre-clinical effects on inflammation, neuro-protection, neuro-modulation and neuro-regulation • NTI164 shown efficacy in serious neuroinflammatory developmental disorder: Autism Spectrum Disorder • Often chronic disorders requiring continued therapeutic intervention (higher lifetime patient value) • Regulated Drug Product via FDA, TGA, EMA (barrier to entry) • Manufacture under Good Manufacturing Practice (GMP) & robust CMC (Chemistry, Manufacture, Controls)(barrier to entry) • Premium Drug Pricing • Reimbursement for “on-label” prescribing • Paediatric Neurology focus with supportive Human Research Ethics Committees (HRECs) • Availability of patients / caregivers for clinical trials • Decades of experience in paediatric clinical trials – sound trial design frameworks and outcomes • Paediatric neurological disorders tend to have strong clinical networks / advocacy groups Clinical Focus 19 ASD PANDAS/PANS Cerebral Palsy Neurological & Neuroinflammation Lack of effective treatments Paediatric Onset Rare / Orphan Strong Scientific Rationale for NTI164 • Anti-inflammatory effects + safety • Clinician support • High Patient/Caregiver interest About PANDAS / PANS 20 No Treatments About Rare, Neuroinflammation No FDA or EMA approved treatments: Intravenous immunoglobulin (IVIG) off-label: not proven, v. high cost Release of PANDAS/PANS Diagnostic Criteria (2015) and Treatment Guidelines (2017) and the World Health Organisation recognition within the International Classification of Diseases (ICD-11) for the first time (2022) Paediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections (PANDAS) and Paediatric Acute-Onset Neuropsychiatric Syndrome (PANS) 2015 | 2017 | 2022 Considered a rare paediatric orphan disorder, with strong neuroinflammatory effects – ideally suited for NTI164 clinical trial Source: PACE Foundation About Cerebral Palsy 21 Lacking Treatments About Neuroinflammation • Primary treatment options for CP are medication, therapy, and surgery. The goal of CP treatment is to manage symptoms – specifically, spasticity and/or dystonia • Botulinum A : no improvement in motor function(s) • Baclofen – unwanted side-effects, weak evidence for quality of life benefits • 500,000 children under age of 18 currently have Cerebral Palsy (USA)1 • 8,000-10,000 babies born each year with CP • US$4.3 billion treatment market (mostly spastic CP) by 20302 • Most common motor disability in childhood, abnormal brain development or damage to the developing brain • Stratified by: Spastic CP (80% of cases), Dyskinetic CP (6% of cases), Ataxic CP (6% of cases) and Mixed CP (balance of cases) Significant Market • Available evidence supports the pathogenic role of inflammation and its ongoing role as a comorbidity of CP – Advantages for NTI164 1. www.cerebralpalsy.org 2. https://www.emergenresearch.com/industry-report/cerebral-palsy-treatment-market Interventions ideally seek to: improve gross motor function, to increase participation at a social role level, to improve comfort, to improve the ease of care by others or to improve the overall quality of life of the individual Clinical Pipeline – 2023 22 Pre-Clinical NTI164 Combination Therapies Prednisone, Diclofenac, Other Phase I/II Phase II/III NTI164 Cerebral Palsy NTI164 PANDAS / PANS NTI164 ASD Other Licensed Strains NTI164 ASD (52 week open label extension) Pipeline (2020/1) NTI164 Neuronal Cell Assays Other Licensed Strains NTI164 Combination Therapies Prednisone, Diclofenac, Other NTI164 [Undisclosed] (Expected 1H CY23) Summary of Strategy 23 Phase I/II PANDAS/PANS Phase I/II Cerebral Palsy Phase II/III ASD Group Strategy Implementation to Development Potential Regulatory Levers Commercialisation Examples* * For illustrative purposes only highlighting transactions in the rare paediatric neurological disorder field Pre-IND Feedback IND Orphan Drug Designation Priority Review Breakthrough Therapy Fast-Track Rare Pediatric Priority Voucher Scientific Advice Protocol Assistance Orphan Drug Designation Accelerated Assessment Current Potential ADHD Rett Syndrome Fragile-X Dravet Lennox-Gastaut Neuroinflammation Dravet Lennox-Gastaut US$7.2 Billion acquisition of GW1 2022 Epidiolex® Sales: US$736 Million1 20212018/92016 Phase III Trials FDA approval EMA approval FDA,EMA Orphan Designations, Fast- Track Status 202320182016 US$455 Million Licence for Trofinetide in Rett2 NDA approved with FDA for Rett (10 March 2023) Multiple FDA,EMA Orphan Designations, Fast- Track Status in Rett, Fragile-X, Angelman, Phelan-McDermid, Pitt Hopkins, Prader-Will NEU Market Cap: $1.5Bn Pipeline focus on rare neurodevelopmental disorders ASX:NEU Market Cap: $200M 1. Jazz Pharmaceuticals 2. Neuren Pharmaceuticals Key 12 Month Milestones – NTI164 1H CY2023 24 2H CY2023 • HREC/TGA Extension of ASD Phase I/II Clinical Trial – 6 months • Final results of ASD Phase I/II Clinical Trial (52 weeks) • Commence Patient Recruitment PANDAS/PANS Phase I/II Clinical Trial • FDA Pre-IND Meeting • HREC/TGA Approval Cerebral Palsy Phase I/II Clinical Trial • Completion of Patient Recruitment PANDAS/ PANS Phase I/II Clinical Trial • Additional paediatric neurological disorder Phase I/II Clinical Trial launch • Results of PANDAS/PANS Phase I/II Clinical Trial • Commencement of Patient Recruitment Cerebral Palsy Phase I/II Clinical Trial • Completion of Patient Recruitment ASD Phase II/III Clinical Trial • US FDA IND submission • Completion of recruitment new neurological disorder Phase I/II Clinical Trial Outlook 25 • Focus on rare paediatric neurological disorders • Long term safety and efficacy of NTI164 now established in a predominant paediatric neurological disorder with strong neuroinflammatory effects (ASD) • Accelerated clinical development via rapid & cost-effective proof of concept Phase I/II clinical trials in Australia for new paediatric neurological disorders (PANDAS/PANS, CP & 1 Other Undisclosed disorder pending) • Strong clinician engagement • Access to numerous regulatory levers from the FDA and EMA • Funding provides sufficient runway to complete all current clinical trials and pathway with the US FDA – significant valuation upside if met Contact Details Dr Tom Duthy Executive Director [email protected] +61 402 493 727 www.neurotechinternational.com Neurotech International Limited (ASX: NTI) 26 *This presentation has been authorised by the Board of Neurotech International Limited

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