Core Insights - PolyPid Ltd. is advancing discussions for a commercial partnership in the U.S. for its product D-PLEX₁₀₀, following positive Phase 3 trial results and FDA engagement [3][5] - The company expects to begin the rolling NDA submission process by the end of Q1 2026, marking a significant step towards regulatory approval [3][5] - 2026 is anticipated to be a transformative year for PolyPid as it transitions from late-stage development to full commercial execution [3][14] Recent Corporate Highlights - The completion of the SHIELD II Phase 3 trial has positioned D-PLEX₁₀₀ for advanced partnership discussions in the U.S. [3][5] - Positive FDA feedback supports the planned rolling NDA submission for D-PLEX₁₀₀ aimed at preventing surgical site infections [5][14] - Brooke Story has been appointed as Chairman of the Board, bringing extensive experience in medical technology [5] - A Key Opinion Leader event highlighted the clinical and economic burden of surgical site infections and the potential of D-PLEX₁₀₀ to improve outcomes [5] Financial Results - For Q4 2025, R&D expenses decreased to $6.2 million from $7.0 million in Q4 2024, reflecting the completion of the SHIELD II trial [6] - G&A expenses increased to $1.8 million in Q4 2025 from $1.0 million in Q4 2024, while marketing expenses rose to $0.6 million from $0.2 million [6] - The net loss for Q4 2025 was $8.5 million, or $0.41 per share, compared to a net loss of $8.5 million, or $1.13 per share, in Q4 2024 [7][20] Full Year Financial Overview - For the full year 2025, R&D expenses totaled $23.8 million, up from $22.8 million in 2024, driven by trial completion and regulatory preparations [13] - G&A expenses for 2025 were $7.2 million, compared to $4.3 million in 2024, primarily due to non-cash expenses related to performance-based options [13] - The net loss for 2025 was $34.2 million, or $2.09 per share, compared to a net loss of $29.0 million, or $4.91 per share, in 2024 [13][18] Balance Sheet Highlights - As of December 31, 2025, the company had cash and cash equivalents of $6.4 million, down from $15.6 million in 2024 [15] - Total assets decreased to $22.3 million in 2025 from $25.2 million in 2024 [16] - Shareholders' equity increased to $10.973 million in 2025 from $7.684 million in 2024, reflecting additional capital raised through warrant exercises [13][17]