Kodiak Sciences Inc. SEC 10-Q Report

Kodiak Sciences Inc., a biopharmaceutical company specializing in the development of novel therapeutics for retinal diseases, has released its Form 10-Q report for the third quarter. The report provides a comprehensive overview of the company's financial performance and key business developments, reflecting its ongoing commitment to advancing its clinical programs and expanding its therapeutic pipeline.

Financial Highlights

• Loss from operations: $(59.1) million, reflecting increased research and development expenses primarily due to ongoing pivotal Phase 3 clinical trials and manufacturing activities.
• Net loss: $(57.5) million, compared to $(43.0) million in the prior year period, driven by higher operating expenses.
• Net loss per common share, basic and diluted: $(1.09), compared to $(0.82) in the prior year period, due to increased net loss.

Business Highlights

• Tarcocimab Clinical Program: Kodiak's lead investigational medicine, tarcocimab, is being developed for high prevalence retinal vascular diseases. It is currently in two Phase 3 clinical trials, GLOW2 for diabetic retinopathy and DAYBREAK for wet AMD. GLOW2 has completed enrollment, and DAYBREAK is actively enrolling patients.
• KSI-501 Clinical Program: KSI-501, a bispecific antibody biopolymer conjugate, is in a Phase 3 study (DAYBREAK) for wet AMD. The study evaluates KSI-501's efficacy and safety, with the aim to explore the potential of bispecific VEGF and IL-6 inhibition.
• KSI-101 Clinical Program: KSI-101 is being developed for retinal inflammatory diseases. The Phase 1b APEX study is ongoing, with early data showing strong treatment response. Further data is expected to be presented in July 2025.
• ABC Platform Development: Kodiak is advancing its platform to include small molecule drugs, aiming to create high drug-antibody-ratio medicines. This includes programs for glaucoma and geographic atrophy, targeting unmet needs with potential quarterly dosing.
• Digital Health Platform Development: The VETi program, an AI-enabled headset for eye engagement, is being developed to complement Kodiak's retinal medicines. It has potential applications beyond retina, possibly diagnosing and monitoring various diseases.
• Future Outlook: Kodiak plans to announce topline data for GLOW2 in 1Q 2026 and for DAYBREAK in 2Q 2026. The company aims to file a single Biologics License Application for tarcocimab in wet AMD, DR, and RVO after DAYBREAK data is available.

SEC Filing: Kodiak Sciences Inc. [ KOD ] - 10-Q - May. 14, 2025