PolyPid Ltd. (Nasdaq: PYPD) ("PolyPid" or the "Company"), an innovative biopharmaceutical company dedicated to improving patient outcomes by elevating treatment effectiveness, right where care begins, today announced the successful completion of its New Drug Application ("NDA") submission on a rolling review basis to the U.S. Food and Drug Administration ("FDA") for D-PLEX100, the Company's lead product candidate for the prevention of surgical site infections ("SSIs") in patients undergoing colorectal surgery. The Company anticipates a potential FDA decision in the first quarter of 2027 under the Prescription Drug User Fee Act ("PDUFA") review timeline.

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