TeloGenomics - October 2020...Liquid Biopsy Industry 11 • Liquid-biopsy platforms are attracting...
Transcript of TeloGenomics - October 2020...Liquid Biopsy Industry 11 • Liquid-biopsy platforms are attracting...
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CorporatePresentation
October 2020
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ForwardLookingStatement
Thisdocumentandanyattachmentsareintendedforinformationpurposesonlyandshouldnotbeconstruedasonofferorsolicitationforthesaleofsecurities.Statements inthispresentationincludeforward-lookingstatementswithinthemeaningofcertainsecuritieslaws.Theseforward-lookingstatementsinclude,amongothers,statementswithrespecttoourobjectives,goalsandstrategiestoachievethoseobjectivesandgoals,aswellasstatementswithrespecttoourbeliefs,plans,objectives,expectations,anticipations,estimatesandintentions.Thewords “expected to” “illustrate” “has thepotential to” “willbe”, “evaluating” “plans” “canbe” “planning” “to predict” “potential” “may” “should” andwords and expressions of similar import, areintendedtoidentifyforward-lookingstatements.Resultsinearlystageclinicaltrialsmaynotbeindicativeoffullresultsorresultsfromlaterstageorlargerscaleclinicaltrialsanddonotensureregulatoryapproval.Youshouldnotputunduerelianceonthesestatementorthescientificdatapresentedasanumberofimportantfactors,manyofwhicharebeyondourcontrol,couldcauseouractualresultstodiffermaterially fromthebeliefs, plans, objectives, expectations, anticipations, estimates and intentions expressed in such forward-looking statements.We do not undertake to update any forward-looking statements,whetherwritten ororal,thatmaybemadefromtimetotimebyusoronourbehalf;suchstatementsspeakonlyasofthedatemade. The forward-looking statements included herein are expressly qualified in their entirety by thiscautionarylanguage.
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MissionStatement
TeloGenomicsprovidesactionableinformationthatisrelevanttomedicalprofessionals in themanagementof cancer and cognitivedisease. It is adiagnostic company that applies innovative and minimally-invasiveanalysisofgenomicinstability,basedonthe3Dorganizationoftelomeres,toimprovequalityoflifeandreducetreatmentcost.
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ExecutiveSummary
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Genomicinstabilityiscriticalintheevolutionofprecisionmedicineforcancerandcognitivedisease
TeloView®uses3Danalyticsoftelomerestoanalyzegenomicinstabilityasadiseasepredictor
Focusingontherapidlyemergingfieldofminimallyinvasive/liquidbiopsy
Evaluatedover3,000patients,130+peer-reviewedpapers&$25millionnon-dilutivefunding
Opportunitiesindiagnostic/prognosticproducts,pharma&academicpartnerships
CollaborationwiththeMayoClinicfocusingonunmetclinicalneedsinmultiplemyeloma
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TeloView®–ExtensivelyDevelopedPlatform
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14+ diseaseswithidentifiable3D
telomeresignatures
3,000+ patientsevaluated
25+ confirmatoryclinical
studies
130+ peer-reviewedpapers
18 patentsinCanada,USA
&Europe
$25M+ innon-dilutiveR&D
funding
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Technology–TeloView®(3DTelomereAnalysis)
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DNAispackagedintochromosomes.AtthetipsofeachchromosomeareprotectiveregionsofDNAcalledtelomeres
The3Dorganizationoftelomereswithinagivencellishighlypredictiveofgenomicinstability
AMeasureofGenomicInstability
Usingfluorescentmarkersandhighresolutionmicroscopes,thelocationofeachtelomerewithinacellnucleuscanbevisualizedanddigitallyanalyzed
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TeloView®&GenomicInstability
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TeloView®Single-cellAnalysis
- Basedontheassessmentof6uniquetelomereparameters- Cellsareanalyzedindividuallyusing3D-TelomereFISH*:
