Financial Data and Key Metrics Changes - The company ended 2024 with a strong balance sheet of $371 million in cash and investments and no debt, bolstered by a $161 million oversubscribed follow-on equity offering in Q4 2024 [17][32] - Total net revenue for Q4 2024 was $11.6 million, down from $14 million in Q4 2023, while net product revenue increased slightly to $0.8 million from $0.7 million [33] - For the full year 2024, total net revenue was $43.3 million, down from $46 million in 2023, with net product revenue dropping significantly to $3.2 million from $14.2 million due to the sale of YUTIQ product rights [36][37] - Operating expenses for Q4 2024 totaled $56.8 million, up from $30.4 million in the prior year, primarily due to ongoing Phase 3 trials for DURAVYU [35] - The net loss for Q4 2024 was $41.4 million or $0.64 per share, compared to a net loss of $14.1 million or $0.33 per share in the prior year [36] Business Line Data and Key Metrics Changes - The company expects net product revenue to remain at immaterial levels as it will cease supplying YUTIQ to ANI Pharmaceuticals as of May 31, 2025 [33] - Net revenue from royalties and collaborations in Q4 2024 was $10.8 million, down from $13.3 million in Q4 2023, primarily due to lower recognition of deferred revenue from the license of YUTIQ product rights [34] Market Data and Key Metrics Changes - Enrollment in the Phase 3 trials for DURAVYU in wet AMD is exceeding expectations, with the LUGANO trial over 50% enrolled and the Lucia trial tracking ahead of schedule [13][28] - The company anticipates completion of enrollment in both trials in the second half of 2025, with top-line data expected in 2026 [14][39] Company Strategy and Development Direction - The company is focused on advancing DURAVYU, a sustained delivery program for treating wet AMD and DME, with a goal to be the first to submit a new drug application for a six-month intravitreal therapy [14][22] - The strategic focus is on clinical trials and regulatory approvals, with plans to engage in discussions with regulatory agencies regarding pivotal trial design for DME [26][90] - The company aims to provide a product that maintains stable vision for wet AMD patients with a six-month dosing interval, significantly improving upon current anti-VEGF treatments [27][119] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's position as a leader in ocular sustained drug delivery, with a compelling clinical pipeline representing multibillion-dollar opportunities [30][41] - The management highlighted the importance of successful execution in the ongoing Phase 3 trials and maintaining a strong cash runway to support operations into 2027 and beyond [39][130] Other Important Information - The company has established a state-of-the-art manufacturing facility in Northbridge, Massachusetts, which is now operational and focused on supporting NDA filing and commercial launch [100][102] - DURAVYU is positioned as a best-in-class therapy with a unique mechanism of action and a strong safety profile, differentiating it from existing treatments [12][22] Q&A Session Summary Question: How many clinical sites have been activated for the wet AMD pivotal program? - The company has most sites activated in the U.S., with approximately 60 active sites per study, and plans to have between 60 and 80 sites per study internationally [49][51] Question: Can you comment on the subgroup analysis of the 2.7% milligram versus aflibercept? - The analysis shows a strong dose response, with the 2.7% dose demonstrating significant improvements in visual acuity and fluid control compared to the control group [56][57] Question: What is the current status of the razuprotafib program? - The razuprotafib program is on a lower priority as the company focuses on wet AMD, but preclinical activities will continue [130] Question: What are the plans for the DME pivotal program? - The company is awaiting feedback from regulatory agencies to design an efficient study for DME, with robust data from the Phase 2 study providing flexibility [71][90]