Kodiak Sciences Inc · NASDAQ:KOD
Kodiak Sciences — Jefferies Global Healthcare Conference 2024
28 slides from Kodiak Sciences's conference presentation, June 2024
Slide 1: Jefferies Global Healthcare Conference June 2024
NASDAQ: KOD KODIAK.COM MEDICINES COMPANY Jefferies Global Healthcare Conference June 2024
Slide 2: Special Note Regarding Forward-Looking Statements
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS These slides contain “forward-looking statements.” Forward-looking statements are based on our current expectations of future events and are subject to risks and uncertainties that could cause actual results to differ materially and adversely from th
Slide 3: The Ophthalmology Medicines Company
THE OPHTHALMOLOGY MEDICINES COMPANY OUR MISSION |] TRAILBLAZING 2 “GO-TO” 3% SINGULAR FOCUS IN SCIENCE MEDICINES OPHTHALMOLOGY Our creative and Our challenge to the Our 24/7/365 thoughtful foundation status quo KODIAK
Slide 4: ABC Platform
ABC Platform: Enabling multi-mechanism therapies empowered for durability * Our Antibody Biopolymer Conjugate ("ABC") Platform combines the best durability with the right efficacy and is the foundation of tarcocimab tedromer and KSI-501, two "ABC" investigational medicines in late-phase clinical dev
Slide 5: ABC Platform Evolution
ABC Platform Evolution: Powering multi-specific, high “DAR” medicines * We have expanded our early research pipeline of duet and triplet inhibitors that embed small molecules and other active pharmaceutical ingredients ("API"), such as oligonucleotides and peptides, in the biopolymer backbone to ena
Slide 6: Our product candidates: a portfolio of three clinical programs
Our product candidates: a portfolio of three clinical programs to address key limitations of today's therapies across a broad spectrum of retinal diseases “ABC” Platform-derived biologics: The best durability with the right efficacy for high-prevalence retinal vascular diseases ~) Tarcocimab J Anti-
Slide 7: Tarcocimab Tedromer
TARCOCIMAB TEDROMER Our objective is for tarcocimab to have a compelling first-line durability profile without compromising immediacy for patients with high-prevalence retinal vascular diseases + Five Phase 3 studies are planned for inclusion in a Biologic License Application (BLA) + Three are compl
Slide 8: Three successful Phase 3 studies in DR, RVO and wet AMD
Three successful Phase 3 studies in diabetic retinopathy (DR), retinal vein occlusion (RVO) and wet AMD with compelling durability demonstrated . Primary Extended Study design . oye y 9 endpoint durability A A A * Superiority study Signature durability Diabetic retinopathy + tarcocimab Q24W after 3
Slide 9: New Phase 3 study: GLOW2 in Diabetic Retinopathy
New Phase 3 study: GLOW2 in Diabetic Retinopathy * GLOW2 features a similar study design as the successful GLOW] study, with the benefit of an additional 3 monthly loading dose (Week 0, 4, 8) for greater flexibility to physicians and patients ae KODIAK recruiting 3 monthly loading doses a ee Tarcoci
Slide 10: New Phase 3 study: DAYBREAK in Wet AMD
New Phase 3 study: DAYBREAK in Wet AMD * DAYBREAK is designed to include tarcocimab and KSI-501 investigational groups vs aflibercept * The objective is to evaluate the efficacy, safety and durability oftarcocimab and KSI-501 and to support registration in wet AMD for both investigational medicines
Slide 11: GLOW2 and DAYBREAK study: philosophy and rationale
GLOW2 and DAYBREAK study: philosophy and rationale Indications Phase 3 studies Diabetic Retinopathy Wet AMD Retinal Vein Occlusion KODIAK {DAYLIGHT Vv r DAYBREAK ) Go live soon —— > MS BEACON | {GLOW Study design philosophy Insights: + Two studies needed in a single indication for FDA approval + Hig
Slide 12: Product vision for tarcocimab
Product vision for tarcocimab "My experience with tarcocimab-treated patients in your trial is you have the durability but you didn't dry as well in the loading phase. But with a formulation of conjugated and unconjugated antibody, then you have fixed that, and you have a drug that primes itself and
Slide 13: Inflammation in high-prevalence retinal vascular diseases
* Inflammation has been shown to play a significant role in high-prevalence retinal vascular diseases. However, no treatments exist that concurrently address vascular permeability and inflammation * KSI-501 is designed to inhibit VEGF and interleukin-6 (IL-6), a pro-inflammatory cytokine and immune
Slide 14: KSI-501 first-in-class bispecific binding IL-6 and VEGF
KSI-501 is a first-in-class bispecific designed for highly efficient binding to both IL-6 and VEGF, built on Kodiak’s “ABC” platform * The anti-permeability effect of VEGF inhibition is the primary effector, with the anti-inflammiatory effect of IL-6 inhibition offering the potential for additional
Slide 15: IL-6 driven inflammation in retinal vascular disease
