Kiora Pharmaceuticals, Inc. · NASDAQ:KPRX
Kiora Pharmaceuticals — Eyegate Pharmaceuticals — Investor Presentation (December 2018)
26 slides from Kiora Pharmaceuticals's investor presentation, Dec 12, 2018
Slide 1: Corporate Presentation: Two Versatile Platforms Moving Towards Commercialization
NASDAQ: EYEG Corporate Presentation Two Versatile Platforms Moving Towards Commercialization December 2018
Slide 2: 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 OBG and EGP - 437 product candidates , for the timing and outcome of the Company’s clinical trial
Slide 3: Company Highlights
Two ophthalmic platform technologies: CMHA - S and Iontophoresis drug delivery CMHA - S platform (cross - linked Hyaluronic Acid) – first product is an eye drop formulation (OBG) OBG eye drop regulated as a device, accelerating the product development plan and time to market, with FDA filing expecte
Slide 4: CMHA-S Platform Ocular Bandage Gel (OBG) Eye Drop
CMHA - S Platform Ocular Bandage Gel (OBG) Eye Drop
Slide 5: OBG: A Differentiated Product on a Rapid Path to Approval
5 OBG: A Differentiated Product on a Rapid Path to Approval Proprietary Formulation of a Known and Trusted Substance Creates a Unique and Differentiated Product » Following a medical device pathway, filing expected in 2019 » Unique crosslinked HA produces a preservative - free, high concentration (0
Slide 6: Hyaluronic Acid (HA)
6 Hyaluronic Acid (HA) HA is a Naturally Occurring Molecule that Possesses Beneficial Properties Hyaluronic Acid » Non - immunogenic: does not illicit an immune response » Binds up to 1,000 times its volume in water weight providing hydration and lubrication ideal for the ocular surface » Contribute
Slide 7: Ocular Bandage Gel (OBG) Eye Drop: Unique Cross-Linked Formulation
Ocular Bandage Gel (OBG) Eye Drop OBG is Differentiated by its Unique Cross - Linked, High Concentration (0.75%) Formulation of HA The unique cross - linked HA creates a 3D structure that stabilizes the molecule providing: Hyaluronic Acid Hyaluronic Acid Hyaluronic Acid 7 » A scaffolding matrix whic
Slide 8: OBG Eye Drop: Efficacy of CMHA-S in Animal Conditions
8 » A clear, viscous, preservative - free eye drop containing a high concentration (0.75%) of crosslinked hyaluronic acid (CMHA - S) » A long - acting lubricant that protects the corneal surface to promote healing and reduce staining associated with Punctate Epitheliopathies in dry eye patients » De
Slide 9: Broad Market Opportunity
PE (non - dry eye) ~45.0 million Epithelial injury (exposure) ~16.0 million Ocular trauma ~1.8 million Surgery ~1.0 million Broad Market Opportunity 9 Wounds: Surgery • Refractive surgeries (PRK) • LASIK • Collagen cross - linking Wounds: Trauma • Injuries / Abrasions • Chemical burns • Difficult to
Slide 10: Increasing Prevalence of Dry Eye Disease with Favorable Economics
10 Increasing Prevalence of Dry Eye Disease with Favorable Economics 1. Gayton JL. Clin Ophthalmol . 2009;3:405 - 12.; 2. Report of the international dry eye workshop (DEWS). Ocul Surf. 2007;5(2):65 - 204.; 3. Allergan Dry Eye Survey, American Optometric Association, November 6, 2011. Dry Eye Diseas
Slide 11: Near-Term Milestones
Near - Term Milestones 11 Program Disease Area Q4 2018 Q1 2019 OBG Eye Drop Cross - linked Hyaluronic Acid Large Corneal Wounds: Photorefractive Keratectomy (PRK) 2 nd Clinical Study Completed Pre - Submission Meeting with FDA (CDRH) Punctate Epitheliopathies (PE): e.g. Dry Eye, Contact Lens Wear, e
Slide 12: Positive Clinical Trial Results: First Human Trial in PRK Patients
Positive Clinical Trial Results 12 Completed First Human Clinical Trial in PRK Patients Healed Wound on Day 3 Day 1 Day 3 Number of Subjects Per Arm Number Percent Horizontal* Vertical* Horizontal Vertical Arm 1 Ocular Bandage Gel 12 10 83.3% 4.1 4.5 0.1 0.2 Arm 2 Ocular Bandage Gel + Bandage Contac
Slide 13: Second PRK Pilot Study
13 Second PRK Pilot Study
