Neurotech International Ltd. · ASX:NTI
Neurotech International — Investor Presentation (October 2022)
32 slides from Neurotech International's investor presentation, Oct 28, 2022
Slide 1: Phase I/II ASD 20 Week Results & Capital Raise: Investor Presentation
For personal use only Improving Lives Phase I/II ASD 20 Week Results & Dr Tom Duthy Capital Raise: Investor Presentation Executive Director 26 October 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 ASD Phase I/II Neurotech Pipeline & Summary & Capital Results Strategies Milestones Outlook Raise 3
Slide 4: 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 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: 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 14 patients from 8 to 17yo, Level II and III Autism Spectrum Disorder Data
Slide 7: NTI164 – Safety/Efficacy (28 Day Recap)
NTI164 ASD Phase I/II – Safety/Efficacy (28 Day Recap) For personal use only NTI164 was Safe No serious adverse events recorded Less Severe More Severe Across all doses 1 = normal (not at all) 2 = Borderline mentally ill 3 = Mildly ill 4 = Moderately ill 5 = Markedly ill 6 = Severely ill 7 = Among t
Slide 8: NTI164 – Safety (20 week Data)
NTI164 ASD Phase I/II – Safety (20 week Data) For personal use only NTI164 Safety Effects Maintained Over 20 Weeks No serious adverse events recorded Across all doses 58% patients continued to tolerate maximum dose (20 mg/kg/day) over course of 20 weeks Only 1 patient on Risperidone at enrollment (n
Slide 9: NTI164 – Efficacy (20 week Data)
NTI164 ASD Phase I/II – Efficacy (20 week Data) Summary Outcome Measures For personal use only Sub-Domain Scale P-value (Paired T-Test) Wilcoxon Signed-Rank Test Clinical Interpretation Severity of illness CGI-S 0.005 0.010 Global improvement CGI-S n/a* n/a* Therapeutic effect Adaptive behaviour com
Slide 10: NTI164 – Efficacy (20 week Data): CGI-Global improvement
NTI164 ASD Phase I/II – Efficacy (20 week Data) For personal use only CGI-Global improvement 1 100% 8% Percentage of Active Patients 80% Clinical Interpretation 1. Very much improved 67% 60% 75% 2. Much improved • 100% of active patients showed improvement after 20 weeks of daily treatment with NTI1
Slide 11: NTI164 – Efficacy (20 week Data): CGI-Therapeutic Effect
NTI164 ASD Phase I/II – Efficacy (20 week Data) For personal use only CGI-Therapeutic Effect1 1 = Marked - Vast improvement. Complete or nearly complete remission of all symptoms. No side effects. 2 = Marked - Vast improvement. Complete or nearly complete remission of all symptoms. Side effects do n
Slide 12: NTI164 – Efficacy (20 Week Data): CGI-Severity of illness
NTI164 ASD Phase I/II – Efficacy (20 Week Data) For personal use only CGI-Severity of illness1 (p = 0.005) Mean Severity of Illness (n=12) 4.3 1.000 Normal Extremely ill 0.900 0.800 3.6 0.700 3.4 3.4 0.600 -1.1 3.2 Baseline 0.500 Week 20 Baseline Week 4 Week 8 Week 12 Week 20 0.400 0.300 0.200 0.100
Slide 13: NTI164 – Efficacy (20 week Data): Vineland-3
NTI164 ASD Phase I/II – Efficacy (20 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 Excellent test, re-test reliability & between rater (clinician, parent) Clinical Interpreta
Slide 14: NTI164 – Efficacy (20 week Data): 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, including establishing and SRS™-21 maintaining relationships, reciprocating social interaction, and communicating with others. SRS-2 is a v
Slide 15: NTI164 – Efficacy (20 week Data): Anxiety
NTI164 ASD Phase I/II – Efficacy (20 week Data) For personal use only Anxiety (Parent/Child) 40% of young people with ASD have clinically elevated levels of anxiety or at least one anxiety disorder. It is particularly important to recognize and treat anxiety in ASD since it has a great impact on the
Slide 16: Data Comparison & Context - Risperidone
Data Comparison & Context - Risperidone For personal use only RISPERIDONE NTI164 • -1.1 change at 20 weeks (p=0.005), 26% improvement • (n=96): -1.0 from baseline at 12 months1 • ~40% of subjects markedly or severely ill at baseline – 0% from CGI-Severity of illness • (n=38): -0.7 from baseline at 4
Slide 17: NTI164 – Conclusions
NTI164 ASD Phase I/II – Conclusions For personal use only • Any significant change over time for measures of CGI-S, Vineland™-3 and SRS™-2 are considered clinically meaningful: NTI164 showed sig. improvement for all measures at 20 weeks v baseline • NTI164 is a patient ‘enabling’ drug with non-drug
Slide 18: Neurotech: Strategies, Pipeline, Milestones, Outlook
Neurotech: Strategies, Pipeline, Milestones, Outlook For personal use only 18
Slide 19: 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 20: 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 20
Slide 21: 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 22: 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 23: 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 24: 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 Clearance ASD Phase II/III PANDAS/PANS Phase I/II Clinical Trial • Completion of Pati
Slide 25: 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 26: 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 27: Highly Experienced Executive Team and Board
Highly Experienced Executive Team and Board For personal use only Dr Thomas Duthy Prof. Allan Cripps AO Mark Davies Gerald Quigley Executive Director Non-Executive Director Winton Willesse Dr Alexandra Andrews Non-Executive Director Non-Executive Director Chief Scientist Non-Executive Director COO M
Slide 28: Capital Raise
For personal use only Capital Raise 28
Slide 29: Structure
Structure For personal use only PRO-FORMA CAPITAL STRUCTURE - $9 Million Placement Current Shares on Issue 717.7M Current Options Outstanding 123.1M New Shares 90.0M New Options1 55.0M Pro-Forma Shares on Issue (fully diluted) 985.8M Pro-Forma Cash2 $10.4M Pro-Forma Enterprise Value3 $88.2M 1. New O
Slide 30: Timetable
Timetable* For personal use only Event Date Trading Halt (For Clinical Trial results + Transaction) Tuesday 25 October 2022 Placement Bookbuild Commences Tuesday 25 October 2022 Allocations and Signed Acceptances Thursday 27 October 2022 ASX Announcement – Transaction, Investor Presentation, Trading
Slide 31: Use of Funds
Use of Funds For personal use only ALLOCATION OF FUNDS EVENT (PLACEMENT) Phase II/III ASD Trial $3.0M Phase I/II PANS/PANDAS Trial $0.5M Phase I/II CP Trial $0.5M Regulatory / FDA IND $1.0M Manufacturing / Production $0.5M Working Capital $3.0M Offer Costs / Other $0.5M TOTAL $9.0M 31
Slide 32: 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) 32
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