Business
PolyPid Provides Corporate Update and Reports Third Quarter 2022 Financial Results
Company Intends to Meet with U.S. and EU Regulatory Authorities to Discuss Data from SHIELD I Phase 3 Study and Regulatory Pathway for D-PLEX100 in First
About this update from Polypid Ltd.
[{"type":"text","content":"Company Intends to Meet with U.S. and EU Regulatory Authorities to Discuss Data from SHIELD I Phase 3 Study and Regulatory Pathway for D-PLEX100 in First Quarter of 2023 Implemented a Cost Reduction Plan, Including a 20% Decrease in Headcount Across All Departments Conference Call Scheduled for Today at 8:30 AM ET PETACH TIKVA, Israel, Nov. 09, 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 and nine months ended September 30, 2022. Recent Corporate Highlights: Announced top-line results from SHIELD I (Surgical site Hospital acquired Infection prEvention with Local D-PLEX100) study evaluating D-PLEX100 for the prevention of abdominal soft tissue surgical site infections (SSIs). PolyPid intends to discuss the SHIELD I study outcomes and potential next steps with U.S. and EU regulatory authorities in the first quarter of 2023. Continued data analysis of SHIELD I study showed encouraging results in certain subpopulations: 54% reduction in the primary endpoint in complex surgeries with large incisions (>20cm) pre-specified subgroup (p=0.0032; n=423) compared to standard of care.34% reduction in the primary endpoint in patients with one or more personal risk factors (post hoc analysis; p=0.047; n=680) compared to standard of care.SHIELD I study demonstrated a good safety profile of D-PLEX100 with no increase in serious or severe treatment emergent adverse events compared to standard of care. Received confirmation from the European Medicines Agency (EMA) that D-PLEX100 is eligible for submission of a Marketing Authorization Application under the EMA’s centralized procedure in the European Union (EU). Positive clinical data from the previously completed Phase 2 study of D-PLEX100 for the prevention of superficial and deep SSIs in abdominal surgery published in peer-reviewed publication, Techniques in Coloproctology. Implemented a cost reduction plan, including a 20% decrease in headcount across all departments, which is expected to extend available cash into the third quarter of 2023 in support of the Company’s long-term growth strategy. “Since the top-line results were announced, we have continued to gather and analyze additional data from SHIELD I,” stated Di...