Kiora Pharmaceuticals, Inc. · NASDAQ:KPRX
Kiora Pharmaceuticals — Eyegate Pharmaceuticals — Investor Presentation (March 2018)
38 slides from Kiora Pharmaceuticals's investor presentation, Mar 12, 2018
Slide 1: Two Versatile Platforms Moving Towards Commercialization
NASDAQ: EYEG EyeGate Pharmaceuticals, Inc. 271 Waverley Oaks Road, Suite 108 Waltham, MA 02452 www.eyegatepharma.com Two Versatile Platforms Moving Towards Commercialization Follow us on Facebook, LinkedIn and Twitter
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 Product Platforms for Eye Disorders
Two platforms in the clinic with two FDA filings expected in first half 2019 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)
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 in the U.S. Targeting Acceleration of Re-Epithelialization
First and Only Eye Drop in the U.S. Targeting Acceleration of Re - Epithelialization 6 EyeGate’s CMHA - S Platform: A unique crosslinked, high concentration version of Hyaluronic acid ▪ Crosslinking creates a 3D structure that stabilizes the molecule R esists degradation ▪ Prolonged residency time
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: Broad Clinical Application & Large Market Opportunity
▪ Corneal foreign bodies ▪ Abrasions / contusions ▪ Chemical burns ▪ Difficult to heal alkali burns (PCED) EyeGate’s proprietary crosslinking has potential to address millions of patients in multiple conditions EyeGate Ocular Bandage Gel (OBG) Broad Clinical Application & Large Market Opportunity 9
Slide 10: Initial Patient Applications & Label Expansion
Initial Indications: PRK & Punctate Epitheliopathies Initial Patient Applications & Label Expansion 10 Focus At launch ▪ Dry Eye – patients not controlled on OTC treatments • With or without concomitant use in patients on Restasis or Xiidra ▪ Wound: Post Surgical healing in PRK (strategic) Clinical
Slide 11: Potential for Future Growth as a Combination Product
CMHA - S a device combined with a therapeutic expands upon wound and dry eye franchises Potential for Future Growth as a Combination Product 11 EyeGate Research Labs currently developing: ▪ CMHA - S + corticosteroid (loteprednol etabonate or dexamethasone) ▪ CMHA - S + antibiotic (fluoroquinolone) ▪
Slide 12: Meeting with FDA Confirms de novo 510(k) Filing Path
Meeting with FDA (Nov 2016) Confirms de novo 510(k) Filing Path 12 Eye Drop Regulated as a Device Accelerates Development Plan Initial Two Indications: Photorefractive Keratectomy and Punctate Epitheliopathies ▪ No predicate device – label determined by clinical trials demonstrating superiority ▪ In
Slide 13: Development Timeline
Development Timeline BYeGate\ ee IDE: Fe amendment to comments (30 day response time) Plot ri: ntcpate geen gt to begin (5 subjects 3 ams) Plo ra: Begin (-2 months rom Flo dats) Pts Tri: Bean aniipate “10 subjects) Prvtal il Toptin ata ("3 months fom Ft data) pe rplratory/Piot Tak Submit prtocl (30
Slide 14: OBG: Proprietary Crosslinked HA Clinical Development
OBG: Proprietary Crosslinked HA 14 Clinical Development
Slide 15: Completed First Human Clinical Trial in PRK Patients
Completed First Human Clinical Trial in PRK Patients 15 x PRK surgery provides several advantages as indication to evaluate the Ocular Liquid Bandage Gel (OBG) ▪ A homogenous patient population with large epithelial defects of the same size x 39 subjects randomized to one of three groups: both eyes
Slide 16: PRK – The Next Clinical Study Trial Design
16 PRK – The Next Clinical Study Trial Design ▪ Randomized, masked, controlled 2 week study in subjects that have undergone bilateral PRK • Epithelial removal using alcohol in a 9 mm well ▪ 45 subjects for 3 arm trial: 15 subjects per arm • Arm 1: OBG every 2 hrs (8x/day) for 3 days then QID for add
Slide 17: Management of Punctate Epitheliopathy Pilot Trial Design
17 Management of Punctate Epitheliopathy Pilot Trial Design ▪ PE as defined by fluorescein staining of cornea: NEI scale • Randomization: NEI score ≥ 4 ▪ 30 subjects for 2 arm trial: 15 subjects per arm • Safety will include both eyes (N = 60) ▪ 42 Day trial: 2 week wash - out/run - in followed by 4
