Financial Data and Key Metrics Changes - For the quarter ended September 30, 2025, total net revenue was $1 million compared to $10.5 million for the same quarter in 2024, primarily due to the recognition of deferred revenue related to a prior year agreement [16] - Operating expenses for the quarter totaled $63 million, an increase from $43.3 million in the prior year, driven by clinical trial costs for ongoing phase three trials [17] - The net loss was $59.7 million, or $0.85 per share, compared to a net loss of $29.4 million, or $0.54 per share, in the prior year [17][18] - Cash and investments totaled $204 million as of September 30, 2025, down from $371 million as of December 31, 2024, but expected to fund operations into Q4 2027 [18] Business Line Data and Key Metrics Changes - Duraview is positioned to be the first to file and first to market among investigational sustained delivery programs for wet AMD and DME, with top-line data expected in mid-2026 [5][6] - Enrollment for the Lucia trial, a phase three trial for Duraview in wet AMD, was completed in July, with over 900 patients recruited across two trials [6] - The phase three DME program is set to begin with first patient dosing expected in Q1 2026, leveraging existing clinical trial infrastructure [11] Market Data and Key Metrics Changes - The global market for wet AMD and DME is currently valued at $10 billion and is expected to grow, dominated by monotherapy anti-VEGF biologics [8] - Current treatment options lead to a high burden of frequent injections, with many patients remaining undertreated [8][9] Company Strategy and Development Direction - The company aims to deliver innovation in wet AMD and DME through Duraview, a sustained-release TKI designed to improve treatment efficacy and reduce patient burden [9][10] - The manufacturing capability is being enhanced to support commercialization, with a GMP-compliant facility already producing registration batches [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the differentiated clinical profile of Duraview and its potential to transform treatment paradigms in retinal diseases [5] - The company is well-capitalized to deliver phase three data in 2026 and advance its DME program [19] Other Important Information - The company completed a $172 million follow-on offering in October, enhancing its cash position [7][16] - Recent preclinical data showed Duraview's active ingredient, virolanib, inhibits both VEGF-mediated vascular permeability and IL-6-mediated inflammation, supporting its multi-mechanism of action [7][12] Q&A Session Summary Question: Market sizing for wet AMD population in the U.S. - Approximately 20% of wet AMD patients require monthly treatment, with 50% unable to extend beyond eight weeks even with newer agents [21][22] Question: Enrollment criteria for DME program - The DME program will enroll both treatment-naive and previously treated patients, using aflibercept as a control [25] Question: Use of blended endpoint in trials - The blended endpoint is used to reduce missing data and capture recovery in vision, which is common in clinical trials for wet AMD [27][29] Question: Differentiation in IL-6 inhibition - IL-6 plays a significant role in DME, and blocking both VEGF and IL-6 pathways could lead to improved outcomes compared to anti-VEGF-only approaches [31][34] Question: Statistical analysis plan for superiority testing - The analysis plan allows for testing superiority if non-inferiority is met, which could position Duraview as a premium medication [36][37]