Kiora Pharmaceuticals, Inc. · NASDAQ:KPRX
Kiora Pharmaceuticals — Eyegate Pharmaceuticals — Investor Presentation (January 2018)
30 slides from Kiora Pharmaceuticals's investor presentation, Jan 8, 2018
Slide 1: Corporate Presentation: Two Versatile Platforms Moving Towards Commercialization
CORPORATE PRESENTATION EyeGate Pharmaceuticals, Inc. 271 Waverley Oaks Road, Suite 108 Waltham, MA 02452 www.eyegatepharma.com Two Versatile Platforms Moving Towards Commercialization
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 uncerta inties, including statements relating to the prospects for the Company’s lead product EGP - 437, for the timing and outcome of the Company’s c
Slide 3: Two platforms in the clinic with two FDA filings expected in 2018
Two platforms in the clinic with two FDA filings expected in 2018 3 Two Product Platforms for Eye Disorders Ocular Bandage Gel (OBG) Eye Drop: Disrupting Dry Eye and Corneal Wound Market EyeGate II Iontophoresis Delivery System: Delivering a Corticosteroid (EGP - 437) Disease Area Preclin Ph 1b/2a P
Slide 4: Ocular Bandage Gel (OBG) Eye Drop
Ocular Bandage Gel (OBG) Eye Drop • A crosslinked hyaluronic acid (CMHA - S) for corneal wounds and epitheliopathies
Slide 5: Hyaluronic Acid Properties
5 Hyaluronic Acid Properties High - molecular weight HA is non - immunogenic High - molecular weight HA binds up to 1,000 times its volume in water weight HA provides: hydration, lubrication of joints, and a meshwork for cell migration Regulatory Approvals U.S. – Dermatology & Osteoarthritis Ex - U.
Slide 6: First and only eye drop candidate in the U.S. targeting re-epithelialization
First and only eye drop candidate in the U.S. targeting acceleration of re - epithelialization 6 EyeGate’s CMHA - S Platform: A unique crosslinked version of Hyaluronic acid ▪ Crosslinking creates a 3D structure that stabilizes the molecule (resists degradation) ▪ Prolonged residency time on the ocu
Slide 7: Demonstrated efficacy and safety in animals
Commercially available as a veterinary device ▪ Manufactured by SentrX Animal Care ▪ Sold in the U.S. and certain European countries by Bayer Animal Health as Remend® Corneal Repair 1 ▪ 5 years in thousands of dogs, cats and horses, with an excellent efficacy/safety profile 1. EyeGate has human opht
Slide 8: Healing Corneal Abrasions and Alkali Burns Efficacy Study: Rabbits
CMHA - S treated cornea exhibited “more normal” epithelial and stromal organization 8 Healing Corneal Abrasions and Alkali Burns Efficacy Study: Rabbits 1 1. Guanghui Yang, Ladan Espandar, Nick Mamalis and Glenn D. Prestwich, Veterinary Ophthalmology 2010 Histology of alkali burn healing A. Control
Slide 9: Meeting with FDA confirms de novo 510(k) filing path
Meeting with FDA (Nov 2016) confirms de novo 510(k) filing path 9 OBG Eye Drop Regulated as a Device Two indications: Photorefractive Keratectomy and Punctate Epitheliopathies ▪ No predicate device – label determined by clinical trials • Superiority claim must be supported by pivotal trial against s
Slide 10: Completed First Human Clinical Trial in PRK Patients
Completed First Human Clinical Trial in PRK Patients 10 CMHA - S Eye Drop Accelerates Corneal Surface Re - Epithelialization x PRK surgery provides several advantages as indication to evaluate the Ocular Bandage Gel (OBG) ▪ A homogenous patient population with same size, large epithelial defects x 3
Slide 11: Management of Punctate Epitheliopathy Pilot Trial Design
11 Management of Punctate Epitheliopathy Pilot Trial Design ▪ PE as defined by fluorescein staining of cornea: NEI scale • Randomization: NEI score between 5 and 12 ▪ 50 subjects for 2 arm trial: 25 subjects per arm • Safety will include both eyes (N = 60) ▪ 28 Day trial: 2 week wash - out/run - in
Slide 12: OBG Market Opportunity
▪ Corneal foreign bodies ▪ Abrasions / contusions ▪ Chemical burns ▪ Difficult to heal alkali burns (PCED) 12 EyeGate Ocular Bandage Gel (OBG) Market Opportunity ▪ Refractive surgeries (PRK) ▪ Vitrectomies (Diabetics) ▪ Collagen crosslinking ▪ Pre - cataract surgery Corneal Wounds and Epitheliopathi
Slide 13: Post Cataract Surgery, Uveitis, Contact Lens, Macular Edema
Iontophoresis Delivery Platform • Post Cataract Surgery • Treatment of Anterior Uveitis • Next Generation Contact Lens Drug Delivery • Treatment of Macular Edema
Slide 14: Non-invasive method of propelling charged compounds into ocular tissues
x Small electrical current propels drug into the eye x Dose controlled by Current (mA) x application time x Improves compliance: reduces applications by almost 98% (2 treatments vs ~154 eye drops) x More than 2,400 treatments performed to date by ophthalmologists and optometrists (<5 minutes) x Util
