PolyPid (Nasdaq: PYPD) signs 20-year D-PLEX100 commercialization deal

Rhea-AI Filing Summary

PolyPid Ltd. entered into a 20-year exclusive License and Supply Agreement with Azurity Pharmaceuticals Ireland Ltd., granting Azurity rights to commercialize D-PLEX100 in the United States and Canada. PolyPid will receive an upfront payment of $15 million on execution and a further near-term milestone of $15 million upon expected U.S. FDA acceptance of the D-PLEX100 New Drug Application. PolyPid is also eligible for up to approximately $300 million in additional regulatory, development and sales-based milestone payments. Upon commercialization, PolyPid will manufacture and supply D-PLEX100 to Azurity for a transfer price and receive tiered royalties ranging from mid-teen to mid-twenties percentages. The parties may collaborate on label expansions for additional surgical site infection indications, with Azurity funding related development, while PolyPid retains rights outside the Territory, global manufacturing, and full ownership of its PLEX/Kynatrix platform.

Positive

• PolyPid secured a long-term commercialization partnership for D-PLEX100 with $15 million upfront, a $15 million near-term NDA acceptance milestone, and eligibility for up to approximately $300 million in additional milestones plus tiered royalties.

Negative

• None.

Filing Explained

Azurity has exclusive U.S. and Canadian rights; PolyPid has a due upfront payment, while commercialization and the FDA milestone remain future-dependent.

As a Form 6-K, this report furnishes material interim information: effective July 17, 2026, PolyPid entered a 20-year agreement giving Azurity exclusive U.S. and Canadian commercialization rights for D-PLEX100.

The filing describes a signed licensing arrangement, not a completed launch or FDA approval; PolyPid retains rights outside those countries and worldwide manufacturing rights.

The $15 million upfront is due upon execution, while another $15 million is payable upon FDA acceptance expected in August 2026; the filing does not report either payment as received.

The additional approximately $300 million in milestones is eligibility rather than committed proceeds, and royalties apply upon commercialization.

The press release targets a first-quarter 2027 launch but expressly conditions commercialization on approval; possible label expansion remains subject to a future agreement, with Azurity funding those programs.

Key Figures

Upfront payment: $15 million NDA acceptance milestone: $15 million Additional milestone potential: Up to approximately $300 million +3 more

6 metrics

Upfront payment $15 million Due upon execution of the License and Supply Agreement dated July 17, 2026

NDA acceptance milestone $15 million Payable upon U.S. FDA acceptance of the D-PLEX100 New Drug Application, expected in August 2026

Additional milestone potential Up to approximately $300 million Regulatory, development and sales-based milestone payments under the Azurity partnership

Agreement term 20 years License and Supply Agreement term measured from the Effective Date of July 17, 2026

Tiered royalty range Mid-teen to mid-twenties percentages Royalties on D-PLEX100 sales in the U.S. and Canada payable to PolyPid

Relative risk reduction in SSIs 60% Secondary endpoint reduction in SSI incidence in Phase 3 SHIELD II trial (p = 0.0013)

Key Terms

License and Supply Agreement, New Drug Application, tiered royalties, surgical site infections, +2 more

6 terms

License and Supply Agreement regulatory

"entered into a License and Supply Agreement (the “Agreement”) with Azurity"

New Drug Application regulatory

"payable upon U.S. Food and Drug Administration acceptance of the Product New Drug Application"

A new drug application is a formal request submitted to government regulators seeking approval to market a new medicine. It is like a detailed proposal that shows the drug has been tested for safety and effectiveness. For investors, receiving approval signals that the drug may soon become available for sale, potentially leading to revenue growth and impacting the company's value.

tiered royalties financial

"will be entitled to tiered royalties ranging from mid-teen to mid-twenties percentages"

Tiered royalties are a payment structure where the percentage of earnings paid as royalties changes based on different levels of sales or production. For example, a company might pay a smaller percentage on initial sales and a higher percentage as sales increase beyond certain points. This system encourages higher sales by adjusting payments, making it important for investors to understand how revenue sharing may vary as a product or project grows.

surgical site infections medical

"for the prevention of surgical site infections (“SSIs”)"

Surgical site infections are infections that occur where a surgical cut was made, caused by bacteria or other germs entering the wound during or after an operation. They matter to investors because higher infection rates can increase hospital costs, lead to regulatory action, product recalls, lawsuits, and damaged reputations—similar to how a manufacturing defect forces costly recalls and repairs—so they affect revenue, margins, and risk for companies in healthcare and medical products.

