Kodiak Sciences Inc · NASDAQ:KOD
Kodiak Sciences — 43rd J.P. Morgan Healthcare Conference 2025
78 slides from Kodiak Sciences's conference presentation, January 2025
Slide 1: Kodiak Sciences
Kodiak Sciences 43'9 J.P. Morgan Healthcare Conference January 2025 KODIAK
Slide 2: Forward-Looking Statements
FORWARD-LOOKING STATEMENTS These slides contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on
Slide 3: The Kodiak Opportunity
THE KODIAK OPPORTUNITY Victor Perlroth, MD 3
Slide 4: Retinal vascular diseases remain a large and growing market
Retinal vascular diseases remain a large and growing market driven by aging populations and increased prevalence of diabetes Retinal Vascular Disease Prevalence Global Net Sales of Branded Intravitreal Biologics for Retinal Vascular Diseases 10 – 15M patients in the U.S. ~$18B2 ~$14B1 Estimated ~8M
Slide 5: In wet AMD, Gen 1.0 anti-VEGF agents achieve modest vision gains
In wet AMD, established Gen 1.0 anti-VEGF agents achieve modest vision gains in the real world and require frequent injections to maintain vision • Gen 1.0 anti-VEGF agents achieve only • Frequent injections are not sustained modest vision gains in Year 1 despite over the long term, which leads to f
Slide 6: Gen 1.5 anti-VEGFs provide modest dosing interval extension in the real world
“Gen 1.5” anti-VEGFs provide modest dosing interval extension in the real world • Accumulating evidence suggests newer anti-VEGF agents such as faricimab only achieve modest dosing intervals extension in real-world data • Real-world durability of faricimab does not match that demonstrated in Phase 3
Slide 7: Durability remains the leading unmet need even with faricimab and aflibercept HD
Durability remains the leading unmet need even with faricimab and aflibercept HD Patients switching to faricimab achieve Retina specialists are still looking for only a modest extension in dosing more durable therapies • In clinical trials, fewer than half of faricimab patients achieved 4-month dosi
Slide 8: Gen 1.5 anti-VEGFs do not provide additional vision benefits in the real world
“Gen 1.5” anti-VEGFs also do not provide additional vision benefits in the real world over Gen 1.0 agents • Newer anti-VEGF agents such as faricimab does not provide additional vision benefits in real-world data compared to previously approved anti-VEGF agents U.S. prevalence Real world visual acuit
Slide 9: In diabetic retinopathy, current wait and watch approach does not treat retinopathy
In diabetic retinopathy, current “wait and watch” approach does not treat retinopathy or prevent progression to vision threatening complications • Currently, patients with diabetic retinopathy are generally not treated given high U.S. prevalence treatment burden associated with frequent injections o
Slide 10: Tarcocimab and KSI-501 as mainstay intravitreal biologic monotherapies
Tarcocimab and KSI-501 are being developed as “mainstay” intravitreal biologic monotherapies that provide high efficacy and high durability and a flexible 1-month through 6-month label Gen 2.0 – Kodiak Investigational Medicines HIGH “Mainstay” intravitreal biologic monotherapies for all patients: Ta
Slide 11: Each incremental improvement has resulted in blockbuster commercial opportunities
Despite limited differentiation and label limitations, each incremental improvement has resulted in blockbuster commercial opportunities for the mainstay biologics Dosing Regimen for Intravitreal Biologics* Worldwide net sales Wet AMD TARCOCIMAB DME $2.0B in 2023 DR Gen 1.0: Good efficacy RVO Limite
Slide 12: KSI-101 potential in retinal inflammatory conditions, a greenfield market
In addition, KSI-101 has the potential to be an important and differentiated medicine in retinal inflammatory conditions, a greenfield market segment A relevant case study TEPEZZA in thyroid eye disease The KSI-101 Opportunity • Launched into a nonexistent • A similar greenfield market opportunity m
Slide 13: Clinical portfolio potential to provide continued revenue stream from 2027
Kodiak’s clinical portfolio has the potential to provide continued revenue stream starting from 2027, with built-in life cycle management and risk diversification Net sales Potential of Kodiak Clinical Portfolio (Illustrative) Revenue potential KSI-101 diversified away from ABCD medicines Potential
