PolyPid(US:PYPD)2025-11-12 12:38Financial Position - PolyPid had cash, cash equivalents, and short-term deposits of $18.8 million as of September 30, 2025, up from $15.6 million on December 31, 2024, indicating a strong liquidity position [8]. - The company reduced current maturities of long-term debt from $6.5 million as of June 30, 2025, to $2.4 million as of September 30, 2025, reflecting significant progress in debt management [8]. - Total assets increased to $26.8 million as of September 30, 2025, compared to $25.2 million on December 31, 2024, indicating growth in the company's financial position [16]. Research and Development - Research and development (R&D) expenses for Q3 2025 were $5.3 million, a decrease from $6.0 million in Q3 2024 and $6.2 million in Q2 2025, attributed to the completion of the SHIELD II Phase 3 trial [9]. - For the nine months ended September 30, 2025, R&D expenses totaled $17.6 million, up from $15.8 million in the same period of 2024, primarily due to activities related to the SHIELD II trial [9]. Net Loss - The net loss for Q3 2025 was $7.5 million, or ($0.37) per share, compared to a net loss of $7.8 million, or ($1.22) per share, in Q3 2024, showing an improvement in loss per share [9]. - For the nine months ended September 30, 2025, the company reported a net loss of $25.7 million, or ($1.72) per share, compared to a net loss of $20.5 million, or ($3.82) per share, in the same period of 2024 [9]. Regulatory and Market Position - The company is on track to submit a New Drug Application (NDA) for D-PLEX₁₀₀ in early 2026, following a pre-NDA meeting with the FDA scheduled for early December 2025 [5]. - PolyPid successfully completed the IMOH GMP inspection, marking the fourth consecutive successful GMP inspection of its manufacturing facility, which is crucial for commercial readiness [5]. - The company is engaged in strategic partnership discussions in the U.S. for D-PLEX₁₀₀, following positive Phase 3 trial results, enhancing its market positioning [5].