Novaliq
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Transcript of Novaliq
![Page 1: Novaliq](https://reader031.fdocument.pub/reader031/viewer/2022030304/58784ef31a28ab68198b5ffb/html5/thumbnails/1.jpg)
!
Bernhard!Guenther!CEO!
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Novaliq GmbH 2
Transforming!Poorly!Soluble!Drugs!!Into!Effec?ve!Therapeu?cs!!
For!Major!Ophthalmic!Markets!!
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Novaliq GmbH 3
Value&Proposi-on&&
• 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!
BUSINESS!MODEL!
• 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!
INNOVATION!–!!Semi!Fluorinated!Alkanes!(SFA’s)!
• 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!!
BESTTINTCLASS!PRODUCTS!
WELL!FUNDED!&!EXPERIENCED!TEAM!
• Heidelberg,!Germany!Based!Pharmaceu?cal!Company!• Extensive!Ophthalmology!Experience!–!Team!and!Advisory!Board!• $42m!capital!raised!
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Novaliq GmbH 4
Product& Indica-on& Research& Preclinic& Phase&I& Phase&II& Phase&III& Registra-on& Market&
Rx!OTC/CE!
CylASol®! Dry!Eye,!severe!
TacroSol®! Uvei?s/Allergy!
NovT143! Pain,!Cataract!Surgery!
NovaTears®! Dry!Eye,!mild!
SFA/Omega3! Dry!Eye,!moderate!
NovT236! Dry!Eye,!mild!
Research& Registra-on& Market&Clinical&Phase&
Ophthalmic&Pipeline&
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Novaliq GmbH 5
Examples&of&Substances&Directly&Soluble&in&SFAs&
aDTocopherol&(VitaminDE)!
Cyclosporin&
Latanoprost&Tacrolimus&&
Omega&3&
Lidocain&
Poorly&Soluble&Drugs&
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Novaliq GmbH 6
!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!!
Clinical&Data&
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Novaliq GmbH 7
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!!
!
OTC&
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Novaliq GmbH 8
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!
NovaTears®&plus&OmegaD3&&!
!
OTC&
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Novaliq GmbH 9
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!!!
Rx&
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Novaliq GmbH 10
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!!
Stable!in!EyeSol®!formula?on!
Inac?ve!in!standard!formula?on!
Insulin&at&50�C&
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Novaliq GmbH 11
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)!!!!!!!!
direct!and!clear!solu?ons! suspension!
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Novaliq GmbH 12
• 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!!!!!!!
!
Summary&
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Novaliq GmbH 13
Novaliq!GmbH!Bernhard!Guenther!President!&!CEO!Im!Neuenheimer!Feld!515!69120!Heidelberg!
Phone:!+49!6221!50259T0!
Email:[email protected]!
Web:!www.novaliq.de!