Slide 14: Commercial manufacturing investment positions Kodiak to launch multiple ABCD products
Longstanding and significant investment in commercial manufacturing has positioned Kodiak well to launch multiple ABCD products into large and growing markets Ursus, a premium commercial manufacturing facility • A commercial scale facility dedicated to the manufacture of Kodiak’s ABC medicines • Cus
Slide 15: VETi as Part of Kodiak's Commercial Franchise
VETi as Part of Kodiak’s Commercial Franchise Retinal images VETi + tarcocimab and OCT by VETi for home monitoring + Ophthalmology Neuro/Cardio Consumer Government Fluid Analysis Metabolic Blood Oxygen Train Your Visual Acuity DRSS Scoring Population Analysis Brain Health VETi + AI Many applications
Slide 16: Kodiak Today
KODIAK TODAY Victor Perlroth, MD Chairman and CEO 16
Slide 17: Kodiak is primed for near-term and long-term success
We believe Kodiak is primed for near-term and long-term success Agile R&D Excellence in Diversified Late- Independence Mindset Execution Stage Pipeline We have made key 3 shots on goal, each Living by our Flexibility to make course corrections and in a BLA-facing “we care more” each right choice for
Slide 18: Kodiak strives to be a learning organization
Kodiak strives to be a learning organization. Through our journey, we have gathered 2020-2021 key insights and transformed learnings into actions 2020- Well tolerated and with a 6-month PHASE 1B POSITIVES 2021 durability profile • Tarcocimab and ABC platform well tolerated Feb. DAZZLE Strong durabil
Slide 19: Summary of clinical programs and timeline of anticipated milestones
Summary of clinical programs and timeline of anticipated milestones 2025 2026 2027 Indication Clinical trial 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q Diabetic Target enrollment Primary endpoint: Topline data Phase 3 Retinopathy complete Week 48 readout GLOW 2 (DR) On track to complete Tarcocimab enrollment for
Slide 20: Spotlight on KSI-101
Spotlight on KSI-101 KODIAK
Slide 21: KSI-101: third clinical program, first-in-class bispecific protein
We have diversified our portfolio with a third clinical program: KSI-101, an ABC platform-independent, first-in-class bispecific protein in a greenfield market KSI-101 Design Opportunity Development • First-in-class dual • Greenfield market • Near-term readout of A potent, high-strength Phase 1b dat
Slide 22: Macular edema is the leading cause of vision loss in intraocular inflammation
Macular edema is the leading cause of vision loss in patients with intraocular inflammation Intraocular 1/3 of patients inflammation is the with intraocular 4th leading cause inflammation of vision loss in the develop macular developed world edema • Up to 50% of patients experience reduced vision •
Slide 23: Current treatment algorithm for macular edema secondary to inflammation
Current treatment algorithm for macular edema secondary to inflammation: unmet need for safer therapies that target the underlying mechanisms of disease First line: Mainstay of treatment Second line Second or third line Third or fourth line or adjunct Local or systemic Immunomodulators Biologic Anti
Slide 24: Vamikibart anti-IL-6 monotherapy improves vision and anatomy
Vamikibart (Roche, anti-IL-6) has shown that anti-IL-6 monotherapy can provide visual and anatomical improvement in patients with inflammatory macular edema Change from Baseline in BCVA Change from Baseline in CST A clear dose response is seen with IL-6 monotherapy in patient with inflammatory macul
Slide 25: IL-6 monotherapy leaves ~50% of patients with persistent IRF
While intravitreal IL-6 monotherapy is useful, ~50% of patients have persistent IRF, which is similar to the overall failure rate of systemic adalimumab1, leaving room for improvement ~50% of patients have persistent IRF Persistent intraretinal fluid (IRF) is known to cause deleterious and permanent
Slide 26: Phase 1b APEX study of KSI-101
Phase 1b APEX study: multiple dose study of KSI-101 in patients with macular Actively edema secondary to inflammation recruiting Weeks 0 4 8 12 16 20 24 2.5 mg Subjects with macular edema secondary to 5 mg inflammation (MESI) (n ~ 36) 10 mg KSI-101 injection End of Study • Emerging APEX data in MESI
