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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) reports significant updates as of February 10, 2021. The company has enrolled 100 patients in the Phase 3 trials of D-PLEX100 aimed at preventing surgical site infections (SSIs) in abdominal surgeries. D-PLEX100 has received Breakthrough Therapy Designation from the FDA specifically for elective colorectal surgery. PolyPid also announced positive preclinical data for its new OncoPLEX cancer therapy and maintains a robust financial position with $66.6 million in cash as of December 31, 2020, following a successful IPO. Top-line results from SHIELD I are anticipated by year-end 2021.
PolyPid Ltd. (Nasdaq: PYPD) announced it will report its Q4 and full year 2020 financial results on February 10, 2021, before U.S. markets open. The company will hold a conference call at 8:30 AM ET to discuss the results and operational updates. PolyPid focuses on improving surgical outcomes with its proprietary PLEX technology that allows for targeted, prolonged-release therapeutics. Its lead product, D-PLEX100, is in Phase 3 trials for preventing surgical site infections.
PolyPid Ltd. (Nasdaq: PYPD) announced positive preclinical data for its OncoPLEX cancer therapy, demonstrating improved overall survival and reduced tumor recurrence in a syngeneic mouse model for colon carcinoma. A single local treatment of OncoPLEX showed a 25% tumor recurrence rate versus 75% in the systemic treatment group, and 75% overall survival compared to 50%. Systemic toxicity was also significantly lower. The company plans to complete an IND package with further preclinical studies and initiate a Phase 1 clinical trial in 2022, showcasing the potential of its novel PLEX technology for cancer treatment.
PolyPid Ltd. (PYPD) announced the enrollment of the first patient in its Phase 3 clinical trial, SHIELD II, for its D-PLEX100 product candidate aimed at preventing surgical site infections (SSIs) post-abdominal surgery. This follows the FDA's Breakthrough Therapy Designation for D-PLEX100. The trial aims to involve up to 1,400 patients across 60 centers. Top-line results from the ongoing SHIELD I trial are expected in the second half of 2021, which, along with SHIELD II, will support the company's New Drug Application submission.
PolyPid Ltd. (Nasdaq: PYPD) announced it will host a key opinion leader (KOL) call on D-PLEX100 on December 15, 2020, at 8:00 AM ET. The call will feature experts discussing the challenges of surgical site infections (SSIs) following colorectal and cardiovascular surgeries and how D-PLEX100 can help. KOLs include Dr. Hartzell Schaff, Dr. Anthony Senagore, and Dr. Oded Zmora. D-PLEX100 is designed to prevent SSIs through prolonged release of doxycycline at surgical sites. The FDA has granted it Breakthrough Therapy Designation for elective colorectal surgeries.
PolyPid Ltd. (Nasdaq: PYPD) has received Breakthrough Therapy Designation from the FDA for D-PLEX100, aimed at preventing surgical site infections in elective colorectal surgery. This designation, attributed to promising Phase 2 clinical trial results, shows a 59% reduction in infections in the Intent to Treat population (p=0.0086) and 69% in the Per Protocol population (n=179; p=0.0024). D-PLEX100 also holds two Fast Track Designations and is in ongoing Phase 3 studies, demonstrating its potential in addressing serious surgical infection risks.
PolyPid Ltd. (Nasdaq: PYPD) announced significant progress in its Phase 3 SHIELD I trial for D-PLEX100, with over 50% of the 60 planned sites receiving IRB approval. The trial aims to prevent surgical site infections (SSIs) in abdominal surgery, enrolling 600-900 patients. Preparations for the second Phase 3 trial, SHIELD II, are underway. The company reported a net loss of $6.5 million for Q3 2020, up from $2.1 million in Q3 2019, and a total net loss of $31.4 million for the nine months ending September 30, 2020. Cash balance as of September 30, 2020, was $71.8 million, sufficient to fund operations into 2022.
PolyPid Ltd. (Nasdaq: PYPD) announced its participation in two investor conferences in November 2020. The company will present at the H.C. Wainwright 6th Annual Israel Conference on November 12 at 1:30 PM ET and at the Stifel 2020 Virtual Healthcare Conference on November 17 at 8:00 AM ET. Additionally, PolyPid will engage in one-on-one meetings during the AGP Virtual Healthcare Symposium on November 19. The company specializes in prolonging drug release using its proprietary PLEX technology, focusing on unmet medical needs, particularly with its lead product candidate, D-PLEX100, in Phase 3 trials.
PolyPid Ltd. (Nasdaq: PYPD) will report its third quarter 2020 financial results on November 11, 2020, before U.S. markets open. The company, focused on Phase 3 clinical development of its PLEX technology for prolonged-release therapeutics, will host a conference call at 8:30 AM ET to discuss results and business operations. Its lead candidate, D-PLEX100, targets surgical site infections and is in Phase 3 trials for various surgeries. More details can be found on the company's website.
PolyPid Ltd. (Nasdaq: PYPD) has initiated the SHIELD I trial, its first Phase 3 clinical study for D-PLEX100, aimed at preventing post-abdominal surgery incisional infections. The trial, which has enrolled its first patient, will assess the efficacy and safety of D-PLEX100 compared to standard care. Funded by a commitment to address surgical site infections, D-PLEX100 has previously shown significant promise in Phase 2 trials. Approximately 616 to 900 patients will be enrolled across 50 centers in the U.S., Europe, and Israel.
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