Kiora Pharmaceuticals, Inc. · NASDAQ:KPRX
Kiora Pharmaceuticals — Eyegate Pharmaceuticals — Investor Presentation (January 2016)
24 slides from Kiora Pharmaceuticals's investor presentation, Jan 19, 2016
Slide 1: Eyegate Pharmaceuticals Corporate Presentation January 2016
Eyegate Pharmaceuticals, Inc. Providing innovative products that enhance drug efficacy and patient compliance to improve vision Corporate Presentation January 2016
Slide 2: Forward Looking Statements
1 Forward Looking Statements Some of the matters discussed in this presentation contain forward - looking statements that involve significant risks and uncertainties, including statements relating to the prospects for the Company’s lead product EGP - 437, for the timing and outcome of the Company’s
Slide 3: Company Overview
2 Company Overview ▪ Ophthalmology company (NASDAQ: EYEG) ▪ EyeGate ® II Delivery System: non - invasive delivery of therapeutics to front or back of eye ▪ Lead program: EGP - 437 (corticosteroid) delivered by system ▪ Licensed to Valeant Pharmaceuticals (Bausch + Lomb ) ▪ License Agreement for firs
Slide 4: Company Overview: Ophthalmology Drug Delivery Platform
CONFIDENTIAL CONFIDENTIAL 3 Company Overview Ophthalmology: Drug Delivery Platform ▪ Drug: EGP - 437, a corticosteroid (Dexamethasone phosphate) ▪ First indication: non - infectious anterior uveitis ▪ 505(b)(2) NDA pathway ▪ Platform: EyeGate II ® Delivery System ▪ Proprietary, non - invasive delive
Slide 5: Unique Ophthalmic Delivery Platform
4 Unique Ophthalmic Delivery Platform
Slide 6: Ophthalmic Delivery Challenges
Ophthalmic Delivery Challenges Anterior Segment : Eye Drops Posterior Segment: Intravitreal Injections ▪ Protective layer and biological functions limit penetration of drug into tissues ▪ Frequent instillations required ▪ Extreme burden on patient: non - compliance ▪ S ight - threatening complicatio
Slide 7: EyeGate has the only Non-Invasive Solution
6 Edelhauser et al IOVS 2010 EyeGate has the only Non - Invasive Solution EyeGate® II Applicator
Slide 8: EyeGate Platform: Non-Invasive Method of Propelling Charged Compounds
▪ Small electrical current (constant ); current has same charge as active substance (drug) ▪ Electrode creates repulsive electromotive forces (like charges repel) ▪ Drug migrates toward return electrode ▪ Drug mobility is a function of molecular weight and charge ▪ Drug dose controlled by 2 variable
Slide 9: Clinical Pipeline
8 Clinical Pipeline EGP - 437 ▪ Confirmatory Phase 3 anterior uveitis trial ▪ Initiated and top - line data expected Q1 2017 ▪ Macular Edema proof - of - concept trial ▪ First leg completed, second leg top - line data expected by end of Q1 2016 ▪ Cataract Surgery Pilot trial ▪ T op - line data expec
Slide 10: EGP-437 Anti-Inflammatory
9 EGP - 437 Anti - Inflammatory
Slide 11: EGP-437: A Potent Anti-inflammatory Agent; Uveitis Overview
10 EGP - 437: A Potent A nti - inflammatory A gent (corticosteroid - dexamethasone phosphate) Uveitis Overview ▪ Inflammation of uvea tract ▪ E stimated 18% experience transient or permanent loss of vision annually. ▪ Responsible for more than 2.8% of blindness in the U.S. ▪ Non - infectious anterio
Slide 12: Initial Phase 3 Non-Inferiority Anterior Uveitis Trial Severity and Primary Endpoint
Initial Phase 3 Non - Inferiority A nterior U veitis Trial Severity and Primary Endpoint 11 Severity of Uveitis: SUN Working Group ▪ Severity determined by number of white blood cells in the anterior chamber of the eye (Slit - lamp is used) ▪ Grading scheme for determining degree of inflammation bas
Slide 13: EGP-437: A Highly Differentiated Product
S tandard of care: corticosteroid eye drops • First pivotal Phase 3 trial: 2 EyeGate treatments vs 154 eye drop treatments EGP - 437: A Highly Differentiated Product Dramatically Reduces Patient Burden from 154 to 2 or 3 Treatments 12
