andrew quick sr vp clinical development october 6,...

AndrewQuickSr VPClinicalDevelopment

October6,2016

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10/6/162

Disclaimer– ForwardLookingStatements

Thispresentationmayincludeforward-lookingstatements.Youcanidentifythesestatementsbythefactthattheyusewordssuchas“anticipate”,“estimate”,“expect”,“project”,“intend”,“plan”,“believe”,“target”,“may”,“assume”orsimilarexpressions.

Theseforwardlookingstatementsspeakonlyasatthedateofthispresentationandarebasedonmanagement’sexpectationsandbeliefsconcerningfutureevents.Forward-lookingstatementsarenecessarilysubjecttorisks,uncertaintiesandotherfactors,manyofwhichareoutsidethecontrolofAvita Medicalthatcouldcauseactualresultstodiffermateriallyfromsuchstatements.

Avita Medicalmakesnoundertakingtosubsequentlyupdateorrevisetheforward-lookingstatementsmadeinthisreleasetoreflecteventsorcircumstancesafterthedateofthisrelease.

Thispresentationisintendedtoprovidebackgroundinformationonlyanddoesnotconstituteorformpartofanofferofsecuritiesorasolicitationorinvitationtobuyorapplyforsecurities,normayitoranypartofitformthebasisof,orbereliedoninanyconnectionwithanycontractorcommitmentwhatsoever.



10/6/163

AGlobalPioneerinRegenerativeCellTherapy

AvitaMedical– CompanyBackground

o Platformautologouscellharvestingtechnologyaddressingunmetneedinclinicalindicationsencompassingarangeofskininjuriesanddefects

o PubliclytradedinAustralia(ASX:AVH)andUSADRs(OTCQX:AVMXY)o ProductsclearedformarketinginEU,Australia,Chinao U.S.HHSBARDAcontract(US$61.9m)forsupportofPMA&Pre-EUAactivity,USburncenter

familiarityandacceptance,andtoestablishanationalstrategicstockpileofReCell®formasscasualtypreparedness

o USFDAPivotalTrialforReCellinburnsfullyrecruitedandparticipantsarebeingfollowedo OperationalbuildcenteredontheLAoffice,asthehubofClinical,Quality,Regulatory,SupplyChain

Financial,andUSSales&Marketingactivities

AcuteWoundsRepairwithlessdonorskin

ChronicWoundsRestarthealing

AestheticsRestorepigmentation

Burn/Trauma Centers

Hospitals

Private Clinics



10/6/164

SkinRegenerationPlatformo AutologousCellHarvestingDevicesusedtotreatwounds

andskindefects• ProprietaryEnzymeformulation,• Processingunitincludingsterileenzymesoak-,bufferrinse-

andfiltering- chambersandasteriletrayformechanicaldisaggregationofskinsample

• Validatedsetofapplicatorsdesignedtooverlaywoundareawithsuspensionofhealthycells

o AllowsrapidcreationofRegenerativeEpithelialSuspension™(RES™)• Disaggregated(activated/“free-edge”),autologousskin

cells(keratinocytes,fibroblasts,melanocytes)• Signalingfactors(cytokines,chaperoneslikehsp90,growth

factors)• Catalyzeregenerativehealinguponapplicationto

wound

Woodetal.2012.Burns 38:44.Singer&Clark.1999.NEJM.341(10):738.

Fast,Easy,SafeandEfficaciousOn-SiteSkinRegenerationSystem

VitalStatistics1. 1hourtolearndeviceuse2. 30minstocreateRES™3. Treatmentareais80x

donorarea

ReCell is an investigational device in the United States and limited by US federal law to investigational use.



10/6/165

RES™Mechanism– supplyingskincells

o Autologoussamplesderivedfromhealthyareasoftheskincontainacompletemixofallskincells (non-cultured)andfactorstocatalyzethehealingprocess

o Cellsinsuspensionarenolongercontact-inhibitedbyneighbouringcells(unlikeintacttissue)andundergophenotypicchangestopromoteclosure(free-edgeeffect)

o ApplicationofRESovercomestheusuallimitedavailabilityofhealthy,signallingcells

Activated,Autologous,AvailableandComplete

Trim&Quick.2015JWoundTech27:20-24.Singer&Clark.1999.NEJM.341(10):738.



