Kiora Pharmaceuticals, Inc. · NASDAQ:KPRX
Kiora Pharmaceuticals — Eyegate Pharmaceuticals — Investor Presentation (January 2017)
28 slides from Kiora Pharmaceuticals's investor presentation, Jan 30, 2017
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
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 1 Forward Looking Statements Some of the matters discussed in this presentation contain forward - looking statements that involve significant risks and uncertainties, including statements
Slide 3: Company Overview
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 2 Company Overview ▪ Ophthalmology company (NASDAQ: EYEG) ▪ EGP - 437 (corticosteroid): proprietary delivery system • Anterior Uveitis: • NDA submission year - end 2017 • Licensed to Vale
Slide 4: Clinical Pipeline
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 Clinical Pipeline 3 Product Indication Stage Targted Filing Dates Photorefractive keratectomy (PRK) OBG Crosslinked HA • Pilot Trial completed: Positive data announced • Next Trial: Initi
Slide 5: Two Unique Ophthalmic Platforms: Iontophoresis
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 4 Two Unique Ophthalmic Platforms Iontophoresis CMHA - S
Slide 6: Iontophoresis Platform: A 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, mobility a function of molecular weight and charge ▪ Drug dose controlled by 2 variables: Current
Slide 7: EGP-437: A Potent Anti-inflammatory Agent - Uveitis Overview
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 6 EGP - 437: A Potent Anti - inflammatory Agent (corticosteroid - dexamethasone phosphate) Uveitis Overview ▪ Inflammation of uvea tract ▪ Estimated 18% experience transient or permanent
Slide 8: EGP-437 Dramatically Reduces Patient Burden from 154 to 2 or 3 Treatments
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 Standard 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
Slide 9: Initial Phase 3 Non-Inferiority Anterior Uveitis Trial Design and Results
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 ▪ 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 -
Slide 10: Similar Outcome to Standard-of-Care
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 Similar Outcome to Standard - of - Care 9 Percent of subjects 1 that achieved primary endpoint 2 (PEP) 1. ITT = Intent to Treat 2. Primary End Point (PEP): Total cell clearing at Day 14 4
Slide 11: Safety: Intraocular Pressure
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 10 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
Slide 12: Anterior Uveitis: Confirmatory Pivotal Phase 3 Trial Design
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 11 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
Slide 13: Licensing Agreement with Valeant - Bausch + Lomb
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 12 ▪ Valeant Pharmaceuticals – Bausch + Lomb (NYSE/TSX : VRX) ▪ Exclusive license to manufacture, sell, distribute and commercialize throughout the world for use in field of uveitis • Upf
Slide 14: EGP-437 Cataract Surgery Overview
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 13 EGP - 437: A Potent Anti - inflammatory Agent (corticosteroid - dexamethasone phosphate) Cataract Surgery Overview ▪ Ocular inflammation and pain are common side effects following cata
Slide 15: Post-Cataract Surgery Inflammation Positive Data Announced
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 Post - Cataract Surgery Inflammation Positive Data Announced 14 * Durezol data from CDER Application Number 22 - 212: Medical Review for Durezol , studies ST - 601A - 002a and 002b. Durez
Slide 16: Macular Edema Interim Results Confirm Non-Invasive Delivery to Retina
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 ▪ Trial confirms iontophoresis can non - invasively deliver efficacious quantities to back of eye ▪ ME: abnormal thickening of macula associated with accumulation of excess fluid in extra
Slide 17: Evolution of a Platform: At Home Version
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 16 ▪ Objective: Drug loaded contact lens with iontophoresis electronics ▪ Two layer lens ▪ Layer 1: sits on surface of eye – loaded with drug ▪ Layer 2: sits on top of Layer 1 – incorpora
Slide 18: Two Unique Ophthalmic Platforms: CMHA-S
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 17 Two Unique Ophthalmic Platforms Iontophoresis CMHA - S
Slide 19: CMHA-S Platform
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 18 CMHA - S Platform ▪ Cross - linked thiolated hyaluronic acid (CMHA - S) platform • Hyaluronic Acid (HA) – a polymer of disaccharides ▪ HA occurs naturally in the human body with qualit
Slide 20: The EyeGate Ocular Bandage Gel Eye Drop Formulation
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 19 The EyeGate Ocular Bandage Gel Eye Drop Formulation ▪ A clear hydrogel (or liquigel ) eye drop with a 0.75% concentration of CMHA - S • Cross - linked to provide reduced degradation on
Slide 21: Healing Corneal Ulcers with an Eye Drop: Cats and Dogs
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 Healing Corneal Ulcers with an Eye Drop Efficacy Study: Cats and Dogs ▪ Post - traumatic corneal stromal ulceration is painful and potentially sight - threatening ▪ Study Objective 1 : Co
Slide 22: Healing Corneal Abrasions and Alkali Burns: Rabbits
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 Healing Corneal Abrasions and Alkali Burns Efficacy Study: Rabbits ▪ Study Objective 1 : Evaluate the efficacy of CMHA - S for treatment of corneal epithelial abrasion and standardized al
Slide 23: Corneal Epithelial Defects Market Opportunity
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 22 ▪ Epithelial defects can lead to ocular infections, inflammation, corneal neovascularization, and vision loss if not treated promptly and healed rapidly. • Infectious keratitis (cornea
Slide 24: Initial Pilot Study in PRK Patients
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 ▪ Initial pilot study will be for photorefractive keratectomy (PRK) patients • Objective is to evaluate safety and performance of our eye drop administered QID for 14 days with or without
Slide 25: The EyeGate Ocular Bandage Gel Top-Line Data
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 ▪ Excellent safety and tolerability ▪ Greater % of pts in arm 1 “OBG alone” were healed by Day 3 • 75% of subjects in arm 1 had full closure at Day 3 vs 53.8% in the BCL arm: a ~40% incre
Slide 26: Solid or Film Formulations: DoD SBIR Grant
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 25 Solid or Film Formulations (2 Versions) Research Funded by Grants 1. DoD SBIR Grant: Phase II Status ▪ Ocular Surface Shield: A sterile, field - stable product that is easily applied t
Slide 27: Solid or Film Formulations: NSF SBIR Grant
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 2. NSF SBIR Grant: Phase II Status ▪ Films/Pellet: Topical sustained - release delivery vehicle placed under inferior fornix • Release Profile: High - load product still releasing at 8 we
Slide 28: Company Overview
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 27 Company Overview ▪ Ophthalmology company (NASDAQ: EYEG) ▪ EGP - 437 (corticosteroid): proprietary delivery system • Anterior Uveitis: • NDA submission year - end 2017 • Licensed to Val
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