Kodiak Sciences Inc · NASDAQ:KOD
Kodiak Sciences — 42nd J.P. Morgan Healthcare Conference (January 2024)
30 slides from Kodiak Sciences's conference presentation, January 2024
Slide 1: The Ophthalmology Medicines Company
THE OPHTHALMOLOGY MEDICINES COMPANY 42nd J.P. Morgan Healthcare Conference January 2024
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,” “will,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar exp
Slide 3: 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 3
Slide 4: Where We Are Today
TARCOCIMAB TEDROMER • 3 positive Phase 3 studies in large indications: Diabetic Retinopathy (NPDR), Retinal Vein Occlusion (RVO) and wet AMD K O D I A K S C I E N C E S • Core differentiation based on science and evidence of durability • Planning towards one confirmatory pivotal study in 1H2024 usin
Slide 5: Kodiak aims to address multiple unmet needs within retinal disease
Kodiak aims to address multiple unmet needs within retinal disease therapy area with a diversified pipeline Antibody Biopolymer Conjugate (“ABC”) Platform-derived biologics Precision engineered for increased durability in high prevalence retinal diseases • A mono or bispecific protein therapeutic, e
Slide 6: Tarcocimab Tedromer
TARCOCIMAB TEDROMER KODIAK
Slide 7: Three successful Phase 3 studies in NPDR, RVO and wet AMD
Three successful Phase 3 studies in NPDR, RVO and wet AMD with compelling durability demonstrated Primary Extended Study design endpoint durability Signature durability • Superiority study NPDR • tarcocimab Q24W after 3 demonstrated with all initiating doses vs sham patients on 6-month dosing Ph
Slide 8: Tarcocimab's durability was consistently differentiated across the pivotal program
Across the pivotal program, tarcocimab’s durability was consistently differentiated. In multiple indications, it delivered on 5- to 6-month durability for the majority of patients RVO (BEACON Study) Wet AMD (DAZZLE Study)1 DME (GLEAM and GLIMMER Studies)2 Tarcocimab doubled the treatment ~60% of tar
Slide 9: Favorable safety profile with more than 2,400 patient years of exposure
Tarcocimab and the ABC Platform have demonstrated a favorable safety profile with more than 2,400 patient years of exposure across the full clinical program 5 Rates of intraocular inflammation (IOI) across pivotal studies of anti-VEGF agents 4 Tarcocimab Faricimab Aflibercept 3 2.3% 2.2% 2.0% 2 1.2%
Slide 10: NPDR: superior efficacy with every 6-month dosing
In NPDR, tarcocimab established superior efficacy with every 6-month dosing and reduced the risk of developing sight-threatening complications by ~90% Results from the GLOW Phase 3 study in NPDR • Patients treated with tarcocimab received only 4 injections in Year 11 • Tarcocimab demonstrated superi
Slide 11: RVO: strong durability, matched efficacy, comparable safety
In RVO, tarcocimab demonstrated strong durability, matched efficacy and comparable safety profile with fewer doses than aflibercept Results from the BEACON Phase 3 study in RVO • Tarcocimab Q8W was non-inferior to aflibercept Q4W in all RVO patients at 6 months, thereby doubling the treatment interv
Slide 12: Wet AMD: monthly dosing favorable safety and non-inferior efficacy
In wet AMD, monthly dosing of tarcocimab demonstrated a favorable safety profile and non- inferior efficacy profile, supporting monthly dosing and wet AMD indication in label Results from the DAYLIGHT Phase 3 study in wet AMD Tarcocimab on intensive Continued dosing through Year Tarcocimab dosed mon
Slide 13: Tarcocimab's breadth of indications and commercial opportunity
Tarcocimab’s breadth of indications, differentiation (science of durability), and a thoughtful commercial strategy may translate into meaningful commercial opportunity The branded anti-VEGF market continues to grow, making room for more differentiated branded therapies • The branded anti-VEGF market
Slide 14: Tarcocimab tedromer in summary
Tarcocimab tedromer in summary • Across the entire tarcocimab clinical program, tarcocimab and the ABC Platform demonstrated consistent and differentiated durability as well as favorable safety • Successful pivotal data demonstrated in NPDR, RVO and wet AMD. Plan to initiate an additional pivotal st
Slide 15: KSI-501
Negative-stain electron microscopy images of KSI-501ABC KSI-501ABC KSI-501ABC + VEGF VEGF anti-IL6 VEGF Trap Fab KSI-501 Fc anti-IL6 Fab Fc Biopolymer Biopolymer In the absence of VEGF, VEGF Upon VEGF binding, VEGF trap arms are not seen trap arms are oriented in an optimal configuration and become
Slide 16: Anti-IL-6 & Anti-VEGF Dual Inhibition
