PolyPid to Present D-PLEX₁₀₀ Microbiology Data at IDWeek 2026

The exploratory analysis examined bacteria in surgical-site infections that occurred despite preventive treatment.

Rhea-AI Summary

PolyPid (PYPD) will present exploratory pooled D-PLEX₁₀₀ microbiology results at IDWeek on October 22, 2026, showing lower bacterial burden in breakthrough infections.

The analysis covered three randomized trials involving 2,185 patients. Wound bacteria were evaluated in 134 patients with culture-positive surgical-site infections: 51 receiving D-PLEX₁₀₀ plus standard care and 83 receiving standard care alone. Heavy bacterial growth occurred in 16% versus 27% (p=0.034), while infections occurred later: median 10.0 versus 6.5 days (p<0.001). Multidrug-resistant organism proportions were similar; doxycycline resistance did not differ significantly. No statistically significant differences emerged in non-wound infections, systemic antibiotic use or inflammation.

Positive

• Minor pointHeavy bacterial growth occurred in 16% with D-PLEX₁₀₀ plus standard care versus 27% with standard care alone (p=0.034).
• Minor pointBreakthrough surgical-site infections occurred later with D-PLEX₁₀₀: median 10.0 versus 6.5 days with standard care (p<0.001).

Negative

• Minor pointExploratory pooled findings evaluated wound bacteria in 134 patients with culture-positive surgical-site infections.
• Minor pointNon-wound infections, systemic antibiotic use and inflammation showed no statistically significant differences across the pooled population.

Key Figures

Pooled study population: 2,185 patients Culture-positive SSI patients evaluated: 134 patients Heavy bacterial growth: 16% vs. 27%; p=0.034 +1 more

Pooled study population

2,185 patients

Exploratory pooled microbiology analysis

Culture-positive SSI patients evaluated

134 patients

D-PLEX₁₀₀ arm n=51; standard-of-care arm n=83

Heavy bacterial growth

16% vs. 27%; p=0.034

D-PLEX₁₀₀ plus standard of care vs. standard of care alone

Median time to breakthrough SSI

10.0 vs. 6.5 days; p<0.001

D-PLEX₁₀₀ arm vs. standard-of-care arm

Historical Context

1 past event · Latest: Oct 01

1 event

1. Oct 01

   EMA application validation

   24h Move

   +1.9%

   SHIELD II reported a 60% relative risk reduction in surgical-site infection incidence (p=0.0013).

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

surgical-site infections, multidrug-resistant organisms, prophylaxis, antimicrobial resistance

4 terms

surgical-site infections medical

"lower bacterial burden in breakthrough surgical-site infections"

An infection that occurs at or near the site of a surgical incision after an operation, caused by bacteria or other pathogens entering the wound. Clinical classifications distinguish superficial incisional infections (skin and subcutaneous tissue), deep incisional infections (deeper soft tissue or muscle), and organ/space infections (the body cavity or organ worked on). For regulatory and surveillance purposes these are usually counted if they appear within 30 days of the procedure, or within 90 days to one year when an implant or prosthesis is involved, depending on the reporting standard.

multidrug-resistant organisms medical

"similar proportions of multidrug-resistant organisms between treatment groups"

Microorganisms—most commonly bacteria, and sometimes fungi—that are not killed or inhibited by multiple classes of antimicrobial drugs. Regulatory and clinical definitions generally identify an organism as multidrug-resistant when it shows non‑susceptibility to at least one agent in three or more antimicrobial categories, which means standard drug regimens are unlikely to work and alternative therapies or infection‑control measures are required.

prophylaxis medical

"infections that occur despite prophylaxis"

Prophylaxis is a medical prevention strategy — a drug, vaccine, device, or procedure given to stop a disease or condition before it starts. For investors, prophylactic products matter because they can create steady, large markets and reduce long‑term healthcare costs; regulatory approval or broader adoption can change demand forecasts much like a new safety feature that becomes standard across an entire industry.

antimicrobial resistance medical

"as antimicrobial resistance is a first-order global health threat"

Antimicrobial resistance is when microbes such as bacteria, viruses or fungi evolve so that medicines meant to kill them no longer work — like a lock changing so the old key no longer fits. For investors, this increases demand and cost for new treatments, prolongs hospital stays, prompts tougher regulation and can shrink sales of once-effective drugs, affecting pharmaceutical revenues, R&D spending and broader healthcare risk.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Analysis demonstrates a lower bacterial burden in breakthrough surgical-site infections, with similar proportions of multidrug-resistant organisms between treatment groups

PETACH TIKVA, Israel, Oct. 21, 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 it will present an oral presentation at IDWeek 2026 on Thursday, October 22, 2026, in Washington, D.C. The presentation will focus on an exploratory pooled analysis of microbiology from SHIELD I, SHIELD II, and D-PLEX₁₀₀ phase 2 trial involving 2,185 patients, demonstrating a lower bacterial burden in breakthrough surgical-site infections (“SSIs”) and later occurrence of breakthrough SSIs in the D-PLEX₁₀₀ treatment arm compared to standard of care (“SoC”), with similar proportions of multidrug-resistant organisms between treatment groups.

