PolyPid Ltd.

Greetings and welcome to the Polypedes second quarter 2023 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 today's PolyPede's second quarter 2023 earnings conference call. Joining me on the call today will be Dikla Chachkis-Axelbrad, Chief Executive Officer of PolyPede, Johnny Misalowan, PolyPede's Chief Financial Officer, and Ori Warshawski, Chief Operating Officer of PolyPede. Earlier today, PolyPede released financial results for the three and six months ended June 30th, 2023. 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 recruitment of additional patients into Shield 2, total recruitment time into the study, and the timing of the top-line results They're from its attention to conduct an unblind interim analysis. Once a total of approximately 400 patients complete their 30 day follow up the potential submission for deplex 100 in the US expectation to have 20 centers open in the US, Europe and Israel by the end of the current quarter. Factors essential in the execution of Shield 2, Plex technology positioning the company well to potentially pursue a number of compelling strategic opportunities, its business plans, prospects, and objectives, including its planned objective to formalize two partnerships in 2023, and the potential of vPlex 100 in addressing the persistent challenge of surgical site infections and the company's expectations regarding its cash balance. 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 any 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 Form 20-F, 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, August 9th, 2023. With the completion of those prepared remarks, it is my pleasure to turn the call over to Dikla Chachkis-Axelbrad, CEO of PolyPede. Dikla?

Thank you, Brian. On behalf of our team at PolyPede, I would like to welcome everyone to our second quarter 2023 earning call. To begin, we are thrilled with the recent progress we have achieved in the advancement of our promising lead product candidate, DIPLEX-100. This May, we announced that the FDA agreed to our SHIELD II Phase III trial design, evaluating DIPLEX-100 for the prevention of abdominal colorectal surgical site infection. The revised trial includes only patients undergoing open colorectal abdominal surgery with large incisions. Importantly, you will recall that we previously generated very positive data in Shield 1 from this more focused patient population. Specifically, this patient population showed a highly statistically significant reduction of 54% in surgical site infection in Shield 1. We intend to enroll an estimated 550 additional patients beyond the 40 patients already recruited into SHIELD2. Total recruitment time into the study is anticipated to be approximately 12 months, and top-line results are expected in mid-2024. We also intend to conduct an unblinded interim analysis once a total of approximately 400 patients complete their 30-days follow-up. In late June, the first patient was recruited in the revised SHIELD2 trial. Multiple countries have now approved the trial protocol, and several recruiting centers were recently opened. We expect to have 20 centers open in the U.S., Europe, and Israel by the end of the current quarter. As a reminder, we have a clear regulatory pathway for the potential NDA submission for DPLEX-100 in the U.S. Earlier this year, the FDA acknowledged not only that SHIELD1 results may provide supportive evidence of the safety and efficacy of DIPLEX-100 in patients with large surgical incision, but also confirmed that, if successful, SHIELD2 is sufficient to support a potential NDA submission. As we have said previously, we strongly believe that SHIELD2 is a de-risk phase 3 trial. Given the more focused patient population in which we have already generated highly positive data in Shield 1 and the fact that it will not be conducted within the tight COVID-related restrictions that were in place during the pandemic and throughout the duration of Shield 1, we are also leveraging key learning from Shield 1 related to the site involved in the study. While we are targeting approximately 50 centers for SHIELD2 around the same number as SHIELD1, we now 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. Moving on, we also continue to progress our business development initiatives. As previously mentioned, we are focused on two key areas. First, we are targeting additional strong partners for DPLEX 100 in different geographies like the US and Asia. Second, we are pursuing Plex platform-related collaborations that would be focused on specific therapeutic area, such as oncology. Our proprietary Plex technology positions us well to potentially pursue a number of compelling strategic opportunities. Over the last quarter, we have significantly ramped up our business development activities across both biotech and big pharma. We are at varying levels of discussions with more than 20 companies, whether to partner on D-Plex 100 or to evaluate co-development partnership opportunities related to the Plex technology. In addition, we recently retained a business development-focused consulting firm to further strengthen the company capabilities and support the company's goal in this key area. As we have said previously, our planned objective is to formalize two partnerships in 2023, although the exact pace of partnership discussions is inherently difficult to predict. While we broaden our business development activities, we also continue to augment the published research in support of DIPLEX-100. Most recently, a paper highlighting the potent antibacterial activity of DIPLEX-100 and its potential as an effective prophylactic drug against the most prevalent bacteria causing surgical site infection, including resistant strains, was published in the European Journal of Pharmaceutical Sciences. This paper highlighted the tremendous potential of DIPLEX-100 in addressing the persistent challenge of surgical site infections, especially in an era of increased multidrug resistant bacteria. The data showed the significant antibacterial activity of DIPLEX-100 in preclinical and Phase II clinical studies against a wide range of bacteria tested, including resistant ones. Finally, while Joni will review our current financials momentarily, I'd like to highlight our cost containment efforts throughout the business in 2023, including in clinical operations, GNA, and manufacturing, most significantly in a challenging inflationary environment, we have generated over $1 million in cost savings year to date. Moreover, our net cash used in operating activities decreased by 59% in the first six months of the year as compared to the first six months of 2022. With that, it is my pleasure to turn the call over to Johnny. Johnny?