Slide 14: PRK Study Design Schematic
Photorefractive Keratectomy (PRK) Study Design Schematic Objective is to demonstrate re - epithelialization of large corneal epithelial defects 14 Additional study for patients that have undergone bilateral Photorefractive Keratectomy (PRK) • 45 subjects (3 arms): OBG (2 dosing regimens) vs standard
Slide 15: Positive Data Confirms Results from First Pilot Study
Positive Data Confirms Results from First Pilot Study 15 OBG Outperformed the Standard of Care in Wound Healing in Second Pilot Study Number of Healed Eyes using OBG vs. Standard of Care Group 1 (N = 15) Group 2 (N = 15) Control Group (N = 15) Day 3 11 13 10 Day 4 15 15 13 Ocular Bandage Gel: % Bett
Slide 16: PRK Wound Size Dramatically Improved using OBG
PRK Wound Size Dramatically Improved using OBG 16 Group 1 (N = 15) Group 2 (N = 15) Control Group (N = 15) Day 2 3.07 3.91 4.15 Day 3 0.10 0.19 0.16 Day 4 0.00 0.00 0.33 Day 14 0.00 0.00 0.00 Average Wound Size (mm 2 ) Day 2 (48 hours post surgery) average wound size 26% and 6% smaller than the Cont
Slide 17: PE Pilot Study
PE Pilot Study aN EyeGate 7 —
Slide 18: Punctate Epitheliopathy (PE) Study Design Schematic
Punctate Epitheliopathy (PE) Study Design Schematic Objective is to establish safety, tolerability and determine a clinically meaningful efficacy outcome 18 • 30 subjects (2 arms): 4 week treatment period of OBG vs rewetting drops • 2 week screening period: patients stop taking Rx eye drops and rece
Slide 19: PE Study Showed Positive Data
Punctate Epitheliopathy (PE) Study Showed Positive Data Statistically significant improvement in symptoms** by Day 7 19 * Wilcoxon Two - Sample Test OBG achieved a 30% decrease from baseline vs only 4% for control OBG demonstrates fast onset with SS p - Value at Day 7 and continues through Day 28 **
Slide 20: PE Pilot Study Results: Staining
Punctate Epitheliopathy (PE) Pilot Study Results: Staining 20 Central Cornea 1 Quickly Improves and Continues to Perform 1) Central Cornea important for visual field 2) Combined Data = Study eye + non - study eye » This data supports and correlates with symptomology due to high concentration of nerv
Slide 21: Iontophoresis Platform EyeGate II Delivery System and EGP-437
Iontophoresis Platform EyeGate® II Delivery System and EGP - 437
Slide 22: EyeGate II Delivery System and EGP-437
EyeGate® II Delivery System and EGP - 437 22 A Non - Invasive Method of Propelling Charged Active Compounds into Ocular Tissues EGP - 437 , a reformulated corticosteroid, Dexamethasone Sodium Phosphate is delivered into the ocular tissues through EyeGate’s proprietary innovative drug delivery system
Slide 23: Exclusive Licensing Agreement with Bausch Health
Exclusive Licensing Agreement with Bausch Health (Formerly Valeant Pharmaceuticals) 23 Worldwide License to Manufacture, Sell, Distribute, and Commercialize EGP - 437 with the EyeGate® II Delivery System for Uveitis and Post - Operative Ocular Inflammation and Pain $136.5 million in potential paymen
Slide 24: EGP-437 Clinical Data Results: Inflammation Post Cataract Surgery
24 EGP - 437 Clinical Data Results Inflammation Post Cataract Surgery Phase 2 Clinical Trial Double - masked, placebo - controlled, two - arms, 101 subjects 5.9% 13.7% 27.5% 43.1% 52.9% 4% 10% 24% 32% 36% Day 1 Day 4 Day 7 Day 14 Day 28 EGP-437 (N=51) Vehicle (N=50) Proportion with Total Cell Cleari
Slide 25: Company Highlights
Two ophthalmic platform technologies: CMHA - S and Iontophoresis drug delivery CMHA - S platform (cross - linked Hyaluronic Acid) – first product is an eye drop formulation (OBG) OBG eye drop regulated as a device, accelerating the product development plan and time to market, with FDA filing expecte
Slide 26: Thank You / Contact Us
Thank You NASDAQ: EYEG Contact Us Joseph Green Edison Advisors Investor Relations Tel: (646) 653 - 7030 E - mail: jgreen@edisongroup.com
Eyegate Pharmaceuticals — Investor Presentation (December 2018) on 6ix