PolyPid Ltd.

Greetings and welcome to Polypeed's fourth quarter and full year 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 ARCS Investor Relations. Mr Liebler, you may begin.

Thank you, Operator, and thank you all for joining PolyPID's fourth quarter and full year 2025 earnings conference call. Joining me on the call today will be Dikla Chachkes-Akselblad, Chief Executive Officer of PolyPID, Jonny Misalawin, PolyPID's Chief Financial Officer, and Ori Warschawski, Chief Operating Officer US of PolyPID. Earlier today, PolyPID released its financial results for the three and 12 months ending December 31st, 2025. A copy of the press release is available in the investor section on the company's website at www.polypid.com. I'd like to remind you that on this call, management will make forward-looking statements within the meaning of the Federal Securities Law. For example, management is making forward-looking statements when it discusses the company's regulatory strategy and the anticipated timing and structure of the planned new drug application or NDA submission for DPLEX 100, including the rolling submission, the potential regulatory and commercial pathways for D-Flex 100, the company's ongoing partnership discussions, commercialization readiness, transition from a primarily R&D and clinically focused organization into one that is preparing for commercialization, the potential for 2026 to be a transformative year for the company, benefits and advantages of D-Flex 100, that Kinatrix represents a broader long-term opportunity for PolyPID, and the expectation that current cash resources will be sufficient to fund operations into the second half of 2026. 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 SEC filings. The company's results may differ materially from those projections. These statements involve material risks and uncertainties that could cause actual results or events to materially differ. Accordingly, you should not place undue reliance on these statements. I encourage you to review the company's filings with the SEC, including, without limitation, the company's annual report on Form 20F, filed on February 26, 2025, which identifies specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements. PolyPID disclaims any intention or obligation, except as required by law, to update or revise any financial projection or forward-looking statements, whether because of new information, future events, or otherwise. This conference call contains time-sensitive information and speaks only as of the live broadcast today, February 11th, 2026. With the completion of those prepared remarks, it is my pleasure to turn the call over to Dikla Chachkes-Axelblad, the CEO of PolyPID. Dikla?

Thank you, Yuda, and thank you all for joining us today. 2025 was a pivotal year for PolyPID. Over the course of the year, we successfully completed the SHIELD 2 Phase 3 trials and announced positive results. with DPLEX 100 meeting its primary endpoint and all key secondary endpoints and demonstrating a meaningful reduction in surgical site infections. Building on that momentum, we advanced DPLEX 100 into the final stages of regulatory preparation, marking an important transition point for the company. In parallel, we continue to advance our broader platform efforts, including our long-acting GLP-1 receptor agonist program. As we continue executing against our strategy, our progress is focused on two priorities, advancing the regulatory pathway for DIPLEX-100 and advancing our commercial U.S. partnership discussion. Starting with regulatory progress, We recently received positive written feedback from the FDA following the pre-NDA meeting communication. Importantly, the agencies supported our plan to pursue a rolling NDA review for DPLEX-100. We expect to begin the rolling NDA submission by the end of the first quarter of 2026, The FDA also agreed that the company's existing clinical data package, including results from the Phase III SHIELD II trial, appears adequate to support NDA submission and review. This feedback provides meaningful clarity on the structure and expectations for our submission and further validates the regulatory pathway we have been preparing for. In parallel with our regulatory efforts, we made significant progress on the commercial front. Following our positive Phase III results and the advancement of our regulatory strategy, we have moved into advanced stages of partnership discussions in the United States. These discussions reflect growing recognition of DPLEX 100's strong clinical profile, its differentiated value proposition, and the significant unmet need it addresses. I'm glad to share that we are very pleased with the progress we made throughout the quarter in our U.S. partnership discussions. have continued to move forward to advanced stages, which Ori will expand on later in the call. During the quarter, we also participated in a virtual Key Opinion Leader webinar featuring Dr. Steven D. Wexner, a globally recognized leader in colorectal surgery. The discussion focused on the real-life clinical and economic burden of surgical site infections and why prevention remains a major unmet need in abdominal colorectal procedures. Importantly, the conversation reinforced what we believe is the core opportunity of DIPLEX-100, a differentiated, long-acting localized approach that can significantly reduce infection while fitting naturally into the surgical workflow. As Dr. Wexner noted, this is truly new. This is a paradigm shift for us. We view this type of external clinical engagement as an important part of building awareness and readiness as we prepare the market for approval and launch. A link to the recording of the webinar is on our website under the investor section. I invite all of you to listen to Dr. Wexner's insights. Looking ahead, we believe 2026 has the potential to be a transformative year for polypedia. With the rolling NDA submission expected to begin by the end of this quarter, partnership discussions continue to advance and an organization increasingly oriented toward commercial execution, we are entering a new chapter for the company. I also want to highlight an important corporate update. In December 2025, we appointed Ms. Brooke Story as chairman of our board of directors. Brooke brings extensive leadership experience in medical technology and surgical solutions, including senior executive role at Beckton Dickinson and Medtronic. As we transition toward commercialization and engage with large strategic partners, we believe her background and perspective will be highly valuable in helping guide PolyPID throughout this next chapter. We look forward to providing updates as these developments continue to unfold. With that, I will now turn the call over to Ori Warschawski, our Chief Operating Officer, U.S., who will discuss how we are approaching commercialization readiness and partner engagement. A refreshed corporate brand and the introduction of our Kinetrix technology. Ori?