PolyPid Ltd.

Greetings and welcome to Polypeed's second 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 Arts Capital Market. Mr. Liebler, you may begin.

Thank you all for participating in Polypeed's second quarter 2025 earnings conference call. Joining me on the call today will be Dikla Chachkis-Axelbrod, Chief Executive Officer of PolyPID, Johnny Misalawin, PolyPID's Chief Financial Officer, and Ori Warschowski, Chief Operating Officer, U.S. of PolyPID. Earlier today, PolyPID released its financial results for the three months ended June 30th, 2025. A copy of the press release is available in the Investors section on the company's website, available 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 DPLEX 100's potential benefits, including its potential to address a significant unmet medical need and to substantially reduce the burden of surgical site infections, improve patient outcomes, and generate meaningful healthcare cost savings. The expected regulatory submissions and their timing, the aim of GLP-1 program and its potential to address significant unmet medical needs in the treatment of metabolic diseases, the company's expected cash runway, and the potential partnership opportunities for DPLEX 100. 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 its SEC filings. The company's results may differ materially from these 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 its 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 foreign looking statements. OEP disclaims any intention or obligation, except as required by law, to update or revise any financial projections 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, August 13th, 2025. With the completion of those prepared remarks, it is my pleasure to turn the call over to Dikla Chachkis-Axelbrad, CEO of PolyPID. Dikla.

Thank you, Yuda. On behalf of our team at PolyPID, I would like to welcome everyone to our second quarter 2025 earnings conference call. The second quarter of 2025 was truly transformational for PolyPID, marked by the successful results of our SHIELD2 phase 3 trial, which demonstrated significant clinical benefits of DIPLEX-100 in preventing surgical site infections or SSI in abdominal colorectal surgeries. As announced in June 2025, the study showed a statistically significant reduction of 38% with a p-value below 0.005 in the primary endpoint, which, as a reminder, is the combination of deep and superficial SSIs, all-cause mortality, and surgical re-intervention. In addition, we demonstrated a robust 58% reduction in the rate of surgical site infection in patients treated with DPLEX-100 versus standards of care with a p-value below 0.005. including a significant reduction in deep surgical site infection with five cases of deep exercise representing approximately 14% out of all exercise in the standard of CAR arm versus zero in D-Plex100 arm with a p-value below 0.05. Importantly, we also saw in the study a clear and statistically significant 62% reduction of patients with an asepsis score over 20. The asepsis score reflects the severity of the wound infection appearance and the clinical consequences of the infection. So DIPLEX-100 not only markedly decreased the rate of superficial and deep SSIs, but even when SSIs occurred, in the DPLEX-100 arm, they were less severe and caused less medical burden, such as prolonged hospitalization or use of IV antibiotics. These robust results validated our conviction in DPLEX-100 potential to address a significant unmet medical need and have generated substantial interest from potential commercial partners. We are extremely encouraged by the enthusiastic reception from healthcare professionals, lead surgeons in different types of surgeries, as well as thought leaders in the field of surgical site infection. All recognize DIPLEX 100 potential to substantially reduce the burden of surgical site infection, improve patient outcomes, and generate meaningful healthcare cost savings. In addition, Farther analysis of the Phase III SHIELD II trial safety data revealed a good safety profile with no difference in serious treatment emergent adverse event between patients treated with DIPLEX-100 versus standard of care. This safety profile farther supports the DIPLEX-100 potential as a well-tolerated prophylactic treatment option for patients undergoing major abdominal surgeries. Following these positive phase three data, we are on track with our new drug application or FDA preparation. Our next steps include a pre-NDA meeting with the FDA planned by the end of this year, leveraging our fast track and breakthrough therapy designation to facilitate regulatory review. We anticipate submitting the NDA to the FDA in early 2026 and marketing authorization application or MAA submission in Europe shortly thereafter. Shifting gears, we recently made significant progress on our GLP-1 program, which leverages the company's extensive long-term experience. This initiative aims to deliver approximately 60 days no-burst GLP-1 receptor agonist peptides for improved patient compliance and enhanced therapeutic outcomes in the rapidly growing weight loss and diabetes market. We have formally unveiled this program early in the current quarter, and we believe it represents an exciting opportunity to expand our therapeutic footprint into the fast-growing metabolic disease market. Following the end of the quarter, yesterday, we announced the appointment of Dr. Ruth Weiser, MD, MBA, as chief medical officer of the company transitioning from a role on the board of directors. Dr. Kaiser's blacks bring extensive medical, R&D, and business development expertise to this executive position, strengthening the company's leadership team as it advances towards NDA submission and commercial preparation following the positive phase 3 shield to result. From a financial perspective, we have significantly strengthened our balance sheet through a successful warranted exercise in human transaction, extending our cash flow one way well into 2026. With that, I will now turn the call over to Ori, our COO of the U.S., to provide more details on our commercial preparations and partnering efforts for DIPLEX 100. Ori?