Financial Data and Key Metrics Changes - The company ended 2025 with a strong balance sheet of $306 million in cash and investments, down from $371 million as of December 31, 2024 [17] - For Q4 2025, total net revenue was $0.6 million, a significant decrease from $11.6 million in Q4 2024, primarily due to the recognition of remaining deferred revenue related to the YUTIQ product rights [15] - Full year 2025 total net revenue was $31 million, compared to $43 million in 2024, again driven by the deferred revenue recognition [16] - Operating expenses for Q4 2025 totaled $71 million, up from $57 million in the prior year, mainly due to ongoing Phase III trials for DURAVYU [16] - The net loss for Q4 2025 was approximately $68 million or $0.81 per share, compared to a net loss of $41 million or $0.64 per share in the prior year [16] Business Line Data and Key Metrics Changes - DURAVYU is on track to deliver top-line data in wet AMD beginning in mid-2026, with the first patients dosed in pivotal Phase III DME trials [7][8] - The company is focused on building DURAVYU into a durable franchise targeting the largest retinal disease markets, which have a combined current global market of $10 billion [12] 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 [12] Company Strategy and Development Direction - The company aims to position DURAVYU as the first to market among current investigational sustained release programs in both wet AMD and DME, with a potential best-in-class profile [11] - The strategy includes a focus on commercial readiness and the appointment of a new Chief Commercial Officer to prepare for a successful U.S. launch [12][13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in DURAVYU's blockbuster potential, citing its compelling clinical profile and favorable safety profile observed in over 190 patients across four completed clinical trials [8][9] - The company is well-capitalized to continue advancing DURAVYU through late-stage development programs, with cash expected to fund operations into Q4 2027 [18] Other Important Information - The company is preparing for regulatory submission and pre-approval inspection as it nears NDA submission for DURAVYU [13] Q&A Session Summary Question: Can you clarify the rate of ocular AEs seen with DURAVYU, particularly around vitreous floaters and cataracts? - The incidence of cataracts in treated patients was 5.8%, while vitreous floaters were reported in 5.2% of patients, consistent with expectations for injection studies [24][26] Question: How are you thinking about recent FDA chatter around single study-driven regulatory approvals? - The company welcomes a more rapid pathway to drug approvals but does not anticipate changing its strategy for current trials [32] Question: Will there be additional looks at masked safety in the wet AMD trials before they read out? - There will be ongoing safety monitoring by both internal and independent committees, with the next review scheduled for May [39] Question: What are the expectations for the reduction in treatment burden in the wet AMD studies? - The treatment burden will be measured after the loading doses, with expectations of a 60% reduction in the DURAVYU arm compared to the control arm [69] Question: How do you expect the steps or requirements to affect the adoption of vorolanib? - Initial adoption is expected among patients requiring frequent treatments, with potential expansion based on clinical trial outcomes [92]