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PolyPid
PolyPid (PYPD) investor relations material
PolyPid Q4 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q4 2025 earnings summary11 Feb, 2026
Executive summary
Completed SHIELD II Phase III trial with D-PLEX100 meeting all primary and key secondary endpoints, showing significant reduction in surgical site infections.
Advanced D-PLEX100 to final regulatory preparation, with positive FDA pre-NDA feedback supporting a rolling NDA submission expected by end of Q1 2026.
Progressed U.S. commercial partnership discussions to advanced stages, reflecting strong clinical data and market need.
Introduced Kynatrix technology, expanding drug delivery capabilities into new therapeutic areas, including metabolic diseases.
Appointed Brooke Story as chairman of the board, enhancing governance and leadership.
Financial highlights
Q4 2025 R&D expenses were $6.2M, down from $7M year-over-year, reflecting trial completion.
Q4 2025 net loss was $8.5M ($0.41/share), unchanged from prior year but with lower per-share loss.
Full-year 2025 net loss was $34.2M ($2.09/share), up from $29M ($4.91/share) in 2024.
Full-year 2025 R&D expenses rose to $23.8M from $22.8M, driven by trial and regulatory activities.
G&A expenses increased to $1.8M in Q4 2025 (from $1M) and $7.2M for the year (from $4.3M), mainly due to non-cash PSU vesting.
Outlook and guidance
Rolling NDA submission for D-PLEX100 to begin by end of Q1 2026, with FDA review expected to be shortened to 6 months due to Fast Track and Breakthrough Therapy Designation.
Existing cash resources expected to fund operations into the second half of 2026 and through key milestones.
Focus remains on U.S. commercialization, with European submission planned after FDA filing.
D-PLEX100 partnership timeline?
Kynatrix GLP-1 program: next development step?
Cash runway beyond H2 2026: funding plan?
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Next PolyPid earnings date
Q1 202613 May, 2026
PolyPid
Next PolyPid earnings date
Q1 202613 May, 2026
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Frequently asked questions
PolyPid Ltd. is a late-stage biopharmaceutical company focused on enhancing surgical outcomes through innovative drug delivery systems. The company's proprietary PLEX (Polymer-Lipid Encapsulation Matrix) technology is designed to enable localized, prolonged, and controlled release of active pharmaceutical ingredients at the surgical site. This technology aims to optimize therapeutic efficacy and minimize side effects by maintaining a consistent drug presence over an extended period. The company is headquartered in Petach Tikva, Israel, and its shares are listed on the NASDAQ.
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