corporate update presentation: sumatriptan alginate film ......3 an enabling and transformative...

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Corporate Update Presentation: Sumatriptan Alginate Film (KL-00119) June, 2019

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Page 1: Corporate Update Presentation: Sumatriptan Alginate Film ......3 An Enabling and Transformative Technology 1) The alginate film is attached to the oral mucosa 2) Film stays in place

CorporateUpdatePresentation:SumatriptanAlginateFilm(KL-00119)

June,2019

Page 2: Corporate Update Presentation: Sumatriptan Alginate Film ......3 An Enabling and Transformative Technology 1) The alginate film is attached to the oral mucosa 2) Film stays in place

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Agenda

§ Technology Description§ Sumatriptan

Page 3: Corporate Update Presentation: Sumatriptan Alginate Film ......3 An Enabling and Transformative Technology 1) The alginate film is attached to the oral mucosa 2) Film stays in place

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An Enabling and Transformative Technology

1)Thealginatefilmisattachedtotheoralmucosa2)Filmstaysinplacefor10to30minutes3)Thedrugtransfersdirectlyintothebloodstream

Byreplacinginjectionswewillbothenableandtransformthetreatmentinmultipleindications

Filmdoesnotmelt,isnotmixedwithsalivaandswallowedlikeotheroralfilmtechnologies thatclaimtrans-mucosaldeliverybutinfactachieveoraldelivery

DrugsthatarenotorallyavailableandhavetobeinjectedcanbedeliveredwithKlaria’s FilmTechnology

Page 4: Corporate Update Presentation: Sumatriptan Alginate Film ......3 An Enabling and Transformative Technology 1) The alginate film is attached to the oral mucosa 2) Film stays in place

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Features and Benefits of Technology

Simpleandnon-invasive

Consistent,lowvariability

Rapiddeliveryofactivesubstance

Easytomanufacture

Easytostore,ship,handle

Enabling usewhereinjectionisnotfeasibleorapooroption•Example:Naloxonefilmvsinjectionbyhealthcareprofessional•Example:Epinephrinevsinjection

Superior tonasaldelivery• Example:Sumatriptanfilmvsnasalspray

Fasterthanoraldelivery• Example:Sumatriptanfilmvstablet• Example:Cannabinoidfilmvsoraldeliverytechnologies

LowerCOGSthaninjectionsystems,nasalspraydevicesetc.• Example:Adrenalinefilmvsinjection

Broaderusagethaninjectiondevicesorinjections• Example:Adrenalinefilmvsinjection• Example:Naloxonefilmvsinjectionbyhealthcareprofessional

Page 5: Corporate Update Presentation: Sumatriptan Alginate Film ......3 An Enabling and Transformative Technology 1) The alginate film is attached to the oral mucosa 2) Film stays in place

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§ AlginatepolymerextractedfromtheNorthSeabrownalgae(Kelp)

§ Extremelymuco-adhesivewhenformulatedusingourproprietaryprocess

§ Approvedforfoodanddruguseworldwide

§ Patentprotectedworldwide

Natural, Uniquely Efficacious, Approved and Patent Protected

Page 6: Corporate Update Presentation: Sumatriptan Alginate Film ......3 An Enabling and Transformative Technology 1) The alginate film is attached to the oral mucosa 2) Film stays in place

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Strategy to Create Value

• Welldefinedregulatorypathwithlowerrisk,lowercosts,shortertimelinesandhigherapprovalrates

• Createmedicalvaluebyfocusingonprojectsthataddresshighunmetmedicalneedsandwhereinjectionornasalrouteispreferred

• SharebenefitsoflowerCOGS betweenstakeholders,allowingforbothlowerpriceandhighgrossmargins

• Createpricingpowerbyavoidingpharmacysubstitutionwithtablets• Clinicalstudies(ph IIsizestudies)showingsuperiorefficacyand/orsafety• Developdosesthatarebioequivalentbutnotidentical• Establishbioequivalencetonon-oralformulations

