Kodiak Sciences (KOD) investor relations material

Key pipeline updates and clinical milestones

• Three late-stage clinical assets (KSI-101, Zenkuda, KSI-501) are in phase III, targeting major causes of vision loss, with top-line data expected in 2026 and multiple BLA filings planned for 2026–2027.

• Zenkuda (tarcocimab) is BLA-ready, with successful pivotal studies in diabetic retinopathy and retinal vein occlusion, and DAYBREAK phase III readout expected in late September, followed by a BLA filing.

• KSI-101 is advancing in MESI, with PEAK and PINNACLE phase III studies enrolling well; PEAK1 top-line data is anticipated before Christmas, and further pivotal data in 2027.

• KSI-501, a bispecific anti-IL-6/VEGF conjugate, is being evaluated in DAYBREAK and a new DME study, with readouts expected in late September and further studies planned.

• Significant investments have been made in clinical and commercial manufacturing, including a Swissmedic-approved and purpose-built bioconjugation facility, positioning for large-scale product launches.

Scientific platform and differentiation

• The ABC Platform combines unconjugated and conjugated antibodies to achieve both rapid efficacy and extended durability in retinal therapies.

• Zenkuda and KSI-501 demonstrate longer intraocular half-lives compared to existing biologics, with over 80% of patients showing half-lives greater than 11 days.

• The platform aims to fill a $15 billion market gap by offering both high immediacy and industry-leading durability in a single biologic.

• Clinical trial designs use AI-based tools for precise fluid measurement and adaptive dosing, aiming for non-inferior efficacy and superior durability.

• Zenkuda and KSI-501 are positioned as Gen 2.0 biologics, aiming to deliver both high immediacy and high durability, with KSI-501 offering differentiated efficacy.

Clinical data highlights and commercial potential

• Zenkuda demonstrated strong efficacy and doubled treatment intervals in RVO, with 75% of patients achieving six-month durability and overlapping vision outcomes with Eylea.

• In diabetic retinopathy, GLOW 1/2 studies showed 100% of patients on six-month dosing and over 85% reduction in risk of sight-threatening complications.

• KSI-101 targets MESI, a large unmet need, showing rapid and sustained visual gains and fluid resolution in phase I-B, with over 50% of patients gaining three lines of vision.

• The addressable MESI population exceeds 150,000 in the US, representing up to 20% of retina practice volumes.

• Current mainstay biologics provide good efficacy but limited durability, while exploratory technologies focus on durability but lack immediacy and have safety concerns.