In addition to VEGF, IL-6 driven inflammation is implicated in retinal vascular disease + IL-6 is a pro-inflammatory cytokine Aqueous humor IL-6 levels significantly correlate with anti-VEGF and immune growth factor treatment response in wAMD! implicated in the pathophysiology patente etrescendi cie
Slide 16: Dual inhibition of VEGF and IL-6 by KSI-501 in preclinical studies
Dual inhibition of VEGF and IL-6 by KSI-501 confers superior normalization of barrier biology vs anti-VEGF or anti-IL-6 monotherapy in preclinical studies RPE Cells Vascular Cells KODIAK Normal Exogenous VEGF and IL-6 Tight junction disruption and changes in cell morphology No Inhibitors Monotherapy
Slide 17: Phase 1 study of KSI-501 in diabetic macular edema
Phase 1 study of KSI-501 was a multiple ascending dose study in patients with diabetic macular edema BAA. DO W4 WS WIZ WIG W20 W24 Primary Endpoint: Ocular and systemic safety at Week 24 T T T T T 1 W4 W8 WIZ WIG W20 W24 T T 1 wa WI2 WI6 W20 W24 13mg fF f I 1 1 7 Do W&4 WS WI2 WIG W20 W24 Study Desi
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15 10 10 5 5 0 0 0 4 8 12 16 20 24 0 4 8 12 16 20 24 0 50 -50 0 -100 -150 -50 0 4 8 12 16 20 24 0 4 8 12 16 20 24 • •
Slide 19: KSI-501 development plan
KSI-501 development plan: advancing from Phase 1 study into staggered Phase 3 registrational studies to accelerate time to pivotal data inflection points Phase 1 sti Diabetic macular edema Amultiple ascending dose study of KS-5O1 in patients with DME, both treatment naive and pre- treated patients D
Slide 20: Macular edema in intraocular inflammation
* In patients with intraocular inflammation, significant vision loss is most commonly a consequence of macular edema * Studies show that inflammation and vascular permeability have a synergistic effect on driving disease progression and vision loss due to macular edema, but there are no approved the
Slide 21: KSI-101 first-in-class bispecific for macular edema
KSI-101 is a first-in-class bispecific for the powerful treatment of macular edema secondary to inflammation * KSI-101 is a bispecific protein designed to directly target both IL-6 mediated inflammation and edema, and VEGF-mediated vascular permeability * The anti-inflammiatory effect of IL-6 inhibi
Slide 22: Macular edema is the leading cause of vision loss in intraocular inflammation
Macular edema is the leading cause of vision loss among patients with intraocular inflammation and IL-6 mediated pro-inflammatory signaling is a key disease driver Macular edema is the leading cause of vision loss among patients with intraocular inflammation * Signaling mediated by pro-inflammatory
Slide 23: Current treatment algorithm for macular edema secondary to inflammation
Current treatment algorithm for macular edema secondary to inflammation: high unmet need for safer therapies that target the underlying mechanisms of disease First line Second line Second or third line Third or fourth line or (Mainstay of treatment) adjunct Local or systemic 9 P . 9 q Immunom lator.
Slide 24: IL-6 and VEGF in retinal inflammatory disease
Studies show that both IL-6 and VEGF play a key role in retinal inflammatory disease Aqueous Humor IL-6 levels were IL-6 levels are elevated in elevated in patients with vitreous fluid of patients with intermediate uveitis! active uveitis? 500 P=0.001 IL-6 (ELISA) in vitreous fluid >1000 + IL-6 leve
Slide 25: KSI-101 development plan
KSI-101 development plan: Phase 1b APEX study to activate mid-2024; FDA alignment on pivotal program: paired studies with 16-week primary endpoint PHASE 1B Diabetic macular edema Macular edema secondary to inflammation (MESI) To evaluate 3 dose levels of KSI-101 in DME patients with 3-5 patients per
Slide 26: Phase 1b APEX study of KSI-101
Phase 1b APEX study: multiple ascending dose study of KSI-101 in patients with DME (Part 2) and macular edema secondary to inflammation (Part 3) | weeks | 0 | 4 | 8 | 12 | 16 | 20 | 24 | Key Inclusion / Exclusion Criteria 5m . . 9 a) a) a) + Adults 221 years of age Part 2: Subjects with biab i Land
Slide 27: Phase 2b/3 Studies PEAK and PINNACLE
Phase 2b/3 Studies PEAK and PINNACLE planned based on regulatory input: identically designed 48-week studies with primary endpoint at Week 16 Primary Last Secondary endpoint dosing visit endpoint wr ww p weeks fo 4 | is | iz | is | 20 | 24 | 28 | 32 | 36 | 40 | 44 | ae | sary (Pi GBEAaRBAAANAANARAN
Slide 28: Summary of programs and cash position
Tarcocimab . Longest-acting anti-VEGF biologic (6-month predominant) while , tedromer preserving the flexibility to dose monthly in high-prevalence retinal vascular diseases * Supported by our science of durability * Enhanced 50 mg/mL formulation of conjugated and unconjugated forms balance towards
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