Kiora Pharmaceuticals, Inc. · NASDAQ:KPRX
Kiora Pharmaceuticals — Eyegate Pharmaceuticals — Investor Presentation (September 2017)
27 slides from Kiora Pharmaceuticals's investor presentation, Sep 12, 2017
Slide 1: Corporate Presentation
Providing innovative products that enhance drug efficacy and patient compliance to improve vision CORPORATE PRESENTATION EyeGate Pharmaceuticals, Inc. 271 Waverley Oaks Road, Suite 108 Waltham, MA 02452 www.eyegatepharma.com
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: Company Highlights
3 Company Highlights Near Term Commercial Ophthalmic Company ▪ De novo FDA 510(k) and CE Mark filings for OBG expected by Mid - Year 2018 ▪ OBG commercial launch anticipated for Mid - Year 2019 ▪ Targeting initially ~160,000 - 240,000 PRK procedures in U.S. annually ▪ NDA filing expected Q3 2018 for
Slide 4: Clinical Pipeline
Two platforms in the clinic with an expected FDA filing as early as Mid - Year 2018 4 Clinical Pipeline Ocular Bandage Gel (OBG) Eye Drop: Crosslinked Hyaluronic Acid (CMHA - S) Iontophoresis Delivery System: Delivering EGP - 437: Corticosteroid Indication(s) Stage Upcoming Milestone(s) Large Cornea
Slide 5: Hyaluronic Acid
5 Hyaluronic Acid Hyaluronic acid (HA) is a naturally occurring compound in the body ▪ ~15 grams of HA in an adult human body ▪ About 50% in the skin (promotes wound healing), also in the synovial fluid (natural lubricant) ▪ Rapidly degrades: one - third is naturally turned - over (degraded and synt
Slide 6: Differentiation: CMHA-S is a crosslinked version of Hyaluronic acid
Differentiation: CMHA - S is a crosslinked version of Hyaluronic acid 6 CMHA - S Platform ▪ Crosslinking HA creates a 3D structure that stabilizes the molecule (resists degradation) ▪ Adheres longer to the ocular surface (90 minutes) ▪ Higher viscosity that thins with blinking and is non blurring ▪
Slide 7: Demonstrated efficacy and safety across several animal studies
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 dogs, cats and horses, with an excellent safety profile 1. EyeGate has human ophthalmic rights only. V
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: OBG PRK first-in-human trial design
x PRK is an efficacious alternative for patients seeking surgical correction of refractive errors who are poor LASIK candidates x PRK surgery provides several advantages as indication to evaluate OBG’s ability ▪ Larger epithelial defects : All eyes randomized at time zero with same size defect ▪ Hom
Slide 10: Data from First-in-human Clinical Trial
x Excellent safety and tolerability ▪ No adverse events in OBG arm ▪ No corneal haze out to Day 28 x ~30% more patients healed by Day 3 with OBG alone than standard - of - care (BCL+AT) x Additionally, wound size was as much as ~36% smaller as early as Day 1 (24 hours post surgery) with OBG alone 10
Slide 11: Meeting with FDA confirms device de novo 510(k) filing available for OBG
Device - Indication for Use (IFU): Acceleration of re - epithelialization of large corneal epithelial defects in patients having undergone PRK ▪ Broader IFU: Demonstrate benefit in additional clinical trial(s) based on size of defect and not a specific underlying cause or indication ▪ Superiority cl
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 EyeGate has exclusive worldwide commercial rights to CMHA - S for use in human ocular space ▪ De novo FDA 510(k) filing targeted for Mid -
Slide 13: CMHA-S Solid or Film Formulations
13 CMHA - S Solid or Film Formulations (2 Versions) A sterile, field - stable product easily applied to immediately protect and promote healing of the ocular surface ▪ Desired Properties of the Film: x Easy to place, requiring no sutures or glue x Allows for immediate stabilization of the eye follow
Slide 14: Iontophoresis Delivery Platform
x Small electrical current (constant); current has same charge as active substance (drug) x Electrode creates repulsive electromotive forces (like charges repel) x Drug migrates toward return electrode, mobility a function of molecular weight and charge x Drug dose controlled by 2 variables: Current
