PolyPid Ltd. Q3 FY2024 earnings call

• SHIELD II trial has enrolled approximately 550 subjects, with ~60 centers open in multiple countries. Enrollment ramped up with over 80 subjects enrolled每月 since summer end, aiming to complete patient enrollment in December with top line results expected in coming quarter. • SHIELD I Phase 3 trial results published in International Journal of Surgery, highlighting positive data in high-risk patient population with lengthy incisions. • As of September 30, 2024, cash and cash equivalents and short-term deposits were $9.5 million; current cash balance expected to fund operations into Q1 2025. Potential to secure additional funds if warrants from recent private placements are exercised, with funding extending into 2026 if all warrants are exercised.

No specific product segment financial performance discussed as the transcript does not break down financials by product segments.

• Current cash balance expected to fund operations into Q1 2025. • Potential to secure additional $18.5 million under January 2024 pipe if unblinded interim analysis of SHIELD II trial results in stopping due to positive efficacy and all warrants exercised. • Potential to secure additional $6.1 million under August 2024 pipe if unblinded interim analysis results in stopping due to positive efficacy or continuation to planned patient recruitment and all warrants exercised. • Anticipate top line results from SHIELD II in coming quarter after completing patient enrollment in December.

• Uncertainties in trial outcomes, including potential early trial conclusion due to efficacy, continuation, sample size reassessment, or futility based on unblinded interim analysis. • Regulatory approval risks and uncertainties. • Market factors and potential differences in actual results from projections due to various risks and uncertainties beyond control.

Q: SHIELD II, can you give a sense of the blinded infection rate is in line with expectations and the bar for stopping for efficacy on the interim?

A: Blinded so don't know infection rate division, but CDC report on 2023 hospital-acquired infection shows 3% increase in SSI overall, which is in line with expected slight increase in infection rates post-COVID. Interim analysis criteria is a p-value of 0.01 or lower.

Q: What's the breakdown in patients U.S. versus ex U.S.?

A: Most patients are ex U.S.

Q: What's the commercial infrastructure plan for D-PLEX100 assuming approval, including size and commercial partners?

A: Looking to have a strategic partner to commercialize in U.S., with discussions ongoing; also in discussions in other areas and geographies.

Q: What other principal regional markets are of greatest value for D-PLEX100?

A: Largest markets aside from U.S. and Europe include South America, China, India, Japan; also markets like Vietnam, Canada, Africa, South Africa.

Q: Time line for regulatory submission to the FDA after SHIELD II trial completes?

A: Have detailed plan for when top line results are obtained, with assumption that with breakthrough therapy designation, NDA with breakthrough therapy designation could be submitted during 2026 depending on top line results timing.