Kodiak Sciences Inc · NASDAQ:KOD
Kodiak Sciences — J.P. Morgan Annual Healthcare Conference 2021
25 slides from Kodiak Sciences's conference presentation, Jan 11, 2021
Slide 1: The Ophthalmology Medicines Company: J.P. Morgan Annual Healthcare Conference
THE OPHTHALMOLOGY MEDICINES COMPANY J.P. Morgan Annual Healthcare Conference January 11, 2021
Slide 2: Special Note Regarding Forward-Looking Statements
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS These slides contain forward-looking statements and information. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and
Slide 3: Where We Are Today
K S I - 30 1 C L I N I C A L E X P E R IE N C E Clinical data from 1,500+ injections in 400+ patients representing 250+ patient-years of exposure in representative populations in wAMD, DME and RVO ▪ Safety: Tracking with current standard of care (Lucentis, Eylea) ▪ Efficacy: Strong and appropriate i
Slide 4: Our Mission
T H E O P H T H A L M O L O G Y M E D I C I N E S C O M P A N Y OUR MISSION 1 TRAILBLAZING 2 GENERATION 2.0 3 SINGULAR FOCUS IN SCIENCE MEDICINES OPHTHALMOLOGY Our creative and Our challenge to the Our 24 / 7 / 365 thoughtful foundation status quo 4
Slide 5: A Pipeline of ABCs for Retina
A PIPELINE MONOSPECIFIC 1 Molecule, 1 Target OF ABC S FOR Antibody conjugated to phosphorylcholine biopolymer RETINA KSI-301 inhibits VEGF— In Phase 3 clinical development BISPECIFIC 1 Molecule, 2 Targets Kodiak’s deepening pipeline Bispecific antibody conjugated to phosphorylcholine biopolymer of m
Slide 6: Focused on Developing ABC Medicines for High Prevalence Retinal Diseases
T H E O P H T H A L M O L O G Y M E D I C I N E S C O M P A N Y FOCUSED ON DEVELOPING ABC MEDICINES FOR HIGH PREVALENCE RETINAL DISEASES KSI-301 AND KSI-501 FOR RETINAL VASCULAR DISEASES A GROWING $11B MARKET WITH CLEAR UNMET NEEDS ▪ Wet age-related macular degeneration (wet AMD) remains a leading c
Slide 7: In Theory
F O C U S O N K S I - 3 0 1 Recommended dosing in first year: IN THEORY Ranibizumab Aflibercept 12 8 monthly bi-monthly after 3 monthly loading doses Intravitreal anti-VEGF PHASE III STUDY OFMARINA MONTHLY 1 ANTI-VEGF 1 agents improve & 10 Ranibizumab Lucentis 0.5 mg 0.5MG maintain vision when 5 Cha
Slide 8: In Practice by Country
F O C U S O N K S I - 3 0 1 Without continuous high-intensity treatment, vision IN PRACTICE loss can begin after only 3 months of anti-VEGF therapy. This pattern is seen globally and with all current medicines. …yet in the real word, 10 EUROPE 1 No. of injections MEAN CHANGE IN VA (N = 2,227 patient
Slide 9: Retinal Thickness on OCT
F O C U S O N K S I - 3 0 1 Bimonthly anti-VEGF therapy results in WHY? disease activity between doses due to insufficient durability. Current, Generation 1.0 AFLIBERCEPT VIEW STUDIES 1 agents do not control 0 disease for long enough Ranibizumab RETINAL THICKNESS ON OCT MEAN CHANGE IN CENTRAL monthl
Slide 10: Now What?
F O C U S O N K S I - 3 0 1 NOW WHAT? Today’s Generation 1.0 anti-VEGF agents are not good enough. Patients, physicians, and health systems struggle with the limitations of today’s Generation 1.0 medicines. A new class of Generation 2.0 intravitreal therapy is needed. 10
Slide 11: What profile may be required to meaningfully change the current paradigm?
