Phase 3-backed SSI drug racing an approval decision against a thin cash cushion, with Azurity's commercialization deal as the bridge

PolyPid is a clinical-stage biopharmaceutical company developing a locally delivered antimicrobial drug to prevent surgical site infections after colorectal surgery, which is not yet approved.

D-PLEX 100, a locally delivered antimicrobial for surgical site infection prevention in colorectal surgery, cleared a pivotal Phase 3 with a 60% relative risk reduction and secured FDA Priority Review, Breakthrough Therapy, and a $30M Azurity commercialization deal. The thesis resolves on whether FDA grants approval at the November 2026 PDUFA date, since the NDA rests on a single pivotal trial without a confirmatory study. Cash of roughly $7M against a $7.8M quarterly burn means the company reaches the PDUFA date but has almost no buffer if approval is delayed or a complete response letter is issued.