PolyPid (PYPD) secures D-PLEX100 FDA priority review and $30M Azurity deal
Rhea-AI Filing Summary
PolyPid Ltd. reported second-quarter and first-half 2026 results and key regulatory milestones. The FDA accepted the NDA for lead product D-PLEX₁₀₀ with Priority Review, setting a PDUFA goal date of November 28, 2026, approximately one quarter earlier than previously guided. The company also entered an exclusive U.S. and Canada commercialization partnership with Azurity Pharmaceuticals, receiving $30 million in upfront and near-term milestone payments following NDA acceptance, with the potential for over $290 million in additional milestones plus tiered royalties up to the mid-twenties percentages. A potential U.S. commercial launch by Azurity is targeted for early 2027.
For the six months ended June 30, 2026, PolyPid recorded a net loss of $15.6 million, improving from a $18.2 million loss a year earlier, with basic and diluted loss per share of $0.70 versus $1.48. For the second quarter, net loss was $7.8 million compared to $10.0 million in 2025, or $0.35 per share versus $0.78. Total assets declined to $15.2 million from $22.3 million at year-end 2025, and shareholders’ equity decreased to $5.4 million from $11.0 million, while ordinary shares outstanding increased to 20.3 million.
Positive
- FDA Priority Review for D-PLEX₁₀₀ NDA with a PDUFA goal date of November 28, 2026, approximately one quarter ahead of previously communicated guidance.
- Commercialization deal with Azurity Pharmaceuticals for U.S. and Canada, delivering $30 million in upfront and near-term milestone payments and over $290 million in additional potential milestones plus tiered royalties.
- Management states the company is in potentially the strongest financial position in its history with no immediate financing needs and expects available resources to fund operations into 2028.
Negative
- PolyPid continues to operate at a loss, with a six-month net loss of $15.6 million and a second-quarter net loss of $7.8 million in 2026.
- Total assets fell from $22.3 million at December 31, 2025 to $15.2 million at June 30, 2026, while shareholders’ equity declined from $11.0 million to $5.4 million, reflecting an ongoing accumulated deficit of $317.1 million.
Filing Explained
The filing states that specified portions of PolyPid’s August 12 corporate update, financial statements, and related disclosures are incorporated by reference into its listed Form F-3 and Form S-8 registration statements, making those materials part of those registration statements.
Key Figures
Key Terms
Priority Review regulatory
PDUFA goal date regulatory
deferred revenues financial
loss on extinguishment of debt financial
forward-looking statements regulatory
operating loss financial
FAQ
What key regulatory milestone did PolyPid (PYPD) achieve for D-PLEX100?
What are the main terms of PolyPid’s Azurity partnership mentioned in this 6-K?
How did PolyPid’s (PYPD) financial performance change in the first half of 2026?
What does the 6-K reveal about PolyPid’s (PYPD) balance sheet as of June 30, 2026?
When is PolyPid targeting a potential U.S. commercial launch of D-PLEX100?
AI-generated analysis. How Rhea-AI works. Not financial advice.
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: August 2026
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
Attached hereto and incorporated herein is PolyPid Ltd.’s (the “Registrant”) press release issued on August 12, 2026, titled “PolyPid Provides Corporate Update and Reports Second Quarter 2026 Financial Results.”
The bullet points under the section titled “Recent Corporate Highlights,” the sections titled “Financial results for the three months ended June 30, 2026,” “Financial results for the six months ended June 30, 2026,” “Balance Sheet Highlights,” and “Forward-looking Statements” and the financial statements in the press release attached hereto as Exhibit 99.1 are incorporated by reference into the Registrant’s registration statements on Form F-3 (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. | ||
| 99.1 | Press Release issued by PolyPid Ltd. on August 12, 2026, titled “PolyPid Provides Corporate Update and Reports Second Quarter 2026 Financial Results.” |
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: August 12, 2026 | By: | /s/ Dikla Czaczkes Akselbrad | |
| Name: | Dikla Czaczkes Akselbrad | ||
| Title: | Chief Executive Officer | ||
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Exhibit 99.1
PolyPid Provides Corporate Update and Reports Second Quarter 2026 Financial Results
FDA Accepted D-PLEX₁₀₀ NDA with Priority Review; PDUFA Goal Date of November 28, 2026, Approximately One Quarter Ahead of Previously Communicated Guidance
Exclusive U.S. and Canada Commercialization Partnership with Azurity Pharmaceuticals; $30 Million in Upfront and Near-Term Milestones Achieved Following NDA Acceptance, with Over $290 Million in Additional Milestones Plus Tiered Royalties Up to Mid-Twenties Percentages
Potential U.S. Commercial Launch of D-PLEX₁₀₀ by Azurity Targeted for Early 2027
Conference Call Scheduled for Today at 8:30 AM ET
PETACH TIKVA, Israel, August 12, 2026 - 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 provided a corporate update and reported financial results for the three and six months ended June 30, 2026.