Slide 18: Continued Unmet Medical Need & Modest Development Investment Creates Opportunity
Over 76M patients with corneal wounds or epitheliopathies in US but only 3.5M Rx’s of current treatment options Continued Unmet Medical Need & Modest Development Investment Creates Opportunity Even in Face of Generic Restasis Entry 18 Primary focus on punctate epitheliopathy/moderate dry eye market
Slide 19: FDA Comments on IDE
19 FDA Comments on IDE ▪ Received comments back from FDA on filed IDE: can’t move into clinic till resolved ▪ Majority of comments relate to manufacturing validation • Evaluate manufacturing process to eliminate sources which contribute to excessive bioburden levels: • implement QC procedures • repe
Slide 20: Iontophoresis Delivery Platform
Iontophoresis Delivery Platform
Slide 21: A non-invasive method of propelling charged active 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 22: 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 23: EGP-437: A Highly Differentiated Product Dramatically Reduces Patient Burden
Corticosteroid eye drops: Standard of care for both indications 23 EGP - 437: A Highly Differentiated Product Dramatically Reduces Patient Burden 2 to 3 EyeGate treatments Up to 154 eye drop treatments VS
Slide 24: 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 25: Cataract Surgery
Cataract Surgery The most common surgical procedure performed by ophthalmic surgeons Iontophoresis Delivery Platform
Slide 26: Cataract Surgery Market Opportunity
26 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 27: Inflammation post Cataract Surgery Phase 2 Trial Highlights
▪ Double - Masked, Placebo - Controlled, Two - arms: • 101 subjects from 7 sites • 51 Randomized to EGP - 437 (Iontophoresis with 40 mg/mL Dexamethasone Phosphate) • 50 Randomized to Placebo (Iontophoresis with 100 mM Sodium Citrate solution) ▪ EGP - 437 demonstrated better clinical performance than
Slide 28: Additional Information Phase 2 Trial Highlights
28 Additional Information Phase 2 Trial Highlights ▪ Secondary endpoints: change in mean cell count and change in mean pain score • EGP - 437 showed statistically significant improvements in both ACC count and pain score • ACC count = 0 on Day 7: p = 0.0096 • Pain Score = 0 on Day 1: p = 0.0149 ▪ EG
Slide 29: Comparing to Durezol
29 Comparing to Durezol * 13.7% 27.5% 43.1% 52.9% 4.7% 22.4% 41.1% 60.7% 0.0% 10.0% 20.0% 30.0% 40.0% 50.0% 60.0% 70.0% Day 4 Day 7 Day 14 Day 28 Proportion with ACC=0 (Active Arms) EGP-437 (N=51) Durezol (N=107) 9.8% 23.5% 31.4% 35.3% 0.9% 7.7% 11.4% 20.9% 0.0% 5.0% 10.0% 15.0% 20.0% 25.0% 30.0% 35
Slide 30: Anterior Uveitis Confirmatory Phase Data in 2Q 2018
Anterior Uveitis Confirmatory Phase 3 Data in 2Q 2018 Iontophoresis Delivery Platform
Slide 31: Anterior Uveitis Market Opportunity
31 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 32: Positive Anterior Uveitis Phase 3 Non-Inferiority Trial Results
EGP - 437 demonstrated safe and effective in reducing inflammation vs positive control 32 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 33: Macular Edema
Macular Edema Efficacious Delivery to the Back of the Eye Iontophoresis Delivery Platform
Slide 34: 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 34 Iontophoresis Delivery Platform Macular Edema - Non - Invasive Delivery to Retina Efficacy: one -
Slide 35: Drug Embedded Contact Lens
Iontophoresis Delivery Platform Drug Embedded Contact Lens The Future of Ocular Drug Delivery
Slide 36: Iontophoresis and Drug Embedded in a Contact Lens
36 ▪ 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 37: Anticipated Inflection Points
Anticipated Inflection Points * Assumes FDA allows clinical studies to begin following their review of the IDE amendment (review period ends April 08, 2018)
Slide 38: Thank You!
EyeGate Pharmaceuticals, Inc. 271 Waverley Oaks Road, Suite 108 Waltham, MA 02452 www.eyegatepharma.com Thank You! NASDAQ: EYEG www.eyegatepharma.com Follow us on Facebook, LinkedIn and Twitter
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