Kodiak Sciences Inc · NASDAQ:KOD
Kodiak Sciences — Jefferies Global Healthcare Conference – London 2025
74 slides from Kodiak Sciences's conference presentation, Nov 17, 2025
Slide 1: Jefferies Global Healthcare Conference – London
THE OPHTHALMOLOGY MEDICINES COMPANY Jefferies Global Healthcare Conference – London 1 November 17, 2025
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding Kodiak’s plans, commitments, aspirations and goals related to Kodiak’s drug
Slide 3: We are a precommercial, retina-focused biotech on the move
We are a precommercial, retina-focused biotech on the move Wholly Owned • Robust 20-week data from Phase 1b APEX • MOA validated by scientific community A potent KSI-101 • Phase 3 PEAK and PINNACLE enrolling at a faster-than- reason to expected pace believe in • Commercial opportunity of 150,000+ in
Slide 4: Phase 3 clinical programs and pipeline assets address leading causes of vision loss
Our Phase 3 clinical programs (3) and pipeline assets (4) are designed to address the leading causes of vision loss Estimated prevalence (US) ABC: antibody biopolymer conjugate; MESI: macular edema secondary to inflammation; AMD: age-related macular degeneration; DR: diabetic retinopathy; RVO: retin
Slide 5: Spotlight on our Phase 3 programs
Spotlight on our Phase 3 programs For patients with retinal vascular diseases For patients with MESI Tarcocimab KSI-501 KSI-101 Anti-VEGF ABC® biologic Anti-IL-6, VEGF trap bispecific Anti-IL-6, VEGF trap bispecific designed for: ABC® biologic designed for: protein designed for: • Strong immediacy •
Slide 6: All three assets on track for Phase 3 topline data readouts in 2026
All three assets are on track for Phase 3 topline data readouts in 2026; a series of BLA filings possible in 2026 and 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 GLOW1 Antibody Tarcocimab Biopolymer Wet AMD DAYLIGHT BLA* Conjuga
Slide 7: Pipeline potential for sustainable revenue streams starting from 2027
Our 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-101 Saf
Slide 8: Tarcocimab & KSI-501
Tarcocimab & KSI-501 KODIAK
Slide 9: The Retinal Vascular Diseases and the Anti-VEGF Market
The Retinal Vascular Diseases and the Anti-VEGF Market: Tarcocimab & KSI-501 9
Slide 10: Open space remains 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 11: Gen 1.0 and Gen 1.5 biologics provide immediacy and incremental 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 Estimated worldwide sales1 Gen 1.0 DR RVO Good e
Slide 12: Real-world data show most wet AMD patients fall short of 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 study1 Treatment-Naïve Eyes (n=389a) Year 2: In Y
Slide 13: 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 14: Open space for high immediacy and high durability in a $15+ billion market
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 15: Kodiak's ABC Platform Science in Retina
Kodiak’s ABC® Platform Science in Retina 15
Slide 16: The ABC Platform supports science of immediacy and durability
The ABC® Platform supports Kodiak’s science of IMMEDIACY and DURABILITY Designed-in High Extended Extended Powerful Extended Extended Tissue In-Vitro Ocular Half- Ocular Half- Immediacy via Clinical Durability Life in Animals Life in Humans Unconjugated via Conjugated Residence Time Potency Antibody
Slide 17: Best of both worlds: high immediacy and high 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 Durability increases as molecular weight increases for intravitreal biologics 149 kDa 1000 kDa 210 kDa Immediacy is achieved with lower mo
Slide 18: 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 IMMEDIACY DURABILITY Unconjugated protein ABC® (conjugated) protein Tarcocimab 1 mg + 4 mg KSI-501 1.5 mg + 3.5 mg Molecular Size (kDa) 18
Slide 19: Tarcocimab mean ocular half-life in humans is 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 ~3x longer (Mean) than faricimab 10-90th percentiles TARCOCIMAB 8.3 31.8 (10th percentile) (90th percentile) FARICIMAB 10-90th percentiles 5.2 11.2 (10th percentile) (90th percentile) Human O
Slide 20: Consistent 20-day ocular half-life across wet AMD, DME and RVO
Tarcocimab demonstrated consistent 20-day 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 T1/2 tarcocimab 20 19.8 Days 10 T1/2 faricimab 7.5 Days 0 All All wAMD Wet AMD DME DME RVO RVO n=47 n=23 n=8 n=16 n=47 n
Slide 21: Modeling suggests extended dosing intervals for all patient types
