73 ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERAT R IONS You should read the following disc i ussion and analys l is of our financial condition and resultst of operations together with our consolidat d ed financial statements and the related notes included else l where in this Annual Repor e t on Form 10-K. This disc i ussion and analys l is and other parts of this Annual Repor e t on Form 10-K contain forward-looking statements based upon current beliefs, f plans and expectations related to future events and our future financial perfor f mance that involve risk i s, k uncertainties and assumptions, such as statements regar e ding our intentions, plans, objectives, expectations, forecastst and projections. Our actual results and the timing of selected events could diff i er f materially from those anticipated in these forward-looking statements as a result of several factors, r including those set fortht under the section titled “Risk Factors” r and else l where in this Annual Repor e t on Form 10-K. Overview Kodiak Sciences (“we,” the “Company” or "Kodiak") is a biopharmaceutical company committed to researching, developing, and commercializing transfor f mative therapeutics to treat a broad spectrum r of retinal diseases. We are focused on bringing new science to the design and manufact f ur t e of next generation retinal medicines to prevent and treat the leading causes of blindness globally. Our ABC Platform™uses molecular engineering to merge the fields of protein-based and chemistry- r based therapies and has been at the core of Kodiak's discovery engine. We are developing a portfol f io of three late- stage clinical programs, two of which are late-stage today and derived from our ABC Platform and one which is platform- independent and which we believe can progress rapi a dly into pivotal studi t es. Kodiak's lead investigational medicine, tarcocimab, is a novel anti-VEGF antibody biopolymer conjugate under development for the treatment of high prevalence retinal vascular diseases including diabetic retinopathy, the leading cause of blindness in working-age patients in the developed world, and wet age-related macular degeneration, the leading cause of blindness in elderly patients in the developed world. KSI-501 is our second investigational medicine, a first-in-class anti-IL-6, VEGF-trap a bispecific f antibody biopolymer conjugate designed to inhibit both IL-6 mediated inflammation and VEGF-mediated angiogenesis and vascular permeability. KSI-501 is being developed for the treatment of high prevalence retinal vascular diseases to address the unmet needs of targeting multiple biologies and extended durability. Additionally, Kodiak is developing a third investigational medicine, KSI-101, a novel anti-IL-6, VEGF-trap a bispecific f protein, the unconjugated protein portion of KSI-501. Kodiak intends to develop KSI-101 for the treatment of retinal inflammatory diseases, as currently there are no availabl a e intravitreal biologic therapies addressing the spectrum of inflammatory conditions of the retina. Kodiak has expanded its early research pipeline of duet and triplet inhibitors 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 multifact f orial ophthalmic and systemic diseases. Recent Updates Tarcocimab Clin l ical Program Summary r and Updatet Kodiak’s lead clinical program tarcocimab a is an investigational anti-VEGF therapy built on Kodiak’s Antibody Biopolymer Conjugate (“ABC”) Platform and is designed to maintain potent and effe f ctive drug r levels in ocular tissues for longer than existing availabl a e agents. Kodiak’s objective with tarcocimab is to enable earlier treatment and prevention of vision loss for patients with diabetic retinopathy and to develop a new durability agent to improve outcomes for patients with retinal vascular diseases. To date, tarcocimab has been studi t ed in six pivotal clinical studi t es: Phase 3 GLOW1 study t in non-prolifer f ative diabetic retinopathy (“NPDR”), Phase 3 BEACON study t in retinal vein occlusion (“RVO”), Phase 3 DAYLIGHT study t in wet age- related macular degeneration (“wet AMD”), Phase 3 GLEAM and GLIMMER studi t es with identical study t design in diabetic macular edema (“DME”), and Phase 2/3 DAZZLE study t in wet AMD. Of the six registrational studi t es, GLOW1, BEACON and DAYLIGHT successful f ly met the primary endpoint. More information about study t design and results from each individual pivotal study t are summarized below:
Kodiak: 2023 Annual Report Page 82 Page 84