Kiora Pharmaceuticals, Inc. · NASDAQ:KPRX
Kiora Pharmaceuticals — Eyegate Pharmaceuticals — IPO Roadshow (September 2014)
38 slides from Kiora Pharmaceuticals's IPO roadshow presentation, Sep 12, 2014
Slide 1: Eyegate Pharmaceuticals, Inc. Free Writing Prospectus
Eyegate Pharmaceuticals, Inc. Providing innovative products that enhance drug efficacy and patient compliance to improve vision Issuer Free Writing Prospectus Filed Pursuant to Rule 433 Registration No. 333 - 197725 Sept 12, 2014
Slide 2: Forward Looking Statements
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 1 Forward Looking Statements Some of the matters discussed in this presentation contain forward - looking statements that involve significant risks and uncertainties, including statements
Slide 3: Free Writing Prospectus Statement
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 2 Free Writing Prospectus Statement ▪ This presentation highlights basic information about us and the offering. Because it is a summary, it does not contain all of the information that yo
Slide 4: Initial Public Offering Summary
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 3 Initial Public Offering Summary Eyegate Pharmaceuticals, Inc. NASDAQ Capital Market / EYEG 1,923,077 shares (100% primary) 15% or 288,462 shares (100% primary) $12.00 - $14.00 Complete
Slide 5: Management Team
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 4 Management Team ▪ Stephen From, President & CEO ▪ With EyeGate since October 2005 ▪ Former CFO, Centelion SAS (Aventis subsidiary) ▪ Healthcare investment Banker ▪ Qualified Chartered A
Slide 6: Selected Board Members and Medical Advisors
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 5 Selected Board Members ▪ Paul Chaney (Chairman) ▪ President and CEO of PanOptica , Inc. ▪ 25 years experience in pharmaceutical industry including several VP positions at Pharmacia ▪ Mo
Slide 7: Company Overview
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 6 Company Overview ▪ Late - stage specialty pharmaceutical and drug delivery company targeting highly prevalent ocular indications ▪ Lead investors include Ventech , IPSA, Natixis ▪ Lead
Slide 8: Investment Highlights
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 7 Investment Highlights ▪ Late - stage lead asset with clear path to commercialization ▪ EGP - 437 completed first Phase 3 study in anterior uveitis; NDA submission expected 2016; Targeti
Slide 9: Unique Ophthalmic Delivery Platform
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 8 Unique Ophthalmic Delivery Platform
Slide 10: Ophthalmic Delivery Challenges
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 Ophthalmic Delivery Challenges Anterior Segment of the Eye Posterior Segment of the Eye ▪ Primary mode of delivery is eye drops ▪ Problem: protective layer and biological functions limit
Slide 11: EyeGate has the only Non-Invasive Solution
10 Edelhauser et al IOVS 2010 EyeGate has the only Non - Invasive Solution EyeGate® II Applicator
Slide 12: EyeGate II Delivery System
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 11 EyeGate ® II Delivery system ▪ Improve patient compliance, main cause of treatment failure ▪ Reduce patient burden dramatically from 154 treatments to 3 ▪ New revenue stream for physic
Slide 13: EyeGate Platform: Non-Invasive Iontophoresis
12 EyeGate Platform: A Non - Invasive M ethod of Propelling C harged A ctive C ompounds I nto O cular Tissues ▪ Small electrical current (constant) ▪ Current has same charge as active substance (drug) ▪ Electrode creates repulsive electromotive forces (electrorepulsion) ▪ Drug migrates toward return
Slide 14: EyeGate II – Substantial Benefits for Clinicians
▪ Non - invasive; can be performed by variety of ophthalmic / optometry staff ▪ Quick; Average treatment time <5 minutes, with no waiting ▪ Able to treat any patient at any time ▪ Non - invasive procedure eliminates need for patient accompaniment ▪ Potential for increased patient compliance ▪ “Fear
Slide 15: Robust Clinical Pipeline
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 14 Robust Clinical Pipeline Program Indication Current Status Near - term Milestones EGP - 437 Anterior Uveitis • Phase 1 - 2 proof of concept trial completed • Phase 3 pivotal trial comp
Slide 16: EGP-Anti-Inflammatory
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 15 EGP - 437 Anti - Inflammatory
Slide 17: EGP-437: A Potent Anti-inflammatory Agent; Uveitis Overview
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 16 EGP - 437: A Potent A nti - inflammatory A gent (corticosteroid - dexamethasone phosphate) Uveitis Overview ▪ Inflammation of the uveal tract may be idiopathic, associated with systemi
Slide 18: Standard of care for anterior uveitis is patient-administered eye drops
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 S tandard of care to treat anterior uveitis is patient administered corticosteroid eye drops • Topical corticosteroids suffer from a number of drawbacks including low ocular bioavailabili
Slide 19: Importance of Treatment Regimen Clinical Case
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 Importance of Treatment Regimen Clinical Case 18 Anterior Uveitis Episode 1994 OD 20/20 OS 20/80 “ low grade chronic inflammation Same Patient 10 Years Later (2004 ): Poor Anti - Inflamma
Slide 20: Phase 3 Anterior Uveitis Trial Severity and Primary Endpoint
