1. PolyPid to present Phase 3 SHIELD II trial results in October 2025. 2. D-PLEX₁₀₀ showed 38% reduction in surgical site infections. 3. 58% reduction in surgical site infection rates with D-PLEX₁₀₀. 4. NDA submission for D-PLEX₁₀₀ expected in early 2026. 5. PolyPid developing pipeline for oncology, obesity, and diabetes.
Positive Phase 3 trial results often lead to increased investor interest, as seen with companies like Acadia Pharmaceuticals post-positive trials, which significantly boosted their stock prices. This suggests confidence in D-PLEX₁₀₀'s potential success in the market.
The article highlights critical clinical trial results directly relevant to PYPD’s main product, suggesting strong potential impact on investor sentiment and future revenue.
While immediate interest may rise, the true impact will depend on the NDA's success and market entry, similar to how BioMarin's drug launches shaped their long-term stock performance.
PETACH TIKVA, Israel, Sept. 30, 2025 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD) ("PolyPid" or the "Company"), a late-stage biopharma company aiming to improve surgical outcomes, today announced that Dr. Shmuel Sharoni will present the topline results from the Company's successful Phase 3 SHIELD II trial of D-PLEX₁₀₀ at the upcoming 2025 American College of Surgeons (ACS) Clinical Congress in Chicago, IL.
Dr. Shmuel Sharoni will deliver a presentation titled "Efficacy Of A Novel Local Prolonged-release Incisional Doxycycline On Surgical Site Infection Prophylaxis In Abdominal Colorectal Surgery: The Shield II Phase 3 Randomized Clinical Trial," during the high-impact clinical trials session on Sunday, October 5, 2025, at 11:30 AM CT.
Conference Details:
The PolyPid management team will be available for meetings during the conference. For more information or to schedule a meeting, please contact IR@Polypid.com.
About SHIELD II
The SHIELD II Phase 3 trial was a prospective, multinational, randomized, double-blind study that successfully met its primary and all key secondary efficacy endpoints. The trial demonstrated that D-PLEX₁₀₀, when administered alongside standard of care, achieved a 38% reduction (p<0.005) in the combined endpoint of surgical site infections, reinterventions, or mortality compared to standard of care alone. Additionally, the trial showed a 58% reduction (p<0.005) in the rate of surgical site infections in the D-PLEX₁₀₀ treatment arm.
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 the presentation of SHIELD II trial results at the upcoming conference, the planned NDA submission for D-PLEX₁₀₀ and timing thereof. 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
IR@Polypid.com
Investor Relations Contact:
Arx Investor Relations
North American Equities Desk
polypid@arxhq.com
