Kodiak Sciences (KOD) investor relations material

Key data flow and clinical catalysts

• Three phase III molecules in four phase III studies, with three major readouts expected in the next 12 months, including GLO2 (diabetic retinopathy), DAYBREAK (wet AMD), and PEAK (KSI-101 in MESI).

• GLO2 study last visit expected January 2026, top-line data in March; DAYBREAK last visit August 2026, top-line data mid-September, with BLA filing planned soon after.

• PEAK study top-line data for KSI-101 anticipated in about 12 months, integrating over a decade of research.

• Full 24-week APEX data to be presented at Angiogenesis in early February.

• Both PEAK and PINNACLE phase III trials are highly powered (>90%) and enrolling rapidly, with a focus on building a robust safety database.

KSI-101 clinical differentiation and trial design

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

• In the APEX phase I/1b study, 10 mg dose achieved a 15.4-letter mean gain at 20 weeks, with over 90% of patients achieving complete retinal dryness by week 8.

• KSI-101 outperformed Roche's IL-6 in both vision improvement and retinal drying, even with a more severe patient population.

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

• PEAK and PINNACLE trials enroll distinct MESI subpopulations to cover the full disease severity spectrum efficiently.

Commercial outlook and competitive positioning

• KSI-101 is expected 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.

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