Latest news with #D-PLEX100
Yahoo
16-06-2025
- Business
- Yahoo
PolyPid Secures $26.7 Million Through Warrant Exercise Following Successful SHIELD II Phase 3 Trial Results
The Company Anticipates that with this Additional Funding, PolyPid's Runway would be Extended beyond Anticipated U.S. Food and Drug Administration ('FDA') Approval of D-PLEX₁₀₀. The Company Recently Announced Successful Topline Results from its Phase 3 SHIELD II Trial; D-PLEX₁₀₀ Demonstrated a Statistically Significant Reduction in Surgical Site Infections ('SSIs') and Successfully Met the Study's Primary Endpoint and all Key Secondary Endpoints. PETACH TIKVA, Israel, June 17, 2025 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) ('PolyPid' or the 'Company'), a late-stage biopharma company aiming to improve surgical outcomes, today announced that following its recently announced successful SHIELD II phase 3 topline results, it has secured additional funding through the exercise of warrants with aggregate gross proceeds of $26.7 million. The Company anticipates that with this additional funding, PolyPid's runway would be extended beyond anticipated FDA approval of D-PLEX₁₀₀. The funding was secured through new agreements the Company has entered into with certain holders of its existing warrants for the immediate exercise of certain outstanding warrants to purchase up to an aggregate of 7,626,514 ordinary shares, no par value, of the Company originally issued in January 2024 and December 2024. As part of the new agreements, the warrants will be exercised at a price of $3.50 per share. The aggregate gross proceeds from the exercise of the existing warrants are expected to total $26.7 million. In consideration for the immediate exercise of the warrants for cash, the Company will issue 7,626,514 new unregistered warrants to purchase ordinary shares. The new warrants will be exercisable for an aggregate of up to 7,626,514 ordinary shares, at an exercise price of $4.50 per share and will be immediately exercisable upon issuance and for a term of two years from the issuance date. As part of the terms of the financing, it has been agreed that if the holder transfers/sells any of the shares acquired upon exercise of the existing warrants prior to the expiration or exercise of the new warrants, the new warrants shall immediately and automatically terminate and be forfeited with respect to the corresponding number of shares sold, unless such new warrants are concurrently exercised. The transaction is expected to close on or about June 18, 2025, subject to satisfaction of customary closing conditions. PolyPid intends to use the net proceeds from the offering for its new drug application ('NDA') submission, launch preparations, working capital and general corporate purposes. The new warrants described above were offered in a private placement pursuant to under Section 4(a)(2) of the Securities Act of 1933, as amended (the '1933 Act') and, along with the ordinary shares issuable upon their exercise, have not been registered under the 1933 Act, and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission ('SEC') or an applicable exemption from such registration requirements. The Company has agreed to file a registration statement with the SEC covering the resale of the ordinary shares issuable upon exercise of the new warrants. This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. About D-PLEX₁₀₀D-PLEX₁₀₀, PolyPid's lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent SSIs. Following the administration of D-PLEX₁₀₀ into the surgical site, the PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in a high local concentration of the drug for a period of 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX₁₀₀ received Breakthrough Therapy designation from the U.S. Food and Drug Administration for the prevention of SSIs in patients undergoing elective colorectal surgery. PolyPid recently announced successful topline results from its Phase 3 SHIELD II trial. In this study, D-PLEX₁₀₀ demonstrated a statistically significant reduction in SSIs and successfully met the study's primary endpoint and all key secondary endpoints. About PolyPidPolyPid 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. PolyPid's lead product candidate, D-PLEX₁₀₀, demonstrated a statistically significant reduction in SSIs and successfully met the primary endpoint and all key secondary endpoints in the SHIELD II Phase 3 clinical trial. In addition, the Company is currently in preclinical stages to test the efficacy of OncoPLEX for the treatment of solid tumors, beginning with glioblastoma. For additional Company information, please visit and follow us on Twitter 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 expected cash runway, the expected closing date of the warrant inducement transaction, the use of proceeds, potential NDA submission and potential clinical benefits of D-PLEX₁₀₀, including safety and efficacy. 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 SEC, 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. Contacts: PolyPid Ltd. Ori WarshavskyCOO – US908-858-5995IR@ Investors:Brian RitchieLifeSci Advisors212-915-2578BRitchie@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
