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Anti-Infective Solutions Leading Development of Novel Anti-Infective Products in the Era of Increasing Bacterial Resistance September 2017 1

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Page 1: Leading Development of Novel Anti-Infective … › wp-content › uploads › 2016 › 08 › CorMedix...*Wound prevalence and wound management, 2012-2020, Pdriscoll, January 29,

Anti-InfectiveSolutions

Leading Development of Novel Anti-Infective Products in the Era of Increasing Bacterial Resistance

September 2017

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This presentation contains certain statements that constitute forward-looking statements within the meaning of the federalsecurities laws. Statements that are not historical facts, including statements about our beliefs and expectations, are forward-looking statements. These statements are not guarantees of future performance and involve risks, uncertainties andassumptions that are difficult to predict. The forward looking statements in this presentation include statements about ourbusiness, including commercialization plans and potential markets for our products and product candidates, clinical trials,potential indications for our product candidates, development timelines, regulatory timelines and future events that have not yetoccurred. Pharmaceutical and medical device development inherently involves significant risks and uncertainties, including therisks outlined in “Risk Factors” in our Annual Report on Form 10-K filed with the Securities and Exchange Commission and in“Risk Factors” in our Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Our actual resultsmay differ materially from our expectations due to these risks and uncertainties, including, but not limited to, our dependenceon the success of our lead product candidate Neutrolin, and factors relating to commercialization and regulatory approvalthereof; unpredictability of the size of the markets for, and market acceptance of Neutrolin; the cost, timing and results of theongoing and planned Phase 3 trials for Neutrolin in the U.S.; our need for and ability to raise sufficient capital; our ability toidentify and enter into strategic transactions; intellectual property protection; retaining our stock’s listing on the NYSEAmerican; research and development activities; competition; industry environment, and other matters. Any forward-lookingstatements included in this presentation are based on information available to us on the date of this presentation. Weundertake no obligation to update or revise any forward-looking statement, whether as a result of new information, futureevents or otherwise.

Forward-LookingStatements

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MissionStatement

Toharnessourtaurolidinetechnologyforthepreventionandtreatmentofinfectious,inflammatory,andotherseriousdiseases

Firstcommercialproductcandidate:Neutrolin®Anovel,non-antibioticantimicrobialsolutiondesignedtopreventcostlyand

dangerousbloodstreaminfectionsassociatedwiththeuseofcentralvenouscatheters

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CorporateOverviewFounded January2006

Exchange:Ticker NYSE American: CRMD

Headquarters Bedminster,NJ

Employees 15

SharesOutstanding 61.7Million

WarrantsOutstanding 23.6Million

Cash(atJune30,2017) $18.8 Million

Debt $0

RecentSharePrice $0.43

RecentMarketCap $26.5million

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CurrentTaurolidine-BasedPipeline

*OrphanDiseaseOpportunity

Product Category Indication Preclinical Phase 1 Phase 2 Phase 3 Marketed

Neutrolin®

U.S.

HemodialysisOncologyICU / CCU

CMDX-001 Pediatric Neuroblastoma*

CurrentlyEnrolling

Product Category Indication(s) Discovery In Vitro PoC

In Vivo PoC 510(k)** Marketed

Neutrolin® Europe Catheter lock solutionCMDX-006

Synthetic sutures Wound closure/surgery

CMDX-008Surgical meshes Burns and hernia

CMDX-007Topical hydrogels Common burns/foot ulcers

Nanoparticle Hydrogel*** Severe burn injury

CEMarked

DrugPipeline:

MedicalDevicePipeline:

**RegulatorypathwaydependentonFDAacceptanceofpredicatedevicesforeachproductcandidate***ProgramfundedbyNIHgrantnumberR43GM122156

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• LeadU.S.productcandidateNeutrolin®inPhase3clinicaldevelopment• Q42017:Interimreview• Q22018:Completepatientenrollment• 2H2018:Reporttop-linedata

• Unlockingadditionalvaluebyleveragingtaurolidineplatform• Q42017:invivoproof-of-conceptdataforvariousmedicaldeviceapplications• Q12018:invivoproof-of-conceptdataforoncology:pediatricneuroblastoma

SummaryandNear-TermMilestones

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MedicalOpportunity

Biofilm CompletelyCovers CatheterSurface

No Biofilm orMicrobialColonization

Untreated 24 hours Neutrolin® 5 mon.Heparin 7 months

Rapid BiofilmFormation

• 250,000 CRBSIs per year in the U.S.

