Neurotech International Ltd. · ASX:NTI
Neurotech International — Investor Presentation (March 2023)
24 slides from Neurotech International's investor presentation, Mar 20, 2023
Slide 1: Improving Lives – Investor Presentation
For personal use only Improving Lives Investor Presentation Dr Tom Duthy Executive Director 20 March 2023
Slide 2: Disclaimer
Disclaimer For personal use only IMPORTANT INFORMATION Purpose of presentation: This presentation (including this document, any related video or oral These events are, as at the date of this presentation, expected to take place, but there cannot be any presentation, any question and answer session a
Slide 3: Presentation Contents
Presentation Contents For personal use only Financials Neurotech Strategies ASD Phase I/II Milestones Summary & & Clinical Focus Results Outlook 3
Slide 4: Corporate / Capital Summary
Corporate / Capital Summary For personal use only $0.057 $49.8M $8.1M ~1,700 Share price (as at 15 March 2023) Market Cash at bank* No. of shareholders capitalisation 873.9M 156.9M^ ~$2.6M 55% Share on issue NTIOA (13.5c) + R&D Investment Top 20 Holders in FY22 Other Options *as at 31 December 2022
Slide 5: Neurotech is a clinical-stage biopharmaceutical development company
Neurotech is a clinical-stage biopharmaceutical development For personal use only company focused predominately on paediatric neurological disorders Novel oral NTI164 exclusive worldwide PCT patent biopharmaceutical licence for neurological applications lodged cannabinoid platform disorders (NTI164)
Slide 6: Neurotech Four Core Strategies
Neurotech Four Core Strategies For personal use only Focus On Rare Focus on Paediatric Patients Neurological Disorders with Neuroinflammation Focus on Partnering with Focus On Drug Product Key Opinion Leaders / Development Clinicians 6
Slide 7: Strategic Focus Offers Significant Value Upside
Strategic Focus Offers Significant Value Upside For personal use only • Often overlooked by big pharma • Can be unencumbered drug therapy markets (no standard of care, no approved treatments) Focus on Paediatric Patients • Lack of clinical trials that may compete for patients • Ability to leverage s
Slide 8: Rapid Progress from Lab to Clinic Drives Strategy
Rapid Progress from Lab to Clinic Drives Strategy For personal use only 2020 Extraction of Drug Product (NTI164) & Pre-Clinical Data 2021 • Reduction in brain cell inflammation (up to Manufacture Scale-Up & 60%) Analytical Methods Established 2022 Phase I/II Clinical Trial (Safety) • Increase in ove
Slide 9: Clinical Pipeline – 2023
Clinical Pipeline – 2023 For personal use only Pre-Clinical Phase I/II Phase II/III NTI164 NTI164 NTI164 Combination Therapies Prednisone, Diclofenac, Other Cerebral Palsy ASD Other Licensed NTI164 Strains PANDAS / PANS Pipeline (2020/1) NTI164 ASD NTI164 Combination Therapies (54 week open label ex
Slide 10: Summary of Strategy
Summary of Strategy For personal use only Implementation Potential Group Strategy to Development Regulatory Levers Commercialisation Examples* Current 2016 2018/9 2021 Phase I/II PANDAS/PANS Pre-IND Feedback IND Orphan Drug Designation Priority Review Phase III Trials US$7.2 Billion Phase I/II acqui
Slide 11: Clinical Focus
Clinical Focus ASD For personal use only PANDAS/PANS Strong Scientific Rationale for NTI164 Neurological & Neuroinflammation Cerebral Palsy • Anti-inflammatory effects + safety Lack of effective treatments Rett Syndrome • Clinician support Paediatric Onset • High Patient/Caregiver interest Rare / Or
Slide 12: ASD and the NDIS
ASD and the NDIS For personal use only The National Disability Insurance Scheme (NDIS) provides assistance to people with a disability, as well as their families and carers • Prevalence of ASD in Australia est. 1 in 50 • 40-fold increase in 20 years $35.5 Billion Cost of NDIS in 2022, to increase to
