Kiora Pharmaceuticals, Inc. · NASDAQ:KPRX
Kiora Pharmaceuticals — Eyegate Pharmaceuticals — Investor Presentation (June 2016)
28 slides from Kiora Pharmaceuticals's investor presentation, Jun 1, 2016
Slide 1: Eyegate Pharmaceuticals Corporate Presentation
Eyegate Pharmaceuticals, Inc. Providing innovative products that enhance drug efficacy and patient compliance to improve vision Corporate Presentation
Slide 2: Forward Looking Statements
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 clinic
Slide 3: Company Overview
Shae, Sa aie Company Overview Ophthalmology company (NASDAQ: EYEG) Two unique and proprietary platforms: + EyeGate® II Delivery System (EGDS): iontophoretic delivery * CMHA-S platform: cross-linked thiolated hyaluronic acid EGP-437/EGDS: NDA submission mid-2017 + Anterior Uveitis: Ongoing Phase 3 co
Slide 4: Clinical Pipeline & Newsflow
ByeGate\ Clinical Pipeline & NewsFlow Anterior Uveitis | + Ewoling confinmstory Phase 3 pivotal tial (Q4 2016: Emoliment completed Q1 2017 Topline data Mid.2017: NDA fling + Enwoling Phase [ba POC tral + QS 2016: Topline data i ' | +3 2016: Initiate follow-on POC trial ' ' ' + Q¢ 2016: Topline data
Slide 5: Ophthalmic Delivery Challenges
= Protective layer and biological functions limit penetration of drug into tissues Ophthalmic Delivery Challenges = Short residency time: frequent instillations required * Extreme burden on patient: non-compliance = Sight-threatening complications Posterior Segment: intravitreal Injections = Potenti
Slide 6: Two Unique Ophthalmic Platforms
Two Unique Ophthalmic Platforms / + / b 4 { {7™\ fect yer" ae, Late) \ oth ee rd th CMHA-S lontophoresis
Slide 7: Iontophoresis Platform: A Non-Invasive Method
lontophoresis Platform: A Non-Invasive Method ByeGate\ of Propelling Charged Active Compounds Into Ocular Tissues ~ ea = Small electrical current (constant); current has same charge as active substance (drug) = Electrode creates repulsive electromotive forces (like charges repel) = Drug migrates tow
Slide 8: EGP-437: A Potent Anti-inflammatory Agent
EGP-437: A Potent Anti-inflammatory Agent — ByeGate\ (corticosteroid - dexamethasone phosphate) ~ y eitis Overview = Inflammation of uvea tract = Estimated 18% experience transient or permanent loss of vision annually. = Incidence in U.S. from approximately 26.6 - 102 per 100,000 annually = Severity
Slide 9: EGP-437: A Highly Differentiated Product
EGP-437: A Highly Differentiated Product EyeGate\ Dramatically Reduces Patient Burden from 154 to 2 or 3 Treatm a Standard of care: corticosteroid eye drops + First pivotal Phase 3 trial: 2 EyeGate treatments vs 154 eye drop treatments 154 treatments
Slide 10: Initial Phase Non-Inferiority Anterior Uveitis Trial Design and Results
Initial Phase 3 Non-Inferiority Anterior Uveii ByeGate\ Trial Design and High-Level Results ~ - = 35 sites: all in U.S. = 193 Subjects randomized 2 arms - 1:1 + 2 EGP-437 iontophoresis treatments + placebo eye drops (N = 96) + 2 placebo iontophoresis treatments + Pred Acet eye drops (N = 97) Tontoph
Slide 11: Sa Mae
Sa Mae Galle 4108 61018 261050 $ 3 Percent that Achieved PEP 4 Es reba SUN 18.2: SUN 3&4: 1110 25 cells, > 26 cells 1 TT= Intent Treat 2 Pray End Point (PEP): Total cell clearing at Day 14 0
Slide 12: Safety: Intraocular Pressure
Shae, Safety: Intraocular Pressure S 2 EGP-437: Subjects with IOP Increase = 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 Pred Acetate: Subjects with IOP Increase ean = 2.4X the number of incid
Slide 13: Anterior Uveitis Confirmatory Pivotal Phase 3 Trial Design
Anterior Uveiti Confirmatory Pivotal Phase 3 Trial Design —— lontophoresis tee 7 First Phase 3 Confirmatory Trial wiPtacebo Number of Subjects 188 250 2(DayOandDay7) 3 (Day 0, Day 4 and Day 9) 1 4:1 and SUN soale severity ACC Count =0 at Day 14 4154 Placebo eye drop installations ‘follow-up period 1
Slide 14: Post-Cataract Surgery Inflammation: Encouraging Interim Data
post-Cataract Surgery Inflammation Encouraging Interim Data Shae, Sa aie Cataract surgery with the implantation of an intraocular lens (IOL) * 28 day, open-label design, without control (Ph 1b/2a): Up to 50 eyes of 50 patients = 5 cohorts: 3 different doses with 2 regimens for the 2 highest doses *