Slide 15: EGP-437: A Potent Anti-inflammatory Agent
▪ Etiology assault based (cataract surgery) vs primarily auto - immune (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 proporti
Slide 16: EGP-437: A Highly Differentiated Product
Standard of care for both indications: corticosteroid eye drops 16 EGP - 437: A Highly Differentiated Product Dramatically Reduces Patient Burden Example from first pivotal anterior uveitis trial… 2 EyeGate treatments 154 eye drop treatments VS
Slide 17: Cataract Surgery Trial Design
EGP - 437 demonstrated safe and effective in reducing inflammation and preventing pain as early as Day 1 with two different iontophoretic doses 17 Cataract Surgery ▪ 80 subjects who underwent unilateral cataract extraction with a monofocal intraocular lens ▪ 7 cohorts whereby EGP - 437 was delivered
Slide 18: Cataract Surgery Positive results announced
EGP - 437 demonstrated safe and effective in reducing inflammation and preventing pain 18 Cataract Surgery Positive results announced 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%
Slide 19: Anterior Uveitis Initial Phase Non-Inferiority Trial
19 Anterior Uveitis Initial Phase 3 Non - Inferiority Trial ▪ Two 3 minute treatments of iontophoretically delivered EGP - 437 (Day 0 and Day 7) vs corticosteroid eye drops taken up to 8 times per day for 28 days ▪ Primary end point: Percentage of subjects with ACC count of zero at Day 14 ▪ Safety:
Slide 20: Anterior Uveitis Results
EGP - 437 demonstrated safe and effective in reducing inflammation vs positive control 20 Anterior Uveitis Results 1. ITT = Intent to Treat 2. Primary End Point (PEP): Total cell clearing (ACC) at Day 14 x Successfully demonstrated similar response to standard of care (corticosteroid eye drops - pre
Slide 21: Licensing Agreement
▪ Exclusive licenses to manufacture, sell, distribute and commercialize throughout the world for use in the fields of cataract surgery and uveitis ▪ Total upfront and milestone payments of $135 million ▪ Includes development and commercial milestones ▪ Royalties based on net sales: high single digit
Slide 22: Macular Edema Results
Macular Edema (ME): Abnormal thickening of macula associated with accumulation of excess fluid within the neurosensory retina Trial demonstrated iontophoresis non - invasively delivers efficacious quantities to back of eye 22 Macular Edema Results Demonstrated Non - Invasive Delivery to Retina Numbe
Slide 23: Evolution of a Platform
23 Evolution of a Platform At Home Version ▪ 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 Visual Center Conductive Haptic Conducting
Slide 24: EyeGate Patent Portfolio
Possesses comprehensive IP protection to ensure long - term leadership in ophthalmology EyeGate Patent Portfolio 24 EyeGate Pharma : 13 families ▪ Iontophoresis + EGP - 437: Ten families ▪ 103 granted patents : 18 U.S. and 85 foreign ▪ 11 pending patents : 3 U.S. and 8 foreign ▪ Expiring out to 2029
Slide 25: Clinical Catalysts
Clinical Catalysts Key Inflection Points Q2 2017 Q3 2017 Q4 2017 Q1 2018 Q2 2018 Q3 2018 Q4 2018 OBG: PRK Trials EGP - 437: Cataract Surgery Trials EGP - 437: Anterior Uveitis Trial EGP - 437: Anterior Uveitis Trial Pilot 2 Trial IDE Amendment Submitted De novo FDA 510(k) & CE Mark Phase 2b Trial Pi
Slide 26: Management and Board of Directors
26 Management and Board of Directors Stephen From, President and CEO ▪ Former CEO at Centelion SAS (Aventis subsidiary) ▪ Qualified Chartered Accountant at PwC Barbara Wirostko , MD, Chief Medical Officer ▪ Former founder and CSO at Jade Therapeutics ▪ Former Senior Medical Director at Pfizer ▪ M.D.
Slide 27: Summary
Clinical - stage Specialty Pharma Ophthalmology Company 27 Summary Ocular Bandage Gel for PRK: ▪ First and only eye drop in the U.S. targeting acceleration of re - epithelization claim ▪ OBG: PRK Pilot 2 trial top - line data expected by YE 2017 / early Q1 2018 ▪ OBG: PRK Pivotal trial top - line da
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