Healthcare
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
About this update from Polypid Ltd.
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, Aug. 12, 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 and six months ended June 30, 2026. Recent Corporate Highlights: "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 Financial Results for the Six Months Ended June 30, 2026 Balance Sheet Highlights Conference Call Dial-In & Webcast Information: 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 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 [email protected] Investor Relations Contact: Arx Investor Relations North American Equities Desk [email protected]