o Representstheoverallgenomicinstabilityprofileofthepatiento Canstratifypatientsbyprogression&theheterogeneityofcancers
- Predictsresponsetotherapy&guidesprecisionmedicinetreatmentsolutions- Requiresnomorethan100cellsanddoesnotrequireDNAamplification
First-in-class diagnostic/prognostic tool used to analyze genomic instability
Heterogeneityofcancer
- Tumorsmayhavegroupsofcellsthatcontributedifferentlytotheaggressivenessofcancers- Preciseprofilingofatumorshouldaccountforitsdistinctgroupsofcancercellsandrarecellsinguidingtreatment
*FISH FluorescentInSitu
Hybridization
Labelingoftelomereswithfluorescenttagscanbevisualizedandimagedin3Dusingamicroscope.Thefluorescentsignalscanthenbequantifiedtomeasurekeyfeaturesoftelomeres
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TeloView®–WorkflowOutline
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Personalized TeloView® Lab Report
TeloView®Analysis
ImageProcessing
3D Image Acquisition
3D – Telomere immuno-FISH
Sample Accession
4 5 6 1 3 2
Samples(fromblood,urine,etc.)areinspectedandassignedanID
Specificlabelingoftelomeresanddiseasespecificproteinswithfluorescenttags
Selectionofindividualtargetcells;adaptimageformatforTeloView®analysis
1.#ofTelomeres2.Telomerelengths3.Telomereaggregates4.a:cRatio5.Nuclearvolume6.Positioninnucleus
Personalizedresultsthatinformandguidetreatment
Acquiresconsecutiveimagesatconsecutivefocalplanesacrossthedepthofthesampletobuildone3Dimage
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PrecisionMedicine
- Thetailoringoftherapiesforgroupsofstratifiedpatientsbasedongenomic,life-style&environmentalfactors
- Itleadstoimprovedclinicaloutcomes&qualityoflifeforpatientsandreducescostsinthelong-term
-
GenomicInstability
- Adefiningfeatureandcauseofcancer&otherdiseases- Isanincreasedtendencyofgenomicmutationsduringcelldivision
Adetailedanalysisofgenomicinstabilitycanbeusedtostratifypatientsbyprogressionoftheirdisease&guidetreatment*
Industry–PrecisionMedicine&GenomicInstability
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*MaiS.Thethree-dimensionalcancernucleus.GenesChromosomesCancer.2019;58:462–473.https://doi.org/10.1002/gcc.22720
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MinimallyInvasive/LiquidBiopsyvTissueBiopsy
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MinimallyInvasive/LiquidBiopsyo Doesnotrequiresurgeryo Usesliquids,hair,skin,etc.o Capturescirculatingtumorcells(CTC’s)o Faster,cheaper&painlesscomparedtosurgeryo Repeatableformonitoringo Providesgenomicanalysisofthenatureofcancers
Tissuebiopsyo Requiresinvasivesurgeryo Expensive($15000–$45,000)o Painful&hardtorepeato Riskofcomplicationso Sideeffectso Providesusefulgenomicinformation
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LiquidBiopsyIndustry
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• Liquid-biopsyplatformsareattractingintenseinvestorinterest• Pharmacompanies&VC’sinvestedover$1.2Bnin2018*
NextGenerationSequencing(NGS)o Prevalentinliquidbiopsyo Allowshighspeedandlowcostgenomicsequencingo RequiresisolationofDNAcellsfollowedbyamplification(theproductionofmultiplecopies
oftargetedsequencesofDNA)o Requireslargerstudiestocompensateforchallengingsignal-to-noiseratioo Risksmissingthepotentialheterogeneityofthecancer
*https://www.prnewswire.com/news-releases/liquid-biopsy-poised-to-revolutionize-prognosis-and-early-detection-300757046.html
• TeloView®doesnotuseNGSorDNAamplification,earlystudieshaveshownTeloView®maybeequivalentorbetterinprofilingprostatecancerbyitsaggressiveness*
*DrachenbergD,AweJ,PozzoA,SaranchukJandMaiS.AdvancingRiskAssessmentofIntermediateRiskProstateCancerPatients.Cancers2019,11,855;doi:10.3390/cancers11060855
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TeloView®–MultipleMyeloma(MM)
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• Telo’sleadapplicationisadiagnostic/prognostictoolforunmetneedsacrossthespectrumofMM
