Kiora Pharmaceuticals, Inc. · NASDAQ:KPRX
Kiora Pharmaceuticals — Eyegate Pharmaceuticals — IPO Roadshow (April 2018)
39 slides from Kiora Pharmaceuticals's IPO roadshow presentation, Apr 9, 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 Issuer Free Writing Prospectus Filed Pursuant to Rule 433 Registration No. 333 - 2
Slide 2: Free Writing Prospectus Statement
Free Writing Prospectus Statement 2 • We have filed a Registration Statement on Form S - 1 with the Securities and Exchange Commission (the “SEC”) , including a preliminary prospectus dated April 9, 2018 (the “Prospectus”), with respect to the offering of our securities to which this communication r
Slide 3: 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 4: Two platforms in the clinic with two FDA filings expected in first half 2019
Two platforms in the clinic with two FDA filings expected in first half 2019 4 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 5: Ocular Bandage Gel (OBG) Eye Drop
Ocular Bandage Gel (OBG) Eye Drop • A crosslinked hyaluronic acid (CMHA - S) for corneal wounds and epitheliopathies
Slide 6: Hyaluronic Acid Properties
6 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 7: 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 7 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 8: 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 9: Healing Corneal Abrasions and Alkali Burns Efficacy Study: Rabbits
CMHA - S treated cornea exhibited “more normal” epithelial and stromal organization 9 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 10: Broad Clinical Application & Large Market Opportunity
Wounds: Trauma ▪ Injuries / Abrasions ▪ Chemical burns ▪ Difficult to heal (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 10 Wounds ▪ Refractive surg
Slide 11: Initial Indications: PRK & Punctate Epitheliopathies
Initial Indications: PRK & Punctate Epitheliopathies Initial Patient Applications & Label Expansion 11 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 12: 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 12 EyeGate Research Labs currently developing: ▪ CMHA - S + corticosteroid (loteprednol etabonate or dexamethasone) ▪ CMHA - S + antibiotic (fluoroquinolone) ▪
Slide 13: Meeting with FDA Confirms de novo 510(k) Filing Path
Meeting with FDA (Nov 2016) Confirms de novo 510(k) Filing Path 13 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 14: Development Timeline
Development Timeline IDE: Fle ammendmentto.comments (20 day response time) Pilot Tal: Anticipate green light to begin (45 subjects -3 arms) Pilot Trial: Begin Pilot Tal: Topline data Pivotal Tra: Begin (anticipate ~100 subjects) Pivotal Tal: Tope data = Explratory/Plot Tria: Submit protocol (30 subj
Slide 15: OBG: Proprietary Crosslinked HA Clinical Development
OBG: Proprietary Crosslinked HA 15 Clinical Development
Slide 16: Completed First Human Clinical Trial in PRK Patients
Completed First Human Clinical Trial in PRK Patients 16 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 17: PRK – The Next Clinical Study Trial Design
17 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 18: Management of Punctate Epitheliopathy Pilot Trial Design
18 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 19: Over 76M patients with corneal wounds or epitheliopathies in US
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 19 Primary focus on punctate epitheliopathy/moderate dry eye market
Slide 20: FDA Feedback on IDE Amendment
20 FDA Feedback on IDE Amendment ▪ Received comments back from FDA on filed IDE and majority of issues have been addressed ▪ FDA identified four deficiencies in our submission, requesting additional information on the manufacturing processes associat ed with the CMHA - S eye drop • The manufacturing
Slide 21: Iontophoresis Delivery Platform
Iontophoresis Delivery Platform
Slide 22: 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 23: 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 24: EGP-437: A Highly Differentiated Product Dramatically Reduces Patient Burden
Corticosteroid eye drops: Standard of care for both indications 24 EGP - 437: A Highly Differentiated Product Dramatically Reduces Patient Burden 2 to 3 EyeGate treatments Up to 154 eye drop treatments VS
Slide 25: 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 26: Cataract Surgery
Cataract Surgery The most common surgical procedure performed by ophthalmic surgeons Iontophoresis Delivery Platform
Slide 27: Cataract Surgery Market Opportunity
27 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 28: 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 29: Additional Information Phase 2 Trial Highlights
29 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 30: Comparing to Durezol
30 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 31: Anterior Uveitis
Anterior Uveitis Confirmatory Phase 3 Data in 2Q 2018 Iontophoresis Delivery Platform
Slide 32: Anterior Uveitis Market Opportunity
32 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 33: Positive Anterior Uveitis Phase 3 Non-Inferiority Trial Results
EGP - 437 demonstrated safe and effective in reducing inflammation vs positive control 33 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 34: Macular Edema
Macular Edema Efficacious Delivery to the Back of the Eye Iontophoresis Delivery Platform
Slide 35: 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 35 Iontophoresis Delivery Platform Macular Edema - Non - Invasive Delivery to Retina Efficacy: one -
Slide 36: Drug Embedded Contact Lens
Iontophoresis Delivery Platform Drug Embedded Contact Lens The Future of Ocular Drug Delivery
Slide 37: Drug Embedded Contact Lens for Macular Edema
37 ▪ 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 38: Anticipated Inflection Points
Anticipated Inflection Points * Assumes FDA allows clinical studies to begin following their review of the IDE amendment (targeting early July for submission: review period is 30 days)
Slide 39: 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