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PolyPid (PYPD) investor relations material
PolyPid 2nd Annual Lytham Partners Healthcare Investor Summit summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.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.
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