Recent Corporate Highlights:
Completed NDA Submission for D-PLEX₁₀₀ and Received FDA Acceptance with Priority Review:
| ● | Completed its New Drug Application (“NDA”) submission to the U.S. Food and Drug Administration (“FDA”) for D-PLEX₁₀₀ for the prevention of surgical site infections (“SSIs”) in patients undergoing abdominal colorectal surgery, supported by positive results from the pivotal Phase 3 SHIELD II trial, which met its primary endpoint and all key secondary endpoints and demonstrated a 60% relative risk reduction in SSIs compared to standard of care (p=0.0013). |
| ● | Subsequent to quarter end, on July 27, 2026, the FDA accepted D-PLEX₁₀₀ NDA submission and granted Priority Review, with a Prescription Drug User Fee Act (“PDUFA”) goal date of November 28, 2026, approximately one quarter ahead of the Company’s previously communicated first quarter 2027 guidance. The FDA did not identify any filing review issues in its acceptance communications. |
Exclusive U.S. and Canada Commercialization Partnership with Azurity Pharmaceuticals:
| ● | Following the end of the quarter, on July 17, 2026, PolyPid entered into a commercial partnership agreement with Azurity Pharmaceuticals (“Azurity”), a privately held global specialty pharmaceutical company with a first-in-class commercial model, deep experience in specialty and hospital-based therapies with more than 50 medicines across 10 therapeutic areas. Azurity has an experienced commercial launch and execution team launching more than one product each year on average in the last several years. |
| ● | Following the FDA’s July 27, 2026 NDA acceptance, PolyPid has achieved the milestones required for the $30 million in upfront and near-term milestone payments from Azurity. |
| ● | Under the partnership, PolyPid is eligible to receive up to approximately $320 million in total upfront and milestone payments, inclusive of the $30 million confirmed to date, structured across a defined series of regulatory, launch, and sales milestones aligned with the anticipated U.S. and Canada commercialization of D-PLEX₁₀₀. |
| ● | In addition to and separate from the milestone payments, PolyPid is entitled to tiered royalties from mid-teen to mid-twenties percentages on sales in the U.S. and Canada. Additionally, PolyPid will manufacture and supply D-PLEX₁₀₀ to Azurity for an agreed transfer price, further strengthening the Company’s expected revenues from product sales. |
| ● | As part of the collaboration, Azurity will fund clinical development to support potential label expansion of D-PLEX₁₀₀ in the U.S. and Canada to additional SSI indications beyond abdominal surgery, potentially expanding the future addressable market. |
| ● | PolyPid retains commercial rights outside the United States and Canada, manufacturing rights worldwide, and full ownership of its Kynatrix™ technology and associated pipeline. |
Advancing EU Regulatory Submission:
| · | PolyPid remains on track for the previously announced third quarter 2026 submission of its Marketing Authorization Application (“MAA”) to the European Medicines Agency (“EMA”) for D-PLEX₁₀₀ under the Centralized Procedure on the basis of therapeutic innovation. During the second quarter of 2026, the Company held productive and positive meetings with the EMA Rapporteur and Co-Rapporteur, aligning on the timeline and requirements for the planned MAA submission. |
Advancing Kynatrix™ Pipeline Beyond D-PLEX₁₀₀:
| · | Beyond D-PLEX₁₀₀, PolyPid continues to advance its proprietary Kynatrix™ technology through additional pipeline programs, including its long-acting metabolic program and additional infection opportunities beyond prevention. These programs are being designed to leverage the Company’s established Kynatrix™ technology capabilities, existing clinical and chemistry, manufacturing and controls (“CMC”) foundation, and known active pharmaceutical ingredient safety profile. |
Upcoming Expected Milestones:
| ● | PDUFA goal date for the D-PLEX₁₀₀ NDA of November 28, 2026. |
| ● | MAA submission to the EMA for D-PLEX₁₀₀ under the Centralized Procedure in the third quarter of 2026. |
| ● | Potential U.S. commercial launch of D-PLEX₁₀₀ in early 2027. |
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“The second quarter of 2026 and the first few weeks of the third quarter completed PolyPid’s transition into a commercial-stage company, with the acceptance by the FDA with Priority Review of our NDA submission for D-PLEX₁₀₀, with no filing review issues and a PDUFA goal date meaningfully ahead of the guidance we have previously communicated,” said Dikla Czaczkes Akselbrad, Chief Executive Officer of PolyPid. “In parallel, the U.S. and Canada commercial partnership we entered into in July, together with the immediate $30 million from the partnership, places PolyPid in potentially the strongest financial position in the Company’s history, with no immediate financing needs. With the NDA review process on track, our substantially strengthened financial position, and our U.S. and Canada commercial partnership with Azurity, we believe PolyPid is well positioned to advance D-PLEX₁₀₀ for abdominal colorectal surgery and, over time, additional broader surgical indications.”
