PolyPid reports Q4 EPS ($1.13), consensus (88c)

“We are thrilled with the impressive clinical and operational progress achieved in 2024 and believe that we are well-positioned for a potentially transformational year in 2025,” stated Dikla Czaczkes Akselbrad, CEO. “Importantly, we remain confident that the DSMB’s recent recommendation to conclude SHIELD II upon the enrollment of 800 patients is suggestive of positive efficacy signals from D-PLEX100. Moreover, the sample size reassessment was an opportunity to ensure the study has sufficient power to conclusively confirm D-PLEX100’s treatment benefit, and we believe this increases the trial’s overall probability of success. We continue to focus on completing the trial, while advancing our planned NDA and Marketing Authorization Application submissions, preparing pre-launch activities, and expediting partnership discussions in and outside of the United States. We are also excited to welcome Mr. Jacobovitz to the Board of Directors and are pleased that AIGH was the lead investor in our most recent equity offering. Mr. Jacobovitz brings extensive healthcare investment experience to our board and we look forward to his contributions.”