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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 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.
PolyPid Ltd. (Nasdaq: PYPD) has partnered with ADVANZ PHARMA to commercialize D-PLEX100 in Europe for preventing surgical site infections (SSIs) in abdominal and cardiac surgeries. The agreement offers PolyPid an upfront payment of $2.6 million and a total of up to $23.5 million in developmental milestones. Additionally, PolyPid anticipates up to $89 million in sales-related milestones and royalties on net sales. This collaboration leverages ADVANZ PHARMA's expertise and resources to enhance access to this vital therapy, pending approval.
PolyPid Ltd. (Nasdaq: PYPD) announced the upcoming release of its Q2 2022 financial results and operational highlights on August 10, 2022, before U.S. market open. A conference call is set for 8:30 a.m. Eastern Time to discuss the results and business updates. PolyPid is a late-stage biopharma company focused on improving surgical outcomes, leveraging its PLEX technology for drug delivery. Their lead candidate, D-PLEX100, is in Phase 3 trials targeting surgical site infections.
PolyPid Ltd. (Nasdaq: PYPD) announced that Phase 2 clinical data for its lead product candidate D-PLEX100 will be presented at the Midwest Surgical Association 2022 Annual Meeting on August 8, 2022. This podium presentation, titled Reduction in Surgical Site Infections by Localized Administration with D-PLEX100 in Patients with Multiple Risk Factors Undergoing Colorectal Surgery, will be given by Senior Medical Director Dr. Anthony J. Senagore. D-PLEX100 aims to prevent infections post-abdominal surgery.
PolyPid Ltd. (Nasdaq: PYPD) has announced the appointment of Dikla Czaczkes Akselbrad as the new CEO, effective July 1, 2022. Formerly the Executive Vice President and CFO, Akselbrad brings over 20 years of experience in life sciences. Her leadership is expected to be vital as the company prepares for a potential New Drug Application submission and the commercialization of D-PLEX100. The company recently completed its SHIELD I Phase 3 study, with top-line results anticipated by the end of the current quarter.
PolyPid Ltd. (Nasdaq: PYPD) announced a webinar on June 23, 2022, featuring key opinion leaders discussing the costs of managing surgical site infections (SSIs). Presentations will include insights from Dr. Kyle Cologne and Dr. Elliot Goodman. The company's leadership will also provide an update on the SHIELD I Phase 3 clinical trial for D-PLEX100, aimed at preventing SSIs in abdominal surgery. This marks a significant milestone following the completion of patient enrollment. Interested participants can register for the event online.
PolyPid Ltd. (Nasdaq: PYPD) announced that data from its Phase 2 clinical trial of D-PLEX100 for preventing surgical site infections in elective colorectal surgery will be presented at the ASM Microbe 2022 conference on June 9-13, 2022. The study evaluates D-PLEX100 alongside standard infection prophylaxis. Dr. Judith Steenbergen will present findings on the impact of the doxycycline-eluting formulation. PolyPid's D-PLEX100 is a lead candidate in Phase 3 trials, targeting soft tissue infections.
PolyPid Ltd. (Nasdaq: PYPD), a late-stage biopharma company, will present at the JMP Securities 2022 Life Sciences Conference in New York City on June 15-16, 2022. The presentation is scheduled for June 15 at 11:00 AM Eastern Time. PolyPid focuses on improving surgical outcomes through its proprietary PLEX technology, which allows controlled, prolonged release of therapeutics. The lead product candidate, D-PLEX100, is currently in Phase 3 trials targeting surgical site infections. For inquiries, investors can reach out to their JMP representatives.
PolyPid Ltd. (Nasdaq: PYPD) announced promising animal study results regarding its lead product candidate, OncoPLEX, presented at the ASCO 2022 Annual Meeting. The studies indicate that locally administered OncoPLEX, which employs the PLEX technology for extended release of docetaxel, significantly reduces local tumor recurrence compared to systemic chemotherapy. In the CT26 model, 75% of OncoPLEX-treated animals were tumor-free versus 25% for the control. Similarly, 80% of U-87 model animals treated with OncoPLEX were tumor-free compared to 30% with the control. The Company plans to initiate a Phase 1/2 study.
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