10/6/166

RES™Mechanism– “Activated”

KeratinocytesfromRES™inawoundbedmodelafterAutologousCellHarvesting*

1day 3 days 5days 7 days

• LargenumbersofviableskincellsinRES™adheretothewoundbedalmostinstantly• Proliferativeandmigratorymorphologiescanbeseenasearlyasday1• Rapidisolationandthenimmediateapplicationtotheidealincubator,thehumanbody,supportsnormalcellprocesses

*RepresentativespecimensroutinelyisolatedusingReCell® deviceatHuddersfieldSkinIntegrityInstitute

RES™IntactskinInvolucrin isasignallingproteinpresentinnormal,intactskin.Whenskincellsareinahealing(proliferative)state,involucrin expressiondecreases.

P-ERK isasignallingproteinthatisactivatedduringskincellproliferation,itplaysaroleinthecoordinationofrepair.p-ERKincreases duringhealing

β-Actin- Loadingcontrol



10/6/167

RES™Mechanism– signalingfortissuerepair

o Dangerassociatedmolecularpatterns(DAMPs)– keytoregulationoftissuerepair• HSP90α andHMGB1arenaturallypresentin

RESasaresultofthecellharvestingprocess

o Secretedfactors- alsoimportantintissuerepair• VEGF,EGF,RANTES,IL-1α,TNF-α – allconfirmed

presentinRES™

HMGB1 30kDa

β-actin 42kDa

HSP90α 90kDa

#1 #2 #5#4#3

Time 0 Time 0 Time 0Time 0 Time 0WoundWound Wound Wound Wound

0

1

2

3

4

Day1 Day3 Day5 Day7

OD450n

m

IL-1α

0

0.1

0.2

0.3

Day1 Day3 Day5 Day7OD450n

m

RANTES



10/6/168

ClinicalEvidenceDemonstratesBetterOutcomesinMultipleIndications

o Earlyproductapprovalsbasedoncaseseries,60+presentationsandpublicationstodate

o Morerecently,pursuingrobust,randomizedcontrolledtrials

ClinicalIndication RCT Readout

Burns ReCelladjuncttowidelyexpandedautografts,fortreatmentofmixed-depth(incl.full-thickness)burninjuries(US,CTP001-6)

FullClinicalDataPackageCompleteQ12017

ChronicWounds ReGenerCellfortreatmentofhard-to-healvenouslegulcers(UK,CTP003)

presented,2016EWMA

ChronicWounds ReGenerCellfortreatmentofchronicwounds(China)

published2015,BritishJSurg

Aesthetics/Repigmentation

ReNovaCellforrepigmentationofsegmentalvitiligo/piedbaldism (Netherlands)

published2015,JAmer AcadDermatol;newpublicationinprep

Aesthetics/Repigmentation

ReNovaCellforrepigmentationofhypopigmentedscar(Germany)

Published2016,Burns(JournalofInt’lSocietyforBurnInjuries)

ClinicalEvidenceBase



10/6/169

ReCell®andMeshedAutograft– healingwithlessdonorskin

o Treatmentoflargesurface/deepburnswithlimiteddonorsiteusage• Addressesunmetneedinburncare• Designedforclinicaleffectivenesswithminimaldonorsiterequirement

• Patientwith64%burn,hospitallengthofstay0.58daysper%TBSA(vs1.9±0.7daysforseveritymatchedhistoricalcontrol)

TreatmentRES™ + Meshed Autograft

1 Month post treatment

Canreducelengthofstayinlargeburnsbyover50%

HolmesJH.2016BiennialMeetingoftheInternationalSocietyforBurnInjuries,Miami,FL



10/6/1610

Treatment: excision, and RES™

Post-operation, Day 9Deep Partial Thickness Burn

Post-Operation, 4 months

Courtesy of Ms Isabel Jones, Chelsea and Westminster Hospital

AchievingHealingand NormalAppearance

o CaseReport:48-year-oldman,flameburninjuryfromanexplodingboiler.TreatedatChelseaandWestminsterHospital

o Sub-optimaltouseskingraftsonfacialwounds

o ApplicationofRES™triggeredwoundhealingo Reintroductionofmelanocytesclearlygivessuperiorcosmeticoutcome

