PolyPid Ltd
NASDAQ:PYPD
PolyPid Ltd
PolyPid Ltd. is a clinical stage biopharmaceutical company focusing on the development, manufacture, and commercialization of administered therapies to improve surgical outcomes. The firm focuses on the development, production and commercialization of new, locally administered therapies to improve surgical results. The main product is PLEX technology, which is located in the place of surgery and ensures controlled and continuous delivery of medicines.
PolyPid Ltd. is a clinical stage biopharmaceutical company focusing on the development, manufacture, and commercialization of administered therapies to improve surgical outcomes. The firm focuses on the development, production and commercialization of new, locally administered therapies to improve surgical results. The main product is PLEX technology, which is located in the place of surgery and ensures controlled and continuous delivery of medicines.
Regulatory Progress: PolyPid’s pre-NDA meeting with the FDA for D-PLEX100 is scheduled for early December, with NDA submission on track for early 2026.
Manufacturing Readiness: The company successfully completed its fourth consecutive Israeli Ministry of Health GMP inspection, supporting both European and US regulatory paths.
Market Interest: Recent US market access study and conference presentations confirmed strong interest and potential for D-PLEX100 among surgeons and pharmacy directors.
Financial Discipline: R&D expenses declined quarter-over-quarter following completion of the SHIELD II trial, and the company reduced current debt maturities significantly.
Cash Runway: Cash and equivalents increased to $18.8 million, expected to fund operations well into 2026.
