PolyPid Secures FDA Pre-NDA Feedback and Advances US Partnership for D-PLEX100
PolyPid advanced D-PLEX100 into advanced US partnership discussions and received positive FDA pre-NDA feedback supporting a rolling NDA submission set to begin by end of Q1 2026. The company reported Q4 R&D expenses of $6.2 million, a net loss of $8.5 million, and held $12.9 million in cash.
1. Corporate Developments
PolyPid moved D-PLEX100 into advanced stages of partnership discussions for US commercialization and received positive feedback from the FDA on its pre-NDA meeting for prevention of colorectal surgical site infections. The company plans to initiate a rolling NDA submission by the end of Q1 2026, reflecting regulatory momentum and partner interest.
2. Financial Results
In Q4 2025, R&D expenses declined to $6.2 million from $7.0 million year-over-year, driven by SHIELD II trial completion and regulatory preparations. The quarter recorded an $8.5 million net loss, flat with prior year, while full-year 2025 net loss widened to $34.2 million and year-end cash and short-term deposits stood at $12.9 million.
3. Governance and Pipeline Expansion
Brooke Story was appointed Chairman of the Board, enhancing leadership with her medical technology and surgical solutions experience. PolyPid also unified its expanded drug delivery platforms under the new Kynatrix™ technology, including an ultra long-acting GLP-1 receptor agonist program targeting metabolic diseases.