Avisa Pharma 1

In

FamilyOfficeMarketplaceDecember2019

Avisa Pharma 2

• DealSize- $2million• MinimumInvestment- $50,000• Healthcare– MedicalTechnology• SeniorConvertibleNote

– 50%discounttoconvertedshareprice

• UseofProceeds• WorkingcapitalfortwophaseIIpilotstudiesforHospitalAcquiredPneumoniaandVentilatorAssociatedPneumonia

• Forpotentialpublicofferingorcorporatestrategicapartnering

Offering

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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• 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

Avisa Pharma 24

ThankYou

Contact Information:

DavidJosephPresident&CEO505-820-1400x114844595076celldsj@avisapharma.comwww.avisapharma.com