Kodiak Sciences Inc · NASDAQ:KOD
Kodiak Sciences — Investor Day (July 2025)
120 slides from Kodiak Sciences's investor day presentation, Jul 16, 2025
Slide 1: Investor R&D Day
INVESTOR R&D DAY July 16, 2025 KODIAK
Slide 2: Welcome & Introductions
KODIAK Vv) ® 6 Ww = Day o> “a re Spe zZ
Slide 3: 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 4: Today's Attendees
Today’s Attendees Presenters from Kodiak Management Industry Experts Charles Wykoff, MD, PhD • Director of Research, Retina Consultants of Texas • Chairman of Research, Retina Consultants of America • Professor of Clinical Ophthalmology and Deputy Chair of Ophthalmology, Blanton Eye Institute, Houst
Slide 5: Guest Speakers and Industry Experts
Guest Speakers and Industry Experts Charles Wykoff, MD, PhD Director of Research, Retina Consultants of Texas Chairman of Research, Retina Consultants of America Professor of Clinical Ophthalmology and Deputy Chair of Ophthalmology, Blanton Eye Institute, Houston Methodist Hospital • Medical and sur
Slide 6: Guest Speakers and Industry Experts
Guest Speakers and Industry Experts Sumit Sharma, MD Enterprise Vice Chair, Integrated Surgical Institute Medical Director, Information Technology – Ophthalmology Vitreoretinal Surgery and Uveitis/Ocular Inflammatory Diseases, Cole Eye Institute, Cleveland Clinic • Vitreoretinal Surgeon and Uveitis
Slide 7: Welcome, Safe Harbor, Agenda
Welcome, Safe Harbor, Agenda John Borgeson, Chief Financial Officer Key Messages, What to Expect Today Victor Perlroth, MD Chief Executive Officer Victor Perlroth, M.D., Chief Executive Officer Tarcocimab and KSI-501: Retinal Vascular Diseases Charles Wykoff, MD, PhD KSI-101: Macular Edema Secondary
Slide 8: Key Messages & What to Expect
Key Messages & What Victor Perlroth, MD to Expect Chairman and CEO 9
Slide 9: Kodiak Investor R&D Day July 2025 – Key Messages
Kodiak Investor R&D Day July 2025 – Key Messages Wholly Owned • Strong 12-week data from Phase 1b APEX A potent • PEAK and PINNACLE – already enrolling reason to KSI-101 • Commercial opportunity of 150,000+ initial believe in addressable patients with headroom Kodiak • Science-based “heavyweights”?
Slide 10: 3 late-stage assets, in 4 Phase 3 studies, topline data across 2026
3 late-stage assets, in 4 Phase 3 studies, with topline data expected across 2026 For patients with retinal vascular diseases For patients with MESI Tarcocimab KSI-501 KSI-101 Anti-IL-6, VEGF trap High-strength anti-IL-6, VEGF Anti-VEGF ABC® bispecific ABC® trap bispecific protein Mainstay biologic
Slide 11: Precommercial retina biotech with three Phase 3 assets
Kodiak is a precommercial retina biotech with a portfolio of three Phase 3 assets, with BLA facing data expected across 2026, and a series of BLA filings possible in 2026 and then 2027 MOA Indication Phase 3 Study Complete Q1 ‘26 Q2 ‘26 Q3 ‘26 Q4 ‘26 1Q ’27 2Q ’27 3Q ‘27 RVO BEACON Anti-VEGF DR GLOW
Slide 12: Net sales potential of Kodiak clinical portfolio
Kodiak’s pipeline has the potential to provide sustainable revenue streams starting from 2027, with built-in life cycle management, risk diversification and continuing technology and product leadership in retina Net Sales Potential of Kodiak Clinical Portfolio (Illustrative) Greenfield market KSI-10
Slide 13: Tarcocimab & KSI-501
Tarcocimab & KSI-501 Charles Wykoff MD, PhD 14
Slide 14: The Retinal Vascular Diseases and the Anti-VEGF Market
The Retinal Vascular Diseases and the Anti-VEGF Market: Tarcocimab & KSI-501 15
Slide 15: Open space in the retinal vascular diseases market
There remains valuable open space in the retinal vascular diseases market, despite the availability of approved biologics and clinical trials of new exploratory technologies Approved mainstay biologics that provide: A biologic that provides: Gen 1.0 Gen 1.5 High Immediacy + High Durability • Eylea •
Slide 16: Gen 1.0 and Gen 1.5 biologics provide immediacy and durability
The Gen 1.0 biologics that provide immediacy and the Gen 1.5 biologics that provide immediacy and incremental durability are meaningful for patients and physicians Dosing regimen per label for approved intravitreal biologics Wet AMD DME $1.2B in 2024 Gen 1.0 DR RVO Good efficacy, Wet AMD limited DME
Slide 17: Real-world wet AMD data fall short of Gen 1.5 durability promise
Despite their commercial success, real-world data in wet AMD show that most patients are falling short of the durability promise of the Gen 1.5 labels Faricimab injections observed after the first 6 months of treatment through Year 2 in the FARENTINA study2 Treatment-Naïve Eyes (n=389a) Year 2: In Y
Slide 18: Implants and gene therapies engineer durability but lack immediacy
Technologies being explored in clinical trials, including implants and gene therapies, are engineering for high durability but are lacking immediacy Implants Gene Therapies • Engineering for durability • Engineering for durability • Long-term safety unknown • Onerous monitoring and inflammation cont
Slide 19: Open space for high immediacy and high durability