Slide 27: Phase 1b APEX MESI clinical cases
Phase 1b APEX MESI clinical cases: strong treatment response demonstrated at all KSI- 101 dose levels, driving program acceleration Baseline Week 1 Week 4 Week 8 Week 12 KSI-101 2.5 mg BCVA 66 letters BCVA +7 BCVA +3 BCVA +6 BCVA +9 CST 760 microns CST -353 CST -456 CST -525 CST -541 KSI-101 5 mg BC
Slide 28: Phase 2b/3 pivotal program primary endpoint at Week 16
Phase 2b/3 pivotal program based on regulatory input: primary endpoint at Week 16 and safety to Week 48 Primary Last dosing Secondary endpoint visit endpoint Weeks 0 4 8 12 16 20 24 28 32 36 40 44 48 KSI-101 low dose (n ~ 75) KSI-101 high dose (n ~ 75) Sham (n ~ 75) Patients diagnosed with a vision
Slide 29: KSI-101 potential in pediatric patients with intraocular inflammation
KSI-101 has the potential to become an important medicine in treating pediatric patients with intraocular inflammation and macular edema • Up to 15% of patients referred to tertiary uveitis clinics are pediatric patients • Like adults, macular edema is a major vision-threatening complication in chil
Slide 30: Three clinical programs and upcoming milestones
With 3 clinical programs leveraging our 15 years of learning, Kodiak is at a decisive moment and represents an exciting investment opportunity UPCOMING MILESTONES Antibody Biopolymer Conjugates (“ABC”s) for Retinal Vascular Diseases TARCOCIMAB Phase 3 • A Generation 2.0 intravitreal biologic for pat
Slide 31: Science of Durability
SCIENCE OF DURABILITY 31
Slide 32: Tarcocimab's extended durability stems from its science of durability
Tarcocimab's extended durability stems directly from its underlying science of durability Tarcocimab and the ABCD platform are supported by CONJUGATE DESIGN The ABCD Platform leverages a proprietary, high our science of durability molecular weight, phosphorylcholine-based biopolymer that enables an
Slide 33: Conjugate Design
CONJUGATE DESIGN KODIAK
Slide 34: Ocular half-life increases proportionally with molecular size
Principal of Design: Ocular half-life increases proportionally with molecular size Relationship between ocular half-life and molecular weight (MW, kDa)¹ 100 Strong positive correlation Vitreous Half-Life (Days) between the ocular half-life of 10 an intravitreally injected protein therapeutic and its
Slide 35: ABC platform leverages a high molecular weight phosphorylcholine biopolymer
Kodiak’s ABC platform leverages a proprietary, high molecular weight, phosphorylcholine-based biopolymer to enable an extended ocular residence time The Antibody Biopolymer Conjugate (“ABC”) Platform is the foundation of tarcocimab tedromer and KSI-501 High molecular weight Biopolymer Antibody or Ot
Slide 36: ABC medicines have high molecular weight increasing ocular half-life
Kodiak’s ABC investigational medicines, tarcocimab and KSI-501, have a high molecular weight which increases their ocular half-life compared to today's anti-VEGFs Tarcocimab : 950 kDa 115 kDa 149 kDa 48 kDa 26 kDa Antibody Biopolymer 150 kDa 800 kDa Brolucizumab Ranibizumab Aflibercept Faricimab (Be
Slide 37: Potency
co R POTENCY KODIAK
Slide 38: Tarcocimab shows high binding affinity and potency in pre-clinical assays
Tarcocimab unconjugated protein and conjugated protein both demonstrate high binding affinity and potency in pre-clinical assays High Binding Affinity for VEGF-A High Potency in Inhibiting VEGF High Potency in Inhibiting Binding to its Receptors VEGF-mediated cell proliferation* Both the tarcocimab
Slide 39: Animal Ocular Half-Life
co ANIMAL OCULAR HALF-LIFE KODIAK
Slide 40: Tarcocimab's ocular half-life is longer than approved biologics in rabbits
Tarcocimab’s ocular half-life is significantly longer than approved intravitreal biologics in the rabbit model 3x – 4x longer half-life versus Lucentis, Eylea and Vabysmo Ranibizumab² Faricimab4 Tarcocimab¹ (48 kDa) (149 kDa) (950 kDa) 3 Days 4 Days 11 Days Half-life (Days) 2 4 6 8 10 12 14 16 Aflib
Slide 41: Human Ocular Half-Life
ae Te HUMAN OCULAR HALF-LIFE KODIAK
Slide 42: Calculating tarcocimab ocular half-life from aqueous humor concentrations