Financial Results for the Three Months Ended June 30, 2026
| ● | Research and development expenses for the three months ended June 30, 2026, were $6.1 million, compared to $6.2 million in the same three-month period of 2025. Research and development activity in the second quarter of 2026 primarily reflects ongoing NDA-related activities and continued commercial readiness preparation. |
| ● | General and administrative expenses for the three months ended June 30, 2026, were $1.3 million, compared to $2.5 million for the same period of 2025. The decrease was primarily due to the decrease of non-cash expenses related to performance-based options (“PSUs”) following the positive Phase 3 SHIELD II topline results, which triggered the vesting of those PSUs. |
| ● | Marketing and business development expenses for the three months ended June 30, 2026, were $0.5 million, compared to $0.7 million for the same period of 2025. |
| ● | For the three months ended June 30, 2026, the Company had a net loss of $7.8 million, or $(0.35) per share, compared to a net loss of $10.0 million, or $(0.78) per share, in the three-month period ended June 30, 2025. |
Financial Results for the Six Months Ended June 30, 2026
| ● | Research and development expenses for the six months ended June 30, 2026, were $11.9 million, compared to $12.3 million in the same six-month period of 2025. The decrease primarily reflects the completion of the SHIELD II Phase 3 trial and the Company’s transition toward regulatory submission and commercial readiness activities. |
| ● | General and administrative expenses for the six months ended June 30, 2026, were $2.9 million, compared to $3.7 million for the same period of 2025. The decrease was primarily due to the decrease of non-cash PSU vesting expenses. |
| ● | Marketing and business development expenses for the six months ended June 30, 2026, were $0.9 million, compared to $1.0 million for the same period of 2025. |
| ● | For the six months ended June 30, 2026, the Company had a net loss of $15.6 million, or $(0.70) per share, compared to a net loss of $18.2 million, or $(1.48) per share, in the six-month period ended June 30, 2025. |
3
Balance Sheet Highlights
| ● | As of June 30, 2026, the Company had cash and cash equivalents of $6.6 million, compared to cash, cash equivalents and short-term deposits of $12.9 million on December 31, 2025, not including $30 million in upfront and near-term milestone payments from Azurity, substantially strengthening the Company’s balance sheet as it approaches the November 28, 2026 PDUFA goal date and prepares for a potential U.S. commercial launch of D-PLEX₁₀₀ in early 2027. |
| ● | The Company believes that its current cash position, together with its expected proceeds from its recently announced commercialization agreement, as well as future potential proceeds, will be sufficient to fund operations into 2028 and through several significant upcoming potential milestones. |
Conference Call Dial-In & Webcast Information:
| Date: | Wednesday, August 12, 2026 |
| Time: | 8:30 AM Eastern Time |
| Conference Call: | https://register-conf.media-server.com/register/BI9a8ec61eabe249f6a1e931836c819ce8 |
| Webcast: | https://edge.media-server.com/mmc/p/3mbsv986 |
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.