The presentation, titled "D-PLEX₁₀₀ Lowers the Microbial Burden Without Selecting for Multidrug-Resistant Bacteria: Pooled Microbiology from Three Randomized Trials (N=2,185)," will be delivered by George M. Viola, M.D., M.P.H., Department of Infectious Diseases, Infection Control, and Employee Health, Division of Internal Medicine, the University of Texas MD Anderson Cancer Center, Houston, Texas. Co-authors are Nurit Tweezer-Zaks, M.D., M.B.A., and Meidan Dvir, Ph.D.

The analysis pooled a Phase 2 trial and two Phase 3 trials to examine the bacteria present in SSIs that occurred despite preventive treatment. Wound microbiology was evaluated in 134 patients (D-PLEX₁₀₀ arm n=51, SoC arm n=83) with culture-positive SSIs. Heavy bacterial growth was less frequent with D-PLEX₁₀₀ plus standard of care than with SoC alone (16% versus 27%, p=0.034) while breakthrough SSIs occurred later in the D-PLEX₁₀₀ arm compared to the SoC (median 10.0 vs 6.5 days; p<0.001). The proportions of multidrug-resistant organisms were similar between groups, and the difference in doxycycline resistance was not statistically significant.

Across the pooled study population, no statistically significant differences were observed in non-wound infections, systemic antibiotic use, or inflammation.

"Preventing surgical-site infections remains our primary objective. Part of infection prevention is understanding the microbiology of infections that occur despite prophylaxis. This matters even more as antimicrobial resistance is a first-order global health threat¹. This exploratory pooled analysis showed that compared with standard of care alone, treatment with D-PLEX₁₀₀ was associated with lower burden of bacterial growth, without evidence of increased antimicrobial resistance. Together with the later recorded onset of breakthrough SSIs, these findings suggest that D-PLEX₁₀₀ do not only demonstrate a relative risk reduction by 60% in the postoperative infection as seen in the SHIELD II trial, but also favourably impact the microbiologic characteristics and severity of infections that emerge despite treatment" said Dikla Czaczkes Akselbrad, Chief Executive Officer of PolyPid.

Presentation Details
Presentation Title: D-PLEX₁₀₀ Lowers the Microbial Burden Without Selecting for Multidrug-Resistant Bacteria: Pooled Microbiology from Three Randomized Trials (N=2,185)
Abstract Number: LB-2201.6
Presenter: George M. Viola, M.D., M.P.H., Department of Infectious Diseases, Infection Control, and Employee Health, Division of Internal Medicine, the University of Texas MD Anderson Cancer Center, Houston, Texas
Session: Late Breaking Abstracts: Antimicrobials
Session Type: Oral Presentation
Session Date/Time: Thursday, October 22, 2026 | 10:30 a.m. - 11:45 a.m. ET
Location: Room 206, Walter E. Washington Convention Center, Washington, D.C.

The abstract will be available on www.polypid.com once the conference concludes.

About D-PLEX₁₀₀
D-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-PLEX₁₀₀ into 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-PLEX₁₀₀ recently 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-PLEX₁₀₀ received Breakthrough Therapy designation from the U.S. Food and Drug Administration for the prevention of SSIs in patients undergoing elective colorectal surgery.

About PolyPid
PolyPid 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 raises the standard of patient care. For additional Company information, please visit http://www.polypid.com and follow us on Twitter (X) and LinkedIn.

Forward-looking Statements
This 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 implications of the exploratory pooled microbiology findings, the potential role of D-PLEX₁₀₀ in improving the prevention of surgical site infections, and its potential implications for antimicrobial resistance, as well as the Company's ongoing regulatory review process for D-PLEX₁₀₀. 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. These risks and uncertainties include, among others, that the pooled microbiology findings are exploratory; that they come from the culture-positive SSI subset; that wound-culture comparisons were not significant after multiplicity adjustment; that the presentation does not constitute a new primary efficacy result; and that the Company’s NDA remains under FDA review. 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 Warshavsky
908-858-5995
IR@Polypid.com

Investor Relations Contact:
Arx Investor Relations
North American Equities Desk
polypid@arxhq.com

¹ World Health Organization. Antimicrobial resistance. Fact sheet. Bacterial AMR was estimated to be associated with more than 4.7 million deaths globally in 2021. https://www.who.int/news-room/fact-sheets/detail/antimicrobial-resistance. Citing GBD 2021 Antimicrobial Resistance Collaborators. Lancet. 2024;404(10459):1199-1226.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did PolyPid's pooled D-PLEX₁₀₀ microbiology analysis show?

Heavy bacterial growth was less frequent with D-PLEX₁₀₀ plus standard care than with standard care alone: 16% versus 27% (p=0.034). Breakthrough surgical-site infections also occurred later, at a median of 10.0 versus 6.5 days (p<0.001). The findings came from an exploratory pooled analysis.

Did PolyPid's D-PLEX₁₀₀ analysis show increased antibiotic resistance?

The proportions of multidrug-resistant organisms were similar between treatment groups, and the difference in doxycycline resistance was not statistically significant. The analysis examined bacteria in surgical-site infections that occurred despite preventive treatment.

Which trials were included in PolyPid's pooled D-PLEX₁₀₀ microbiology analysis?

The analysis combined SHIELD I, SHIELD II and a D-PLEX₁₀₀ Phase 2 trial. It pooled one Phase 2 trial and two Phase 3 trials to examine bacteria in surgical-site infections occurring despite preventive treatment.