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PolyPid Ltd. (Nasdaq: PYPD) is a cutting-edge biopharmaceutical company focused on enhancing surgical outcomes through its innovative drug delivery technology, PLEX™ (Polymer-Lipid Encapsulation matriX). This proprietary technology allows for the precise, prolonged release of drugs directly at the target site, optimizing therapeutic performance and clinical outcomes. PolyPid specializes in the development and manufacturing of products that address unmet medical needs, particularly in the prevention of surgical site infections (SSIs) and treatment of solid tumors.
The company's lead product candidate, D-PLEX100, is designed to provide localized, controlled anti-bacterial activity at surgical sites to prevent SSIs. It is currently undergoing a Phase 3 clinical trial, known as SHIELD II, aimed at preventing infections in patients undergoing open abdominal colorectal surgery. D-PLEX100 has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration, highlighting its potential to address significant medical needs.
PolyPid's product pipeline also includes OncoPLEX, intended for the treatment of solid tumors, beginning with glioblastoma. This product is currently in preclinical stages, showing promising potential in oncology. Additionally, the company's proprietary technology, PLEX™, can encapsulate various drugs, enabling targeted and localized delivery over extended periods, ranging from several days to months.
In terms of recent achievements, PolyPid has successfully enrolled and randomized over 200 patients in its SHIELD II trial, with top-line results expected in the second half of 2024. Moreover, the company recently closed a $16 million private placement financing, which will support ongoing clinical development efforts and extend its cash runway beyond the anticipated interim analysis of the SHIELD II trial.
For more detailed information, visit PolyPid's official website or follow the company on Twitter and LinkedIn.
PolyPid Ltd. (PYPD) announced the completion of patient enrollment in the SHIELD I Phase 3 study of D-PLEX100, aimed at preventing surgical site infections (SSIs) in abdominal surgery. Following an unblinded interim efficacy analysis, the Data Safety Monitoring Board recommended closing the study at 950 patients, the minimum target. Top-line results are expected by the end of Q3 2022, with potential NDA and MAA submissions planned for H1 2023, following a pre-NDA meeting with the FDA. This pivotal trial represents a significant milestone in PolyPid's development efforts.
PolyPid Ltd. (PYPD) announced the expected enrollment of its 950th patient in the SHIELD I Phase 3 study of D-PLEX100 for preventing surgical site infections (SSIs) in abdominal surgeries. The independent Data Safety Monitoring Board recommended concluding enrollment after reviewing data from 750 patients. Top-line results are anticipated by Q3 2022, with potential NDA and MAA submissions targeted for H1 2023. SSIs pose a significant healthcare burden, costing the U.S. nearly $10 billion annually. Successful results could significantly impact surgical outcomes and market opportunities.
PolyPid Ltd. (PYPD) announced significant updates regarding its Phase 3 SHIELD I trial of D-PLEX100, with approximately 900 patients enrolled. An unblinded interim analysis is expected soon, which could lead to early trial adjustments. The company secured a $15 million non-dilutive term loan to enhance cash flow and support commercialization efforts for D-PLEX100. Financial results show a loss of $11.9 million for Q1 2022, up from $8.7 million year-over-year, as R&D expenses increased. Cash reserves are sufficient to sustain operations into Q2 2023.
PolyPid Ltd. (Nasdaq: PYPD) announced it will release its first quarter 2022 financial results on May 11, 2022, before U.S. market opening.
A conference call and webcast will follow at 8:30 AM ET to discuss the results and operational highlights.
PolyPid focuses on improving surgical outcomes with its proprietary PLEX technology, currently advancing its lead product D-PLEX100 in Phase 3 trials for preventing surgical site infections.
PolyPid Ltd. (Nasdaq: PYPD) announced the presentation of clinical data at the 13th European and Global CLINAM Summit for Nanomedicine, focusing on D-PLEX100. The study demonstrated D-PLEX100 as an effective surgical site infection prevention agent in colorectal surgery patients, limiting antimicrobial resistance (AMR) without increasing postoperative colonization by multi-drug resistant organisms. This emphasizes the potential of PolyPid's proprietary PLEX technology in enhancing surgical outcomes. The presentation will be accessible on their website after the summit.
PolyPid Ltd. (Nasdaq: PYPD) announced plans to present clinical data evaluating the addition of D-PLEX100 to standard infection prophylaxis in elective colorectal surgery. This presentation will occur at the Surgical Infection Society 2022 Annual Meeting on April 23-26, 2022. The study titled ‘Incisional microenvironments and reduction in SSIs in patients treated with a local doxycycline-eluting formulation’ will be led by Dr. Anthony Senagore. PolyPid aims to enhance surgical outcomes through its proprietary PLEX technology, with D-PLEX100 currently in Phase 3 trials.
PolyPid Ltd. (Nasdaq: PYPD) has secured a loan facility of up to $15 million with Kreos Capital to extend its cash runway into the second quarter of 2023. The funds will support commercialization efforts for D-PLEX100, aimed at preventing surgical site infections, as well as advancing the OncoPLEX development platform. The loan consists of three tranches, with specific conditions for release based on clinical trial results. The senior secured loan carries an interest rate of 9.25%, adjustable upon achieving certain milestones.
PolyPid Ltd. (Nasdaq: PYPD) will present clinical data for its lead product D-PLEX100 at the SAGES 2022 Annual Meeting in Denver from March 16-19, 2022. The poster presentation evaluates D-PLEX100's effectiveness in reducing surgical site infections in elective colorectal surgery when combined with standard prophylaxis. Dr. Anthony Senagore, Senior Medical Director, will lead the oral review. D-PLEX100 is currently in Phase 3 trials aimed at preventing infections after abdominal and sternal surgeries.
PolyPid Ltd. (Nasdaq: PYPD) announced the enrollment of the 750th patient in its pivotal Phase 3 SHIELD I study evaluating D-PLEX100 for preventing surgical site infections (SSIs) in abdominal surgery. An unblinded interim analysis is expected in Q2 2022, allowing potential early trial conclusion based on efficacy or futility. The FDA has indicated that a single pivotal study may suffice for D-PLEX100's approval, given adequate results. D-PLEX100 uses a novel technology for prolonged antibiotic release at the surgical site.
PolyPid Ltd. (Nasdaq: PYPD) announced its participation in the Barclays Global Healthcare Conference from March 15-17, 2022. The company will present on March 16 at 9:00 AM Eastern Time. PolyPid specializes in Phase 3 biopharmaceutical developments, focusing on targeted, locally administered, prolonged-release therapeutics via its proprietary PLEX technology. Its lead product candidate, D-PLEX100, is undergoing clinical trials aimed at preventing surgical site infections.
Investors interested in the conference can contact Barclays representatives for meetings.
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