Breakthrough Therapy Designation regulatory

"D-PLEX100 received Breakthrough Therapy Designation from the U.S. Food and Drug Administration"

A breakthrough therapy designation is a regulatory fast-track given to a drug or treatment that shows early signs of providing a major improvement over existing options for a serious condition. Think of it as a VIP lane that can speed up development and more intensive guidance from regulators, which matters to investors because it can shorten time to market, reduce development risk and potentially increase a company’s value — though it does not guarantee approval.

relative risk reduction medical

"achieving its primary end point and a 60% (p= 0.0013) relative risk reduction"

Relative risk reduction measures how much a treatment or action lowers the chance of an outcome compared with no treatment, expressed as a percentage. If 10 out of 100 people in a control group experience an event and 5 out of 100 do with the treatment, the relative risk reduction is 50%. Investors use it to gauge headline effectiveness but should also check the actual change in event rates and the study size, since percentages can overstate real-world impact.

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

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FAQ

What agreement did PolyPid (PYPD) sign with Azurity for D-PLEX100?

PolyPid signed a 20-year exclusive License and Supply Agreement granting Azurity rights to commercialize D-PLEX100 in the U.S. and Canada, while PolyPid manufactures the product and receives transfer pricing plus tiered royalties.

How much upfront and near-term cash could PolyPid (PYPD) receive from the Azurity deal?

PolyPid will receive an upfront payment of $15 million at signing and a near-term milestone of $15 million upon U.S. FDA acceptance of the D-PLEX100 NDA, providing substantial non-dilutive funding tied to regulatory progress.

What is the total milestone potential for PolyPid (PYPD) in the Azurity partnership?

Beyond the initial milestones, PolyPid is eligible to receive up to approximately $300 million in additional regulatory, development and sales-based milestone payments, creating significant long-term revenue potential if D-PLEX100 advances and commercial performance meets agreed thresholds.

What royalties will PolyPid (PYPD) earn from D-PLEX100 sales under the Azurity deal?

Upon commercialization, PolyPid will supply D-PLEX100 to Azurity and earn tiered royalties ranging from mid-teen to mid-twenties percentages on sales in the U.S. and Canada, adding ongoing revenue on top of milestones.

Does PolyPid (PYPD) retain rights to D-PLEX100 and its PLEX platform outside North America?

Yes. PolyPid retains global commercial rights to D-PLEX100 outside the U.S. and Canada, maintains worldwide manufacturing rights, and keeps full ownership of its PLEX platform and Kynatrix technology and associated pipeline assets.

How effective was D-PLEX100 in PolyPid’s (PYPD) Phase 3 SHIELD II trial?

In the Phase 3 SHIELD II trial, D-PLEX100 achieved its primary endpoint and showed a 60% relative risk reduction in surgical site infection incidence at a key secondary endpoint (p = 0.0013) following abdominal colorectal surgery with large incisions.

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the Month of: July 2026 (Report No. 2)

Commission File Number: 001-38428

PolyPid Ltd.

(Translation of registrant’s name into English)

18 Hasivim Street

Petach Tikva 495376, Israel

(Address of principal executive office)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:

☒ Form 20-F          ☐ Form 40-F

CONTENTS

On July 17, 2026 (the “Effective Date”), PolyPid Ltd. (the “Company”) entered into a License and Supply Agreement (the “Agreement”) with Azurity Pharmaceuticals Ireland Ltd. (“Azurity”), pursuant to which Company granted the exclusive right to Azurity to commercialize the Company’s product D-PLEX₁₀₀ (the “Product”) in the United States of America and Canada (the “Territory”). The term of the Agreement expires 20 years after the Effective Date. The Agreement is also terminable by either party under certain limited circumstances.

Under the terms of the Agreement, the Company is entitled to receive an upfront payment of $15 million due upon the execution of the Agreement and an additional near-term milestone payment of $15 million payable upon U.S. Food and Drug Administration acceptance of the Product New Drug Application, which is expected in August 2026. The Company is eligible to receive up to approximately $300 million in additional regulatory, development and sales-based milestone payments. Upon commercialization, the Company will manufacture and supply the Product to Azurity for a transfer price and will be entitled to tiered royalties ranging from mid-teen to mid-twenties percentages.

