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© 2016 Novaliq, confidential 1
Ophthalmology Innovation Summit
13th October 2016Bernhard Günther, Co-Founder & CEO
© 2016 Novaliq, confidential 2
Innovation in Artificial Tears: NovaTears®/EvoTears®• EvoTears® first-in-class artificial tears product addressing the lipid layer of the tearfilm• 1 year post launch experience in Europe; approval path for US, JP
Innovation in Technology• EyeSol® - a versatile platform technology for the front of and intraocular eye applications• A platform for collaboration
Novaliq´s pipeline• CyclASol® and NovaTears® Omega 3• Upcoming developments for glaucoma and retina
Overview
© 2016 Novaliq, confidential 3
• Water-free, preservation free, amphiphilic eye lubricant for stabilization of the lipid layer• Excellent spreading, small drops (10µl) , silky feeling, no blurring • Prevents evaporation, supports oxygenation of the cornea, same refractive index as water
Innovation in Tears: NovaTears®/EvoTears®A New Lubricant for the Lipid Layer of the Tear Film
Aqueous-deficient
Evaporative
© 2016 Novaliq, confidential 4
NovaTears®/EvoTears®Successful Market Entry in Europe
Successful market launch in 10 EU countries; partnering opportunities for other geographic regions
Priced at 19.95€ ($23.44) per bottle in the pharmacy, mid 6-digit units sold in y1
EU market entry in October 2015 under brand name “EvoTears®” (www.evotears.com)
European Partnership Agreement with Ursapharm, one of the leading EU ophthalmic players
© 2016 Novaliq, confidential 5
3 Different Populations• Mild to Moderate Evaporative DED• Meibomian Gland Dysfunction• Severe DED due to oGvHD
Results• NT-001 & -002: significant
improvement in signs and symptoms
• NT-003: oGvHD - no added benefit, but excellent safety
Safety• No SAEs • Only 8 AEs : Quickly disappeared
after stopping treatment • Excellent safety and tolerability
Data (N=127) from three Prospective, Multicenter, Non-interventional Studies
© 2016 Novaliq, confidential 6
EvoTears® in Europe One Year Post Launch Buyer’s satisfaction: a 5 star product*
• Sehr gute Augentropfen!
• 1 von 1 Kunden fanden die folgende Meinung hilfreich. Christine Müller schreibt am 07.09.2016
• gutes Produkt
• 3 von 3 Kunden fanden die folgende Meinung hilfreich. Petra Tietz schreibt am 07.09.2016
• Augentropfen die wirklich helfen
• 5 von 5 Kunden fanden die folgende Meinung hilfreich. monilein97 schreibt am 02.06.2016
• eine gute Entwicklung !
• 10 von 13 Kunden fanden die folgende Meinung hilfreich. Rezensentin/Rezensent schreibt am 22.02.2016
• Das Beste!
• 25 von 28 Kunden fanden die folgende Meinung hilfreich. Rezensentin/Rezensent schreibt am 02.12.2015
*https://www.medpex.de/testbericht/trockene-augen-augen-ohren/evotears-augentropfen-p11213615/
Broadly recommended evaporative DED (NT-001) Meibomian Gland Dysfunction (NT-
002) For anterior and posterior blepharitis
(NT-002)
Future potential (clin. Studies started)• After cataract surgery • With 1-day contact lenses • After LASIK
KOL – study ophthalmologist• “Nearly all patients asked to stay on
NovaTears® treatment after the study“
• “We should consider NovaTears® as THE new standard therapy for evaporative Dry Eye Disease”
© 2016 Novaliq, confidential 7
NovaTears®/EvoTears®: US, JP and ROW
Registration & Approval as
Medical DeviceClinical Studies Post Launch / MarketingLaunch JP
2018
Phase IIRegistration &
Approval as RX-Product
Post Launch / Marketing
Launch US 2021
ClinicalResarch & Preclinic
Registration&
Approval
Launch EU
Post Launch/Marketing
Phase III
2015 2016 2017 2018 2019 2020 20212015 2016 2017 2018 2019 2020 2021
Development NovaTears®
Omega 3
Registration & Approval
2017
Post Launch / Marketing NovaTears® extension of product familyLaunch 2018
© 2016 Novaliq, confidential 8
Semifluorinated Alkane Eye Drops for Treatment of Dry Eye Disease - A Prospective, Multicenter Noninterventional StudySteven et al.
