Polypid Ltd. Stock Price, News & Analysis

PolyPid Ltd. (Nasdaq: PYPD) announced the enrollment of the 750^th patient in its pivotal Phase 3 SHIELD I study evaluating D-PLEX₁₀₀ for preventing surgical site infections (SSIs) in abdominal surgery. An unblinded interim analysis is expected in Q2 2022, allowing potential early trial conclusion based on efficacy or futility. The FDA has indicated that a single pivotal study may suffice for D-PLEX₁₀₀'s approval, given adequate results. D-PLEX₁₀₀ uses a novel technology for prolonged antibiotic release at the surgical site.

PolyPid Ltd. (Nasdaq: PYPD) announced its participation in the Barclays Global Healthcare Conference from March 15-17, 2022. The company will present on March 16 at 9:00 AM Eastern Time. PolyPid specializes in Phase 3 biopharmaceutical developments, focusing on targeted, locally administered, prolonged-release therapeutics via its proprietary PLEX technology. Its lead product candidate, D-PLEX100, is undergoing clinical trials aimed at preventing surgical site infections.

Investors interested in the conference can contact Barclays representatives for meetings.

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.