Neurotech International Ltd. · ASX:NTI
Neurotech International — Investor Presentation (June 2024)
30 slides from Neurotech International's investor presentation, Jun 17, 2024
Slide 1: Improving Lives - Investor Presentation
For personal use only Improving Lives Investor Presentation Dr Tom Duthy Executive Director 17 June 2024
Slide 2: Disclaimer
Disclaimer 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 guarantee that such will occur as anticipated, or at all, given that
Slide 3: Corporate / Capital Summary
Corporate / Capital Summary $0.061 $62.0M $13.6M ~2,450 For personal use only Share price (as at 14 Jun 2024) Market Pro-Forma Cash No. of shareholders capitalisation 31 March ’24* 1016.7M 176.5M $6.5M 45.4% Share on issue Options^ FY23 R&D Exp. Top 20 Holders (up from $2.6M in FY22) • 31 March cash
Slide 4: 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 4
Slide 5: Clinical Pipeline – 2024
Clinical Pipeline – 2024 Pre-Clinical Phase I/II Phase II/III For personal use only Other Licensed NTI164 NTI164 Strains Cerebral Palsy ASD Synthetic Cannabinoid(s) NTI164 combinations PANDAS / PANS1 NTI164 ASD2 (90 week+ open label extension) NTI164 Rett Syndrome Data reported (all with statistical
Slide 6: Intellectual Property – 2024
Intellectual Property – 2024 Other IP & Barriers to Entry Vertically Integrated: Seed to Patient Controlled (Trade Secret: continuity of production to SOP, extraction(s)) For personal use only Orphan Drug Designation(s) 10 Years Market Exclusivity from Approval – Europe 7 Years Market Exclusivity fr
Slide 7: Therapeutic Agent: NTI164
Therapeutic Agent: NTI164 THC < 0.3% For personal use only Convenient 1x or 2x (split dose) High potency, Broad Spectrum Cannabinoid Formulation in Oil, C. Major constituent Cannabidiolic oral formulation in oil, ideal acid (CBDA) format for pediatric patients sativa L. (Plant Derived) 20mg/kg (CBDA
Slide 8: Our Target Markets
Our Target Markets Lack of effective therapies, significant unmet medical need Annual Drug Therapy Market opportunity US$2 billion* US$2 billion US$1.4 billion1 US$4.3 billion For personal use only Orphan Orphan Autism Spectrum Disorder (ASD) Rett Syndrome PANDAS/PANS Cerebral Palsy (CP) • Prevalenc
Slide 9: Autism Spectrum Disorder (ASD)
Autism Spectrum Disorder (ASD) “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 For personal
Slide 10: Phase I/II ASD Results to Date (NTIASD1)
Phase I/II ASD Results to Date (NTIASD1) Efficacy AE- adverse event Safety SAE – serious adverse event For personal use only SAEs: Nil AEs: Mild nausea, abdominal discomfort Day 0 20 weeks 90 weeks No SAE, minor AE No SAE, AE recorded No SAE, AE recorded 4 weeks 52 weeks 2 years SAEs: Nil 1. Clinica
Slide 11: Phase II/III ASD Trial Design (NTIASD2)
Phase II/III ASD Trial Design (NTIASD2) Enrolment Primary Endpoint Randomise / Double-Blind • Clinical Global Impression – Severity of illness (CGI-S) For personal use only Placebo NTI164 Baseline Unblind Week 8 NTI164 Maximum Tolerated Dose Maximum Tolerated Dose Week 12 Secondary Endpoints Wash-Ou
Slide 12: NTI164 Exhibits Excellent Safety Over 8 Weeks
8 Week Safety Data A total of 54 patients NTI164 Exhibits Excellent Safety Over 8 Weeks evaluable at 8 weeks No serious adverse events (SAEs) recorded for NTI164 & placebo, across entire period (8 weeks) For personal use only Adverse Events (AEs) were tolerated and manageable (total of 11 AEs across
Slide 13: Primary Endpoint: CGI-S
Primary Endpoint: CGI-S Mean Severity of Illness (n=54) Severity of illness Scale (CGI-S) 5.54 5.25 5.21 For personal use only 1 2 3 4 5 6 7 Mean difference: –1.48 Treatment effect: -1.65 (p<0.001) Placebo NTI164 Baseline (NTI164) Baseline (placebo) 3.77 Week 8 (placebo) Baseline Week 8 Week 8 (NTI1
Slide 14: Secondary Endpoint: CGI-I
Secondary Endpoint: CGI-I Clinical Global Impression – Improvement (CGI-I) is a 7−point scale that reflects experts' clinical judgment of the patient based on the clinician's total experience with the ASD population graded from 1 (very much improved) to 7 (very much worse). A decrease in CGI-I score
Slide 15: Secondary Endpoint: Vineland-3
Secondary Endpoint: Vineland -3 Vineland -31 Standardised measure of adaptive behaviour For personal use only Norm-based: adaptive functioning compared to others of same age Clinical Interpretation Excellent test, re-test reliability & between rater (clinician, parent) • No Secondary endpoints were
Slide 16: Data Comparison & Context - Risperidone
Data Comparison & Context - Risperidone NTI164 Phase NTI164 Phase RISPERIDONE I/II (n=11) II/III (n=54) • -1.1 change at 20 weeks (p=0.005), 26% improvement • -1.48 change v placebo at 8 weeks, 28% improvement For personal use only • (n=96): -1.0 from baseline at 12 months1 • -1.3 change at 52 weeks
