Business
PolyPid Provides Corporate Update and Reports First Quarter 2023 Financial Results
Submitted Revised Protocol for SHIELD II Phase 3 Trial to FDA to Evaluate D-PLEX100 for Prevention of Abdominal Colorectal Surgical Site Infections;
About this update from Polypid Ltd.
[{"type":"text","content":"Submitted Revised Protocol for SHIELD II Phase 3 Trial to FDA to Evaluate D-PLEX100 for Prevention of Abdominal Colorectal Surgical Site Infections; Recruitment Expected to Resume Imminently Received Advice from the Swedish Medical Products Agency Consistent with Feedback Received from the FDA Completed a Series of Transactions to Further Solidify Financial Position and Extend Cash Runway to Late in Q1 2024 Strengthened Board of Directors Through Appointment of Yossi BenAmram, Former SVP and President of Merck & Co.’s Europe, Russia, Africa, and Middle East Region Conference Call Scheduled for Today at 8:30 AM ET PETACH TIKVA, Israel, May 10, 2023 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today provided a corporate update and reported financial results for the three months ended March 31, 2023. Recent Corporate Highlights: Submitted revised protocol to U.S. Food and Drug Administration (FDA) for SHIELD II Phase 3 trial. Based on feedback received from the FDA following a Type D meeting, the revised SHIELD II study will recruit patients undergoing colorectal resection surgery with large incisions (> 20 cm). The study is expected to resume imminently with the enrollment of an estimated 550 additional patients.Unblinded interim analysis is planned to be conducted once approximately 400 patients complete their 30-day follow-up.Total recruitment time into the study is anticipated to be approximately 12 months and top-line results are expected in mid-2024. Completed a series of financial transactions to extend PolyPid’s cash runway into late Q1 2024. Closed on an underwritten public offering that included the full exercise of the underwriter's option to purchase additional Ordinary Shares and a concurrent private placement of pre-funded warrants with certain existing shareholders for total gross proceeds of approximately $11.4 million.Restructured loan agreement with Kreos Capital with over $3 million of deferred repayments, which will be paid from August 2024 onwards, in-line with the expected timing for the top-line results from SHIELD II. Received feedback in a national scientific advice meeting from the Swedish Medical Products Agency (MPA) similar to the Type D meeting feedback previously received from the FDA. Swedish MPA reco...