PolyPid reports Q3 EPS (48c), consensus (54c)

"Since the top-line results were announced, we have continued to gather and analyze additional data from SHIELD I," stated Dikla Czaczkes Akselbrad, PolyPid’s Chief Executive Officer. "These data have been increasingly encouraging. While SHIELD I did not meet its primary endpoint, the significant reduction in SSIs in complex surgeries with large incisions and in high-risk patients, as well as the safety data, are very compelling. As such, we are in the process of preparing a comprehensive package of D-PLEX100 data for a planned meeting with the U.S. Food and Drug Administration (FDA). We expect to meet the FDA and EU regulatory authorities regarding the regulatory pathway for D-PLEX100 in the first quarter of 2023. In parallel to preparing for these important regulatory interactions, we recently implemented a cost reduction plan, including a 20% decrease in headcount across all departments," continued Ms. Czaczkes Akselbrad. "We expect that these significant measures will extend our cash runway into the third quarter of 2023 in support of the Company’s long-term growth strategy."