• Microbial biofilms responsible for majority of CRBSI

• Bacteria are significantly more resistant to antibiotics within a biofilm

• Mortality rate: 12-25%

Despiteimprovementsandinitiativestocontrolinfection,biofilmdevelopsveryquicklyandcanleadtolife-threateningcomplications,costingtheU.S.healthcaresystembillionsofdollarsannually

Significant Unmet Need

Sources:CarusoF,Darnowski JW,Opazo C,GoldbergA,KishoreN,etal.(2010)Taurolidine AntiadhesivePropertiesonInteractionwith E.coli; ItsTransformationinBiologicalEnvironmentandInteractionwithBacteria CellWall.PLoS ONE5(1):e8927.;WorldHealthOrganization:http://www.who.int/patientsafety/implementation/bsi/en/

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Prevents and reduces bloodstream infection• Bacteria and fungi• Antibiotic-resistant strains• No reported resistance in a clinical setting

Inhibits peptide crosslinking in microbial cell walls

Prevents microbial colonization and biofilm formation inside catheter

Neutralizes endotoxins, exotoxins and lipopolysaccharides released by bacteria

Reduces thrombosis; optimizes catheter patency and reduces expensive catheter complications

UntreatedBlood Vessel

Neutrolin

Catheter

Neutrolin®:Non-antibioticAnti-InfectivetoPreventCRBSIProprietary formulation:

ü Taurolidine (anti-infective, anti-inflammatory)ü Heparin (anti-coagulant; current standard of care)

ü Citrate (pH buffer)

Neutrolin®

KeyBenefits:

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Neutrolin®:Non-antibioticAnti-InfectivetoPreventCRBSI

Lack of Microbial Resistance:

• Adaptation of microorganisms to taurolidinehas not yet emerged as a factor in the pathogenesis of CRBSI

• Bacterial resistance has not been reported, as taurolidine’s mode of action resembles a anti-infective rather than an antibiotic

• Broadly active against bacteria, including antibiotic-resistant MRSA, VISA, VRSA, ORSA and VRE

Spectrum of Coverage:

• Gram positive microorganisms:§ Coagulase-negative Staphylococcus

species and Staphylococcus aureus

• Gram negative microorganisms:§ Klebsiella pneumoniae, Escherichia coli

and Pseudomonas aeruginosa

• Clinically relevant fungi:§ Candida albicans and Aspergillus

fumigatus

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FocusedonExecutionofPhase3U.S.ClinicalStrategy

Approval Pathway: Designated an investigational new drug by FDA• Granted FDA Fast Track • Qualified Infectious Disease Product (QIDP)

Phase 3 “LOCK-IT” Program (Catheter LOCK Solution Investigational Trial)• Ongoing: LOCK-IT 100: Currently enrolling hemodialysis patients

• Expected Milestones:• Q4 2017: Interim review• Q2 2018: Complete patient enrollment• 2H 2018: Report top-line data

• LOCK-IT 200: Second clinical study being assessed to seek efficiencies and improvements in design and implementation

10.5yearsPotentialMarket

Exclusivity

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LOCK-IT100:PreventingCRBSIinDialysisPatients

Phase 3, multicenter, double-blind, randomized (1:1), active control (heparin)• Minimum 632 patients on hemodialysis for end stage renal disease (ESRD)• Approximately 70 clinical centers in the U.S.

CurrentStudyDesign

PrimaryEndpoint

Time to occurrence of CRBSI

• Catheter patency: loss of catheter patency following study enrollment• Catheter removal: removal of catheter for any reason following study enrollment

SecondaryEndpoints

Demonstrate the efficacy and safety of Neutrolin® as a catheter lock solution for the prevention of CRBSI and the incidence of treatment-emergent adverse events compared to heparin (1000 u/ml)

• Goal to achieve significant reduction in infection rate vs. heparinObjectives

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NeutrolinClinicallyValidatedinRealWorldStudy

• Primary outcome: monitor safety and efficacy of CE Marked Neutrolin in preventing infection and thrombosis

• Positive results consistent with prior clinical studies• 202 hemodialysis patients• 36,083 catheter days

• Reduces risk in ongoing Phase 3 study

• Data accumulated from NUMP registry add support to NDA

Neutrolin Usage Monitoring Program (NUMP)Open-label, post-market observational study

1CDCGuidelinesforthePreventionofIntravascularCatheterRelatedInfections;O`Gradyetal.,2011;2MorrisP,Knechtle SJ.KidneyTransplantation- PrinciplesandPractice.Saunders,2013.Print.;3NapalkovP,Felici DM,ChuLK,JacobsJR,Begelman SM.Incidenceofcatheter-relatedcomplicationsinpatientswithcentralvenousorhemodialysiscatheters:ahealthcareclaims databaseanalysis.

