Financial Data and Key Metrics Changes - As of March 31, 2025, the company had cash and cash equivalents of $8 million, which is expected to fund operations into the third quarter of 2025 [16] - Research and development expenses for Q1 2025 were $6.1 million, up from $5.1 million in the same period of 2024, driven by the ongoing SHIELD II Phase III trial [17] - The net loss for Q1 2025 was $8.3 million, compared to a net loss of $6.4 million in Q1 2024 [17] Business Line Data and Key Metrics Changes - The SHIELD II Phase III trial for DPLEX100 has successfully concluded enrollment with 800 patients, following a recommendation from the Data Safety Monitoring Board [7][8] - The company anticipates top line data availability by the end of next month, with plans for NDA submission in early 2026 [8][9] Market Data and Key Metrics Changes - The total addressable market for DPLEX100 in the U.S. is estimated at over 12 million surgeries annually, with approximately 4.4 million being abdominal soft tissue surgeries [12] - Recent market research identified four groups of surgeons as potential users for DPLEX100, indicating a significant unmet need in high-risk surgical procedures [13] Company Strategy and Development Direction - The company is focused on identifying a U.S. partner with an existing dedicated hospital product sales force to maximize DPLEX100's sales potential [10] - An exclusive licensing agreement is already in place with Advanced Pharma for commercialization in Europe, with pre-launch activities being planned [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term prospects of DPLEX100 and is preparing for regulatory submissions while awaiting SHIELD II trial results [51] - The company is actively engaging in partnership discussions in the U.S. as interest in DPLEX100 is gaining momentum [15] Other Important Information - The company is in the finalization stages of CMC and nonclinical NDA modules, with plans for a pre-NDA meeting with the FDA [30][32] - The company plans to conduct several mock inspections to prepare for FDA review [43] Q&A Session Summary Question: Pricing strategy for DPLEX100 - Management has not finalized the pricing strategy but is considering a preliminary price of $600 per vial, with an average usage of 2.5 vials per procedure [21] Question: NDA filing requirements - The NDA will consist of three modules, with the company preparing the CMC and preclinical data while working on the clinical module post top line data [29][30] Question: Expectations for top line data - The company expects to report both primary and key secondary endpoints upon unblinding the data, with plans for an investor call shortly after [41][36] Question: Inspection readiness and capacity - The company is prioritizing inspection readiness and believes its facility will be sufficient for the first four to five years post-launch [44]