Polypid Ltd. Stock Price, News & Analysis

PolyPid Ltd. (Nasdaq: PYPD) has received a notice from Nasdaq indicating non-compliance with the minimum bid price requirement of $1.00 per share. The company has 180 days until June 5, 2023, to regain compliance. During this grace period, trading of PYPD shares will continue on Nasdaq. If PolyPid fails to meet the requirement, it may be eligible for an additional compliance period, provided it meets other listing standards. The notice does not immediately affect the company’s listing status.

PolyPid Ltd. (Nasdaq: PYPD) announced the presentation of Phase 2 clinical data for D-PLEX₁₀₀ aimed at preventing surgical wound infections, including those caused by multi-drug resistant organisms. This will occur at the International Orthopaedic Trauma Association meeting from December 14-16, 2022, in Amsterdam. The presentation, titled 'Surgical wound infection reduction with locally administered product releasing doxycycline,' will be delivered by Chief Scientific Officer Noam Emanuel. D-PLEX₁₀₀ is currently in Phase 3 trials for soft tissue infections.

PolyPid Ltd. (PYPD) announced its corporate update and financial results for Q3 2022, reporting a net loss of $9.3 million, reduced from $9.9 million year-over-year. The company plans to engage with U.S. and EU regulators regarding the D-PLEX100 Phase 3 study outcomes and has noted a 54% reduction in surgical site infections for specific subpopulations. A cost reduction plan, including a 20% workforce cut, aims to extend cash runway into Q3 2023, with available funds reported at $18.1 million.

PolyPid Ltd. (Nasdaq: PYPD) announced it will release its third quarter 2022 financial results and operational updates on November 9, 2022, prior to the U.S. market opening. The company will host a conference call at 8:30 AM ET to discuss these results. PolyPid focuses on enhancing surgical outcomes through its PLEX technology, deploying drug delivery systems that provide controlled release of pharmaceuticals. Its lead candidate, D-PLEX100, is in Phase 3 trials for infection prevention following surgeries.

PolyPid Ltd. (Nasdaq: PYPD) has announced a substantial 20% reduction in headcount as part of a cost-cutting plan aimed at extending its financial runway into Q3 2023. This initiative aligns with their preparations for discussions with U.S. and EU regulatory authorities regarding D-PLEX100 for preventing surgical site infections (SSIs) in abdominal surgeries. Notably, the company received confirmation from the European Medicines Agency for the eligibility of D-PLEX100’s Marketing Authorization Application under the centralized procedure.

PolyPid Ltd. (Nasdaq: PYPD) has announced that the European Medicines Agency (EMA) confirmed D-PLEX₁₀₀ is eligible for a centralized Marketing Authorization Application (MAA). This allows D-PLEX₁₀₀ to be marketed across all EU member states upon approval. The centralized procedure highlights D-PLEX₁₀₀ as a potential new option for preventing post-abdominal surgical site infections (SSIs). The company is also evaluating data from its recent Phase 3 SHIELD I trial and plans discussions with regulatory authorities in early 2023.

PolyPid Ltd. (Nasdaq: PYPD) announced positive clinical data from a Phase 2 study of D-PLEX₁₀₀, aimed at preventing surgical site infections (SSIs) in abdominal surgery. The study showed a 64% relative risk reduction in infection rates, with 8% in the D-PLEX₁₀₀ group compared to 22% in the control group. Following the results, the company plans to meet with FDA and EU regulatory authorities in Q1 2023 to discuss next steps for D-PLEX₁₀₀ as it transitions into Phase 3 trials. The product has already received Breakthrough Therapy Designation from the FDA.

PolyPid Ltd. (Nasdaq: PYPD) announced that Phase 2 clinical data for D-PLEX₁₀₀ will be presented at the European Society for Coloproctology Scientific Conference from September 21-23, 2022, in Dublin, Ireland. The lead candidate D-PLEX₁₀₀ is designed to prevent surgical site infections through a controlled release of doxycycline for 30 days. The presentation, by Dr. Anthony J. Senagore, aims to highlight the product's potential in improving surgical outcomes.

PolyPid Ltd. announced top-line results from its SHIELD I Phase 3 study of D-PLEX100 for preventing surgical site infections (SSIs) in abdominal surgery. The trial did not achieve its primary endpoint of reducing SSIs and mortality overall, with a 23% reduction in SSIs (p=0.1520). However, a subgroup analysis of patients with incision lengths over 20 cm showed a significant 54% reduction in SSIs (p<0.0032). The independent Data Safety Monitoring Board found no safety concerns. PolyPid plans to discuss results with the FDA and further assess next steps.