In addition to the upfront and milestone payments, as part of the collaboration, the parties may agree to jointly pursue potential label expansion of the Product in the Territory into additional surgical site infections indications beyond abdominal, with Azurity providing funding for these additional clinical development programs. The Company will retain global commercial rights to the Product outside of the Territory, manufacturing rights worldwide, and full ownership of its PLEX platform, Kynatrix™ technology and associated pipeline assets.

Attached hereto as Exhibit 99.1 and incorporated herein is the Company’s press release issued on July 21, 2026, titled “PolyPid Announces Exclusive Partnership with Azurity Pharmaceuticals for the Commercialization of D-PLEX₁₀₀ in the U.S. and Canada.”

Forward-Looking Statements

This Report of Foreign Private Issuer on Form 6-K (this “Form 6-K”) contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. For example, the Company is using forward-looking statements when it discusses the expected acceptance of the Product New Drug Application and timing thereof, the Company’s eligibility to receive up to approximately $300 million in additional regulatory, development and sales-based milestone payments and that the parties may agree to jointly pursue potential label expansion of the Product in the Territory into additional surgical site infections indications beyond abdominal. All statements other than statements of historical facts included in this Form 6-K are forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on the Company’s current beliefs, expectations and assumptions regarding the future of its business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of the Company’s control. The Company’s actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these 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. The Company undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

The paragraphs above (and not Exhibit 99.1) are incorporated by reference into the Company’s registration statements on Form F-3 (File No. 333-257651, File No. 333-276826, File No. 333-280658, File No. 333-281863, File No. 333-284376 and File No. 333-289034) and Form S-8 (File No. 333-239517, File No. 333-271060, File No. 333-277703, File No. 333-280662 and File No. 333-289570), filed with the Securities and Exchange Commission, to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.

1

EXHIBIT INDEX

Exhibit No.
10.1*		License and Supply Agreement, dated July 17, 2026, by and between PolyPid Ltd. and Azurity Pharmaceuticals Ireland Ltd.
99.1		Press release issued by PolyPid Ltd. on July 21, 2026, titled “PolyPid Announces Exclusive Partnership with Azurity Pharmaceuticals for the Commercialization of D-PLEX₁₀₀ in the U.S. and Canada.”

* Certain identified information in the exhibit has been excluded from the exhibit because it is both (i) not material and (ii) is the type that the Company treats as private or confidential.

2

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

	POLYPID LTD.
Date: July 21, 2026	By:	/s/ Dikla Czaczkes Akselbrad
		Name	Dikla Czaczkes Akselbrad
		Title:	Chief Executive Officer

3

Exhibit 99.1

PolyPid Announces Exclusive Partnership with Azurity Pharmaceuticals for the Commercialization of D-PLEX₁₀₀ in the U.S. and Canada

● PolyPid to potentially receive over $320 million in upfront and milestone payments, including $30 million in upfront and near-term milestone payments, plus tiered royalties ranging from mid-teen to mid-twenties percentages

● Azurity, a private global pharmaceutical company, to commercialize D-PLEX100 upon approval in the U.S. and Canada for the prevention of surgical site infections, leveraging its first-in-class commercial model. PolyPid to manufacture and supply D-PLEX100

● Azurity will also fund clinical development of D-PLEX100, supporting the potential label expansion in the U.S. and Canada beyond SSI indications for abdominal surgery

● Partnership follows positive Phase 3 SHIELD II results, demonstrating achievement of the primary endpoint and a 60% relative risk reduction at the secondary endpoint in SSI incidence, with PolyPid’s NDA submission to the FDA recently completed

● U.S. launch targeted for the first quarter of 2027

PETACH TIKVA, Israel, July 21, 2026 -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), an innovative biopharmaceutical company dedicated to elevating treatment effectiveness, right where care begins, today announced that it has entered into an exclusive commercial partnership agreement (the “Agreement”) with Azurity Pharmaceuticals (“Azurity”), a privately held specialty pharmaceutical company, for the commercialization of D-PLEX100 in the United States and Canada for the prevention of surgical site infections (“SSIs”).

Under the terms of the Agreement, PolyPid will receive an upfront payment of $15 million due upon signing and an additional near-term milestone payment of $15 million payable upon U.S. Food and Drug Administration (“FDA”) acceptance of the D-PLEX₁₀₀ New Drug Application (“NDA”), which is expected in August 2026. PolyPid is eligible to receive up to approximately $300 million in additional regulatory, development, and sales-based milestone payments. Upon commercialization, the Company will manufacture and supply D-PLEX₁₀₀ to Azurity for a transfer price and will be entitled to tiered royalties ranging from mid-teen to mid-twenties percentages.

