1 PART I ITEM 1. BUSINESS Overview Since its founding in 2009, Kodiak Sciences Inc. (“Kodiak,” the “Company,” “we” or “our”) has developed a new technology platform, the Antibody Biopolymer Conjugate (“ABC”) Platform, for retinal medicines. Our goal is to prevent and treat the major causes of blindness by developing and commercializing next-generation therapeutics to address multiple unmet needs on the spectrum of retinal diseases. Kodiak has developed three clinical programs based on its internal discovery and development engine. The lead investigational medicine, tarcocimab tedromer (“KSI-301” or “tarcocimab”), is built from Kodiak’s ABC Platform and to date, has completed three successful Phase 3 pivotal clinical studies across three high prevalence retinal vascular diseases. Tarcocimab is intended to be a mainstay intravitreal biologic 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 who may benefit from anti-vascular endothelial growth factor (“anti-VEGF”) therapy. Tarcocimab is currently being studied in two Phase 3 clinical studies, the GLOW2 study in diabetic retinopathy (“DR”) and the DAYBREAK study in wet age-related macular degeneration (“AMD”). GLOW2 has completed enrollment, 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 and for the primary endpoint for DAYBREAK in 2Q 2026. If both are successful, we intend to file a single Biologics License Application (“BLA”) in 2026 in the three large indications of wet AMD, retinal vein occlusion (“RVO”) and DR. Kodiak’s second investigational medicine, KSI-501, is a first-in-class bispecific antibody biopolymer conjugate designed to inhibit interleukin-6 (“IL-6”)-mediated inflammation and VEGF-mediated vascular permeability. KSI-501 is being developed for the treatment of high prevalence retinal diseases to address the leading unmet needs targeting multiple disease biologies beyond VEGF for differentiated efficacy together with extended durability. KSI-501 is designed to provide high immediacy/efficacy, driven by the enhanced formulation, and high durability, driven by the ABC Platform and our science of durability. A Phase 1 study was conducted to evaluate KSI-501’s safety, tolerability and bioactivity. Based on the positive results from this study, Kodiak has advanced KSI-501 into the Phase 3 DAYBREAK study to evaluate its efficacy and safety in wet AMD. DAYBREAK is actively enrolling patients. Additionally, Kodiak is developing a third investigational medicine, KSI-101, an unconjugated bispecific protein targeting IL-6 and VEGF. KSI-101 is being developed for patients who have retinal fluid and inflammation, a new market segment separate from the established anti-VEGF market. KSI-101 is a clinical program with opportunities and risks uncoupled from the ABC Platform, and as such we believe it is an important part of our portfolio. We initiated the Phase 1b study APEX to evaluate KSI-101’s safety and tolerability and to identify two dose levels to progress into Phase 2b/3 pivotal studies (PEAK and PINNACLE). We expect to initiate our pivotal program in 2Q 2025. In January 2025, we presented early APEX data in patients with macular edema secondary to inflammation (“MESI”) that demonstrated strong treatment response at all KSI-101 dose levels. We expect to present additional APEX data at an Investor R&D update in June 2025. Beyond its clinical pipeline, Kodiak is advancing its platform technology to embed small molecules and other active pharmaceutical ingredients (“API”), into Kodiak’s proprietary biopolymer backbone to enable high drug-antibody ratio (“DAR”) medicines. The diverse APIs are designed to be released over time to achieve targeted, multi-specific and tailored modulation of biological pathways. We believe this unique combination of high DAR and extended therapeutic benefit offers potential for broad and important utility for multifactorial ophthalmic and systemic diseases. We call this platform extension our Antibody Biopolymer Conjugate Drug ("ABCD") Platform because we are extending our platform capabilities to include the conjugation of small molecule drugs whereas historically we primarily conjugated biologics such as antibodies. Our ABCD platform is advancing a next set of investigational therapies for high prevalence retinal diseases, including our novel “duet” technology for glaucoma and geographic atrophy. In addition to advancing our pipeline, we have made progress in process development and commercial scale manufacturing, including the commissioning and regulatory approval of Ursus, our dedicated commercial-scale drug substance manufacturing facility that was custom-designed and built in collaboration with Lonza. We believe these manufacturing efforts could position Kodiak well for potential market share capture if tarcocimab and KSI-501 are approved.