Neurotech International Ltd. · ASX:NTI
Neurotech International — Investor Presentation (April 2024)
35 slides from Neurotech International's investor presentation, Apr 17, 2024
Slide 1: Investor Presentation: Autism and Rett Syndrome Trial Results, Capital Raise
For personal use only Improving Lives Investor Presentation: Dr Tom Duthy Autism Phase II/III Clinical Trial Results Executive Director Rett Syndrome Phase I/II Clinical Trial Top-Line Results 17 April 2024 Capital Raise
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: Autism Spectrum Disorder (ASD) Goals
Autism Spectrum Disorder (ASD) Goals “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 per
Slide 4: Autism Spectrum Disorder (ASD)
Autism Spectrum Disorder (ASD) PREVALENCE OF ASD TREATMENT MARKET SIZE ~1 in 44 children 2 in the US1 US$2.0bn 2 Approved Drugs (* limited use) For personal use only Risperidone, Aripiprazole Market Current Treatment Clinical Trial ASD is a serious Huge unmet medical Initial Focus of NTI164 – A full
Slide 5: ASD and the NDIS
ASD and the NDIS The National Disability Insurance Scheme (NDIS) provides assistance to people with a disability, as well as their families and carers For personal use only There is a strong market need for an $35.5 Billion effective therapeutic intervention such as NTI164 to improve ASD symptoms &
Slide 6: NTI164 ASD Program Highlights
NTI164 ASD Program Highlights The Program First in human Phase I/II ASD paediatric study (open-label n=14) Commenced in May 2021 at Monash Children’s Hospital led by A/Prof. Michael Fahey For personal use only 28 Day Data 20 Week Data 52 Week Data 90 Week Safety Released Released Released Data Relea
Slide 7: ASD Trial Design (NTIASD2)
ASD Trial Design (NTIASD2) Enrolment Randomise / Double-Blind Primary Endpoint Placebo NTI164 Baseline • Clinical Global Impression – Severity of illness (CGI-S) For personal use only Unblind Week 8 NTI164 Maximum Tolerated Dose Secondary Endpoints Maximum Tolerated Dose Week 12 • Vineland -3 (adapt
Slide 8: Baseline Patient Characteristics
Baseline Patient Characteristics Characteristic Number (%) / Mean NTI164 Placebo For personal use only P Value (n=26) (n=28) Age 12.4 years 12.0 years 0.442 A total of 54 patients Male 14 (54%) 15 (54%) Sex 0.982 evaluable for Primary Female 12 (46%) 13 (46%) Endpoint Overall Score 5.54 (100%) 5.21
Slide 9: Summary of Efficacy Measures
Summary of Efficacy Measures Primary Endpoint CGI-S For personal use only Significant treatment effect -1.65 (95% CI; -2.3, -1.0) versus placebo at 8 weeks (p<0.001) Key Secondary Endpoints Vineland-3 Significant treatment effect 3.23 (95% CI; 0.44, 6.0) versus placebo at 8 weeks (p=0.024) CGI-I Sig
Slide 10: Expert Interpretation of Results
Expert Interpretation of Results For personal use only Professor Michael Fahey – Lead Investigator “The analysis so far of the trial, which compared NTI164 to placebo over 8 weeks of daily treatment, have demonstrated statistically significant and clinically meaningful improvements in the severity o
Slide 11: 8 Week Safety Data
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 12: 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 13: 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 14: 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 15: 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 16: Secondary Endpoint: SRS
Secondary Endpoint: SRS 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 validated measurement tool of assessing these f
Slide 17: Conclusions
Conclusions Met Primary Endpoint NTI64 has demonstrated a statistically significant and clinically meaningful improvement in ASD across multiple measures of For personal use only assessments relating to severity of illness, drug-related improvement, adaptive behaviours and socialisation Met All Seco
Slide 18: Rett Syndrome Phase I/II Trial
Rett Syndrome Phase I/II Trial “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 c
Slide 19: About Rett Syndrome
About Rett Syndrome 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 For personal use only • Currently there is no c
Slide 20: 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 21: Safety Data of Interest
Safety Data of Interest Safety Over 12 Weeks: Key Focal Points For personal use only 12% pts with >7% weight loss Weight Loss Kidney/Liver Function No significant weight change noted for Neurotech ASD & PANDAS/PANS Phase I/II trials All normal across Neurotech’s previous ASD (90 weeks+) and PANDAS/P
Slide 22: Rett Syndrome Trial Design (NTIRTT1)
Rett Syndrome Trial Design (NTIRTT1) Primary Endpoint For personal use only * Available • 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) • R
Slide 23: Top-Line Clinical Results
Top-Line Clinical Results A total of 14 patients evaluable at 12 weeks For personal use only CGI-I Primary Endpoint Significantly Improved CGI-I versus baseline mean difference of -0.3 (95% CI -0.015, -0.56; p = 0.04) Data compares favourably to DAYBUE (trofinetide) Phase 3 data v placebo (mean diff
Slide 24: Capital Raise
For personal use only Capital Raise 24
Slide 25: Pro-Forma Capital Structure
Pro-Forma Capital Structure PRO-FORMA CAPITAL STRUCTURE - $10 Million Placement For personal use only Current Shares on Issue 917.4M New Shares 100.0M Pro-Forma Shares on Issue 1017.4M Pro-Forma Cash1 $15.5M Pro-Forma Enterprise Value (undiluted)2 $86.2M 1. Cash at 31 December 2023 - $4.5 million, O
Slide 26: Timetable
Timetable* Event Date For personal use only Settlement of Placement Shares & Unlisted Options 23 April 2024 Allotment of Placement Shares on ASX & Commencement of Trading 24 April 2024 Allotment of Unlisted Options 24 April 2024 * Timetable is indicative and subject to change 26
Slide 27: Use of Funds
Use of Funds ALLOCATION OF EVENT FUNDS (PLACEMENT) For personal use only Further human clinical trials NTI164 (Rett, PANS, Other) $5.5M Regulatory Development $0.5M IND Enabling Toxicology $2.4M Manufacturing / Production Expansion $1.0M Offer Costs / Other $0.6M TOTAL $10.0M * In addition, the Comp
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 Europe – Rett Syndrome For personal use only • 24-week PANDAS/PANS Phase I/II Clinical Trial Data • Orphan Drug Designation Europe – PANDAS/PANS • Rett Syndrome Phase I/
Slide 29: Neurotech International
ENDS *) Neurotech International
Slide 30: Neurotech: Strategies, Pipeline, Milestones, Outlook
Neurotech: Strategies, Pipeline, Milestones, Outlook For personal use only 30
Slide 31: Neurotech is a clinical-stage biopharmaceutical development company
Neurotech is a clinical-stage biopharmaceutical development company focused predominately on paediatric neurological disorders For personal use only NTI164 exclusive worldwide Novel oral Patents Pending – biopharmaceutical licence for neurological Use, Composition disorders cannabinoid platform (NTI
Slide 32: 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 32
Slide 33: 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 34: 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 35: 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) 35
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