PolyPid Positive Topline Results from Phase 3

 

• D-PLEX100 successfully met the primary efficacy endpoint, with statistically significant results (p<0.005) in 798 patients with large abdominal surgery incisions.
• The trial successfully met all key secondary efficacy endpoints, including a 58% reduction in the rate of surgical site infections (“SSI”) in patients treated with D-PLEX100 arm versus standard of care (“SoC”) arm (p<0.005).
  
• The Company expects to submit a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) in early 2026, with a Marketing Authorization Application (“MAA”) in the E.U. to follow shortly thereafter.
  
• PolyPid will conduct a conference call and webcast at 8:30 A.M. ET today.

Conference Call Dial-In & Webcast Information:

Date:	Monday, June 9, 2025
Time:	8:30 A.M. Eastern Time
Conference Call:	https://register-conf.media-server.com/register/BIb5bb85aa1ffc4940b78f7191b278ca77
Webcast:	https://edge.media-server.com/mmc/p/k6n5hrft

A replay of the presentation will be available on the Company’s Investor Relations Events and Presentations webpage following the event.

https://finviz.com/news/76248/polypid-announces-positive-topline-results-from-phase-3-shield-ii-trial-d-plex-demonstrated-significant-reduction-in-surgical-site-infections-and-successfully-met-primary-and-all-key-secondary-endpoints