PolyPid (PYPD) investor relations material

Background and clinical need for SSI prevention

• Surgical site infections (SSIs) are a major cause of morbidity, prolonged hospitalization, and increased healthcare costs, especially in colorectal surgery, with high risk due to the nature of the procedures and patient comorbidities.

• SSIs can double or even increase mortality by up to 11-fold, and cost the U.S. healthcare system over $3 billion annually, not including lost productivity or long-term disability.

• Current prevention strategies involve bowel cleansing, oral and IV antibiotics, and meticulous surgical technique, but these are not fully effective and can have their own complications.

Impact of SSIs on hospitals and physicians

• SSIs lead to financial penalties for hospitals, including CMS penalties and lower star ratings, which can affect reputation and reimbursement.

• High SSI rates can negatively impact surgeons' professional standing and may influence bonuses or rankings within healthcare systems.

• SSIs can result in additional surgeries, long-term complications like hernias, and potential legal exposure, though not all SSIs are considered negligence.

D-PLEX100: Innovation and clinical data

• D-PLEX100 is a novel formulation of doxycycline with polymers and lipids, designed for local, extended antibiotic delivery at the surgical site for 30 days.

• The SHIELD II phase 3 trial showed a 60% reduction in SSI rates (from ~10% to <4%) and a 40% reduction in the composite endpoint of SSI, mortality, and reoperation, with robust statistical significance.

• Safety data from over 1,000 patients indicate no increased adverse events, and the product is considered very safe by the Data Safety Monitoring Board.