Kodiak Sciences Inc. 10-K filed Mar 31, 2026

Modified · Overview

Kodiak has developed three late-stage clinical programs based on its internal discovery and development engine. The lead investigational medicine, tarcocimab tedromer (“Zenkuda” or “KSI-301” or “tarcocimab”), is an anti-VEGF therapy built from Kodiak’s on Kodiak's proprietary ABC Platform and to date, has completed platform. Zenkuda has a mean ocular half-life in humans of 20 days, approximately three successful Phase 3 pivotal clinical studies across three high prevalence retinal vascular diseasestimes longer than approved anti-vascular endothelial growth factor ("VEGF") therapies, and is designed to maintain effective drug levels in ocular tissues for longer. TarcocimabZenkuda is intended to bebeing developed as a mainstay intravitreal biologic monotherapy that provides high immediacy, driven by the enhanced formulation, and high durability, driven by the ABC Platformplatform and our science of durability, with the ultimate objective of providing, once approved, a flexible 1-month through 6-month label for all patients who may benefit from anti-vascular endothelial growth factor with retinal vascular disease (“anti-VEGF”) therapy. Tarcocimab is currently being studied in two Phase 3 clinical studiestreatment-naïve, the GLOW2 study in diabetic retinopathy (“DR”) and the DAYBREAK study in wet age-related macular degeneration (“AMD”). GLOW2 has completed enrollmenttreatment-experienced, and DAYBREAK is actively enrolling. Kodiak anticipates to be in a position to announce topline data for the primary endpoint for GLOW2 in 1Q 2026 mild patients and for the primary endpoint for DAYBREAK in 2Q 2026. If both are successful, we intend to file a single Biologics License Application (“BLA”severe patients) in 2026 in the three large indications of wet AMD, retinal vein occlusion (“RVO”) and DR.