PolyPid Ltd. announced on December 24, 2024, that the independent Data Safety Monitoring Board (DSMB) recommended continuing enrollment of the SHIELD II Phase 3 trial for D-PLEX100 to 800 patients. This recommendation, based on unblinded efficacy data from the first 430 enrolled patients, is considered suggestive of positive efficacy signals.
The DSMB also confirmed the good safety profile of D-PLEX100 in the trial to date. Enrollment completion is now expected in the first quarter of 2025, with top-line results anticipated in the second quarter of 2025.
Concurrently, PolyPid entered into a private placement financing agreement for $14.5 million in gross proceeds, priced at $3.22 per share. Investors will also receive warrants to purchase up to 6,740,745 ordinary shares at an exercise price of $4.00 per share, which, if fully exercised, would provide an additional $27.0 million in gross proceeds, bringing the total potential financing to $41.5 million.
The PIPE financing is expected to close on December 26, 2024, and the gross proceeds are projected to extend PolyPid’s cash runway into the third quarter of 2025. If all warrants are exercised, the company expects to have capital beyond potential New Drug Application (NDA) approval.
PolyPid expects to submit an NDA for D-PLEX100 under Fast Track and Breakthrough Therapy designations upon potential positive Phase 3 data. Additionally, Yitzchak Jacobovitz, CFA, partner and lead healthcare analyst at AIGH Capital Management, is being considered for appointment to the Company's board of directors.
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