Neurotech International Ltd. · ASX:NTI
Neurotech International — Shareholder Meeting (November 2022)
22 slides from Neurotech International's shareholder meeting presentation, Nov 30, 2022
Slide 1: Improving Lives: 2022 Annual General Meeting
For personal use only Improving Lives 2022 Annual General Meeting Dr Tom Duthy Executive Director 30 November 2022
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 Neurotech Strategies ASD Phase I/II Pipeline & Summary & Results + Update Milestones Financials Outlook & Clinical Focus 3
Slide 4: 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 5: 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 5
Slide 6: 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 7: 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 8: 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 9: Rapid Pipeline Progression
Rapid Pipeline Progression For personal use only Pipeline (Pro-Forma 1 Jan 2023) Pipeline (2020/1) Pre-Clinical Phase I/II Phase II/III NTI164 Combination Therapies Prednisone, Diclofenac, Other NTI164 NTI164 NTI164 Combination Therapies Prednisone, Diclofenac, Other Cerebral Palsy ASD NTI164 Neuron
Slide 10: 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 1. Weitla
Slide 11: 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 12: 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 13: Phase I/II Clinical Results: Autism Spectrum Disorder (ASD)
Phase I/II Clinical Results: Autism Spectrum Disorder (ASD) 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 f
Slide 14: 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 14 patients from 8 to 17yo, Level II and III Autism Spectrum Disorder Data
Slide 15: NTI164 ASD Phase I/II – Efficacy (20 week Data)
NTI164 ASD Phase I/II – Efficacy (20 week Data) For personal use only Summary Outcome Measures Clinical Interpretation • Statistical significance (p<0.05): • 20/27 measures assessed at 20 weeks • Study was not statistically powered for any efficacy measures (safety was primary endpoint) • Highly sig
Slide 16: NTI164 ASD Phase I/II – Conclusions
NTI164 ASD Phase I/II – Conclusions For personal use only • 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
Slide 17: Improvements Continue to Week 32
32 Week Data - Preliminary Severity of illness Scale (CGI-S) For personal use only Severity of illness (CGI-S) 1 2 3 4 5 6 7 Improvements Continue to Week 32 Baseline Week 4 Mean CGI-S of 12 Children now at Week 20 intersection of “Borderline mentally Week 32 ill” to “Mild” from “Moderate” at Baseli
Slide 18: Financials
Financials For personal use only • Pro-Forma1 Cash and Cash Equivalents of $10.3 million $9.0 Million Share Placement Completed November 2022 $1.1 Million R&D Tax Incentive Rebate Received October 2022 $0.7 Million Cash on Hand 30 September 2022 1. Cash as at 30 September 2022 of $0.7 million, $8.5
Slide 19: Deployment of $9M Nov Share Placement
Deployment of $9M Nov Share Placement For personal use only $4.0 Million NTI164 Clinical Trial Programs $1.0 Million Regulatory Development (Europe – EMA; US – FDA) $3.5 Million Manufacturing scale-Up & NTI164 production Working Capital New Indication Development 19
Slide 20: Key Month Milestones – NTI164
Key 12 Month Milestones – NTI164 For personal use only Q4 CY2022 1H CY2023 2H CY2023 • Human Research Ethics Committee (HREC) • Commencement of Patient Recruitment • Results of PANDAS/PANS Phase I/II Clinical Trial Approval ASD Phase II/III PANDAS/PANS Phase I/II Clinical Trial • Completion of Patie
Slide 21: 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 22: 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 Thomas Duthy, Executive Director of Neurotech International Limited www.neurotechinternational.com www.mentetech.com Neurotech International L
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