Investor Presentation
2022-10-28 · Neurotech International Limited · original investi.com.au ↗
Phase I/II ASD 20 Week Results & Capital Raise: Investor Presentation Improving Lives Dr Tom Duthy Executive Director 26 October 2022 Disclaimer Purpose of presentation: This presentation (including this document, any related video or oral presentation, any question and answer session and any written or oral material discussed or distributed in relation to this presentation) has been prepared by Neurotech International Limited (ACN 610 205 402) (Neurotech or Company). It has been prepared for the sole purpose of providing general information on Neurotech and its business. Not an offer or solicitation: This presentation is not investment advice nor an offer to subscribe for securities or otherwise invest in Neurotech, and it should not be relied upon to make any investment decision. 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IMPORTANTINFORMATION 2 ASD Phase I/II Results Neurotech Strategies Presentation Contents 3 Pipeline & Milestones Summary & Outlook Capital Raise Phase I/II Clinical Results: Autism Spectrum Disorder (ASD) 4 “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 1. Weitlauf AS, McPheeters ML, Peters B, et al. Therapies for Children With Autism Spectrum Disorder: Behavioural Interventions Update. Rockville (MD): Agency for Healthcare Research and Quality (US); 2014 Aug. (Comparative Effectiveness Review, No. 137.) Introduction. PREVALENCE OF ASD ~1 in 44 children in the US1 Current TreatmentMarket ASD is a serious neuro inflammatory developmental disorder that impairs the ability to communicate & interact Common symptoms; behavioural issues, agitation, repetitive movements, inability to focus & compulsive neurological patterns Clinical Trial Huge unmet medical need - patients need better treatment Current drugs have numerous side effects; weight gain, breast tissue development, nausea, dry mouth, anxiety, irritability, insomnia, stomach pain & movement disorders RISPERIDONE Approved 2006 (irritability label claim) 1. www.cdc.gov/ncbddd/autism/addm.html 2. https://www.fortunebusinessinsights.com/industry-reports/autism-spectrum-disorder-therapeutics-market-101207-CAGR-of-7-4.html Autism Spectrum Disorder (ASD) 5 2 TREATMENT MARKET SIZE US$1.85b Strong Scientific Rationale • Anti-inflammatory effects + safety • Clinician support • High Patient/Caregiver interest • Risperidone not a clinical standard Initial Focus of NTI164 – A full spectrum, oral cannabinoid biopharmaceutical product NTI164 ASD Phase I/II - Trial Design 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 Dose regime assessments 5mg/kg, 10mg/kg, 15mg/kg and 20mg/kg 2,250 Assessment points Parameters Anxiety, Participation, Irritability, Hyperactivity, Mood and Self-stimulation 6 Data Released 8 July 2022 NTI164 ASD Phase I/II – Safety/Efficacy (28 Day Recap) NTI164 was Safe No serious adverse events recorded Across all doses 7 All participants requested to continue for at least 54 weeks – progressive data collected including at 20 weeks NTI164 reduced ‘Severity of Illness’ score by 0.8 (18%) CGI - Global Improvement 64% of patients "much improved” 29% of patients "minimally improved 7% of patients "no change" Average rating for the severity of illness at baseline: 4.4 Average rating for the severity of illness at 28 Days of treatment with NTI164 was 3.6 p= 0.027 More Severe Less Severe 1 = normal (not at all) 2 = Borderline mentally ill 3 = Mildly ill 4 = Moderately ill 5 = Markedly ill 6 = Severely ill 7 = Among the most extremely ill 93% of patients showed improvement Note: Baseline and 28 day data reported above (ASX Announcement 8 July 2022) represents 14 patients having completed daily treatment with NTI164 to 28 days per study protocol (Note: A p-value < 0.05 is considered statistically significant) NTI164 ASD Phase I/II – Safety (20 week Data) NTI164 Safety Effects Maintained Over 20 Weeks 8 Conclusion: NTI164 longer term (chronic) administration now established with an excellent safety profile and minimal patient-specific side-effects: safety data collected to 54 weeks ongoing 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 (not considered a preferred standard of care) Adverse events were tolerated and manageable i.e. mild nausea, abdominal pain A total of 12 patients evaluable at 20 weeks 2 patients stopped treatment (not drug related) NTI164 ASD Phase I/II – Efficacy (20 week Data) Summary Outcome Measures 9 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 