Slide 15: Dexamethasone: a potent anti-inflammatory corticosteroid
▪ Etiology assault based (cataract surgery) vs primarily auto - immune (anterior uveitis) ▪ Inflammation of uveal tissue including iris and/or ciliary body ▪ Inflammation severity determined by number of white blood cells in the anterior chamber of the eye (slit - lamp used) ▪ Primary end - point is
Slide 16: EGP-437: Highly Differentiated Product Reduces Patient Burden
Corticosteroid eye drops: Standard of care for both indications 16 EGP - 437: A Highly Differentiated Product Dramatically Reduces Patient Burden 2 to 3 EyeGate treatments Up to 154 eye drop treatments VS
Slide 17: Partnered with a Leading Ophthalmic Company
▪ Worldwide exclusive licenses to manufacture, sell, distribute and commercialize EGP - 437 delivered with Iontophoresis EG II Delivery System for Cataract Surgery and Uveitis only ▪ $135M in potential payments, including up - front, development & commercial milestones ▪ Cataract : $4M up - front ,
Slide 18: Cataract Surgery
Cataract Surgery The most common surgical procedure performed by ophthalmic surgeons Iontophoresis Delivery Platform
Slide 19: Cataract Surgery Market Opportunity
19 Iontophoresis Delivery Platform Cataract Surgery Market Opportunity Cataract surgery incidence: ~4 million 1 annually in U.S. in 2015 Likely to double (following incidence rates) by 2050 Source: National Institute of Health - National Eye Institute 1. Market Scope, 2015 Comprehensive Report on Th
Slide 20: Positive Cataract Surgery Phase 1b/2a Clinical Trial Results
EGP - 437 demonstrated safe and effective in reducing inflammation and preventing pain 20 Cohorts receiving the 4.5 mA - min and the 14 mA - min doses of iontophoretic EGP - 437 generated the most encouraging results x Cell count (ACC) of zero in 20 - 30% of patients at day 7 and 70 - 80% of patient
Slide 21: Anterior Uveitis
Anterior Uveitis Confirmatory Phase 3 Data in 2Q 2018 Iontophoresis Delivery Platform
Slide 22: Anterior Uveitis Market Opportunity
22 Iontophoresis Delivery Platform Anterior Uveitis Market Opportunity EyeGate II Iontophoresis System reduces dosing burden by 98% from standard eye drops 2015 Anterior Uveitis incidence: ~26.6 to 102 per 100,000 annually in U.S. Incidence of Anterior Uveitis in the U.S. 2008 - 2016 0 80,000 160,00
Slide 23: Positive Anterior Uveitis Phase 3 Non-Inferiority Trial Results
EGP - 437 demonstrated safe and effective in reducing inflammation vs positive control 23 Iontophoresis Delivery Platform Positive Anterior Uveitis Phase 3 Non - Inferiority Trial Results 1. ITT = Intent to Treat 2. Primary End Point (PEP): Total cell clearing (ACC) at Day 14 x Successfully demonstr
Slide 24: Macular Edema
Macular Edema Efficacious Delivery to the Back of the Eye Iontophoresis Delivery Platform
Slide 25: Macular Edema: Non-Invasive Delivery to Retina
Macular Edema (ME): Abnormal thickening of macula associated with accumulation of excess fluid within the neurosensory retina Iontophoresis delivers efficacious quantities of EGP - 437 to back of eye 25 Iontophoresis Delivery Platform Macular Edema - Non - Invasive Delivery to Retina Number DME RVO
Slide 26: Drug Embedded Contact Lens
Iontophoresis Delivery Platform Drug Embedded Contact Lens The Future of Ocular Drug Delivery
Slide 27: Drug Embedded Contact Lens for Macular Edema
27 ▪ First indication: dexamethasone for macular edema ▪ Two layer lens: ▪ Layer 1: Sits on surface of eye – loaded with drug ▪ Layer 2: Sits on top of Layer 1 – incorporates iontophoresis electronics ▪ In vitro work nearing completion, anticipate proof - of - concept animal data in 2018 ▪ Treating
Slide 28: Development Timeline
Development Timeline Program Disease Area 2017 2018 2019 2020 Large Corneal Wounds Photorefractive Keratectomy (PRK) Punctate Epitheliopathies Focus: Moderate Dry Eye OBG + Corticosteroid Eye Drop Crosslinked Hyaluronic Acid Punctate Epitheliopathies Focus: Severe Dry Eye Anterior Uveitis Cataract S
Slide 29: Year-to-Date (Q3) 2017 Financial Results
29 Year - to - Date (Q3) 2017 Financial Results Cash through mid - 2018 & multiple late - stage clinical trial data readouts ($000 except per share) Revenue $407 R&D Expense $7,253 G&A Expense $3,541 Net Loss $10,387 Net Loss per Share $0.78 Weighted Avg. Shares O/S 13,268 No. Shares O/S 17,205 Cash
Slide 30: Two platforms in the clinic with two FDA filings expected in 2018
Two platforms in the clinic with two FDA filings expected in 2018 30 Two Product Platforms for Eye Disorders Ocular Bandage Gel (OBG) Eye Drop: Crosslinked Hyaluronic Acid (CMHA - S) EyeGate II Iontophoresis Delivery System: Delivering a Corticosteroid (EGP - 437) Disease Area Preclin Ph 1b/2a Ph 2b
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