4DMT Reports First Quarter 2025 Financial Results, Operational Highlights and Expected Upcoming Milestones

Core Insights - 4D Molecular Therapeutics reported significant advancements in its clinical pipeline, particularly with 4D-150 for wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME), and initiated its first Phase 3 clinical trial [2][5][12] Financial Performance - As of March 31, 2025, the company had cash, cash equivalents, and marketable securities totaling $458 million, down from $505 million at the end of 2024, with expectations to fund operations into 2028 [9][20] - Research and development expenses for Q1 2025 were $40.7 million, an increase from $27.9 million in Q1 2024, primarily due to the initiation of the Phase 3 clinical trial for 4D-150 [10] - General and administrative expenses rose to $12.9 million in Q1 2025 from $10.3 million in Q1 2024 [11] - The net loss for Q1 2025 was $48.0 million, compared to a net loss of $32.4 million in Q1 2024 [11][18] Clinical Development Highlights - The first patients were enrolled in the 4D-150 Phase 3 clinical trial (4FRONT-1) for wet AMD, with over 50 clinical trial sites currently open [5][6] - The second Phase 3 clinical trial (4FRONT-2) is expected to initiate in Q3 2025, with topline data from both trials anticipated in H2 2027 [5][6] - 4D-150 received RMAT designation from the FDA for DME, adding to its previous designations for wet AMD [5][6] Product Pipeline Focus - The company has identified core programs: 4D-150 for wet AMD and DME, and 4D-710 for cystic fibrosis lung disease, while pausing investment in other programs pending additional financing or partnerships [6][12] - Development of 4D-110 for choroideremia and 4D-125 for X-linked retinitis pigmentosa has been terminated [6] Upcoming Milestones - Data and programmatic updates for 4D-150 in wet AMD and DME, as well as for 4D-710 in cystic fibrosis, are expected in H2 2025 [2][5]