Kiora Pharmaceuticals, Inc. · NASDAQ:KPRX
Kiora Pharmaceuticals — Eyegate Pharmaceuticals — Investor Presentation (September 2016)
27 slides from Kiora Pharmaceuticals's investor presentation, Sep 12, 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
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) ▪ Two unique and proprietary platforms: • EyeGate ® II Delivery System (EGDS): iontophoretic delivery • CMHA - S platform: cross - linked thiolated hyaluronic acid ▪ EGDS/EGP - 437: NDA submission late 2017 • Anterior Uveitis: Second Phase 3
Slide 4: Clinical Pipeline
Clinical Pipeline Platform Product Indication Stage Additional Information • Pilot Trial: Initiation Phase CMHA-S Photorefractive keratectomy (PRK) • Trial with 0.75% CMHA-S eye drop for the acceleration of re-epithelization of corneal epithelial defects Ocular Bandage Gel Macular Edema • Phase 3 Pi
Slide 5: 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 ▪ Short residency time: frequent instillations required ▪ Extreme burden on patient: non - compliance ▪ Sight - th
Slide 6: Two Unique Ophthalmic Platforms: Iontophoresis
5 Two Unique Ophthalmic Platforms Iontophoresis CMHA - S
Slide 7: 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 8: EGP-437: A Potent Anti-inflammatory Agent
7 EGP - 437: A Potent Anti - inflammatory Agent (corticosteroid - dexamethasone phosphate) Uveitis 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 determi
Slide 9: EGP-437: A Highly Differentiated Product
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 Patient Burden from 154 to 2 or 3 Treatments 8
Slide 10: Initial Phase 3 Non-Inferiority Anterior Uveitis Trial
▪ 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 9 Tr
Slide 11: Similar Outcome to Standard-of-Care
Similar Outcome to Standard - of - Care 10 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 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
Slide 12: Safety: Intraocular Pressure
11 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 13: Anterior Uveitis: Confirmatory Pivotal Phase 3 Trial Design
12 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 14: Post-Cataract Surgery Inflammation Interim Data
Cataract surgery with the implantation of an IOL ▪ 28 day, dose - ascending open - label design ( Ph 1b/2a): Up to 80 eyes of 80 patients ▪ Patients enrolled into cohorts of 10 ▪ Primary outcome: Proportion of subjects with anterior chamber cell (ACC) count of zero Results ▪ Still enrolling but resu
Slide 15: Macular Edema Interim Results
▪ 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 extracellular space of neurosensory retina ▪ Efficacy: one - third of subjects responded • Positive response from all
Slide 16: Licensing Agreement: EG II Delivery System + EGP-437
15 ▪ 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 17: Evolution of a Platform: At Home Version
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 – incorporates iontophoresis electronics Evolution of a Platform At Home Version Visual center Conductive Haptic Conducting
Slide 18: Two Unique Ophthalmic Platforms: CMHA-S
17 Two Unique Ophthalmic Platforms Iontophoresis CMHA - S
Slide 19: CMHA-S Platform
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 qualities ideal for ocular surface • Promotion of wound healing and lubrication ▪ Native HA has a relatively short half
Slide 20: The EyeGate Ocular Bandage Gel Eye Drop Formulation
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 the eye • Exhibits significant shear thinning properties, that enables better residence time with less optical b
Slide 21: Healing Corneal Ulcers with an Eye Drop: Cats and Dogs
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 : Compare healing time (corneal re - epithelialization) of corneal stromal ulcers in cats and dogs in a clinical sett
Slide 22: Healing Corneal Abrasions and Alkali Burns: Rabbits
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 alkali burn injuries • 12 NZW rabbits, 6 per group, both eyes, wounds = 6.0mm x 6.0mm • Rabbits received CMHA - S dr
Slide 23: Corneal Epithelial Defects Opportunity
22 ▪ Epithelial defects can lead to ocular infections, inflammation, corneal neovascularization, and vision loss if not treated promptly and healed rapidly. • Infectious keratitis (corneal infections and ulcers) that result from an exposed corneal surface can be a major cause of vision loss. ▪ The W
Slide 24: Initial Pilot Study in PRK Patients
▪ 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 a bandage contact lens (BCL) as compared to artificial tears and a bandage contact lens. • Primary effectiveness
Slide 25: Solid or Film Formulations: DoD SBIR Grant
24 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 to immediately protect and promote healing of the ocular surface ▪ Applied directly onto the damaged cornea at the
Slide 26: NSF SBIR Grant: Phase II Status
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 weeks ( in vitro study ongoing) • Retention Rate: Re - engineering design for longer retention rates to mirror rele
Slide 27: Company Overview
26 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 ▪ EGDS/EGP - 437: NDA submission late 2017 • Anterior Uveitis: Second Phase 3
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