Kiora Pharmaceuticals, Inc. · NASDAQ:KPRX
Kiora Pharmaceuticals — Eyegate Pharmaceuticals — Investor Presentation (March 2017)
24 slides from Kiora Pharmaceuticals's investor presentation, Mar 10, 2017
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) ▪ Platform 1: Crosslinked HA (eye drop formulation) • Corneal Epithelial Defects: • Positive results announced from pilot clinical trial • FDA De Novo 510(k) filing by year - end 2017 • European CE Mark by year - end 2017 ▪ Platform 2: Propriet
Slide 4: Clinical Pipeline
Clinical Pipeline 3 Iontophoresis Crosslinked HA Two platforms in the clinic with expected FDA filings by year - end 2017 ▪ Crosslinked HA: OBG ▪ Iontophoresis: EGP - 437 Product Indication Stage Targeted Filing Dates Large Corneal Epithelial Defects • Pilot Trial completed in patients having underg
Slide 5: Hyaluronic Acid
4 Hyaluronic Acid Hyaluronic acid 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 synthesiz
Slide 6: CMHA-S Platform
5 CMHA - S Platform Differentiating CMHA - S vs HA • CMHA - S is a crosslinked version of HA HA crosslinking prevents degradation and increases viscosity • Crosslinking HA creates a 3D structure that stabilizes the molecule ( resists degradation ) • Adheres longer to the ocular surface (90 minutes)
Slide 7: EyeGate OBG – proven efficacy and safety across several animal studies
EyeGate OBG – proven efficacy and safety across several animal studies (already commercialized in vet. space) ▪ Efficacy of CMHA - S has been demonstrated in various animal pathology models: • Post traumatic corneal stromal ulcers (dogs and cats) • Corneal abrasion and alkali burn injuries (rabbits)
Slide 8: Healing Corneal Abrasions and Alkali Burns Efficacy Study: Rabbits
Healing Corneal Abrasions and Alkali Burns Efficacy Study: Rabbits 1 CMHA - S treated cornea exhibited “more normal” epithelial and stromal organization than control group 7 1. Guanghui Yang, Ladan Espandar , Nick Mamalis and Glenn D. Prestwich, Veterinary Ophthalmology 2010 A. Fluorescein staining
Slide 9: Positive data on OBG accelerating corneal re-epithelialization following PRK
Announced positive data evaluating ability of EyeGate OBG to accelerate corneal surface re - epithelialization following bilateral photorefractive keratectomy (PRK) ▪ PRK is an efficacious alternative for patients seeking surgical correction of refractive errors who are poor LASIK candidates ▪ PRK s
Slide 10: Data from First Human Clinical Trial
▪ Excellent safety and tolerability • No adverse events in OBG arm • No corneal haze out to Day 28 ▪ ~30% more patients healed by Day 3 with OBG than standard - of - care (BCL+AT) ▪ Additionally, wound size was ~53% smaller as early as Day 1 (24 hrs post surgery) with OBG ▪ Next Steps: File IDE Q1 1
Slide 11: Meeting with FDA confirms device 510(k) de novo filing for OBG
Meeting with FDA (Nov 2016) confirms device 510(k) de novo 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
Slide 12: Worldwide commercial rights to CMHA-S and OBG opportunity
EyeGate has retained control of worldwide commercial rights to CMHA - S • FDA 510(K) de novo filing targeted for year - end 2017 • European CE Mark targeted for year - end 2017, commercializing H1 2018 EyeGate Ocular Bandage Gel (OBG) Surgeries : >4 million (~ 0.8 million prescriptions) • R efractiv
Slide 13: CMHA-S Solid or Film Formulations
12 CMHA - S Solid or Film Formulations (2 Versions) Research Funded by Grants ▪ Desired Properties of the Film: • Easy to place, requiring no sutures or glue • Allows for immediate stabilization of the eye following trauma • No refrigeration or freezer required: room stable • Prevents adhesions and
Slide 14: Iontophoresis Platform: Non-Invasive Delivery into Ocular Tissues
▪ 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 15: EGP-437: A Potent Anti-inflammatory Agent
14 EGP - 437: A Potent Anti - inflammatory Agent (corticosteroid - dexamethasone phosphate) Two indications licensed by Valeant: cataract surgery and anterior uveitis ▪ Etiology assault based (cataract surgery) vs primarily auto - immune (uveitis) ▪ Inflammation of uveal tissue including iris and/or
Slide 16: EGP-437: A Highly Differentiated Product Dramatically Reduces Patient Burden
Standard of care for both indications: corticosteroid eye drops • Example from first pivotal anterior uveitis trial: 2 EyeGate treatments vs. 154 eye drop treatments EGP - 437: A Highly Differentiated Product Dramatically Reduces Patient Burden 15
Slide 17: Cataract Surgery
16 Cataract Surgery ▪ EGP - 437 safe and effective in reducing inflammation and preventing pain as early as Day 1 with 2 different iontophoretic doses ▪ Trial design • 80 subjects who underwent unilateral cataract extraction with a monofocal intraocular lens • 7 cohorts whereby EGP - 437 was deliver
Slide 18: Cataract Surgery Positive Results Announced
17 Cataract Surgery Positive results announced ▪ EGP - 437 safe and effective in reducing inflammation and preventing pain • Cohorts receiving the 4.5 mA min and the 14 mA min doses of iontophoretic EGP - 437 generated the most encouraging results • Cell count (ACC) of zero in 20 - 30% of patients a
Slide 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: review of side effects, steroid induced increase in intraocu
Slide 20: Anterior Uveitis Results
19 1. ITT = Intent to Treat 2. Primary End Point (PEP): Total cell clearing (ACC) at Day 14 ▪ EGP - 437 safe and effective in reducing inflammation vs positive control • Successfully demonstrated similar response to standard of care (corticosteroid eye drops - prednisolone acetate 1%) • Lower incide
Slide 21: Licensing Agreement with Valeant
20 ▪ Valeant Pharmaceuticals – Bausch + Lomb (NYSE/TSX : VRX) ▪ Exclusive license to manufacture, sell, distribute and commercialize throughout the world for use in field of cataract surgery and uveitis • Total upfront and milestone payments of $ 135 million • Includes development milestones • Royal
Slide 22: Macular Edema 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 within the neurosensory retina ▪ Efficacy: one - third of subjects responded • Positive response from all subtypes (DME,
Slide 23: Evolution of a Platform
22 ▪ 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 24: Summary
23 Summary Ophthalmology company (NASDAQ: EYEG) ▪ OBG 510(K) de novo filing targeted for year - end 2017: first and only eye drop in the US with acceleration of re - epithelization claim ▪ OBG CE Mark targeted for year - end 2017, commercial launch Q1 2018 ▪ EGP - 437 NDA filing for Uveitis targeted
Eyegate Pharmaceuticals — Investor Presentation (March 2017) on 6ix