PolyPid (PYPD) investor relations material

Key product and clinical data

• Lead product D-PLEX100 uses a unique platform for prolonged, linear drug delivery, targeting prevention of surgical site infections, with positive Phase 3 data recently published and NDA submission planned for Q1 next year.

• SHIELD 2 study showed nearly 40% reduction in composite primary endpoint and 60% reduction in surgical site infections, with robust statistical significance and strong feedback from surgeons on clinical value.

• Real-world infection rates may be higher than those observed in the study, suggesting even greater potential impact in practice.

Market opportunity and commercialization

• Preventing one surgical site infection saves hospitals an average of $25,000, with the initial U.S. target market covering 4.4 million abdominal surgeries annually and 3 million in Europe.

• D-PLEX100 has breakthrough therapy and QIDP designations, making it eligible for up to 75% reimbursement for hospitals in the first 2-3 years post-launch.

• Plans include expanding indications to other surgeries such as open heart, breast, and orthopedics, with future studies expected to be less complex.

• Active discussions are ongoing with potential U.S. commercial partners, with strong interest from companies with robust hospital sales forces.

Regulatory and operational progress

• Frequent, proactive communication with the FDA has helped clarify requirements for NDA submission, with CMC and preclinical modules nearly finalized.

• Facility has passed inspections by European and Israeli authorities, with preparations underway for FDA inspection post-NDA submission.

• Pre-NDA meeting with FDA planned before year-end, with label expansion discussions expected around NDA submission.