Core Insights - PolyPid Ltd. is progressing towards the market launch of D-PLEX₁₀₀, with a pre-NDA meeting with the FDA scheduled for early December and NDA submission expected in early 2026 [1][4][3] Regulatory Pathway Advancement - The company is on track to submit an NDA for D-PLEX₁₀₀ aimed at preventing abdominal colorectal surgical site infections (SSIs), leveraging Fast Track and Breakthrough Therapy designations [4] - A face-to-face pre-NDA meeting with the FDA is set for early December 2025 [4] Partnership Discussions - PolyPid is engaged in strategic discussions with potential U.S. partners for D-PLEX₁₀₀, which have advanced following positive Phase 3 trial results [4][3] Commercial Readiness - The company successfully completed the Israeli Ministry of Health Good Manufacturing Practice inspection, marking the fourth consecutive successful GMP inspection [4] - Recent U.S. market access research indicates a strong value proposition for D-PLEX₁₀₀ in reducing clinical and economic burdens of SSIs [4] Financial Performance - R&D expenses for Q3 2025 were $5.3 million, down from $6.0 million in Q3 2024 and $6.2 million in Q2 2025 [5] - G&A expenses for Q3 2025 were $1.8 million, compared to $1.2 million in Q3 2024 [5] - The company reported a net loss of $7.5 million, or ($0.37) per share, for Q3 2025, an improvement from a net loss of $7.8 million, or ($1.22) per share, in Q3 2024 [5] Balance Sheet Highlights - As of September 30, 2025, cash and cash equivalents totaled $18.8 million, up from $15.6 million on December 31, 2024 [7] - 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 [7] Overall Financial Results - For the nine months ended September 30, 2025, R&D expenses were $17.6 million, compared to $15.8 million for the same period in 2024 [11] - The net loss for the nine months ended September 30, 2025, was $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 [11]

Core Insights - PolyPid Ltd. has appointed Dr. Nurit Tweezer-Zaks as Chief Medical Officer, effective August 18, 2025, transitioning from her role on the Board of Directors [1][2][3] - The appointment comes after positive results from the Phase 3 SHIELD II trial, as the company prepares for a New Drug Application (NDA) submission for its lead product candidate, D-PLEX₁₀₀ [2][4] - Dr. Tweezer-Zaks brings extensive experience in medical and executive roles, including her previous position as CEO of MediCane Health Inc. and senior roles at aMOON Venture Capital Fund and Sanofi [2][3] Company Overview - PolyPid Ltd. is a late-stage biopharma company focused on improving surgical outcomes through its proprietary PLEX technology, which allows for controlled, prolonged-release therapeutics [4] - The company is preparing for an NDA submission for D-PLEX₁₀₀, aimed at preventing abdominal colorectal surgical site infections, expected in early 2026 [4] - PolyPid has a pipeline that includes innovative programs in oncology, obesity, and diabetes [4]