CreateCommercialValue

ClaimCommercialValue

CreateMedicalValue

Lower:Risk,Time,Cost

Page 7: Corporate Update Presentation: Sumatriptan Alginate Film ......3 An Enabling and Transformative Technology 1) The alginate film is attached to the oral mucosa 2) Film stays in place

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Agenda

§ Technology Description§ Sumatriptan

Page 8: Corporate Update Presentation: Sumatriptan Alginate Film ......3 An Enabling and Transformative Technology 1) The alginate film is attached to the oral mucosa 2) Film stays in place

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Migraine is Prevalent, Debilitating and Costly

§ Occursin12%ofpopulationinUSandEU§ 85%ofMigrainesufferersarewomen§ 25%ofwomensuffer4ormoreattacks/month§ 90%ofsufferersareunabletofunctionnormally

§ >2.5millionhospitalemergencyroomvisits/yearinUSandEUduetoMigraineAttacks

§ Highsocietalcost§ $70billionperyearinlostproductivityinEUandUS§ $9billionperyearintotaltreatmentcostsinEUandUS

Sources:Migraine ResearchFoundation,TheMigraine Trust,DMKG,InternationalHeadache Society

Page 9: Corporate Update Presentation: Sumatriptan Alginate Film ......3 An Enabling and Transformative Technology 1) The alginate film is attached to the oral mucosa 2) Film stays in place

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80%1,2

ofmigrainepatientssufferfromNausea

79%willingtotryanewacutemedication2

Injectionsareriskyanddistressingtopatients

• Fearofinjection

• Difficulttoadministercorrectly

• Potentialcomplications

à

Under-treatedpatients

Nasaladministrationisapoordeliverymethod

• Highvariabilityinuptakeresultsinvariableefficacy

• Drugfallsthroughnasalcavityresultinginoraldelivery

à

Sub-optimaltreatment

1:BeckerWJ.Headache.2015;55(6):778-793.2:Lipton RB.Headache.199939(Suppl.)S20-S263:Source:Migraine ResearchFoundation

Migraine Patients are Willing to Try a New Medication- Tablet, Nasal and Injection are Poor Options

Page 10: Corporate Update Presentation: Sumatriptan Alginate Film ......3 An Enabling and Transformative Technology 1) The alginate film is attached to the oral mucosa 2) Film stays in place

10 Klaria Confidential

OralTablet

NasalSpray

Injection

Tabletand/orNasalSpray

Suboptimal/under

treatment UnmetMedicalNeed

80%donottoleratetabletduetonausea

NasalAdministrationisvariableandsuffersfrompoorefficacy

Patientsbouncebetweentreatmentoptions,notfinding

relief

Injectionsarepainful,causeunwantedsideeffectsandpatientsfearthem

Large Pool of Migraine Patients Currently Poorly Served

Sub-optimal treatment and under-treatment causes:- Significant patient suffering3

-High societal cost due to lost productivity and co-morbidities3

Page 11: Corporate Update Presentation: Sumatriptan Alginate Film ......3 An Enabling and Transformative Technology 1) The alginate film is attached to the oral mucosa 2) Film stays in place

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Administration to the Vasculature around the Trigeminal Nerves to Achieve Maximum Efficacy

Placement of Film and absorption of Sumatriptan is local on the facial artery which has its terminus in the ophthalmic and maxillary regions of the facewhere migraines originate1, 2

1:Moskowitz,M.A.:Theneurobiologyofvascularheadpain.AnnNeurol1984;16:157–168.2:Goadsby,P.J.:Thepharmacologyofheadache.ProgNeurobiol2000;62:509–525.

Page 12: Corporate Update Presentation: Sumatriptan Alginate Film ......3 An Enabling and Transformative Technology 1) The alginate film is attached to the oral mucosa 2) Film stays in place

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§ TheFilmwillclaimsignificantshareoftablet,nasalandinjectionmarket§ Theoral/tabletmarketislargeandlow-priced§ ThefilmwillbepricedsimilarlytocurrentUSmarketpricesfornasal

spraysandinjections

Sumatriptan Film is a $300+ million peak sales opportunity