PolyPid to present phase 3 SHIELD II trial results at ACS congress

Published 30/09/2025, 13:58
PolyPid to present phase 3 SHIELD II trial results at ACS congress

PETACH TIKVA, Israel - PolyPid Ltd. (NASDAQ:PYPD), a clinical-stage pharmaceutical company with a market capitalization of $52 million, will present topline results from its Phase 3 SHIELD II trial of D-PLEX at the American College of Surgeons Clinical Congress in Chicago on Sunday, October 5, 2025, the company announced Tuesday. According to InvestingPro data, the company maintains a strong liquidity position with more cash than debt on its balance sheet.

Dr. Shmuel Sharoni will deliver the presentation titled "Efficacy Of A Novel Local Prolonged-release Incisional Doxycycline On Surgical Site Infection Prophylaxis In Abdominal Colorectal Surgery: The Shield II Phase 3 Randomized Clinical Trial" during the high-impact clinical trials session at 11:30 AM CT.

According to the press release, the SHIELD II trial met its primary and key secondary efficacy endpoints. The study showed that D-PLEX, when used alongside standard of care, achieved a 38% reduction in the combined endpoint of surgical site infections, reinterventions, or mortality compared to standard of care alone. The trial also demonstrated a 58% reduction in surgical site infections in the D-PLEX treatment arm. Despite these positive results, InvestingPro analysis shows that four analysts have recently revised their earnings expectations downward for the upcoming period.

PolyPid describes D-PLEX as a locally administered, controlled, prolonged-release therapeutic utilizing the company’s PLEX technology, which pairs with active pharmaceutical ingredients to enable precise drug delivery.

The company expects to submit a New Drug Application for D-PLEX for the prevention of abdominal colorectal surgical site infections in early 2026.

The 2025 ACS Clinical Congress will take place at McCormick Place in Chicago from October 4-7.

In other recent news, PolyPid Inc. reported its second-quarter 2025 earnings, revealing a larger net loss than anticipated. The company’s earnings per share (EPS) were -$0.78, falling short of the forecasted -$0.57. This earnings report highlights a significant deviation from analysts’ expectations, which is a crucial aspect for investors to consider. Despite the earnings miss, the market reaction was relatively subdued. Analysts and investors will likely scrutinize these results to assess the company’s financial health and future prospects. The earnings report did not significantly impact the company’s stock price, as it showed only minor fluctuations during trading. PolyPid’s financial performance in this quarter will be an important factor for stakeholders to monitor in the coming months.

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