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 22: ABC Enabled Mainstay Biologics
ABC® Enabled Mainstay Biologics Tarcocimab KSI-501 • Better Efficacy • Strong Immediacy • Strong Immediacy • Industry-leading Durability • Industry-leading Durability 22
Slide 23: Ongoing and planned studies support tarcocimab BLA in 2026 and KSI-501 in 2027
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 24: DAYBREAK study explores tarcocimab and KSI-501 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 25: GLOW2 study design mirrors successful GLOW1 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 26: GLOW1 shows tarcocimab opens door to 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 ~9,000,0001 Microhemorrhages visible on the retina even if no visual symptoms are present yet DR
Slide 27: Tarcocimab in RVO addresses core unmet need
Tarcocimab in RVO: 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 9
Slide 28: Comparable visual and anatomical outcomes in RVO regardless of treatment paradigm
Tarcocimab in RVO: tarcocimab achieves comparable visual and anatomical outcomes in all RVO patients, irrespective of the treatment paradigm used 80 Mean BCVA over time 75.4 (12.3) 75 74.6 (12.3) (ETDRS Letters) 74.7 (12.1) 74.3 (13.4) Mean BCVA 70 65 60 55 0 1 4 8 12 16 20 24 24 28 32 36 40 44 48 T
Slide 29: Revisiting the core unmet need: 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 30: KSI-101 Macular Edema Secondary to Inflammation (MESI)
Macular Edema Secondary to Inflammation KSI-101 (MESI) 30
Slide 31: What is MESI?
Macular Edema Secondary to Inflammation What is MESI? 31
Slide 32: Macular edema can be 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 33: What is macular edema secondary to inflammation (MESI)?
What is macular edema secondary to inflammation (MESI)? Common Common Clinical Unifying Therapy? Pathophysiology Presentation Inflammation VEGF Macular edema with visual impairment Blood IL-6 IL-6 Retinal Barrier Disruption Angiogenesis KSI-101 MESI is a heterogenous group of diseases that clinicall
Slide 34: MESI comprises heterogenous diseases with a 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 35: Macular edema is the 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 36: What causes MESI?
Macular Edema Secondary to Inflammation What causes MESI? 36
Slide 37: 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 1 Immune Trigger 2 Blood-Retinal Barrier Breaks Down 3 IL-6 and VEGF Amplify Leakage Causes immune cells to release IL-6 upregulates VE
Slide 38: What is the unmet need?
Macular Edema Secondary to Inflammation What is the unmet need? 38
Slide 39: Core unmet need in MESI for a potent, high-strength, safe therapy
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-IL-6 • Potential to be disease modifying Core monotherapy • High strength unmet need open • Potent • Minimally
Slide 40: What have we learned? IL-6 inhibition in inflammatory macular edema
IL-6 inhibition in inflammatory macular edema What have we learned? 40
Slide 41: DOVETAIL Study: intravitreal anti-IL-6 monotherapy (vamikibart)
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 42: Vamikibart shows anti-IL-6 monotherapy provides 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 43: 50% of patients have persistent IRF with IL-6 monotherapy
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 44: IL-6 pathway validated in recent pivotal studies
The IL-6 pathway has been further validated in recent pivotal studies as a key target for inhibition in inflammatory macular edema Vamikibart Phase 3 Program Vamikibart Phase 3 Program Change from Baseline in OCT CST Change from Baseline in BCVA MEERKAT SANDCAT MEERKAT SANDCAT Clear anatomical Visua
Slide 45: No on-target adverse effects identified in pivotal studies
No on-target adverse effects were identified in pivotal studies, derisking intravitreal IL-6 inhibition in inflammatory macular edema Vamikibart Phase 3 Program Summary of Ocular (Study Eye) and Vamikibart Phase 3 Program non-ocular adverse events Selected oular adverse events MEERKAT SANDCAT MEERKA
Slide 46: Vamikibart had no effect on VEGF aqueous humor concentrations
Importantly, vamikibart was shown to have no effect on VEGF aqueous humor concentrations in DOVETAIL Median Aqueous Humor VEGF concentration is not suppressed Evaluation of the Role of Interleukin-6 and Vascular Endothelial Growth Factor in Uveitic Macular Edema and Uveitis. Presented by Roche at Cl
Slide 47: How can this unmet need be addressed?