In addition to the upfront and milestone payments, as part of the collaboration, the parties may agree to jointly pursue potential label expansion of D-PLEX₁₀₀ in the U.S. and Canada into additional SSI indications beyond abdominal, with Azurity providing funding for these additional clinical development programs. PolyPid will retain global commercial rights to D-PLEX100 outside of the U.S. and Canada, manufacturing rights worldwide, and full ownership of its PLEX platform, Kynatrix™ technology and associated pipeline assets.

“This partnership is a defining step in PolyPid’s transition into a commercial-stage company, and Azurity is the right partner to bring D-PLEX100 to U.S. and Canadian patients, hospitals and surgeons,” said Dikla Czaczkes Akselbrad, Chief Executive Officer of PolyPid. “We believe that Azurity’s first-in-class commercial model and demonstrated commercial execution will be invaluable in expanding access to D-PLEX100, if approved. Importantly, this collaboration represents a meaningful validation of our unique platform, and allows us to fully realize the U.S. and Canadian commercial value of D-PLEX100 while putting us in a position of financial strength to continue investing in our Kynatrix technology, pipeline, and the next generation of therapies.”

“At Azurity, we believe meaningful innovation is measured by the difference a therapy makes in the realities of patient care,” said Ronald Scarboro, Chief Executive Officer of Azurity Pharmaceuticals. “D-PLEX₁₀₀ is a differentiated therapy addressing an important unmet need, and we are excited to partner with PolyPid to help bring it to patients in the United States and Canada, if approved. Our commercial model was built to support specialized therapies like this-connecting the right treatment to the right healthcare professionals and patients through efficient, focused execution. Together, we believe we can expand access to an important new option while exploring opportunities to broaden its impact in the years ahead.”

Confidential

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 with the goal of preventing abdominal surgical site infections (“SSIs”). Following the administration of D-PLEX₁₀₀ into the surgical site, PolyPid’s delivery technology, Kynatrix, is designed to pair 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. In the Phase 3 SHIELD II trial, D-PLEX₁₀₀ recently demonstrated positive results in achieving its primary end point and a 60% (p= 0.0013) relative risk reduction at the secondary end point 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 raise the standard of patient care. For additional Company information, please visit http://www.polypid.com and follow us on Twitter (X) and LinkedIn.

About Azurity Pharmaceuticals

Azurity Pharmaceuticals is a privately held global pharmaceutical company dedicated to redefining medicine for the real world. Azurity’s first-in-class enterprise model challenges the status quo by rethinking how therapies are designed, delivered, and accessed. With more than 50 medicines across 10 therapeutic areas, Azurity’s mission is fueled by a growing portfolio that reaches millions of people in more than 50 countries. Learn more at www.azurity.com

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 and Azurity are using forward-looking statements when discussing the potential benefits, terms and structure of the exclusive commercial partnership between PolyPid and Azurity; the timing, receipt and amount of upfront, regulatory, development and sales-based milestone payments and royalties; the timing of FDA acceptance and potential approval of the NDA for D-PLEX₁₀₀; the anticipated timing of a U.S. commercial launch of D-PLEX₁₀₀, including the target of the first quarter of 2027; the potential for label expansion of D-PLEX₁₀₀ into indications beyond abdominal colorectal surgery and the funding of related clinical development; the ability to successfully commercialize D-PLEX₁₀₀, if approved, in the U.S. and Canada; the therapeutic and commercial potential of D-PLEX₁₀₀, including its ability to reduce the incidence of SSIs and that D-PLEX₁₀₀ is a differentiated therapy addressing an important unmet need. 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 and Azurity assume 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 or Azurity do update one or more forward-looking statements, no inference should be drawn that the Company or Azurity 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 and Azurity are not responsible for the contents of third-party websites.

PolyPid Investor Relations and Media Contacts

Ori Warshavsky
908-858-5995
IR@Polypid.com

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

Azurity Pharmaceuticals Media Contacts
Media Relations
media@azurity.com

Confidential

Filing Exhibits & Attachments

2 documents

Press Releases

• EX-99.1 PRESS RELEASE ISSUED BY POLYPID LTD. ON JULY 21, 2026, TITLED "POLYPID ANNOUNCES 23.9 KB

Agreements & Contracts

• EX-10.1 LICENSE AND SUPPLY AGREEMENT, DATED JULY 17, 2026, BY AND BETWEEN POLYPID LTD. A 505.2 KB