PolyPid Ltd.

PolyPid Ltd. announced it will hold its Annual and Extraordinary General Meeting of Shareholders on July 15, 2026, in Petach Tikva, Israel. Shareholders will vote on the re-election of the independent registered public accountants and eight board members, as well as approving their compensation. Additionally, proposals include amending non-executive directors' annual options grants and approving an option grant for CEO Ms. Dikla Czaczkes Akselbrad. The meeting will also include a discussion of the financial statements for the fiscal year ended December 31, 2025.

PolyPid Ltd. announced the successful completion of its New Drug Application (NDA) submission to the U.S. FDA for D-PLEX100, its lead product candidate for preventing surgical site infections (SSIs) in colorectal surgery patients. The NDA is supported by positive Phase 3 SHIELD II trial results, which demonstrated a 60% relative risk reduction in SSIs. The company anticipates a potential FDA decision in the first quarter of 2027 under the PDUFA review timeline, with D-PLEX100 having received Breakthrough Therapy, Fast Track, and QIDP designations.

PolyPid initiated its New Drug Application (NDA) submission to the FDA for D-PLEX₁₀₀ for preventing surgical site infections, with completion expected imminently. The company also reported late-stage discussions for a U.S. commercial partnership and scheduled meetings with the EMA for a Marketing Authorization Application (MAA) in Q2 2026. New Phase 3 data showed a 64% relative risk reduction in wound infection severity. For Q1 2026, PolyPid reported a net loss of $7.7 million, or ($0.35) per share, an improvement from $8.3 million, or ($0.70) per share, in Q1 2025. The company also repaid its remaining venture loan and strengthened its cash position through warrant exercises.

PolyPid Ltd. announced it will present detailed analysis of the ASEPSIS score data from its Phase 3 SHIELD II trial of D-PLEX100 at the 45th Annual Meeting of the Surgical Infection Society on May 6, 2026. The analysis demonstrated a statistically significant 64% relative risk reduction in the proportion of patients with clinically significant wound infections (ASEPSIS score > 20). This outcome, alongside the previously reported 60% relative risk reduction in overall SSI incidence, indicates D-PLEX100 not only reduces infections but also lessens their severity, leading to better patient outcomes and significant hospital economic benefits.