for personal use only - asx · shenzhen lightning digital ... neuro products as well as services...
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Disclaimer
This presentation prepared by Orthocell Limited ("Company") does not constitute, or form part of, an offer to sell or the solicitation of an offer to subscribe for or buy any securities, nor the solicitation of any vote or approval in any jurisdiction, nor shall there be any sale, issue or transfer of the securities referred to in this presentation in any jurisdiction in contravention of applicable law. Persons needing advice should consult their stockbroker, bank manager, solicitor, accountant or other independent financial advisor. This document is confidential and has been made available in confidence. It may not be reproduced, disclosed to third parties or made public in any way or used for any purpose other than in connection with the proposed investment opportunity without the express written permission of the Company. This presentation should not be relied upon as a representation of any matter that an advisor or potential investor should consider in evaluating the Company. The Company and its related bodies corporate or any of its directors, agents, officers or employees do not make any representation or warranty, express or implied, as to the accuracy or completeness of any information, statements or representations contained in this presentation, and they do not accept any liability whatsoever (including in negligence) for any information, representation or statement made in or omitted from this presentation. This document contains certain forward looking statements which involve known and unknown risks, delays and uncertainties not under the Company’s control which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or expectations implied by these forward looking statements. The Company makes no representation or warranty, express or implied, as to or endorsement of the accuracy or completeness of any information, statements or representations contained in this presentation with respect to the Company. It is acknowledged that the Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances or unanticipated events occurring after the date of this presentation except as required by law or by any appropriate regulatory authority.
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Deliveringbreakthroughproductsinregenera6vemedicine
Celltherapies:‣ Ortho-ATI®.World’sleadingstemcelltherapytoregeneratetendons‣ Ortho-ACI®.3rdgenera6onarthroscopiccar6lagerepair‣ Ac6velyengagingstrategicpartnersinUSandJapan
CelGro®regenera7vemedicinecollagendevice
‣ HighestqualitycollagenscaffoldtoenhancesoD6ssueandboneregenera6on‣ PlaFormtechnology‣ EU(CEMark)andUS(510K)approvalsinprogress
Regenera7ngMobility
CompanyOverviewF
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KeyFacts
ASX OCC
SharePrice AU$0.47(@22ndFeb2017)
OrdinaryShareson 101.4million Issue
MarketCap AU$47million
Op6ons&Warrants 24.3million outstanding
Cashatbank AU$8million(@2Feb2017)
Experiencedteamtoexecute
CEO PaulAnderson •Verigen •Genzyme •Biomet
CSO Prof.MingHao •Verigen Zheng •Genzyme •UWA
Execu6ve DrStewart •Cynata Chairman Washer •Minomic
Director MadCallahan •iCeu6caInc •BotanixPharmaceu6cals •Dimerix Director Prof.LarsLidgren •UNBoneandJointChair •Biomet •Uni.Lund
Director QuiXiaoZhoa •ShenzhenLightningDigital •TechnologyCoLtd
ShareholdingStructure
Shareholders3,500 Directors&Management----30% 60%--------Top20
CorporateOverviewF
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Ageingpopula6onandrisingmusculoskeletaldisorders‣ Demandforsafe,efficient,costeffec6vetreatments‣ GlobalsoD6ssuerepairmarket-US$7Bin2013expectedUS$10Bby2020
Superiorproductswithcompellingclinicalevidence‣ Ortho-ATI®TendonRegenera6on-380pa6entstreated‣ Ortho-ACI®Car6lageRegenera6on-390pa6entstreated‣ CelGro®-ParadigmshiDinsoD6ssuerepair
Validatedpathwaytomarketandtechtransferready‣ Op6misedmanufacturingfacilityinAustraliaapprovedforcommercialproduc6on
Significantpartnerinterest‣ Largepharmacurrentlyinves6ng/partneringincelltherapiesandscaffolds/devices‣ RecentM&Adealsshowstronginterestforinnova6vetreatments
GlobalNeed&Opportunity
Orthocellisdealreadyandposi6onedforgrowth
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ProductPipeline
Neartermregulatoryapprovals
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Ortho-ATI ®
AutologousTenocyteImplanta6on
‣Breakthroughregenera-vemedicinetherapy‣Mul-pletendonapplica-ons‣ TGALicence‣Publishedlongtermclinicaldata
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Ortho-ATI ®
Collaboration with Johnson & Johnson Innovation
‣Collabora6onagreementsignedJanuary2017
‣Coopera6vestudydesignedtosupportUSpivotalstudy
‣PlannedtocommenceinQ12017andwillbeenrolling20pa6ents,randomizedtoreceiveeitherOrtho-ATI®orcor6costeroids.
‣ ThetrialwillbeledbyProfessorAllanWang,currentPresidentoftheAustralianElbowandShoulderSociety.
