© 2019 Novaliq 1

Breaking the Vicious Circle of Dry Eye DiseaseBernhard Guenther, Founder & President Novaliq Inc.

OIS@SECO | Feb 21th 2019, New Orleans

© 2019 Novaliq 2

Challenge water-based drug deliveryOnly 1-10% of a water-based topical eye medication reachestarget tissue

First and only water-free technology – EyeSol®Technology is clinically validated, safe and well accepted

EyeSol® unlocks the full potential of APIs for drug treatmentsPipeline addresses all key indications in Ophthalmology

NOV03 and CyclASol® have potential to redefine current DED treatmentsBoth programs well positioned to generate two NDA submissions by 2021

Novaliq is Transforming Ocular Therapeutics

© 2019 Novaliq 3

EyeSol® Technology – First and Only Water-free Drug Delivery Technology

1) ARVO 2018, Poster: Ocular and Systemic Distribution of 14C-Perfluorohexyloctane following Topical Ocular Administration to Rabbits2) Agarwal et al.; Semifluorinated alkane based systems for enhanced corneal penetration of poorly soluble drugs; IntJPharm 2018; 538:119-129

© 2019 Novaliq 4

Pathogenesis-driven Dry Eye Disease Clinical PhenotypesOcular Surface Damage and Tear Film Instability impair Visual Function

aqueous deficient

evaporative

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• Aqueous deficient DED− Early onset of action − Sustained efficacy on ocular surface healing− High responder rates− Impact on visual symptoms

• Critical Mode-of-Action in DED − Immunomodulator & anti-inflammatory

• Outstanding tolerability & safety profile

• Evaporative DED associated with MGD− Impressive effect on a variety of symptoms− Early onset of action − Treats signs and symptoms of DED

• Unique Mode-of-Action− Stabilizes lipid layer for hours− Penetrates meibomian glands

• Outstanding tolerability & safety profile

Two Late-Stage Drug Candidates in Dry Eye – Breaking the Vicious Circle of DED

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Recent Randomized Double Masked Controlled US Trials

ESSENCE: 328 patients pivotal US trial Predominantly aqueous deficient DED

• Low Schirmer: ~5 mm• Significant corneal damage

• Central cornea involved• Symptomatic, OSDI: ~45

SEECASE: 336 patients phase 2 US trial Predominantly evaporative DED associated with Meibomian Gland Dysfunction (MGD)

• Low TBUT: ~ 3 sec• MGD involvement

• Normal Schirmer: ~15 mm• Highly symptomatic, OSDI: ~55 • Mild to moderate corneal damage

© 2019 Novaliq 7

NOV03 – Clinically Significant Improvements in Signs and Symptoms of DED

SEECASE trial met its prespecified primary sign endpoints at 8 weeksHighly clinically relevant improvements in various symptoms over active control

Severely symptomatic population characterized by MGD and low TFBUT

tCFS scale ranges from 0 to 15; tCFS graph relates to „study eyes“; error bars show standard error of the mean (SEM); VAS scales ranges from 0 to 100, p-values relate to two sided testing

© 2019 Novaliq 8

CyclASol® 0.1% – Clinical Significant Improvement in Sign and Symptoms

Significant symptom improvements at primary endpoint

Onset of effect as early as 2 weeks and sustained over trial duration

tCFS scale ranges from 0 to 15; tCFS graph relates to „study eyes“; error bars show standard error of the mean (SEM); VAS scales ranges from 0 to 100, p-values relate to two sided testing

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Highly significant and clinical meaningful benefit in majority of patients

High responder rates on cornea and conjunctiva

CyclASol® 0.1% – Majority of Patients Benefit from Treatment

all graphs relate to „study eyes“, scales are cCFS: 0-3, tCFS: 0-15, conjunctival: 0-10, p-values relate to Fisher‘s exact test

p=0.004 p=0.03 p=0.03

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Dry Eye Disease Impacts Visual FunctionImprovement in Corneal Fluorescein Staining is associated with improvements in visual function

ESSENCE data show response in tCFS resulted in a clinically relevant improvement in reading speed (>10 words per minute)

*p=0.049

p=0.296

***p=0.0009

tCFS response was defined as ≥ 3 scores (NEI scale) improvement from baseline

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CyclASol® 0.1% – Fastest Onset of Action with Excellent Tolerability

Instillation site irritation (burning) in % of patients (meta-analysis)0 5 10 15 20 25 30

2%

2.5%

Onset of action defined as primary sign improvement statistically superior to vehicle(in months)

0 1 2 5 7643

CYS-0020.05% (N=51)

0.1% (N=51)

ESSENCE (CYS-003)0.1% (N=162)

2%

CYS-002ESSENCE (CYS-003)

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Novaliq DED Rx Portfolio Has Ability to Redefine DED Therapy

SEECASE (NOV03) and ESSENCE (CyclASol® 0.1%) provide novelties in DED therapy in two distinct patient groups

1) Outcomes for both studies are clinically relevant

2) Both products have the potential to treat more patients for better treatment outcomes:

• NOV03 for treating evaporative DED associated with Meibomian Gland Dysfunction

• CyclASol® is intended for treating predominantly aqueous deficient DED

3) Both products show an unprecedented risk - benefit profile

Novaliq intends to accelerate both development programs for NDA submission in 2021

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Novaliq’s Clinical Pipeline

Product/Program Indication Disc. Pre-clinic Phase I Phase II Phase III Reg. Market Near-term milestonesCyclASol® (cyclosporin)

Rx Dry Eye aqueous deficient

3Q2019: FPFV 2nd Phase 3NDA submission 2021

NOV03(perfluorohexyloctane)

Rx Dry Eye evaporative, MGD*

4Q2019: FPFV final Phase 3NDA submission 2021

NOV07(cannabinoid)

Rx Dry Eyeocular pain Prepare for clinical phase

Dry Eye Disease Product Family

Glaucoma & Retina Development Programs

Product/Program Indication Disc. Pre-clinic Phase I Phase II Phase III Reg. Market Near-term milestones

NOV04 Rx Glaucoma(topical)

License-out and develop a glaucoma asset in the USA

NOV05(Tacrolimus)

Non infectious anterior Uveitis (topical) Ready for pre-IND meeting

NOV06(sustained release)

Rx Retinal Diseases (Back of the Eye, IVI) Sustained release of IVI

„ESSENCE“ US trial, 328 patients

Successful pre-IND, Dec 2017

„SEECASE“ US trial, 336 patients

* MGD = Meibomian Gland Dysfunction

Successful proof-of-principle studies in dogs completed

Safety of in vitreous and protein stability/activity demonstrated

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Your Contacts

Bernhard Günther, Founder & President Novaliq Inc.+1-617-580-1721bguenther@novaliq.com

Novaliq Inc., Harvard SquareOne Mifflin Place, Suite 400Cambridge, MA 02138, USAwww.novaliq.com