Kodiak Sciences (KOD) Evercore ISI 8th Annual HealthCONx Conference summary

Key data flow and clinical catalysts

• Three phase III molecules are being studied in four phase III trials, with three major readouts expected in the next 12 months, including GLOW2, DAYBREAK, and PEAK studies.

• GLOW2 (tarcocimab in diabetic retinopathy) expects last patient visit in January 2026 and top-line data in March 2026.

• DAYBREAK (tarcocimab and KSI-501 in wet AMD) expects last visit in August 2026 and top-line data by mid-September 2026, with a BLA filing planned soon after.

• PEAK (KSI-101 in MESI) expects top-line phase III data in about 12 months, with full last patient in during the first half of 2026.

• Over 10 years of research will culminate in these pivotal data releases, integrating results across all three molecules.

Clinical trial design and differentiation

• KSI-101 targets MESI, a heterogeneous group with macular edema secondary to inflammation, and shows strong efficacy in retinal drying and vision improvement.

• APEX phase I/1b showed 15.4-letter mean gain at 10 mg and 13.4 at 5 mg, with over 90% of patients achieving complete retinal dryness by week 8.

• KSI-101 demonstrated superior drying and higher rates of significant vision gain compared to Roche’s IL-6, even with a more diverse patient group.

• Phase III dosing is monthly for six months, aiming for remission rather than durability, with PRN retreatment criteria post-24 weeks.

• Both PEAK and PINNACLE phase III trials are over 90% powered, enrolling a broad spectrum of MESI severity, with PINNACLE expected to enroll more patients for safety database needs.

Commercial outlook and strategic positioning

• KSI-101 is likely to be positioned as a first-line biologic after topical steroids, with the 150,000 addressable patient estimate considered conservative.

• Pricing may follow an orphan drug model due to the severity and lack of current therapies, but final decisions will depend on trial outcomes.

• KSI-501, a polymerized bispecific, could potentially outperform tarcocimab in wet AMD, raising questions about future product cannibalization.

• The company is prepared to address any overlap in product indications if both are approved.