07:06 AM EST, 12/24/2024 (MT Newswires) -- PolyPid ( PYPD ) said Tuesday it now expected to complete patient enrollment for its late-stage trial of D-PLEX100, used to prevent surgical site infections, in the first quarter of 2025, with top-line results from the study expected in Q2, following a review of efficacy data from an independent safety monitoring board.

After reviewing efficacy data from the first 430 enrolled in the phase 3 trial, the independent board recommended that the company could conclude the study upon enrollment of 800 patients and confirmed the "good safety profile of D-PLEX100 in SHIELD II to date," the company said.

This was the lowest sample size reassessment stop after the minimum planned number of 624 patients, it added.

The study had enrolled 630 patients to date and enrollment of the last 170 patients is expected to occur in the first quarter of 2025.

The company said it is now focused on completing the trial, while advancing planned New Drug and Marketing Authorization application submissions, and speeding up partnership discussions.

PolyPid ( PYPD ) also said it has entered into a securities purchase agreement for a private placement round of financing led by existing institutional shareholders for $14.5 million in gross proceeds and priced at $3.22 per share.

Under the purchase agreement, the investors have agreed to purchase 4.5 million shares or pre-funded warrants at $3.22 per share, the company said. The investors will also receive warrants to purchase up to 6.7 million shares at an exercise price of $4.00 per share, the company said.

The placement is expected to close on Thursday, the company said.