PolyPid Ltd. Q3 FY2025 earnings call

• Regulatory: Pre-NDA meeting with the FDA is scheduled for early December 2025, aiming for NDA submission of DPLEX 100 in early 2026. Preparing for the European Marketing Authorization Application. Successfully completed the Israeli Ministry of Health Good Manufacturing Practice (GMP) inspection, the fourth consecutive successful inspection.
• Commercial: Completed a US market access study showing strong interest from surgeons and hospital pharmacy directors. Medical team presented data at major US conferences, receiving positive responses. Advancing strategic discussions with potential US partners.
• Manufacturing: GMP inspection completion brings them closer to commercial readiness for DPLEX 100, with ongoing efforts to improve facility and QC laboratory.

In the third quarter of 2025, research and development expenses totaled $5.3 million, down from $6.2 million in the third quarter of 2024. General and administrative expenses were $1.8 million compared to $1.2 million in the third quarter of 2024, while marketing and business development expenses were $400,000, up from $200,000 in the same period last year. The net loss for the quarter was $7.5 million or $0.37 per share, an improvement from the net loss of $7.8 million or $1.22 per share in 2024. For the nine months ended September 30, 2025, R&D expenses totaled $17.6 million compared to $15.8 million in the prior year period. G&A expenses increased to $5.4 million from $3.3 million last year, and marketing and business development expenses rose to $1.4 million from $700,000 last year. Net loss for the nine-month period was $25.7 million or $1.72 per share, compared to $20.5 million or $3.82 per share for the same period in 2024. As of September 30, 2025, PolyPid Ltd. had $18.8 million in cash, cash equivalents, and short-term deposits, up from $15.6 million at year-end 2024. The company also reduced its debt, decreasing current maturities from $6.5 million to $2.4 million.

• Pre-NDA meeting with the FDA is set for early December 2025, with plans to submit the NDA in early 2026.
• Expected cash balance to fund operations well into 2026.
• Continued progress in regulatory, commercial, and manufacturing aspects towards DPLEX 100's market entry.

• Risks associated with forward-looking statements, including regulatory uncertainties, market adoption, reimbursement, and potential differences from projections.
• Uncertainties related to GMP inspection follow-ups and potential FDA inspection requirements that may arise.

Q: Could you walk us through the findings of the Israeli Ministry of Health's successful inspection and your confidence heading into the FDA inspection?

A: We passed the Israeli Ministry of Health inspection, which is recognized by European authorities. There were ongoing comments for improvement, but we are focused on continuously improving our facility. We are confident in passing the FDA inspection as we have experience in GMP facilities and are addressing areas for improvement.

Q: Any specific items crucial to align with the FDA ahead of the NDA filing in the pre-NDA meeting?

A: We expect to review the data package, submission format, and label. Our goal is to get agreement on the data support for the NDA filing and clarity on remaining requests before the rolling submission.

Q: Can you talk about the sample size of the market research study and preliminary thoughts on utilizing DPLEX 100 in gynecology and urology?

A: The study was qualitative with 10 surgeons (general, colorectal, gynecology) and 10 pharmacy directors. It's a qualitative study focused on formulary decision-makers. Regarding gynecology and urology, the study was detailed but primarily focused on initial feedback from the participants involved in the P&T process Q: Potential challenges with domestic manufacturing push in the US for commercializing DPLEX 100?

A: Our current facility is not the end goal. We are planning to expand or build a new facility to address the trend of local manufacturing in the US and are considering expansion to meet future commercial needs