(RTTNews) - Kodiak Sciences Inc. (KOD), a pre-commercial, retina-focused biotechnology company, is expected to report topline results from DAYBREAK, a Phase 3 study evaluating both Zenkuda (tarcocimab tedromer) and KSI-501 (tabirafusp alfa tedromer) in patients with wet age-related macular degeneration today (Monday, September 28, 2026).
Zenkuda is an investigational anti-VEGF therapy built on Kodiak's proprietary Antibody Biopolymer Conjugate (ABC) Platform.
KSI-501 is an investigational anti-IL-6, VEGF-trap bispecific therapy built on the ABC platform and is being developed for high-prevalence retinal vascular diseases.
The Phase 3 DAYBREAK study is a non-inferiority study evaluating parallel investigational arms of Zenkuda and KSI-501 against active comparator aflibercept.
Patients randomised to Zenkuda received individualised dosing every 4 to 24 weeks on an as-needed basis following four monthly loading doses. Patients randomized to aflibercept received treatment according to its labeled dosing regimen.
Specific objectives for Zenkuda in DAYBREAK include safety assessment; the primary endpoint of non-inferiority in change in visual acuity from baseline to the average of week 40, 44, and 48; the strength of fluid control through the loading phase; and the durability profile.
The objective for KSI-501 in DAYBREAK is to explore the efficacy potential of bispecific IL-6 and VEGF inhibition in a broad treatment-naïve wet AMD population.
The company will report topline data from the one-year primary endpoint for both Zenkuda and KSI-501.
According to Kodiak, Zenkuda and KSI-501 target the $15 billion anti-VEGF market across retinal vascular diseases.
For the second quarter ended June 30, 2026, net loss was $65.6 million, or $1.05 per share, compared with a net loss of $54.3 million, or $1.03 per share, in the prior year.
The company ended the second quarter with $125.9 million of cash and cash equivalents and expects it to support operations into 2027.
KOD has traded between $10.94 and $47.84 over the last year. The stock closed Friday's trade at $32.35, down 2.62%.
In the overnight market, KOD is up 10.70% at $35.81.
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