Kiora Pharmaceuticals, Inc. · NASDAQ:KPRX
Kiora Pharmaceuticals — EyeGate Pharmaceuticals — Investor Presentation (September 2020)
27 slides from Kiora Pharmaceuticals's investor presentation, Sep 14, 2020
Slide 1: Corporate Presentation September 2020
NASDAQ: EYEG Corporate Presentation September 2020
Slide 2: Forward-looking statements
TB D 2 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
Slide 3: EyeGate Pharma: Company Highlights
TB D 3 EyeGate Pharma: Company Highlights Clinical - stage ophthalmology company focused on developing products for the treatment of ocular disorders Main platform and intellectual property is based on modifying hyaluronic acid (“HA”) Lead product from the platform is the Ocular Bandage Gel (“OBG”)
Slide 4: OBG Eye Drop: A Therapeutic Lubricant
OBG Eye Drop: A Therapeutic Lubricant 4 OBG is a preservative - free eye drop that promotes corneal health by providing a protective barrier on the ocular surface. Key ingredient is a crosslinked or chemically modified version of hyaluronic acid (“HA”) • HA is a natural substance found in the body,
Slide 5: Product Development Pipeline
TB D 5 Product Category Indication Pre - Clinical Pilot / Phase 2 Pivotal / Phase 3 FDA Filing Commercial OBG Wound Healing Post PRK Surgery Punctate Epitheliopathies Moderate / Severe Dry Eye MoxiGel Infectious Disease Bacterial Conjunctivitis Clinical Development Completed Moving into Pivotal Stud
Slide 6: Key Development Milestones
TB D 6 Product Indication 2020 2021 2H 1H 2H OBG Wound Healing Post - PRK File de novo Application de novo Clearance & Launch Preparation Punctate Epitheliopathies (Moderate / Severe Dry Eye) File IDE Pivotal Study First Patient In & Study Execution Top - line Data & File de novo Application MoxiGel
Slide 7: OBG Stand-Alone Device Market Opportunity
TB D 7 OBG Stand - Alone Device Market Opportunity There are over 50 million potential patients with corneal wounds or epitheliopathies in the United States. Source: American Academy of Ophthalmology (https://www.aao.org/newsroom/eye - health - statistics) OBG drops are being developed to address op
Slide 8: OBG Combination Product (MoxiGel) Market Opportunity
TB D 8 OBG Combination Product (MoxiGel) Market Opportunity 1 IMS Health (Division of IQVIA) MoxiGel has the potential to become the first eye drop that both accelerates healing and includes an antibiotic. Antibiotic eye drops are widely prescribed to help treat the following: ▪ Conjunctivitis ▪ Wou
Slide 9: OBG Commercialization Strategy
TB D 9 OBG Commercialization Strategy • Wound healing at ~$100 per 5mL fill (one - time use) • PE (dry eye) at ~$140 per 10mL fill (monthly supply) Anticipated Net Selling Price per unit • Scale - up: completing increase from 40L to 200L batch size • Packaging: FDA agreed on use of multi - dose pres
Slide 10: OBG: Wound Healing in patients who have undergone PRK surgery
10 OBG: Wound Healing in patients who have undergone PRK surgery
Slide 11: Refractive Market Opportunity for Wound Healing
TB D 11 Refractive Market Opportunity for Wound Healing What Is PRK? • PRK is a surgical correction of refractive errors for patients who are not suitable candidates for LASIK due to: o Inadequate corneal thickness o Larger pupil size o Dry eye o Anterior basement membrane disease • PRK involves con
Slide 12: Pivotal Study Design
TB D 12 Pivotal Study Design Enrolled patients undergoing PRK surgery (N=250) Day 0 PRK Surgery Week 2 Post - surgery Follow - up Measure differences in outcomes Screening (n=234) OBG (crosslinked HA eye drop) Standard - of - care (bandage contact lens) Randomize Day 2 Fluorescein Stain Day 3 F luor
Slide 13: OBG Demonstrated Superiority Versus BCL In Pivotal Study
TB D 13 PRIMARY ENDPOINT Percentage healed at day 3 in each group without a recurrent erosion RECURRENT EROSION Only 1 (0.9%) study eye in the OBG group had a recurrent erosion; there were 4 (3.5%) in the BCL group DAY 3 RESULTS At day 3, 79% of study eyes receiving OBG were completely healed compar
Slide 14: Wound Size On Average Was 46% Smaller For OBG Patients On Day 2