significant results for the most clinically important measures: • Severity of illness • Adaptive behaviour • Anxiety, depression and mood • Social responsiveness • Consistent improvements across multiple standard clinical measures at 20 weeks versus baseline do not support a placebo effect Note: Baseline and 28 day data as previously reported has been normalised to exclude those two patients who did not complete 20 weeks of daily NTI164 treatment. Sub-Domain Scale P-value (Paired T-Test) Wilcoxon Signed-Rank Test Severity of illness CGI-S 0.005 0.010 Global improvement CGI-S n/a* n/a* Therapeutic effect CGI-S n/a* n/a* Adaptive behaviour composite (Total) Vineland-3 0.0005 0.003 Communication Vineland-3 0.002 0.004 Daily living skills Vineland-3 0.019 0.025 Socialisation Vineland-3 0.014 0.012 Social responsive scale – Total SRS-2 0.012 0.013 Social awareness SRS-2 0.596 0.439 Social cognition SRS-2 0.028 0.036 Social communication SRS-2 0.019 0.018 Social motivation SRS-2 0.118 0.138 Restricted interest and repetitive behaviour SRS-2 0.009 0.014 Social communication and interaction SRS-2 0.029 0.021 Anxiety scale for children - Child's total ASC-ASD-C 0.025 0.012 Performance anxiety ASC-ASD-C 0.364 0.474 Anxious arousal ASC-ASD-C 0.12 0.089 Separation anxiety ASC-ASD-C 0.025 0.035 Uncertainty ASC-ASD-C 0.033 0.035 Anxiety scale for children - Parent's total ASC-ASD-P 0.034 0.053 Performance anxiety ASC-ASD-P 0.07 0.096 Anxious arousal ASC-ASD-P 0.333 0.229 Separation anxiety ASC-ASD-P 0.025 0.033 Uncertainty ASC-ASD-P 0.066 0.084 Sleep disturbances scale for children - Total SDSC 0.016 0.018 Disorders of initiating and maintaining sleep SDSC 0.01 0.026 Sleep breathing disorders SDSC 0.047 0.042 Sleep-wake transition disorders SDSC 0.094 0.072 Anxiety, depression and mood scale – Total ADAMS 0.001 0.009 * t-test cannot be performed due to different measurement scale used at baseline NTI164 ASD Phase I/II – Efficacy (20 week Data) CGI-Global improvement 1 101. Clinical Global Impression (CGI) - is a physician/observer-rated scale synthesizing the clinician’s impression of the global state of an individual & frequently employed in clinical trials for neuropsychiatric disorders. Baseline and 28 day data as previously reported has been normalised to exclude those two patients who did not complete 20 weeks of daily NTI164 treatment. The CGI is a 3-item observer-rated scale that measures illness severity, global improvement and therapeutic effect. 8% 25% 25% 8% 75% 67% 83% 100% 8% 0% 20% 40% 60% 80% 100% Week 4 Week 8 Week 12 Week 20 Percentage of Active Patients 1. Very much improved 2. Much improved 3. Minimally improved 4. No change Clinical Interpretation • 100% of active patients showed improvement after 20 weeks of daily treatment with NTI164 • All patients had a global improvement of 2: Much improved NTI164 ASD Phase I/II – Efficacy (20 week Data) CGI-Therapeutic Effect1 11 Clinical Interpretation • 67% of active patients demonstrated the highest possible efficacy indexes of 1 and 2: Complete or nearly complete remission of all symptoms. • 33% of patients were decidedly improved. Partial remission of symptoms • Potential for further improvement to 54 weeks 1. Clinical Global Impression (CGI) - is a physician/observer-rated scale synthesizing the clinician’s impression of the global state of an individual & frequently employed in clinical trials for neuropsychiatric disorders. Baseline and 28 day data as previously reported has been normalised to exclude those two patients who did not complete 20 weeks of daily NTI164 treatment. The CGI is a 3-item observer-rated scale that measures illness severity, global improvement and therapeutic effect. 8% 17% 8% 83% 67% 58% 33% 17% 8% 33% 67% Week 4 Week 8 Week 12 Week 20 Therapeutic Effect (Efficacy Index) 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 not significantly interfere with patient's functioning. 5 = Moderate - Decided improvement. Partial remission of symptoms. No side effects. 6 = Moderate - Decided improvement. Partial remission of symptoms. Side effects do not significantly interfere with patient's functioning. 7 = Moderate - Decided improvement. Partial remission of symptoms. Side effects significantly interfere with patient's functioning. 9 = Minimal - Slight improvement. Doesn’t alter status of care of patient. No side effects. 10 = Minimal - Slight Improvement. Doesn’t alter status of care for patient. Side effects do not significantly interfere with patient's functioning. 