PolyPid provides corporate update

The independent Data Safety Monitoring Board recommended to conclude the SHIELD II Phase 3 trial of D-PLEX100 upon enrollment of 800 patients in the study, which is the lowest sample size reassessment stop after the minimum planned number of patients. The study has enrolled more than 700 patients to date and enrollment of the last patient is expected to occur in March 2025. The Company anticipates reporting top-line results in the second quarter of 2025. Upon potential positive Phase 3 data, PolyPid (PYPD) expects to submit a New Drug Application with the advantages of the Fast Track and Breakthrough Therapy designations. Concurrent with the DSMB’s positive recommendation, as previously reported, PolyPid entered into a securities purchase agreement for a private placement financing led by existing institutional shareholders for $14.5M in gross proceeds. Under the securities purchase agreement, the investors also received warrants which will expire upon the earlier of nine months from the date of issuance and 10 trading days following PolyPid’s announcement of top-line results from its SHIELD II Phase 3 trial. Exercise of the warrants in full would result in an additional $27M in gross proceeds to the Company. 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. Announced a research and development collaboration with ImmunoGenesis, Inc. which focuses on the development of novel formulations utilizing PolyPid’s experience with its proprietary PLEX Technology and ImmunoGenesis’ potent STimulator of INterferon Genes agonist drug candidate to potentially enhance treatment for solid tumors. Appointed Mr. Yitzchak Jacobovitz, CFA, to the Board of Directors, effective as of February 10, 2025. Mr. Jacobovitz is a partner and lead healthcare analyst at AIGH Capital Management and affiliates.