! Bernhard!Guenther!CEO! Transforming!Poorly!Soluble!Drugs!! Into!Effec?ve!Therapeu?cs!! For!Major!Ophthalmic!Markets!! Novaliq GmbH 2 Value&Proposi-on&& Semi!Fluorinated!Alkanes! (SFA’s)! • Unique!excipient!that!increases!solubility,!stability!and!penetra?on!of! poorly!soluble!drugs! • Mul?!dose,!preserva?ve!free,!nonTirrita?ng! • Strong!Global!IP!posi?on! BUSINESS!MODEL! • OTC:!Innova?ve!ar?ficial!tears!based!on!SFAs!! • RX:!!Internal!development!–!poorly!soluble!APIs!–!new!therapeu?cs!!! • Drug!delivery!partnerships!for!pharma’s!proprietary!NCEs! BESTTINTCLASS! PRODUCTS! • OTC:!NovaTears®!(CE!mark)!–!NovaTears!Omega!3!(CE!mark!2015)!! • Rx:!!Phase!2!ready:!CyclASol®!and!TacroSol®!! • Excellent!human!data!for!OTC!and!Rx!products!! WELL!FUNDED!&! EXPERIENCED!TEAM! • Heidelberg,!Germany!Based!Pharmaceu?cal!Company! • Extensive!Ophthalmology!Experience!–!Team!and!Advisory!Board! • $42m!capital!raised! INNOVATION!–!! Novaliq GmbH 3 Ophthalmic&Pipeline& Product& Indica-on& Rx! CylASol®! Dry!Eye,!severe! TacroSol®! Uvei?s/Allergy! NovT143! Pain,!Cataract! Surgery! Research& Preclinic& Research& NovaTears®! Phase&I& Phase&II& Phase&III& Registra-on& Market& Clinical&Phase& Registra-on& Market& Dry!Eye,!mild! OTC/CE! SFA/Omega3! Dry!Eye,!moderate! NovT236! Novaliq GmbH Dry!Eye,!mild! 4 Poorly&Soluble&Drugs& Examples&of&Substances&Directly&Soluble&in&SFAs& Latanoprost& Tacrolimus&& aDTocopherol& (VitaminDE)! Cyclosporin& Omega&3& Lidocain& Novaliq GmbH 5 Clinical&Data& • • • • Novaliq GmbH ! CyclASol®!Phase!I!Study! ! No!Burning! No!S?nging! Excellent!Tolerability! No!Systemic!Exposure! ! NovaTears®!Observa?onal!Study! ! • Non!Aqueous! • Preserva?veTFree! • No!Blurring! • Superior!Weeng! • Excellent!Safety!and!Efficacy!! 6 OTC& Posi-ve&Results&from&NovaTears®&Observa-onal&Study&in&Mild&to&Moderate& Evapora-ve&Dry&Eye&Disease&(DED)& ! • The!company's!first!ophthalmic!OTC!product!T!CE!Mark! !! • Human!Data:!Observa?onal!Study!NTT001!with!NovaTears®OTC!eye!drops!successfully! completed!in!July!2014:!!excellent!clinical!performance!and!safety!in!pa?ents!with! hyperTevapora?ve!dry!eye!disease:! ! ! Increases!tear!fluid!produc?on! ! Prolongs!tear!film!stability!(TFBUT)! ! Reduces!objec?ve!(corneal!staining)!and!subjec?ve!signs!and!! symptoms!of!DED! Novaliq GmbH 7 OTC& NovaTears®&plus&OmegaD3&& ! Background& ! • OmegaT3!fajy!acids!are!currently!used!systemically!(capsules)!! • Stabiliza?on!of!the!lipid!film!with!OmegaT3!fajy!acids! & Formula-on& • Clear!solu?on!! • Preserva?ve!free!mul?Tdose!units,!! • No!irrita?ng!excipients!(e.g.!surfactants)!required! • 12!Month!stable!at!40 C/75! & Status! • CETmark!registra?on!expected!in!EU!for!Q1/2015! • Partnered!with!leading!EU!ophthalmic!player,!EU!market!entry!2016! • Available!for!partnering!outside!EU! Novaliq GmbH 8 Rx& Posi-ve&Results&From&CyclASol®&(CsA&solu-on)&Eye&Drops&Repeated&and& Ascending&Dose&Phase&1&Study:& ! • CyclASol®!(CsA!0,05%!solu?on!formula?on!in!the!semiTfluorinated!alkane!vehicle!F4H5)!! eye!drops!are!safe!and!well!tolerated!! ! • CyclASol®!is!the!first!and!only!clear!solu?on!based!eye!drop!formula?on!in!clinical!development!for! pa?ents!with!dry!eye!disease!! ! ! Available!in!preserva?veTfree!mul?Tdose!bojles! ! Excellent!spreading!and!wejability! ! Superior!pharmacokine?cs!and!biocompa?bility!! ! Proven!longTterm!stability!! ! Broad!patent!protec?on!in!major!markets! ! ! Novaliq GmbH 9 Novaliq’s&EyeSol®&PlaRorm&Technology&Allows&Formula-on&and&Stabilisa-on&of& Pep-des&and&Proteins&at&High&Temperatures:&& & • Therapeu?c!pep?des,!proteins!and!monoclonal!an?bodies!show!excellent!stability!and!ac?vity!! Insulin&at&50 C& Stable!in!EyeSol®!formula?on! Inac?ve!in!standard!formula?on! Novaliq GmbH 10 Novaliq&Offers&Access&to&EyeSol®&PlaRorm&Technology&For&Ophthalmic&Drug& Development& & • • • • Combina?on!of!Novaliq’s!EyeSol®!plaqorm!technology!with!pharma’s!proprietary!NCEs! Technology!Access!Fee! Milestone!payments!for!formula?on/stablility,!licensing!op?on! Licensing!agreement!for!clinical!development!(Upfront,!milestones,!royal?es)! ! ! ! ! ! ! ! Novaliq GmbH direct!and!clear!solu?ons! suspension! 11 Summary& • Novaliq!GmbH!offers!a!compelling!and!proven! drug!delivery!opportunity!to!enhance!the! performance!of!topical!eye!drops! ! • A!new!genera?on!of!Rx!and!OTC!products! based!on!unique!and!proprietary!proper?es!of! SFA’s!as!the!delivery!vehicle! ! • Novaliq!welcomes!invita?ons!to!enter!into! discussions!on!development!or!partnership! opportuni?es!!!!!!! Novaliq GmbH 12 Novaliq!GmbH! Bernhard!Guenther! President!&!CEO! Im!Neuenheimer!Feld!515! 69120!Heidelberg! Phone:!+49!6221!50259T0! Email:!info@novaliq.de! Web:!www.novaliq.de! Novaliq GmbH 13
© Copyright 2024