family office marketplace december 2019 · • lack of rapid diagnostics force physicians to use...
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![Page 1: Family Office Marketplace December 2019 · • Lack of rapid diagnostics force physicians to use broad-spectrum antibiotics in “One-Size-Fits-All” approach – Sputum microbiology](https://reader034.vdocuments.us/reader034/viewer/2022050406/5f8384ce36b5c35f07639f65/html5/thumbnails/1.jpg)
Avisa Pharma 1
In
FamilyOfficeMarketplaceDecember2019
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Avisa Pharma 2
• DealSize- $2million• MinimumInvestment- $50,000• Healthcare– MedicalTechnology• SeniorConvertibleNote
– 50%discounttoconvertedshareprice
• UseofProceeds• WorkingcapitalfortwophaseIIpilotstudiesforHospitalAcquiredPneumoniaandVentilatorAssociatedPneumonia
• Forpotentialpublicofferingorcorporatestrategicapartnering
Offering
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Avisa Pharma 3
Faster,MoreAccurateDetectionofBacteriaImprovesOutcomes
InitialTargetMarketsCommunity AcquiredPneumonia (CAP)Hospital Acquired Pneumonia (HAP)
Ventilator Associated Pneumonia (VAP)
AvisaisaU.S.companyformedtodevelopa10-minutepoint-of-carebreathtestforthedetectionandmonitoringofpulmonarybacterialinfections
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Avisa Pharma 4
• TheAvisa BreathTest– Vitalinformationto“treatornottreat” - guidanceinminutes
• Iftreated– quantitative,measurebacterialloadinminutes
• Lackofrapiddiagnosticsforcephysicianstousebroad-spectrumantibioticsin“One-Size-Fits-All”approach– Sputummicrobiologyhas40%sensitivity,poorspecimenattainment,and
resultstakeupto3days–– PCRmoleculardiagnosticrequiressputumforbacterialpanel,centrallab– Prescribedantibiotictherapyisincorrectinupto50%ofcases– 2millioncasesofARintheU.S.accountedforover23,000deaths
Broad-spectrumantibioticsneedtobereservedforonlythemostvirulentbacteria
OveruseofBroadSpectrumAntibioticsleadstoAntibioticResistance
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Avisa Pharma 5
• PrevalenceoftheseUreasepathogensinpneumoniavariesbytype– 5%to15%forPneumoniaintheEmergencyDepartment(CAP)– 30%to50%forHospitalAcquiredPneumonia(HAP)– 40%to60%forVentilatorAssociatedPneumonia(VAP)– S.aureusandPseudomonas is themostcommonamongCAPandVAP
MostDangerousBacterialPneumoniaPathogensExpressUrease
Acinetobacter Staphylcoccus aureus Pseudomonas Klebsiella
CoccidioidomycosisHaemophilis influenzae Tuberculosis Burkholderia
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Avisa Pharma 6
• Simple,pointofcaretestthatmeasuresthewholelung• Onlytechnologytodetectliveorganisms,realtime
– Uniquedrug-devicecombinationproducesresultin10minutes– Detectspneumoniacausedbyureasepathogensthatrequirerapid
intravenous,broadspectrumantibiotictreatment
• AV-U13(13C-urea)– Safe,non-radioactive,stable
Solution:AvisaBreathTest (ABT)
• AV BreathTest– AVISARTM laser
spectrometer– ABT Kit
(Nebulizer+Drug)
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Avisa Pharma 7
Avisar isalaser-basednear-IRspectrometer• Accuratelymeasuresbreathforchangesin13CO2
thatareindicativeofactive ureaseinfections• Itsnumericaltestresultindicatesthelevelof
ureasepathogenactivityintherespiratorytract• Graphicinterfaceguidesusersclearlythrough
eachtest• Designpermitsitsuseinabroadrangeof
temperaturesandenvironments• Compactandportableunitcanbetransportedto
thepointofcareinsideoroutsideamedicalfacility
• Designedforlowcomplexity,durabilityandmanufacturability
AVISAR:FirstPoint-of-CareSystemtoDetectUreasePathogens
Weight =8pounds
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Avisa Pharma 8
AVISAR:UltimatePortabilityPointOfCare
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Avisa Pharma 9
• Theinitialinvestigator-initiatedproof-of-conceptstudywasconductedattheUniversityofNewMexicotodetectP.aeruginosa,theresultsofwhichshowedcleardifferentiationofcysticfibrosis subjectsinfectedwithP.aeruginosa bacteriavshealthycontrolswhenadministerednebulized13C-urea.