09-06-2025
- Business
- Yahoo
Nano-Cap PolyPid's Lead Drug Candidate Cuts Surgical Infection Risk by 38% In Phase 3 Trial
PolyPid Ltd. (NASDAQ:PYPD) on Monday announced topline results from its pivotal SHIELD II Phase 3 trial of D-PLEX100 to prevent surgical site infections (SSIs) in patients undergoing abdominal colorectal surgery with large incisions. The SHIELD II trial is designed to assess the efficacy and safety of D-PLEX100 administered concomitantly with the standard of care (SoC), which includes prophylactic systemic antibiotics, compared to the SoC alone arm in the prevention of post-abdominal-surgery incisional infection in patients undergoing abdominal colorectal surgeries with large incisions. The trial's primary endpoint is measured by the proportion of subjects with a surgical site infection or mortality for any reason within 30 days post-surgery. FDA Pushes Pause On Axsome Fibromyalgia Drug, New Trial Required Patient safety will be monitored for an additional 30 days. The trial will enroll patients in centers in the United States, Europe, and Israel. D-PLEX100, PolyPid's lead product candidate, is designed to provide local, prolonged, and controlled antibacterial activity directly at the surgical site to prevent SSIs. Following the administration of D-PLEX100 into the surgical site, the PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in a high local concentration of the drug for 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. The trial met the primary efficacy endpoint, with a significantly lower proportion of primary endpoint events among patients who received D-PLEX100 plus SoC (n=405; 10.9%), compared to SoC alone (n=393; 18.1%), representing a 38% reduction (p<0.005). SHIELD II included three key secondary endpoints: The first key secondary endpoint was met, with a 58% reduction in deep and superficial SSI rates among patients who received D-PLEX100 plus SoC (3.8%) compared to those who received SoC alone (9.5%) (p<0.005). The second key secondary endpoint showed statistical significance in favor of D-PLEX100 plus SoC over SoC alone (p<0.005). The third key secondary endpoint was met with a 62% reduction of patients with an ASEPSIS1 score >20 in the D-PLEX100 plus SoC arm compared to the SoC alone arm (p<0.05). The ASEPSIS score is a clinical tool used to assess surgical wound infections objectively. The independent Data Safety Monitoring Board raised no safety concerns in SHIELD II. The company expects to submit a New Drug Application to the U.S. Food and Drug Administration in early 2026, with a Marketing Authorization Application in the E.U. to follow shortly thereafter. Price Action: PYPD stock is trading higher by 12% to $3.66 at last check Monday. Read Next:Photo by ittawit21 via Shutterstock Up Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market. Get the latest stock analysis from Benzinga? This article Nano-Cap PolyPid's Lead Drug Candidate Cuts Surgical Infection Risk by 38% In Phase 3 Trial originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved.
Yahoo
09-06-2025
- Business
- Yahoo
PESG Research Report: Revolutionary Surgical Infection Prevention: PolyPid's D-PLEX100 Approaches Critical Phase 3 Data Readout
New report from PESG Research brand covers PolyPid*, which is tackleing the $10 billion dollar a year surgeical site infections cost with its innovative PLEX technology New York, May 30, 2025 (GLOBE NEWSWIRE) -- PESG Research is releasing a report today examining PolyPid Ltd.*, an innovative late-stage biopharmaceutical company developing revolutionary localized drug delivery technologies for surgical infection prevention. The below report explores the company's breakthrough PLEX platform technology, its upcoming topline phase 3 data, and potential implications for transforming surgical care practices in the multi-billion dollar surgical site infection prevention market. This report contains sponsored content, please see refer to the disclaimers and disclosures included at the end of this report. Executive Summary The surgical site infection (SSI) prevention landscape stands at a potential inflection point as PolyPid Ltd. prepares to announce topline results from its pivotal SHIELD II Phase 3 trial by the end of Q2 2025. The company's D-PLEX100 represents a paradigm shift in infection prevention, utilizing novel polymer-lipid encapsulation matrix (PLEX) technology to deliver sustained antibiotic release directly at surgical sites for 30 days. With SSIs affecting up to 30% of colorectal surgeries and imposing substantial healthcare costs estimated at $10 billion annually in the US and EU, successful development of D-PLEX100 could address a critical unmet medical need. The FDA's assignment of Breakthrough Therapy, Fast Track, and Qualified Infectious Disease Product (QIDP) designations underscores the regulatory recognition of this approach's potential Critical