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 majo a r causes of blindness by developing and commercializing next-generation therapeutics to address multiple unmet needs on the spectrum r of retinal diseases. Kodiak has developed three clinical programs based on its internal discovery and development engine. The lead investigational medicine, tarcocimab a tedromer (“KSI-301” or “tarcocimab” a ), was built from Kodiak’s ABC Platform and has been studi t ed in six pivotal clinical studi t es across four high prevalence retinal diseases, three of which were successful f . The tarcocimab a clinical program was designed to target high prevalence retinal diseases that are treated with anti-vascular endothelial growth factor (“anti-VEGF”) therapies and was designed as a package to suppor u t a broad product labe a l, which we hope will include the key diseases and the longest dosing intervals among anti-VEGF therapies. Tarcocimab a is being developed to become a differentiated, long-interval therapy for use in many patients who may benefit from anti-VEGF therapy. Kodiak’s second investigational medicine, KSI-501 (for f merly KSI-501ABC), is a bispecific f antibody biopolymer conjugate targeting the pro-inflammatory cytokine interleukin-6 (IL-6) and VEGF. KSI-501 is built from Kodiak’s ABC Platform and designed to address the underlying inflammatory cascade in addition to vascular permeability in high prevalence retinal diseases. A Phase 1 study t was conducted to evaluate KSI-501’s safety, tolerabi a lity and bioactivity. Positive results from the Phase 1 study t were recently shared. Kodiak expects to advance KSI-501 into pivotal clinical studi t es in 2024. Additionally, Kodiak is developing a third investigational medicine, KSI-101 (formerly KSI-501P), an unconjugated bispecific protein targeting IL-6 and VEGF. KSI-101 is being developed for retinal inflammatory conditions, a new market segment separate from the establ a ished anti-VEGF market. KSI-101 is a clinical program with opportunities and risks uncoupled from the ABC Platform, and as such is an important part of our portfol f io. Kodiak intends to advance KSI-101 into a Phase 1b study t in 2024 to evaluate its safety and tolerabi a lity and to identify f two dose levels to progress into pivotal studi t es, which are being planned to initiate later in 2024. Beyond its clinical pipeline, Kodiak is progressing its ABC Platform with “due d t” and “triplet” programs that embed small molecules and other bioactive molecules in the biopolymer backbone k to provide a high drug- r antibody ratio (“DAR”). The diverse bioactives are designed to be released over time to achieve sustained inhibition of targeted biological pathways. We believe this unique combination of high DAR and extended therapeutic benefit offe f rs potential for broad and important utility for multifac f torial ophthalmic and systemic diseases. In addition to advancing our pipeline, we have made important progress in process development and commercial scale manufac f turing, including the commissioning and regulatory r approval of Ursus, our dedicated commercial-scale drug r subs u tance manufact f ur t ing facility that was custom-designed and built in collabor a ation with Lonza. We believe these manufac f turing effo f rts would position Kodiak well for potential market share capture if tarcocimab a is approved. Notabl a y, 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 effo f rts, we believe we have demonstrated a disciplined and creative approach to building and financing the Company. As of December 31, 2023, we had $285.5 million in cash and cash equivalents. Our objective is to develop our retina-focused product candidates, seek FDA approval, and ultimately commercialize our product candidates. Following from these effo f rts, we believe Kodiak has the potential to achieve our ambition of becoming an important retinal development and commercialization franchise, but recognize that there are subs u tantial risks to realizing this potential.
Kodiak: 2023 Annual Report Page 10 Page 12