July 2016 Corporate Presentation
`
`DAVID P. SOUTHWELL, President and CEO
`Cantor Fitzgerald 2nd Annual Health Care Conference
`
`Exhibit 1061
`ARGENTUM
`IPR2017-01053
`
`000001
`
`

`

`Forward Looking Statements
`
`This presentation contains forward-looking statements that are based on
`our management’s belief and assumptions and on information currently
`available to our management. Although we believe that the expectations
`reflected in these forward-looking statements are reasonable, these
`statements relate to future events or our future financial performance,
`and involve known and unknown risks, uncertainties and other factors
`that may cause our actual results, levels of activity, performance or
`achievements to be materially different from any future results, levels of
`activity, performance or achievements expressed or implied by these
`forward-looking statements.
`
`In some cases, you can identify forward-looking statements by
`terminology such as “may,” “might,” “could,” “would,” “will,” “should,”
`“expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,”
`“project,” “target,” “potential,” “continue” or the negative of these
`terms or other comparable terminology. These statements are only
`predictions. You should not place undue reliance on forward-looking
`statements because they involve known and unknown risks,
`uncertainties and other factors, which are, in some cases, beyond our
`control and which could materially affect results. If one or more of these
`risks or uncertainties occur, or if our underlying assumptions prove to be
`incorrect, actual events or results may vary significantly from those
`implied or projected by the forward-looking statements. No forward-
`looking statement is a guarantee of future performance.
`
`The forward-looking statements in this presentation represent our views
`as of the date of this presentation. We anticipate that subsequent events
`and developments will cause our views to change. However, while we
`may elect to update these forward-looking statements at some point in
`the future, we have no current intention of doing so except to the extent
`required by applicable law. You should therefore not rely on these
`forward-looking statements as representing our views as of any date
`subsequent to the date of this presentation.
`
`All trademarks and registered trademarks are the property of their
`respective owners.
`
`Trabodenoson is an investigational compound and is not yet approved
`by the FDA for any indication.
`
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`Inotek: Transforming Glaucoma Treatment
`
`Trabodenoson: Novel
`adenosine mimetic that
`stimulates a natural pathway
`
`• Glaucoma: *$5.6 billion worldwide market with low
`compliance. 1
`
`1
`Phase 1 Monotherapy showed no
`dose related side effects (ocular or
`systemic) at greater than Phase 3
`doses
`
`2
`Phase 2 Monotherapy showed clear
`dose response, good ocular and
`systemic safety, ability to dose QD or
`BID, additive efficacy to prostaglandins
`
`3
`First Phase 3 Monotherapy,
`MATrX-1, tests QD and BID
`doses against placebo.
`Results 4Q’16
`
`First fixed-dose combination trial to initiate in 2016 | Adenosine A1 activation is neuroprotective in the retina and brain.2-4
`1-3
`
`neuroprotective in the back of the eye
`
`*Source: IMS Health in 2013
`
`00003
`1Schwartz, Quigley, Survey of Ophthalmology, 2008, in press
`
`2Gomes et al. 2011, 3Zhong et al. 2013, 4Cunha 2005
`
`3
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`

`

`Leadership with History Together
`
`David P.
`Southwell, MBA
`President & CEO
`
`Rudolf
`Baumgartner, M.D.
`Chief Medical Officer
`
`William
`McVicar, Ph.D.
`Chief Scientific Officer
`
`Claudine
`Prowse, Ph.D.
`VP Strategy
`
`Cadmus Rich,
`M.D., MBA
`VP Clinical and
`Medical Affairs
`
`4
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`

`

`$2 Billion U.S. Glaucoma Market
`
`Unmet Need: Effective QD treatment with minimal side effects
`
`GLAUCOMA PRESCRIPTION MARKET SHARE
`
`First Line:
`Prostaglandin Analogs
`
`Monotherapy QD Dosing
`IOP Drop from Baseline: 6–8 mmHg*
`
`Ocular Side Effects
`
`• Red eye (hyperemia)
`• Iris discoloration
`• Blurred vision
`• Darkening of the eyelids
`• Adipose tissue shrinkage
`• Eye pain
`
`beta blockers
`(combo)
`14%
`
`Second Line:
`Adjunctive Agents
`
`Monotherapy BID or TID Dosing
`
`Latanoprost
`31%
`
`beta blockers
`(alone)
`14%
`
`49%
`
`alpha agonist
`10%
`
`51%
`
`Travatan
`Travoprost
`10%
`
`carbonic
`anhydrase
`inhibitor
`6%
`
`Other
`5%
`
`Lumigan
`Bimatoprost
`10%
`
`Ocular and Systemic Side Effects
`
`• Severe respiratory and cardiac
`reactions
`• Blurred vision
`• Allergic conjunctivitis
`• Itching (pruritus), burning, stinging
`
`* Per Latanoprost Package Insert Source: Share data represents total prescriptions for IMS Health in 2013
`
`5
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`

