PolyPid Ltd.

Greetings and welcome to the Polypeed first quarter 2024 conference call. At this time, all 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, Brian Ritchie from LifeSci Advisors. Mr. Ritchie, you may begin.

Thank you all for participating in Polypeed's first quarter 2024 earnings conference call. Joining me on the call today will be Dikla Chachkis-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 financial results for the three months ended March 31, 2024. A copy of the press release is available in the Investors section on the company's website, www.polypede.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 expected timing for recruitment, number of centers, Top line results from the SHIELD II trial and of the unblinded interim analysis, the planned new drug application submission for DPLEX-100, the strength of the company's intellectual property, the company's expected cash runway, and the potential to receive additional funds if warrants are exercised. 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. Our 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 companies 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 8th, 2024. With the completion of these prepared remarks, it is my pleasure to turn the call over to Dikla Chachkis-Axelbrand, CEO of PolyPede. Dikla?

Thank you, Brian. On behalf of our team at PolyPede, I would like to welcome everyone to our first quarter 2024 Earnings Conference. We are excited about the substantial momentum throughout our business. Most importantly, as it relates to enrollment in our ongoing SHIELD2 pivotal trial for DIPLEX-100 for the prevention of abdominal colorectal surgical site infection. Importantly, this clinical progress is being achieved with a recently fortified balance sheet. Let's begin with the status of SHIELD2. I'm pleased to report today that the study has now enrolled more than 200 subjects and approximately 50 centers are currently open in multiple countries around the world, including the U.S., Germany, Italy, Ireland, Portugal, Hungary, and Israel. As a reminder, we intend to conduct an unblinded interim analysis once approximately 400 patients of the planned total of 600 subjects complete the 30-day follow-up, which is expected to occur in mid-2024. Topline results are anticipated in the second half of this year. Therefore, SHIELD2 is now more than half enrolled for the interim analysis and more than one-third fully enrolled. Importantly, as the current status would indicate, enrollment is now progressing at a constantly robust pace. With respect to the expected recruitment rate, as we said on our last call, once the site is fully up and running, which takes several weeks following its being formally opened, we anticipate approximately one and a half patients being recruited into this trial per center per month, and we expect to have a total of approximately 60 centers opened and recruiting patients. So, at the peak of the enrollment period, we anticipate recruiting 90 patients per month, similar to the enrollment rate we had in Shield 1. With that said, having crossed the important 200-subject threshold, we thought we'd provide some color on several encouraging enrollment trends we are seeing. Of note, the median age male-female split and percentage of enrolled cancer patients in SHIELD2 are similar to the patient population in the SHIELD1 large incision pre-specified subgroup. This is significant because we are thus far observing similar demographics in this more focused patient population in which we have already generated highly positive data in SHIELD1. This is yet another reason we continue to strongly believe that SHIELD2 is a de-risked phase 3 trial, along with the fact that SHIELD2 is not being conducted within the tight COVID-related restrictions that were in place during the pandemic and throughout the duration of SHIELD1. Of course, we are also leveraging key learning from SHIELD1 related to the sites involved in the study. To this end, While we are targeting approximately 60 centers for SHIELD2 around the same number as SHIELD1, we have firm knowledge of the best performing sites from SHIELD1 in terms of recruitment, patient monitoring, and good clinical practice. We believe this to be essential in the execution of SHIELD2. We have also enhanced our clinical operations team another key step towards supporting a successful study. Moreover, the Data Safety Monitoring Committee, in charge of the review of accumulated safety data and study conduct for SHIELD2 study, has twice recommended to continue the study without modification, meaning that no safety issues related to DPLEX 100 have been observed in SHIELD2 to date. Moving on. To reiterate what we have said previously, we have a clear regulatory pathway for the potential NDA submission for DIPLEX-100 in the U.S. Last year, the FDA acknowledged not only that Shield-1 results may provide supportive evidence of the safety and efficacy of DIPLEX-100 in patients with large surgical incisions, but also confirm that if successful, SHIELD 2 is sufficient to support a potential NDA submission. I'd like to take a moment to acknowledge an often overlooked key aspect of the compelling DPLEX 100 product profile, and that is its substantial intellectual property foundation. Specifically, we are fast approaching 175 granted and pending applications, patents, or the Plex platform and its users for the treatment of different indications. Among those method of use patents are a significant number of patents with long-term protection for DPLEX-100 for the prevention of surgical site infection. For example, our DPLEX-100 SSI patent is expected to remain in effect until 2035 in more than 40 countries worldwide. This incredibly strong IP position only enhances the value of this promising late-stage product candidate for us. Shifting gears, we continue to advance Shield 2 from a strengthened financial position following our January 2024 private placement financing, or PIPE, for $16 million of gross proceeds. Importantly, our cash one-way now extends into the fourth quarter of this year and beyond the anticipated timing of Shield 2's planned unblinded interim analysis. Moreover, the company has the potential to secure an additional $19 million if the results of the unblinded interim analysis are positive and all warrants issued in the financing are exercised, which would fund PolyPEAT to the start of a planned rolling NDA submission for BIPLEX 100. As a reminder, the PIPE syndicate was comprised of new and existing investors, including participation from U.S. life science focused investors, Daphna Capital Management, and Roswind Advisors. Before I turn the call over to Johnny for his review of the financials, I'd like to let you all know that we have recently posted a newly revamped corporate presentation on our IR website. We would encourage all of you to take a look at your convenience. With that, it is my pleasure to now turn the call over to Johnny. Johnny?