Business
PolyPid Provides Corporate Update and Reports First Quarter 2022 Financial Results
• Planned Unblinded Interim Analysis of Phase 3 SHIELD I Trial of D-PLEX100 in Abdominal Soft Tissue Surgery Expected to Occur Imminently • Recruitment
About this update from Polypid Ltd.
[{"type":"text","content":"• Planned Unblinded Interim Analysis of Phase 3 SHIELD I Trial of D-PLEX100 in Abdominal Soft Tissue Surgery Expected to Occur Imminently • Recruitment Progressing as Planned with Approximately 900 Patients Enrolled into Phase 3 SHIELD I Trial of D-PLEX100 in Abdominal Soft Tissue Surgery • Extended Cash Runway into the Second Quarter of 2023 with $15 million Non-Dilutive Secured Term Loan Facility • Strengthened Executive Management Team • Conference Call Scheduled for Today at 8:30 AM ET PETACH TIKVA, Israel, May 11, 2022 (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, 2022. Recent Corporate Highlights: Unblinded interim analysis of SHIELD I (Surgical site Hospital acquired Infection prEvention with Local D-PLEX) study evaluating D-PLEX100 for the prevention of abdominal soft tissue surgical site infections (SSIs) expected to occur imminently. Once 750 patients complete their 30-day follow-up and statistical analysis is finalized, the results will allow for early trial stoppage due to efficacy, futility, or for sample size reassessment. Recruitment progressing as planned with approximately 900 patients enrolled into the ongoing Phase 3 SHIELD I study.Obtained a non-dilutive secured term loan facility for up to $15 million from Kreos Capital VI (Expert Fund) LP (“Kreos”) that broadens financing options and provides access to significant additional capital, which bolsters the Company’s ability to invest in commercial capabilities for D-PLEX100, as well as its development activities utilizing its promising PLEX technology platform. The first $10 million of the facility was drawn in April 2022. Strengthened the executive management team with the recent appointment of Evgeny Valdman as PolyPid’s new Executive Vice President of Operations and the promotion of Dalit Hazan to Executive Vice President, Research & Development, and Clinical & Regulatory Affairs. Evgeny brings to PolyPid more than 25 years of experience in senior management positions at Teva Pharmaceuticals and other pharmaceutical companies with approved products, with success at all levels of operations. Since 2016, Ms. Hazan has served in various leadership roles at PolyPi...