PolyPid Ltd. (PYPD) Announces Cost Reduction Plan

PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced a cost reduction plan, including a 20% reduction in headcount across all departments as the Company prepares for planned discussions in the first quarter of 2023 with the U.S. Food and Drug Administration (FDA) and EU regulatory authorities regarding the regulatory pathway for D-PLEX100 for the prevention of surgical site infections (SSIs) in abdominal surgery. PolyPid expects that these actions will extend the Company’s cash runway into the third quarter of 2023.

“As we prepare for our planned discussions with the FDA and EU regulatory authorities, we are taking these decisive actions in order to further enhance PolyPid’s long-term growth strategy,” said Dikla Czaczkes Akselbrad, PolyPid’s Chief Executive Officer. “Based on the collective data generated to date, we remain confident in the potential of D-PLEX100 to prevent SSIs in abdominal surgery, and we look forward to discussing the ongoing late-stage clinical program for our lead product candidate with U.S. and EU regulatory authorities in the first quarter of next year.”

“We were pleased to recently receive confirmation from the European Medicines Agency that D-PLEX100 is eligible for submission of a Marketing Authorization Application in the EU under the Agency’s centralized procedure, which we view as reflective of the potential innovation behind our lead product candidate,” continued Ms. Czaczkes Akselbrad.

PolyPid will provide further details on its regulatory plans and cash position on its third quarter 2022 financial results and corporate update call on November 9, 2022.

About D-PLEX100D-PLEX100, PolyPid’s lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent SSIs. Following the administration of D-PLEX100 into the surgical site, the PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in high local concentration of the drug for a period of 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 received Breakthrough Therapy Designation from the U.S. FDA for the prevention of SSIs in patients undergoing elective colorectal surgery. D-PLEX100 also received three Qualified Infectious Disease Product (QIDP) designations, and three Fast Track designations for the prevention of SSIs in patients undergoing elective colorectal surgery, post-abdominal surgery incisional infection and for the prevention of sternal wound infection post-cardiac surgery.

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