Core Viewpoint - PolyPid Ltd. has successfully completed enrollment in the Phase 3 SHIELD II trial of D-PLEX100, with top-line results expected in the current quarter, marking a significant milestone for the company as it prepares for regulatory submissions and commercial launch discussions [1][4]. Clinical Development - The SHIELD II Phase 3 trial has enrolled 800 patients, following a recommendation from the Data Safety Monitoring Board to conclude the study at this sample size, indicating potential positive efficacy signals for D-PLEX100 [7]. - Top-line results from the SHIELD II trial are anticipated by the end of the second quarter of 2025, which could be transformative for the company [7]. Regulatory Pathway - PolyPid plans to submit a New Drug Application (NDA) to the FDA in early 2026, leveraging its Fast Track and Breakthrough Therapy designations, with a Marketing Authorization Application (MAA) in the EU to follow shortly thereafter [7]. Commercial Strategy - The company is advancing its commercialization preparations and engaging in partnership discussions with multiple potential partners in the United States to maximize D-PLEX100's market potential [7]. Financial Results - For the three months ended March 31, 2025, PolyPid reported a net loss of $8.3 million, or $0.70 per share, compared to a net loss of $6.4 million, or $1.37 per share, in the same period of 2024 [8]. - Research and development expenses increased to $6.1 million from $5.1 million year-over-year, driven by the ongoing SHIELD II trial [8]. - As of March 31, 2025, the company had cash and cash equivalents of $8.0 million, down from $15.6 million at the end of 2024, which is expected to fund operations into the third quarter of 2025 [9]. Balance Sheet Highlights - Total assets as of March 31, 2025, were $16.8 million, a decrease from $25.2 million at the end of 2024 [20]. - Current liabilities stood at $12.4 million, slightly down from $12.7 million at the end of 2024 [21].