Kiora Pharmaceuticals, Inc. · NASDAQ:KPRX
Kiora Pharmaceuticals — Eyegate Pharmaceuticals — IPO Roadshow (January 2015)
33 slides from Kiora Pharmaceuticals's IPO roadshow presentation, Jan 16, 2015
Slide 1: Eyegate Pharmaceuticals, Inc. Issuer 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 January 16, 2015
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: Free Writing Prospectus Statement
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 you should consider before investing in our company. ▪ We have filed a registration statement (including a prospect
Slide 4: Initial Public Offering Summary
3 Initial Public Offering Summary Eyegate Pharmaceuticals, Inc. NASDAQ Capital Market / EYEG 1,428,572 shares (100% primary) 15% or 214,286 shares (100% primary) $6.00 - $8.00 Continue clinical development of lead program for anterior uveitis indication and conduct proof - of - concept macular edema
Slide 5: Management Team
4 Management Team ▪ Stephen From, President & CEO ▪ With EyeGate since October 2005 ▪ Former CFO, Centelion SAS (Aventis subsidiary) ▪ Healthcare investment Banker ▪ Qualified Chartered Accountant (PwC) ▪ Michael Manzo, VP Engineering ▪ With EyeGate since October 2006 ▪ Over 30 years of experience i
Slide 6: Selected Board Members and Medical Advisors
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 ▪ Morton Goldberg M.D.* ▪ Joseph E. Green Professor of Ophthalmology at the Wilmer Eye Institute, Johns Hopkins Unive
Slide 7: Company Overview
6 Company Overview ▪ Late - stage specialty pharmaceutical and drug delivery company targeting highly prevalent ocular indications ▪ Lead investors include Ventech , IPSA, Natixis ▪ Lead product candidate, EGP - 437 for anterior uveitis, matched response rate for standard of care in non - inferiorit
Slide 8: Investment Highlights
7 Investment Highlights ▪ Late - stage lead asset with clear path to commercialization ▪ EGP - 437 completed first Phase 3 trial in anterior uveitis, and one pivotal trial left to complete, NDA submission expected by end of year 2016 ▪ EGP - 437 will be developed for additional indications like macu
Slide 9: Unique Ophthalmic Delivery Platform
8 Unique Ophthalmic Delivery Platform
Slide 10: Ophthalmic Delivery Challenges
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 penetration of drug into tissues ▪ Frequent instillations required: up to 16 per day ▪ Extremely heavy burden on
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 Platform: A Non-Invasive Method of Propelling Charged Compounds
▪ Small electrical current (constant ); Current has same charge as active substance (drug) ▪ Electrode creates repulsive electromotive forces (electrorepulsion) ▪ Drug migrates toward return electrode ▪ Drug delivered in high local concentration with minimized systemic absorption ▪ Drug mobility is
Slide 13: EyeGate II Delivery System: Substantial Benefits for Clinicians and Patients
12 EyeGate ® II Delivery system No more self - administered drops ▪ New revenue stream for physicians (CPT Code) ▪ 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 ▪ Less travel for patient
Slide 14: Robust Clinical Pipeline
13 Robust Clinical Pipeline Program Indication Current Status Use of Proceeds Milestones EGP - 437 Anterior Uveitis • Phase 1 - 2 dose ranging trial completed • First non - inferiority trial completed • Initiate Phase 3 pivotal trial Macular Edema • Initiate and complete back - of - the - eye dose c
Slide 15: EGP-Anti-Inflammatory
14 EGP - 437 Anti - Inflammatory
Slide 16: EGP-437: A Potent Anti-inflammatory Agent
15 EGP - 437: A Potent A nti - inflammatory A gent (corticosteroid - dexamethasone phosphate) Uveitis Overview ▪ Inflammation of the uveal tract may be idiopathic, associated with systemic diseases or result from a variety of infectious agents ▪ An annual estimated 17.6% of active uveitis patients e
Slide 17: Standard of care is patient administered corticosteroid eye drops