13 = Unchanged or Worse. No side effects. NTI164 ASD Phase I/II – Efficacy (20 Week Data) CGI-Severity of illness1 (p = 0.005) 12 Clinical Interpretation • NTI164 treatment is associated with a significant reduction in disease severity (1.1 scale change, 26% improvement) • ~40% of subjects markedly or severely ill at baseline – 0% from week 4 onwards • Potential for further improvement to 54 weeks 4.3 3.6 3.4 3.4 3.2 Baseline Week 4 Week 8 Week 12 Week 20 Mean Severity of Illness (n=12) 0.000 0.100 0.200 0.300 0.400 0.500 0.600 0.700 0.800 0.900 1.000 1 2 3 4 5 6 7 Baseline Week 20 1. Normal, not at all ill 5. Markedly ill 2. Borderline mentally ill 6. Severely ill 3. Mildly ill 7. Among the most extremely ill patients 4. Moderately ill -1.1 Extremely illNormal 1. Clinical Global Impression (CGI)- is a physician/observer-rated scale synthesizing the clinician’s impression of the global state of an individual & frequently employed in clinical trials for neuropsychiatric disorders. Baseline and 28 day data as previously reported has been normalised to exclude those two patients who did not complete 20 weeks of daily NTI164 treatment. The CGI is a 3-item observer-rated scale that measures illness severity, global improvement and therapeutic effect. NTI164 ASD Phase I/II – Efficacy (20 week Data) Vineland™-31 13 1. Vineland™-3 is internationally recognised as a leading instrument for supporting the diagnosis of intellectual and developmental disabilities in ASD; specifically adaptive behaviour. Adaptive functioning, which are skills people need to function independently at home, at school and in the community is an important factor in predicting long-term outcomes for people with ASD. Improving adaptive abilities in patients is therefore a desirable treatment goal. The adaptive behaviour composite consists of (a) communication, (b) daily living skills & (c) socialisation. Baseline data as previously reported has been normalised to exclude those two patients who did not complete 20 weeks of daily NTI164 treatment. Clinical Interpretation • Adaptive behaviour improvement is a treatment goal in ASD • Highly significant improvements in composite outcome AND individual domains of communication, daily living, socialisation at 20 weeks 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) Vineland-3 Domain P-value (Paired T-Test) Adaptive behaviour composite 0.0005 Communication 0.002 Daily living skills 0.019 Socialisation 0.014 NTI164 ASD Phase I/II – Efficacy (20 week Data) 14 Clinical Interpretation • Achieved strong overall statistical significance for social responsiveness (p=0.012) • NTI164 targets social skills: beneficial for social functioning and social anxiety symptoms • Social communication differences are one of the core features of ASD SRS™-21 1. Social Responsiveness Scale (SRS™-2) is internationally recognised as a leading instrument (65 items) for identifying the presence and severity of social impairment within the autism spectrum and differentiates it from that which occurs in other disorders. The SRS-2 total score is the most reliable measure for social deficits related to ASD. SRS-2 is distinct from other measures in that it provides a continuous measure of social ability (from impaired to above average) instead of a categorical yes/no identification of ASD impairments. High scores are associated with more severe social impairments. SRS-2 is a valid and reliable quantitative measure of core ASD symptoms related to social impairment. SRS-2 Domain P-value (Paired T-Test) Total 0.012 Social awareness 0.596 Social cognition 0.028 Social communication 0.019 Social motivation 0.118 Restricted interest and repetitive behaviour 0.009 Social communication and interaction 0.029 Children with autism spectrum disorder have difficulty with social interaction behaviours, including establishing and maintaining relationships, reciprocating social interaction, and communicating with others. SRS-2 is a validated measurement tool of assessing these factors NTI164 ASD Phase I/II – Efficacy (20 week Data) Anxiety (Parent/Child) 15 Clinical Interpretation • Statistically significant and clinically meaningful 24% improvement in anxiety scale (parent, p=0.034) and 38% improvement in child version (p=0.025) • Improvements in anxiety, adaptive behaviour and social responsiveness: important benefits for 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 course and the core aspects of the disorder, exacerbating social withdrawal as well as repetitive behaviours. 