Therefore, the open space remains. A biologic that provides high immediacy and high durability at the same time and in the same therapy has the potential to be a heavy weight in this important $15+ billion marketplace Mainstay intravitreal biologic monotherapies for all patients A biologic that prov
Slide 20: Kodiak's ABC Platform Science in Retina
Kodiak’s ABC® Platform Science in Retina 21
Slide 21: Science of immediacy and durability
The ABC® Platform supports Kodiak’s SCIENCE OF IMMEDIACY and DURABILITY Designed-in High in-Vitro Extended Extended Powerful Extended Ocular Half-Life Ocular Half- Immediacy via Clinical Durability Extended Tissue Potency in Animals Life in Humans Unconjugated via Conjugated Residence Time Antibody
Slide 22: Best of both worlds: immediacy and durability in a single biologic
Tarcocimab and KSI-501 bring the best of both worlds – with a science of high immediacy and high durability at the same time in a single biologic 950 kDa 149 kDa Immediacy is achieved with lower molecular weight intravitreal biologics 149 kDa 1000 kDa 210 kDa Durability increases as molecular weight
Slide 23: Tarcocimab and KSI-501 molecular design
Tarcocimab and KSI-501 bring the best of both worlds – with a science of high immediacy and high durability at the same time in a single biologic Tarcocimab 1 mg 4 mg high unconjugated molecular weight protein for immediacy + ABC® for durability 1.5 mg 3.5 mg high KSI-501 unconjugated protein for +
Slide 24: Tarcocimab ocular half-life 3-fold longer than faricimab
Tarcocimab has a mean ocular half-life in humans of 20 days, which is 3-fold longer than faricimab 19.8 days 8.3 (Mean) 31.8 (10th percentile) (90th percentile) TARCOCIMAB 10-90th percentiles FARICIMAB Human Ocular Half-Life (Days) 5.2 11.2 (10th percentile) (90th percentile) 100 81% Percent of Pati
Slide 25: Consistent 20-day ocular half-life across indications
Tarcocimab demonstrated consistent 20-day ocular half-life across wet AMD, DME and RVO patients Tarcocimab Human Ocular Half-Life by Indication 50 40 Aqueous Humor t 1/2 (days) 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 Height of the box represents the mean; er
Slide 26: Modeling of extended dosing intervals
Modeling suggests tarcocimab may provide a similar immediacy of efficacy while meaningfully extending dosing intervals for all patient types From 4 to From 7 to From 12 to TARCOCIMAB 10 days 18 days 28 days Extended T1/2 10-90th percentiles FARICIMAB Human Ocular Half-Life (Days) Patient with Patien
Slide 27: ABC Enabled Mainstay Biologics: Tarcocimab and KSI-501
ABC® Enabled Mainstay Biologics Tarcocimab KSI-501 • Better Efficacy • Strong Immediacy • Strong Immediacy • Industry-leading Durability • Industry-leading Durability 28
Slide 28: Clinical studies supporting tarcocimab BLA and KSI-501
Kodiak’s ongoing and planned clinical studies have a high probability of success to support a tarcocimab BLA in 2026 and a potential KSI-501 BLA in 2027 while supporting complementary and potentially differentiated commercial profiles Phase 3 Primary 6-Month Indication Results / Progress Study Endpo
Slide 29: DAYBREAK study in wet AMD
Tarcocimab and KSI-501 in wet AMD: DAYBREAK study explores in a definitive manner immediacy through the loading phase and real-world durability and, in the case of KSI-501, the potential for better efficacy DAYBREAK study design: a registrational study for both tarcocimab and KSI-501 Quadrant of cor
Slide 30: GLOW2 study design and GLOW1 results in DR
Tarcocimab in DR: the GLOW2 study in DR features a similar study design as the successful GLOW1 study, with the benefit of an additional 3rd initiating dose Proportion of patients with ≥2-Step Proportion of patients developing any sight- improvement in DRSS from Baseline to Week 48 threatening compl
Slide 31: GLOW1 shows potential for earlier DR treatment
Tarcocimab in DR: the GLOW1 study shows that tarcocimab opens the door to earlier treatment with only 2 doses a year – a transformative potential for millions of patients Baseline Week 48 U.S. Prevalence 8,000,000 Microhemorrhages visible on the retina even if no visual symptoms are present yet DR <
Slide 32: Tarcocimab in RVO: BEACON durability
Tarcocimab is uniquely poised to address the core unmet need in RVO with high efficacy and best-in-class durability Number of injections through Year 1 Tarcocimab Quadrant Number of doses of core 50% in the second 6 months of Year 1 unmet need Tarcocimab Aflibercept 4-6 doses 40% 78% received 93% re
Slide 33: Tarcocimab and KSI-501 poised to fill the golden quadrant
Revisiting the core unmet need: based on a science of high immediacy and high durability, tarcocimab and KSI-501 are poised to fill the ‘golden quadrant’ Mainstay intravitreal biologic Quadrant monotherapies for all patients of core Gen 2.0 – Kodiak Intravitreal Biologic unmet need Efficacy Tarcocim
Slide 34: KSI-101 Macular Edema Secondary to Inflammation
Macular Edema Secondary to Inflammation KSI-101 (MESI) 35
Slide 35: What is MESI?
