"Kodiak Sciences has entered a period of strong, sustained momentum driven by compelling clinical data, accelerated execution and growing external enthusiasm...across all three of our late-stage programs," said Victor Perlroth, M.D., Chief Executive Officer of Kodiak Sciences.
"Looking ahead, we expect this momentum to continue building as we enter an action-packed 2026 with all three of our Phase 3 assets on track for Phase 3 topline data readouts as well as our first planned BLA filing. On top of our late-stage programs, Kodiak's early-stage pipeline is also advancing with increasing speed and conviction, positioning Kodiak for sustained scientific and pipeline leadership globally," continued Dr. Perlroth.
Recent Business Highlights
Announced follow-up data through week 20 from the Phase 1b APEX study of KSI-101 in patients with macular edema secondary to inflammation (MESI)
Meaningful vision gains were rapidly achieved as early as week 4 and showed continued improvement in best corrected visual acuity (BCVA) through week 20, with more than half of patients achieving improvement of 3-lines or more on the eye chart (≥15 letter gain).
≥90% of patients in the top two dose levels achieved and sustained real dryness of the retina, as demonstrated by absence of intraretinal fluid (IRF) as well as subretinal fluid (SRF), key markers of disease activity.
The Phase 3 PEAK and PINNACLE studies of KSI-101 are enrolling at a faster-than-expected pace, evaluating the top two dose levels (5 mg and 10 mg) in patients with MESI.
Validation from the scientific community for the mechanism of action behind KSI-101
At the recent American Academy of Ophthalmology (AAO) meetings, intraocular interleukin-6 inhibition was shown in Phase 3 clinical trials to deliver a meaningful improvement in vision and anatomy in patients with uveitic macular edema, a key component of MESI. Local IL-6 inhibition also appeared to be well tolerated in these trials.
Data appear to highlight a significant opportunity for KSI-101, a potent inhibitor of interleukin-6 that layers on potent inhibition of VEGF, to drive a stronger clinical effect.
Completed enrollment in the Phase 3 DAYBREAK study of both tarcocimab and KSI-501 in patients with treatment naive neovascular age-related macular degeneration (wet AMD)
DAYBREAK enrolled approximately 690 subjects, with last visit for the 48-week primary endpoint expected in August 2026.
Hosted an investor R&D Day webcast on July 16, 2025, providing a comprehensive overview of Kodiak's three late-phase clinical assets
Presentations by Dr. Charles Wykoff and Dr. Sumit Sharma, leading retina specialists, shared perspectives on Kodiak's clinical assets.
Key highlights included KSI-101: Strong 12-week APEX data; initial addressable market of 150,000+ patients.
Upcoming Catalysts
Tarcocimab
Phase 3 GLOW2 diabetic retinopathy study, topline data on track for 1Q 2026
Phase 3 DAYBREAK wet AMD study, topline data expected 3Q 2026
KSI-501
Phase 3 DAYBREAK wet AMD study, topline data expected 3Q 2026
KSI-101 in MESI
Phase 1b APEX study, Week 24 data to be presented by Dr. Sumit Sharma on February 7 at the Angiogenesis, Exudation, and Degeneration 2026 Annual Meeting
Phase 3 PEAK study, topline data expected 4Q 2026
Phase 3 PINNACLE study, topline data expected 1Q 2027
Third Quarter 2025 Financial Results
Cash Position
Kodiak ended the third quarter of 2025 with $72.0 million cash and cash equivalents.
Net Loss
Net loss for the third quarter of 2025 was $61.5 million, or $1.16 per share on a basic and diluted basis, as compared to a net loss of $43.9 million, or $0.84 per share on a basic and diluted basis, for the third quarter of 2024. Net loss for the third quarter of 2025 included non-cash stock-based compensation expense of $14.0 million, as compared to $14.8 million for the third quarter of 2024.
R&D Expenses
Research and development ("R&D") expenses were $50.5 million for the third quarter of 2025, as compared to $31.9 million for the third quarter of 2024. R&D expenses for the third quarter of 2025 included non-cash stock-based compensation expense of $7.2 million, as compared to $6.3 million for the third quarter of 2024. The increase in R&D expenses in the third quarter of 2025 was primarily driven by increased clinical activities related to our active DAYBREAK and PEAK/PINNACLE studies and increased manufacturing activities across our Phase 3 programs.
G&A Expenses
General and administrative ("G&A") expenses were $11.9 million for the third quarter of 2025, as compared to $14.8 million for the third quarter of 2024. G&A expenses for the third quarter of 2025 included non-cash stock-based compensation expense of $6.9 million, as compared to $8.5 million for the third quarter of 2024. Additionally, sublease income from one of our corporate office buildings helped offset G&A expenses in the third quarter of 2025.