Slide 13: About PANDAS / PANS
About PANDAS / PANS For personal use only About Paediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections (PANDAS) and Paediatric Acute-Onset Neuropsychiatric Syndrome (PANS) No Treatments No FDA or EMA approved treatments: Intravenous immunoglobulin (IVIG) off-label:
Slide 14: About Cerebral Palsy
About Cerebral Palsy Interventions ideally seek to: improve gross motor function, to increase participation at a For personal use only social role level, to improve comfort, to improve the ease of care by others or to improve About the overall quality of life of the individual • Most common motor di
Slide 15: About Rett Syndrome
About Rett Syndrome For personal use only About • Rare genetic neurological and developmental disorder and is almost exclusively the result of a mutation(s) in the methyl CpG binding protein 2 (MECP2) gene located on the X chromosome: impaired brain development and function First Ever Approval1 • Ne
Slide 16: Phase I/II Clinical Results: Autism Spectrum Disorder (ASD) – 52 weeks
Phase I/II Clinical Results: Autism Spectrum Disorder (ASD) – 52 weeks For personal use only “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 develo
Slide 17: NTI164 ASD Phase I/II - Trial Design
NTI164 ASD Phase I/II - Trial Design For personal use only 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 28 Day Data 14 patients from 8 to 17yo, Level II and III Autism Spectrum Di
Slide 18: NTI164 ASD Phase I/II – Safety (52 week Data)
NTI164 ASD Phase I/II – Safety (52 week Data) For personal use only NTI164 Safety Effects Maintained Over 52 Weeks No serious adverse events recorded Across all doses Only 1 patient on Risperidone at enrollment (not considered a pref. standard of care) A total of 11 patients evaluable at 52 weeks Ad
Slide 19: NTI164 ASD Phase I/II – Efficacy (52 week Data)
NTI164 ASD Phase I/II – Efficacy (52 week Data) Summary Outcome Measures For personal use only Sub-Domain Scale 20 Weeks P-value 52 Weeks P-value Clinical Interpretation (Paired T-Test) (Paired T-Test) Severity of illness CGI-S 0.005 0.032 Global improvement CGI-I n/a* n/a* Therapeutic effect Adapti
Slide 20: NTI164 ASD Phase I/II – Efficacy (52 Week Data)
NTI164 ASD Phase I/II – Efficacy (52 Week Data) For personal use only Mean Severity of Illness (n=12) Severity of illness Scale (CGI-S) 4.3 1 2 3 4 5 6 7 3.6 3.4 3.4 3.2 Baseline 3.0 3.0 Week 4 Week 20 Baseline Week 4 Week 8 Week 12 Week 20 Week 32 Week 52 Week 32 Week 52 CGI-Severity of illness1 (p
Slide 21: NTI164 ASD Phase I/II – Conclusions
NTI164 ASD Phase I/II – Conclusions • Continued excellent durability of results at 52 weeks, with clinical benefits showing a significant For personal use only improvement across a large number of clinically validated assessments versus baseline (Day 0) • Any significant change over time for measure
Slide 22: Key Month Milestones – NTI164
Key 12 Month Milestones – NTI164 For personal use only 1H CY2023 2H CY2023 • Final results of ASD Phase I/II Clinical Trial (52 weeks) • Results of PANDAS/PANS Phase I/II Clinical Trial • Commencement of Patient Recruitment PANDAS/PANS Phase I/II • Commencement of Patient Recruitment Cerebral Palsy
Slide 23: Outlook
Outlook For personal use only • Focus on rare paediatric neurological disorders • Longer term safety and solid efficacy of NTI164 now established in a predominant paediatric neurological disorder with strong neuroinflammatory effects (ASD) • Accelerated clinical development via rapid & cost-effectiv
Slide 24: Contact Details
For personal use only Contact Details Dr Tom Duthy Executive Director [email protected] +61 402 493 727 *This presentation has been authorised by the Board of Neurotech International Limited www.neurotechinternational.com www.mentetech.com Neurotech International Limited (ASX: NTI) 24
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