Macular Edema Secondary to Inflammation Sumit Sharma What is MESI? MD 36
Slide 36: Macular edema caused by inflammation and/or VEGF over-expression
Macular edema, the common clinical presentation of a wide spectrum of diseases, can be caused by inflammation and/or by VEGF over-expression Macular Edema Spectrum of Diseases Diabetic Macular Uveitis Edema Inflammation driven VEGF driven Retinal Vein Systemic or Occlusion Autoimmune Disease Myopic
Slide 37: What is macular edema secondary to inflammation (MESI)?
What is macular edema secondary to inflammation (MESI)? Common Common Clinical Potential common Pathophysiology Presentation therapy Inflammation VEGF IL-6 IL-6 Blood Retinal Barrier Disruption Angiogenesis Macular Edema with visual impairment KSI-101 MESI is a heterogenous group of diseases that cl
Slide 38: MESI: heterogenous diseases with common clinical presentation
MESI comprises a heterogenous group of diseases with a common, readily identifiable clinical presentation: macular edema with visual impairment Anterior Intermediate Posterior Panuveitis Location of inflammation Irrespective of the anatomical location of the inflammation or the specific etiology, th
Slide 39: Macular edema leading cause of vision loss in ocular inflammation
Macular edema is the leading cause of vision loss among patients with ocular inflammation Normal Retina on OCT • Noninfectious MESI represents a set of serious ocular inflammatory conditions that cause significant vision loss. • Ocular inflammation is the 4th leading cause of vision loss among worki
Slide 40: What causes MESI?
Macular Edema Secondary to Inflammation Sumit Sharma What causes MESI? MD 41
Slide 41: Immune dysregulation breaks down the blood-ocular barrier
Dysregulation of the immune system causes a series of insults to the blood-ocular barrier, leading to breakdown of the barrier and release of inflammatory mediators 3 IL-6 and VEGF are co-induced: VEGF promotes 1 vascular leak and neovascularization, while IL-6 sustains inflammation and upregulates
Slide 42: IL-6 and VEGF elevated in ocular inflammation
Both IL-6 and VEGF levels are elevated in patients who have ocular inflammation and macular edema IL-6 VEGF • IL-6 levels are elevated in patients with ocular • Persistent inflammation triggers VEGF inflammation and further elevated in patients upregulation. VEGF levels are found to be elevated with
Slide 43: IL-6 and VEGF disrupt the blood-retinal barrier
IL-6 and VEGF each disrupt the blood-retinal barrier independently. When combined, they cause an even greater loss of barrier integrity Assessing vascular endothelial barrier integrity Treatments • Ocular inflammation damages using electrical resistance measurements tight junctions between endotheli
Slide 44: What is the unmet need?
Macular Edema Secondary to Inflammation Sumit Sharma What is the unmet MD need? 45
Slide 45: Corticosteroids most used for MESI but carry safety risks
Corticosteroids are used most often for MESI, but carry significant safety risks and efficacy can be limited Most frequently prescribed medications in patients • Steroids were the most with macular edema due to noninfectious uveitis, common medication class and across any line of therapy1 remain the
Slide 46: Only a third achieve treatment goal on topical steroids
My clinical experience: while topical steroids are the first line of therapy for MESI, only a third of patients achieve the treatment goal without the negative side effects Response to topical steroid treatment (diflupredprednate, Durezol) as first line of treatment in MESI patients Sumit Sharma, MD
Slide 47: Adverse effects of MESI treatments require surgical interventions
Adverse effects from today’s treatments for MESI often require multiple surgical interventions, but surgeries are complicated in MESI patients and require complete control of inflammation before, during and after each procedure Cataract repair in MESI patients is Visual damage from glaucoma is compl
Slide 48: Patient journey: steroid-induced glaucoma with recurrent MESI
Patient journey: steroids induced glaucoma with recurrent MESI over the course of approximately 2 years Patient presented to uveitis specialist Trial of bromfenac IOP stable and Patient presented in Developed drops with initial macular edema now August 2023 with a 12- worsening of improvement then r
Slide 49: Core unmet need in MESI
There is a core unmet need in MESI for a potent, high-strength, locally administered and safe therapy Illustrative complications • Targets both IL-6 and VEGF disease drivers Fewer IVT anti-VEGF Core • Potentially disease monotherapy modifying unmet • High strength need open • Potent • Minimally inva
