Business
PolyPid Provides Corporate Update and Reports Second Quarter 2024 Financial Results
Approximately 320 Patients Enrolled in Ongoing SHIELD II Phase 3 Trial of D-PLEX100 for the Prevention of Abdominal Colorectal Surgical Site Infections
About this update from Polypid Ltd.
[{"type":"text","content":"Approximately 320 Patients Enrolled in Ongoing SHIELD II Phase 3 Trial of D-PLEX100 for the Prevention of Abdominal Colorectal Surgical Site Infections Unblinded Interim Analysis to be Conducted Once Approximately 400 Patients Complete Their 30-Day Follow-up, Which is Expected in Fourth Quarter of 2024; Top-Line Results Anticipated in First Quarter of 2025 Recent Successful Financing of Up to $14 Million Extends Company’s Cash Runway into Second Quarter of 2025, Beyond the Anticipated Timing for SHIELD II Top-line Results, Assuming Warrants are Fully Exercised Conference Call Scheduled for Today at 8:30 AM ET PETACH TIKVA, Israel, Aug. 14, 2024 (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 and six months ended June 30, 2024. Recent Corporate Highlights: Approximately 320 patients have been enrolled to date in the ongoing SHIELD II Phase 3 trial that is recruiting patients undergoing colorectal abdominal surgery with large incisions. Unblinded interim analysis is planned to be conducted once approximately 400 patients complete their 30-day follow-up, which is expected to occur in the fourth quarter of 2024.Top-line results are anticipated in the first quarter of 2025. Closed a private placement financing (“PIPE”) with existing and new investors for $8.1 million of gross proceeds, which extends the Company’s cash runway into the first quarter of 2025, beyond expected interim analysis results and the completion of enrollment of approximately 600 patients in SHIELD II. PolyPid has the potential to secure an additional $6.1 million if the unblinded interim analysis of its SHIELD II Phase 3 trial of D-PLEX100 results in either the stopping of the trial due to positive efficacy, or continuation to planned patient recruitment (up to 630 subjects). If all warrants issued in that financing are exercised, the Company would be funded beyond top-line results and into second quarter 2025.In addition, the Company announced that it has restructured its existing secured loan agreement with Kreos Capital VI (Expert Fund) LP with over $2 million of deferred repayments, which will be paid from April 2025 onwards, in line with the expected timing for the top-line results fr...