Slide 15: Macular Edema
Macular Edema Sa aie 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 wit
Slide 16: Macular Edema Results
Macular E = Proof of concept trial confirms that iontophoresis can non-invasively deliver efficacious quantities of drug to back of eye Phakic 9 6 3 Pseudophakic 9 4 3 2 = Efficac third of subject: + Positive response from all subtypes (DW = Excellent Safety: no increase in |OP = Second leg: additio
Slide 17: Licensing Agreement
Sa aie Licensing Agreement EG® Il Delivery System + EGP-437 = 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 base
Slide 18: Evolution of a Platform
Evolution of a Platform 7 ByeGate\ At Home Version ~ a * Objective: In Vivo (rabbits) proof-of-concept data expected 2H 2016 = Stage 1: Screening = The effect of specific parameters determined + polymer charge and composition + polymer drug loading and drug release = Stage 2: Testing In Vivo - on th
Slide 19: Two Unique Ophthalmic Platforms
Two Unique Ophthalmic Platforms lontophoresis e
Slide 20: Proprietary CMHA-S Platform
Proprietary CMHA-S Platform Cross-linked thiolated hyaluronic acid (CMHA-S) Sa aie = Natural polymer of disaccharide units (hyaluronic acid) + Prevalent throughout the body and roles include: + Water homeostasis + Joint lubrication + ECM stabilization + Influences morphogenesis, development, healing
Slide 21: Advantages of Crosslinked Gels
Advantages of Crosslinked Gels Shae, Sa aie Crosslinking HA creates a 3D structural matrix and stabilizes the molecule making it suited for treating various ocular surface injuries via the following advantages: Matrix protects the ocular surface Residency time: adheres longer to the ocular surface M
Slide 22: Real World Animal Experience
Sg BEE Real World Animal Experience = CMHA-S has demonstrated global safety and efficacy in small animals in real world setting + Marketed as a highly efficacious veterinary product by Bayer ‘Animal Health under the Remend™ brand to treat comeal wounds (0.75% concentration) and dry eye (0.4% concent
Slide 23: JDE-003: Large Unmet Medical Need
JDE-003: Large Unmet Medical Need (Eye Drop at 0.75% Concentration) = Addressing Large Unmet Medical Need in Comeal Repair + Currently no US-approved eye drop to promote comeal wound repair + Comeal specialists desire a product that improves/accelerates healing = Ocular injuries resulting in corneal
Slide 24: JDE-003: Market Size
JDE-003: Market Size ByeGate\ (Eye Drop at 0.75% Concentration) ~ y Persistent Corea! Pow Diabet Post PRK Moderate & Severe Epithelial Detects vitrectomy (non {roebytorpment {non PCED) Dry Eye "eCeB)” oui ~125,000 ~75,000 33MM 600,000 #0 Treatments 103 1 2 4 ‘Siro of Markat $100 $25 > $1 Billion 817
Slide 25: Thicker Formulations: DoD SBIR Grant
Thicker Formulations (2 Versions) ByeGate\ hee Research Funded by Grants 1. DoD SBIR Grant: Phase 2 Status (funding in place through 8/2017) + Ocular Surface Shield: A sterile, field-stable product that is easily applied to immediately protect and promote healing of the ocular surface = Design: A th
Slide 26: Thicker Formulations: NSF SBIR Grant
Thicker Formulations (2 Versions) Research Funded by Grants 2. NSF SBIR Grant Sg BEE = Films: Topical sustained-release delivery of antibiotic for bacterial keratitis/conjunctivitis + Safety and tolerability study in NZW rabbits + Engineered using a Finite computational model + Films molded 3 mm x 1
Slide 27: Potential Intraocular Applications
Shae, Sa aie Potential Intraocular Applications = Vitreous is composed of water and hyaluronic acid + CMHA-S degraded very slowly in this environment + CMHA-S appears to be highly biocompatible in the vitreous = Intravitreal extended/sustained release + Unmet need to decrease frequency of injection
Slide 28: Investment Highlights
Shae, Sa aie Investment Highlights Ophthalmology company (NASDAQ: EYEG) Two unique and proprietary platforms: + EyeGate® II Delivery System (EGDS): iontophoretic delivery * CMHA-S platform: cross-linked thiolated hyaluronic acid EGP-437/EGDS: NDA submission mid-2017 + Anterior Uveitis: Ongoing Phase
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