Neurotech International Ltd. · ASX:NTI
Neurotech International — Investor Presentation (March 2023)
26 slides from Neurotech International's investor presentation, Mar 17, 2023
Slide 1: Improving Lives: Phase I/II ASD 52 Week Results
For personal use only Improving Lives Phase I/II ASD 52 Week Results Dr Tom Duthy Investor Presentation Executive Director 17 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 ASD 52 Week Neurotech Clinical Focus, Summary & Phase I/II Results Strategies Pipeline & Milestones Outlook 3
Slide 4: Autism Spectrum Disorder (ASD) Goals
Autism Spectrum Disorder (ASD) Goals 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 develop greater functional skills and in
Slide 5: Autism Spectrum Disorder (ASD)
Autism Spectrum Disorder (ASD) For personal use only PREVALENCE OF ASD TREATMENT MARKET SIZE ~1 in 44 children 2 in the US1 US$1.85b RISPERIDONE Approved 2006 (irritability label claim) Market Current Treatment Clinical Trial ASD is a serious Huge unmet medical Initial Focus of NTI164 – A full spect
Slide 6: 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 years5 $35.5 Billion Cost of NDIS in 2022, to increase t
Slide 7: NTI164 - 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 8: NTI164 – 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 9: NTI164 – 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-S n/a* n/a* Therapeutic effect Adapti
Slide 10: NTI164 – Efficacy: Mean Severity of Illness
NTI164 ASD Phase I/II – Efficacy (52 Week Data) For personal use only Mean Severity of Illness Severity of illness Scale (CGI-S) 4.3 1 2 3 4 5 6 7 3.6 3.4 3.4 Baseline 3.2 Week 4 3.0 Week 20 3.0 Week 32 Baseline Week 4 Week 8 Week 12 Week 20 Week 32 Week 52 Week 52 CGI-Severity of illness1 (p = 0.03
Slide 11: NTI164 – Efficacy: CGI-Global improvement
NTI164 ASD Phase I/II – Efficacy (52 week Data) For personal use only CGI-Global improvement 1 1. Very much improved 100% 9% 10% 2. Much improved 3. Minimally improved Percentage of Active Patients 80% 4. No change Clinical Interpretation 64% • 100% of active patients showed improvement 60% 82% afte
Slide 12: NTI164 – Efficacy: CGI-Therapeutic Effect
NTI164 ASD Phase I/II – Efficacy (52 week Data) For personal use only CGI-Therapeutic Effect1 100% 9% 10% Marked (1-2) 18% Percentage of Active Patients 80% 36% Moderate (5-7) Minimal (9-10) 73% 60% 64% Clinical Interpretation Unchanged or worse (13) 90% 40% 82% • After 52 weeks of daily NTI164 trea
Slide 13: NTI164 – Efficacy: Vineland-3
NTI164 ASD Phase I/II – Efficacy (52 week Data) For personal use only Vineland™-31 Standardised measure of adaptive behaviour (3 month+ measure) Norm-based: adaptive functioning compared to others of same age Clinical Interpretation • Adaptive behaviour improvement is a treatment goal Excellent test
Slide 14: NTI164 – Efficacy: SRS-2
NTI164 ASD Phase I/II – Efficacy (20 week Data) For personal use only Children with autism spectrum disorder have difficulty with social interaction behaviours, SRS™-21 including establishing and maintaining relationships, reciprocating social interaction, and communicating with others. SRS-2 is a v
Slide 15: NTI164 – 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 16: Neurotech: Strategies, Pipeline, Milestones, Outlook
Neurotech: Strategies, Pipeline, Milestones, Outlook For personal use only 16
Slide 17: 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 17
Slide 18: 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 19: Clinical Focus
Clinical Focus For personal use only ASD Strong Scientific Neurological & PANDAS/PANS Rationale for NTI164 Neuroinflammation Lack of effective treatments Cerebral Palsy • Anti-inflammatory effects + safety • Clinician support Paediatric Onset • High Patient/Caregiver interest Rare / Orphan 19
Slide 20: 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 21: 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 22: 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 (52 week open label ex
Slide 23: 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 24: Key Month Milestones – NTI164
Key 12 Month Milestones – NTI164 For personal use only 1H CY2023 2H CY2023 • HREC/TGA Extension of ASD Phase I/II Clinical Trial – 6 months • Results of PANDAS/PANS Phase I/II Clinical Trial • Final results of ASD Phase I/II Clinical Trial (52 weeks) • Commencement of Patient Recruitment Cerebral Pa
Slide 25: Outlook
Outlook For personal use only • 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
Slide 26: Contact Details
For personal use only Contact Details Dr Tom Duthy Executive Director td@neurotechinternational.com +61 402 493 727 *This presentation has been authorised by the Board of Neurotech International Limited www.neurotechinternational.com Neurotech International Limited (ASX: NTI) 26
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