Kodiak Zenkuda Clears Daybreak Endpoint, Plans Year-End BLA

The Tip Desk · November 12, 2026 · 3 min read

Zenkuda met Daybreak's primary endpoint with a p-value of 0.0007 as Kodiak posted a $66.2 million third-quarter net loss and $88.7 million of cash.

Kodiak Sciences Inc. (KOD) reported that Zenkuda (tarcocimab tedromer) met the primary endpoint in the Phase 3 DAYBREAK study of wet age-related macular degeneration, with a p-value of 0.0007, and said it plans a multi-indication biologics license application in the fourth quarter of 2026 covering five Phase 3 studies.

The precommercial retina-focused biotechnology company said 54% of Zenkuda patients were on 6-month dosing under treat-to-dry and maintain-dry criteria, and that safety was consistent with the established aflibercept profile. Chief Executive Officer Victor Perlroth said the results reinforce Zenkuda’s potential as a first-line therapy in wet AMD.

DAYBREAK was a non-inferiority study of parallel Zenkuda and KSI-501 arms against aflibercept. The one-year primary endpoint of non-inferiority in best-corrected visual acuity was met in September 2026. A second year of treatment is ongoing. Zenkuda has now completed five Phase 3 studies: DAYBREAK and DAYLIGHT in wet AMD, GLOW1 and GLOW2 in diabetic retinopathy, and BEACON in retinal vein occlusion. The company said it is planning a three-indication BLA covering wet AMD, diabetic retinopathy and retinal vein occlusion.

Tabirafusp-ted, the anti-IL-6/VEGF-trap bispecific, also met its DAYBREAK vision primary endpoint (p-value 0.0036) and anatomical key secondary endpoint (p-value <0.0001). The company said it is accelerating the program in diabetic macular edema and is actively enrolling in the Phase 3 ALTO study versus aflibercept. Post-hoc analyses of treatment-naïve wet AMD subgroups are planned.

KSI-101, a bispecific antibody for macular edema secondary to inflammation, remains on a December 2026 timeline for topline data from Pivotal Analysis 1 of the PEAK trial. Enrollment of the first 300-patient cohort supporting that analysis had already completed in the second quarter. Completion of enrollment in a second pivotal cohort of 600 subjects across PEAK and PINNACLE is still expected in the fourth quarter of 2026, with topline data anticipated in the second quarter of 2027. Perlroth said the company expects to announce the first Phase 3 KSI-101 results in December and, if successful, plans to file a BLA in the second quarter of 2027.

Research and development expenses were $58.3 million in the third quarter of 2026, compared with $50.5 million a year earlier. The company said the increase was primarily driven by increased clinical activities related to the active PEAK/PINNACLE and ALTO studies and increased manufacturing activities to support Phase 3 programs. R&D included $6.7 million of non-cash stock-based compensation.

General and administrative expenses were $8.8 million, compared with $11.9 million a year earlier. The remaining decrease was primarily driven by a non-cash non-recurring gain on termination of a Palo Alto building lease, for which the company received an option to lease a separate building on the same campus with certain lease incentives. G&A included $6.1 million of stock-based compensation.

Net loss for the third quarter of 2026 was $66.2 million, or $1.05 a share on a basic and diluted basis, compared with a net loss of $61.5 million, or $1.16 a share, a year earlier. Net loss included $12.8 million of non-cash stock-based compensation. Weighted-average shares outstanding were 62.96 million.

Cash and cash equivalents were $88.7 million at September 30, 2026, down from $125.9 million at the end of the second quarter. The company said it expects current cash to support operations into 2027. Subsequent to September 30, Kodiak raised $69 million of aggregate net proceeds from sales of common stock under its at-the-market equity offering facility.

Perlroth said the company is also on track to submit the multi-indication BLA for Zenkuda by year-end, supported by five successful Phase 3 studies.