PolyPid Ltd.

Good day and thank you for standing by. Welcome to the Polypeed first quarter 2025 conference call. At this time all participants are in a listen only mode. After the speaker's presentation there will be a question and answer session. To ask a question during this session you will need to press star 1 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1, 1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Brian Ritchie. Please go ahead.

Thank you all for participating in Polypeach's first quarter 2025 earnings conference call. Joining me on the call today is will be Dikla Tchotchkes-Axelbrad, Chief Executive Officer of PolyPede, Johnny Misalowan, PolyPede's Chief Financial Officer, and Ori Warshawski, Chief Operating Officer, U.S. of PolyPede. Earlier today, PolyPede released its financial results for the three months ended March 31st, 2025. A copy of the press release is available in the investor section on the company's website, www.polypeed.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 it discusses the potential efficacy of D-Plex 100 and the probability of success of the trial, that the gross proceeds from the company's last financing extend the company's cash runway into the third quarter of 2025, beyond the expected top-line results from Shield 2, the expected timing for top-line results from the Shield 2 trial, potential NDA and MAA submissions and the timing thereof, preparations for regulatory submissions, finalization of CMC and non-clinical NDA modules, potential clinical benefits of DPLEX-100, potential market size for DPLEX-100 in the United States, potential partnership opportunities, the potential to receive up to an additional $27.0 million from the exercise of the warrants from the recent financing, the company's anticipation that with such additional funding, its runway would be extended beyond anticipated NDA approval, opportunities for the use of DPLEX-100 in additional procedures, and the company's long-term prospects. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond our control, including the risks described from time to time in our 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 Securities and Exchange Commission, including, without limitation, the company's annual report on Form 20F, which identifies specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements. PolyP 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, May 14th, 2025. With the completion of those prepared remarks, it is my pleasure to turn the call over to Dikla Chachkas-Axelbrad, CEO of Polypedia. Dikla.

Thank you, Brian. On behalf of our team at PolyPede, I would like to welcome everyone to our first quarter 2025 earnings conference call. We were thrilled to recently successfully conclude enrollment of the SHIELD2 phase three trial assessing the efficacy of DIPLEX100 for the prevention of surgical site infection in patients undergoing abdominal colorectal surgery. As a reminder, This significant milestone followed an independent data safety monitoring board, or DSMB, recommendation to conclude the SHIELD2 phase 3 trial of DIPLEX100 at the lowest sample size reassessment stop, 800 patients, after the minimum planned number of patients. We are now rapidly approaching the availability of stop-line data by the end of next month. To reiterate, what we have said previously, we view the DSMB's recommendation to conclude SHIELD2 upon the enrollment of 800 patients as a favorable outcome, as it is suggestive of positive efficacy signals from DPLEX-100. Of course, the data generated from SHIELD2 to date remain fully blinded to polypid and others outside of the DSMB until top line results are available. Upon potential positive phase three data, PolyPID expects to submit a new drug application or NDA with the advantages of the fast track and breakthrough therapy designations in early 2026. With a marketing authorization application or MAA submission in the EU anticipated shortly thereafter. Importantly, as a result of our December 2024 $15 million financing, we are funded into the third quarter of 2025, beyond the expected top line results from SHIELD 2. Further, data-triggered warrants from this financing, if exercised in full, would result in an additional $27 million. We anticipate that with such additional funding, our runway would be extended beyond anticipated NDA approval. While we await the SHIELD II trial top-line data readout, we are intensely focused on advancing the preparation of our regulatory submissions. With the anticipated NDA filing timeline of early 2026 in mind, CMC and non-clinical NDA modules are currently being finalized. Additionally, we continue to progress prelaunch activities and expedite partnership discussions in and outside the United States. Importantly, identifying a U.S. partner is the path we have strategically identified as the most effective commercial course for DPLEX 100. Finding the right partner with an existing dedicated hospital product sales force with significant resources will best enable DPLEX 100 to maximize its sales potential in the U.S., which we believe is substantial. To this end, as Ori will detail shortly, U.S. partnering interest in DPLEX 100 is gaining meaningful momentum amongst multiple parties as we approach our pivotal data readout. With that, I will now turn the call over to Ori to revisit the DPLEX-100 market potential and review our partnering efforts. Ori?