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 bioavailability, rapid clearance and steroid - related side effects, including elevated intraocular pressure, or IOP • At mini
Slide 18: Importance of Treatment Regimen Clinical Case
Importance of Treatment Regimen Clinical Case 17 Anterior Uveitis Episode 1994 OD 20/20 OS 20/80 “ low grade chronic inflammation Same Patient 10 Years Later (2004 ): Poor Anti - Inflammatory Therapeutics OD 20/ 400 Legally Blind OS No Light Perception “Blind
Slide 19: Initial Phase 3 Non-Inferiority Anterior Uveitis Trial
Initial Phase 3 Non - Inferiority A nterior U veitis Trial Severity and Primary Endpoint 18 Severity of Uveitis: SUN Working Group ▪ Debilitating form of intraocular inflammation of the anterior portion of the uvea ▪ Confirmation and severity of disease is determined by the number of white blood cel
Slide 20: Trial Design and High-Level Results
▪ 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 incidence of increased intraocular pressure (IOP ) with EGP - 437 treatment Initial Phase 3 Non - Inferiority Anterio
Slide 21: Similar Outcome to Standard-of-Care
Similar Outcome to Standard - of - Care 20 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 Day 56 EGP-437 Pred Acet PEP** *Per Protocol population ** PEP = Primary Endpoint
Slide 22: Safety
21 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 number of incidents in the control arm 146 128 Total Number of Incidents 110 85 Incidents Related to Eye Disorders Bot
Slide 23: Primary Endpoint
▪ 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. Important as response rate similar for both arms in this population (43.2% vs 41.4% for EGP - 437 vs PA 1% respectiv
Slide 24: Primary Endpoint Results by Severity
▪ 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 grades 3.0 and 4.0 results in 25.0% and 20.5% response rates for EGP - 437 and PA 1% respectively. Primary Endpo
Slide 25: Additional Phase 3 Pivotal Trial Modified Design
▪ 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 will be stratified by the baseline severity of the condition, according to the SUN scale, to ensure a more even di
Slide 26: EGP-437: Use of Proceeds and Milestones
25 EGP - 437: Use of Proceeds and Milestones POC Phase 2 Trials for Additional Indications: allocated $1.2 million from proceeds Anterior Uveitis: allocated $3.5 1 million from proceeds Confirmatory Phase 3 Trial ▪ Initiation: by end of Q1 2015 ▪ First Patient In (FPI): by end of Q2 2015 1. does not
Slide 27: EGP-437 Commercial Strategy
26 ▪ 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 to build key capabilities to support specialty sales team ▪ Marketing, market access, sales management and medic
Slide 28: Single-Use Kit and Reimbursement
27 ▪ 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 29: Strong Patent Portfolio
28 Protection from 2018 through 2029* Strong Patent P ortfolio Ten families (72 patents granted) ▪ Eight belong to the “ever growing” delivery system patent portfolio • 13 U.S. and 58 foreign patents granted • 3 U.S. and 16 foreign pending applications ▪ Two relate to drug compositions and treatment
Slide 30: Evolution of a Platform: Applicator
29 ▪ 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 31: Evolution of a Platform: Generator
30 ▪ 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 32: Pre-IPO Capitalization Structure
31 Pre - IPO Capitalization Structure Capitalization Shares Outstanding % Outstanding Common Stock* 5,512,608 78.1% Stock Options** 1,539,156 21.8% Warrants 7,247 0.1% Fully - Diluted Shares Outstanding 7,059,011 100.0% *Common Stock number includes Convertible Notes, Warrants and Preferred Stock th
Slide 33: Investment Highlights
32 Investment Highlights ▪ Late - stage lead asset with clear path to commercialization ▪ EGP - 437 completed first Phase 3 trial in anterior uveitis, and one pivotal trial left to complete, NDA submission expected by end of year 2016 ▪ EGP - 437 will be developed for additional indications like mac
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