Core Insights - Kodiak Sciences Inc. announced new data from the APEX study of KSI-101, a novel therapy for macular edema secondary to inflammation (MESI), presented at the Retina Society Annual Scientific Meeting [1][2] Group 1: Study Findings - The APEX Phase 1b study showed that patients with MESI experienced clinically meaningful gains in best-corrected visual acuity (BCVA) and rapid retinal drying by Week 12 [2][5] - In the study, the proportion of patients achieving a 15-letter gain in BCVA was 31% at the 2.5 mg dose, 62% at the 5 mg dose, and 54% at the 10 mg dose [5] - The mean change in BCVA from baseline to Week 12 was +8.8 letters for 2.5 mg, +10.7 letters for 5 mg, and +12.1 letters for 10 mg [5] - Patients with diabetic macular edema (DME) also showed significant visual and anatomical improvements, gaining an average of 12.0 letters and reducing retinal thickness by 157 microns by Week 24 [5] Group 2: Mechanism and Safety - KSI-101 is a bispecific antibody targeting interleukin-6 (IL-6) and vascular endothelial growth factor (VEGF), designed to treat MESI [4][10] - The therapy demonstrated a favorable safety profile, being well tolerated in both MESI and DME patients [6][12] - The drying effect of KSI-101 was reported to be comparable or superior to existing treatments like Ozurdex, without associated side effects [7] Group 3: Future Developments - Ongoing Phase 3 studies, PEAK and PINNACLE, are actively enrolling patients to further evaluate KSI-101 at the 5 mg and 10 mg dose levels [8][14] - The studies aim to cover a wide spectrum of MESI patients, with PEAK focusing on more severe cases and PINNACLE on milder cases [14] - Topline data readouts for KSI-101 are expected in late 2026 or early 2027, indicating a significant market opportunity for the treatment of MESI [17]

Core Insights - Kodiak Sciences Inc. reported a net loss of $57.5 million for Q1 2025, compared to a net loss of $43.0 million in Q1 2024, reflecting an increase in operational expenses and R&D investments [4][28]. - The company ended Q1 2025 with $138.9 million in cash and cash equivalents, which is expected to support operations into 2026 [3][29]. - Kodiak is focused on advancing its pipeline, particularly three Phase 3 assets, with topline data anticipated in 2026 [2][3]. Financial Results - The net loss for Q1 2025 was $57.5 million, or $1.09 per share, compared to a net loss of $43.0 million, or $0.82 per share, in Q1 2024 [4][28]. - R&D expenses increased to $43.6 million in Q1 2025 from $29.9 million in Q1 2024, driven by heightened clinical activities [5][28]. - General and administrative expenses decreased slightly to $15.4 million in Q1 2025 from $16.1 million in Q1 2024 [8][28]. Pipeline and Upcoming Events - Kodiak plans to host an Investor R&D Update on July 16, 2025, to discuss scientific, clinical, and commercial perspectives across its pipeline [3]. - The company is advancing its investigational therapies, including Tarcocimab, KSI-501, and KSI-101, with ongoing Phase 3 studies and new clinical trial data expected [7][19][21]. Product Development - Tarcocimab is being studied in two Phase 3 trials: GLOW2 for diabetic retinopathy and DAYBREAK for wet AMD, with both studies utilizing an enhanced formulation [11][19]. - KSI-501 is designed to target both IL-6 and VEGF, with a focus on treating wet AMD and is currently in the DAYBREAK study [17][20]. - KSI-101 is being evaluated in a Phase 1b study for diabetic macular edema and macular edema secondary to inflammation, with plans for dual Phase 3 studies [21][22].