Financial Performance - Kodiak Sciences reported a net loss of $54.3 million for Q2 2025, compared to a net loss of $45.1 million in Q2 2024, representing a 20% increase in losses year-over-year[8]. - Total operating expenses for the second quarter of 2025 were $55.5 million, up from $48.0 million in the same quarter of 2024, indicating a 15.7% increase[32]. - As of June 30, 2025, Kodiak Sciences had cash and cash equivalents of $104.2 million, down from $168.1 million at the end of 2024, a decrease of 38.0%[33]. - The company's accumulated deficit increased to $1.44 billion as of June 30, 2025, compared to $1.33 billion at the end of 2024[33]. Research and Development - Research and development expenses increased to $42.8 million in Q2 2025, up from $32.5 million in Q2 2024, driven by increased clinical activities[9]. - Research and development expenses increased to $42.8 million in Q2 2025 from $32.5 million in Q2 2024, reflecting a 31.5% rise[32]. - Kodiak is developing a portfolio of three late-stage clinical programs, two of which are derived from its ABC Platform[29]. - The company anticipates potential regulatory milestones for its product candidates, including KSI-101, which addresses high unmet needs in retinal diseases[31]. - Forward-looking statements indicate that Kodiak aims to maximize the probability of success for its clinical programs and is focused on advancing investigational therapies for retinal diseases[31]. Clinical Trials and Data - KSI-101 Phase 3 topline data is anticipated in Q4 2026 to Q1 2027, while Tarcocimab Phase 3 topline data is expected in Q1 2026 and Q3 2026[4][6]. - In the APEX Phase 1b study, over 90% of patients achieved dryness by week 8 after two doses of KSI-101, with half of the patients showing a ≥15 letter gain in visual acuity[6]. - Tarcocimab demonstrated a 29-fold increased response rate in the GLOW1 study, with 41.1% of patients achieving at least a 2-step improvement on the Diabetic Retinopathy Severity Scale[15]. - The GLOW2 study has completed enrollment, and the DAYBREAK study is actively enrolling patients, both utilizing Tarcocimab's enhanced formulation[13][20]. - KSI-501 is currently in the Phase 3 DAYBREAK study, which is actively enrolling patients and aims to evaluate its efficacy and safety in wet AMD[20][21]. - Kodiak Sciences is actively enrolling patients in the PEAK and PINNACLE studies, which evaluate KSI-101 for treating macular edema[28]. - The primary and key secondary endpoints for the PEAK and PINNACLE studies will be evaluated at Week 24[28]. Strategic Initiatives - Kodiak's VETi program has made significant advancements in AI and machine learning, with potential applications in retinal health and cognitive science[6]. - The company is exploring broader applications of its advancements in identity security and cognitive science, indicating a strategic expansion beyond retinal diseases[6].
Kodiak(KOD) - 2025 Q2 - Quarterly Results