Kiora Pharmaceuticals, Inc. · NASDAQ:KPRX
Kiora Pharmaceuticals — Eyegate Pharmaceuticals — IPO Roadshow (July 2015)
33 slides from Kiora Pharmaceuticals's IPO roadshow presentation, Jul 16, 2015
Slide 1: Eyegate Pharmaceuticals, Inc.
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 - 204780
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: Follow-on Offering Summary
3 Follow - on Offering Summary Eyegate Pharmaceuticals, Inc. NASDAQ Capital Market* / EYEG 869,566 shares (100% primary) 15% or 130,434 shares (100% primary) Continue clinical development of lead program, including Phase 3 non - infectious anterior uveitis trial, endothelial cell count clinical safe
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: Update Since OTCQB Listing
6 Update Since OTCQB Listing ▪ Licensing Agreement with Valeant Pharmaceuticals ▪ Exclusive , worldwide commercial and manufacturing rights for uveitis ▪ Upfront cash payment, milestone payments and royalties ▪ Valeant responsible for 100% of costs outside U.S. ▪ Positive Guidance from FDA ▪ We beli
Slide 8: Company Overview
7 Company Overview Ophthalmology: Drug Delivery Platform ▪ Drug: EGP - 437, a corticosteroid, developed for anterior uveitis ▪ 505(b)(2) NDA filing scheduled for Q2 2017 ▪ Being evaluated for back - of - eye disease, macular edema ▪ Platform: EyeGate II® Delivery System ▪ Proprietary, non - invasive
Slide 9: Investment Highlights
8 Investment Highlights ▪ Phase 3 program with clear path to commercialization ▪ First Phase 3 trial completed ▪ Potent drug with proven safety profile when delivered by our system ▪ Mitigates corticosteroid side - effect, elevated IOP ▪ Eliminates non - compliance issue ▪ Medical Benefit NOT Formul
Slide 10: Unique Ophthalmic Delivery Platform
9 Unique Ophthalmic Delivery Platform
Slide 11: 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 12: EyeGate has the only Non-Invasive Solution
11 Edelhauser et al IOVS 2010 EyeGate has the only Non - Invasive Solution EyeGate® II Applicator
Slide 13: EyeGate Platform: A Non-Invasive Method of Propelling Charged Active 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 14: EyeGate II Delivery System: Substantial Benefits for Clinicians and Patients
13 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 ▪ Less travel for patient and companion not required to accompany
Slide 15: Clinical Pipeline and Use of Proceeds
14 Clinical Pipeline and Use of Proceeds Use of Proceeds ▪ Confirmatory Phase 3 anterior uveitis trial: $8 million ▪ First patient in by year - end 2015 and top - line data Q1 2017 ▪ Endothelial cell count safety trial: $2.4 million ▪ Remainder for working capital and other general corporate purpose
Slide 16: EGP-Anti-Inflammatory
15 EGP - 437 Anti - Inflammatory
Slide 17: EGP-437: A Potent Anti-inflammatory Agent
16 EGP - 437: A Potent A nti - inflammatory A gent (corticosteroid - dexamethasone phosphate) Uveitis Overview ▪ Inflammation of the uvea tract ▪ E stimated 17.6% experience transient or permanent loss of vision annually. ▪ Responsible for more than 2.8% of blindness in the U.S. ▪ Non - infectious a
Slide 18: Standard of care is patient administered corticosteroid eye drops
S tandard of care is patient administered corticosteroid eye drops • Topicals suffer from a number of drawbacks including low ocular bioavailability, rapid clearance and steroid - related side effects, including elevated intraocular pressure (IOP) EGP - 437: A Highly Differentiated Product Dramatica
Slide 19: Importance of Treatment Regimen
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 - Inflammatory Therapeutics OD 20/ 400 Legally Blind OS No Light Perception “Blind
Slide 20: Initial Phase 3 Non-Inferiority Anterior Uveitis Trial
Initial Phase 3 Non - Inferiority A nterior U veitis Trial Severity and Primary Endpoint 19 Severity of Uveitis: SUN Working Group ▪ Confirmation and severity of disease is determined by the number of white blood cells in the anterior chamber of the eye (Slit - lamp is used) ▪ The Standardization of
Slide 21: Initial Phase 3 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 22: Similar Outcome to Standard-of-Care
Similar Outcome to Standard - of - Care 21 Percent of subjects* that achieved primary endpoint *ITT = Intent to Treat 43.2% 25.0% 41.4% 20.5% 0% 5% 10% 15% 20% 25% 30% 35% 40% 45% 50% SUN 1 & 2: 11 to 25 cells SUN 2 & 3: > 26 cells Percent that Achieved PEP Ratio that Achieved PEP per Arm (ITT Popul
Slide 23: Safety: Intraocular Pressure
22 Safety: Intraocular Pressure ▪ 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 standard - of - care control arm
Slide 24: FDA Meeting and Modified Phase 3 Trial
▪ FDA provided guidance and we believe that if the planned Phase 3 trial meets non - inferiority criteria, data from this trial along with data from the previously completed Phase 3 trial this will be sufficient to support a New Drug Application (“NDA”) filing. ▪ FDA also communicated and we believe
Slide 25: Macular Edema Trial Design
▪ An abnormal thickening of the macula associated with the accumulation of excess fluid in the extracellular space of the neurosensory retina ▪ Considered the leading cause of central vision loss in the developed world ▪ Open - label , multi - center, Phase 1b / 2a clinical trial ▪ Up to 20 patients
Slide 26: EGP-437 Commercial Strategy
25 ▪ Licensing Agreement with Valeant Pharmaceuticals ( NYSE/TSX : VRX) ▪ Exclusive license to manufacture, sell, distribute and commercialize throughout the world for use in the field of uveitis ▪ Exclusive license to develop the product in the field of uveitis outside of the U . S . ▪ Upfront cash
Slide 27: Single-Use Kit and Reimbursement
26 ▪ 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 28: Strong Patent Portfolio
27 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 29: Evolution of a Platform: Applicator
28 ▪ 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 30: Evolution of a Platform: Generator
29 ▪ 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 31: Ophthalmology Companies Valuation
OPHTHALMOLOGY COMPANIES 14 - Jul - 15 Company Ticker Focus Stage of Lead Product Share Price Valuation (Millions) Avalanche Biotechnologies, Inc. AAVL Gene Therapy Phase 1/2 $16.55 $422 Ocular Therapeutix, Inc. OCUL Drug Delivery Commercial $21.11 $522 Applied Genetic Technologies AGTC Gene Therapy
Slide 32: Pre-Offering Capitalization Structure
31 Pre - Offering Capitalization Structure Capitalization Shares Outstanding % Outstanding Common Stock 6,404,354 75.3% Stock Options* 1,467,824 17.2% Warrants 637,980 7.5% Fully - Diluted Shares Outstanding 8,510,156 100.0% * Includes all options outstanding under our 2005 and 2014 Equity Incentive
Slide 33: Investment Highlights
32 Investment Highlights ▪ Phase 3 program with clear path to commercialization ▪ First Phase 3 trial completed ▪ Potent drug with proven safety profile when delivered by our system ▪ Mitigates corticosteroid side - effect, elevated IOP ▪ Eliminates non - compliance issue ▪ Medical Benefit NOT Formu