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 Phase 3 A nterior U veitis Trial Severity and Primary Endpoint 19 Severity of Uveitis: SUN Working Group ▪ Debilitating form of intraocular inflammation of the anterior portion of the uve
Slide 21: Phase 3 Anterior Uveitis Trial Design and High-Level Results
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 ▪ Successfully demonstrated same response rate when comparing EGP - 437 to standard of care ( prednisolone acetate 1 %) in Phase 3 trial of 193 patients with anterior uveitis ▪ Lower inci
Slide 22: Similar Outcome to Standard-of-Care
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 Similar Outcome to Standard - of - Care 21 Percent of subjects with cell count of 0 at each visit* 16.9 37.6 55.1 80.4 14.1 36.0 58.6 84.3 0 10 20 30 40 50 60 70 80 90 Day 7 Day 14 Day 28
Slide 23: Safety
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 22 Safety ▪ Each subject had four IOP measurements (Day 7, 14, 28, and 56) compared to baseline (Day 0 ) ▪ Significantly less subjects with incidents in the EGP - 437 arm ▪ 2.4X the numbe
Slide 24: Primary Endpoint Results
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 ▪ Just outside non - inferiority margin ▪ Proportion of subjects randomized with fewer than 25 cells (least severe population) was significantly higher in the control arm at baseline. Imp
Slide 25: Primary Endpoint Results by Severity
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 ▪ EGP - 437 has demonstrated equivalent response rates for SUN grades 1.0, 2.0 and 3.0 and has demonstrated much better results (29% better) for the more severe 4.0 grade. ▪ Combining SUN
Slide 26: Confirmatory Trial
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 ▪ Modification: Three (3) treatments of EGP - 437 prior to Day 14 primary endpoint (PEP) ▪ N: 250 subjects (90% powering for non - inferiority PEP with whole population) ▪ Randomization w
Slide 27: EGP-437: Milestones and Costs to NDA
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 26 EGP - 437: Milestones and Costs to NDA ▪ Initiation: Q4 2014 ▪ First Patient In (FPI): Q1 2015 ▪ Last Patient In (LPI): Q1 2016 ▪ Top - Line Date: Mid - year 2016 Confirmatory Phase 3
Slide 28: EGP-437 Commercial Strategy
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 27 ▪ Clearly - defined and sufficiently concentrated universe of clinicians that treat anterior uveitis in the U . S . which can be addressed by small, focused specialty sales team ▪ Plan
Slide 29: Single-Use Kit and Reimbursement
28 ▪ Includes device and drug ▪ Combining drug vial and device disposables together: • Ensures use of approved drug with applicator • Provides simplification of inventory and invoicing ▪ Shelf - life established at 24 months (drug and applicator) ▪ CPT Code: In addition to office reimbursement, clin
Slide 30: Additional Programs And Corporate
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 29 Additional Programs And Corporate
Slide 31: Leveraging Platform for Long-term Value Creation
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 ▪ Delivery of molecules not suitable for topical formulation (Medical Need) • Various rare (orphan) diseases exist whereby our platform would be ideal for treatment i.e. anti - infectives
Slide 32: Evolution of a Platform: Applicator
31 ▪ Foam reservoir for drug ▪ Circular design ▪ Therapeutic supplied in separate vial ▪ Transfer system required to fill applicator EyeGate ® II Next Generation ▪ Pre - filled with therapeutic ▪ Eliminates need for transfer system ▪ Smaller package design ▪ Oval ocular interface facilitates placeme
Slide 33: Evolution of a Platform: Generator
32 ▪ Current generator in clinical use EyeGate ® II ▪ Easy to program ▪ Allows for custom menus ▪ Ability to upgrade interface via firmware Timelines allow for next generation re - usable and/or disposable generator to be available for commercial launch Re - Usable Generator Disposable Generator ▪ D
Slide 34: Strong Patent Portfolio
33 Protection from 2018 through 2029* Strong Patent P ortfolio Eleven families (68 patents granted) ▪ Eight belong to the “ever growing” delivery system patent portfolio • 13 U.S. and 55 foreign patents granted • 2 U.S. and 20 foreign pending applications ▪ Three relate to drug compositions and trea
Slide 35: Value Drivers
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 34 Value Drivers ▪ Phase 3 trial • FPI: Q1 2015 • Phase 3 trial top - line data: mid 2016 – non - inferiority with potential for superiority with more severe population on the label ▪ End
Slide 36: Ophthalmology Class of IPOs Last Twelve Months
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 35 Ophthalmology Class of IPO’s Last Twelve Months *Share price and valuation at mid - point of price range OPHTHALMOLOGY CLASS: LTM Share Price Listing Date Company Ticker Stage of Lead
Slide 37: Pre-IPO Capitalization Structure
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 36 Pre - IPO Capitalization Structure Capitalization Shares Outstanding % Outstanding Common Stock* 5,133,667 76.8% Stock Options 1,543,559 23.1% Warrants 7,246 0.1% Fully - Diluted Share
Slide 38: Investment Highlights
40 82 140 147 189 107 177 194 217 109 141 72 254 215 84 176 216 190 142 163 194 241 249 244 191 201 221 25 52 87 37 Investment Highlights ▪ Late - stage lead asset with clear path to commercialization ▪ EGP - 437 completed first Phase 3 study in anterior uveitis; NDA submission expected 2016; Target
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