ET Chief Executive Officer - Dikla Czaczkes Akselbrad Chief Financial Officer - Jonny Missulawin Chief Operating Officer, U.S. - Ori Warshavsky Operator: Greetings, and welcome to the PolyPid's Second Quarter 2026 Conference Call. As a reminder, this call is recorded. And I would now like to introduce your host for today's conference, Yehuda Leibler, from Arx Investor Relations.
Yehuda Leibler: Thank you, operator, and thank you all for joining PolyPid's Second Quarter 2026 Earnings Conference Call. Joining me on the call today will be Dikla Czaczkes Akselbrad, Chief Executive Officer of PolyPid; Jonny Missulawin, PolyPid's Chief Financial Officer; and Ori Warshavsky, Chief Operating Officer, U.S., of PolyPid. Earlier today, PolyPid released its financial results for the 3 and 6 months ended June 30, 2026.
A copy of the press release is available on the Investors section of the company's website at www.polypid.com. I'd like to remind you all 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's discussing the company's exclusive commercialization partnership with Azurity Pharmaceuticals for the United States and Canada.
These forward-looking statements include the partnership's economic structure, including the potential milestone payments, tiered royalties and transfer price, the joint development activities and label expansion program contemplated under the agreement, the expected timing and progress towards potential U.S. Food and Drug Administration or FDA approval of D-PLEX100, including the assigned Prescription Drug User Fee Act or PDUFA goal date and the FDA's grant of Priority Review. Additional forward-looking statements include the company's engagements with the European Medicines Agency, including meetings with the Rapporteur and Co- Rapporteur regarding the planned Marketing Authorization Application, or MAA, and the anticipated timing thereof, the expected commercial launch of D-PLEX100 by Azurity in the United States in early 2027.
Further forward-looking statements include the company's manufacturing readiness and preparation for the FDA pre-approval inspection, the potential clinical and economic value of D-PLEX100, the company's Kynatrix technology and additional pipeline opportunities, growth drivers and the expectation that the company's existing cash resources will be sufficient to fund operations into 2028 and through several significant upcoming potential milestones. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond the company's control, including the risks described from time to time in the company's Securities and Exchange Commission filings. Accordingly, you should not place undue reliance on these statements.
I encourage you to review the company's filings with the SEC, including the company's annual report on Form 20-F filed on February 25, 2026. PolyPid disclaims any intention or obligation, except as required by law, to update or revise any forward-looking statements. This conference call contains time-sensitive information and speaks only as of the live broadcast today, August 12, 2026.
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