About tarcocimab
Tarcocimab is an investigational anti-VEGF therapy built on Kodiak's proprietary Antibody Biopolymer Conjugate ("ABC") Platform and is designed to maintain potent and effective drug levels in ocular tissues for longer than existing available agents. Tarcocimab is being developed as a mainstay intravitreal biologic monotherapy that provides high immediacy, driven by the enhanced formulation, and high durability, driven by the ABC® platform and our science of durability, with the ultimate objective of providing, once approved, a flexible 1-month through 6-month label for all patients with retinal vascular disease (treatment-naïve, treatment-experienced, mild patients, severe patients).
To date, tarcocimab has completed three successful Phase 3 pivotal clinical studies: the Phase 3 GLOW1 study in diabetic retinopathy ("DR"), the Phase 3 BEACON study in retinal vein occlusion ("RVO") and the Phase 3 DAYLIGHT study in wet AMD. In the GLOW1 study, tarcocimab successfully treated DR patients and prevented disease progression with 100% of patients on extended 6-month dosing. In the BEACON study, in the first 6 months tarcocimab-treated patients were dosed on every 8-week interval (as opposed to every 4-week interval for aflibercept) and in the second 6 months nearly half of tarcocimab patients did not require any treatment while achieving similar vision and anatomical outcomes as the aflibercept group at one year. In the DAYLIGHT study, tarcocimab demonstrated non-inferior efficacy results and compelling safety and tolerability on a once monthly dosing interval.
Tarcocimab is currently being studied in two Phase 3 clinical trials, the GLOW2 study in DR and the DAYBREAK study in wet AMD. Both studies have completed enrollment. The GLOW2 study design mirrors that of our successful GLOW1 study in DR, with the advantage of a third monthly loading dose (baseline, Week 4, Week 8) to provide dosing flexibility to providers. All patients randomized to investigational therapy will receive tarcocimab on extended, 6-month dosing.
Both GLOW2 and DAYBREAK use tarcocimab's enhanced 50 mg/mL formulation containing both conjugated and unconjugated antibody that is intended to balance immediacy and durability.
About GLOW1 (complete) and GLOW2 (ongoing)
The Phase 3 GLOW1 study demonstrated that with extended 6-month dosing in every patient, tarcocimab can achieve strong efficacy both in treating existing disease (primary endpoint) and preventing vision threatening complications and disease progression (key secondary endpoint). In GLOW1, tarcocimab met its primary endpoint of the proportion of patients with at least a 2-step improvement on the Diabetic Retinopathy Severity Scale ("DRSS") score with 41.1% of tarcocimab-treated patients demonstrating at least a 2-step improvement vs. 1.4% of patients in the sham group, a 29-fold increased response rate ratio (p-value less than 0.0001). Tarcocimab also met all key secondary endpoints, including greater reductions in the proportion of patients developing sight-threatening complications (such as diabetic macular edema and proliferative diabetic retinopathy), versus sham, demonstrating an 89% decreased risk, achieving 21.0% versus 2.3% (p-value less than 0.0001). Tarcocimab also showed a 95% risk reduction in the development of DME, versus sham, from 13.7% on sham versus 0.7% on tarcocimab.
The Phase 3 GLOW2 study is a prospective, randomized, double-masked, multi-center pivotal superiority study designed to evaluate the efficacy and safety of tarcocimab tedromer in treatment-naïve patients with DR. Patients are randomized 1:1 and receive either sham injections or tarcocimab via intravitreal injection at baseline, Week 4, Week 8, Week 20 and Week 44. The primary endpoint is the proportion of eyes improving ≥2 steps on Diabetic Retinopathy Severity Scale ("DRSS") from baseline at Week 48. Additional outcome measures include the proportion of eyes developing a sight threatening complication of diabetic retinopathy and the proportion of eyes improving ≥3 steps on DRSS from baseline at Week 48. Additional information about GLOW2 (also called Study KS301P108) can be found on www.clinicaltrials.gov under Trial Identifier NCT06270836 (https://clinicaltrials.gov/show/NCT06270836).
About DAYBREAK and tarcocimab
The Phase 3 DAYBREAK study is a non-inferiority study evaluating parallel investigational arms of tarcocimab and KSI-501 against active comparator aflibercept. The DAYBREAK study incorporates learnings from prior pivotal trials of tarcocimab and was designed to maximize the probability of meeting the primary endpoint of non-inferiority in visual acuity gains. Patients randomized to tarcocimab will receive individualized dosing every 4 to 24 weeks on an as needed basis following four monthly loading doses. Patients randomized to aflibercept will be dosed per label. The individualized dosing of tarcocimab is determined by a treat-to-dryness proactive approach using presence of retinal fluid as a disease activity marker, which resembles retina specialists' ...
