Successful Pre-NDA and European Readiness
PolyPid Ltd. is on track with its pre-NDA meeting scheduled for early December with the FDA and plans to submit the NDA for DPLEX 100 in early 2026, leveraging Fast Track and Breakthrough Therapy designations. The company is also preparing for the submission of the European Marketing Authorization Application following the NDA.
Positive Phase III Trial Results
The SHIELD II trial demonstrated a 58% reduction in surgical site infections with DPLEX 100, resulting in strong interest from surgeons and pharmacy directors and indicating significant commercial potential.
Financial Performance Improvements
PolyPid Ltd. reported a reduced net loss of $7.5 million for the quarter, compared to $7.8 million in the prior year, and increased cash reserves to $18.8 million, up from $15.6 million at year-end 2024.
Market Access Study Validation
A new US market study confirmed strong interest in DPLEX 100 from surgeons and hospital pharmacy directors, with 80% of surgeons likely to use it for eligible patients and 70% of pharmacy directors likely to add it to the formulary.