Slide 50: MERIT: Ozurdex does not resolve edema in many MESI patients
MERIT Study – Ozurdex (dexamethasone implant, Abbvie) does not resolve the edema in almost half of MESI patients at any point, and the treatment effect wanes by Week 12 Proportion of eyes with normalization of OCT CST Mean change in BCVA 15 10 Patients, % Dexamethasone Letters Dexamethasone implant
Slide 51: MERIT: anti-VEGF monotherapy response in a subset
MERIT Study –anti-VEGF monotherapy can provide a meaningful fluid response in a subset of MESI patients Proportion of eyes with Proportion of eyes with a normalization of OCT CST meaningful OCT CST response Eyes with a ≥20% decrease in OCT CST, % Dexamethasone implant Eyes, % Dexamethasone implant R
Slide 52: DOVETAIL: anti-IL-6 vamikibart study
DOVETAIL Study - intravitreal anti-IL-6 monotherapy (Roche, vamikibart) has been studied as a potential therapy for patients with inflammatory macular edema Sharma, et al. A Novel Intravitreal Anti-IL-6 Monoclonal Antibody for Uveitic Macular Edema (UME): Preliminary Results From the Phase 1 DOVETAI
Slide 53: Vamikibart shows visual and anatomical improvement
Vamikibart (Roche, anti-IL-6) has shown that anti-IL-6 monotherapy can provide visual and anatomical improvement in patients with inflammatory macular edema DOVETAIL DOVETAIL Change from Baseline in BCVA Change from Baseline in OCT CST A clear dose response is seen with IL-6 monotherapy in patients
Slide 54: IL-6 monotherapy leaves ~50% with persistent IRF
While intravitreal IL-6 monotherapy is helpful, 50% of patients have persistent IRF1, similar to the overall failure rate of systemic adalimumab, leaving room for a more potent and/or broader spectrum biologic therapy DOVETAIL DOVETAIL DOVETAIL Absence of IRF Absence of SRF ≥15-letter gainers at Wee
Slide 55: How can this unmet need be addressed?
Macular Edema Secondary to Inflammation Sumit Sharma How can this unmet MD need be addressed? 56
Slide 56: KSI-101 first-in-class high-strength bispecific biologic
KSI-101 is a first-in-class, high-strength intravitreal biologic designed to target IL-6 mediated inflammation and VEGF-mediated vascular permeability simultaneously KSI-101: high formulation strength (100 mg/mL) VEGF IL-6 IL-6 57
Slide 57: KSI-101 potent dual inhibitor of VEGF and IL-6 signaling
KSI-101 is a potent dual inhibitor of VEGF signaling and IL-6 classic (cis) and soluble (trans) receptor-mediated pathways KSI-101 inhibits IL-6 KSI-101 inhibits soluble IL-6 KSI-101 inhibits VEGF classic signaling receptor-mediated signaling signaling 150 IC50 = 77 pM 150 IC50 = 2.3 nM KSI-101 IC50
Slide 58: KSI-101 improves barrier tight junctions
Bispecific KSI-101 improves barrier tight junctions greater than anti-IL-6 or anti-VEGF monotherapies alone Exogenous VEGF and IL-6 Tight junction disruption and changes in cell morphology Monotherapy Inhibition Dual inhibition No Inhibitors Anti-VEGF Anti-IL-6 KSI-101 Dual inhibition by B KSI-101 c
Slide 59: KSI-101 restores barrier resistance
Bispecific KSI-101 restores barrier resistance from pre-existing insult greater than anti-IL-6 or anti-VEGF monotherapies alone 150 High barrier resistance Intact tight junctions No Exposure No Exposure VEGF + IL-6/R VEGF++KSI-101 IL-6/R + KSI-101 KSI-101 restores barrier integrity to 100 % Resistan
Slide 60: KSI-101 poised to fulfill core unmet need in MESI
KSI-101 is poised to fulfill the core unmet need in MESI based on its potential to be a disease modifying, high-strength, locally administered and safe biologic Illustrative KSI-101 is designed to address the core unmet need complications • Targets both IL-6 and VEGF disease drivers • Dual anti-IL-6
Slide 61: Rapid response across MESI diseases after single dose
After a single dose of KSI-101, heterogenous MESI diseases show rapid and meaningful responses to the simultaneous IL-6 and VEGF inhibition, irrespective of the location of the inflammation or the specific macular edema diagnosis Location of inflammation Anterior Intermediate Posterior Panuveitis Da
Slide 62: KSI-101 in DME and MESI: Phase 1b APEX Study
Phase 1b APEX Study Sumit Sharma KSI-101 in DME and MESI MD 63
Slide 63: Phase 1b APEX study in DME and MESI
Phase 1b APEX study: KSI-101 in patients with diabetic macular edema (DME) and macular edema secondary to inflammation (MESI) • APEX is an ongoing, open label, multicenter platform study on the safety, tolerability, bioactivity, and pharmacokinetics of multiple intravitreal therapies in retinal dise
