PolyPid Ltd.

Greetings and welcome to the PolyPete fourth quarter 2024 conference call. At this time, participants are in listen-only mode. As a reminder, this call is recorded, and I would now like to introduce your host for today's conference, Brian Ritchie from LifeSci Advisors. Mr. Ritchie, you may begin.

Thank you all for participating in PolyPete's fourth quarter and full year 2024 earnings conference call. Joining me on the call today will be Dikla Chakchis-Axelbrad, Chief Executive Officer of PolyPede, Johnny Misalawan, 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 and 12 months ended December 31st, 2024. A copy of the press release is available in the Investors 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 recent financing extend the company's cash runway into the third quarter of 2025, beyond the expected top-line results from SHIELD2, the expected timing for completion of enrollment of the SHIELD2 trial, the expected timing for top-line results from the SHIELD2 trial, potential NDA submission, accelerating preparations for regulatory submissions, and pre-launch activities, potential clinical benefits of DPLEX-100, potential market size for DPLEX-100 in the United States, potential partnership opportunities, potential benefits from the collaboration with immunogenesis, that the exercise of the warrants from the pipe in full would result in additional $27 million in gross proceeds, that proceeds of all warrants issued in the pipe, if exercised, would provide the company with capital beyond 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, February 12th, 2025. With the completion of those prepared remarks, it is my pleasure to turn the call over to Dikla Chachkis-Axelbrad, CEO of Polypeed. Dikla?

Thank you, Brian. On behalf of our team at Polypeed, I would like to welcome everyone to our fourth quarter and full year 2024 earnings conference call. We are very pleased with the recent critical advancement in our business, most notably as it relates to the recommendation by the Independent Data Safety Monitoring Board, or DSMB, to conclude the SHIELD2 Phase 3 trial assessing the efficacy of DIPLEX100 for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery upon enrollment of 800 patients. which is the lowest sample size reassessment stopped after the minimum planned number of patients. 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 DIPLEX100. As a reminder, the data generated from SHIELD2 to date remain fully blinded to polypid and others outside of the DSMB until top line results are available. As previously reported, we concurrently announced that we entered into a securities purchase agreement for a private placement financing led by existing institutional shareholders for $14.5 million in gross proceeds. The gross proceeds from the financings extend polypedes cache runway into the third quarter of 2025 beyond the expected topline result from SHIELD2. More on this transaction in a moment. First, however, some further discussions around the DSMB recommendation and our planned next steps. Most importantly, the sample size reassessment is an opportunity to ensure the study has sufficient power to conclusively confirm 100 treatment benefit, and we believe this increases the trial's overall probability of success. The study has enrolled over 700 patients to date, and at the current enrollment rate of roughly 20 patients per week, we expect to complete enrollment of SHIELD2 next month. We anticipate reporting top line results in the second quarter of 2025. Upon potential positive phase three data, PolyPID expects to submit a new drug application, or NDA, with the advantages of fast track and breakthrough therapy designations. We are thrilled to welcome Mr. Yitrak Jacobovich to the company's board of directors. Mr. Jakubowicz is a partner and a lead healthcare analyst at AIGH Capital Management and affiliates, the lead investor from the December financing. He is also a board member at Myomo, Inc. Mr. Jakubowicz earned his MBA from John Hopkins University and is a chartered financial analyst. We look forward to completing the trial and are focused on accelerating preparations for our regulatory submissions, prelaunch activities, and expediting partnership discussions in and outside of the United States. I will now turn the call over to Ori to discuss market potential, partnering efforts, and our recently announced technology collaboration. Ori?