Kiora Pharmaceuticals, Inc. · NASDAQ:KPRX
Kiora Pharmaceuticals — EyeGate Pharmaceuticals — Investor Presentation (June 2020)
28 slides from Kiora Pharmaceuticals's investor presentation, Jun 1, 2020
Slide 1: Corporate Presentation
NASDAQ: EYEG Corporate Presentation
Slide 2: Forward-looking statements
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 tri
Slide 3: EyeGate Pharma: Company Highlights
3 EyeGate Pharma: Company Highlights Nasdaq: EYEG » EyeGate is NASDAQ listed; went public in 2015 » Product under development, OBG, is an eye drop formulation of modified hyaluronic acid (HA) ▪ Currently being developed for two indications: wound healing and dry eye » HA is a natural substance in th
Slide 4: OBG: A Therapeutic Lubricant
OBG: A Therapeutic Lubricant » OBG supports corneal health and protects/treats the eye » OBG is a crosslinked or chemically modified version of the natural polymer hyaluronic acid (“HA”) ▪ HA has a high viscosity that promotes wound healing and provides hydration and lubrication ▪ Crosslinking stabi
Slide 5: OBG: Wound Healing and Dry Eye
OBG: Wound Healing and Dry Eye » Recently, demonstrated statistical significance in a pivotal study against a bandage contact lens for the acceleration of wound healing in patients undergoing PRK surgery (9mm epi defects) ▪ Development for this indication complete; preparing de novo filing » OBG has
Slide 6: The OBG Franchise
» OBG Stand - Alone Device ▪ Wound Healing: Development completed for wound healing (post PRK surgery) ▪ Completing manufacturing testing required to file de novo application ▪ Targeting filing de novo application by end of 2020 ▪ Dry Eye: FDA meeting scheduled for July 13 to discuss moving into piv
Slide 7: OBG: Dry Eye Follow-on Pilot Study
• Follow - on Pilot Study OBG: Dry Eye
Slide 8: Punctate Epitheliopathy and Dry Eye
Punctate Epitheliopathy and Dry Eye » 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 of c
Slide 9: Focusing on the Moderate Dry Eye Patient Population
Focusing on the Moderate Dry Eye Patient Population » Approximately 18 million diagnosed with dry eye in the U.S. 1 » Severe Population is well served: 1.4 million patients diagnosed with 62% actively taking Rx anti - inflammatory drops and 94% of these patients are also taking OTC lubricant drops »
Slide 10: Dry Eye Study Design (PE-042)
» 20 patients and 40 eyes as both eyes must qualify for study randomization » Investigator masked with positive - control » Patient acted as own control; one eye randomized to OBG and one eye randomized to Refresh® » 7 day run - in period with all eyes taking Refresh QID, followed by 14 day QID trea
Slide 11: Dry Eye Study: Positive Results
» POSITIVE RESULTS ▪ Objectives – corneal health, tear film and vision • All OBG assessments support central cornea healing (Staining, HOA, TFBUT and BCVA) ▪ OBG outperforms in central cornea staining with a 25% improvement from baseline vs only 15% for Refresh® • Supports data seen in first study w
Slide 12: OBG: Dry Eye Study Treatment Assessments
OBG: Dry Eye Study Treatment Assessments • Corneal Staining • High Order Aberrations (HOA) • Best Corrected Visual Acuity (BCVA)
Slide 13: Fluorescein Stain: Central Corneal
13 Fluorescein Stain: Central Corneal » NEI Composite Corneal Staining Score: Central Cornea Quadrant Staining Very Important for Vision 13
Slide 14: Healing the Central Region of the Cornea
» All 5 corneal regions assessed but central region of cornea is most important as it covers pupil region » Responsible for vision quality and corneal sensitivity » Central corneal staining demonstrated a positive treatment effect at Day 7 and Day 14 » At Day 14, OBG had a strong improvement from ba
Slide 15: Central Region: Treatment Effect Stronger