F O C U S O N K S I - 3 0 1 What profile may be required to meaningfully change the current paradigm? Durability Potential Impact Maintenance Phase Loading Phase Efficacy Profile Safety Profile wAMD: >50% reach Q20W wAMD, DME, and RVO: Non- DME: >50% reach Q20W inferior to comparator Safety profile
Slide 12: Disruptive durability with an intravitreal biologic
F O C U S O N K S I - 3 0 1 Disruptive durability with an intravitreal biologic: 2/3 patients on a ≥6-month treatment-free interval at Year 1; ≥75% on ≥4-month interval Interval at YEAR 1 Wet AMD DME RVO N = 49 N = 32 N = 32 1 month (Q4W) 2% 3% 3% 2 months (Q8W) 16% 3% 9% 3 months (Q12W) 6% 9% 13% 4
Slide 13: Safety detail from Phase 1b open-label study
F O C U S O N K S I - 3 0 1 Safety detail from Phase 1b open-label study: Multiple dose exposure is well tolerated 130 697 160 + 121 96 Subjects dosed Total doses Patient-years Completed the Phase 1b subjects at Week 12 or later that Across the Phase 1a/1b program loading phase in have received all
Slide 14: ABC Platform
ANTIBODY BIOPOL YMER CONJUGATE ABC PLATFORM ™ Biologics precision-engineered for increased durability and efficacy SAME WHERE IT MATTERS o Clinically proven targets o Antibody-based biologic o Intravitreal: 25M+ injections annually +stable linkage = o Optically clear, no residues o Fast and potent c
Slide 15: Generation 2.0 Anti-VEGF
K S I - 3 0 1 : A N A N T I - V E G F A B C GENERATION 2.0 ANTI-VEGF KSI-301 KSI-301’s high molecular weight & formulation strength can provide an important dosing advantage Antibody Biopolymer Conjugate (ABC) Drug: RANIBIZUMAB AFLIBERCEPT BEVACIZUMAB (Lucentis) (Eylea) (Avastin) Recombinant Molecul
Slide 16: More Than the Sum of Its Parts
KSI-301 ANTIBODY BIOPOLYMER CONJUGATE “MORE THAN THE SUM OF ITS PARTS” Artistic representation Electron microscope of KSI-301 image of KSI-301 Class-leading Intraocular Excellent Retinal Deeper Inhibitory Fast Systemic Half-life1 Bioavailability2 Potency3 Clearance4 Primary human retinal cell-based
Slide 17: Our Goal with KSI-301
OUR GOAL Patient & Patient’s Family WITH KSI-301 Retina Specialist & Care Team Develop KSI-301 as a meaningfully Retina Practice Owner differentiated first-line treatment in each retinal vascular disease Payor Better meet the individual needs of Health System key stakeholders globally 17
Slide 18: We are developing KSI-301 to be first line in the major retinal vascular diseases
We are developing KSI-301 to be first line in the 4 major retinal vascular diseases Target enrollment exceeded Now Recruiting Enrollment Start 1Q 2021 Recruitment closed First patients randomized in GLEAM / GLIMMER and BEACON Planned Non-Proliferative Wet AMD Diabetic Macular Edema Retinal Vein Occl
Slide 19: Building Capacity to Supply Rapid Market Uptake
KSI-301 COMMERCIAL MANUFACTURING BUILDING CAPACITY TO SUPPLY RAPID MARKET UPTAKE Case study on market adoption Can Eylea market share growth educate KSI-301 adoption? Worldwide anti-VEGF revenue Expected Year 1 manufacturing capacity to supply Billions of USD 8 2.5M+ doses with the ability to flex u
Slide 20: Our 2022 Vision
OUR 2022 VISION WET AMD RETINAL VEIN OCCLUSION 2022 DAZZLE Phase 2b/3 top-line data 2022 BEACON Phase 3 top-line data 2022 BLA filing 2022 BLA filing DIABETIC MACULAR EDEMA 2022 GLEAM / GLIMMER Phase 3 top-line data 2022 BLA filing 2022 KSI-501 anti-VEGF/IL-6 THE OPHTHALMOLOGY 2021 IND submitted MED
Slide 21: Milestones and KSI-301 Development Acceleration
MILESTONES AND KSI -301 DEVELOPMENT ACCELERATION 2023 2022 KSI-301 2021 KSI-301 • Potential regulatory KSI-301 2020 • DAZZLE wAMD pivotal study top-line readout approval for wAMD, DME • Presentation of one-year and RVO in US and EU KSI-301 Phase 1b results in wet • RVO pivotal study AMD, DME and RVO
Slide 22: KSI-301 Accelerated Development Strategy
KSI-301 Accelerated Development Strategy 4 Pivotal Studies to support BLA with All 3 Major Anti-VEGF Indications Run Concurrently 2019 2020 2021 2022 2023 Phase 1b 121 treatment-naïve wAMD, DME, RVO patients Ongoing Safety, efficacy, durability - 18 months follow-up DAZZLE ~550 treatment naïve patie
Slide 23: Conclusion
Conclusion — 23
Slide 24: Where We Are Today
K S I - 30 1 C L I N I C A L E X P E R IE N C E Clinical data from 1,500+ injections in 400+ patients representing 250+ patient-years of exposure in representative populations in wAMD, DME and RVO ▪ Safety: Tracking with current standard of care (Lucentis, Eylea) ▪ Efficacy: Strong and appropriate i
Slide 25: The Ophthalmology Medicines Company
THE OPHTHALMOLOGY MEDICINES COMPANY
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