PolyPid Ltd. (PYPD) Q3 2025 Earnings Call

Investor webinar replay

Replay transcript excerpt

Greetings, and welcome to Polypeed's third quarter 2025 conference call. At this time, participants are in a listen-only mode. As a reminder, this call is recorded. And I would now like to introduce your host for today's conference, Yuda Liebler from ARX Investor Relations. Mr. Liebler, you may begin. Thank you all for participating in Polypid's third quarter 2025 earnings conference call. Joining me on the call today will be Diklan Chachkis-Akselbrad, Chief Executive Officer of Polypid, Johnny Misalawin, Polypid's Chief Financial Officer, and Ori Warshawski, Chief Operating Officer US of Polypid. Earlier today, Polypid released its financial results for the three months ended September 30th, 2025. Copy of the press release is available in the investor section on the company's website. at www.polyphys.com. I'd like to remind you that on this call, management will make forward-looking statements within the meaning of the federal securities laws. For example, management is making forward-looking statements when it discusses the anticipated timing of the pre-new drug application, or NDA, meeting of the US Food and Drug Administration, or FDA, the planned NDA submission for DPLEX-100, the expected submission of the European Marketing Authorization application, the potential regulatory and commercial pathways for D-Plus 100, including leveraging its fast track and breakthrough therapy designations, the company's ongoing partnership discussions, market adoption, reimbursement assumptions, the company's commercial manufacturing readiness, U.S. market access study, and utilization of D-Plus 100, regulatory inspection readiness, and the expected cash runway to fund operations well into 2026. Forward-looking statements are subject to numerous risks and uncertainties, many of w...