Slide 1: SHIELD II Topline Results
NASDAQ: PYPD SHIELD II Topline Results June 9, 2025
Slide 2: Cautionary Note Regarding Forward Looking Statements
Cautionary Note Regarding Forward Looking Statements This presentation of PolyPid Ltd. (the “Company”) contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “beli
Slide 3: Trial scope, endpoints and patient population
Scope Primary efficacy endpoint Safety assessment at 60 assessment within 30 days • Assess the efficacy and safety of D-PLEX100 in the post index surgery days post index surgery prevention of post abdominal surgery incisional infection • Prospective, multinational, randomized, controlled, two- 0 30
Slide 4: Standard of Care (SoC)
Standard of Care (SoC) • IV antibiotic only / IV antibiotic with mechanical bowel prep / IV antibiotic with oral antibiotics Change picture combined with mechanical bowel • 1st , 2nd or 3rd generation cephalosporin family plus metronidazole given within 60 minutes prior to surgery and discontinued a
Slide 5: SHIELD II Demographics & Surgery Characteristics (ITT Cohort)
SHIELD II Demographics & Surgery Characteristics (ITT Cohort) D-PLEX100 SoC Parameter (N=405) (N=393) Age (yrs) 67.0 68.0 Female (%) 44.0% 37.9% BMI (Kg/m2) 26.2 26.4 Charlson co-morbidity index 4.0 5.0 Surgery duration (hrs) 2.4 2.3 Indication for index surgery (%) Cancer 86.2% 91.1% Inflammatory B
Slide 6: Primary Efficacy Endpoint
Primary Efficacy Endpoint The Primary Efficacy Endpoint is the combination of the following events measured for 30 days from index surgery: 1. Surgical Site Infections (SSI), deep & superficial, as approved by adjudication committee 2. All-cause mortality 3. Reintervention Re-opening through the sam
Slide 7: D-PLEX100 Showed Statistically Significant Reduction in the Primary Efficacy Endpoint
D-PLEX100 Showed Primary Efficacy Endpoint Statistically Significant (ITT cohort) Reduction in the 71 38% Primary Efficacy (18.1%) reduction (p<0.005) Endpoint 44 (10.9%) SoC * D-PLEX100 D-PLEX + SOC + SoC 100 n=393 n=405 7 * SoC - Standard of Care
Slide 8: Key Secondary Efficacy Endpoint #1
Key Secondary Efficacy Endpoint #1 Surgical Site Infection (SSI) (ITT Cohort) Surgical Site Infection rate – intention to treat population: At least one abdominal incisional surgical site infection event, 36 58% occurring within 30 days post abdominal (index) surgery in (9.5%) reduction the populati
Slide 9: Key Secondary Efficacy Endpoint #2
Key Secondary Efficacy Endpoint #2 Combined Efficacy Endpoint (Overall Study Population) Combined Efficacy Endpoint - overall study population: A combination of at least one SSI event in the overall study 85 36% population of subjects with incision length >7 cm (n=975 (17.4%) reduction patients), al
Slide 10: Key Secondary Efficacy Endpoint #3
Key Secondary Efficacy Endpoint #3 ASEPSIS Score >20 (ITT Cohort) ASEPSIS Score – ITT Cohort: Number of subjects with ASEPSIS score >20 within 30 days 21 post abdominal (index) surgery. The ASEPSIS score is a 62% (5.6%) reduction clinical tool used to objectively assess surgical wound (p<0.05) infec
Slide 11: Next Steps
Next Steps Pre-NDA meeting with the FDA planned by end of 2025 NDA submission planned for early 2026 11
Slide 12: Q&A
Q&A