D-PLEX100

Note: Exhibit 99.1 to PolyPid's Form 6-K, press release dated 2026-07-29: 'the U.S. Food and Drug Administration ("FDA") has accepted for filing the New Drug Application ("NDA") and granted the NDA a Priority Review for D-PLEX 100 for the prevention of surgical site infections ("SSIs") in patients undergoing abdominal colorectal surgery. The FDA did not identify any filing review issues and set a Prescription Drug User Fee Act ("PDUFA") target action date of November 28, 2026, approximately one quarter ahead of the Company's previously communicated first quarter 2027 guidance.' Basis = Phase 3 SHIELD II (met primary endpoint). Holds FDA Breakthrough Therapy Designation for SSI prevention in colorectal surgery. Acceptance triggered a $15M milestone from Azurity Pharmaceuticals, completing $30M in upfront/near-term payments under the US/Canada commercialization partnership signed 2026-07-17. RESOLVES the pdufa-calendar.json parse-error row 'PolyPid Ltd. / drugName: "with" / November 28, 2026' - 'with' was a scraper artifact, the real drug is D-PLEX100.