Investor Presentation
2022-07-08 · Neurotech International Limited · original investi.com.au ↗
Improving Lives Dr AlexandraAndrews PhDNeuroscience,BBMedSci(Hons1st) ChiefExecutiveOfficer Phase I/II Trial Results Webinar July2022 Gerald Quigley B(Pharm) Non-Executive Director Brian Leedman BEc, MBA (UWA) Chairman Disclaimer Purposeofpresentation:Thispresentation(includingthisdocument,anyrelatedvideoororal presentation,anyquestionandanswersessionandanywrittenororalmaterialdiscussedordistributed inrelationtothispresentation)hasbeenpreparedbyNeurotechInternationalLimited(ACN610205402) (NeurotechorCompany).Ithasbeenpreparedforthesolepurposeofprovidinggeneralinformationon Neurotechanditsbusiness. 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Theseeventsare,asatthedateofthispresentation,expectedtotakeplace,buttherecannotbeany guaranteethatsuchwilloccurasanticipated,oratall,giventhatmanyoftheeventsareoutsideNeurotech’s control.Thestatedeventsmaydiffermateriallyfromresultsultimatelyachieved.Accordingly,neither Neurotechnoranyofitsdirectors,employees,contractorsoradvisorsmakeanywarrantyorassurancethat theresults,performanceorachievementsexpressedorimpliedbytheforward-lookingstatementscontained inthispresentationwillactuallyoccur.Further,otherthanasrequiredbylaw,Neurotechmaynotupdate orreviseanyforward-lookingstatementifeventssubsequentlyoccurorinformationsubsequentlybecomes availablethataffectstheoriginalforward-lookingstatement. 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IMPORTANTINFORMATION 2 15 minute presentation 20 minute live Q & A BrianLeedman Chairman Webinar Agenda -8 July 2022 3 DrAlexandraAndrews CEO Brian Leedman Chairman Gerald Quigley Non-Executive Director Exclusive worldwide licence PTC Patentslodged Successful Phase I/II Trial 93% of patients showed improvement PotentialforNTI164 totreatneurological disorders World’s firstwhole plant extractcannabis clinicalstudy Neurotech’sMente device & therapy Neurotechisa biopharmaceutical company focusedonthedevelopment& commercialisationof neurological solutionsthatimprove qualityoflife. 4 CapitalStructure $0.075 Shareprice (asat1stJuly 2022) 697M Shareonissue ~$52M Market capitalisation 143M^ Options/rights ~$2.33M Cashatbank* 51. *as at COB 31 March 2022 2. ^Options are comprised at various strike prices between $0.005 to $0.09 as at31 December 2021 WhatmakesNTI164different? 6 NTI164 PhaseI/IITrials The Program First in human Phase I/II ASD paediatric study (S8) Commenced in May 2021 at Monash Children’s Hospital led by A/Prof. Michael Fahey Openlabel–singlegroup 14patientsfrom8to17yo, 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 7 NTI164 PhaseI/IITrials Outcomes 93% of patients showed improvement Global Improvement 64% of patients "much improved” 29% of patients "minimally improved” 7% of patients "no change" No “washout” period Due to the positive therapeutic effects of NTI164 combined with feedback from parents and clinicians NTI164 measures favourably when compared to other recently completed CBD and/or THC paediatric studies1,2 Therapeutic Effect (Efficacy Index) 2 patients Therapeutic Index Score of 2 Vast Improvement complete or near remission of all symptoms 10 patients Therapeutic Index Score of 5 & 6 Decided improvement” –Partial remission of symptoms 1Thomas, M. & Frampton, C., (2022) HOPE® 1 demonstrates improvements in Clinical Global Impression (CGI) in patients with Autism Spectrum Disorder. https://zeliratx.com/wp-content/uploads/2022/04/ZEL040-White-Paper_Hope_FA.pdf 2Shani Poleg, et al (2019). Cannabidiol as a suggested candidate for treatment of autism spectrum disorder. Progress in Neuro-Psychopharmacology and Biological Psychiatry. https://www.sciencedirect.com/science/article/abs/pii/S0278584618304445 8 NTI164 PhaseI/IITrials NTI164 was well-tolerated No serious adverse events recorded Across all doses (5, 10, 15 and 20 mg/kg) NTI164 shows promise compared to other current treatments Risperidone Existing prescribed medications for the treatment of symptoms associated with ASD have untoward side effects including: •Weight gain, •Sedation and •Hormonal imbalance 9 10 Chief Investigator Professor Fahey, Monash Children’s Hospital said, “I am very encouraged with these results. We have designed a rigorous study on all fronts to assess the potential application of NTI164 for the treatment of ASD. We are encouraged by the efficacy shown by NTI164 in this trial and we are looking forward to the extension of this trial, in addition to the planned initiation of a Phase II/III trial, to further assess the long- term safety and efficacy of NTI164 with the potential to lead to drug registration.” PREVALENCEOFASD ~1in 44 children in the US1 TREATMENT MARKET SIZE