Kodiak Sciences (KOD) 7th Annual Evercore ISI HealthCONx Conference summary

Business highlights and 2024 outlook

• Significant operational and scientific progress achieved over the past 6–18 months, with multiple clinical catalysts expected in 2024.

• GLOW2 phase III pivotal study for Tarcocimab in diabetic retinopathy nearing full enrollment, with last patient in expected within months and a 48-week endpoint readout about a year later.

• DAYBREAK study for Tarcocimab and KSI-501 in wet AMD and other indications to complete enrollment a few months after GLOW2, with a Q2 2026 readout anticipated.

• Enhanced Tarcocimab formulation combines conjugated and unconjugated forms to improve immediacy and durability of efficacy.

• Additional phase III studies and a robust safety database will support a BLA filing for three diseases.

Clinical development and trial design

• GLOW2 targets diabetic retinopathy, with readout expected late 2025 or early 2026; DAYBREAK targets wet AMD and retinal vein occlusion.

• Enhanced Tarcocimab formulation uses a 1 mg unconjugated to 4 mg conjugated antibody ratio, providing strong VEGF binding and immediacy comparable to marketed doses of Eylea and Lucentis.

• DAYBREAK study employs innovative AI-guided retreatment criteria using fluid as a biomarker, aligning with real-world clinical practice.

• KSI-501, a bispecific conjugate, is being tested alongside Tarcocimab and Aflibercept, with subgroup analyses planned if primary endpoints are non-inferior.

• KSI-101, the unconjugated protein, is being evaluated in the APEX study for macular edema secondary to inflammation, with high-dose cohorts up to 10 mg.

Regulatory and physician feedback

• FDA requested one additional phase III study with the enhanced formulation; two new studies are being conducted to strengthen the BLA package.

• Physicians and patients are enthusiastic about the new formulations and trial designs, especially the added loading dose in GLOW2 and the innovative DAYBREAK design.

• Approval for diabetic retinopathy would allow off-label use in DME, as all DME patients have diabetic retinopathy.

• Positive interactions with FDA regarding the use of AI-guided tools and fluid-based biomarkers in clinical trials.