PETACH TIKVA, Israel — August 13, 2025 — Leads & Copy — PolyPid Ltd. (Nasdaq: PYPD) announced positive results from its SHIELD II Phase 3 trial of D-PLEX₁₀₀, which demonstrated a 58% reduction in surgical site infections (SSIs). The company expects to submit a New Drug Application (NDA) to the FDA in early 2026. PolyPid also unveiled a long-acting GLP-1 receptor agonist delivery platform targeting the obesity and diabetes market, and its balance sheet has been strengthened through a successful warrant exercise.
The SHIELD II Phase 3 trial showed a statistically significant reduction of 38% (p<0.005) in the primary endpoint and a 58% reduction in the rate of SSIs in patients treated with D-PLEX₁₀₀ versus standard of care (p<0.005), including a significant reduction in deep SSIs. Safety data showed no difference in serious treatment-emergent adverse events between the D-PLEX₁₀₀ arm and the standard of care arm.
PolyPid is advancing commercialization preparations and strategic partnership discussions in the U.S. to maximize D-PLEX₁₀₀’s market potential. The company’s GLP-1 program aims to deliver approximately 60 days no-burst GLP-1 for improved patient compliance and therapeutic outcomes in the obesity and diabetes market.
On August 12, 2025, Dr. Nurit Tweezer-Zaks, M.D., M.B.A., was appointed Chief Medical Officer. The company completed a warrant exercise inducement transaction, extending its cash runway into 2026.
R&D expenses for the three months ended June 30, 2025, were $6.2 million, compared to $4.8 million in the same period of 2024. G&A expenses were $2.5 million, compared to $1.1 million. Marketing and business development expenses were $0.7 million, compared to $0.3 million. The net loss for the quarter was $10.0 million, or ($0.78) per share, compared to a net loss of $6.3 million, or ($1.25) per share, in 2024.
For the six months ended June 30, 2025, R&D expenses were $12.3 million, compared to $9.8 million in 2024. G&A expenses were $3.7 million, compared to $2.1 million. Marketing and business development expenses were $1.0 million, compared to $0.5 million. The net loss for the period was $18.2 million, or ($1.48) per share, compared to a net loss of $12.7 million, or ($2.62) per share, in 2024.
As of June 30, 2025, the Company had cash and cash equivalents and short-term deposits in the amount of $29.5 million.
Contact:
Ori Warshavsky
908-858-5995
IR@Polypid.com
Source: PolyPid Ltd.