3.50

2.50

0.142 0.085

0.00

0.50

1.00

1.50

2.00

2.50

3.00

3.50

4.00

Infection Thrombosis

BenchmarkData Neutrolin

Neutrolin Significantly Reduces Infection and Thrombosis

Rate per 1000 catheter days

96%Reduction

96.7%Reduction

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CatheterLockSolutions-U.S.MarketPotentialisSignificant;DrivenbyCatheterDays

CatheterPopulationandOpportunityareSignificant

Neutrolin® PatientsEstimatedCatheter

DaysVials per

Catheter DayTotal Units

Hemodialysis 660,000 63mm 0.5 31mm

Oncology/TPN 7,740,000 90mm 3 270mm

ICU 5,700,000 29mm 5 143mm

444mm

Companyestimates,usingsources:Hemodialysis:USRDS2015AnnualDataReport:2015USRDSAnnualDataReportVolumeESRDinthe UnitedStatesandCorMedixestimatesOncology:AmericanCancerSociety.CancerFactsandStatistics.http://www.cancer.org/research/cancerfactsstatistics/.AccessedonApril1,2015andCorMedixestimatesIntensiveCareUnits:SocietyofCriticalCareMedicine.CriticalCareStatistics.http://www.sccm.org/Communications/Pages/CriticalCareStats.aspx. AccessedonApril10,2015andCorMedixestimates

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ExpandingtheTaurolidineFranchise

NeuroblastomaSynergywithVincristine

IncreasedEfficacyLowerToxicity

OsteosarcomaSynergywithVincristine

IncreasedEfficacyLowerToxicity

DrugOpportunities

TopicalHydrogelsBurnsandWoundsDiabeticFootUlcersBiofilmPrevention

SuturesProtectssurgicalsitesfrominfection

MeshesHerniaRepair

WoundManagementBurns

MedicalDevice

Opportunities

AdvancedNanoparticleHydrogelsSevereBurnInjury

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InvestigationalTaurolidine-BasedTherapyforNeuroblastoma

IncidenceRate(U.S.)*RareDisease- occursin1/100,000children

(usuallyunder5yearsofage)

Feasibility• EncouragingIC50dataagainstneuroblastomacelllineswithnanoparticlesoftaurolidinealoneandincombinationwithvincristine

• Intendedtoenhanceactivityofoncologicagent• Neuroblastoma– OrphanDrugopportunity• ExperiencedexternalteamtoguideeffortsMSKCC(POETIC)andHarvard

Milestones• Q12017– Completedfeasibilitystudies• Q12018– ProofofConceptinvivoanimalstudies

PatentApplicationPCTPatentApplicationfiledJanuary11,2017:SynergisticActivityofTaurolidineandOncologicDrugsforTreatmentofNeuroblastoma

Unmet Medical NeedSynergy with vincristine with the potential for more consistent delivery by using nanoparticle technology

February 2017: Agreement with Pediatric Oncology Experimental Therapeutics Investigators Consortium (POETIC)

*Meddevice Tracker.MedicalMarketandTechnologyReports:U.S. MARKETSFORNEUROSURGICALANDNEUROINTERVENTIONALPRODUCTS(Sept2014)

(Potentialtoexpandtootheroncologyindications)

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InvestigationalTaurolidineAntibacterialSyntheticAbsorbableSutures

Unmet Medical NeedAntibacterial sutures inhibit surgical site infections (SSIs)

Currently marketed antimicrobial sutures use components with known adverse effects and environmental impact

Government movement to remove products containing these components** (likely to be banned in Europe first)

IncidenceRate(WW)*300K-500KSSI’spredictedtooccurannually

Approximately40millionprocedures Eachyearwithantimicrobialsutures

Feasibility• Prototypesdemonstratedeffectiveantimicrobialactivity• Twopotentialpredicatedevices• Clear,feasibledevelopmentpath• Potentialhighprofitmargin

PlannedMilestones• Q32017– Additionalfeasibilitywithrefinedprototype• Q42017– ProofofConceptAnimalModel

PatentApplicationPCTPatentApplicationfiledAugust18,2016:AntimicrobialSuturesandMethodforClosingaWoundUsingtheSame

*LSI-WW141WO:GLOBALMARKETSFORWOUNDCLOSUREDEVICESIN2014:SUTURES,STAPLINGPRODUCTS,HERNIAMESHES,ANDNEGATIVEPRESSUREWOUNDTHERAPY**FDAPressRelease(Sept2,2016):FDAissuesfinalruleonsafetyandeffectivenessofantibacterialsoaps

