leading development of novel anti-infective products in ...€¦ · • q4 2017 –proof of concept...
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Anti-InfectiveSolutions
Leading Development of Novel Anti-Infective Products in the Era of Increasing Bacterial Resistance
October 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 BerkeleyHeights,NJ
Employees 15
CommonStockO/S 62.0Million
Pref/CSEquivalents 6.0Million
WarrantsOutstanding 23.2Million
Cash(atJune30,2017) $18.8 Million
Debt $0
RecentSharePrice $0.60
RecentMarketCap $37.2million
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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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CorMedixStrategy– Buildon3CoreDrivers
Foundation
• Ensurefavorablefinancing• Quicklycompletethe
registrationstudiesforNeutrolin intheUS&submitforNDAapproval
• SuccessfullyachieveNeutrolin FDAapprovalforHD&oncology
• SuccessfullylaunchNeutrolin intheUS/P4studiesforICUandTPN
Partnerships
• BringclosuretotheEuropelegalcases
• Neutrolin:FortheROW,findcapablepartnerstocommercializeinallkeymarkets
• Continuetoimprovethesupplychainandreducingcostofgoods
Leverage
• LeveragetaurolidinetechnologyviathemedicaldevicepathwaycoupledwithastrongIPposition
• ExploreTaurolidineincombinationwithchemotherapeuticagentsinorphanoncologicindications
Createvalueforpatients,theirfamiliesandsocietyatlarge
Createvalueforshareholdersandemployees
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• LeadU.S.productcandidateNeutrolin®inPhase3clinicaldevelopment*• Q42017:Interimreview- Efficacy• Q22018:Completepatientenrollment• 2H2018:Reporttop-linedata
• Unlockingadditionalvaluebyleveragingtaurolidineplatform• Q42017:invivoproof-of-conceptdataforvariousmedicaldeviceapplications• Q12018:invivoproof-of-conceptdataforoncology:pediatricneuroblastoma
*Milestones dependent on achieving the requisite number of CRBSI events
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.
• Significant cost to the healthcare system
• 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 - Efficacy• 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
*Dependent on achieving the requisite number of CRBSI events
10.5yearsPotentialMarket
Exclusivity
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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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• Partnershipmodel– CountryorRegional• TerritoriesthatrecognizeCEMark• Idealcommercialpartners
• Provencapabilitiesandinfrastructure• EstablishedpresencewithNeutrolincustomerbase
StrategyforEx-U.S.CommercializationofNeutrolin®
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• Germany• France• Greece• TheNetherlands• SaudiArabia
• UnitedArabEmirates• Qatar• Kuwait• Israel• Lebanon
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ExpandingtheTaurolidineFranchise
NeuroblastomaSynergywithVincristine
IncreasedEfficacyLowerToxicity
OsteosarcomaSynergywithVincristine
IncreasedEfficacyLowerToxicity
DrugOpportunities
TopicalHydrogelsBurnsandWoundsDiabeticFootUlcersBiofilmPrevention
SuturesProtectssurgicalsitesfrominfection
MeshesHerniaRepair
WoundManagementBurns
MedicalDevice
Opportunities
AdvancedNanoparticleHydrogelsSevereBurnInjury
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Anti-tumorPropertiesReportedinLiterature• Broadlyactiveagainstmanydiversetumor types
• Enhancesoxidativestress(ROS)selectivelyintumorcells• Canbeattenuatedwithglutathione;taurolidinemayinterferewithglutathione-s-transferase1
• Inducesapoptosis,necroptosisandautophagy;InhibitsVEGF-inducedangiogenesis
• Highselectivityfortumorcellsvsnon-cancercellsinvitro• Reducedcytotoxicityinnon-cancerousversuscancerouscelllines
• Reducesinflammation,especiallyperi-operatively• Mediatedbycytokines:IL-1,IL-6andTNF
• Abilitytoshowdrugsynergyincombinationstudies
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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
Approximately40millionproceduresEachyearwithantimicrobialsutures
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
NextSteps- Timelines• H1,2018– Preparedataforpotential510(k)andCEMark• H2,2018– 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- Efficacy• Q22018:Completepatientenrollment• 2H2018:Reporttop-linedata
• Unlockingadditionalvaluebyleveragingtaurolidineplatform• Q42017:invivoproof-of-conceptdataforvariousmedicaldeviceapplications• Q12018:invivoproof-of-conceptdataforoncology:pediatricneuroblastoma
*Milestones dependent on achieving the requisite number of CRBSI events
SummaryandNear-TermMilestones
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400 Connell Drive, 5th FloorSuite 5000Berkeley Heights, NJ 07922
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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