‣ TheDePuySynthescompaniesarepartoftheJohnson&JohnsonFamilyofCompanies
‣DePuySynthesofferstheworld’smostcomprehensiveporFoliooforthopaedicandneuroproductsaswellasservicesforjointreconstruc6on,trauma,spine,sportsmedicine,neuro,cranio-maxillofacial,powertoolsandbiomaterials.
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Ortho-ATI ®
1. Biopsy procedure 2. Tenocyte cultivation
4-5 week end-to-end process
3. Ultrasound guided tenocyte implantation
Twostage,minimallyinvasive,walk-in&walk-outprocess.
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Ortho-ATI ®
MOVIE 1.1 Ortho-ATI® and tendon repair
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Ortho-ATI ®
OnlytherapyaddressingunderlyingpathologyLongtermefficacy
Totalcostofsurgeryisuptofour(4)-mesmorethanOrtho-ATI
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Ortho-ATI ®
ClinicaldatasupportsefficacyanddurabilityOver300pa7entstreatedwithOrtho-ATI
ClinicaltrialsconfirmOrtho-ATIissafe,durableandcosteffec;ve
Pa7entsfailedallprevioustreatments,withaverageover30mthsymptoms
207.6%increaseingripstrengthat4.5yrs:tenniselbow
148.1%increaseinqualityoflife,2yrdurabilityreported:glutealtendon
88%ofpa7entsreturnedtowork:workerscompensa;onretrospec;vestudy
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25
35
45
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0M 3M 6M 12M 4.5Years
TennisElbowStudyGripStrength
2024283236404448
0M 3M 6M 12M 24M
GlutealTendonStudyQualityofLife
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Ortho-ATI ®
“Howstemcellsgaveviolinistherlifeback”
Orthocellistechtransferready
AUSandUSaddressablemarkets‣ Tenniselbowmarket>$850M‣ Rotatorcuffmarket>$900M
Regulatorytargets‣ USapplica?on(IND)inprepara?on‣ AUSapplica?on(ARTG)inprogress‣ JPapplica?on(PMDA)commencing
Strategicpartnering‣ DiscussionsongoingwithUS&EUpoten?alpartners‣ DiscussionsinJapanunderwaytoleverageabridged
approvalprocessFor
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CelGro®
Atrueregenera?vemedicinescaffold
‣Highestqualityavailable‣Mul?pleapplica?ons
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AparadigmshiDinsoD6ssuereconstruc6on
‣Regenera-vemedicinefocusindesignanddevelopment‣HighestqualityscaffoldavailablethatdirectlymeetstherequirementsofsoD-ssuereconstruc-on‣Versa-leplaFormwithapplica-onsinbone,tendon,nerve,MATTandothers‣Cell/scaffoldcombinedproduct‣Fitforpurpose
CelGro®
CelGro®isatrueregenera6vemedicinescaffoldmanufacturedbyOrthocelltoaugmentsoD6ssue
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CelGro®isaplaFormtechnologywithsignificantcompe66veadvantages
SuperiorsoD6ssueandbonerepairquali6es
✓Guided?ssuerepair/op?mal?ssueintegra?onandremodelling
✓Versa?leplaTorm
✓Provencompa?bility,purecollagenandacellular
✓Hightensilestrength
✓Highestqualityrawmaterialgloballyavailable
KeyBenefitsandFeatures
Bone
CelGro®regenerativemedicinescaffold
PipelineLigamentreplacement-ACL,
generalsurgical,urogynaelogical
Tendon Nerve Cartilage
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HowCelGro®Works
1.Smooth layerDensely packed collagenPassage of fluids
2.Rough layerLoosely arranged collagen Applied to tissue defect
3. Tissue remodellingIntegration of cellsGuiding quality tissue regeneration
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✙650,000
# annual rotator cuff procedures
suitable for Celgro 1.
1.6billion
Value of addressable market
in rotator cuff surgeries 1.
1. US, JP, EU & AUS
4.3.
2.1.
Applica6ons-rotatorcuff
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TendonOpportunity
Opportunity
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Applica6ons-Dental
✙2million
# annual dental membranes used in
conjunction with bone graft
substitutes 1.
800million
Value of addressable market in dental 1.
1. US, JP, EU & AUS - 2015
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DentalOpportunity
4.3.
2.1.