RES™onaburninjury– excellentoutcome



10/6/1611

AutograftSparingandEmergencyPreparedness

o Greatbenefitisassociatedwithuseoflessdonorskintoachievedefinitiveclosureandbetterlong-termoutcomesinburncare

o WeareworkingtoestablishReCell®asthego-to autograft-sparingtechnique,basedonclinicalandeconomicbenefito Autograftsparingreducestheburdenonthealready-injuredpatientfaced

withtheharvestingoftheirhealthyskino Autograftsparingpotentiallyreducesthenumberofproceduresandoverall

lengthofhospitalstayo Theneedforskinisakeybottleneckinmassresponse

o ReCell®isversatile,portableandself-contained



10/6/1612

TheBARDAContract

BARDAaddsresourcesandvalidationtoAvita

o AtotalofUSD$61.9mcommittedunderthefive-yearcontractawardedSept29

o BARDAislockedintopay$27.9mtocompletetheFDA-PMAprocess,ensureAvita ismarket-ready,andbuyaninitialinventoryofmorethan5,000devicestobestockpiled

o BARDAalsohasoptionstospend$34mmoreonlargerprocurement, andvariousstrandsofpost-marketentrysupport

o AvitaisalsoengagedwithotherbranchesoftheUSFederalgovernment:thedeviceisportable,flexibleandself-contained,andhasgreatpotentialformilitaryuse

o AvitaisnowusingBARDAfundstostrengthenitsoperationsandtodevelopclinicalandeconomicdatafortheburnscommunityinadvanceofaUSlaunch



10/6/1613

ProjectedU.S.ReCell® BurnsApproval:Q32017

InitiateCTP001-6

CompleteU.S.enrollment

PotentialFDAApproval*

ClinicalStudyReport,PMA

Submission

6months

1Q2015 1Q2016 1Q2018

LastSubjectLastFollow-up

1Q2017

FDAAdvisoryPanel

CompleteInitialPMAReview

*Estimated,timingsmayimprovebasedonFDA’s

ExpeditedAccessPathwaydesignation



10/6/1614

CaseStudy1:67yearoldfemalewithperipheralarterialdisease,controlledtypeIIdiabetesVLU(10cm2)onrightlateralmalleolusopenfor46weeks beforetreatmentwithReGenerCell.

CaseStudy2:70yearoldmalewithperipheralarterialdisease,controlledtypeIIdiabetes.RightmedialVLU(13cm2)openfor212weeksbeforetreatmentwithReGenerCell.

Baseline Week1 Week6 Week10 Week14

“Changed within a month, could see the change, getting smaller and not so deep. Pain was reduced after thecells were applied, no pain at all after week 4”

“[It’s] just a miracle. Got my life back, can go out and socialise. Three years ago I couldn’t walk 10 yards”

ReGenerCell™- ClosingWoundswhereotherroutesFailed



10/6/1615

ReGenerCell– venouslegulcerpilotRCThighlights

• Statistically significant improvements shown in wound size, pain and health-related quality of life

• Positive trends both in healing time, incidence of closure and all aspects of theQuality of Life questionnaire were observed. This was of particular note in largeulcers (over 10 cm2) which comprise the majority of VLUs

• Treatment using ReGenerCell™ definitively places the wounds on a healingtrajectory

*p=0.022



10/6/1616

Admission&Debridement

Courtesy of Dr Robert Manton, Charing Cross Hospital London

Treatment Potential only now being Realized

o CaseStudy:an85-year-oldwoman,suffered8cmx5cmgashonleftleg.TreatedatKingsCollegeHospital,Londono RES™appliedinanoutpatientclinic

o Patientreportedtobeverysatisfiedwiththeoutcome,whichallowedhertomaintainherindependentlifestyleo Pre-tibial Lacerationsareafrequentproblemforwomenagedover60,andarechallengingtotreat

ReNovaCellappliedafterone

weekofconventionalcare

ThreeweeksafterReNovaCell

treatment,25%reduction

Afterfiveweeks,75%reduction

After11weeks,100%healing

ReGenerCell™forpre-tibial laceration



10/6/1617

ReNovaCell:SimpleSolutionforSkinRepigmentationo Repigmentation ofhypo-pigmentedskinduetooldage,injury,skintreatments,vitiligo