US$1.85b4 CurrentTreatmentMarket ASDisa serious neuroinflammatory developmentaldisorder thatimpairstheabilityto communicateandinteract •Commonsymptomsinclude;behavioural issues,agitation, repetitivemovements, inabilitytofocus&compulsiveneurological patterns Trials NTIhascompletedworldfirst trial using whole plant (low THC) medicinalcannabisstrainin childrenwithASD Hugeunmetmedicalneed- patientsneedbettertreatment •Currentdrugs have numerous sideeffects; weightgain,breasttissuedevelopment,nausea, drymouth, anxiety,irritability, insomnia,stomach pain&movementdisorders RISPERIDONE US$5.6b2 US ANNUAL SALES US$2.1b3 RitalinandConcerta ActiveingredientMethylphenidate 1.www.cdc.gov/ncbddd/autism/addm.html 2.www.dataintelo.com/report/risperidone-market/ 3.www.businesswire.com/news/home/20190405005332/en/Concerta---API-Insight-2019-2021-Historical-Forecasted-Sales-Analysis---ResearchAndMarkets.com 4.https://www.fortunebusinessinsights.com/industry-reports/autism-spectrum-disorder-therapeutics-market-101207-CAGR-of-7-4.html WhytargetAutismSpectrumDisorders(ASD)? 11 8 US$2.3b1 PhaseI/IIcompleted Phase II/III due to commence Q3 2022 Current and Future Opportunities for NTI164 Prednisone Diclofenac & other MIGRAINE US$1.7b5 Future Target CEREBRAL PALSY US$4.4b3 by2030 Future Target MULTIPLE SCLEROSIS US$20b2 Preclinical studies in progress Future Target 1. Coherent Market Insights2.Transparency Market Research 3. Market Watch 4. Grand View Research 5. Allied Market Research6.Grand View Research US$2.7b6 Future Target ADHD $21b4 Future Target 12 AUTISM SPECTRUM DISORDER TRAUMATIC BRAIN INJURY COMBINATION THERAPIES PathwaystoCommercialisation Theanti-inflammatorypropertiesNTIstrainsin combinationwithminimalpresenceofTHC(<0.3%) providesclearpathwaystocommercialisation: •FDA new drug registration •Hugepotentialupside •Partnering/licensing opportunities GW Pharmaceuticals US$7.2B Acquisition byJazzPharmaceuticals1 •Fast route to commercialisation via the505B2route •Combinationwithexistingdrugs i.e. Prednisone,Diclofenac,Celebrex Pharmaceutical Combination 131. Wrays Commercial in Confidence V6. 13 March 2022 –NTI164 Novel Cannabis Strain StrongPatentPosition Neurotechhaslodgedtwo strategicprovisionalpatent applicationswithIPAustralia tounderpinfutureworldwide commercialisationin Neurologicalapplications and has completed international prior art search. Theapplication,formulationanduseof NTI164 Uniquenessofthe NTI-164strain – composition profilewithlowTHC(<0.3%) anda unique combinationof‘rarer’ cannabinoids: CBDA, CBC, CBDP, CBDB & CBN LodgedOct2021 Combination Composition LodgedOct2021 14 Commence Phase II/III Registration Study (Monash Children’s HospitalDepartment of Neurology) NTI164 Development Program Timeline Q4Q32022 Pre-IND US FDA Meeting | Initiate Agency Dialogue Drug Master File Submission US FDA Phase II/IIIstudy completion US FDA IND Submission Q12023 Q2 Q3 Q4 US based efficacy study 15 Licensing & Commercialisation Discussions Initiate Phase I/II Cerebral Palsy Trial DrAlexandraAndrews CEO Expertiseincorporate development,investor engagement,product developmentand commercialisation,clinical trialsandregulatory environments. FormerDirectorof OperationsatNeuroScientific BiopharmaceuticalsLtd. PhDNeuroscience,BBMed Sci(Hons1st) BrianLeedman Chairman Morethan15years’ experienceinthe biotechnologysector Co-founder/Director/ ChairmanofsixASXlisted healthcare/biotechnology companiesincluding:RAP, NGS,NSB,OSL,IMU,ALC FormerChairmanof Ausbiotech(WA) BEc,MBA(UWA) Krista Bates Non-ExecutiveDirector 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 BA(Hons),GradDip(Law),Po stGradDip(Law),GAIDC Prof.AllanCrippsAO Non-ExecutiveDirector MarkDavies Non-ExecutiveDirector WintonWillesse Non-ExecutiveDirector Experiencedcompany director withover20years experience invariousroles withinthe Australian capitalmarkets Coreexpertiseinstrategy, companydevelopment, corporategovernance, company publiclistings, mergerand acquisition transactionsand corporate finance MCom, FFin,CPA, GAICD, FGIA/FCG HighlyExperiencedExecutiveTeam andBoard 16 Gerald Quigley Non-ExecutiveDirector 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) 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 Experienced boardand management Unique biopharmaceutical cannabinoid platform Why Invest Clinical programs underway targetingpivotal, unmet needs Significant near term milestones & newsflow 17 Contact Details Dr Alexandra Andrews CEO [email protected] +61 405 339 788 www.neurotechinternational.com www.mentetech.com Neurotech International Limited (ASX: NTI) Media: Amalie Schreurs White Noise Communications [email protected] +61 (0)431 636 033 18
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