Macular Edema Secondary to Inflammation How can this unmet need be addressed? 47
Slide 48: KSI-101 is a first-in-class, high-strength intravitreal 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 48
Slide 49: KSI-101 poised to fulfill the 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 1. Targets both IL-6 & Core VEGF disease drivers IVT anti-VEG
Slide 50: Phase 1b APEX KSI-101 in MESI Week 20 Extended Follow-up Data
Phase 1b APEX KSI-101 in MESI Week 20 Extended Follow-up Data 50
Slide 51: Phase 1b APEX study: multiple dose study of KSI-101 in MESI
Phase 1b APEX study: multiple dose study of KSI-101 in patients with MESI Study Design: Ongoing, Open-label Phase 1b in MESI Baseline Characteristics Weeks 0 4 8 12 16 20 24 KSI-101 2.5 mg KSI-101 5 mg KSI-101 10 mg All KSI-101 (n=13) (n=14) (n=14) (N=41) Subjects with MESI 2.5 mg Age, years, mean (
Slide 52: Top two dose levels achieve meaningful vision gains
The top two dose levels achieve meaningful vision gains of >10 letters by Week 4, subsequently achieving a 20/25 Snellen visual acuity by Week 20, with continued strengthening of visual acuity from week 12 to week 20 New Data Mean Change in BCVA over time Observed BCVA over time 20 80 +15.4 Mean ETD
Slide 53: More than half of patients achieved a ≥15 letter gain
More than half of patients have achieved a ≥15 letter gain, with additional benefit observed at the top highest dose levels New Data Proportion of ≥15 letter gainers 100 80 Patients, % 60 62 54 51 40 38 20 0 2.5 mg 5 mg 10 mg All patients (n=13) (n=13) (n=13) (n=39) Preliminary Analysis The APEX stu
Slide 54: Meaningful anatomical improvements rapidly achieved
Meaningful anatomical improvements are rapidly achieved, with OCT CST levels <325 µm observed as early as Week 4, further deepening over time New Data Observed OCT CST over time 600 2.5 mg 5 mg 10 mg 500 Mean CST (µm) 400 Mean Change 300 -151 -230 Dryness -218 (CST 250-325) 200 0 4 8 12 16 20 24 Wee
Slide 55: ≥90% of patients at top two doses achieved absence of IRF and SRF
≥90% of patients in the top two dose levels achieved and maintained absence of both intraretinal and subretinal fluid New Data Proportion of patients in the 5 and 10 mg Proportion of patients in the 5 and 10 mg (pooled) dose level achieving absence of IRF (pooled) dose level achieving absence of SRF
Slide 56: KSI-101 has been well-tolerated
KSI-101 has been well-tolerated New Data 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 2 (15.4) 3 (21.4) 2 (14.3) 7 (17.1) Treatment-related AEs 1 (7.7)a 1 (7.1)b 0 2 (4.9) Serious AEs 0 0 0 0 Treatment-r
Slide 57: How does KSI-101 fit into the emerging treatment landscape?
Macular Edema Secondary to Inflammation How does KSI-101 fit into the emerging treatment landscape? 57
Slide 58: DOVETAIL vamikibart: 50% of patients have persistent IRF
DOVETAIL vamikibart – while intravitreal IL-6 monotherapy is helpful, 50% of patients have persistent Intra Retinal Fluid 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 negativ
Slide 59: KSI-101 seems to provide faster and better disease control
KSI-101 seems to provide faster and better disease control, with ≥90% of patients in the top two dose levels achieving and maintaining absence of both intraretinal and subretinal fluid Proportion of patients in the 5 and 10 mg Proportion of patients in the 5 and 10 mg (pooled) dose level achieving a
Slide 60: Mean change in OCT CST and absolute CST
Mean Change in OCT CST and Absolute CST APEX3 DOVETAIL1 MEERKAT2 SANDCAT2 550 Day 1 Day 1 550 Week 1 Week 1 500 500 Week 4 Week 4 450 450 OCT CST (µm) OCT CST (µm) Week 8 Week 8 400 400 Week 12 Week 12 350 350 Week 16 Week 16 300 300 Dryness (CST 250 – 325) 250 250 2.5 mg 5 mg 10 mg 0.25 mg 1 mg 2.5
Slide 61: Rapid onset of action observed with KSI-101