Tarcocimab’s ocular half-life in humans was calculated by measuring aqueous humor concentrations over time from patients in the Phase 1b Study Using Aqueous Humor Concentration of Tarcocimab to Determine Ocular t1/2 in human • Aqueous humor samples were collected AH samples from from 47 subjects in
Slide 43: Tarcocimab achieved ocular half-life >20 days in 45% of patients
Tarcocimab achieved an extended ocular half-life of >20 days in 45% of sampled patients from the Phase 1b Study All Patients Patients Ocular t½ Distribution Select Individual Patients* (n=47) (N=47) 100000 100000 t1/2 = 39.8 days 10000 10000 45% >20 Days Tarcocimab aqueous humor t1/2 = 27.5 days con
Slide 44: Tarcocimab mean ocular half-life in humans is 3x longer than faricimab
Tarcocimab has a mean ocular half-life in humans of 20 days, which is 3x longer than faricimab 8.3 19.8 days 31.8 (10th percentile) (Mean) (90th percentile) Tarcocimab 10-90th percentiles Faricimab Human Ocular Half-Life (Days) 5.2 11.2 (10th percentile) (90th percentile) 100 Percent of Patients 81%
Slide 45: Consistent ocular half-life across wet AMD, DME and RVO
Tarcocimab demonstrated consistent ocular half-life across wet AMD, DME and RVO Patients Tarcocimab Human Ocular Half-Life by Indication 50 Acqueous humor t1/2 (days) 40 30 20 10 0 All All wAMD Wet AMD DME DME RVO RVO n=47 n=47 n=23 n=23 n=8 n=16 n=16 45 Height of the box represents the mean; error
Slide 46: From principle of design to human durability
From Principal of Design to Human Durability (“A Science of Durability”): Tarcocimab's Ocular Half-Life in Human is Much Longer Than Approved Intravitreal Biologics Human Ocular Half-Life and Molecular Weight of Current Intravitreal Biologics1,2 Tarcocimab⁶ Ranibizumab² 48 kDa 950 kDa T½: 7.2 Days T
Slide 47: What is the evidence longer half-life translates into clinical durability?
What is the evidence this longer ocular half-life in human translates into clinical durability? 47
Slide 48: Differentiated clinical durability across all retinal vascular diseases tested
Consistent with its science of extended ocular half life, tarcocimab has shown a differentiated clinical durability profile in all retinal vascular diseases tested Durability Interval at Year 1 Number of doses in the second 6 months of Year 1 4-6 doses 2% 3 doses 5% Q8W Q12W 2 doses 28% 6-month 30.3
Slide 49: DME studies: pseudophakic patients achieved comparable improvements with fewer doses
Wait a minute. The DME studies did not meet their primary endpoint. How do we know the durability is real? Pseudophakic patients treated with tarcocimab achieved comparable improvements vs aflibercept patients, with significantly fewer doses (5 tarcocimab vs 10 aflibercept) GLEAM and GLIMMER Pooled
Slide 50: DAZZLE: 5-month durability in ~2/3 of tarcocimab patients
Wait a minute. The wAMD durability study did not meet its primary endpoint. What is the durability evidence here? In DAZZLE, ~2/3 of tarcocimab patients achieved 5-month durability with visual and anatomical improvements comparable to the overall aflibercept group Mean BCVA Over Time in Tarcocimab P
Slide 51: Relevance of 6-month durability in diabetic retinopathy
How relevant is 6-month durability in Diabetic Retinopathy? With only 4 doses in the first year (a ‘gentle on-ramp’) and 100% of tarcocimab patients on 6-month dosing, the drug treats current retinopathy and prevents diabetic complications Primary endpoint met Proportion of patients with ≥2-Step Pro
Slide 52: Durability benefit in RVO
Is there any durability benefit in RVO? Even after receiving 2 fewer initiating doses (4 vs 6, respectively), tarcocimab treated patients at one year had a ~30% higher chance of not requiring any additional doses versus aflibercept Primary endpoint met Tarcocimab Number of injections through Year 1
Slide 53: Tarcocimab and the ABC platform are supported by our science of durability
Tarcocimab and the ABC platform are supported by our SCIENCE OF DURABILITY Designed-in Extended Tissue High in-Vitro Extended Ocular Extended Ocular Extended Clinical Residence Time Potency Half-Life in Animals Half-Life in Humans Durability A proprietary Both unconjugated 3x the ocular t½ of 3x the
Slide 54: Does this durability come at a cost?
