PolyPid Announces Enrollment of 200th Patient in Ongoing SHIELD II Phase 3 Trial Evaluating D-PLEX₁₀₀ for the Prevention of Abdominal Colorectal Surgical Site Infections

Study Approximately Half Enrolled to the Planned Unblinded Interim Analysis

Unblinded Interim Analysis to be Conducted Once Approximately 400 Patients Complete Their 30-Day Follow-up

Top-line Results Expected in Second Half of 2024

PETACH TIKVA, Israel, April 30, 2024 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced that it has enrolled the 200^th patient in its ongoing SHIELD II Phase 3 trial for D-PLEX₁₀₀ for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery with large incisions. The study is now approximately one-third enrolled and is anticipated to continue enrollment at a pace of 1.5 patients per center per month. There are currently approximately 40 centers open and the Company expects to add approximately 20 more centers over the next couple of months.

An unblinded interim analysis is anticipated to be conducted in mid-2024, once a total of approximately 400 patients complete their 30-day follow-up.

“Enrollment into SHIELD II has significantly ramped-up during the last two months and is now progressing at a consistently robust pace,” said Dikla Czaczkes Akselbrad, PolyPid’s Chief Executive Officer. “We continue to expect top-line results from SHIELD II in the second half of 2024. Importantly, the $16 million financing we successfully completed earlier this year extends our cash runway beyond the anticipated timing of the study’s planned unblinded interim analysis, and we have the potential to secure an additional $19 million if the results of the unblinded interim analysis are positive and warrants are exercised, which would fund the Company to the start of a planned rolling New Drug Application (“NDA”) submission for D-PLEX₁₀₀.”

In January 2024, PolyPid closed a private placement financing (the “PIPE”) for $16 million of gross proceeds. The PIPE syndicate was comprised of new and existing investors, including participation from new U.S. life sciences-focused investors, DAFNA Capital Management and Rosalind Advisors. The Company has the potential to secure an additional $19 million if the results of the unblinded interim analysis are positive and all warrants issued in the financing are exercised, which would fund PolyPid to the start of a planned rolling NDA submission for D-PLEX₁₀₀.