Challenge of Surgical Site Infections Surgical site infections remain one of healthcare's most persistent challenges, representing 20% of all healthcare-associated infections in US hospitals. Despite advances in surgical techniques and prophylactic protocols, SSI rates in high-risk procedures like colorectal surgery can reach 30%, leading to extended hospital stays of 7-11 additional days and mortality risk increases of 2-11 fold. The economic burden is staggering, with direct costs averaging $11,000-26,000 per infection and total annual costs reaching approximately $10 billion in the US alone. Current prevention strategies rely primarily on systemic antibiotic prophylaxis administered intravenously 30-60 minutes before surgery. However, this approach faces fundamental limitations. Surgical incisions disrupt local blood flow, significantly limiting antibiotic penetration to the precise site where infections occur. Moreover, systemic administration exposes patients to higher drug concentrations throughout the body, potentially increasing toxicity risks and contributing to antimicrobial resistance development. PLEX Technology: A Novel Approach to Localized Drug Delivery PolyPid's proprietary PLEX technology represents a sophisticated advancement in controlled drug delivery systems. The platform creates thousands of alternating layers of biocompatible polymers and lipids that physically embed active pharmaceutical ingredients. As these outer layers gradually disintegrate upon exposure to body fluids, they enable precise, predetermined drug release rates spanning several days to months. For D-PLEX100, this technology pairs with doxycycline, a broad-spectrum antibiotic effective against both gram-positive and gram-negative bacteria, including methicillin-resistant Staphylococcus aureus (MRSA) and other antibiotic-resistant strains. The formulation achieves local antibiotic concentrations 10-115 times higher than systemic administration while using only a fraction of the total drug amount, potentially minimizing systemic exposure and associated side effects. Clinical Development Progress and Regulatory Recognition The clinical development program for D-PLEX100 has demonstrated encouraging signals across multiple surgical contexts. In Phase 2 abdominal surgery trials, D-PLEX100 plus standard of care achieved a statistically significant 59% reduction in the primary endpoint compared to standard of care alone (p=0.0086). Perhaps more notably, the treatment group experienced zero deaths compared to five in the control arm within 60 days post-surgery. The pivotal SHIELD I Phase 3 trial, while not meeting its primary endpoint in the full intent-to-treat population, revealed compelling efficacy in a pre-specified subgroup analysis. Among patients with large surgical incisions (>20 cm), D-PLEX100 demonstrated a statistically significant 54% reduction in the composite primary endpoint of SSIs, reinterventions, and mortality (p=0.0032). This finding directly informed the design of the ongoing SHIELD II trial, which focuses specifically on this higher-risk patient FDA's regulatory designations reflect recognition of D-PLEX100's potential significance. Breakthrough Therapy designation is reserved for drugs that demonstrate substantial improvement over existing treatments for serious conditions. Fast Track designation facilitates more frequent FDA communications and potentially accelerated review timelines. The QIDP designation provides additional market exclusivity incentives for addressing antimicrobial resistance challenges. SHIELD II: A Potentially Definitive Study The ongoing SHIELD II Phase 3 trial represents a carefully designed study incorporating lessons learned from SHIELD I. Following an independent Data Safety Monitoring Board's review of unblinded efficacy data from the first 430 enrolled patients, the board recommended concluding the study at 800 patients—the lowest sample size reassessment option available. This recommendation, while requiring additional enrollment beyond the initially planned 624 patients, may suggest positive efficacy trends in the analyzed interim data. The study's multinational design spans approximately 60 centers across the United States, Europe, and Israel, enhancing the generalizability of results across different healthcare settings and patient populations. The primary endpoint focuses on a composite of SSI events, reinterventions, and mortality within 30 days post-surgery, as adjudicated by an independent committee. Broader Industry ImplicationsSuccess of D-PLEX100 could catalyze broader adoption of localized drug delivery approaches in surgical settings. The technology's platform nature suggests potential applications beyond infection prevention, including localized chemotherapy delivery through the company's OncoPLEX program, currently in preclinical development for solid tumor treatment. The substantial market opportunity—with approximately 12 million eligible procedures annually in the US and 8 million in Europe—underscores the potential healthcare impact. PolyPid