PolyPid (PYPD) Earnings Call Presentation

Efficacy Results - The primary efficacy endpoint showed a statistically significant reduction of 38% (p<0.005) in the D-PLEX100 + SOC group (10.9%, n=405) compared to the SOC group (18.1%, n=393) [15] - Surgical Site Infection (SSI) rate was reduced by 58% (p<0.005) in the D-PLEX100 + SOC group (3.8%, n=391) compared to the SOC group (9.5%, n=377) [18] - The combined efficacy endpoint in the overall study population showed a 36% reduction (p<0.005) in the D-PLEX100 + SOC group (11.1%, n=487) compared to the SOC group (17.4%, n=488) [21] - ASEPSIS Score >20 was reduced by 62% (p<0.05) in the D-PLEX100 + SOC group (2.0%, n=391) compared to the SOC group (5.6%, n=377) [25] Study Design and Patient Population - The study was a prospective, multinational, randomized, controlled, two-arm, double-blind trial assessing D-PLEX100 in preventing post-abdominal surgery incisional infections [6] - The trial included approximately 60 sites in the US, Europe, and Israel [6] - The ITT cohort consisted of 798 patients undergoing elective abdominal colorectal surgery with incision length > 20 cm, randomized 1:1 [6] - The primary efficacy endpoint was a combination of surgical site infections, all-cause mortality, and reintervention within 30 days post-surgery [11, 13] Demographics - In the ITT cohort, the average age was 67.0 years in the D-PLEX 100 group (N=405) and 68.0 years in the SoC group (N=393) [10] - The percentage of female patients was 44.0% in the D-PLEX 100 group and 37.9% in the SoC group [10] Next Steps - A pre-NDA meeting with the FDA is planned by the end of 2025 [26] - An NDA submission is planned for early 2026 [26]