PolyPid (PYPD) investor relations material

Key milestones and regulatory progress

• NDA submission for D-PLEX100 initiated at the end of Q1 2026, with FDA acceptance expected within 74 days and a PDUFA date anticipated in early 2027.

• Priority review status could lead to a six-month FDA review period; parallel meetings with European authorities are planned to align on MAA submission.

• MAA submission in the EU is planned for the quarter following the U.S. NDA submission, targeting EU approval in the second half of 2027.

• NTAP program application and FDA acceptance letter expected in the second half of 2026.

Technology and clinical results

• PLEX technology enables long-acting, controlled drug release for weeks to months, with over 170 patents covering the approach.

• D-PLEX100 demonstrated a 40% reduction in the composite endpoint of infection, mortality, and reoperation in an 800-patient phase III study.

• Infection rates dropped from 10% to 3.8% in treated cancer patients, a 60% relative risk reduction (P=0.001).

• Severe infection rates, measured by ASEPSIS score, were reduced by 64% in the treated group.

• All key secondary endpoints were met and results were recently published at the Surgical Infection Society conference.

Market opportunity and commercialization plans

• U.S. market includes 12 million inpatient surgical procedures at risk for infection, with 4.4 million abdominal procedures as the initial target.

• D-PLEX100 offers potential cost savings for hospitals, including direct infection costs and CMS penalties, and is eligible for up to 75% NTAP reimbursement in the first 2–3 years.

• Market research shows 80% of surgeons and 90% of pharmacy directors are likely to prescribe D-PLEX100 with NTAP incentives.

• Discussions are underway with a U.S. commercialization partner, aiming for a 2027 launch.

• Manufacturing is conducted in a dedicated GMP facility designed for the Kynatrix platform.