Operator
Greetings, and welcome to the PolyPid third quarter 2026 conference call. As a reminder, this call is being recorded. I would now like to introduce your host for today’s conference, Yehuda Leibler from ARX Investor Relations. Mr. Leibler, you may begin.
Yehuda Leibler
Thank you, operator. Thank you all for joining PolyPid’s third quarter 2026 earnings conference call. Earlier today, PolyPid released its financial results for the three and nine months ended September 30, 2026. A copy of the press release is available on the investor section of the company’s website at www.polypid.com.
Joining me on the call today are Dikla Czaczkes Akselbrad, Chief Executive Officer of PolyPid, Ori Warshavsky, Chief Operating Officer U.S. of PolyPid, and Jonny Missulawin, Chief Financial Officer of PolyPid. I’d like to remind you that on this call, management will make forward-looking statements within the meaning of the federal securities laws. These include statements about the FDA’s review of the D-PLEX100 NDA, including labeling discussions, the PDUFA goal date, and the FDA pre-approval inspection.
They also cover the potential approval of D-PLEX100 and the anticipated timing of its U.S. commercial launch by Azurity Pharmaceuticals, as well as potential reimbursement for D-PLEX100, including the anticipated timing of a CMS decision on a New Technology Add-on Payment, or NTAP. We will also discuss the potential label expansion of D-PLEX100 and planned communications with the FDA and
