Kodiak Completes First PEAK Cohort and Starts ALTO Enrollment
Cash and cash equivalents were $125.9 million as the company said funds will support operations into 2027.
Kodiak Sciences Inc. (KOD) completed enrollment of the first 300-patient cohort supporting Pivotal Analysis 1 of the Phase 3 PEAK study of KSI-101 in macular edema secondary to inflammation, with topline data expected in December 2026.
The retina-focused biotechnology company also initiated patient enrollment in the Phase 3 ALTO study of KSI-501 in diabetic macular edema, an approximately 910-patient superiority trial versus aflibercept. Chief Executive Officer Victor Perlroth said Kodiak remains on track for September 2026 DAYBREAK Phase 3 topline results evaluating both Zenkuda and KSI-501 in treatment-naïve wet AMD, followed by the December PEAK readout.
Completion of enrollment in the second pivotal cohort, 600 subjects across PEAK and PINNACLE supporting Pivotal Analysis 2, is expected in the fourth quarter of 2026, with topline data anticipated in the second quarter of 2027. Zenkuda BLA preparation activities continue.
Research and development expenses were $56.1 million for the three months ended June 30, 2026, up from $42.8 million a year earlier. The increase was primarily driven by increased clinical activities related to the active PEAK/PINNACLE studies and increased manufacturing activities across Phase 3 programs. General and administrative expenses were $10.8 million, down from $12.8 million a year earlier.
Net loss for the second quarter of 2026 was $65.6 million, or $1.05 a share on a basic and diluted basis, versus $54.3 million, or $1.03 a share, a year earlier. Net loss included non-cash stock-based compensation expense of $11.6 million, compared with $15.6 million a year earlier.
Cash and cash equivalents were $125.9 million at June 30, 2026, down from $209.9 million at December 31, 2025. Current cash and cash equivalents are expected to support current and planned operations into 2027.
DAYBREAK is a non-inferiority study evaluating parallel investigational arms of Zenkuda and KSI-501 against aflibercept in treatment-naïve wet AMD. Enrollment was complete at approximately 690 subjects. Topline data for the one-year primary endpoint are expected in September 2026. Zenkuda, an investigational anti-VEGF therapy on Kodiak’s Antibody Biopolymer Conjugate platform, has completed four Phase 3 pivotal studies in diabetic retinopathy, retinal vein occlusion and wet AMD. KSI-501 is an investigational anti-IL-6, VEGF-trap bispecific also built on the ABC platform.
ALTO is a global, multicenter, randomized, double-masked, active comparator-controlled Phase 3 study evaluating intravitreal KSI-501 5 mg compared with intravitreal aflibercept 2 mg in patients with visual impairment secondary to center-involved diabetic macular edema. Approximately 910 patients will be randomized 5:3:5 to three arms, including KSI-501 every 8 weeks with individualized dosing, KSI-501 on an individualized every 4 to 24 weeks regimen, and aflibercept every 8 weeks. The primary endpoint is mean change in best-corrected visual acuity from baseline to the average of Week 48 and Week 52.
PEAK and PINNACLE are superiority studies evaluating 5 mg and 10 mg KSI-101 versus sham in MESI. PEAK includes more severe disease; PINNACLE includes milder disease as well as moderate-to-severe edema with good vision. Patients in KSI-101 arms receive fixed monthly dosing for six doses, then individualized dosing for six additional visits. Primary and key secondary endpoints are evaluated at Week 24.
Zenkuda and KSI-501 target the $15 billion anti-VEGF market across retinal vascular diseases, and KSI-101 is being explored in two BLA-facing Phase 3 studies in MESI.