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 for retinal medicines. Our goal is to prevent and treat the major causes of blindness by developing and commercializing next-generation therapeutics for chronic, high-prevalence retinal diseases. Kodiak’s lead product candidate, tarcocimab tedromer (“KSI-301” or “tarcocimab”), has been advanced into six registrational clinical studies, four of which are actively ongoing. The comprehensive clinical program targets high prevalence retinal diseases that are treated with anti-vascular endothelial growth factor (“anti-VEGF”) therapies. Our clinical program is designed as a package to support a broad product label, which we hope will include the key diseases and the longest dosing intervals among anti-VEGF therapies. Tarcocimab is being developed to become a differentiated, long-interval therapy for use in many patients who may benefit from anti-VEGF therapy. At the same time, Kodiak is investing in commercial scale manufacturing. We aim to provide a pre-filled syringe early in commercialization and are working actively towards this goal. We believe these combined clinical and manufacturing efforts set the stage for potential market share capture with tarcocimab if approved. In addition, Kodiak is investing in its pipeline. The Company is progressing its Antibody Biopolymer Conjugate (“ABC”) PlatformTM towards suboptimal anti-VEGF responder patients, a group estimated to be as large as 30 – 66% of treated patients, with its bispecific conjugate KSI-501. Beyond today’s anti-VEGF market, Kodiak’s new triplet medicines are being designed on its ABC Platform in an effort to bring new capabilities to treat the even higher prevalence retinal diseases of dry age-related macular degeneration (“AMD”) and glaucoma. Notably, up to this point, Kodiak has retained all global rights to make, use and sell its product candidates, which we believe preserves future value and allows for agile decision-making. While engaged in these research and development efforts, we believe we have demonstrated a disciplined and creative approach to building and financing the Company. As of December 31, 2022, we had $478.9 million in cash, cash equivalents and marketable securities. Our objective is to develop our retina-focused product candidates, seek FDA and worldwide health authority marketing authorization approvals, and ultimately commercialize our product candidates. Following from these efforts, we believe Kodiak has the potential to achieve our ambition of becoming an important retinal development and commercialization franchise. Tarcocimab Clinical Program Update We continue advancing the pivotal clinical program of our lead product candidate tarcocimab across major retinal vascular diseases including wet age-related macular degeneration (“wet AMD”), diabetic macular edema (“DME”), retinal vein occlusion (“RVO”) and non-proliferative diabetic retinopathy (“NPDR”) without DME. We reported topline results from two of our six pivotal clinical studies in 2022, the Phase 2b/3 DAZZLE study in wet AMD and the Phase 3 BEACON study in RVO. DAZZLE – Phase 2b/3 Study in Patients with Treatment-Naïve Wet AMD Our initial Phase 2b/3 pivotal study was a global, multi-center, randomized pivotal study designed to evaluate the durability, efficacy and safety of tarcocimab in patients with treatment-naïve wet AMD. We announced in February 2022 that this initial pivotal study did not meet its primary efficacy endpoint of non-inferior visual acuity gains for subjects dosed on extended regimens every 12-, 16- or 20 weeks with tarcocimab compared to subjects given aflibercept every 8 weeks. Following this announcement, we discontinued the study and concluded remaining trial-associated activities. BEACON – Phase 3 Study in Patients with Treatment- Naïve Retinal Vein Occlusion The BEACON study was a randomized, double-masked, multicenter, active comparator-controlled Phase 3 clinical trial in treatment naïve patients with vision loss and macular edema due to retinal vein occlusion, including both branch ("BRVO") and central ("CRVO") subtypes. We announced in August 2022 that the BEACON study met the primary efficacy endpoint of non-inferior visual acuity change from baseline at week 24 for subjects given tarcocimab every two months after 2 monthly loading doses compared to subjects given monthly aflibercept. We intend to include the primary results of the BEACON study in potential licensing applications for tarcocimab to serve as the basis for potential approval of tarcocimab in RVO.