Slide 64: Phase 1b APEX KSI-101 in DME
Diabetic Macular Edema Phase 1b APEX Sumit Sharma KSI-101 in DME MD 65
Slide 65: APEX first-in-human study in DME
Phase 1b APEX study: a first in human study of KSI-101 in patients with DME Weeks 0 4 8 12 16 20 24 2.5 mg Enrollment Subjects completed with DME 5 mg (n=12) 10 mg KSI-101 injection End of Study Key inclusion criteria • Treatment-naive center-involving DME • OCT CST of ≥400 and ≤650 microns • BCVA s
Slide 66: APEX KSI-101 in DME – Baseline Characteristics
APEX KSI-101 in DME – Baseline Characteristics KSI-101 2.5 mg KSI-101 5 mg KSI-101 10 mg All KSI-101 (n=4) (n=4) (n=4) (N=12) Age, years, mean (SD) 54.5 (10.6) 68.3 (5.74) 56.5 (4.7) 59.8 (9.3) Female, n (%) 0 0 2 (50) 2 (16.7) Race, White, n (%) 4 (100) 4 (100) 4 (100) 12 (100) DME disease duration
Slide 67: APEX DME – anatomical gains at all dose levels
APEX KSI-101 in DME – Meaningful anatomical gains were achieved with all KSI-101 dose levels tested Mean Change in OCT CST Mean Change in OCT CST by KSI-101 dose level all KSI-101 dose levels combined 0 0 Treatment Phase Off-treatment Phase Treatment Phase Off-treatment Phase -50 -50 2.5 mg 5 mg 10
Slide 68: APEX DME – vision gains at all dose levels
APEX KSI-101 in DME – Meaningful vision gains were achieved with all KSI-101 dose levels tested Mean Change in BCVA Mean Change in BCVA by KSI-101 dose level all KSI-101 dose levels combined 20 20 Treatment Phase Off-treatment Phase Treatment Phase Off-treatment Phase 15 15 ETDRS Letters ETDRS Lette
Slide 69: APEX KSI-101 in DME – well-tolerated
APEX KSI-101 in DME – KSI-101 was well-tolerated KSI-101 2.5 mg KSI-101 5 mg KSI-101 10 mg All KSI-101 (n=4) (n=4) (n=4) (N=12) Summary of AEs in the Study eye, n (%) Subjects with ≥1 AEs 1 (25) 0 0 1 (8.3) Treatment-related AEs 0 0 0 0 Serious AEs 0 0 0 0 Treatment-related serious AEs 0 0 0 0 Sever
Slide 70: Phase 1b APEX KSI-101 in MESI
Macular Edema Secondary to Inflammation Sumit Sharma Phase 1b APEX MD KSI-101 in MESI 71
Slide 71: APEX multiple dose study in MESI
Phase 1b APEX study: multiple dose study of KSI-101 in patients with MESI Weeks 0 4 8 12 16 20 24 2.5 mg Enrollment Subjects completed with MESI 5 mg (n=41) 10 mg KSI-101 injection End of Study Key inclusion criteria • Macular edema secondary to inflammation (MESI) • Diagnosis of active or inactive
Slide 72: APEX KSI-101 in MESI – Baseline Characteristics
APEX KSI-101 in MESI – Baseline Characteristics KSI-101 2.5 mg KSI-101 5 mg KSI-101 10 mg All KSI-101 (n=13) (n=14) (n=14) (N=41) Age, years, mean (SD) 74.2 (11.6) 67.4 (8.1) 67.5 (18.8) 69.6 (13.7) Female, n (%) 8 (61.5) 7 (50.0) 8 (57.1) 23 (56.1) Race, White, n (%) 11 (84.6) 11 (78.6) 14 (100) 36
Slide 73: APEX MESI – rapid anatomical gains
APEX KSI-101 in MESI – Meaningful anatomical gains are rapidly achieved, with all dose levels achieving dryness OCT CST levels as early as Week 4 Mean Change in OCT CST Observed OCT CST over time in patients completing Week 12 in patients completing Week 12 0 600 2.5 mg 2.5 mg 5 mg 5 mg 10 mg 10 mg
Slide 74: APEX MESI – visual acuity gains of more than two lines
APEX KSI-101 in MESI – Meaningful visual acuity gains of more than two lines of vision have been achieved with the top two dose levels tested Mean Change in BCVA Observed BCVA over time in patients completing Week 12 in patients completing Week 12 15 80 2.5 mg 2.5 mg 5 mg 5 mg 10 mg 10 mg 75 ETDRS L
Slide 75: Half of patients achieved a ≥15 letter gain
APEX KSI-101 in MESI – Half of patients have achieved a ≥15 letter gain, with an apparent additional benefit in the top two dose levels Proportion of ≥15 letter gainers in patients completing Week 12 100 80 60 Patients, % 63 50 48 40 33 20 0 2.5 mg 5 mg 10 mg All patients (n=9) (n=8) (n=10) (n=27) P
Slide 76: Majority achieve dryness; over 90% by Week 8
APEX KSI-101 in MESI – A single dose of KSI-101 results in the majority of patients achieving dryness. Over 90% of patients achieve dryness by Week 8 Proportion of patients Proportion of patients achieving absence of IRF achieving absence of SRF 100 100 100 100 92 91 92 80 80 79 74 Patients, % Patie
Slide 77: APEX KSI-101 in MESI – well-tolerated
APEX KSI-101 in MESI – KSI-101 was well-tolerated KSI-101 2.5 mg KSI-101 5 mg KSI-101 10 mg All KSI-101 (n=13) (n=14) (n=14) (N=41) Summary of AEs in the Study eye, n (%) Subjects with ≥1 AEs 1 (7.7)a 2 (14.3) 2 (14.3) 5 (12.2) Treatment-related AEs 1 (7.7)a 1 (7.1)b 0 2 (4.9) Serious AEs 0 0 0 0 Tr
Slide 78: How does KSI-101 fit into the emerging treatment landscape?
