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PolyPid to Present New Phase 3 SHIELD II Data Demonstrating D-PLEX₁₀₀ Sustained Local Release at ESCMID Global 2026

Key Takeaway: PolyPid Ltd. announced it will present new pharmacokinetic data from the Phase 3 SHIELD II trial for D-PLEX100 at the ESCMID Global 2026. The data shows a sustained release of doxycycline for up to 763 hours with minimal systemic exposure. This highlights D-PLEX100's potential to effectively prevent surgical site infections during critical post-surgical periods.
Price reaction · baseline $4.31 (2026-04-10 close) · hit pre-market · 1 other PYPD headline(s) in the window, move may be shared
day 0 close · peak
+2.1%

Market Sentiment Analysis

POSITIVE FACTORS

  • D-PLEX100 shows sustained release of doxycycline for up to 763 hours.
  • Minimal systemic exposure indicates safety compared to oral doxycycline.
  • The product received Breakthrough Therapy designation from the FDA.
  • Positive results in Phase 3 SHIELD II trial with significant SSI reduction.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+50%
120-day peak, hindsight
Typical move
4.8%
average across 4 past catalysts
Lead asset
D-PLEX
Phase 3 · Surgical Site Infection

Full Press Release Details

PETACH TIKVA, Israel, April 13, 2026 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), an innovative biopharmaceutical company dedicated to improving patient outcomes by elevating treatment effectiveness, right where care begins, today announced that the Company will present new pharmacokinetic data from the Phase 3 SHIELD II trial evaluating D-PLEX₁₀₀ at the Congress of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Global 2026 (formerly known as ECCMID), the world’s leading congress for clinical microbiology and infectious diseases, taking place on April 17-21, 2026, in Munich, Germany.
The abstract titled “Pharmacokinetics of local extended-release incisional doxycycline in patients undergoing abdominal colorectal surgery from the SHIELD II Phase 3 clinical trial,” was co-authored by Prof. Antonino Spinelli, Director of the Division of Colon and Rectal Surgery and a Professor of Surgery at Humanitas University, in Milan, Italy and PolyPid.

Key findings from the SHIELD II analysis:

Sustained and controlled release profile:Detectable doxycycline concentrations were observed for up to 763 hours (approximately 32 days), with no burst, following local application of D-PLEX₁₀₀ during surgery.
Figure 1. Mean (+ standard deviation) plasma doxycycline concentration versus time profile
Minimal systemic exposure:Plasma doxycycline concentrations remained below 100 ng/mL, indicating negligible systemic levels relative to oral doxycycline administration where Cmaxlevels are approximately 16 to 26 times higher (1,613.3 ng/mL for 100 mg1and 2,600 ng/mL for 200 mg2doses).
“These pharmacokinetic results further support the mechanism of D-PLEX₁₀₀, which is designed to deliver sustained and controlled antibiotic exposure for 30 days directly at the surgical incision site,” said Dikla Czaczkes Akselbrad, Chief Executive Officer of PolyPid. “The findings reinforce the potential of D-PLEX₁₀₀ to address a key limitation of conventional systemic prophylactic antibiotics by maintaining local antimicrobial activity during the critical 30 days post-surgical period when infections most commonly develop.”

ESCMID Global 2026Presentation Details

Poster Title: Pharmacokinetics of Local Extended-Release Incisional Doxycycline in Patients undergoing Abdominal Colorectal Surgery from the SHIELD II Phase 3 Clinical Trial
Presenter: Eyal Shoshani, VP Clinical Affairs, PolyPid Ltd.
Lead Author: Prof. Antonino Spinelli, Humanitas University and IRCCS Humanitas Research Hospital, Milan, Italy
Poster Details: #P2740 (Presented at: Poster Hall B3)
Session: 05b. Pharmacokinetics/pharmacodynamics of antibacterial drugs & therapeutic drug monitoring
Date/Time: Sunday, April 19, 2026 | 12:00 – 13:30 CEST
The abstract will be available onwww.polypid.comonce the conference concludes.
About D-PLEX100D-PLEX100, PolyPid’s lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent surgical site infections (“SSIs”). Following the administration of D-PLEX100into the surgical site, PolyPid’s delivery technology, Kynatrix, pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in a high local concentration of the drug for a period of 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100recently demonstrated positive results in the Phase 3 SHIELD II trial, achieving a statistically significant 60% (p=0.0013) relative risk reduction in SSI incidence following abdominal colorectal surgery with large incisions. D-PLEX100received Breakthrough Therapy designation from the U.S. Food and Drug Administration for the prevention of SSIs in patients undergoing elective colorectal surgery.
About PolyPidPolyPid Ltd. (Nasdaq:PYPD) is an innovative biopharmaceutical company dedicated to elevating treatment effectiveness, right where care begins. The Company develops long-acting, controlled-release drugs designed to deliver therapy precisely at the site of care, addressing critical unmet medical needs across a wide and diverse pipeline spanning surgical care, metabolic diseases, and beyond. PolyPid’s lead product, D-PLEX₁₀₀, successfully met its primary and all key secondary endpoints in the landmark Phase 3 SHIELD II trial for the prevention of surgical site infections. Guided by a commitment to precision and innovation, PolyPid is redefining how therapies perform and raise the standard of patient care. For additional Company information, please visithttp://www.polypid.comand follow us onTwitter (X)and LinkedIn.
Forward-looking StatementsThis press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses the potential mechanism and benefits of D-PLEX₁₀₀, including its ability to deliver sustained and controlled antibiotic exposure for 30 days directly at the surgical incision site, and the potential role of D-PLEX₁₀₀ in improving the prevention of surgical site infections. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission, including, but not limited to, the risks detailed in the Company’s Annual Report on Form 20-F filed on February 25, 2026. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. PolyPid is not responsible for the contents of third-party websites.

Company Contact:PolyPid Ltd.Ori Warshavsky908-858-5995IR@Polypid.com

Investor Relations Contact:Arx Investor RelationsNorth American Equities Deskpolypid@arxhq.com

1Gschwend MH, Martin W, Erenmemişoğlu A, et. al.. Pharmacokinetics and Bioequivalence Study of Doxycycline Capsules in Healthy Male Subjects. Arzneimittelforschu 2007;57(6):347-512Vibramycin (doxycycline hyclate) [capsules]: Full Prescribing Information. New York, NY: Pfizer Labs; August 2025.

Frequently Asked Questions

What is D-PLEX100 designed for?

D-PLEX100 is designed to provide local prolonged and controlled antibacterial activity at surgical sites to prevent surgical site infections.

What were the key findings from the SHIELD II trial?

The SHIELD II trial found D-PLEX100 had a sustained release of doxycycline for 763 hours with minimal systemic exposure.

When will the data be presented?

The new pharmacokinetic data will be presented at the ESCMID Global 2026 from April 17-21, 2026.

What designation did D-PLEX100 receive from the FDA?

D-PLEX100 received Breakthrough Therapy designation from the FDA for preventing surgical site infections.

Last updated: Apr 13, 2026