Slide 14: Initial Phase 3 Trial Design and High-Level Results
▪ Successfully demonstrated same response rate when comparing EGP - 437 to standard of care ( prednisolone acetate 1 %) ▪ Lower incidence of increased intraocular pressure (IOP ) with EGP - 437 treatment Initial Phase 3 Non - Inferiority Anterior Uveitis Trial Trial Design and High - Level Results 1
Slide 15: Similar Outcome to Standard-of-Care
Similar Outcome to Standard - of - Care 14 Percent of subjects* that achieved primary endpoint (PEP) *ITT = Intent to Treat 43.2% 25.0% 41.4% 20.5% 0% 5% 10% 15% 20% 25% 30% 35% 40% 45% 50% SUN 1 & 2: 11 to 25 cells SUN 3 & 4: > 26 cells Percent that Achieved PEP Ratio that Achieved PEP per Arm EGP
Slide 16: Safety: Intraocular Pressure
15 Safety: Intraocular Pressure ▪ Each subject had four IOP measurements (Day 7, 14, 28, and 56) compared to baseline (Day 0 ) ▪ Significantly less subjects with incidents in the EGP - 437 arm ▪ 2.4X the number of incidents in the standard - of - care control arm
Slide 17: Anterior Uveitis: Confirmatory Pivotal Phase 3 Trial Design
16 Visit 1 Day 0 Visit 3 Day 9 Visit 4 Day 14 Visit 5 Day 28 Visit 6 Day 56 154 Pred Acet eye drop installations 154 Placebo eye drop installations follow - up period follow - up period 1 st Treatment Iontophoresis w/ EGP - 437 or w/Placebo Primary endpoint proportion of patients w/ ACC count = 0 2
Slide 18: Macular Edema Trial Design
▪ Abnormal thickening of macula associated with accumulation of excess fluid in extracellular space of neurosensory retina ▪ Considered leading cause of central vision loss in developed world ▪ Phase 1b / 2a clinical trial: First Leg ▪ Up to 20 patients with macular edema associated with Retinal Vei
Slide 19: Macular Edema Results
▪ Proof of concept trial confirms that iontophoresis can non - invasively deliver efficacious quantities of drug to back of eye ▪ Efficacy : one - third of subjects responded • Pseudophakic eyes responded better than phakic eyes • Positive response from all subtypes (DME, RVO and CME ) ▪ Excellent S
Slide 20: Licensing Agreement
19 ▪ Valeant Pharmaceuticals – Bausch + Lomb (NYSE/TSX : VRX) ▪ Exclusive license to manufacture, sell, distribute and commercialize throughout the world for use in field of uveitis • Upfront cash payment and milestone payments • Royalties based on net sales : high single digits ▪ EyeGate responsibl
Slide 21: Single-Use Kit and Reimbursement
20 ▪ Combines drug vial and device disposables: • Ensures use of approved drug with applicator ▪ Shelf - life established at 24 months (drug and applicator) ▪ CPT Code: In addition to office reimbursement, reimbursement for performing treatment ▪ J - code: The kit (drug + disposables) will be billed
Slide 22: Strong Patent Portfolio
21 Strong Patent P ortfolio Ten families (73 patents granted) ▪ Eight belong to delivery system patent portfolio • 13 U.S. and 58 foreign patents granted • 3 U.S. and 16 foreign pending applications ▪ Two relate to drug compositions and treatments utilizing delivery system: • 1 U.S. and 1 foreign pa
Slide 23: Evolution of a Platform: At Home Version
22 ▪ Objective: In Vivo (rabbits) proof - of - concept by end of Q1 2016 ▪ Stage 1: Screening ▪ The effect of specific parameters determined • polymer charge and composition • p olymer drug loading and drug release ▪ Stage 2: Testing In Vivo - on the Eye ▪ Demonstrate results of a loaded lens design
Slide 24: Investment Highlights
23 Investment Highlights ▪ Licensing deal signed with Valeant ▪ Exclusive, worldwide commercial and manufacturing rights for uveitis ▪ Upfront cash payment, milestone payments and royalties ▪ Phase 3 program with clear path to commercialization ▪ Confirmatory pivotal Phase 3 trial initiated ▪ Potent
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