Opportunity
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•TwentymillionAmericanssufferfromperipheralnerveinjurycausedbytraumaandmedicaldisorders
•$150billionspentinannualhealth-caredollarsintheUS
•Devasta-ngimpactonapa-ent’squalityoflife
•Clearunmetmarketneedforafitforpurposepurecollagenscaffold:
✓Superiorhandlingquali-es✓Biocompa-ble✓Guidesnerveregenera-on✓Accelerateshealing
NerveOpportunityF
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Compe6torsLimita6ons
Compe6torslimita6onsinclude:notfitforpurpose,poorintegra6onandlimitedapplica6on
CelGro® Biogide®
(porcine mesentery)
BioMend Extend®
(bovine tendon)
GraftJacket®
(human dermis)
Tissuemend®
(bovine dermis)
AxoGuard®
(porcine s.i.s)
Neuroflex®
(bovine tendon)
Highest quality raw material ✓ ✗ ✗ ✗ ✗ ✗ ✗
Proven compatibility ✓ ✓ +/- +/- +/- +/- +/-
Native bi-layer structure ✓ ✓ ✗ ✗ ✗ ✗ ✗
Strong mechanical properties ✓ +/- ✓ ✓ ✓ ✓ ✓
Versatile platform ✓ ✗ ✗ ✗ ✗ ✗ ✗
Superior handling characteristics ✓ +/- +/- +/- +/- +/- +/-
Dental NerveTendon
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TheCelGro®Advantage
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CelGro®-CEMark
EUapprovalfor“guidedboneregenera3onandso53ssuereconstruc3on”infinalstages
EUapprovalprovidesafounda3onforregulatoryapplica/onsinUS(FDA),JP(PMDA)andAUS(ARTG):
! Tendon! Nerve! Car3lage
StrategicPartnering&Distribu3on• EUdiscussioncon/nueforDentalapplica/on• USandJapancommenced
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Next Generation Pipeline
Strongproductpipeline:
CelGro®
• ACLligamentreplacement• collagenpowderforbonevoidfillers
LabGrownTendons
• laboratorymanufacturedhumantendon• replacementtendonsforhandsandotherapplica;ons
GrowthFactors
• ;ssuespecificgrowthfactor‘CellFactory’• offtheshelfgrowthfactors-bone,car;lageandtendon
Thesepipelineproductsandconceptsareearlystageopportuni;esthatrequirefurtherresearchanddevelopmentpriorcommercialisa;on
Lab grown tendon
ACL Ligament Replacement
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GF’s
CelGro
SurgicalCelGro - Regenerative Medicine ScaffoldG.F - Growth FactorsATI - Autologous Tenocyte ImplantationMATT - Matrix Augmented Tendon Therapy
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Tendon Therapy Continuum
ACUTE DEGENERATE
ATI
Non-Surgical
Physical therapies
Surgery - rupture Surgery - chronic injury
Rehab. - post surgery
CelGro
[ MATT ]
ATI
CelGro
ATI
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Ortho-ACI®AutologousChondrocyteImplanta?on
✓Goldstandardcar-lagerepair✓Mul-pleapplica-ons
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Ortho-ACI ®
FDAapprovesfirstautologouscellularizedscaffoldfortherepairofcar,lagedefectsoftheknee (December 13, 2016)
Ortho-ACIisthegoldstandardinterven<onforsymptoma,cdefectsofthear,cula,ngcar,lageofthejoints,predominatelythekneeandankle(lesionsgreaterthan2cm2)
Over380pa<entstreatedinAUS,HKandSG
Highlycustomised,highestqualitycells,lesion-focusedtreatmenttherapy
Significantlymorecosteffec<vetreatment
Therapeu<cGoodsAdministra<on(TGA)licenseMI-19052008-LI-002420-11OrthocellistheonlyaccreditedmanufacturerandsupplierofACIinSEAsia
Arthroscopic3rdgenera<onautologouschondrocyteimplanta<on
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Ortho-ACI ®
1. Biopsy procedure
4. Implant completed3. Arthroscopic implant
2. Seeding scaffold in theatre
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UpcomingMilestones
Regulatoryapplica6onsandapprovals•CelGro®-EUapprovalfor“GuidedBoneRegenera-onandSoDTissueReconstruc-on”•CelGro®-Regulatoryapplica-ons/approvalsforDental,TendonandNerveinEU,US,AUSandJP•Ortho-ATI®–AdvanceUStendonandligamentapplica-on(preINDmee-ng)
Genera6ngfurtherclinicaldata•CelGro®-dentalstudycomple-onandpublica-onsubmission•CelGro®-interimtrialresultsfortendon,car-lageandnervestudies•Ortho-ATI®vSurgeryfortenniselbowinterimresults•Ortho-ATI®GlutealTendonstudyandWorkersCompensa-onretrospec-vestudypublica-on
Strategicpartnering•CelGro®-EUpartner/distributordealfortheDentalapplica-on•Ortho-ATI® -US/AUSpartneringdeal•Ortho-ATI® andOrthoACI®–Japanpartnering/licensingdealF
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InvestmentHighlights
➢Superior products
➢Significantde-riskedopportunity
➢Clearpathwaytolargemarkets
➢Strongpartner interest
➢Exper6setopartnerandexecuteFor
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Advancing tissue repair and regeneration
Paul Anderson Managing Director
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