Does this durability come at a cost? 54
Slide 55: Immediacy seems to be the cost
Immediacy seems to be the cost. A deficit is seen in the loading phase, in the “immediacy” of the effect. After the loading phase, the drying potential or “potency” is comparable to aflibercept Mean Change in OCT CST Over Time In the wet AMD DAYLIGHT Study Immediacy gap Comparable potency 0 -50 Week
Slide 56: We have applied course corrections to solve this challenge in immediacy
We have applied course corrections to solve this challenge in immediacy 56
Slide 57: Enhanced Formulation
ENHANCED FORMULATION 57
Slide 58: Enhanced formulation includes free protein to solve the immediacy issue
How can the enhanced formulation solve the immediacy issue? By including free protein (unconjugated), the enhanced formulation is primed to solve the immediacy issue Tarcocimab Old Formulation Tarcocimab Enhanced Formulation 80% Conjugated The enhanced formulation was 100% Conjugates 20% Unconjugate
Slide 59: Unconjugated portion contains a high molar equivalent to approved biologics
The unconjugated portion of the enhanced formulation of tarcocimab contains A high molar equivalent to approved intravitreal biologics Tarcocimab Tarcocimab Brolucizumab Ranibizumab Aflibercept Faricimab Old Formulation Enhanced Formulation Single-Chain Unconjugated Antibody Antibody Fusion Antibody
Slide 60: How much unconjugated protein is there? Is it enough?
How much unconjugated protein is there? Is it enough? The unconjugated portion is equivalent to 1.3 mg of aflibercept, sufficient to provide a strong immediacy after dosing The 20% of free protein alone in the 0.5 mg aflibercept achieved similar CST enhanced formulation is equivalent to 67% improvem
Slide 61: Objective of each component: pulse of inhibition and sustained durability
What is the objective of each component? The unconjugated protein delivers a strong “pulse” of VEGF inhibition, meanwhile the conjugate continues to deliver sustained durability The 1 mg of free protein in the enhanced Similar efficacy benefits were observed among formulation is expected to meaningf
Slide 62: Objective: close the immediacy gap
What is the objective? A key objective of the enhanced formulation was to close the immediacy gap, while improving manufacturability, dose administration and patient safety CST Reduction Through Loading Dose Phase in Wet AMD* 0 Tarcocimab Tarcocimab (old (clinical formulation) formulation) Afliberce
Slide 63: Modeling the expected pharmacology of tarcocimab in patients
Bringing it all together: modeling the expected pharmacology of tarcocimab in patients 63
Slide 64: Tarcocimab extends human ocular t1/2 by 3x vs faricimab
Tarcocimab extends human ocular t1/2 by 3x vs faricimab; modeling suggests tarcocimab may meaningfully extend dosing intervals for patients while providing immediacy Tarcocimab extends t1/2 Tarcocimab extends t1/2 Tarcocimab extends t1/2 from 4 to 10 days from 7 to 18 days from 12 to 28 days Tarcoci
Slide 65: Formulation improvements extended into all ABC medicines
We have extended these formulation improvements into all our ABC medicines 65
Slide 66: Enhanced formulation incorporated into KSI-501
We have incorporated the enhanced formulation into KSI-501 Enhanced Formulation Enhanced Formulation Tarcocimab KSI-501 The enhanced formulation for KSI-501 also features an optimized combination of conjugated and unconjugated (free protein) forms Based on antibody mass (injection volume of 100 µL a
Slide 67: Tarcocimab Tedromer Clinical Program Overview
TARCOCIMAB TEDROMER CLINICAL PROGRAM KSI-501 OVERVIEW KSI-101 67
Slide 68: Tarcocimab Tedromer