Macular Edema Secondary to Inflammation Sumit Sharma How does KSI-101 fit into MD the emerging treatment landscape? 79
Slide 79: DOVETAIL vamikibart ≥15 letter gain with anti-IL-6
DOVETAIL vamikibart – approximately a quarter of patients exhibit a ≥15 letter gain with anti-IL-6 monotherapy DOVETAIL vamikibart ≥15 letter gainers at Week 12 Sharma, et al. A Novel Intravitreal Anti-IL-6 Monoclonal Antibody for Uveitic Macular Edema (UME): Preliminary Results From the Phase 1 DOV
Slide 80: Dual inhibition confers additional visual benefits
The dual IL-6 and VEGF inhibition of KSI-101 seems to confer additional visual benefits in patients with MESI, with ~half of patients achieving a ≥15-letter improvement APEX KS1-101 ≥15 letter gainers in patients completing Week 12 100 80 Patients, % 60 63 50 48 40 33 20 0 2.5 mg 5 mg 10 mg All pati
Slide 81: DOVETAIL vamikibart persistent IRF
DOVETAIL vamikibart – while intravitreal IL-6 monotherapy is helpful, 50% of patients have persistent IRF DOVETAIL vamikibart DOVETAIL vamikibart Absence of IRF Absence of SRF ~50% of patients have persistent IRF Persistent intraretinal fluid (IRF) is known to cause permanent negative effects on vis
Slide 82: Dual inhibition provides faster, better disease control
APEX KSI-101 in MESI – the dual IL-6 and VEGF inhibition of KSI-101 seems to provide faster and better disease control, with a clear effect seen as early as Week 1 APEX KS1-101 APEX KS1-101 Proportion of patients Proportion of patients achieving absence of IRF achieving absence of SRF 100 100 100 10
Slide 83: KSI-101 rapidly dries the retina after a single injection
KSI-101 rapidly dries the retina after a single injection Mean Change in OCT CST and absolute CST achieved by Week 4 550 DOVETAIL1 PEACHTREE2 MERIT3 APEX4 Legend 500 -4 Baseline 4 OCT CST, microns 450 Mean Change 400 -89 -136 350 -166 -149 300 -89 -183 -180 -229 Dryness 250 -187 200 0.25 mg 1 mg 2.5
Slide 84: Synergistic anatomical benefits over monotherapy at Week 4
Dual IL-6 and VEGF inhibition seems to provide a synergistic effect that results in additional anatomical benefits over either individual monotherapy Mean Change in OCT CST and absolute CST achieved by Week 4 550 DOVETAIL1 PEACHTREE2 MERIT3 APEX4 Legend 500 -4 Baseline 4 OCT CST, microns 450 MTX Mea
Slide 85: Continued disease control at Week 12
KSI-101 provides continued disease control for MESI patients, as evaluated at Week 12 with the effect of 3 monthly doses Mean Change in OCT CST and absolute CST achieved by Week 12 550 DOVETAIL1 PEACHTREE2 MERIT3 APEX4 Legend 500 -16 Baseline 450 OCT CST, microns Mean Change 400 -73 350 -126 -185 -1
Slide 86: Synergistic anatomical benefits over monotherapy at Week 12
Dual IL-6 and VEGF inhibition seems to provide a synergistic effect that results in additional anatomical benefits over either individual monotherapy Mean Change in OCT CST and absolute CST achieved by Week 12 550 DOVETAIL1 PEACHTREE2 MERIT3 APEX4 Legend 500 -16 MTX Baseline 450 OCT CST, microns Mea
Slide 87: In Summary: Sumit Sharma, MD
In Summary: “Kodiak has designed a thoughtful bispecific trap- antibody-fusion protein. Early data from the Phase 1b APEX study are promising and show that –to date– the molecule appears safe and potent and to have a broad-spectrum activity in patients. I attribute this to the high strength and the
Slide 88: PEAK and PINNACLE KSI-101 Pivotal Program
Macular Edema Secondary to Inflammation Charles Wykoff PEAK and PINNACLE MD, PhD KSI-101 Pivotal Program 89
Slide 89: Phase 3 pivotal program in MESI – study design
Phase 3 pivotal program in MESI – PEAK and PINNACLE Study Design Fixed monthly dosing Individualized dosing Weeks D1 4 8 12 16 20 24 28 32 36 40 44 48 KSI-101 5 mg (n~50) KSI-101 10 mg (n~50) Sham (n~50) KSI-101 5 mg injection Individualized treatment (PRN) KSI-101 10 mg injection Sham PRN Primary e
Slide 90: PEAK and PINNACLE study design – rescue criteria
Phase 3 pivotal program in MESI – PEAK and PINNACLE Study Design Fixed monthly dosing Individualized dosing Weeks D1 4 8 12 16 20 24 28 32 36 40 44 48 KSI-101 5 mg (n~50) KSI-101 10 mg (n~50) Sham (n~50) KSI-101 5 mg injection Individualized treatment (PRN) KSI-101 10 mg injection Sham PRN Primary e
Slide 91: PEAK and PINNACLE study design – endpoints
Phase 3 pivotal program in MESI – PEAK and PINNACLE Study Design Fixed monthly dosing Individualized dosing Weeks D1 4 8 12 16 20 24 28 32 36 40 44 48 KSI-101 5 mg (n~50) KSI-101 10 mg (n~50) Sham (n~50) KSI-101 5 mg injection Individualized treatment (PRN) KSI-101 10 mg injection Sham PRN Primary e
Slide 92: Are PEAK and PINNACLE identical studies?