has already secured European commercialization rights through a partnership with Advanz Pharma, valued at up to $115 million plus royalties, while advancing discussions for US market partnerships. Conclusion As the pharmaceutical industry grapples with antimicrobial resistance and healthcare systems seek cost-effective solutions to persistent clinical challenges, D-PLEX100's approaching data readout represents a potentially significant milestone. The convergence of compelling preclinical and early clinical data, regulatory recognition, and substantial unmet medical need positions this development as one to monitor closely in the evolving landscape of surgical infection News Highlight from PolyPid: PolyPid Announces Successful Completion of Enrollment in Phase 3 SHIELD II Trial of D-PLEX₁₀₀ for the Prevention of Abdominal Colorectal Surgical Site Infections >> Click here to Subscribe for more updates like this or go to * Legal Disclaimer & Disclosure: Nothing in this report constitutes medical, financial or any form professional or licensedadvice. This report is published by 'PESG Research', a digital promotional content brand who's operators are compensated to provide digestable and favorabel coverage of companies. This report contains and is a form of paid promotional content or advertising for PolyPid Ltd and was produced as part of the fee's they pay PESG's operators, Arx Advisory Ltd. This report has not been reviewed or approved by PolyPId prior to publication and it does not represent an official communication from PolyPid. The operators of PESG Research received or are expected to receive a monthly recurring fee of five thousand united states dollars via wire transfer from PolyPid as part of an ongoing agreement starting May 1, 2025 in return for distribution and promotional coverage services, and receive additional monthly compensation for non promotional unrelated data and advisory services on top of that. Please review the full disclaimers and compensation disclosures here for further details: Readers are advised to refer to the official materials of the company aforementioned. The report should not be treated as objective.
Yahoo
06-06-2025
- Business
- Yahoo
PolyPid to Host Conference Call and Webcast to Discuss D-PLEX₁₀₀ SHIELD II Phase 3 Trial Topline Results on Monday, June 9, 2025
PETACH TIKVA, Israel, June 06, 2025 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD), ('PolyPid' or the 'Company'), a late-stage biopharma company aiming to improve surgical outcomes, today announced that it will host a conference call and webcast to report topline data for the SHIELD II Phase 3 trial, evaluating D-PLEX100 for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery, on Monday, June 9, at 8:30 a.m. ET. To ensure you are connected prior to the beginning of the call, PolyPid suggests registering a minimum of 5 minutes before the start of the call. Conference Call Dial-In & Webcast Information: Date: Monday, June 9, 2025 Time: 8:30 AM Eastern Time Conference Call: Webcast: 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. PolyPid's lead product candidate D-PLEX100 is in Phase 3 clinical trial for the prevention of abdominal colorectal surgical site infections. In addition, the Company is currently in preclinical stages to test the efficacy of OncoPLEX for the treatment of solid tumors, beginning with glioblastoma. For additional Company information, please visit and follow us on Twitter and LinkedIn. Contacts:PolyPid Ltd. Ori WarshavskyCOO – US908-858-5995IR@ Investors:Brian RitchieLifeSci Advisors212-915-2578britchie@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
06-06-2025
- Business
- Yahoo
PolyPid to Host Conference Call and Webcast to Discuss D-PLEX₁₀₀ SHIELD II Phase 3 Trial Topline Results on Monday, June 9, 2025
PETACH TIKVA, Israel, June 06, 2025 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD), ('PolyPid' or the 'Company'), a late-stage biopharma company aiming to improve surgical outcomes, today announced that it will host a conference call and webcast to report topline data for the SHIELD II Phase 3 trial, evaluating D-PLEX100 for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery, on Monday, June 9, at 8:30 a.m. ET. To ensure you are connected prior to the beginning of the call, PolyPid suggests registering a minimum of 5 minutes before the start of the call. Conference Call Dial-In & Webcast Information: Date: Monday, June 9, 2025 Time: 8:30 AM Eastern Time Conference Call: Webcast: 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. PolyPid's lead product candidate D-PLEX100 is in Phase 3 clinical trial for the prevention of abdominal colorectal surgical site infections. In addition, the Company is currently in preclinical stages to test the efficacy of OncoPLEX for the treatment of solid tumors, beginning with glioblastoma. For additional Company information, please visit and follow us on Twitter and LinkedIn. Contacts:PolyPid Ltd. Ori WarshavskyCOO – US908-858-5995IR@ Investors:Brian RitchieLifeSci Advisors212-915-2578britchie@
