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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 that its Co-Founder and CSO, Dr. Noam Emanuel, will present virtually at the World Association against Infection in Orthopaedics and Trauma Congress on August 28, 2021. The presentation, titled Improved Healing of Gustilo Type IIIA and IIIB Open Long Bone Fractures, focuses on a clinical trial of a biodegradable antibiotic bone graft. This session aims to discuss septic non-union and bone loss management and will be attended by 1,700 members globally.
PolyPid Ltd. (PYPD) announced significant recruitment progress in its Phase 3 SHIELD I trial for D-PLEX100, with over 300 patients enrolled. The FDA indicated that a single Phase 3 study might suffice for D-PLEX100's approval in colorectal surgery. Additionally, PolyPid has chosen brain tumors as the initial target for its OncoPLEX therapy. Financially, R&D expenses rose to $7.4 million in Q2 2021, while net losses decreased to $10.5 million compared to $19.1 million in 2020. The company maintains a cash position of $52.9 million, projected to sustain operations into late 2022.
PolyPid Ltd. (Nasdaq: PYPD), a biopharma company focused on improving surgical outcomes with advanced therapeutics, announced that Dikla Czaczkes Akselbrad, Executive Vice President and CFO, will present at the Investor Summit Virtual Conference on August 18, 2021, at 9:30 am ET. The event is scheduled from August 17-18, 2021, with opportunities for one-on-one meetings throughout. PolyPid's lead product candidate, D-PLEX100, is currently in Phase 3 clinical trials aimed at preventing surgical site infections.
PolyPid Ltd. (Nasdaq: PYPD) announced its second quarter 2021 financial results will be reported before the U.S. markets open on August 11, 2021. The company will hold a conference call at 8:30 AM Eastern Time to discuss these results and operational updates. PolyPid specializes in locally administered therapeutics aimed at improving surgical outcomes, with its lead candidate D-PLEX100 currently in Phase 3 trials to prevent surgical site infections. The company emphasizes its proprietary PLEX technology for effective drug delivery.
PolyPid Ltd. (Nasdaq: PYPD) has appointed renowned colorectal surgeon Dr. Anthony J. Senagore as its Senior Medical Director. Dr. Senagore will lead the development of PolyPid’s medical infrastructure in the U.S. and play a pivotal role in the NDA submission for D-PLEX100, aimed at preventing surgical site infections (SSIs). His extensive experience in surgery and healthcare economics is expected to enhance the company’s mission to improve surgical outcomes. The D-PLEX100 candidate is currently in Phase 3 clinical trials.
PolyPid (Nasdaq: PYPD) announced a presentation by CFO Dikla Czaczkes Akselbrad at The Raymond James Human Health Innovation Conference on June 23, 2021, at 9:20 am EDT. The conference aims to highlight innovations in healthcare, with PolyPid focusing on improving surgical outcomes through its proprietary PLEX technology, which enhances drug delivery. The lead candidate, D-PLEX100, is undergoing Phase 3 trials for preventing surgical site infections. The presentation will be available on the company’s Investor Relations site for 90 days following.
PolyPid Ltd. (Nasdaq: PYPD) is a biopharma company focused on enhancing surgical outcomes with controlled, extended-release therapeutics. On June 2, 2021, the company announced its executive team will present at three upcoming healthcare investor conferences: the LD Micro Invitational XI on June 10, the JMP Securities Life Sciences Conference on June 16, and the Raymond James Human Health Innovation Conference on June 21. The Raymond James presentation will be webcast live and available for 90 days on PolyPid's Investor Relations website.
PolyPid Ltd. (PYPD) announced FDA approval for a single pivotal Phase 3 study of D-PLEX100 for preventing surgical site infections (SSIs) in colorectal surgery. This decision is based on the adequate results expected from the SHIELD I trial, which has already enrolled over 200 patients. The trial aims to include a total of 616 to 900 participants across multiple centers and is set to deliver top-line results by year-end 2021. This breakthrough designation could expedite development and reduce costs significantly, addressing a major healthcare issue costing up to $10 billion annually.
PolyPid Ltd. (Nasdaq: PYPD) announced significant recruitment progress in its Phase 3 SHIELD I trial of D-PLEX100, with nearly 200 patients enrolled, a doubled recruitment rate in the last three weeks. The manufacturing facility is fully equipped to meet the first 30 months of commercial demand for D-PLEX100. Financial results reveal a net loss of $8.7 million for Q1 2021, an increase from $5.9 million in Q1 2020. Cash reserves stand at $61.4 million, expected to sustain operations into 2022. Top-line results for SHIELD I are anticipated by year-end 2021.
PolyPid Ltd. (Nasdaq: PYPD) announced it will release its first quarter 2021 financial results on May 12, 2021, before the U.S. market opens. A conference call is scheduled for 8:30 AM ET to discuss the results and business updates. PolyPid is focused on enhancing surgical outcomes through its patented PLEX technology, which offers controlled drug delivery over extended periods. Their lead candidate, D-PLEX100, is currently undergoing Phase 3 trials targeting surgical site infections.
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