Kodiak Sciences (KOD) Goldman Sachs 45th Annual Global Healthcare Conference summary

Program pipeline and scientific progress

• Three lead programs are advancing: tarcocimab, KSI-501, and KSI-101, each targeting distinct retinal indications with significant unmet needs.

• Tarcocimab and KSI-501 leverage the ABC Platform for enhanced durability and efficacy, while KSI-101 is a naked antibody targeting inflammation-driven macular edema.

• Over 55,000 patient visits and 2,500 patient-years of exposure have informed program development and course corrections.

• Recent formulation changes increase free antibody content, improving early efficacy and reducing adverse events like cataracts.

• All three programs are entering or progressing through pivotal Phase 3 trials in 2024, with BLA-facing studies planned.

Industry landscape and competitive analysis

• Current market leaders (Vabysmo, Eylea HD) offer incremental improvements but leave key needs for durability and efficacy unmet.

• Surgical and gene therapy approaches remain complex and less attractive compared to biologic-based solutions.

• The anti-VEGF market remains robust, with new entrants demonstrating multibillion-dollar potential despite biosimilar competition.

• Patent protections may delay biosimilar competition for Eylea until 2027, impacting market dynamics.

• Physician feedback highlights the importance of both rapid efficacy and long-interval dosing for adoption.

Clinical and regulatory strategy

• Tarcocimab is entering two new Phase 3 studies: a repeat of the successful GLOW1 study in diabetic retinopathy and the DAYBREAK study in wet AMD, both using improved formulations.

• KSI-501 will be tested alongside tarcocimab in DAYBREAK, focusing on superior efficacy against aflibercept.

• KSI-101 is advancing into a multiple-dose Phase 1B study for macular edema secondary to inflammation, with pivotal PEAK and PINNACLE studies planned.

• Regulatory engagement has supported recent formulation changes, with bridging through two Phase 3 studies to address early efficacy deficits.

• Safety profile remains strong, with no cases of severe inflammation and improved cataract rates in recent studies.