• InaseparatepilotstudyinDurban,SouthAfrica,ABT illustrateditssafetyandefficacyindetectingactivetuberculosisconfirmedbysputum culturemicrobiology.
• DatafromAvisa’srecentlycompleted75subject(clinicalstudyofpneumoniaintheemergencydepartment(CAP)showedpositiveefficacyresultswithacleansafetyprofileoftheABT confirmedbysputumculturemicrobiology.
ClinicalValidationinThreePilotStudies
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Avisa Pharma 10
ABT – DetectionofCAP,HAP,andVAP
SwiftIdentificationofUreasePathogens:ToTreatornotTreat
CurrentStandardofCare AvisaBreathTest
Sputumsample taken,1to3daysuntil results
Pneumonia Patient
Empiric Therapy=BroadSpectrum IVAntibiotics
(100%) Unlikely toNeed BroadSpectrum IVAntibiotics
UreasePathogen(15%)
NoUreasePathogen(85%)
LikelytoNeed BroadSpectrum IVAntibiotics
Pneumonia Patient
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Avisa Pharma 11
• VentilatorAssociatedPneumonia(VAP)– Develops48ormorehoursaftermechanicalventilationisperformedbyan
endotrachealtubeortracheostomy– 1.7MannualICUpatientsenduponventilators– ABT canbeusedtomonitorthesepatientsfortheearlypresenceofactive
ureasepathogenspriortotheonsetofclinicalsymptoms– ABTwillbeusedmultipletimesoverthecourseofseveraldaysasa
monitoringtestduringintubation,thusgeneratingmaximalrevenues
• HospitalAcquiredPneumonia(HAP)– Patientsdeveloppneumoniaafter48hoursfollowinghospitalization– 589,000annualU.S.cases– ABTwillbeusedtodeterminetheearlypresenceofactiveurease– ABTwillbeusedmultipletimesoverthecourseofseveraldaysasa
monitoringtest
VAP&HAPInpatientReimbursement– DRG
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Avisa Pharma 12
ABT CanServeasMonitoringforTreatmentEffectiveness
QuantitativeEvidencetoUreaseLevelWillAdjustTreatment
HAPPatientsABT onday1,3and4
VAPPatientsABT onday1,3and4
AvisaBreathTest
Antibiotic TreatmentAdjusted
Decrease inBacterial Load
Increase inBacterial Load
Clinical SignsandSymptoms,Culture
Discontinue Treatment
Pneumonia PatientReceivesTreatment
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Avisa Pharma 13
AVISABreathTest
Culture PCR Procalcitonin, ProteomicsPanel
Specimen ExhaledBreath Sputum,blood Sputum,nasalswab, blood Blood
Detects liveorganisms Yes No No No
Measureswholelung Yes No No No
Monitor treatment Yes No No Yes
Turnaroundtime <10min 24hrs to48 hrs 2hrs to24hrs 2hrs to4hrs
Sensitivity High Low Moderate Moderate
Specificity HighUrease High High Low
Pointofcare,portable Yes No No No
Testcomplexity Low High High Moderate
Instrumentcost ProvidedFree $60k $49kto $78k $20kto$49k
Costpertest $200to$300 $60 $514 $99
ComplementarytoABT --- Yes Yes No
CompetitiveMatrixforPneumoniaDiagnostics
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Avisa Pharma 14
• ABT Advantages– ABT measures thewhole lung, liveorganisms inminutes– ABT ishighlysensitive andspecific tourease pathogens– ABTdetects colonization andmonitors antibiotic use