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InvestigationalNon–WovenMeshforHerniaRepair

Unmet Medical NeedNo marketed resorbableantimicrobial synthetic mesh product currently exists

Currently available options consist of permanent or living tissue

Additional needs in the prevention of infection in hernia repair as well as in other soft tissue applications

IncidenceRate*Totalherniasurgeriesperyear

~400kfailuresrequiringsurgicalinterventionandrepair

PatentApplicationPCTPatentApplicationfiledAugust31,2016:DeliveryofActiveAgentsusingNanofiberWebs

PlannedMilestones• Q42017– ProofofConceptAnimalModel

Feasibility• Meshprototypesdemonstratehighlyeffectiveantimicrobialactivity• Severalpotentialpredicatedevicesidentified;clear,feasibledevelopmentpath• Successfullyincorporatedtaurolidineintofibersbyelectrospinningtechnique• Potentialhighprofitmargin

(AdditionalPotentialApplicationsinWoundandBurns)

*LSI-WW141WO:GLOBALMARKETSFORWOUNDCLOSUREDEVICESIN2014:SUTURES,STAPLINGPRODUCTS,HERNIAMESHES,ANDNEGATIVEPRESSUREWOUNDTHERAPY

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InvestigationalHydrogelsforBurns,DiabeticFootUlcers,andWounds

Unmet Medical NeedNo Current antimicrobial treatments contain Ag (silver) and leptospermum scoparium honey

Ag (silver) needs to be replaced for environmental reasons and to formulate

PatentApplicationsPCTPatentApplicationsfiled:August31,2016:CompositionsfortheTreatmentofJointsOctober7,2016:Skin-PenetratingFormulationofTaurolidine

PlannedMilestones• Q42017:ProofofConceptAnimalModel

Feasibility• Hydrogelprototypesdemonstratedhighlyeffectiveantimicrobialactivity• PrototypesdemonstratedeffectivenessagainstmatureBiofilms(verydifficulttoachieve)• Anumberofpotentialpredicatedevices;clear,feasibledevelopmentpath• Potentialhighprofitmargin

*Woundprevalenceandwoundmanagement,2012-2020,Pdriscoll,January29,2013** BoultonAJ,ArmstrongDG,AlbertSF,etal.Comprehensivefootexaminationandriskassessment:areportofthetaskforceof thefootcareinterestgroupoftheAmericanDiabetesAssociation,DiabetesCare2008;31:1679

IncidenceRate(WW)Wounds(surgical,traumatic,chronic),

lacerations,anddiabeticfootulcers(lifetimeincidenceupto25%ofdiabetespopulation**)

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PlannedMilestonesforMedicalDevicePipeline

4Q2017:• CompleteProof-of-Conceptanimalmodelingforantimicrobialsutures,nonwovenmeshes,andtopicalhydrogels

DevelopmentStrategy:• Continuetoadvancemedicaldeviceprogramsthroughanimalproof-of-concept• Preparedataforpotential510(k)submission• Submission(s)beginningin2018for510(k)andCEMark

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Projectedmarketsformedicaldevices

ProductCategoryMarketSize– Forecasted,2018

IndicationsU.S. Europe Worldwide

Sutures $1.7B $550M $3.9B All

Hydrogels $1.02B $220M $1.9B Burns/DFU/Osteoarthritis

Mesh $1.0B $250M $2.0B Herniarepair/Burns/Wounds/ReconstructiveSurgery

1. Sutures:ReferenceLSI- WW141WO2. Hydrogels:ReferenceUSMarketsforAdvancedWoundCareProducts,August20153. Mesh:LSIMarketResearchLSI-WW1518SU

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• LeadU.S.productcandidateNeutrolin®inPhase3clinicaldevelopment• Q42017:Interimreview• Q22018:Completepatientenrollment• 2H2018:Reporttop-linedata• Additionalpivotalandpost-marketstudiestoexpandNeutrolinuse

• Unlockingadditionalvaluebyleveragingtaurolidineplatform• Q42017:invivoproof-of-conceptdataforvariousmedicaldeviceapplications• Q12018:invivoproof-of-conceptdataforoncology:pediatricneuroblastoma

SummaryandNear-TermMilestones

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1430 Route 206Suite 200Bedminster, NJ 07921

908.517.9500

NYSE American: CRMD

@CorMedixInc

Investor & Media ContactsTiberend Strategic Advisors, Inc.

Josh Drumm, [email protected]; 212-375-2664

Janine [email protected]; 646-604-5150

Thank You

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