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PolyPid Provides Corporate Update and Reports Fourth Quarter and Full-Year 2024 Financial Results
PYPDPolyPid(PYPD) GlobeNewswire· Globenewswire·2025-02-12 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 41million,whichisexpectedtoextenditscashrunwaybeyondpotentialNewDrugApplication(NDA)approval[4][8]−Thecompanyhasreportedsignificantclinicalandoperationalprogressin2024,positioningitselfforapotentiallytransformativeyearin2025[4]ClinicalTrialUpdates−TheSHIELDIItrialhasenrolledover700patientstodate,withatargetenrollmentof800patients[4][12]−ThetrialaimstoassesstheefficacyandsafetyofD−PLEX100inpreventingsurgicalsiteinfections(SSIs)inpatientsundergoingabdominalcolorectalsurgeries[12][13]−TheprimaryendpointistheproportionofsubjectswithSSIeventswithin30dayspost−surgery[12]FinancialHighlights−AsofDecember31,2024,PolyPidhadcashandcashequivalentsof41 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 5.3millionayearearlier,whichisexpectedtofundoperationsintoQ32025[8][22]−ForthethreemonthsendedDecember31,2024,thecompanyreportedanetlossof5.3 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)pershare,comparedtoanetlossof1.13) per share, compared to a net loss of 6.4 million, or (3.97)pershare,inthesameperiodof2023[11][23]−ForthefullyearendedDecember31,2024,thenetlosswas3.97) 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)perdilutedshare,comparedtoanetlossof4.91) 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]