• PCRChallenges– PCR’sactualturnaround timefrom2to24hoursbycentral lab,andifbatched and
senttooutside lab,couldbeuptothreedays– PCRpicksupboth liveanddeadbugsthereby impacting sensitivity andrequires
sputum inordertotest andneeds toobtain sputum inthe infected lungregion– PCRdoes notmonitor therapy– BioFire FilmArraylungbacteria panelrecent FDAapprovalviaretroactive curatingof
cherry-picked sputum culture samples
• ABT andPCR/BioFire arecomplementary– Combination ofahighlysensitive breathtestmorehighlyspecificmolecular tests
wouldrendersputum culture obsolete
ABT vs.RespiratoryMolecularDiagnostics(PCR)
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Avisa Pharma 15
• Over30,550InpatientandAmbulatoryFacilitiesintheU.S.§ 5,500Hospitals- emergencydepartments,ICU/CCU’s,nursingunitsand
clinics§ 15,000skillednursingfacilities§ 7,500urgentCareCenters§ 550freestandingemergencyRooms§ 2,000walk-inclinics
• AvisaStrategyInvolvesAnAccelerativeBusinessModel§ AvisaprovidesAVISARdeviceatnocosttoencourageadoption:80%ofunits
suppliedwillbeatnocost,remaining20%willbesoldatlistprice§ AvisawillsellABT kitscomprisedofthe13Cbiomarkersubstrate,nebulizer
andinhaler:§ Detectioncost/testinU.S.:$200forCAP/$200forHAP/$300forVAP§ Monitoringcost/testinU.S.:$200forCAP/$200forHAP/$300forVAP
ABT TargetsLargeMarketsAcrossMultipleHealthcareSectors
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Avisa Pharma 16
U.S.PneumoniaMarket– $2.9BAnnually
US:$2.9B(11.6Mtests)EU:$2.4B(11.2Mtests)Japan:$75M(2.9Mtest)China:$13B(60Mtests)
Pneumonia
CommunityAcquired
HospitalAcquired
PneumoniainED
Hospital(non-vent)
VentilatorAssociated
1testeach(@$200/test)$840M
(4.2Mtests)
6.6Mcases
6Mcases
0.6Mcases
70%
10%
90%
33%
67%
4.2MCAPcases
0.2MHAPcases
1.7Mventpatients(0.4MVAPcases)
3testseach(@$300/test)$1.5B
(5.1Mtests)
1testeach(@$200/test)$40M
(0.2Mtests)
$2.4B(9.5Mtests)
10%
40%
50%
UreaseCAP
UreaseHAP
UreaseVAP
0.4Mpatients
0.1Mpatients
0.2Mpatients
3testeach(@$200/test)$252M
(1.3Mtests)
3testseach(@$300/test)$180M
(0.6Mtests)
3testeach(@$200/test)$50M
(0.2Mtests)
$482M(2.1Mtests)
Detection Monitoring
+
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Avisa Pharma 17
ValueBasedEconomicAnalysisislinkedto:– Shorteninghospitalstays,avoidingreadmissionandkeepinghealthypeople
outofthehospital– Avisapharmaco-economicmodelfocuseson:
• CAP/HAP- $200ABT disposablecansavea$15,000hospitaladmissionthroughtheemergencydepartment
• VAP- a$300disposablewilldetectseriousinfectionsintheICUatanearly,treatablestage.ABTmayhaveasubstantialimpactonmorbidityandmortalityassociatedwithVAP
ValueBasedEconomicsDriveRapidAdoption
#1ValueProposition:ReducingUnnecessaryHospitalizationsandtherebyMitigatingAntibioticResistance
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Avisa Pharma 18
• Assumesjust2U.S.products:CAP+HAPandVAP• Doesnotincludeinternationallicensingorroyaltyreceipts
AvisaFinancialProjections– PneumoniaintheU.S.