1 1. Anxiety and Depression Association of America Anxiety Scale Baseline Mean Week 20 Mean Mean Difference P Value (Paired T-test) Parent Version (ASC-ASD-P) n=10 29.4 22.2 -7.2 0.034 Child Version (ASC-ASD-C) n=11 29.5 18.2 -11.2 0.025 Data Comparison & Context - Risperidone 16 1. Kent, et al. Risperidone Dosing in Children and Adolescents with Autistic Disorder: A Double-Blind, Placebo-Controlled Study. Journal of autism and developmental disorders. 2012. 43. 10.1007 2. A Study to Evaluate the Efficacy and Safety of Risperidone (R064766) in Children and Adolescents With Irritability Associated With Autistic Disorder, 2015 3. Ghaeli P et al. Effects of risperidone on core symptoms of autistic disorder based on childhood autism rating scale: an open label study. Indian J Psychol Med. 2014 Jan;36(1):66-70. 4. McDougle CJ, et al.. Risperidone for the core symptom domains of autism: results from the study by the autism network of the research units on pediatric psychopharmacology. Am J Psychiatry. 2005 Jun;162(6):1142-8 CGI-Severity of illness RISPERIDONE NTI164 Vineland™-31 CGI- Improvement Vineland™-3 Safety • (n=96): -1.0 from baseline at 12 months1 • (n=38): -0.7 from baseline at 48 weeks2 • -1.1 change at 20 weeks (p=0.005), 26% improvement • ~40% of subjects markedly or severely ill at baseline – 0% from week 4 onwards • At 20 weeks, mean result: 100% mildly ill • (n=15): CGI-I changes after 8 weeks from baseline3 • 27% - very much improved • 47% - much improved • 20% - minimal improved • 6.6% - no change • 100% of active patients showed improvement after 20 weeks of daily treatment with NTI164 • All patients had a global improvement of ‘2. Much improved’ • Near absence of RCTs examining Vineland noted in the medical literature • No impact on social interaction and communication4 • Adaptive behaviour composite score (p=0.001) • Highly significant improvement • Highly significant improvements also in domains of communication, daily living, socialisation at 20 weeks • Significant weight gain Increase in BMI by 0.621 • Weight gain2 • Increase in appetite, sedation3 • No change to weight • No change to appetite • Mild nausea, stomach pain RCT- randomised controlled trial; BMI – Body Mass index “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.” NTI164 ASD Phase I/II – Conclusions 17 • 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 behavioural therapies, by improving daily living and allowing children to integrate into society via significant improvements in socialisation & anxiety versus ‘restrictive’ prescription of Risperidone (prevention of aggression, irritability) • Approximately 6,300 assessment points now collected at 20 weeks. Trial continues to 54 weeks, with data to form part of FDA IND submission • Data strongly supports progression to randomised, double-blind, placebo-controlled ASD Phase II/III clinical trial: expected to commence in Q4 CY2022 – HREC has been submitted Professor Michael Fahey – Lead Investigator “I am extremely encouraged by the 20-week results and the clinical improvements in troubling symptoms we have seen to date. These benefits, as measured by standardised scales, relate to global improvement, severity of illness, socialisation, adaptive behaviour, communication and reduction in anxiety. These results provide positive momentum as we move to the commencement of the next phase of clinical development. This is a strong indication that NTI164 has the potential to be an enabling treatment for some of the symptoms that cause people with Autism Spectrum Disorder distress.” * Subject to further clinical analysis and interpretation, along with the receipt of the complete Clinical Trial Report from the Study Investigator / Contract Research Organisation Neurotech: Strategies, Pipeline, Milestones, Outlook 18 NTI164 exclusive worldwide licence for neurological disorders PCT patent applications lodged Extensive pre-clinical studies completed (NTI164) World first Phase I/II trial in ASD completed Mente device & therapy for ASD Neurotech is a clinical -stage biopharmaceutical development company focused predominately on paediatric neurological disorders 19 Novel oral biopharmaceutical cannabinoid platform (NTI164) Neurotech Four Core Strategies 20 Focus on Partnering with Key Opinion Leaders / Clinicians Focus on Paediatric Patients Focus On Drug Product Development Focus On Rare Neurological Disorders with Neuroinflammation Strategic Focus Offers Significant Value Upside 21 Focus on