Core Insights - PolyPid Ltd. reported positive results from the SHIELD II Phase 3 trial for D-PLEX₁₀₀, achieving a 58% reduction in surgical site infections (SSIs) compared to standard care [1][4] - The company plans to submit a New Drug Application (NDA) to the U.S. FDA in Q1 2026, leveraging Fast Track and Breakthrough Therapy designations [1][4] - A successful warrant exercise has strengthened the company's balance sheet, providing a cash runway into 2026 [1][4] Recent Corporate Highlights - The SHIELD II trial demonstrated significant clinical benefits, generating interest from potential commercial partners [3] - Healthcare professionals have shown enthusiasm for D-PLEX₁₀₀, recognizing its potential to reduce SSI burden and improve patient outcomes [3] - The company is well-positioned to maximize the value of its technology with a strengthened balance sheet and strategic options [3] Clinical Trial Results - The SHIELD II trial showed a statistically significant 38% reduction in the primary endpoint and a robust 58% reduction in SSIs [4] - Safety data indicated no difference in serious treatment-emergent adverse events between D-PLEX₁₀₀ and standard care [4] - The company is advancing its NDA preparation following the positive trial results [4] Pipeline Developments - PolyPid is making progress on a GLP-1 delivery platform aimed at the obesity and diabetes market, targeting approximately 60 days of no-burst GLP-1 delivery [4] - The appointment of Dr. Nurit Tweezer-Zaks as Chief Medical Officer is expected to strengthen the leadership team as the company prepares for NDA submission [4] Financial Position - As of June 30, 2025, the company had cash and cash equivalents of $29.5 million, up from $15.6 million at the end of 2024 [7] - The net loss for the three months ended June 30, 2025, was $10.0 million, compared to a net loss of $6.3 million for the same period in 2024 [10] - For the six months ended June 30, 2025, the net loss was $18.2 million, compared to $12.7 million for the same period in 2024 [10]