`Usually Treated
`>25 mmHg
`
`First Line
`
`Second Line
`
`Co-Administration
`or
`Fixed-Dose
`Combination
`
`IOP Elevation Drives Treatment
`Objective: Normalized Intraocular Pressure (IOP)
`
`Suspected Glaucoma
`>22-25 mmHg
`Medical treatment based
`on associated risk factors
`
`First Line
`“Monotherapy”
`
`Normal IOP
`10-21 mmHg
`Usually not treated without
`serious risk factors
`
`Increasing IOP
`
`High
`
`Medium
`
`Low
`
`Probability of Being Treated
`
`Market Opportunity as First or Second Line
`First Line: IOP Lowering; Safety/Tolerability = Compliance
`Second Line: Additive efficacy to latanoprost; Minimal added side effects, QD dosing
`
`6
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`Trabecular Meshwork:
`The Natural Mechanism for Regulating IOP
`
`70%
`
`Natural pressure
`regulating outflow
`via trabecular
`meshwork
`
`Aqueous
`humor
`production
`
`30%
`
`Secondary
`outflow via
`uveoscleral
`pathway
`
`Trabecular Meshwork
`
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`

`

`Trabodenoson’s Novel Mechanism*
`
`Mechanism:
`
`• Binds to A1 receptors on
`Trabecular Meshwork
`
`• Upregulates MMP-2,
`digesting extracellular matrix
`proteins that clog the TM
`
`• Research supporting
`trabodenoson’s MOA
`presented at the 2016
`American Glaucoma Society
`
`*Increased secretion of MMPs contributes to trabodenoson-induced changes in conventional outflow facility;
`DS Albers, CE Crosson, JS Myers, CC Rich, R Baumgartner, and WK McVicar; American Glaucoma Society Annual Meeting, March 2016, Poster #: PO047
`
`8
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`From Adenosine to Trabodenoson
`Trabodenoson Rational Design
`
`Trabodenoson is an adenosine mimetic optimized
`to selectively target the A1 receptor
`
`Developed by medicinal chemists at Inotek
`
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`

`From Adenosine to Trabodenoson
`Trabodenoson Rational Design
`
`Trabodenoson is an adenosine mimetic optimized
`to selectively target the A1 receptor
`
`Potency
`High affinity for A1 receptor
`
`Selectivity
`Non-target
`receptor interactions
`systematically removed
`
`Trabodenoson bound to A1 receptor
`
`Corneal Penetration
`Lipid solubility = ocular
`penetration
`
`Eye Tissue
`Compatibility
`High compatibility with sensitive
`tissues in front of eye
`
`Compound
`
`Trabodenoson
`
`A1 (Ki, nM)
`
`0.97
`
`A2a (Ki, nM)
`
`4,690
`
`A3 (Ki, nM)
`
`704
`
`10
`
`000010
`
`

