PolyPid (PYPD) 2nd Annual Lytham Partners Healthcare Investor Summit summary

Platform technology and pipeline

• Developing a unique platform for prolonged, linear local drug delivery, combining polymers and lipids in a self-assembling matrix.

• Over 170 patents protect the technology, with headquarters in New Jersey and Israel.

• Lead asset D-PLEX 100 is in late-stage development, with NDA submission planned for early this year.

• Pipeline includes a GLP-1 program, with preclinical and efficacy data expected later this year.

Clinical results and regulatory progress

• D-PLEX 100 targets the large U.S. surgical site infection market, covering 12 million procedures annually.

• Phase 3 trial in colorectal resection showed a 40% reduction in infection, mortality, and re-intervention rates (from 18% to 9.9%).

• Statistically significant results across all primary and secondary endpoints, including a drop in infection rate from 10% to 3.8%.

• Achieved 60% reduction in severe sepsis scores and maintained robust results in minimally invasive procedures.

• Pre-NDA meeting with FDA resulted in alignment on approval and submission process; NDA submission imminent.

Commercialization and market strategy

• Product has breakthrough therapy, fast track, and QIDP designations, making it eligible for priority review and a six-month FDA review period.

• Commercial launch planned with a U.S. partner; discussions are ongoing and announcement expected around NDA submission.

• Hospitals bear direct costs of surgical site infections and face CMS penalties, making cost-saving solutions attractive.

• Eligible for NTAP program, providing additional hospital reimbursement in the first 2-3 years post-launch.