Business
PolyPid Announces Cost Reduction Plan
Reduction of Approximately 20% in Organization Headcount Company Expects to Extend Cash Runway into Q3 2023 PolyPid Intends to Discuss Regulatory Pathway for
About this update from Polypid Ltd.
[{"type":"text","content":"Reduction of Approximately 20% in Organization Headcount Company Expects to Extend Cash Runway into Q3 2023 PolyPid Intends to Discuss Regulatory Pathway for D-PLEX100 for Prevention of Surgical Site Infections in Abdominal Surgery with U.S. and EU Regulatory Authorities in Q1 2023 PETACH TIKVA, Israel, Oct. 20, 2022 (GLOBE NEWSWIRE) -- 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 Phar...