Clinical TrialsThe DSMB recommended the SHIELD II trial be upsized to 800 subjects, indicating a meaningful signal of benefit for D-PLEX100.
Financial PositionPolyPid's cash runway is extended through top-line pivotal results, expected to support operations into the third quarter of 2025.
Partnership OpportunitiesThe company is in active discussions with multiple potential commercial partners for D-PLEX100, with a focus on the U.S. opportunity.
Regulatory ProcessD-PLEX100 has Fast Track and Breakthrough designations, with management planning to submit the NDA on a rolling basis.