Paediatric Patients Focus On Rare Neurological Disorders with Neuroinflammation Focus on Partnering with Key Opinion Leaders / Clinicians Focus on Drug Product Development • Often overlooked by big pharma • Can be unencumbered drug therapy markets (no standard of care, no approved treatments) • Lack of clinical trials that may compete for patients • Ability to leverage significant regulatory levers at FDA & EMA: orphan designation, breakthrough status, fast-track, priority review • Literature well-established for cannabinoids / extracts on inflammatory processes • NTI164 shown strong pre-clinical effects on inflammation, neuro-protection, neuro-modulation and neuro-regulation • NTI164 shown efficacy in serious neuroinflammatory developmental disorder: Autism Spectrum Disorder • Often chronic disorders requiring continued therapeutic intervention (higher lifetime patient value) • Regulated Drug Product via FDA, TGA, EMA (barrier to entry) • Manufacture under Good Manufacturing Practice (GMP) & robust CMC (Chemistry, Manufacture, Controls)(barrier to entry) • Premium Drug Pricing • Reimbursement for “on-label” prescribing • Paediatric Neurology focus with supportive Human Research Ethics Committees (HRECs) • Availability of patients / caregivers for clinical trials • Decades of experience in paediatric clinical trials – sound trial design frameworks and outcomes • Paediatric neurological disorders tend to have strong clinical networks / advocacy groups Rapid Progress from Lab to Clinic Drives Strategy 22 Extraction of Drug Product (NTI164) & Pre-Clinical Data Manufacture Scale-Up & Analytical Methods Established Phase I/II Clinical Trial (Safety) + Efficacy Shown in Autism Spectrum Disorder (ASD) Children Patent Applications (Novel Composition & Methods) Beach Head ASD Results Drives New Clinical Trials in Pediatric Neurological Disorders • Reduction in brain cell inflammation (up to 60%) • Increase in overall brain cell health and viability (in the absence of toxic insult up to 80%) • Increase in mitochondrial viability and output (in the presence of toxic insult up to 60%) • Significant suppression of neuro-markers linked to MS (GM-CSF < 40% and TNF-alpha < 30%) • Multi-functional Mode of Action | neuro- protection, neuro-modulation and neuro- regulation 2020 2021 2022 Phase I/II PANDAS/PANS1 1. Paediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections (PANDAS) and Paediatric Acute -Onset Neuropsychiatric Syndrome (PANS) Phase I/II Cerebral Palsy Phase II/III ASD 2023 8 Pipeline (Pro-Forma 1 Jan 2023) 23 Pre-Clinical NTI164 Combination Therapies Prednisone, Diclofenac, Other Phase I/II Phase II/III NTI164 Cerebral Palsy NTI164 PANDAS / PANS NTI164 ASD Other Licensed Strains NTI164 ASD (54 week open label extension) Rapid Pipeline Progression Pipeline (2020/1) NTI164 Neuronal Cell Assays Other Licensed Strains NTI164 Combination Therapies Prednisone, Diclofenac, Other Breadth Depth Q4 CY2022 Key 12 Month Milestones – NTI164 1H CY2023 24 2H CY2023 • Human Research Ethics Committee (HREC) Clearance ASD Phase II/III • HREC/TGA Approval PANDAS/PANS Phase I/II Clinical Trial • Completion of FDA Pre-IND Package • Commencement of Patient Recruitment ASD Phase II/III Clinical Trial • HREC Submission Cerebral Palsy Phase I/II Clinical Trial • Commencement of Patient Recruitment PANDAS/PANS Phase I/II Clinical Trial • HREC/TGA Approval Cerebral Palsy Phase I/II Clinical Trial • Commencement of Patient Recruitment Cerebral Palsy Phase I/II Clinical Trial • Completion of Patient Recruitment PANDAS/ PANS Phase I/II Clinical Trial • FDA Pre-IND Meeting • Additional paediatric neurological disorder clinical trial launch • Results of PANDAS/PANS Phase I/II Clinical Trial • Completion of Patient Recruitment Cerebral Palsy Phase I/II Clinical Trial • Completion of Patient Recruitment ASD Phase II/III Clinical Trial • US FDA IND submission • Results of Cerebral Palsy Phase I/II Clinical Trial Summary of Strategy 25 Phase I/II PANDAS/PANS Phase I/II Cerebral Palsy Phase II/III ASD Group Strategy Implementation to Development Potential Regulatory Levers Commercialisation Examples* * For illustrative purposes only highlighting transactions in the rare paediatric neurological disorder field Pre-IND Feedback IND Orphan Drug Designation Priority Review Breakthrough Therapy Fast-Track Rare Pediatric Priority Voucher Scientific Advice Protocol Assistance Orphan Drug Designation Accelerated Assessment Current Potential ADHD Rett Syndrome Fragile-X Dravet