TB D 14 Wound Size On Average Was 46% Smaller For OBG Patients On Day 2 3.6 0.2 0.1 6.7 1.1 0.3 0.0 1.0 2.0 3.0 4.0 5.0 6.0 7.0 Day 2 Day 3 Day 4 Wound Size - Both Eyes (mm 2 ) DAY 2 WOUND SIZE Average wound size in the OBG arm was half that of the control arm (3.6mm 2 vs. 6.7mm 2 , respectively) Th
Slide 15: OBG: Punctate Epitheliopathies in patients who have moderate and severe dry eye
15 OBG: Punctate Epitheliopathies in patients who have moderate and severe dry eye
Slide 16: Punctate Epitheliopathies
TB D 16 What Is Punctate Epitheliopathy? ▪ Punctates are a sign of epithelial compromise (corneal barrier disruption) and is characterized by a breakdown of the epithelium of the cornea and an increased permeability to fluorescein dye ▪ Corneal barrier disruption is associated with an increased risk
Slide 17: Major Opportunity In The Dry Eye Patient Population
TB D 17 Mild Moderate Severe Total 9.0M 7.6M 1.4M 18.0M 50% 42% 8% 100% Major Opportunity In The Dry Eye Patient Population 1 Global Data. Dry Eye Syndrome Drug Forecast and Market Analysis to 2026. Published June 2018. Year 2020 data. Mild Patient Population Mild population does not require healing
Slide 18: Pilot Study Design
TB D 18 Pilot Study Design Day 0 Measure differences in outcomes Screening (n= 40 eyes) OBG (crosslinked HA eye drop) Standard - of - care (Refresh® Plus Preservative - Free Lubricant) Randomize Day 7 Fluorescein Stain 1 ° Endpoint Study Design • Two - arm, randomized, positive - controlled, investi
Slide 19: Improvement of Central Cornea Staining
TB D 19 Improvement of Central Cornea Staining (NEI Scale 0 - 3) OBG Demonstrates Healing of the Central Region of the Cornea Central Cornea: NEI Score (Max=3) N=16 Subjects Per Group RPF OBG Average Baseline Score 1.44 1.63 Day 7 1.53 1.47 Change from Baseline 0.10 (0.16) Treatment Effect 0.25 Day
Slide 20: Comparing Staining: OBG vs. XIIDRA
TB D 20 OBG Central Region Xiidra Inferior Region Staining of the Inferior Region (below the pupil: does not affect vision) Staining of the Central Region (over the pupil: affects vision) Product Corneal Region Control Treatment Effect OBG Central Refresh Lubricant 0.31 Xiidra Inferior Vehicle 0.17
Slide 21: Clinical Data Supporting Tear-Film Stability Without Blurriness
TB D 21 VBUT: Vision Break - up Time; Using a HD Analyzer, it is a non - invasive method to determine Tear - Film Stability or Break - up Time BCVA: Best Corrected Visual Acuity First clinical evidence demonstrating that OBG does not cause blurriness while residing on the ocular surface A positive V
Slide 22: Pivotal Study Design
TB D 22 Pivotal Study Design Day 0 Measure differences in outcomes Run - in period (n=376 for randomization) OBG (crosslinked HA eye drop) Standard - of - care (Refresh® Plus Preservative - Free Lubricant) Randomize Day 7 Fluorescein Stain 1 ° Endpoint Study Design • Two - arm, randomized, positive
Slide 23: MoxiGel: Infectious Disease in patients with bacterial conjunctivitis
23 MoxiGel: Infectious Disease in patients with bacterial conjunctivitis
Slide 24: Upcoming Clinical Development Plan
TB D 24 Upcoming Clinical Development Plan FDA Confirmed ▪ Preclinical plan (i.e. only one 28 - day ocular tox study required for IND filing) ▪ Two well - controlled registration studies required (one can be the Phase 2b study) ▪ One of the two registration studies must include an arm for each of th
Slide 25: Next Steps
25 Next Steps
Slide 26: Recent Milestones and Next Steps
TB D 26 OBG demonstrated superiority over standard - of - care in wound healing pivotal study ▪ File de novo application by YE 2020 Completed 3 FDA meetings with positive outcomes ▪ Test new multi - dose preservative - free packaging for OBG ▪ File OBG IDE for pivotal punctate epitheliopathies study
Slide 27: Thank You
NASDAQ: EYEG THANK YOU Contact Joseph Green/Laine Yonker Edison Advisors for EyeGate Pharmaceuticals 646 - 653 - 7030/7035 jgreen@edisongroup.com / lyonker@edisongroup.com
EyeGate Pharmaceuticals — Investor Presentation (September 2020) on 6ix