Polypid Ltd. Stock Price, News & Analysis

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.

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.