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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 anticipated timing of the FDA’s review and potential approval of the D-PLEX₁₀₀ NDA, including the PDUFA goal date; the anticipated timing of the Company’s planned MAA submission to the EMA for D-PLEX₁₀₀; the timing, receipt and amount of regulatory, launch and other milestone payments and royalties under the Company’s agreement with Azurity; the potential label expansion of D-PLEX₁₀₀ and its funding by Azurity; the anticipated timing of a potential U.S. commercial launch of D-PLEX₁₀₀ by Azurity; the Company’s belief that it is potentially in the strongest financial position in the Company’s history, with no immediate financing needs; the Company’s belief that its current cash position, together with its expected proceeds from its recently announced commercialization agreement, as well as future potential proceeds, will be sufficient to fund operations into 2028 and through several significant upcoming potential milestones; the therapeutic and commercial potential of D-PLEX₁₀₀; and the Company’s plans to advance Kynatrix™ technology through additional pipeline programs, including its long-acting metabolic program and additional infection opportunities beyond prevention. 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
5
INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)
U.S. dollars in thousands
| June 30, | December 31, | |||||||
| 2026 | 2025 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 6,563 | $ | 6,402 | ||||
| Restricted deposits | 207 | 193 | ||||||
| Short-term deposits | - | 6,531 | ||||||
| Pre-launch inventories | 1,359 | 1,106 | ||||||
| Prepaid expenses and other current assets | 757 | 995 | ||||||
| Total current assets | 8,886 | 15,227 | ||||||
| LONG-TERM ASSETS: | ||||||||
| Property and equipment, net | 4,613 | 5,094 | ||||||
| Operating lease right-of-use assets | 1,408 | 1,675 | ||||||
| Long-term deposits | 327 | 311 | ||||||
| Total long-term assets | 6,348 | 7,080 | ||||||
| Total assets | $ | 15,234 | $ | 22,307 | ||||
6
INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)
U.S. dollars in thousands (except share and per share data)
| June 30, | December 31, | |||||||
| 2026 | 2025 | |||||||
| LIABILITIES AND SHAREHOLDERS’ EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Trade payables | $ | 1,662 | $ | 2,856 | ||||
| Accrued expenses and other current liabilities | 3,651 | 2,734 | ||||||
| Current maturities of long-term debt | - | 988 | ||||||
| Current maturities of operating lease liabilities | 1,290 | 1,161 | ||||||
| Total current liabilities | 6,603 | 7,739 | ||||||
| LONG-TERM LIABILITIES: | ||||||||
| Deferred revenues | 2,548 | 2,548 | ||||||
| Long-term operating lease liabilities | 282 | 647 | ||||||
| Other liabilities | 413 | 400 | ||||||
| Total long-term liabilities | 3,243 | 3,595 | ||||||
| COMMITMENTS AND CONTINGENT LIABILITIES | ||||||||
| SHAREHOLDERS’ EQUITY: | ||||||||
| Ordinary shares, no par value - Authorized: 107,800,000 shares at June 30, 2026 and December 31, 2025; Issued and outstanding: 20,311,766 and 18,204,002 shares at June 30, 2026 and December 31, 2025, respectively | - | - | ||||||
| Additional paid-in capital | 322,465 | 312,473 | ||||||
| Accumulated deficit | (317,077 | ) | (301,500 | ) | ||||
| Total shareholders’ equity | 5,388 | 10,973 | ||||||
| Total liabilities and shareholders’ equity | $ | 15,234 | $ | 22,307 | ||||
7
INTERIM CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
U.S. dollars in thousands (except share and per share data)
| Six Months Ended | Three Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 11,881 | $ | 12,332 | $ | 6,125 | $ | 6,215 | ||||||||
| Marketing and business development | 873 | 989 | 459 | 700 | ||||||||||||
| General and administrative | 2,855 | 3,661 | 1,265 | 2,488 | ||||||||||||
| Operating loss | 15,609 | 16,982 | 7,849 | 9,403 | ||||||||||||
| Loss on extinguishment of debt | - | 512 | - | - | ||||||||||||
| Financial expense (income), net | (38 | ) | 687 | (6 | ) | 521 | ||||||||||
| Loss before income tax | 15,571 | 18,181 | 7,843 | 9,924 | ||||||||||||
| Income tax expenses | 6 | 64 | 6 | 53 | ||||||||||||
| Net loss | $ | 15,577 | $ | 18,245 | $ | 7,849 | $ | 9,977 | ||||||||
| Basic and diluted loss per ordinary share | $ | 0.70 | $ | 1.48 | $ | 0.35 | $ | 0.78 | ||||||||
| Weighted average number of ordinary shares used in computing basic and diluted loss per share | 22,280,991 | 12,298,113 | 22,637,513 | 12,841,621 | ||||||||||||
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