• MMisacancerofwhitebloodcells:o Occursinplasmacells-atypeofwhitebloodcellthatgrowsinbonemarrowo Symptomsincludebonepain/fractures,anemia,fatigue,recurrentinfections&kidney
problemso Over140,000activecasesofMMintheUSin2020*o Anincurablediseasethatcanbemoderatedthroughtreatment&hasa52%survival
rateover5years*
• StandarddiagnosisforMMarebloodtestsandinvasivebonemarrowbiopsyandlimitedgenomictestingavailable
*https://seer.cancer.gov/statfacts/html/mulmy.html
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MultipleMyeloma–DiseaseProgression
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Initiation Progression
Clonalplasmacells
Post-germinalcentralBcell MGUS
SmolderingMultipleMyeloma
MultipleMyeloma
Plasmacellleukemia
Clonal,malignantplasmacells
• Normalmatureplasmacells
• Highlycomplicatedandaggressiveformofmyeloma
• Symptomaticfullstageofthedisease
• Abnormalmyelomacellsaccumulatedinthebonemarrow
• AsymptomatichigherriskprecursorofMM
• HigherlevelsofMproteins
• Elevatedplasmainbonemarrow
• AsymptomaticlowriskprecursorofMM
• Mildlyelevatedantibodies(calledMproteins)
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MultipleMyeloma–DiseaseProgression
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TeloView®hasthepotentialtoguidediseasemanagementinmultipleareas
Initiation Progression
Post–germinalcentralBcell
MGUS
Clonalplasmacells
SmolderingMultipleMyeloma
MultipleMyeloma
Plasmacellleukemia
Clonal,malignantplasmacells
TELO-MM#1a TELO-MM#1b
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MayoCollaboration#1a–MultipleMyeloma
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AretrospectivestudydesignedtoshowsignificantdifferencesbetweenstableSMMpatientsvs.highriskSMMpatients
TransitionofSMMtoActiveMM
• SMMisaprecursortoactiveMM:o Standardofcarehasbeentomonitorbutnottreat,butischangingtoearlier
treatmentofhighriskpatientso Currentdiagnosisisasimplebloodtestandinvasivebonemarrowbiopsyo Thereareover250,000peoplewithSMMintheUS*o 13-14%SMMpatientstransitiontoactiveMMeachyear*
• TeloView®isnon-invasive,itcanbeused2-3timesperyearinregularmonitoring• Addressablemarketisover500,000testsperyear
TherearecurrentlynoteststhataccuratelypredictwhowilltransitionfromSMMtoactiveMM
*RavindranA,BartleyAC,HoltonSJ.Prevalence,incidenceandsurvivalofsmolderingmultiplemyelomaintheUnitedStates.BloodCancerJournal(2016)6,e486;publishedonline21October2016
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MayoCollaboration#1b–MultipleMyeloma
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MMistreatedwithcombinationtherapy,thereareover40differentcombinationsavailable,gettingtherightinitialtherapyiscritical:
o Itcandelaysymptomsandorgandamage,improvingoutcomesandreducingcostso Patientsbuildupresistancetotherapyandcanchangecombinationsmultipletimeso Typesoftreatmentincludes;chemotherapy,immunotherapy,proteasomeinhibitors,stemcell
therapyandradiationo Annualcostoftherapyis$125-250ko Thereareover32,000newcasesofMMayearintheUS*o Addressablemarketforguidinginitialtherapyisover32,000testsperyear,andover100000
testsperyearwhenchangingtherapies
AretrospectivestudydesignedtoshowsignificantdifferencesbetweenMMpatientswhofailedinitialtherapyfromthosewhoremainedinremission
InitialResponsetoTherapyinMM
*https://seer.cancer.gov/statfacts/html/mulmy.html
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MultipleMyeloma–RepresentativePublications
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Summary#22016studyconductedon10patientsex-vivo
• Tested3MMdrugsunderdevelopmentforefficacy• SuccessfullyshowedthatTeloView®couldpredictpatientresponsetoeachdrug
- Thefollowingkeysummariesarefrompeerreviewedpublications(2013-2019)- Included158patientswithMM,SMMorMGUS&providedthecatalystfortheMayoCollaboration
Summary#12013studyincluded86patients
