PolyPid Ltd. provided a corporate update on May 14, 2025, in conjunction with its first quarter 2025 financial results. The company confirmed the successful completion of enrollment in its Phase 3 SHIELD II trial for D-PLEX100.
Top-line results from the SHIELD II trial are anticipated in the current quarter, the second quarter of 2025. PolyPid continues to advance its preparations for New Drug Application (NDA) and Marketing Authorization Application (MAA) submissions in 2026.
The company is also progressing its commercial plans and engaging in partnership discussions with multiple potential partners in the United States. PolyPid's cash balance is expected to be sufficient to fund operations into the third quarter of 2025, with potential additional funding from warrant exercises extending the runway beyond anticipated NDA approval.
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