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PolyPid Provides Corporate Update and Reports Fourth Quarter and Full-Year 2024 Financial Results
PolyPidPolyPid(US:PYPD) Globenewswireยท2025-02-12 12:00

Core Insights - The independent Data Safety Monitoring Board (DSMB) has recommended continuing the SHIELD II Phase 3 trial of D-PLEX100, suggesting positive efficacy signals, with enrollment expected to complete by March 2025 and top-line results anticipated in Q2 2025 [4][12] - PolyPid has completed a private placement financing of up to $41 million, which is expected to extend its cash runway beyond potential New Drug Application (NDA) approval [4][8] - The company has reported significant clinical and operational progress in 2024, positioning itself for a potentially transformative year in 2025 [4] Clinical Trial Updates - The SHIELD II trial has enrolled over 700 patients to date, with a target enrollment of 800 patients [4][12] - The trial aims to assess the efficacy and safety of D-PLEX100 in preventing surgical site infections (SSIs) in patients undergoing abdominal colorectal surgeries [12][13] - The primary endpoint is the proportion of subjects with SSI events within 30 days post-surgery [12] Financial Highlights - As of December 31, 2024, PolyPid had cash and cash equivalents of $15.6 million, up from $5.3 million a year earlier, which is expected to fund operations into Q3 2025 [8][22] - For the three months ended December 31, 2024, the company reported a net loss of $8.5 million, or ($1.13) per share, compared to a net loss of $6.4 million, or ($3.97) per share, in the same period of 2023 [11][23] - For the full year ended December 31, 2024, the net loss was $29.0 million, or ($4.91) per diluted share, compared to a net loss of $23.9 million, or ($16.93) per diluted share, in 2023 [11][23] Strategic Developments - PolyPid has announced a research and development collaboration with ImmunoGenesis, Inc. to enhance treatment for solid tumors using its proprietary PLEX Technology [4] - The company appointed Mr. Yitzchak Jacobovitz, CFA, to its Board of Directors, bringing extensive healthcare investment experience [4][5]