Slide 17: Rett Syndrome
Rett Syndrome “Caregivers of children with RTT experience the illness as being like an “obstacle course”, where they must continuously overcome hurdles. These include hindrances for finding responses to their symptoms and achieving a diagnosis, for managing the treatment and daily care, and for find
Slide 18: Rett Syndrome Market Dynamics
Rett Syndrome Market Dynamics Significant Market Single Approved Therapy Valuation/Pricing Benchmarks For personal use only 6,000-9,000 2,000-3,000 9,000-14,000 200 • 17-26k patients in USA, Europe, Japan, • First FDA approved therapy (March 2023) • Neuren (ASX:NEU) license deal with Acadia Australi
Slide 19: Rett Syndrome Trial Design (NTIRTT1)
Rett Syndrome Trial Design (NTIRTT1) Primary Endpoint For personal use only • Clinical Global Impression – Improvement (CGI-I) All patients completed 12 weeks i.e. no adverse events requiring Secondary Endpoints withdrawal from the study • Rett Syndrome Behaviour Questionnaire (RSBQ) • CGI-severity
Slide 20: NTI164 Exhibits Excellent Safety Over 12 Weeks
12 Week Safety Data A total of 14 patients NTI164 Exhibits Excellent Safety Over 12 Weeks evaluable at 12 weeks One serious adverse event (SAE) recorded (Urticaria-hives) Across all doses, across entire period (12 weeks) For personal use only Adverse events (AEs) were tolerated and manageable 11 AEs
Slide 21: Summary of Efficacy Measures
Summary of Efficacy Measures CGI-I Co-primary endpoints used for FDA Primary Endpoint approval in trofinetide Phase 3 trial RSBQ CGI-I Improvement of 10% from Baseline at 12 weeks (p=0.009) – 9 exploratory Rett-Specific Anchors Improvement of 23% from Baseline at 12 weeks (p=0.001) – 4 core Rett Anc
Slide 22: CGI-I: Specific Rett Anchor Analysis
CGI-I: Specific Rett Anchor Analysis • As a first in human trial of NTI164 in Rett patients, Neurotech examined nine (9) anchors/sub-domains to further understand what domain benefits NTI164 could target for registration-directed trials • Only 2-3 sub-domains are typically examined in Phase 3 trials
Slide 23: Secondary Endpoint: RSBQ
Secondary Endpoint: RSBQ The Rett Syndrome Behaviour Questionnaire (RSBQ) assesses the severity of neurobehavioral problems from the perspective of the caregiver and is one of the most widely used measures due to the specificity of its psychometric profile to the core features of Rett and is accepte
Slide 24: PANDAS/PANS
PANDAS/PANS “We encourage clinicians, teachers, providers, extended family, and friends to understand the human aspects of PANDAS/PANS as symptoms are often so distressing, causing high levels of caregiver burden. 1 For personal use only 1. https://aspire.care/what-is-pans/caregiver-experience/ 24
Slide 25: About PANDAS / PANS
About PANDAS / PANS What is it? Paediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections (PANDAS) and Paediatric Acute-Onset Neuropsychiatric Syndrome (PANS) – PANDAS is a subgroup of PANS For personal use only PANS and PANDAS are severe forms of obsessive-compulsive
Slide 26: Recognised Diagnostic & Treatment Guidelines
Recognised Diagnostic & Treatment Guidelines Diagnostic Criteria (2015) Treatment (2017) The PANS/PANDAS Research Consortium, in conjunction with the NIMH, The PANS/PANDAS Research Consortium, consisting over 30 experts and issued a consensus statement regarding diagnosing PANS/PANDAS in the the NIM
Slide 27: PANDAS/PANS
PANDAS/PANS Paediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections (PANDAS) and Paediatric Acute-Onset Neuropsychiatric Syndrome (PANS) Phase I/II reported: 15 patients with moderate-severe PANDAS/PANS recruited,12-week data (Oct 23), 24-week data (Feb 24), 52-week
Slide 28: Key Milestones – NTI164
Key Milestones – NTI164 1H CY2024 2H CY2024 • HREC/TGA Approval Cerebral Palsy Phase I/II Clinical Trial • Orphan Drug Designation USA – Rett Syndrome For personal use only • 24-week PANDAS/PANS Phase I/II Clinical Trial Data • Orphan Drug Designation USA – PANDAS/PANS • Rett Syndrome Phase I/II (14
Slide 29: Outlook
Outlook • Completed $10.0 million capital raise, $13.6 million in available pro-forma funds: well-funded to accelerate development activities in Australia and US, EU • Continued safety/efficacy data releases across 3 indications (ASD, PANDAS/PANS, Rett) as For personal use only patients enter or are
Slide 30: 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 Neurotech International Limited (ASX: NTI) 30
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