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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 the FDA approved an unblinded interim analysis for its Phase 3 SHIELD I trial of D-PLEX100, aimed at preventing surgical site infections in abdominal surgeries. The company is on track to enroll 750 patients by Q1 2022, with the interim analysis expected in Q2 2022. Financial results for Q4 2021 show a loss of $13.2 million, up from $7.5 million in Q4 2020, while full-year losses totaled $42.3 million. As of Dec 31, 2021, cash reserves were $32.2 million, expected to sustain operations through 2022.
PolyPid Ltd. (Nasdaq: PYPD) announced it will release its fourth quarter and full year 2021 financial results on February 9, 2022, before the U.S. market opens. The company will hold a conference call at 8:30 AM ET to discuss these results and provide operational updates. PolyPid specializes in developing targeted, long-lasting therapeutics through its proprietary PLEX technology, with its lead product candidate, D-PLEX100, currently undergoing Phase 3 trials aimed at preventing surgical site infections.
PolyPid Ltd. (Nasdaq: PYPD) has appointed Dr. Mitchel S. Berger to its Oncology Advisory Board to enhance its expertise in brain tumor treatment. Dr. Berger, a leading figure in neurosurgery, is expected to contribute significantly to the development of OncoPLEX, PolyPid’s intra-tumoral therapy targeting glioblastoma multiforme (GBM). The company plans to initiate a Phase 1/2 clinical trial for OncoPLEX by the end of 2022, following positive preclinical results. This advancement aims to improve local chemotherapy delivery and patient outcomes in challenging brain tumors.
PolyPid Ltd. (Nasdaq: PYPD) announced the appointment of Dikla Czaczkes Akselbrad as its new CEO, effective July 1, 2022. Akselbrad, previously the company's EVP and CFO, takes over from Amir Weisberg, who has led PolyPid for over 11 years. During her tenure, she has played a vital role in guiding the company through significant financial and operational transitions. PolyPid is advancing its Phase 3 clinical program for D-PLEX100, aimed at preventing surgical site infections, while preparing for commercial launch.
PolyPid Ltd. (PYPD) announced enrollment of the 500th patient in its Phase 3 SHIELD I study evaluating D-PLEX100 for preventing surgical site infections (SSIs) following abdominal surgery. The company aims to complete enrollment by Q2 2022 and expects top-line results two months later. D-PLEX100 offers prolonged antibiotic release at the surgical site and has received Breakthrough Therapy Designation from the FDA.
SHIELD I involves around 900 patients across 60 centers in the U.S., Europe, and Israel. Positive trial results could lead to FDA approval.
PolyPid Ltd. (Nasdaq: PYPD) announced the appointment of Frederick Lang, M.D., to its Oncology Advisory Board, effective November 2021. Dr. Lang, a prominent figure at MD Anderson, co-leads the Glioblastoma Moon Shot initiative, focusing on brain cancer. The company is set to conduct a pre-IND meeting with the U.S. FDA later this month to potentially initiate a Phase 1/2 clinical trial of its intra-tumoral therapy, OncoPLEX, in 2022. OncoPLEX aims to enhance localized drug delivery for treating aggressive brain tumors, addressing significant treatment challenges.
PolyPid Ltd. (PYPD) announced significant recruitment progress in its Phase 3 SHIELD I trial of D-PLEX100, with about 480 patients enrolled to date. Following FDA agreement that a single pivotal study suffices for potential approval, the company aims to reach approximately 900 patients for robust data. Cash runway has extended to year-end 2022, a notable improvement from earlier estimates. Despite a net loss of $9.9 million for Q3 2021, a decrease from $6.5 million in Q3 2020, PolyPid remains positioned for clinical and commercial advancements.
PolyPid Ltd. (Nasdaq: PYPD) will report its third quarter 2021 financial results and operational highlights on November 10, 2021, before U.S. markets open. The company is focused on developing therapeutics using its PLEX technology, currently advancing its lead candidate D-PLEX100 through Phase 3 clinical trials aimed at preventing surgical site infections. A conference call and webcast will take place at 8:30 AM ET on the same day to discuss results and updates.
PolyPid Ltd. (Nasdaq: PYPD) announced its participation in the Cantor Fitzgerald Virtual Global Healthcare Conference scheduled for September 29 at 2:00 PM EDT. During the event, Dikla Czaczkes Akselbrad, EVP and CFO, will present corporate highlights and discuss recent developments, particularly focusing on PolyPid's Phase 3 clinical trials for its lead product candidate D-PLEX100, aimed at preventing surgical site infections.
PolyPid specializes in developing targeted therapeutics using its proprietary PLEX technology.
PolyPid Ltd. (Nasdaq: PYPD) announced promising preclinical results for OncoPLEX, a therapy designed for glioblastoma multiform (GBM), demonstrating significant inhibition of tumor growth in two animal models. A single application of OncoPLEX achieved 98% tumor growth inhibition and a 60% survival rate after 41 days, outperforming systemic treatments. The company is preparing for a pre-IND meeting with the U.S. FDA by year-end and aims to initiate a phase 1/2 clinical trial in 2022. The results highlight OncoPLEX's potential to improve patient outcomes in aggressive brain tumors.
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