PolyPid Ltd.

Greetings and welcome to Polypeed's first quarter 2026 earnings 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, Yehuda Libra from ARX Investor Relations. Mr. Libra, you may begin.

Thank you, Operator, and thank you all for joining PolyPID's first quarter 2026 earnings conference call. Joining me on the call today will be Dikla Chachkis-Axelbrad, Chief Executive Officer of PolyPID, Johnny Misalawin, PolyPID's Chief Financial Officer, and Ori Warshavsky, Chief Operating Officer, U.S. of PolyPID. Earlier today, PolyPID released its financial results for the three months ended March 31st, 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 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 discussing the company's regulatory strategy, including the expected completion of the rolling new drug application, or NDA, submission for DPLEX-100. Management may also discuss the company's planned engagements with the European Medicines Agency, or EMA, including meetings with the repertoire or co-repertoire regarding the planned marketing authorization application, or MAA, and the anticipated timing thereof. In addition, management may discuss the company's ongoing U.S. commercial strategic partnership discussions, its belief that those discussions are in late stages, and expected launch plans and timing. Other forward-looking statements may relate to the potential clinical and economic value proposition of V-Plex 100, the company's preparations for potential commercialization, the potential for 2026 to be a transformative year for PolyPID, and the expectation that current cash resources will be sufficient to fund operations into the second half of 2026 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 20F, filed on February 25th, 2026. Polycorp 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, May 13th, 2026. With that, it is my pleasure to turn the call over to Dikla Chachkis-Axelbrad, the CEO of PolyPID. Dikla?

Thank you, Yuda, and thank you all for joining us today. The first quarter of 2026 was a defining transition for PolyPID. We moved from late-stage clinical development to final NDA regulatory submission. Our U.S. commercial strategic partnership discussion advanced to what we believe are their late stages. And we continue to build the foundation for what we expect will be a transformative year. Our focus remains on two priorities. Advancing DIPLEX 100 towards potential FDA approval and finalizing a U.S. strategic partnership that will execute commercial launch in the first quarter of 2027. Starting with our regulatory progress, on March 30, 2026, we initiated our NDA submission to the FDA. As a reminder, DPLEX-100 is our lead product candidate for the prevention of surgical site infections, or SSI, in patients undergoing abdominal colorectal surgery. With this initial filing, we submitted the CMC and non-clinical modules as well as other more administrative modules. We expect to submit the remaining components, including the clinical module, imminently. This will complete the full NDA submission. Once the FDA accepts our submission and given our fast track and breakthrough therapy designation, the product is eligible for priority review. If received, this would shorten the standard review period from 10 months to six months. In parallel, in March 2026, we received a small business waiver from the FDA for the PDUFA fee. This waiver was approximately $4.3 million, and it allows us to focus our resources on commercialization preparation as we move closer to potential approval. Turning to Europe, we have scheduled meetings in this quarter with the repertoire and corepertoire, which are the European regulatory authorities designated to lead the assessment of our plan MAA for DPLEX 100. The purpose of these meetings is to align on the content and structure of the submission. Importantly, the NEA will be submitted to the EMA under the centralized procedure on the basis of therapeutic innovation. The centralized procedures allows the submission of a single marketing application to the EMA that, if approved, enables the product to be marketed in all EU member states. Subject to the outcome of these meetings, we currently plan to submit the EMA in the third quarter of this year. On the commercial front, our strategic partnership discussion with potential U.S. partners have continued to progress. We believe they are now in their late stages as the due diligence and evaluation work that defined earlier phases of this discussion is well behind us. And we are currently focused on the active negotiation of definitive agreement terms. Another important area of commercial readiness is our manufacturing and inspection preparation. Once the FDA accepts our NDA submission, the agency is expected to inspect our manufacturing facility. This is a critical step on the path to potential approval, and we are devoting significant resources to these preparations. We are working closely with experienced external consultants, including industry quality veterans with robust FDA experience, who provide us with valuable guidance regarding FDA expectations. We have also conducted multiple mock inspections to ensure our site is ready, the team is prepared, and the FDA inspection passes without any major issues. As a reminder, our facility has already passed four consecutive successful GMP inspections, including the most recent one by the Israeli Ministry of Health. We are entering the FDA inspection process from a position of strength, and we are highly focused on getting it right at first time. We have also continued to advance our engagement with the scientific community surrounding the SHIELD2 phase three results, with two important data presentations this quarter. In early May, 2026, at the 45th annual meeting of the Surgical Infection Society we presented an analysis of SHIELD2 asepsis score data, a clinical measure of wound infection severity. The results show a 64% relative risk reduction in patients with an asepsis score greater than 20, which is the threshold for clinically significant wound infection. What this tells us is that even among patients in the diplex arm, who did experience wound events, severity was meaningfully reduced. Ori will speak in a moment to what this potentially means commercially. In April 2026, at the European Society of Clinical Microbiology and Infectious Diseases, also known as ESCMID, we presented new pharmacokinetic or PK data providing further evidence that DIPLEX-100 delivers sustained control release of doxycycline for approximately 30 days. This result in our largest human data set to date supports the core mechanistic premise of our technology. With that, I will now turn the call over to Ori Warschawski, our Chief Operating Officer, US. Ori?