Avisa Pharma 1
In
FamilyOfficeMarketplaceDecember2019
Avisa Pharma 2
• DealSize- $2million• MinimumInvestment- $50,000• Healthcare– MedicalTechnology• SeniorConvertibleNote
– 50%discounttoconvertedshareprice
• UseofProceeds• WorkingcapitalfortwophaseIIpilotstudiesforHospitalAcquiredPneumoniaandVentilatorAssociatedPneumonia
• Forpotentialpublicofferingorcorporatestrategicapartnering
Offering
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Faster,MoreAccurateDetectionofBacteriaImprovesOutcomes
InitialTargetMarketsCommunity AcquiredPneumonia (CAP)Hospital Acquired Pneumonia (HAP)
Ventilator Associated Pneumonia (VAP)
AvisaisaU.S.companyformedtodevelopa10-minutepoint-of-carebreathtestforthedetectionandmonitoringofpulmonarybacterialinfections
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• 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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• 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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• 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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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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AVISAR:UltimatePortabilityPointOfCare
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• 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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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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• 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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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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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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• 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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• 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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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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ValueBasedEconomicAnalysisislinkedto:– Shorteninghospitalstays,avoidingreadmissionandkeepinghealthypeople
outofthehospital– Avisapharmaco-economicmodelfocuseson:
• CAP/HAP- $200ABT disposablecansavea$15,000hospitaladmissionthroughtheemergencydepartment
• VAP- a$300disposablewilldetectseriousinfectionsintheICUatanearly,treatablestage.ABTmayhaveasubstantialimpactonmorbidityandmortalityassociatedwithVAP
ValueBasedEconomicsDriveRapidAdoption
#1ValueProposition:ReducingUnnecessaryHospitalizationsandtherebyMitigatingAntibioticResistance
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• 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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• 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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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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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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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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• Avisaisthefirstcompanytoenterthepotentiallyhugemarketofvalidatingthepresenceofvirulentpneumoniawithitsnoveldiagnostictechnology
• ABT isaninnovativetechnologyprovidinggrowthopportunitiestoacorporatepartner
• ShortpivotaltrialswithPMAregulatorypathprovidesyearsofmarketexclusivity,complementedbystrongIPandfavorablereimbursement:allpositiveelementsforcommercializationinthenearterm
• Theevolutionofdrugresistanceposesaglobalhealthcrisisandmillionsofpeopleareatriskifthatproblemisnotaddressedbylimitingthespreadofexcessiveuseofantibiotics–
Avisa isaleaderinaddressing thiscrisis
Summary
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ThankYou
Contact Information:
DavidJosephPresident&CEO505-820-1400x114844595076celldsj@avisapharma.comwww.avisapharma.com