Ocugen Provides Business Update with Fourth Quarter and Full Year 2024 Financial Results

Core Insights - Ocugen, Inc. reported its fourth quarter and full year 2024 financial results, highlighting advancements in its clinical programs and regulatory achievements [1][2][12] Clinical Developments - The company is advancing its clinical programs, including a Phase 2/3 trial for OCU410ST targeting Stargardt disease, which affects approximately 100,000 patients in the U.S. and Europe [2][3] - OCU410ST showed a 52% reduction in lesion growth and a statistically significant improvement in visual function in treated eyes during the Phase 1 trial [3] - The OCU410 clinical trial for geographic atrophy (GA) reported a 44% reduction in lesion growth and a meaningful improvement in visual function [5] - Two-year data from the OCU400 trial for retinitis pigmentosa (RP) demonstrated a 100% improvement in visual function among treated subjects [6] Regulatory Achievements - Ocugen received orphan medicinal product designation from the EMA for OCU410ST and positive opinions for ATMP classification for OCU400, OCU410, and OCU410ST [7][8] - The FDA has aligned with Ocugen on the Phase 2/3 trial for OCU410ST, potentially expediting clinical development by two to three years [7] Financial Performance - For Q4 2024, research and development expenses were $8.3 million, up from$7.8 million in Q4 2023, while general and administrative expenses increased to $6.3 million from$5.2 million [14] - The company reported a net loss of $0.05 per share for Q4 2024, compared to a loss of$0.04 per share in Q4 2023 [14] - Full year 2024 research and development expenses totaled $32.1 million, down from$39.6 million in 2023, with a net loss of $0.20 per share compared to$0.26 in 2023 [15] Cash Position - As of December 31, 2024, Ocugen had cash and restricted cash totaling $58.8 million, an increase from$39.5 million in 2023, which is expected to fund operations into Q1 2026 [15]