PolyPid Regains European Commercialization Rights for D-PLEX₁₀₀, Expanding Global Commercialization Opportunities

PolyPid now holds the European rights alongside its established North American commercialization partnership with Azurity Pharmaceuticals.

Rhea-AI Summary

PolyPid (PYPD) has regained exclusive European commercialization rights for D-PLEX₁₀₀ following the mutually agreed termination of its agreement with ADVANZ PHARMA.

The terminated 2022 agreement covered licensing, distribution and supply in Europe. PolyPid has completed its Phase 3 SHIELD II trial, its New Drug Application submission to the US Food and Drug Administration and its EMA submission. D-PLEX₁₀₀ met the trial’s primary and all key secondary endpoints for preventing surgical site infections. PolyPid also established a North American commercialization partnership with Azurity Pharmaceuticals. The company believes these milestones make D-PLEX₁₀₀ attractive to multinational pharmaceutical companies for Europe and other large markets.

4 points · 1 major

PositiveiHow this balance works

How this balance works

Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.

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Rhea-AI Sentiment measures something else, the tone of the wording.

How the balance worksHow Sentiment works

0 major · 1 point

How the balance works

Positive

• Major pointPhase 3 SHIELD II met its primary and all key secondary endpoints for preventing surgical site infections.
• Moderate pointExclusive European commercialization rights for D-PLEX₁₀₀ have reverted to PolyPid.
• Moderate pointUS New Drug Application submission and EMA submission have been completed.
• Moderate pointNorth American commercialization partnership with Azurity Pharmaceuticals has been established.

Negative

• Minor pointADVANZ PHARMA agreement covering European licensing, distribution and supply has ended by mutual agreement.

Historical Context

1 past event · Latest: Jul 21

1 event

1. Jul 21

   Commercial partnership

   24h Move

   -27.4%

   Azurity received exclusive U.S. and Canada rights, while PolyPid retained rights outside those territories.

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

Key Terms

nda, phase 3, surgical site infection

3 terms

nda regulatory

"completion of our New Drug Application (“NDA”) submission"

An NDA, or nondisclosure agreement, is a legal contract that keeps certain information private between parties. It’s like a promise not to share sensitive details, helping protect business ideas, strategies, or data from being leaked or used without permission. For investors, NDAs help ensure that confidential information remains secure, enabling trust and open communication during business discussions.

phase 3 medical

"successful completion of our Phase 3 SHIELD II trial"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

surgical site infection medical

"for the prevention of surgical site infections"

An infection that develops at or near the site of a surgical incision within the time period tied to the operation (commonly within 30 days of surgery, or within 90 days if a prosthetic implant is involved) and that affects the skin and subcutaneous tissue, deeper soft tissues, or an organ/space opened or manipulated during the procedure. Public-health and clinical definitions classify surgical site infections as superficial incisional, deep incisional, or organ/space infections; diagnosis relies on local signs (redness, pain, drainage), systemic findings, and often microbiological culture or imaging.

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

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PETACH TIKVA, Israel, Oct. 01, 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 PolyPid and ADVANZ PHARMA have mutually agreed to terminate their 2022 exclusive License, Distribution and Supply Agreement for D-PLEX₁₀₀ in Europe. As a result, the exclusive European commercialization rights for D-PLEX₁₀₀ have reverted to PolyPid.

"We appreciate the collaboration with the ADVANZ PHARMA team over the past several years and thank them for working with us to reach a mutually agreeable conclusion," said Dikla Czaczkes Akselbrad, Chief Executive Officer of PolyPid. "Since entering into the original agreement in 2022, several transformative milestones have been achieved, including the successful completion of our Phase 3 SHIELD II trial, completion of our New Drug Application (“NDA”) submission to the US Food and Drug Administration (“FDA”), our EMA submission, and the establishment of our recently announced North American commercialization partnership with Azurity Pharmaceuticals . We believe that this makes D-PLEX₁₀₀ a highly attractive opportunity for multinational pharmaceutical companies looking to enhance their product portfolio in the surgical site infection space in Europe and other large markets.”

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 raise 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 its plans and expectations regarding the future commercialization of D-PLEX₁₀₀ in Europe following the termination of the ADVANZ PHARMA agreement, its evaluation of potential commercialization opportunities, the continued advancement of D-PLEX₁₀₀ toward potential regulatory approval and commercialization, and the potential role of D-PLEX₁₀₀ in improving surgical outcomes and addressing the burden 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 Warshavsky
908-858-5995
IR@Polypid.com

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

FAQ

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Who now holds European commercialization rights for PolyPid’s D-PLEX₁₀₀?

PolyPid holds the exclusive European commercialization rights for D-PLEX₁₀₀. The rights reverted to the company after PolyPid and ADVANZ PHARMA mutually agreed to terminate their 2022 License, Distribution and Supply Agreement.