Kodiak Sciences Inc (KOD) News & EventsKODKodiak Sciences Inc

Kodiak Ends Q2 with $125.9M Cash, Expects to Support Operations into 2027

Ended Q2 with $125.9M of cash and cash equivalents, expects that current cash and cash equivalents will support current and planned operations into 2027. "Kodiak continues to execute broadly across our late-stage clinical portfolio as we approach three Phase 3 readouts between now and the end of this year," said CEO Victor Perlroth. "We remain on track for September 2026 DAYBREAK Phase 3 topline results evaluating both Zenkuda and KSI-501 in treatment-naive wet AMD, followed by December 2026 PEAK Phase 3 Pivotal Analysis 1 topline results evaluating KSI-101 in Macular Edema Secondary to Inflammation. We completed enrollment of the first 300-patient cohort supporting Pivotal Analysis 1 of the Phase 3 PEAK study, initiated patient enrollment in the Phase 3 ALTO study of KSI-501 in Diabetic Macular Edema, and we continue BLA preparation activities for Zenkuda. Together, these efforts reflect our continued focus on disciplined execution as we advance our late-stage portfolio toward important clinical and regulatory milestones."

Kodiak Sciences Launches Global Phase 3 Trial for KSI-501

Kodiak Sciences announces the first patients have been enrolled in the global Phase 3 ALTO trial evaluating KSI-501 in patients with diabetic macular edema, or DME. KSI-501 is an investigational, first-in-class bispecific therapy built on Kodiak's ABC Platform and designed to potently inhibit two complementary pathways implicated in retinal vascular disease: interleukin, or IL,-6-mediated inflammation and vascular endothelial growth factor, or VEGF,-mediated vascular permeability and neovascularization. The ALTO trial is designed to demonstrate the superiority of bispecific (anti-VEGF, anti-IL-6) KSI-501 versus monospecific aflibercept in patients with DME. ALTO is the second registrational Phase 3 trial of KSI-501, following the DAYBREAK study in patients with wet AMD. ALTO explores whether dual inhibition of immune and vascular pathways can deliver deeper and more sustained disease control for patients with DME and evaluates two dosing regimens, one regimen with intensive dosing and a second regimen with individualized dosing intervals of up to every six months. The ALTO Study is a global, multicenter, randomized, double-masked, active comparator-controlled Phase 3 study evaluating the efficacy and safety of intravitreal KSI-501 5 mg compared with intravitreal aflibercept 2 mg in patients with visual impairment secondary to center-involved DME. Approximately 910 patients, treatment-naive or previously treated, will be randomized 5:3:5 to one of three arms: Arm A: KSI-501 5 mg every 8 weeks, with monthly assessment for additional individualized dosing, following six monthly loading doses; Arm B: KSI-501 5 mg on an individualized regimen of every 4 to 24 weeks, following six monthly loading doses; and Arm C: aflibercept 2 mg every 8 weeks, following five monthly loading doses. The primary endpoint is the mean change in best-corrected visual acuity from baseline to the average of Week 48 and Week 52. The key secondary endpoint is the proportion of patients improving two or more steps on the DRSS from baseline at Week 48.

Kodiak Sciences Completes Enrollment of First 300 Patients in PEAK Trial

Kodiak Sciences announced that it has completed enrollment of the first 300-patient cohort in its PEAK trial, supporting Pivotal Analysis 1 of the KSI-101 Phase 3 program in macular edema secondary to inflammation. Kodiak also reaffirmed its plan to release the topline data from Pivotal Analysis 1 in December 2026.