» Enrollment based on Total Corneal Staining » 3 subjects (of the 20 enrolled) had a zero score in staining of central region of the cornea in at least 1 eye » Removing these subjects demonstrates a much stronger positive treatment effect for OBG for central region of cornea » The treatment effect i
Slide 16: Central Region: Positive Response Repeated from First Study
16 OBG= Ocular Bandage Gel, RPF= Refresh Plus® Preservative Free (Refresh PF) » Staining improvement in central region of cornea was similar to first pilot study against vehicle (wetting drops) » Both studies demonstrated that OBG works quickly, with a treatment effect of 0.13 and 0.16 at Day 7 agai
Slide 17: Comparing Staining: OBG vs XIIDRA
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 0.15 Xiidra Inferior Vehicle 0.17 OBG pilo
Slide 18: OBG: Dry Eye Study Post Application Assessments
OBG: Dry Eye Study Post Application Assessments • Vision Break - Up Time (VBUT) • Best Corrected Visual Acuity (BCVA)
Slide 19: Clinical Data Supporting Tear-Film Stability without Blurriness
19 » First clinical evidence demonstrating that OBG does not cause blurriness while residing on the ocular surface » Positive VBUT means tear - film more stable. This is expected while OBG resides on the ocular surface. While a very small sample size for VBUT 1 , this validates that OBG is staying o
Slide 20: Symptomology: From Study 1
» OBG achieved a 30% improvement (decrease) from baseline vs only 4% for control (vehicle) » OBG demonstrates fast onset with Statistical Superiority at Day 7, which continues through Day 28 Symptomology: From Study 1 20
Slide 21: OBG: Wound Healing
OBG: Wound Healing
Slide 22: PRK Surgery and Wound Healing Opportunity
» PRK is a surgical correction of refractive errors for patients who are not suitable candidates for LASIK due to: ▪ Inadequate corneal thickness, larger pupil size, dry eye, and anterior basement membrane disease » PRK involves controlled mechanical removal of corneal epithelium with subsequent las
Slide 23: Pivotal Study Design
» Clinical development complete ▪ Next step is to file de novo application for commercialization ▪ Completing manufacturing testing required to file Pivotal Study Design » Two - arm, controlled pivotal study masked via reading center ▪ OBG (crosslinked HA eye drop) vs. standard - of - care (bandage
Slide 24: Pivotal Study: Primary Endpoint of Accelerated Healing
» Comparator is SOC: Bandage contact lens (BCL) » Primary is percentage healed at Day 3 in each group » At day 3, 80% of study eyes receiving OBG were completely healed compared with 67% in the BCL group » Results in a p - value of 0.0203, in favor of OBG: OBG has demonstrated superiority over BCL »
Slide 25: Pivotal Study: Wound Size
Pivotal Study: Wound Size Wound size on average was 46% smaller for OBG subjects on day 2 » Day 2, the average wound size for all eyes treated with OBG was only 3.61mm 2 , compared to 6.66mm 2 for eyes treated with BCL » Day 2 is 48 hours post surgery and subjects have only taken 8 drops of OBG » Th
Slide 26: OBG: Combination Product
OBG: Combination Product
Slide 27: Combining Wound Healing with an Antibiotic
Large market opportunity: • 16 million Rx’s written annually in the U.S. 1 • Highly - differentiated product (wound healing device & antibiotic) Combining Wound Healing with an Antibiotic » OBG plus Moxifloxacin Hydrochloride ( Vigamox ) ▪ A 505(b)(2) filing requiring only one pivotal study for regi
Slide 28: Next Steps
Next Steps » Three FDA Meetings Requested • June 9 : Meeting with CDRH to discuss final packaging (manufacturing) • July 13 : Meeting with CDRH to discuss Dry Eye Pivotal Study • Aug 10 : pre - IND meeting requested with CDER to discuss combination product » PRK de novo filing : Completing manufactu
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