PolyPid Provides Corporate Update and Reports Fourth Quarter and Full-Year 2025 Financial Results

The Company is inAdvancedStagesofCommercialU.S.PartnershipDiscussions forD-PLEX₁₀₀

Positive FDA Pre-NDA Feedback Supports Rolling NDAReview;SubmissionExpected to BeginbytheEnd ofthe First Quarter of2026

Conference Call Scheduled for Today at 8:30 AM ET

PETACH TIKVA, Israel, Feb. 11, 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 provided a corporate update and reported financial results for the three months and full year ended December 31, 2025.

“2025 was a pivotal year for PolyPid as we successfully completed the SHIELD II Phase 3 trial and advanced D-PLEX₁₀₀ into the final stages of regulatory approval,” said Dikla Czaczkes Akselbrad, Chief Executive Officer of PolyPid. “Following our positive Phase 3 results and progress made in the past quarter, we have moved into advanced stage discussions for potential commercial partnership in the U.S., reflecting the growing recognition of D-PLEX₁₀₀’s clinical and commercial value. At the same time, positive engagement with the FDA, including agreement on a rolling NDA review, further advanced our regulatory path as we work toward an NDA submission beginning by end of the first quarter of 2026. We believe 2026 has the potential to be a transformative year for PolyPid, marking our transition from late-stage development into full commercial execution, and we look forward to providing updates as these developments occur.”

About PolyPidPolyPid 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 visithttp://www.polypid.comand follow us onTwitter (X)and LinkedIn.

Forward-looking StatementsThis 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 regulatory strategy and planned timing for the submission of an NDA for D-PLEX₁₀₀, including the use of a rolling NDA review, advanced stages of commercial U.S. partnership discussions for D-PLEX₁₀₀, the potential role of D-PLEX₁₀₀ in improving surgical outcomes, the Company’s evolution toward commercialization, the growing recognition of D-PLEX₁₀₀’s clinical and commercial value, its belief that 2026 has the potential to be a transformative year for the Company, marking its transition from late-stage development into full commercial execution, and its expectation that current cash resources will be sufficient to fund operations into the second half of 2026 and through several significant upcoming potential milestones. 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.