Financial Data and Key Metrics Changes - Research and development expenses for Q4 2025 were $10.7 million, up from $8.3 million in Q4 2024, while general and administrative expenses decreased slightly to $6.1 million from $6.3 million in the same period [22] - For the full year 2025, research and development expenses totaled $39.8 million compared to $32.1 million in 2024, and general and administrative expenses increased to $27.6 million from $26.7 million [23] - The net loss per common share for Q4 2025 was $0.06, compared to a loss of $0.05 in Q4 2024, and for the full year, the net loss was $0.23 compared to $0.20 in 2024 [22][23] Business Line Data and Key Metrics Changes - OCU400's Phase 3 liMeliGhT trial has completed enrollment, with top-line data expected in Q1 2027, which will support the BLA filing anticipated in 2027 [6][8] - OCU410ST for Stargardt disease is ahead of schedule, with top-line data expected in Q2 2027, and the program has received Rare Pediatric Disease Designation [10][11] - OCU410 for geographic atrophy has shown a 46% reduction in lesion growth at 12 months, significantly outperforming existing therapies [16] Market Data and Key Metrics Changes - The U.S. and European markets for retinitis pigmentosa (RP) include approximately 300,000 patients, while Stargardt disease affects about 100,000 patients in the U.S. and Europe combined [5][10] - The estimated market for geographic atrophy (GA) includes 2 million to 3 million patients in the U.S. and Europe [15] Company Strategy and Development Direction - The company aims to file three BLAs in the next three years, focusing on advancing its gene therapy programs into commercialization [18] - Ocugen is pursuing regional partnerships to maximize patient reach while retaining full commercial rights in larger markets [9] - The company has strengthened its leadership team to support its transition into a commercial stage company [19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in meeting timelines for clinical trials and emphasized the importance of upcoming data releases as catalysts for growth [26][30] - The company is focused on addressing significant unmet medical needs in the gene therapy space, particularly for conditions like Stargardt disease and GA [30][31] Other Important Information - Ocugen's cash runway extends into Q4 2026, bolstered by a recent $22.5 million capital raise [23][24] - The company has established Ocucelix as a subsidiary for regenerative cell therapy assets, aiming for independent financing [18] Q&A Session Summary Question: Confidence in data turnaround for liMeliGhT study - Management expressed confidence in meeting the timeline for releasing top-line data in Q1 2027 [26] Question: Modifications for navigation assessment course - The primary metric for RP was chosen for its sensitivity and specificity, validated by FDA [27][28] Question: Impact of other therapies on OCU410ST - Management believes OCU410ST will set the standard of care, regardless of other therapies entering the market [30][31] Question: CMC feedback timeline for OCU400 - CMC feedback from FDA is expected after the final clinical module is filed [41] Question: Commercial value of Ellipsoid Zone as an endpoint - The Ellipsoid Zone is gaining traction among clinicians and may provide meaningful information for commercial claims [46][48] Question: Characteristics of responders in OCU410 program - Baseline characteristics were uniform across groups, with no unique criteria identified yet [80]