Chase Knickerbocker

Boobalan Pachaiyappan

Brandon Folkes

Raghuram Selvaraju

Ram Selvaraju

Roy Buchanan

- 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.  **[1611842_2162626_0]** **[1611842_2162626_1]** 
- 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.  **[1611842_2162626_2]** **[1611842_2162626_3]** 
- 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.  **[1611842_2162626_2]**  Preventing one infection can save hospitals an average of **$25,000** per patient in the U.S..  **[1611842_2162626_2]** 
- PolyPid is also advancing a **GLP-1 program** in preclinical stages, aiming for extended dosing (50-60 days) and a smoother pharmacokinetic profile.  **[1611842_2162626_4]** 
- The company reported **sufficient cash into 2026**, covering the period post-NDA submission.  **[1611842_2162626_5]**

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

- 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**.  **[1611842_d99deb2248f74fb08904f2e2a944d526_0]** 
- 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.  **[1611842_d99deb2248f74fb08904f2e2a944d526_1]** 
- Following these positive results, PolyPid expects to submit a New Drug Application (NDA) for D-PLEX₁₀₀ in **early 2026**.  **[1611842_d99deb2248f74fb08904f2e2a944d526_1]**

PolyPid to Present Positive Phase 3 SHIELD II Trial Results

- 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.  **[1611842_0001213900-25-087942_ea025753001ex99-1_polypid.htm:0]** 
- 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**.  **[1611842_0001213900-25-087942_ea025753001ex99-1_polypid.htm:0]** 
- 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**.  **[1611842_0001213900-25-087942_ea025753001ex99-1_polypid.htm:0]** **[1611842_0001213900-25-087942_ea025753001ex99-1_polypid.htm:1]**

PolyPid (PYPD)