Kiora Pharmaceuticals, Inc. · NASDAQ:KPRX
Kiora Pharmaceuticals — Investor Presentation (January 2022)
31 slides from Kiora Pharmaceuticals's investor presentation, January 2022
Slide 1: Corporate Overview
CORPORATE OVERVIEW January 2022
Slide 2: Forward Looking Statements
Forward Looking Statements Some of the statements in this press release are “forward-looking” and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These “forward-looking” statements include statements relating to, among other things, the develop
Slide 3: Addressing Unmet Needs in Eye Care
Addressing Unmet Needs in Eye Care Compelling Value Proposition Diversified Portfolio New Leadership – Renewed Focus Revolutionary small molecule with the potential to restore vision in patients ▪ Efficient investment to clinical inflection with inherited or age-related retinal degeneration points ▪
Slide 4: Pipeline
Pipeline Development Stage Product Therapeutic Category Indication Delivery Route Pre-clinical Phase 1 Phase 2 Phase 3 KIO-101 Ocular Manifestations of Ocular Surface Disease Eye Drop Rheumatoid Arthritis Segment Anterior KIO-201 Ocular Wound Healing PRK Surgical Recovery Eye Drop Posterior Segment
Slide 5: KIO-301: Small Molecule Photoswitch for Retinal Reanimation
KIO-301 Small Molecule Photoswitch for Retinal Reanimation 5
Slide 6: Retinitis Pigmentosa (RP) Disease Overview
Retinitis Pigmentosa (RP) Disease Overview Prevalence ▪ 1:3,000-1:5,000 (Orphan Disease) Etiology ▪ 50+ genetically distinct subtypes from 150+ mutations ▪ Inherited disease Clinical Presentation ▪ Night blindness, reduced visual field range and eventual loss of central vision ▪ Visual acuity declin
Slide 7: RP – How Retinal Degeneration Occurs
RP – How Retinal Degeneration Occurs RGC Bipolar Cell Rod Cone To the brain (connection intact) Bipolar cells and RGCs relay signal from rods and Photoreceptors (rods and cones) sense light cones to the brain, where the image is “processed” and pass the signal to special transmitting cells ▪ Normal
Slide 8: KIO-301 Turns RGCs “ON” in the Presence of Light
KIO-301 Turns RGCs “ON” in the Presence of Light 1. In RP, photoreceptors are no longer viable and therefore their companion “signal” cells (RGCs) are not capable of being activated or set to “OFF” 2. KIO-301 preferentially enters these “OFF” RGCs and turns them “ON” in the presence of light* KIO-30
Slide 9: Light Response Index
KIO-301: Light Intensity and Wavelength Moonlight Cloudy Day Sunlight 100w Incandescent Light Bulb Light Response Index Light Intensity (photons/cm2 · sec) Wavelength (nm) Sci. Rep. 7, 45487 (2017), Banghart, Trauner et al (2008) 9
Slide 10: KIO-301: Phase 1b Study Design
KIO-301: Phase 1b Study Design Open Label, Single Ascending Dose Trial – Royal Adelaide Hospital, Australia KIO-301 3 Patients (NLP/LP) Cohort 1 Day 1 Single IVT dosing (single eye) X µg Day 2, 4, 7, 14, 28 Safety, pK (plasma), and efficacy Worse eye 3 Patients (NLP/LP) KIO-301 Contralateral eye of
Slide 11: KIO-101: Potential 1st in Class Treatment for Ocular RA
KIO-101 Potential 1st in Class Treatment for Ocular Manifestations of Rheumatoid Arthritis (RA) 11
Slide 12: Ocular Involvement of RA Overview
Ocular Involvement of RA Overview Rheumatoid Arthritis (RA) is a chronic, systemic autoimmune disease that primarily effects joint linings, causing swelling, bone erosion and deformity ▪ No cure exists but symptoms can be managed with disease modifying medications ▪ DHODH inhibitors, IL-6, TNF-α ant
Slide 13: RA Ocular Signs & Symptoms are Mediated by T Cells
RA Ocular Signs & Symptoms are Mediated by T Cells KIO-101 acts upstream to inhibit proliferation of T helper cells (Th1 and Th17) in lymph node and on-site to suppress pro-inflammatory cytokine release Arch Ophthalmol. 2012 Jan;130(1):90-100 13
Slide 14: DHODH Inhibitors
DHODH Inhibitors Validated Drug Class for Autoimmune Diseases Company Drug Status* Market / Revenue ~$2.5B annual revenue Arava (leflunomide) On market for RA Low selectivity and potency results in off-target side effects Sanofi Aubagio (teriflunomide) On market for MS ▪ Safety concerns of severe li
Slide 15: KIO-101: Exploratory Phase 1b Ocular Surface Inflammation Trial