AVISAR Placements: 45 194 514 913 1,751ABT Sold: 6.2k 59.7k 163.7k 311.3k 534.4k
$2$20
$53
$99
$169
($7) $1$20
$38$63
($50)
$0
$50
$100
$150
$200
2022 2023 2024 2025 2026
Millions
AvisaFinancialProjections
REVENUE
EBITDA
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Avisa Pharma 19
• DevelopmentStrategy– Avisawillpursueapivotal clinical trial forindication CAP/HAP– RapidfollowupSupplemental IDEforVAPpivotaltrial– Avisa willhaveoptionality oftwoIDEPMAtrials in2021
DevelopmentforCAP/HAP/VAPPrograms
AvisahasdevelopedastreamlineddevelopmentpathinCAP+HAPandVAPwiththepotentialformultiplecommercial launches
2019 2020 2021 2022+
ProductDevelopment
AVISAR™
AV-U13
Clinical&Regulatory
CAP+HAP
VAP
Equity
Drug Batch
VAPPilot
CAP+HAPPivotal
VAPPivotal
FDA
FDA
$20MM
ClinicalUnits
HAPPilot
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Avisa Pharma 20
AvisaDevelopmentPipelineTakesFullAdvantageofAV-U13AvisaPharma’s initial focusistocommercializetheAVBreathTest™forCAP+HAP thenVAP;
however,therobustplatformtechnologyofferssignificantpotentialacrossavarietyofdiseases
AVBreathTest™Portfolio Pre-Clinical Pilot Pivotal
AV-U13CAP+HAPCommunityAcquiredPneumonia+HospitalAcquiredPneumonia
AV-U13 VAPVentilatorAssoc.Pneumonia
AV-U13COPDChronicObs. Pulm.Disease
AV-U13TBTuberculosis
AV-U13CFCystic Fibrosis
AV-U13HP(China)H.Pylori
AV-U13VFValleyFever
AV-T13C.diffClostridiumdifficile
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Avisa Pharma 21
Patents PatentLife• ISSUED7,717,857MethodfordiagnosingP.aeruginosa – U.S. 2033• RE-ISSUEDRE44533Expanded coverageforotherureasebacteria– U.S. 2033• ISSUED7,897,400RapidTestforM.tuberculosis Infection– U.S. 2033• ISSUED10,000,787MethodDiagnosingClostridiumDifficile – U.S. 2040
• PendingNon-USEP13845074.7• ISSUED9,453,253UsingIsoniazidfortheDiagnosis ofLungInfections– U.S. 2038• ISSUED9,518,972MethodofUsingparticular wavelengthpairs
fordiagnosing bacterial infections– U.S. 2038EP13779680.1.Granted(France,Germany,GreatBritain,Italy); 2038ZL2011380054746.4(China); 2038PendingJP2015-537719(Japan)
• Pending62/277/121MethodofBreathFractionationforDetectingLungInfections– filingdate 2018
BroadandDeepIntellectualPropertyProtection
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Avisa Pharma 22
SeasonedManagementTeam
DavidJosephPresident&CEOCo-Founder
• 40+yrsofexperience commercializing medical devices andpharmaceuticals• Co-founder offourlifescience companies withsuccessful exits(IPO, M&A)
• Multiple pastandpresent boardpositions
Elizabeth Perkett,MD
ChiefMedical Officer
• ProfessorofPediatrics specializing inpulmonary medicine, Vanderbilt University• Over50recent scientific andclinical publications
• Cystic FibrosisFoundation committee member
DavidKarshmer
SVP,ProductDevelopment
• 25+yrsofexperience inmedical device design• Founded IDEOHealthcare practice, developed numerousmedical products
• Successful serialentrepreneur (Avisa is6thstart-up company)
MattCuller
VP, Finance
• 15+years investment andfinancial management experience• Acting CFOatmultiple venture backed startups
• Venture Capital andInvestment Banking experience
GrahamTimmins,PhD
ChiefScience Advisor
• Associate ProfessorofMedicinal Chemistry atthe University ofNewMexico• Co-inventor ofthe Company’s patent portfolio
• Author/co-author ofover50publications andrecipient ofseveral federal grants
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Avisa Pharma 23
• Avisaisthefirstcompanytoenterthepotentiallyhugemarketofvalidatingthepresenceofvirulentpneumoniawithitsnoveldiagnostictechnology
• ABT isaninnovativetechnologyprovidinggrowthopportunitiestoacorporatepartner
• ShortpivotaltrialswithPMAregulatorypathprovidesyearsofmarketexclusivity,complementedbystrongIPandfavorablereimbursement:allpositiveelementsforcommercializationinthenearterm
• Theevolutionofdrugresistanceposesaglobalhealthcrisisandmillionsofpeopleareatriskifthatproblemisnotaddressedbylimitingthespreadofexcessiveuseofantibiotics–
Avisa isaleaderinaddressing thiscrisis
Summary
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Avisa Pharma 24
ThankYou
Contact Information:
DavidJosephPresident&CEO505-820-1400x114844595076celldsj@avisapharma.comwww.avisapharma.com