Kodiak(US:KOD)2025-11-13 21:05Financial Performance - Net loss for Q3 2025 was $61.5 million, or $1.16 per share, compared to a net loss of $43.9 million, or $0.84 per share, in Q3 2024[9] - Total operating expenses for the three months ended September 30, 2025, were $62.352 million, compared to $46.632 million for the same period in 2024, reflecting a 33.7% increase[33] - The net loss for the nine months ended September 30, 2025, was $173.231 million, compared to $132.102 million for the same period in 2024, indicating a 31.1% increase in losses[33] - Cash and cash equivalents decreased to $72.038 million as of September 30, 2025, down from $168.074 million at the end of 2024[34] - The accumulated deficit increased to $1.501 billion as of September 30, 2025, compared to $1.329 billion at the end of 2024[34] - General and administrative expenses for the nine months ended September 30, 2025, were $40.055 million, down from $46.347 million for the same period in 2024, showing a decrease of 13.9%[33] Research and Development - R&D expenses increased to $50.5 million in Q3 2025 from $31.9 million in Q3 2024, driven by increased clinical activities[10] - KSI-101 showed over 50% of patients achieving a ≥15 letter gain in best corrected visual acuity by week 20 in the Phase 1b APEX study[6] - The Phase 3 PEAK and PINNACLE studies of KSI-101 are enrolling at a faster-than-expected pace, evaluating the top two dose levels of 5 mg and 10 mg[6] - Tarcocimab's Phase 3 GLOW2 diabetic retinopathy study is on track for topline data in Q1 2026[6] - The Phase 3 DAYBREAK study has enrolled approximately 690 subjects, with the last visit for the primary endpoint expected in August 2026[6] - KSI-501 is being developed for high prevalence retinal vascular diseases and has completed enrollment in the DAYBREAK study[21] - Kodiak Sciences is actively enrolling patients in the PEAK and PINNACLE studies, which are designed to cover a wide spectrum of MESI patients[29] - KSI-101 is being evaluated in two Phase 3 studies for Macular Edema Secondary to Inflammation (MESI), with topline data readouts anticipated in 4Q 2026 (PEAK) and 1Q 2027 (PINNACLE)[30] Company Outlook - Kodiak expects continued momentum into 2026 with all three Phase 3 assets on track for topline data readouts and the first planned BLA filing[3] - Kodiak Sciences is focused on developing transformative therapeutics for retinal diseases, targeting a $15 billion anti-VEGF market with two Phase 3 studies for Tarcocimab and KSI-501, expecting topline data in 1Q 2026 and 3Q 2026[30] Technology and Innovation - The company’s ABC® Platform utilizes molecular engineering to develop next-generation retinal medicines[30]