K S I - 5 0 1 : F I R S T - I N - C L A S S B I S P E C I F I C M O L E C U L E T O U N L O C K A N E W C A T E G O R Y ANTI-IL-6 & ANTI-VEGF DUAL INHIBITION A new category of retinal medicine: to address inflammation and the underlying inflammatory cascade present in many patients SUPERIOR MOLECULA
Slide 17: Patient variability observed with anti-VEGF monotherapy
Substantial patient-to-patient variability is observed with anti-VEGF monotherapy BCVA change from baseline during year 1 for OCT CST change from baseline during year 1 for individual patients treated with Q8W aflibercept individual patients treated with Q8W aflibercept OCT CST change from baseline
Slide 18: KSI-501 bispecific protein unique design
KSI-501 bispecific protein features unique design “Two hands on the ball” that enables highly efficient binding to both IL-6 and VEGF ENHANCED BINDING CAPACITY Each molecule has the ability to Both arms inhibit multiple targets, inhibit up to two VEGF molecules, unlike the canonical bispecific depen
Slide 19: KSI-501P and KSI-501ABC preclinical potency vs aflibercept and vamikibart
KSI-501P and KSI-501ABC demonstrate comparable VEGF binding affinity and potency to REGN aflibercept and comparable IL-6 potency as Roche vamikibart Key disease drivers in retinal Aflibercept Vamikibart (anti-IL-6 mAb) KSI-501P & KSI-501ABC^ diseases Inflammation Angiogenesis Barrier function Vascul
Slide 20: Effect on barrier biology in preclinical studies
Powerful effect on barrier biology: KSI-501ABC inhibits angiogenesis and normalizes inner and outer blood retinal barriers in preclinical studies • Inner blood-retinal barrier: leakage from vascular endothelium disruption leads to macular edema and hemorrhage1 • Outer blood-retinal barrier: RPE inte
Slide 21: Dual inhibition confers superior normalization vs monotherapy
Strong scientific rationale: dual inhibition of VEGF and IL-6 by KSI-501ABC confers superior normalization vs either anti-VEGF or anti-IL-6 monotherapy Normal Exogenous VEGF and IL-6 Tight junction disruption and changes in cell morphology Monotherapy Inhibition Dual inhibition No Inhibitors Afliber
Slide 22: KSI-501P
KSI-501P Unconjugated Bispecific Protein 24
Slide 23: High unmet need for safer, disease modifying therapies
High unmet need for safer, disease modifying therapies. The opportunity is primed for safe and effective biologics to move up the treatment pathway towards first line therapy Current treatment algorithm for retinal inflammatory diseases 1L: Local or systemic 2L: Immunomodulators 2L or 3L: Biologics
Slide 24: IL-6 plays a key role in retinal inflammatory diseases
IL-6 plays a key role in retinal inflammatory diseases and is a newly validated target for Uveitic Macular Edema (UME) treatment IL-6 levels are elevated in vitreous fluid of patients with active uveitis1,2,3 • Aqueous Humor IL-6 levels were further elevated in uveitis patients with cystoid macular
Slide 25: Adding anti-VEGF to anti-inflammatory agents may add benefit
The addition of anti-VEGF to anti-inflammatory agents may provide further clinical benefit in treatment of retinal inflammatory diseases • Role of VEGF is well established in VEGF levels are elevated in macular edema aqueous humor of uveitis patients with macular edema • VEGF levels are found to be
Slide 26: KSI-501ABC
KSI-501ABC Bispecific Antibody Biopolymer Conjugate 28
Slide 27: KSI-501ABC for high prevalence retinal diseases
KSI-501ABC for high prevalence retinal diseases: maintains signature durability of the ABC platform while benefiting from learnings of tarcocimab program • KSI-501ABC is currently in a Ph1 study in DME patients and aims to evaluate safety, tolerability and early signals of bioactivity; data is expec
Slide 28: Phase 1 study of KSI-501ABC completed enrollment in DME
Phase 1 study of KSI-501ABC has completed enrollment of DME patients; data to be shared at Angiogenesis, Exudation, and Degeneration 2024 virtual meeting Primary Endpoint: Ocular and systemic safety at Week 24 Results expected Feb 2024 Study Design Key Inclusion Criteria • Multiple ascending dose de
Slide 29: KSI-501P and KSI-501ABC in summary
KSI-501P and KSI-501ABC in summary KSI-501P – unconjugated bispecific protein • Novel anti-IL-6 and VEGF trap bispecific protein being developed in retinal inflammatory diseases • Risk profile uncoupled from ABC platform-derived pipeline & defines a new market segment separate from the established a
Slide 30: Where We Are Today
K O D I A K S C I E N C E S WHERE WE ARE TODAY • Pipeline of three clinical prospects moving forward expeditiously to achieve pivotal value inflections in 2 - 3 years • $346M in cash and cash equivalents as of the end of 3Q23 • Maturing investments in retina product platforms and technology to enabl
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