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Edge12 Dec 2025
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The story of how a Swiss runner's pursuit of a new running sensation became On, aiming to be the most premium global sportswear brand worldwide.
Kodiak Sciences (KOD) investor relations material
Kodiak Sciences Evercore ISI 8th Annual HealthCONx Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Evercore ISI 8th Annual HealthCONx Conference summary3 Dec, 2025
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.
What drives KSI-101's superior drying and vision gains
Explain PEAK/PINNACLE design for MESI spectrum
KSI-501's potential impact on tarcocimab sales?
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Next Kodiak Sciences earnings date
Q4 202526 Mar, 2026
Next Kodiak Sciences earnings date
Q4 202526 Mar, 2026
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Frequently asked questions
Kodiak Sciences Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapeutics for the treatment of retinal diseases. The company's research and development efforts are centered on novel biologics designed to treat conditions like age-related macular degeneration and diabetic eye diseases, which are major causes of blindness in the developed world. Kodiak's product pipeline includes advanced clinical candidates such as tarcocimab tedromer (KSI-301), which is designed to inhibit vascular endothelial growth factors. Additionally, the company is exploring other candidates targeting different mechanisms involved in retinal diseases. The company is headquartered in Palo Alto, California, and its shares are listed on the NASDAQ.
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