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Visual21 Nov 2025
Data center suppliers
PolyPid (PYPD) investor relations material
PolyPid Q3 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q3 2025 earnings summary12 Nov, 2025
Executive summary
Pre-NDA meeting with FDA for D-PLEX100 scheduled for early December, aiming for NDA submission in early 2026 leveraging fast track and breakthrough therapy designations.
European marketing authorization application preparation underway, following successful Israeli Ministry of Health GMP inspection.
Strategic partnership discussions in the U.S. progressing, supported by positive SHIELD II phase III trial results.
Achieved commercial manufacturing readiness milestone with successful IMOH GMP inspection.
Market access study confirms strong interest and commercial potential for D-PLEX100 among surgeons and hospital pharmacy directors.
Financial highlights
Q3 2025 R&D expenses were $5.3M, down from $6.2M in Q2 2025 and $6M in Q3 2024, reflecting SHIELD II trial completion.
General and administrative expenses rose to $1.8M from $1.2M in Q3 2024; marketing and business development expenses increased to $0.4M from $0.2M.
Net loss for Q3 2025 was $7.5M ($0.37/share), improved from $7.8M ($1.22/share) in Q3 2024.
For the nine months ended September 30, 2025, net loss was $25.7M ($1.72/share) vs. $20.5M ($3.82/share) in 2024.
Cash, cash equivalents, and short-term deposits totaled $18.8M as of September 30, 2025, up from $15.6M at year-end 2024.
Outlook and guidance
NDA submission for D-PLEX100 expected in early 2026, with rolling submission planned post-December FDA meeting.
Current cash balance expected to fund operations well into 2026.
Ongoing evaluation of manufacturing expansion to address U.S. local production trends and future peak sales.
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Q4 202511 Feb, 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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