• Establishedproofofconcept• Canbeconductedwithliquidbiopsy• Stratifiespatientsbydistinct3Dtelomereprofilesforstageofthedisease
Summary#32019studyincluded62patients
• UsedTeloView®tostratifypatientsbydistinct3Dtelomereprofile• Successfullystratified&groupedpatientsbetweenMGUS&activeMM
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0 1,000 2,000 3,000 4,000 5,000 6,000 7,000 8,000
List
Pric
e ($
USD
) GenomicTesting=PremiumPricing
18
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Commercialization
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There are several potential paths to revenues: • Licenseorsaledirectlytopharmaceuticalcompaniesforresearchorasa
companiondiagnostic• Licenseorsalewithdiagnosticlaboratorycompaniesorestablisheddiagnostic
companies• DirectsalesthroughasinglespecializedCLIAlaboratoryasaLabDevelopedTest
(LDT)• Directsaleswithaninvitrodiagnostictest(IVT)underFDAapprovalasanew
product
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TeloView®informsonarangeofcancersandneurologicaldiseases
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MultipleMyelomaHodgkin’sLymphomaMyelodysplasticSyndrome/AcuteMyeloidLeukemiaChronicMyeloidLeukemia
ProstateCancerAlzheimer’sDiseaseLungCancer(NSCLC)
BreastCancerMelanomaCutaneousLymphomaPancreaticCancerThyroidCancerHeadandNeckCancerOralCancerEsophagealCancer
TeloView®
GastrointestinalCancerRhabdomyosarcomaEpendymomaCholangiocarcinomaGlioblastomaOligodendrogliomaNeuroblastoma
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TELOLeadership
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SabineMai,PhD,DirectorandChair,Clinical&ScientificAdvisoryBoardProfessor,UniversityofManitoba,TIER-ICanadaResearchChairfromTheCanadianInstituteofHealthResearch.Aworldleaderin3Dmicroscopy,telomeresbiology,genomicinstabilityandcancer.
SherifLouis,PhD,PMP,ChiefExecutiveOfficerAnexperiencedbusinessleaderandaccomplishedscientistwithstrongtrackrecordinthebiotechnologyindustryfocusedontechnologydevelopmentandcommercialization.
GuidoBaechler,Chairman25yearsofexperienceworkingwithemergingtechnologiesinlifesciences/medicaldiagnostics.ServedasPresident&ChiefExecutiveOfficerofSingulex.PriortoSingulex,heldexecutiveleadershippositionsatbothRocheDiagnosticsandRocheMolecularDiagnostics.
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Clinical&ScientificAdvisoryBoard
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Sabine Mai, PhD – Chair, Clinical & Scientific Advisory Board
Kenneth C. Anderson, MD – Harvard & Dana-Farber Cancer Institute (USA)
Laurence Klotz, MD – Sunnybrook Hospital (Canada) Hans Knecht, MD – McGill & The Jewish General Hospital (Canada)
Darrel Drachenberg, MD – CancerCare Manitoba (Canada)
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Pubco&Capitalization
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SharesIssued:
52-WeekRange:
RecentPrice:(10/15/20)
MarketCap:
PrivatePlacement:(11/25/2019)
ProjectBurnRate:
42.0m
$0.30-$0.10
$0.21
$8.8m
$1.74m
<$100k/mo.
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InvestmentSummary
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• TeloView®isafirst-in-classprognostic/diagnostictoolusedtoanalyzegenomicinstabilityasapredictorofdiseaseandguidetreatment
• Uniquespaceintherapidlyemergingfieldofminimallyinvasive/liquidbiopsy• CollaborationwiththeMayoClinic,focusingonunmetclinicalneedsinmultiple
myeloma(MM),usingTeloView®topredict:o TransitionfromsmolderingMMtoactiveMMo EfficacyofinitialtherapyinMMo Theaddressablemarketfortheseindicationsisover$1.0billion
• Over130+peer-reviewedpapersevaluatingover3,000patientsand14+diseases• Opportunitiesindiagnostic/prognosticproducts,pharmaceuticalpartnershipsand
academiccollaborations
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ContactInformation
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MaRSDiscoveryDistrict101CollegeSt.,Suite200Toronto,Ontario,Canada
E:[email protected]:416.673.8487