PEAK and PINNACLE – Key question: are these identical studies? Master Protocol Design A single screening process for both studies CST≥320 and BCVA 25-78 letters Moderate to severe Day 1 enroll in either study Mild macular edema based on CST and BCVA macular edema CST ≥400 CST≥320 and <400 Moderate t
Slide 93: Why were the APEX top two dose levels selected?
PEAK and PINNACLE – Key question: Why are the APEX top two dose levels selected? APEX APEX Mean Change in BCVA ≥15 letter gainers in patients completing Week 12 in patients completing Week 12 15 100 80 ETDRS Letters 10 Patients, % 60 63 40 50 48 5 2.5 mg 33 20 5 mg 10 mg 0 0 0 4 8 12 16 20 24 2.5 mg
Slide 94: Why is mean change in BCVA the primary endpoint?
PEAK and PINNACLE – Key question: Why is mean change in BCVA the primary endpoint and not ≥15 letter gainers or losers? PEACHTREE1 APEX2 Mean Change in BCVA Mean Change in BCVA in sham treated patients in patients completing Week 12 15 15 ETDRS Letters ETDRS Letters 10 10 5 5 5 mg Sham 10 mg 0 0 0 4
Slide 95: Why is mean change in BCVA the primary endpoint?
PEAK and PINNACLE – Key question: Why is mean change in BCVA the primary endpoint and not ≥15 letter gainers or losers? APEX2 PEACHTREE1 Mean Change in BCVA in patients that would Mean Change in BCVA meet criteria for PEAK or PINNACLE in sham treated patients Week 12 completers 15 15 ETDRS Letters E
Slide 96: Why are key secondary endpoints different?
PEAK and PINNACLE – Key question: why are the key secondary endpoints different between PEAK and PINNACLE? PEAK PINNACLE Patient Moderate to severe edema with Moderate to severe edema with Mild edema with any vision Population moderate to severe vision impairment good vision impairment Treatment Mac
Slide 97: How APEX data inform probability of success
PEAK and PINNACLE – Key question: how do the APEX data educate the probability of success of PEAK and PINNACLE? Improving vision Preventing vision loss ≥15-letter gainers ≥15-letter losers Rescue medication APEX1 patients that over 24 weeks would meet criteria for APEX1 patients that would PEAK or P
Slide 98: Why endpoints are evaluated up to Week 24
PEAK and PINNACLE – Key question: Why are the primary and key secondary endpoints evaluated up to Week 24 and not at Week 16? APEX Case Example Patient treated with KSI-101 5 mg 30 +28 Change in BCVA at Week 20 and 24: +26.5 +25 ≥15 letter gainer up to Week 24: yes 25 Vision continues to Change in B
Slide 99: KSI-101 potential first-line common therapy for MESI
MESI is a heterogeneous spectrum of diseases with a common clinical presentation and a common pathophysiology. KSI-101 has the potential to become the first line common therapy for MESI Common Common Clinical Potential common Pathophysiology Presentation therapy Inflammation Macular Edema VEGF IL-6
Slide 100: A Patient's MESI Journey
A Patient’s MESI Journey Dolly S. Chang, MD, PhD Chief Scientific Officer 101
Slide 101: Dolly S. Chang, MD, PhD
Kodiak, Ophthalmologist and Glaucoma Surgeon Dolly S. Chang, MD, PhD Chief Scientific Officer, Kodiak Sciences Inc. Ophthalmologist, Glaucoma Surgeon Adjunct Clinical Assistant Professor of Ophthalmology, Stanford University • At Kodiak, Dr. Chang oversees pipeline development and advances transform
Slide 102: Patient journey #1: eye drops for macular edema
Patient journey #1: “a crazy amount of eye drops for macular edema and inflammation” – a physician's perspective as a patient “I had macular edema that rose and fell with each flare, and I went through what felt like a million OCTs. The only treatment was Durezol eyedrops, which kept the inflammatio
Slide 103: Limited resolution and IOP risk of steroid eyedrops
Limited resolution and IOP risk highlight limitations of steroid eyedrops in MESI In 36% of patients, topical steroids 32% of patients on Durezol drops (difluprednate, Durezol) controlled the had an IOP response that is disease. In 40% of patients, the disease clinically concerning was refractory to
Slide 104: Patient journey #2: 52-year-old woman with blurry vision
Patient journey #2: 52-year-old healthy woman with bilateral blurry vision and floaters Physical exam Differential Diagnosis No prior ocular history, only requires Rashes/lesions/ulcers Behcet’s, psoriasis, VKH, Lupus, herpes reading glasses Joints/arthritis/spine mobility RA, ankylosing spondylitis
Slide 105: Treatment today is complex
Treatment today is complex: MESI can persist and recur despite inflammation resolution and multiple therapies Months 0 2 4 6 8 10 12 14 16 18 20 0.00 20/20 700 MESI temporarily responds to Ozurdex Visual MESI temporarily 600 0.10 20/25 Fluid responded, Acuity responds to Ozurdex but patient needed a