• Mostsignificantunmetmedicalneedinaestheticdermatologyo CurrentInadequateTreatmentOptionsforRepigmentation

• Non-surgicaloptions“lotions&potions”andlighttherapysometimesefficacious• Lab-basedmelanocytetransferissolesurgicalchoicebutexpensive,timeconsuming

o ReNovaCell istheonlysimplified,cost-effectivesolutionforskinrepigmentation

Baseline 6-monthsfollow-up

RES™-treated

NegativeControl

From published RCT*: patient with segmental vitiligo (duration > 5yrs)

*KomenL,Vrijman C,Tjin EPM,Krebbers G,deRie MA,Luiten RM,vanderVeenJPW,Wolkerstorfer A.Autologouscellsuspensiontransplantationusingacellharvestingdeviceinsegmentalvitiligoandpiebaldism patients:arandomizedcontrolledpilotstudy.JAmAcad Dermatol 2015;73(1):170-172.



10/6/1618

SubstantialOpportunityTreatingLarge,ComplexWounds

SelectedIndicationse.g.,excludesplasticandmaxillofacialsurgeries

Incidence/Prevalence (Patients)Percent

Applicable

PotentialMarketSize(assume1device

perpatient)

USpop.316M

(11.4%diabetes1)

UK,FR, DE,ITpop.271M

(8%diabetes,avg1)

Auspop.23M

(5.1%diabetes1)

Chinapop.1.4B

(9.3%diabetes1)

ChronicUlcers

DFU2 9.0M 5.5M 0.3M 31.6M 20– 40% 9 – 19MVLU3 3.2M 2.7M 0.2M 13.6M 60– 65% 12– 13M

Burnsannual admissions

40K4 42K5 8.6K6 3.4M7 90% 3.1M

Aestheticsannual procedures8 1.7M 585K 117K 157K 90% 2.3M

Vitiligo0.1%to2%ofpop.9 316K 271K 23K 1.4M 30% 0.6M

TOTAL* 14.3M 9.1M 0.7M 50.1M 35%-50% ~27-38M1InternationalDiabetesFederation(IDF)DiabetesAtlas,SixthEdition(2014)2[Lifetimeincidence:25%ofdiabetics]Singhetal."Preventingfootulcersinpatientswithdiabetes." JAMA 293,no.2(2005):217.3[Prevalence:1%ofpop.]Humphreysetal."Managementofmixedarterialandvenouslegulcers.“Br.J.Surg.94,no.9(2007):1104.4 AmericanBurnAssociation2013FactSheet(www.ameriburn.org)5Brusselaers etal."SevereburninjuryinEurope:asystematicreviewoftheincidence,etiology,morbidity,andmortality."Crit Care14(5)(2010):R188.6 Australianhospitalstatistics.AustralianInstituteofHealthandWelfare.(2012)7 PeckMD.Epidemiologyofburninjuriesglobally www.uptodate.com8 ISAPS2013InternationalSurveyonAesthetic/CosmeticProceduresPerformed(dermabrasion,resurfacing,facialrejuvenation)9 Alkhateeb A,FainPR,Thody A,BennettDC,SpritzRA."EpidemiologyofvitiligoandassociatedautoimmunediseasesinCaucasianprobands andtheirfamilies." PigmentCellResearch 16,no.3(2003):208-214.



10/6/1619

o USBurnstrialenrollmentcomplete• ExpeditedAccessPathway(EAP)designation• ContinuedAccessandCompassionateUseIDEPrograms

o RCTsinotherkeyareaseitherpublishedorinprepforpublication

o MechanismofActiondetailsfurtherexploredandinprepforpublication

o Currentlygeneratingadditionaldatainlargermarketopportunities(chronicwounds,aesthetics,etc.)

o Broadeningandbolsteringsalesandmarketingarmamentariumwithrobusthealtheconomicanalysestoshowpositivebudgetimpacttobothpayersandproviders

o Acceleratingbusinessdevelopmentactivitiesforindication-specificcommercialpartnering

Translatingclinicaldevelopmenttosuccessfulcommercialization

Formoreinformation

www.avitamedical.com

andrew quick sr vp clinical development october 6,...

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