J Ocul Pharmacol Ther. 2015 Oct;31(8):498-503
NovaTears® as new Therapy in Dry Eye. Results from three prospective, multicenter, non-interventional studies in different patient populationsKaercher T.1, Steven P.2, Messmer E.M.3, Beckert M.4, Krösser S.5Poster: TFOS, Montpellier Sep 2016
Semifluorierte Alkane als Therapie bei Meibomdrüsen-DysfunktionErgebnisse einer prospektiven, multizentrischen BeobachtungsstudieMessmer E.M.1, Kaercher T.2, Kunert K.S.3, Schrems W.4, Menzel-Severing J.4, Schrage N.5,Augustin A.J.6, Dacheva I.7, Geerling G.8, Krösser S.9, Beckert M.10, Poster: German Ophthalmologic Society; Berlin Oct 2016
Peer Reviewed Scientific Publications on NovaTears®/EvoTears®:
© 2016 Novaliq, confidential 9
Innovation in Technology: EyeSol® Delivers Solutions to Key Ophthalmic Challenges
1. Innovative formulations of poorly soluble drugs
Direct and clear solutions
Suspension
2. Improved Penetration
3. Higher stability and activity
Stable in EyeSol® formulation
Inactive in standard
formulation
Therapeutic protein at 50°C
© 2016 Novaliq, confidential 10
Rx - CyclASol® is Currently Being Tested in Phase 2
Timeline
Phase 2 study designDesign:• 4 arm randomized parallel
double masked vehicle controlled study with two doses of CyclASol® and open label comparator arm
• N= 50/arm • 2 weeks run-in, 4 month
treatment
Timeline for results • Headline data Q1 2017
available• Significant value inflection
point
Screening andRun-in with Systane® Balance2 weeks
CyclASol® 0.05 % BID 4 month N=50
Placebo to CyclASol® BID 4 month N=50
Restasis® BID 4 month N=50
V 1
CyclASol® 0.1 % BID 4 month N=50
Visit 0 V 2 V 3 V 4 V 5
PlanningClinical FPFV-LPLV
Top Line Data
CSR Start Preparation
Phase 3
End of Phase 2 Meeting
© 2016 Novaliq, confidential 11
Omega 3 Fatty Acids:• Stabilize the lipid film• Demonstrate an anti-inflammatory effect• Unstable in water based systems and under air
The product:• Clear solution of 2mg/ml Omega-3 oil in an EyeSol® formulation• Preservative free multidose units • 1 month in-use and so far 12 month stability at ambient conditions (study on-going)• Commercial supply chain established
Regulatory:• Registration as medical device ongoing in Europe• Expected launch in Europe Q4/2017
NovaTears® + Omega-3: A Long-term Stable Omega-3 Eye Drop Formulation for Treatment of Evaporative Dry Eye Disease
© 2016 Novaliq, confidential 12
OTC/CE
Novaliq’s Pipeline Addresses Key Indications in Ophthalmology
Product
EvoTears® (EU)
NovaTears® & Omega3 (EU)
NovaTears® (JP)
Dry Eye evaporative
Dry Eye moderate
Dry Eye evaporative
Rx
Product/Program
CyclASol®
Nov-03 (NovaTears®) (US)
Nov-04
Dry Eye moderate – severe
Dry Eye (evaporative,MGD)
Glaucoma
Nov-05
Nov-06
Retinal Diseases
Retinal Diseases
Research MarketRegistration(Clinical Study)
Research MarketAppro-val
Indication
Pre-clinic Phase I Phase II Phase III
© 2016 Novaliq, confidential 13
Novaliq Summary
• Innovative technology platform
• First OTC product successful in the $2bn Artificial Tears Market
• Advanced Phase 2 Study for Dry Eye underway • Pharma collaborations via EyeSol® licensing
© 2016 Novaliq, confidential 14
Your contacts
Bernhard Günther+49 [email protected]
Novaliq GmbHIm Neuenheimer Feld 51569120 HeidelbergGermanywww.novaliq.com
Dr. Frank Löscher+49 [email protected]. Hartmut Voss+49 [email protected]
Dr. Oliver Schlüter+49 [email protected]
Dr. Christian Roesky+49 [email protected]
© 2016 Novaliq, confidential 15
