PolyPid's D-PLEX₁₀₀ Wins BioTech Breakthrough Award for "Therapeutics Solution of the Year"

Rhea-AI Summary

PolyPid (Nasdaq: PYPD) announced that its lead candidate D-PLEX₁₀₀ won BioTech Breakthrough's Therapeutics Solution of the Year award on Nov 6, 2025. D-PLEX₁₀₀ is a localized, 30-day doxycycline delivery platform aimed at preventing surgical site infections (SSIs).

The company reported Phase 3 SHIELD II results showing a 58% relative risk reduction in SSIs after abdominal colorectal surgery (p<0.005). D-PLEX₁₀₀ holds Breakthrough Therapy, three QIDP and three Fast Track designations from the FDA, and an NDA submission is expected early 2026.

Positive

• Phase 3 SHIELD II: 58% relative risk reduction in SSIs (p<0.005)
• 30-day localized doxycycline release at surgical site
• Holds Breakthrough Therapy, three QIDP and three Fast Track FDA designations
• NDA submission expected early 2026

Negative

• Phase 3 result reported for abdominal colorectal surgery only
• Product is not yet approved; regulatory outcome pending after NDA

PolyPid's Lead Candidate Recognized for Addressing Critical Unmet Need in Surgical Site Infection Prevention Following Positive Phase 3 Results

PETACH TIKVA, Israel, Nov. 06, 2025 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) ("PolyPid" or the "Company"), a late-stage biopharma company focused on improving surgical outcomes, today announced that D-PLEX₁₀₀, the company’s lead candidate, has been named "Therapeutics Solution of the Year" by BioTech Breakthrough, a leading independent market intelligence organization which evaluates and recognizes standout life sciences and biotechnology companies, products and services around the globe.

D-PLEX₁₀₀, powered by PolyPid’s proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology is designed to prevent surgical site infections (SSIs) with extended, localized antibiotic delivery directly at the surgical site. Administered during the surgery, D-PLEX₁₀₀ delivers continuous, targeted release of doxycycline for 30 days, protecting patients during the period of highest vulnerability to infection.

"PolyPid is setting a new standard for SSI prevention. These infections remain among the most common and costly post-operative complications, causing extended hospital stays and higher morbidity rates. Standard antibiotics often fail to reach surgical sites due to disrupted blood supply," said Bryan Vaughn, Managing Director, BioTech Breakthrough. "By addressing one of surgery's most persistent challenges, D-PLEX₁₀₀ delivers better patient outcomes while reducing provider burdens and generating healthcare savings. Congratulations on winning 'Therapeutics Solution of the Year!'"

"We are deeply honored by this recognition, which recognizes the importance of our mission to address one of healthcare's most persistent challenges," said Dikla Czaczkes Akselbrad, Chief Executive Officer of PolyPid. "With SSIs accounting for 20% to 31% of all hospital-acquired infections¹ , D-PLEX₁₀₀ represents a significant breakthrough. Our Phase 3 SHIELD II trial demonstrated a remarkable relative risk reduction of 58% (p< 0.005) in SSIs following abdominal colorectal surgery, addressing a critical gap where current approaches often fall short. At a time when hospitals face complex challenges in both preventing and reporting infections, D-PLEX₁₀₀ has the potential to transform surgical care by directly improving patient outcomes and hospital efficiency through meaningful infection reduction."

D-PLEX₁₀₀ has received Breakthrough Therapy Designation, three QIDP designations, and three Fast Track designations from the U.S. Food and Drug Administration. NDA submission is expected early 2026.

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, the PLEX (Polymer-Lipid Encapsulation matriX) technology 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 58% (p< 0.005) 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 a late-stage biopharma company aiming to improve surgical outcomes. Through locally administered, controlled, prolonged-release therapeutics, PolyPid's proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients (APIs), enabling precise delivery of drugs at optimal release rates over durations ranging from several days to months. Following positive phase 3 results, New Drug Application (NDA) submission of D-PLEX₁₀₀, PolyPid's lead product candidate, for the prevention of abdominal colorectal surgical site infections, is expected in early 2026. In addition, the Company has an innovative pipeline in oncology, obesity and diabetes.

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 D-PLEX₁₀₀ potential to transform surgical care by directly improving patient outcomes and hospital efficiency through meaningful infection reduction, the planned NDA submission for D-PLEX₁₀₀ and timing thereof. 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 26, 2025. 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 

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¹ The Burden of Health Care Utilization, Cost, and Mortality Associated with Select Surgical Site Infections Shambhu, Sonali et al. Joint Commission Journal on Quality and Patient Safety, Volume 50, Issue 12, 857 - 866

FAQ

What did PolyPid announce about D-PLEX₁₀₀ on Nov 6, 2025 (PYPD)?

D-PLEX₁₀₀ won BioTech Breakthrough's Therapeutics Solution of the Year award and PolyPid highlighted Phase 3 results and regulatory designations.

What were the Phase 3 SHIELD II results for D-PLEX₁₀₀ reported by PolyPid (PYPD)?

The SHIELD II trial showed a 58% relative risk reduction in surgical site infections after abdominal colorectal surgery (p<0.005).

What regulatory milestones does D-PLEX₁₀₀ have according to PolyPid (PYPD)?

D-PLEX₁₀₀ has Breakthrough Therapy, three QIDP and three Fast Track designations from the FDA, with an NDA expected early 2026.

How does D-PLEX₁₀₀ deliver antibiotics and for how long (PYPD)?

D-PLEX₁₀₀ is applied during surgery and provides continuous, localized doxycycline release for 30 days at the surgical site.

Does the Phase 3 data for D-PLEX₁₀₀ cover all surgery types (PYPD)?

No; the announced SHIELD II Phase 3 readout specifically addresses outcomes after abdominal colorectal surgery.