Bernhard!Guenther!CEO! !

!
Bernhard!Guenther!CEO!
Transforming!Poorly!Soluble!Drugs!!
Into!Effec?ve!Therapeu?cs!!
For!Major!Ophthalmic!Markets!!
Novaliq GmbH
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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
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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!
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Poorly&Soluble&Drugs&
Examples&of&Substances&Directly&Soluble&in&SFAs&
Latanoprost&
Tacrolimus&&
aDTocopherol&
(VitaminDE)!
Cyclosporin&
Omega&3&
Lidocain&
Novaliq GmbH
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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!!
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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
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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
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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
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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
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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!
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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
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Novaliq!GmbH!
Bernhard!Guenther!
President!&!CEO!
Im!Neuenheimer!Feld!515!
69120!Heidelberg!
Phone:!+49!6221!50259T0!
Email:[email protected]!
Web:!www.novaliq.de!
Novaliq GmbH
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