PolyPid (PYPD) Company Report

PolyPid Ltd. announced on December 3, 2025, that it received positive FDA Pre-NDA meeting minutes for D-PLEX100, its lead product candidate for preventing surgical site infections.
The FDA agreed that the existing clinical data package, including Phase 3 SHIELD II trial results, is adequate to support the New Drug Application (NDA) submission and review.
The FDA also approved a rolling NDA review, with PolyPid planning to submit the first completed sections in early 2026.

4 days ago

6-K

PolyPid Reports Q3 2025 Financial Results and Advances D-PLEX100 Regulatory and Commercial Milestones

PYPD

Earnings

Guidance Update

New Projects/Investments

PolyPid reported a net loss of $7.5 million or $0.37 per share for Q3 2025, an improvement from the prior year, and held $18.8 million in cash, cash equivalents, and short-term deposits as of September 30, 2025, with an expected cash runway well into 2026.
The company is on track for a pre-NDA meeting with the FDA for D-PLEX100 in early December and plans to submit the New Drug Application (NDA) in early 2026, leveraging its Fast Track and Breakthrough Therapy Designations.
PolyPid successfully completed its fourth consecutive Israeli Ministry of Health Good Manufacturing Practice (GMP) inspection, an important step towards commercial manufacturing readiness for D-PLEX100.
A recent US market access study for D-PLEX100 showed strong commercial potential, with 80% of surgeons indicating they are extremely likely to use the product and 70% of hospital pharmacy directors reporting a high likelihood to add and stock it; strategic partnership discussions are progressing.

Nov 12, 2025, 1:30 PM

Transcript

PolyPid Reports Q3 2025 Financial Results and Provides Corporate Update

PYPD

Earnings

Guidance Update

Product Launch

PolyPid reported a net loss of $7.5 million, or ($0.37) per share, for the three months ended September 30, 2025.
Research and development expenses decreased to $5.3 million for the three months ended September 30, 2025, compared to $6.0 million in the same period of 2024, primarily due to the successful completion of the SHIELD II Phase 3 trial.
As of September 30, 2025, the company had $18.8 million in cash, cash equivalents, and short-term deposits, which is expected to fund operations well into 2026.
A face-to-face pre-New Drug Application (NDA) meeting with the FDA is scheduled for early December, with the NDA submission for D-PLEX₁₀₀ on track for early 2026.
The company is advancing strategic partnership discussions with potential U.S. partners for D-PLEX₁₀₀ following positive Phase 3 trial results and successfully completed an IMOH GMP inspection as part of commercial manufacturing readiness.

Nov 12, 2025, 12:38 PM

6-K

PolyPid Reports Q3 2025 Financial Results and Corporate Update

PYPD

Earnings

Guidance Update

New Projects/Investments

PolyPid is on track to submit a New Drug Application (NDA) for D-PLEX100 in early 2026, with a face-to-face pre-NDA meeting with the FDA scheduled for early December 2025.
The company is advancing strategic partnership discussions in the U.S. for D-PLEX100 following positive Phase 3 trial results.
For the three months ended September 30, 2025, PolyPid reported a net loss of $7.5 million, or ($0.37) per share.
As of September 30, 2025, PolyPid held $18.8 million in cash, cash equivalents, and short-term deposits, which is expected to fund operations well into 2026.

Nov 12, 2025, 12:30 PM

Press Release

PolyPid's D-PLEX₁₀₀ receives "Therapeutics Solution of the Year" award

PYPD

Product Launch

PolyPid's lead candidate, D-PLEX₁₀₀, has been named "Therapeutics Solution of the Year" by BioTech Breakthrough.
D-PLEX₁₀₀ is designed to prevent surgical site infections (SSIs) by providing continuous, localized antibiotic delivery for 30 days at the surgical site, utilizing PolyPid's proprietary PLEX technology.
The Phase 3 SHIELD II trial demonstrated a statistically significant 58% (p< 0.005) relative risk reduction in SSIs following abdominal colorectal surgery.
D-PLEX₁₀₀ has received Breakthrough Therapy Designation, three QIDP designations, and three Fast Track designations from the U.S. Food and Drug Administration, with NDA submission expected early 2026.

Nov 6, 2025, 1:30 PM

Press Release

PolyPid Discusses Positive D-PLEX100 Phase 3 Data and Q1 2026 NDA Submission Plans

PYPD

Product Launch

New Projects/Investments

Guidance Update

PolyPid's lead product, D-PLEX100, recently published positive Phase 3 data for the prevention of surgical site infection, demonstrating a nearly 40% reduction in the composite primary endpoint and over 50% reduction in surgical site infections in open colorectal surgery.
The company plans to submit the NDA application for D-PLEX100 in Q1 2026, with a pre-NDA meeting scheduled before the end of 2025.
The initial target market for D-PLEX100 in abdominal surgeries is 7.4 million operations annually (4.4 million in the U.S. and 3 million in Europe), with potential for expansion into other surgical areas. Preventing one infection can save hospitals an average of $25,000 per patient in the U.S..
PolyPid is also advancing a GLP-1 program in preclinical stages, aiming for extended dosing (50-60 days) and a smoother pharmacokinetic profile.
The company reported sufficient cash into 2026, covering the period post-NDA submission.

Sep 30, 2025, 4:30 PM

Transcript

PolyPid to Present Positive Phase 3 SHIELD II Trial Results

PYPD

New Projects/Investments

Product Launch

PolyPid Ltd. announced that Dr. Shmuel Sharoni will present the topline results from the successful Phase 3 SHIELD II trial of D-PLEX₁₀₀ at the 2025 American College of Surgeons Clinical Congress on October 5, 2025.
The SHIELD II trial demonstrated that D-PLEX₁₀₀ achieved a 38% reduction (p<0.005) in the combined endpoint of surgical site infections, reinterventions, or mortality, and a 58% reduction (p<0.005) in surgical site infections alone.
Following these positive results, PolyPid expects to submit a New Drug Application (NDA) for D-PLEX₁₀₀ in early 2026.

Sep 30, 2025, 12:45 PM

Press Release

PolyPid Completes Israeli Ministry of Health GMP Inspection

PYPD

Product Launch

New Projects/Investments

Guidance Update

PolyPid Ltd. announced the successful completion of a routine Good Manufacturing Practice (GMP) inspection by the Israeli Ministry of Health, marking its fourth consecutive successful inspection of its manufacturing facility.
This milestone confirms the facility's readiness for commercial production in the European market under the EU-Israel ACAA framework and serves as crucial preparation for a U.S. FDA facility inspection.
The company anticipates submitting a New Drug Application (NDA) for D-PLEX100 in early 2026, following positive Phase 3 SHIELD II trial results that demonstrated a 58% relative risk reduction in surgical site infections.