PolyPid Ltd. Q4 FY2024 earnings call

• Critical advancement with DSMB recommendation to conclude SHIELD II Phase 3 trial after enrolling 800 patients, expecting top-line results in Q2 2025 and potential NDA submission with Fast Track and Breakthrough Therapy designations.
• Entered a $14.5M private placement financing, extending cash runway into Q3 2025.
• Welcomed Yitzchak Jacobovitz to the Board of Directors.
• SHIELD II trial has enrolled over 700 patients, expected to complete enrollment next month.
• Discussed U.S. market potential for D-PLEX100 with TAM over 12 million surgeries annually, partnering efforts including exclusive license with Advanced Pharma for Europe, and collaboration with ImmunoGenesis to combine PolyPid's technology with ImmunoGenesis’ STING agonist for solid tumor treatment.

No specific product segment financial performance discussed as the transcript does not break down by product segments. Financial highlights: Q4 2024 R&D expenses $7M vs $4.6M in 2023 Q4; full-year 2024 R&D expenses $22.8M vs $16.1M in 2023; Q4 2024 net loss $8.5M vs $6.4M in 2023 Q4; full-year 2024 net loss $29M vs $23.9M in 2023.

• Gross proceeds from recent financing extend the cash runway into Q3 2025.
• Expect to report SHIELD II top-line results in Q2 2025.
• Plan to submit an NDA with Fast Track and Breakthrough Therapy designations upon positive Phase 3 data.
• Exercise of warrants from the financing could provide an additional $27M in gross proceeds, extending capital beyond NDA approval.

• Forward-looking statements are subject to numerous risks and uncertainties, including those detailed in SEC filings, which could cause actual results to materially differ from projections.

Q: Expectations for label and commercialization plans.

A: Expect label in the abdominal surgery area initially with a detailed plan to expand, seeking an ideal partner with presence in the surgery suite and hospital.

Q: Enrollment dynamics and readout timing.

A: Enrollment is in line with expectations, expects last patient in March, and top-line results around a quarter after last patient enrollment.

Q: Ideal commercial partner properties and responsibilities.

A: Ideal partner has presence in the surgery suite, with PolyPid handling global marketing, medical, and HEOR; the partner handling day-to-day on-ground activities.

Q: R&D platform and ImmunoGenesis collaboration.

A: Platform worked with chemotherapy, growth factors, steroids, analgesics; collaboration aims to enhance STING agonist activity via prolonged drug release.

Q: Label language and capital allocation.

A: Plan to have a pre-NDA meeting with the FDA to discuss label and expansion, and look to partner earlier for future development of new indications