Slide 106: When steroids help and harm: glaucoma in MESI
When steroids help and harm: the challenge of managing glaucoma in MESI patients requiring ocular steroids Combined glaucoma tube The stronger the steroid, shunt surgery + complex the stronger the side cataract surgery 60 effects For example, RETISERT® (fluocinolone acetonide 40 Intraocular intravit
Slide 107: Toward unified MESI management with KSI-101
Toward unified MESI management: can KSI-101 deliver potency without the glaucoma and surgical burden of steroids? Today Complex Treatment Simplified Diagnosis Complex Diagnosis Decisions and Treatment Journey Considerations in Steroid • Idiopathic Selection Diagnosis MESI with OCT • Vogt-Koyanagi-Ha
Slide 108: KSI-101 commercial opportunity
KSI-101 commercial Victor Perlroth, MD opportunity Chairman and CEO 109
Slide 109: Problem Statement: ocular inflammation and MESI
Problem Statement: Ocular inflammation is the 4th leading cause of blindness among the working-age population in the developed world MESI, a serious complication of ocular inflammation, is the primary contributor to vision loss and blindness in this group Br Journal of Ophthalmology 1996;80:844-848,
Slide 110: KSI-101 commercial opportunity highlights
>150,000 initial KSI-101 Differentiated potent Potential for a A serious vision Excitement from addressable MESI high strength simplified and safer threatening disease physician interviews patients in the US dual MOA MESI patient journey I M E S I A chronic retinal condition The initial KSI-101 KSI-
Slide 111: MESI affects ~450,000 US patients
MESI affects ~450,000 US patients (~300,000 trial eligible), estimated by two methodologies and often reported by etiology (defined autoimmune, idiopathic, procedural, infectious and other) U.S. MESI EPIDEMIOLOGY (2025) Thousands of patients Method 1 DEFINED AUTOIMMUNE ME3 Method 2 ~5,415 ~1,665 HLA
Slide 112: KSI-101 initial addressable population greater than 150,000
KSI-101 initial addressable population is greater than 150,000 MESI patients in the US KSI-101 ADDRESSABLE POPULATION KSI-101 initial addressable population is >150,000 # of Patients 1L 2L 3L Minus (4-6 weeks) (~3 months) (6+ months) Acute post- procedural and infectious >150,000 157K 300K 455K 70K
Slide 113: Most MESI patients are in care of general ophthalmologists and retina specialists
Most MESI patients are in the care of General Ophthalmologists and Retinal Specialists; complex cases are referred out to Uveitis Specialists 17% of retina specialists’ current case load is MESI today OPHTHALMOLOGY PRACTICE BREAKDOWN % of ME patients by patient subtype across physician types 8% 6% 1
Slide 114: Physicians impressed with rapid response and diversity of etiologies
Physicians are impressed with both the rapid response by Week 4 and the diversity of etiologies responding to KSI-101 “… It’s not much different than using anti-VEGF to treat DME, AMDs, and RVOs. Those are very different diseases with very different pathophysiology but at the end of the day the medi
Slide 115: Patients present with central vision loss; routine workup
Patients typically present with central vision loss or distortion, and ophthalmologists conduct routine workup and targeted tests MESI DIFFERENTIAL DIAGNOSIS PATIENT ARRIVES IN CLINIC ROUTINE WORKUP TARGETED TESTS • Blurry vision • Clinical history & symptoms • Targeted lab tests for infection (e.g.
Slide 116: MESI diagnosed via dilated fundus exam and OCT
MESI is diagnosed via dilated fundus exam & OCT, with subtypes often distinguished through clinical history and targeted lab testing MESI DIAGNOSIS BY SUBTYPE OVERVIEW MACULAR EDEMA SECONDARY TO INFLAMMATION INITIAL WORKUP DIFFERENTIAL DIAGNOSIS • Diagnosis of exclusion, where ME cannot be attribute
Slide 117: Physicians open to using KSI-101 before steroid injections
Physicians were open to using KSI-101 after eye drops and before steroid injections; Uveitis Specialists may use first-line in severe cases TREATMENT PARADIGM EVOLUTION ILLUSTRATIVE • KSI-101 is generally considered MACULAR EDEMA SECONDARY TO INFLAMMATION early second line, but may be first-line in
Slide 118: Summary
Summary Victor Perlroth, MD Chairman and CEO 119
Slide 119: Kodiak Investor R&D Day July 2025 – Key Messages
Kodiak Investor R&D Day July 2025 – Key Messages Wholly Owned • Strong 12-week data from Phase 1b APEX A potent • PEAK and PINNACLE – already enrolling reason to KSI-101 • Commercial opportunity of 150,000+ initial believe in addressable patients with headroom Kodiak • Science-based “heavyweights”?
Slide 120: Q&A
Q&A KODIAK