KIO-101: Exploratory Phase 1b Ocular Surface Inflammation Trial Dose Escalation Cohort 1: KIO-101 (0.05%) Enrolled healthy volunteers Cohort 2: KIO-101 (0.15%) (N=24, 8/cohort) Key Inclusion Criteria Cohort 3: KIO-101 (0.30%) ▪ Ocular surface inflammation defined by OSDI of at least 22 Day 1 Days 8-
Slide 16: Safety Analysis – Summary Statistics Table
Safety Analysis* – Summary Statistics Table (p values) All Actives (healthy only) Cohort 4 Only: Active vs vs Vehicle Vehicle Key Takeaways AEs 0.6653 0.3615 SAEs** NC NC Topical KIO-101 at low and mid doses tested is safe & well Ocular AEs 0.2500 0.3371 tolerated in both healthy subjects and those
Slide 17: Conjunctival Hyperemia (sign)
Conjunctival Hyperemia (sign) P = 0.006 Key Finding • Hyperemia was a key inclusion criteria • 100% of subjects on active experienced improvement @ D13 • Hyperemia is an 0 acceptable endpoint as a ‘sign’ for US FDA p value calculated using Fisher’s Exact Test 17
Slide 18: Change In Hyperemia By Day
Change In Hyperemia By Day Drug Effect Encouraging to see drug effect increase & decrease. Day 20 is 8 days following last dose. 18
Slide 19: Top-Line Data: OSDI
Top-Line Data: OSDI • Inclusion criteria was OSDI > 22 • OSDI measured @ screen & D11 • Active demonstrated small trend toward significance 19
Slide 20: KIO-201: Accelerating Ocular Surface Wound Healing
KIO-201 Accelerating Ocular Surface Wound Healing 20
Slide 21: Ocular Surface Diseases
Ocular Surface Diseases Wounds: Surgery Wounds: Trauma ~5 million US patients ~2 million US patients 9% Refractive surgeries (e.g., PRK) 3% Injuries/abrasions Cataracts Chemical burns Collagen cross-linking Difficult to heal PED/ulcers Epitheliopathies: Dry Eye Epitheliopathies: Non-Dry Eye 35% ~18
Slide 22: Refractive Surgery Overview
Refractive Surgery Overview PRK The Unmet Need The Opportunity ▪ PRK is a surgical correction of refractive ▪ While PRK yields superior visual ▪ Enabling the epithelium to heal faster errors for patients who are not suitable results, complications include: may mitigate peri-operative candidates for
Slide 23: KIO-201
KIO-201 ▪ KIO-201 is based on a modified form of the natural polymer hyaluronic acid (HA) ▪ HA is a material with a high viscosity that promotes wound healing by enabling enhanced cell migration ▪ 5 clinical trials completed (3 PRK surgical recovery and 2 dry eye) > Approximately 400 eyes have been
Slide 24: PRK Study Design
PRK Study Design Randomize Enrolled patients KIO-201 (QID – Eye Drop) Screening Measure differences undergoing PRK (n=234) in outcomes surgery (N=250) Standard-of-Care (Bandage Contact Lens) Day 0 Day 2 Day 3 Day 4 Week 2 PRK Surgery Fluorescein Stain Fluorescein Stain Fluorescein Stain Post-surgery
Slide 25: KIO-201 Demonstrated Superiority versus BCL
KIO-201 Demonstrated Superiority versus BCL Percent of Patients with Complete Mean Wound Size (mm2) Re-Epithelialization Day 3 (Mean ± SEM) *p < 0.05 (Mean ± SEM) 8 * Recurrent Erosion 7 *p < 0.01 100% 6 ▪ Only 1 (0.9%) study eye in 80% * 5 the KIO-201 group had recurrent erosion 4 ▪ 4 (3.5%) study
Slide 26: Corporate Overview
Corporate Overview 26 &KIORA
Slide 27: Executive Team
Executive Team Brian M Strem, PhD Sarah Romano, CPA Eric J Daniels, MD, MBA President & CEO Chief Financial Officer Chief Development Officer Brenda Mann, PhD Stefan Sperl, PhD Angela Dentiste, MBA VP – Research EVP – CMC & Operations VP – Clinical Operations 27
Slide 28: Board of Directors
Board of Directors Paul Chaney Stephen From Ken Gayron Lead Independent Director Executive Chairman David Hollander, MD, MBA Aron Shapiro Praveen Tyle Brian M Strem, PhD President & CEO 28
Slide 29: Scientific Advisory Board
Scientific Advisory Board Allen Ho, MD, PhD Christine Kay, MD, PhD Russel Van Gelder, MD, PhD Charlie Wykoff, MD Vitreo Retinal ASSOCIATES Daniel Durrie, MD Paul Karpecki, OD, FAAO Francis Mah, MD Victor Perez, MD 29
Slide 30: Key Expected 2022 Milestones
Key Expected 2022 Milestones KIO-301 ODD KIO-301 Ph1b FPI KIO-301 Ph1b Interim Data KIO-201 Regulatory Path Clarity* KIO-101 Ph2 FPI Q1 Q2 Q3 Q4 KIO-301 pIND KIO-301 Ph1b Approval * - After regulatory clarity from FDA, will seek commercial partnership 30 FPI – First Patient In, ODD – Orphan Drug Des
Slide 31: Contact
Contact: [email protected]
Kiora Pharmaceuticals — Investor Presentation (January 2022) on 6ix