PolyPid announces DSMB recommendation to continue Phase 3 D-PLEX study

The company states: “PolyPid (PYPD) announced that following the independent Data Safety Monitoring Board’s, DSMB, review of unblinded efficacy data from the first 430 enrolled patients in the SHIELD II Phase 3 trial for D-PLEX100 for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery with large incisions, the DSMB’s recommendation was to conclude the study upon enrollment of 800 patients, which is the lowest sample size reassessment stop after the minimum planned number of 624 patients. At this interim analysis, the DSMB also had the option to recommend stopping SHIELD II due to futility or overwhelming efficacy or to reassess the trial’s sample size to a maximum of 1,100 patients. In addition, the DSMB’s confirmed the good safety profile of D-PLEX100 in SHIELD II to date. The study has enrolled 630 patients to date and enrollment of the last 170 patients is expected to occur in the first quarter of 2025. The Company anticipates reporting top-line results in the second quarter of 2025. Upon potential positive Phase 3 data, the Company expects to submit an NDA with the advantages of the Fast Track and Breakthrough Therapy designations, which were granted to D-PLEX100 in 2020. PolyPid also announced that it has entered into a securities purchase agreement for a private placement financing – the “PIPE” – led by existing institutional shareholders for $14.5M in gross proceeds priced at $3.22 per share, the closing price on December 20, 2024. In connection with the PIPE financing, the Company has agreed to consider Yitzchak Jacobovitz, CFA, partner and lead healthcare analyst at AIGH Capital Management, for appointment to the Company’s board of directors. The PIPE is expected to close on December 26, 2024, subject to the satisfaction of customary closing conditions. The Company intends to use the net proceeds from the sale of the securities for its ongoing SHIELD II Phase 3 clinical trial, working capital and general corporate purposes. The gross proceeds from the financing extend PolyPid’s cash runway into the third quarter of 2025, beyond expected top-line results from SHIELD II. Proceeds of all warrants issued in this transaction, if exercised, would provide the Company with capital beyond NDA approval. Citizens JMP is acting as exclusive placement agent in the offering.”