Mean Change in OCT CST and Absolute CST APEX3 DOVETAIL1 MEERKAT2 SANDCAT2 550 Day 1 Day 1 550 Week Effect of a Effect of a Week11 Week 11 Week 500 single dose single dose 500 Week 4 Week 4 450 450 OCT CST (µm) OCT CST (µm) Week 8 Week 8 400 400 Week 12 Week 12 350 350 Week 16 Week 16 300 300 Dryness
Slide 62: Dryness levels observed with a single dose of KSI-101
Mean Change in OCT CST and Absolute CST APEX3 DOVETAIL1 MEERKAT2 SANDCAT2 550 Day 1 Day 1 550 Week 1 Week 1 500 500 Effect of a Effect of a Week44 Week Week 4 Week 4 single dose single dose 450 450 OCT CST (µm) OCT CST (µm) Week 8 Week 8 400 400 Week 12 Week 12 350 350 Week 16 Week 16 300 300 Drynes
Slide 63: Dryness levels with a single dose versus two doses
Mean Change in OCT CST and Absolute CST APEX3 DOVETAIL1 MEERKAT2 SANDCAT2 550 Day 1 Day 1 550 Week 1 Week 1 500 500 Effect of a Week44 Week Week 4 single dose 450 450 Effect of 2 OCT CST (µm) OCT CST (µm) Week 8 Week 8 Week 8 doses 400 400 Week 12 Week 12 350 350 Week 16 Week 16 300 300 Dryness (CST
Slide 64: Dryness levels with a single dose versus three doses
Mean Change in OCT CST and Absolute CST APEX3 DOVETAIL1 MEERKAT2 SANDCAT2 550 Day 1 Day 1 550 Week 1 Week 1 500 500 Effect of a Week44 Week Week 4 single dose 450 450 OCT CST (µm) OCT CST (µm) Week 8 Week 8 400 400 Effect of 3 Week 12 Week Week 12 12 doses 350 350 Week 16 Week 16 300 300 Dryness (CS
Slide 65: Single dose of KSI-101 provides deeper drying than 4 doses of anti-IL-6
Mean Change in OCT CST and Absolute CST APEX3 DOVETAIL1 MEERKAT2 SANDCAT2 550 Day 1 Day 1 550 Week 1 Week 1 500 500 Effect of a Week44 Week Week 4 single dose 450 450 OCT CST (µm) OCT CST (µm) Week 8 Week 8 400 400 Week 12 Week 12 350 Effect of 4 350 Week 16 Week Week 16 16 doses 300 300 Dryness (CS
Slide 66: Continued dosing deepens dryness corridor
Mean Change in OCT CST and Absolute CST APEX3 DOVETAIL1 MEERKAT2 SANDCAT2 550 Day 1 Day 1 550 Week 1 Week 1 500 500 Week 4 Week 4 450 450 Effect of 2 OCT CST (µm) OCT CST (µm) Week88 Week Week 8 doses 400 400 Week 12 Week 12 350 Effect of 4 350 Week 16 Week Week 16 16 doses 300 300 Dryness (CST 250
Slide 67: Continued dosing deepens dryness corridor (3 doses)
Mean Change in OCT CST and Absolute CST APEX3 DOVETAIL1 MEERKAT2 SANDCAT2 550 Day 1 Day 1 550 Week 1 Week 1 500 500 Week 4 Week 4 450 450 OCT CST (µm) OCT CST (µm) Week 8 Week 8 400 400 Effect of 3 Week1212 Week Week 12 doses 350 Effect of 4 350 Week 16 Week Week 16 16 doses 300 300 Dryness (CST 250
Slide 68: Dual inhibition of IL-6 and VEGF provides synergistic drying effect
Mean Change in OCT CST and Absolute CST APEX3 DOVETAIL1 MEERKAT2 SANDCAT2 550 Day 1 Day 1 550 Week 1 Week 1 500 500 Week 4 Week 4 450 450 OCT CST (µm) OCT CST (µm) Week 8 Week 8 400 400 Week 12 Week 12 350 Effect of 4 Effect of 4 350 Week1616 Week Week Week 16 16 doses doses 300 300 Dryness (CST 250
Slide 69: PEAK and PINNACLE KSI-101 Pivotal Program
Macular Edema Secondary to Inflammation PEAK and PINNACLE KSI-101 Pivotal Program 69
Slide 70: Phase 3 pivotal program in MESI – study design and inclusion 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 Primar
Slide 71: Phase 3 pivotal program in MESI – 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 Primar
Slide 72: Phase 3 pivotal program in MESI – 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 Primar
Slide 73: PEAK and PINNACLE – are these 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 74: We are a precommercial, retina-focused biotech on the move
We are a precommercial, retina-focused biotech on the move Wholly Owned • Robust 20-week data from Phase 1b APEX • MOA validated by scientific community A potent KSI-101 • Phase 3 PEAK and PINNACLE enrolling at a faster-than- reason to expected pace believe in • Commercial opportunity of 150,000+ in
Kodiak Sciences — Jefferies Global Healthcare Conference – London 2025 on 6ix