Kiora Pharmaceuticals, Inc. · NASDAQ:KPRX
Kiora Pharmaceuticals — Eyegate Pharmaceuticals — Rodman & Renshaw Annual Global Investment Conference 2015
24 slides from Kiora Pharmaceuticals's conference presentation, Sep 8, 2015
Slide 1: Eyegate Pharmaceuticals, Inc.
Eyegate Pharmaceuticals, Inc. Providing innovative products that enhance drug efficacy and patient compliance to improve vision Rodman & Renshaw Annual Global Investment Conference 09 September 2015
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: 2015 Major Milestones Accomplished
2 2015 Major Milestones Accomplished ▪ Licensing Agreement with Valeant Pharmaceuticals ▪ Exclusive , worldwide commercial and manufacturing rights for uveitis ▪ Upfront cash payment, milestone payments and royalties ▪ Valeant responsible for 100% of costs outside U.S. ▪ Positive Guidance from FDA ▪
Slide 4: Company Overview
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, A Non-Invasive Method of Propelling Charged Active 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 ▪ First patient: year - end 2015 and f ully - enrolled: Q4 2016 ▪ Macular Edema proof - of - concept trial ▪ Top - line data: Q4 2015 ▪ Cataract Surgery Phase 2 trial ▪ Exploring opportunity for cataract surgery as additiona
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: EGP-437: A Highly Differentiated Product
S tandard of care: corticosteroid eye drops • Eye drops suffer from number of drawbacks: low ocular bioavailability and rapid clearance EGP - 437: A Highly Differentiated Product Dramatically Reduces Patient Burden from 154 to 3 Treatments 11
Slide 13: Importance of Treatment Regimen
Importance of Treatment Regimen Clinical Case 12 Anterior Uveitis Episode 1994 OD 20/20 OS 20/80 low grade chronic inflammation Same Patient 10 Years Later (2004 ): Poor Anti - Inflammatory Therapeutics OD 20/ 400 Legally Blind OS No Light Perception Blind
Slide 14: Initial Phase Non-Inferiority Anterior Uveitis Trial Severity and Primary Endpoint
Initial Phase 3 Non - Inferiority A nterior U veitis Trial Severity and Primary Endpoint 13 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 15: Initial Phase 3 Non-Inferiority Anterior Uveitis Trial Design and 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 16: Similar Outcome to Standard-of-Care
Similar Outcome to Standard - of - Care 15 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 17: Safety: Intraocular Pressure
16 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 18: Confirmatory Phase 3 Trial Timing
17 ▪ Three major stages to trial 1. Start - up : Clinical supply manufacturing, CRO selection, & site initiations — 5 months 2. Enrollment : First Patient In (FPI) to Last Patient In (LPI) — 10 to 12 months 3. Close - out : Last Patient Out (LPO), Database lock, Top - line data analysis, & clinical
Slide 19: 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 ▪ Up to 20 patients with macular edema associated with Retinal Vein Occlusion
Slide 20: EGP-437: Licensing Agreement
19 ▪ Valeant Pharmaceuticals ( 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 responsible for developme
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
22 ▪ At - home applied by patient ▪ No serviceable parts ▪ Option to customize program with interface and mobile app Generator integrated with return electrode generator Evolution of a Platform: At - Home
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 ▪ First Phase 3 trial completed ▪ Potent drug with prov
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