TARCOCIMAB Design Differentiation Development TEDROMER • Anti-VEGF antibody • 1 successful pivotal • High efficacy with biopolymer high durability study away from BLA • Only intravitreal biologic conjugate (“ABC”) remains a key submission that has demonstrated unmet need consistent 6-month • Only in
Slide 69: Planned BLA package in 2026 supported by 5 pivotal studies
Tarcocimab: planned BLA package in 2026 for 3 disease indications supported by 5 pivotal studies in diabetic retinopathy, wet AMD & RVO based on FDA alignment Completed Phase 3 studies: Two Phase 3 studies actively enrolling: Primary endpoint met and extended durability demonstrated using the enhanc
Slide 70: GLOW2 Phase 3 study in diabetic retinopathy
New DR Phase 3 study: GLOW2 features a similar study design as the successful GLOW1 study, with the benefit of an additional 3rd monthly loading dose 3 monthly loading doses 12-week interval 24-week interval Actively recruiting Weeks 0 4 8 12 16 20 24 28 32 36 40 44 48 Tarcocimab 5 mg Extended dosin
Slide 71: DAYBREAK Phase 3 wAMD registrational study
New wAMD Phase 3 study: DAYBREAK is designed as a registrational study for both tarcocimab tedromer and KSI-501 Actively recruiting Weeks 0 4 8 12 16 20 24 28 32 36 40 44 48 52 – 88 92 96 Tarcocimab Q4-24W (n~225) KSI-501 Q8W (n~225) Aflibercept Q8W (n~225) Tarcocimab injection Aflibercept injection
Slide 72: Tarcocimab failed in a wAMD durability study. What has changed?
Tarcocimab already failed in a wAMD durability study. What has changed? The DAYBREAK Study is designed to address each of the flaws of the DAZZLE Study DAZZLE Study Q12W Q16W Q20W Allowed Intervals Q4W Q8W Q12W Q16W Q20W Q24W DAYBREAK Study Allowed Intervals Shorter intervals Enables 6-month prevent
Slide 73: DAYBREAK's disease activity criteria: Would you treat?
What is so special about DAYBREAK’s disease activity criteria? Using fluid volumes instead of CST as a marker of disease activity resembles retina specialists’ practice, optimizes each patient’s treatment, and generates data on how the molecule will perform in the real world 354 microns of OCT CST ?
Slide 74: Patients treated more does not mean less durability
So patients will be treated more. That means less durability, right? Not necessarily. It means that patients will receive treatment only when indeed needed. This is intended to maximize both the chance of meeting non-inferiority and having a strong and real durability profile DAYBREAK disease activi
Slide 75: KSI-501
KSI-501, our second ABC investigational medicine, now reflects the enhanced formulation with the potential for best efficacy and best durability KSI-501 Design Differentiation Development • First-in-class dual • Designed to address • Exploring potential First-in-class bispecific ABC inhibition: anti
Slide 76: DAYBREAK registrational study for tarcocimab and KSI-501
New wAMD Phase 3 study: DAYBREAK is designed as a registrational study for both tarcocimab tedromer and KSI-501 Actively recruiting Weeks 0 4 8 12 16 20 24 28 32 36 40 44 48 52 – 88 92 96 Tarcocimab Q4-24W (n~225) KSI-501 Q8W (n~225) Aflibercept Q8W (n~225) Tarcocimab injection Aflibercept injection
Slide 77: Why allow monthly dosing?
Why allow monthly dosing? Meaningfully better visual outcomes have been observed with monthly dosing in patients with persistent fluid BCVA in aflibercept’s registrational VIEW studies in wAMD 15 15 Aflibercept monthly BCVA (EDTRS letter Score) BCVA (EDTRS letter Score) 12 Aflibercept bimonthly 12 9
Slide 78: 3 clinical programs advancing in parallel
3 clinical programs advancing in parallel, collectively addressing limitations of today’s therapies across a broad spectrum of retinal diseases Retinal Vascular Diseases Inflammatory Retinal Diseases TARCOCIMAB TEDROMER KSI-501 KSI-101 • Anti-VEGF “ABC” • First-in-Class, bispecific anti-IL-6 , VEGF
Kodiak Sciences — 43rd J.P. Morgan Healthcare Conference 2025 on 6ix