Business
PolyPid Provides Corporate Update and Reports Third Quarter 2025 Financial Results
Face-to-Face Pre-NDA Meeting with the FDA Scheduled for Early December; NDA Submission for D-PLEX₁₀₀ On Track for Early 2026 Advancements in Discussions with Potential U.S. Partners Following Positive Phase 3 Trial Results Company Continues to Advance Towards Commercial Manufacturing Readiness with Successful Completion of IMOH GMP Inspection Conference Call Scheduled for Today at 8:30 AM ET PETACH TIKVA, Israel, Nov. 12, 2025 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) ("PolyPid" or the "Co
About this update from Polypid Ltd.
Face-to-Face Pre-NDA Meeting with the FDA Scheduled for Early December; NDA Submission for D-PLEX₁₀₀ On Track for Early 2026 Advancements in Discussions with Potential U.S. Partners Following Positive Phase 3 Trial Results Company Continues to Advance Towards Commercial Manufacturing Readiness with Successful Completion of IMOH GMP Inspection Conference Call Scheduled for Today at 8:30 AM ET PETACH TIKVA, Israel, Nov. 12, 2025 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) ("PolyPid" or the "Company"), a late-stage biopharma company aiming to improve surgical outcomes, today provided a corporate update and reported financial results for the three and nine months ended September 30, 2025. Recent Corporate Highlights: "This past quarter was significant for PolyPid as we continue to progress toward bringing D-PLEX₁₀₀ to market," said Dikla Czaczkes Akselbrad, Chief Executive Officer of PolyPid. "With our upcoming pre-NDA meeting with the FDA and our NDA submission on track for early 2026, we continue to execute on our regulatory strategy while in parallel, advancing discussions with potential U.S. partners.” Financial results for three months ended September 30, 2025 Financial results for nine months ended September 30, 2025 Balance Sheet Highlights Conference Call Dial-In & Webcast Information: 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 its regulatory strategy and timeline for its pre-NDA meeting and NDA submission, ongoing partnership discussions with potential U.S. partners, benefits, value proposition and advantages of D-PLEX 100 and the Company’s ability to bring D-PLEX₁₀₀ to market, readiness for commercialization and its ability to fund operations well into 2026. 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 [email protected] Investor Relations Contact: Arx Investor Relations North American Equities Desk [email protected] INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) U.S. dollars in thousands INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) U.S. dollars in thousands (except share and per share data) INTERIM CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) U.S. dollars in thousands (except share and per share data)