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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. (Nasdaq: PYPD) announced the presentation of Phase 2 clinical data for D-PLEX100 aimed at preventing surgical wound infections, including those caused by multi-drug resistant organisms. This will occur at the International Orthopaedic Trauma Association meeting from December 14-16, 2022, in Amsterdam. The presentation, titled 'Surgical wound infection reduction with locally administered product releasing doxycycline,' will be delivered by Chief Scientific Officer Noam Emanuel. D-PLEX100 is currently in Phase 3 trials for soft tissue infections.
PolyPid Ltd. (PYPD) announced its corporate update and financial results for Q3 2022, reporting a net loss of $9.3 million, reduced from $9.9 million year-over-year. The company plans to engage with U.S. and EU regulators regarding the D-PLEX100 Phase 3 study outcomes and has noted a 54% reduction in surgical site infections for specific subpopulations. A cost reduction plan, including a 20% workforce cut, aims to extend cash runway into Q3 2023, with available funds reported at $18.1 million.
PolyPid Ltd. (Nasdaq: PYPD) announced it will release its third quarter 2022 financial results and operational updates on November 9, 2022, prior to the U.S. market opening. The company will host a conference call at 8:30 AM ET to discuss these results. PolyPid focuses on enhancing surgical outcomes through its PLEX technology, deploying drug delivery systems that provide controlled release of pharmaceuticals. Its lead candidate, D-PLEX100, is in Phase 3 trials for infection prevention following surgeries.
PolyPid Ltd. (Nasdaq: PYPD) has announced a substantial 20% reduction in headcount as part of a cost-cutting plan aimed at extending its financial runway into Q3 2023. This initiative aligns with their preparations for discussions with U.S. and EU regulatory authorities regarding D-PLEX100 for preventing surgical site infections (SSIs) in abdominal surgeries. Notably, the company received confirmation from the European Medicines Agency for the eligibility of D-PLEX100’s Marketing Authorization Application under the centralized procedure.
PolyPid Ltd. (Nasdaq: PYPD) has announced that the European Medicines Agency (EMA) confirmed D-PLEX100 is eligible for a centralized Marketing Authorization Application (MAA). This allows D-PLEX100 to be marketed across all EU member states upon approval. The centralized procedure highlights D-PLEX100 as a potential new option for preventing post-abdominal surgical site infections (SSIs). The company is also evaluating data from its recent Phase 3 SHIELD I trial and plans discussions with regulatory authorities in early 2023.
PolyPid Ltd. (Nasdaq: PYPD) announced positive clinical data from a Phase 2 study of D-PLEX100, aimed at preventing surgical site infections (SSIs) in abdominal surgery. The study showed a 64% relative risk reduction in infection rates, with 8% in the D-PLEX100 group compared to 22% in the control group. Following the results, the company plans to meet with FDA and EU regulatory authorities in Q1 2023 to discuss next steps for D-PLEX100 as it transitions into Phase 3 trials. The product has already received Breakthrough Therapy Designation from the FDA.
PolyPid Ltd. (Nasdaq: PYPD) announced that Phase 2 clinical data for D-PLEX100 will be presented at the European Society for Coloproctology Scientific Conference from September 21-23, 2022, in Dublin, Ireland. The lead candidate D-PLEX100 is designed to prevent surgical site infections through a controlled release of doxycycline for 30 days. The presentation, by Dr. Anthony J. Senagore, aims to highlight the product's potential in improving surgical outcomes.
PolyPid Ltd. announced top-line results from its SHIELD I Phase 3 study of D-PLEX100 for preventing surgical site infections (SSIs) in abdominal surgery. The trial did not achieve its primary endpoint of reducing SSIs and mortality overall, with a 23% reduction in SSIs (p=0.1520). However, a subgroup analysis of patients with incision lengths over 20 cm showed a significant 54% reduction in SSIs (p<0.0032). The independent Data Safety Monitoring Board found no safety concerns. PolyPid plans to discuss results with the FDA and further assess next steps.
PolyPid Ltd. (Nasdaq: PYPD) announced the presentation of Phase 2 clinical and animal study data for D-PLEX100 at the 2022 Military Health System Research Symposium from September 12-15, 2022. The podium presentation will address D-PLEX100's efficacy in reducing surgical site infection rates and drug-resistant bacteria in surgical trauma injuries. This presentation will be led by Noam Emanuel, PhD, Co-Founder and Chief Scientific Officer. D-PLEX100 is currently in Phase 3 trials aimed at preventing surgical site infections.
PolyPid Ltd. (Nasdaq: PYPD) announced an exclusive licensing agreement with ADVANZ PHARMA for D-PLEX100, targeting over $110 million in upfront and milestone payments, plus potential royalties. The agreement aims to commercialize D-PLEX100 for preventing surgical site infections in Europe. The independent Data Safety Monitoring Board recommended concluding the Phase 3 SHIELD I trial after 950 patient enrollments. Top-line results are expected by the end of Q3 2022, with potential NDA submission in 2023. For Q2 2022, the company reported a loss of $11.8 million, increasing R&D expenses to $8.4 million.
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