Lennox-Gastaut Neuroinflammation Dravet Lennox-Gastaut US$7.2 Billion acquisition of GW1 2021 Epidiolex® Sales: US$464 Million1 20212018/92016 Phase III Trials FDA approval EMA approval FDA,EMA Orphan Designations, Fast- Track Status 202220182016 US$455 Million Licence for Trofinetide in Rett2 NDA filed with FDA for Rett Multiple FDA,EMA Orphan Designations, Fast- Track Status in Rett, Fragile-X, Angelman, Phelan-McDermid, Pitt Hopkins, Prader-Will NEU Market Cap: $900M Pipeline focus on rare neurodevelopmental disorders ASX:NEU Market Cap: $200M 1. Jazz Pharmaceuticals 2. Neuren Pharmaceuticals Outlook 26 • 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-effective proof of concept Phase I/II clinical trials in Australia for new paediatric neurological disorders (PANDAS/PANS & CP) • Strong clinician engagement • Access to numerous regulatory levers from the FDA and EMA • Additional funding provides sufficient runway to complete all current clinical trials and pathway with the US FDA – significant valuation upside if met Dr Thomas Duthy Executive Director Dr Duthy has over 18 years of direct financial market and executive level/ Board experience with ASX listed companies. Director of Nemean Group -corporate advisory and investor relations services in the Life Sciences and Technology sectors. PhD Molecular Microbiology, MBA, MAICD Mark Davies Non-Executive Director Winton Willesse Non-Executive Director Experienced company director with over 20 years experience in various roles within the Australian capital markets Core expertise in strategy, company development, corporate governance, company public listings, merger and acquisition transactions and corporate finance MCom, FFin, CPA, GAICD, FGIA/FCG Highly Experienced Executive Team and Board 27 Gerald Quigley Non-Executive Director Pharmacist and consumer health commentator. Leading media health commentator heard each week on television and radio stations across Australia. Extensive knowledge relating to pharmaceutical/nutraceutica l product development, dispensing & marketing in addition to product positioning within the relevant regulatory landscapes (eg. TGA, FDA). B(Pharm) Prof. Allan Cripps AO Non -Executive Director Chief Scientist Distinguished academic, clinical scientist and health services leader Independent Chair of the Children’s Health Research Alliance Board and Non- Executive Director at Bard1 (BD1) Formerly the Pro Vice Chancellor (Health) at Griffith University and currently professor emeritus at Griffith University PhD, BSc (Hons), FAHSM, FASM, FAIMS, FIBMS, FCHSM, MACID More than 20 years’ experience in trading, investment banking & providing corporate advice Specialises in providing corporate advice & capital raising services to emerging companies seeking business development opportunities and funding from the Australian market Managing Director of 1861 Capital and co- founder of investment banking firm, Cygnet Capital BCom Dr Alexandra Andrews COO Expertise in corporate development, investor engagement, product development and commercialisation, clinical trials and regulatory environments. Former Director of Operations at NeuroScientific Biopharmaceuticals Ltd. PhD Neuroscience, BBMed Sci (Hons1st) Capital Raise 28 Structure 29 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 Options include 45,000,000 issued to shareholders under the Transaction as well as an additional 10,000,000 issued to the JLMs on the same terms 2. Cash at 30 June 2022 - $1.9 million, Placement of $9.0 million minimum, transaction costs of $(0.5) million 3. Assumes $0.10 share price 4. The Company has also agreed to issue 35 million adviser options, 30 million director options and 33 million licensor shares, subject to shareholder approval 30 Timetable* * Timetable is indicative and subject to change 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 Halt Lifted Friday 28 October 2022 Settlement of Placement Shares Thursday 3 November 2022 Allotment of Placement Shares on ASX & Commencement of Trading Friday 4 November 2022 Allotment of Placement Options Friday 3 December 2022 Event Date Use of Funds 31 EVENT ALLOCATION OF FUNDS (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 Contact Details Dr Tom Duthy Executive Director [email protected] +61 402 493 727 www.neurotechinternational.com www.mentetech.com Neurotech International Limited (ASX: NTI) 32 *This presentation has been authorised by the Board of Neurotech International Limited
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