`

`Phase 1: Good Safety Profile and Tolerable
`
`Design
`
`Subjects
`
`Cohort
`1
`1-10
`
`Cohort
`2
`11-20
`
`Cohort
`3
`21-30
`
`Cohort
`4
`31-40
`
`Cohort
`5
`41-50
`
`Cohort
`6
`51-60
`
`Cohort
`7
`61-70
`
`Results – No Dose Limiting Toxicity; no dose-
`related ocular or systemic side effects; limited
`systemic exposure at high doses
`
`Journal of Ocular Pharmacology and Therapeutics. April 2016, ahead of
`print. doi: 10.1089/jop.2015.0147. Trial authors; Alan Laties1, Cadmus C.
`Rich2, Randall Stoltz3, Vernon Humbert4, Chaim Brickman2, William
`McVicar2, and Rudolf A. Baumgartner2
`
`11
`
`6,400
`
`3,200
`
`2,400
`
`200
`
`400
`
`800
`
`1,600
`
`7000
`
`6000
`
`5000
`
`4000
`
`3000
`
`2000
`
`1000
`
`0
`
`Trabodenoson mcg
`
`Treatment 14-day
`BID
`
`14-day
`BID
`
`14-day
`BID
`
`14-day
`BID
`
`14-day
`BID
`
`14-day
`BID
`
`Escalating
`SD
`
`BID: Twice Daily | SD: Single Dose
`
`Journal of Ocular Pharmacology and Therapeutics. April 2016, ahead of print. doi:
`10.1089/jop.2015.0147. Trial authors; Alan Laties1, Cadmus C. Rich2, Randall Stoltz3,
`Vernon Humbert4, Chaim Brickman2, William McVicar2, and Rudolf A. Baumgartner2
`
`000011
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`

`No Clinically Significant Safety Signals in Trials to Date
`Phase 1 Comprehensive Safety Assessments included:
`
`• Continuous cardiac monitor
`• 12-lead ECG
`• Orthostatic BP and heart rate
`• Vital signs
`• Blood cardiac troponin I
`• Spirometry – FEV1
`• Blood pharmacokinetic sampling
`• Urine pharmacokinetic sampling
`• Renal biomarkers
`• Karolinska sleepiness scale
`
`• Adverse events
`• Physical examinations
`• Clinical laboratory assessments
`• Toxicology screen
`• Ophthalmology assessments
`– Slit lamp exam/hyperemia
`– Fundus exam
`– Best-corrected visual acuity
`– Intraocular pressure
`
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`

`Monotherapy Phase 2 Results
`Dose-Dependent IOP Reduction, Increases with Treatment Duration
`
`Day 14
`
`Day 28
`
`50 mcg
`
`100 mcg
`
`200 mcg
`
`500 mcg
`
`500 mcg
`
`*
`
`*
`
`*
`
`*
`
`** p=0.016
`
`*
`
`0
`
`-1
`
`-2
`
`-3
`
`-4
`
`-5
`
`-6
`
`-7
`
`IOP Drop SEM (mmHg)
`
`IOP Drop from Diurnal Baseline on Day -1
`
`IOP Drop from Study Baseline on Day 1
`
`*Indicates comparison to placebo group; p-value <0.05
`** p-value refers to Signed Rank test Day 28 versus Day 14
`
`Journal of Ocular Pharmacology and Therapeutics. March 2016, ahead of print. doi:10.1089/jop.2015.0148.
`Trial authors; Jonathan S. Myers1, Kenneth N. Sall2, Harvey DuBiner3, Natanya Slomowitz4, William
`McVicar4, Cadmus C. Rich4 and Rudolf A. Baumgartner4
`
`13
`
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`

`

`Phase 2: IOP Statistically Lowered at All Timepoints on Day 28
`
`FIG. 2. Mean IOP for the trabodenoson 500 mcg and placebo groups before randomization (Day −1)
`and after randomization (Days 14, 28, and 29).
`
`Published in Journal of Ocular Pharmacology and Therapeutics. Ahead of Print
`DOI: 10.1089/jop.2015.0148
`
`14
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`

`MATrX-1 Phase 3 Trial Design
`
`Identical population to Phase 2
`• IOP >24 mmHg
`• ~ 360 patients treated for 12 weeks
`Three trabodenoson doses:
`• 1000 mcg QD
`• 2000 mcg QD
`• 1500 mcg BID
`Placebo controlled
`• Statistical comparator
`Timolol 0.5% BID
`• Internal control
`• Not part of statistical
`comparison
`
`Screening
`Period
`
`1 to 14
`Days
`
`ClinicalTrials.gov Identifier: NCT02565173
`
`*Endpoint.
`
`Trabodenoson 1000 mcg (3.0%) QD OU
`
`Trabodenoson 2000 mcg (6.0%) QD OU
`
`Placebo
`
`BID
`
`Trabodenoson 1500 mcg (4.5%) BID OU
`
`No Ocular
`
`Treatment
`
`Timolol BID OU
`
`Placebo BID OU
`
`Day 28*
`
`Day 42*
`
`Day 84*
`
`Washout
`Period
`
`1 to 39
`Days
`
`Run-in
`Period
`
`5 to 9
`Days
`
`3 Month Treatment Period
`
`Day 1 to Day 84 AM
`
`Observation
`Period
`
`7
`Days
`
`15
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`

