PolyPid (PYPD) investor relations material

Regulatory and clinical progress

• NDA submission for D-PLEX₁₀₀ is imminent, with rolling submission starting before month-end and full completion within a few months.

• FDA pre-NDA meeting confirmed Phase 3 SHIELD I and Phase 2 data are sufficient for approval, with clear alignment on efficacy and safety.

• Priority review is expected, targeting a PDUFA date around year-end or January.

• European regulatory submission will follow a few months after FDA submission.

• Product holds Breakthrough Therapy Designation, enabling frequent FDA communication.

Clinical data and product impact

• Phase 3 trial in open colorectal resection showed 40% reduction in mortality, reoperation, and surgical site infection, with a p-value of 0.0013.

• Achieved 60% reduction in surgical site infection as a key secondary endpoint.

• Severity of infections was also reduced by over 60% based on ASEPSIS score.

• Benefits include earlier patient discharge, reduced hospital costs, and fewer delays in oncology protocols for cancer patients.

• Product is designed to supplement standard of care, providing an additional layer of protection.

Market strategy and commercialization

• Initial label expected for colorectal surgery, with plans to expand to abdominal and other high-risk surgeries.

• U.S. market opportunity estimated at 4.4 million abdominal surgeries annually.

• Early adoption likely in academic centers, with pilot studies targeting high-risk patients.

• Market research and pharmacoeconomic studies underway to support payer and hospital adoption.

• Product is eligible for NTAP, which could drive hospital uptake.