PolyPid Ltd. Q1 FY2025 earnings call

• Successfully concluded enrollment of the SHIELD 2 Phase 3 trial assessing D-PLEX100 for preventing surgical site infections in abdominal colorectal surgery patients.
• Approaching top line data from SHIELD 2 by the end of the next month.
• Anticipates submitting an NDA with fast track and breakthrough therapy designations in early 2026 and a MAA in the EU shortly after.
• Funded into the third quarter of 2025 via December 2024 $15 million financing, with potential additional $27 million from warrant exercise.
• Progressing regulatory submissions, finalizing CMC and non-clinical NDA modules, and advancing pre-launch activities and partnering discussions.

As of March 31, 2025, PolyPid had cash and cash equivalents of $8 million. Research and development expenses for the three months ended March 31, 2025, were $6.1 million compared to $5.1 million in the same period in 2024. Marketing and business development expenses for the first quarter of 2025 were $0.3 million compared to $0.2 million in the prior year period. General and administrative expenses for the first quarter of 2025 were $1.2 million compared to $1 million in the same period in 2024. The company had a net loss of $8.3 million for the first quarter of 2025 compared to $6.4 million in the first quarter of 2024.

• Funded into the third quarter of 2025 beyond SHIELD 2 top line results.
• Potential additional $27 million from warrant exercise could extend runway beyond NDA approval.
• Anticipates top line results from SHIELD 2 by end of next month.

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

Q: Can you discuss the price per vial for D-PLEX100?

A: Pricing strategy not finalized; preliminary research done, with pricing potentially refined post-top line data. Dosing is 1-3 vials per procedure, average assumption of 2.5 vials, with preliminary pricing of $600 per vial being considered.

Q: For SHIELD 2, was there a strict requirement for the number of vials used per procedure?

A: There is a strict requirement on incision size; the primary endpoint statistical analysis doesn't include patients with smaller incisions.

Q: On NDA filing timing, what's required between data and filing?

A: NDA is composed of CMC, preclinical, and clinical modules. CMC and preclinical are in finalization; plan to meet FDA for pre-NDA meeting and submit early 2026.

Q: On SHIELD 2 top line data, what will be reported?

A: Will report primary endpoint (combination of SSI, mortality, re-intervention) and secondary endpoint (SSI alone), with plans to share data soon after un-blinding.

Q: On commercial manufacturing and inspection readiness, any preliminary thoughts?

A: Top priority is preparing for FDA inspection, with mock inspections and consultant engagement; CMC pack modules are in finalization, and capacity plans assume facility sufficient for first 4-5 years post-launch.