`Additional Phase 3 Trials
`
`MATrX-2
`• Similar design as MATrX-1
`
`Long-Term Safety Trial
`• Primary endpoint = safety
`
`• Optimized dose to be selected from MATrX-1
`
`• Greater IOP range
`
`• Large sample size
`
`• At least 300 patients treated for at least
`6 months, and 100 patients for at least
`12 months
`
`Phase 3 Program
`Optimized for Success:
`
`• Similar patient population to Phase 2
`• Primary endpoint versus placebo
`• Higher doses than in Phase 2
`– Below the maximum dose tested in Phase 1
`
`16
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`

`Path to Approval for Fixed-Dose Combination (FDC)
`
`• Latanoprost efficacy and hyperemia are
`dose-related
`Latanoprost IOP
`Reduction
`
`Latanoprost
`Hyperemia
`
`Hyperemia Rate (%)
`
`IOP Drop from BL (mmHg)
`
`• U.S. Regulatory Requirements:
`– Each individual active component adds to
`efficacy
`– FDA determination of FDC benefit/risk profile
`• Objectives:
`– Phase 2 optimizes dose for Phase 3
`– Differentiated on efficacy and safety
`
`Raber, Mandema, Li, Nickens, 2015, J. Ocul. Pharmacol. Ther.
`
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`

`FDC Trial Progress
`
`Phase 2 trial of trabodenoson co-administered with latanoprost – completed
`• Additive efficacy to latanoprost in PGA poor-responders
`
`Phase 2 dose-ranging trial to begin in 2016 – top line data in 2017
`• Determine optimal combination of trabodenoson and latanoprost
`
`Phase 3 program to commence following Phase 2
`
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`

`Back of Eye: Potential for Orphan Indications
`
`Optic Neuropathies and Degenerative Retinal Diseases
`
`• Trabodenoson shows potential
`in treating the back of the eye:
`
`• Preclinical data support effect:
`
`– High Pressure Optic Neuropathy
`Model
`
`– Eye drops shown to deliver drug to
`retina in rabbits and monkeys
`
`• Orphan indications being
`evaluated:
`
`– Retinitis Pigmentosa
`
`– Non-Arteritic Ischemic Optic
`Neuropathy (NAION)
`
`Adenosine receptors in the back of the eye/Retina
`Section through retina
`
`Cells
`
`Retinal Layers
`
`Nerve fiber layer
`
`Ganglion cell layer
`
`Inner plexiform layer
`
`Inner nuclear layer
`
`Outer plexiform layer
`
`Outer nuclear layer
`
`Photoreceptor layer
`
`Pigment epthelium
`
`Inner limiting membrane
`
`Axons at surface of retina passing
`via optic nerve, chiasm, and tract
`to lateral geniculate body
`
`Ganglion cell
`
`Müller cell (supporting glial cell)
`
`Bipolar cell
`
`Amarcine cell
`
`Horizontal cell
`
`Rod
`
`Cone
`
`Pigment cells of choroid
`
`A1
`
`A1 Receptors
`
`19
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`

`

`Inotek Value Drivers
`
`2015
`
` End-of Phase 2
`Meeting
` Phase 3 MATrX-1
`Initiation
`
`2016
`
`2017
`
`2018
`
` Presented at
`Glaucoma 360
` Presented Preclinical
`Research at AGS
` Presented at GTC BIO
` ARVO Poster
`Presentations
` Publication of Phase
`1/2 Clinical Data
`• Initiation of FDC Dose
`Ranging Trial
`• Presenting at OIS
`• Top-Line Phase 3
`MATrX-1 Results
`
`• Initiation of Phase 3
`MATrX-2
`• Initiation of
`Monotherapy Long-
`Term Safety Trial
`• FDC Dose Ranging
`Results
`
`• Results of
`Neuroprotection Clinical
`PoP Trial
`• Initiation of FDC Phase 3
`Trial
`• Phase 3 MATrX-2 Results
`• Monotherapy NDA
`Submission
`
`20
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`

`Thankyou
`
`Thank you
`
`000021
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`PHARMACEUTICALS
`
`TEK
`
`./
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`000021
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