Kodiak Sciences Inc. reported a net loss of $176.2 million for the year ended December 31, 2024, a 32% decrease compared to the $260.5 million loss in 2023. Research and development expenses decreased by 39% to $126.1 million, primarily due to reduced manufacturing and clinical activities for completed trials, partially offset by costs from ongoing trials. General and administrative expenses also decreased by 14% to $60.8 million, mainly due to stock-based compensation. The company ended the year with $168.1 million in cash and cash equivalents.
Significant changes compared to the previous year include the completion of enrollment in the Phase 3 GLOW2 study for diabetic retinopathy and continued enrollment in the Phase 3 DAYBREAK study for wet age-related macular degeneration. Topline data for GLOW2's primary endpoint is anticipated in the first quarter of 2026, and for DAYBREAK in the second quarter of 2026. A single Biologics License Application (BLA) is planned for 2026, pending successful results from both studies, covering wet AMD, retinal vein occlusion (RVO), and diabetic retinopathy. The company also advanced its KSI-501 and KSI-101 programs, with KSI-501 included in the DAYBREAK study and KSI-101 undergoing a Phase 1b study.
Kodiak Sciences commissioned its commercial-scale drug substance manufacturing facility, Ursus, in January 2023, releasing its first commercial-scale cGMP batch of tarcocimab in July 2023. The company also released tarcocimab drug product in March 2024 for use in the GLOW2 and DAYBREAK studies. The company reported 109 employees worldwide as of December 31, 2024, with 74 involved in research, development, and clinical activities. The company is advancing its ABC Platform and its extension, the ABCD Platform, to develop new therapies for glaucoma and geographic atrophy.
The company faces competition from established players like Roche (Vabysmo) and Regeneron (Eylea HD), as well as other companies developing treatments for retinal diseases. Kodiak Sciences' success depends on obtaining and maintaining regulatory approvals for its product candidates, achieving market acceptance, and securing adequate reimbursement from third-party payors. The company acknowledges substantial risks related to drug development, regulatory approvals, manufacturing, commercialization, and intellectual property protection.
Kodiak Sciences' outlook anticipates continued operating losses for the foreseeable future and a need for additional funding to support its operations and development programs. The company plans to raise additional capital through equity or debt financings, collaborations, or a combination of these methods. The company's financial condition raises substantial doubt about its ability to continue as a going concern.
About Kodiak Sciences Inc.
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