PolyPid Ltd.

greetings and welcome to the polypeed first quarter 2023 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 brian ritchie from life site advisors mr ritchie you may begin

Thank you all for participating in PolyPede's first 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. Earlier today, PolyPede released financial results for the three months ended March 31st, 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 meeting of the federal securities laws. For example, management is making forward-looking statements when it discusses the expected resumption of recruitment for the Shield 2 Phase 3 trial and the timing of top-line results therefrom. potential MAA and NDA submissions, the expected timing of the completion of the commercial manufacturing process and packaging validation for D-Flex 100, potential partnering and collaboration opportunities, and the company's expectations regarding its cash balance and additional compelling financing opportunities. 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 place no 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 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 10th, 2023. With the completion of these prepared remarks, it is my pleasure to turn the call over to Dikla Tachkis-Axelbrot, CEO of Polypeat. Dikla?

Thank you, Brian. On behalf of our team at Polypeat, I would like to welcome everyone to our first quarter 2023 earning call. To begin, we are thrilled with the recent progress we have achieved throughout our business, including the significant strengthening of our balance sheet, which I will review a bit later in my remarks. From a clinical perspective, we have submitted the revised protocol for SHIELD2 to the FDA and await their feedback. Assuming no major comments from the agency, we expect very soon to be in a position to begin recruiting your patient into SHIELD2, which today has enrolled approximately 40 target patients. As a reminder, we now have a clear regulatory pathway for the potential NDA submission for DIPLEX-100 in the U.S. Earlier this year, the FDA acknowledged that the SHIELD1 result may provide supportive evidence of safety and efficacy of DIPLEX-100 in patients with surgical incisions greater than 20 centimeters. The agency also recommended that the company conduct an additional study on this focused patient population to support a potential NDA submission and confirmed that CHEO-2 could serve as such a study. To reiterate what we said on our last call, we intend to recruit a total of approximately 600 patients or an additional 550 subjects beyond the 40 patients already recruited into SHIELD2. Total recruitment time into the study is expected to be approximately 12 months from the time we resume SHIELD2 enrollment. Topline results are expected mid-next year. We also plan to conduct and unblinded interim analysis once a total of approximately 400 patients complete their 30-day follow-up. As we prepare to resume recruiting for Shield 2, one of the key learnings from Shield 1 is on the sites involved in the study. While we are targeting approximately 50 centers for Shield 2, around the same number as Shield 1, we now have firm knowledge of the best performing sites from Shield 1 in terms of recruitment, patient monitoring, and good clinical practice. We believe this to be essential in the execution of Shield 2. We also have announced our clinical operations team, another key step towards supporting a successful study. While we have made modest modifications to the Shield 2 protocol based on the Shield 1 results, The design of the SHIELD-2 trial is very similar to the SHIELD-1 study in terms of primary and secondary endpoints. Patients in the intervention arm will receive DPLEX-100 on top of standards of care, and subjects in the control arm will receive standards of care alone. The primary endpoint of the trial will be a combination of exercise, re-intervention, and mortality rate of 30 days post-index surgery as defined in the CDC SSI guidelines. Patient safety will be monitored for an additional 30 days, and the study will take place in the US, Europe, and Israel. As we have said previously, I would like to emphasize that we view SHIELD2 as a de-risked phase three trial, giving 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. In addition, as I noted a moment ago, we are leveraging the key learnings from Shield 1 study. In Europe, we recently received feedback in a national scientific advice meeting from the Swedish Medical Products Agency, or Swedish MPA, that was in line with the feedback received from the FDA following the Type D meeting. Specifically, similar to the FDA, the Swedish MPA acknowledged that the SHIELD1 result may provide supportive evidence in patients with large surgical incisions. and recommended that the company confirm the results with an additional phase three study to support an MAA submission. The Swedish MPA also noted that clinical safety data obtained to date is sufficient for an MAA submission. Importantly, we continue to work closely with our European partner, Advanced Pharma, with respect to the European development pathway and are fully aligned on the regulatory strategy for this region, including the preparation surrounding our recent meeting with the Swedish MPA. I should add that we expect to complete the commercial manufacturing process and packaging validation for DIPLEX 100 in the next few months. We continue to expect to have the CMC and preclinical data needed to support an NDA well in advance of the top line results. In regard to our financial strength, we completed a series of financial transactions late in the first quarter to further solidify our financial position. First, we closed on an underwritten public offering that included the full exercise of the underwriter's option to purchase additional ordinary shares and a concurrent private placement of a pre- funded warrants with certain existing shareholders for total gross proceeds of approximately $11.4 million. In addition, we restructured our existing secured loan agreement with Krails Capital, resulting in over $3 million of deferred repayment, which will be paid from August 2024 onwards in line with the expected timing of our top-line results from year two. The proceeds from the financing transactions, combined with the loan repayment default, extend our cash runway into late Q1 of next year. Looking ahead, we anticipate having a number of additional compelling financing opportunities to further enhance our balance sheet later in 2023 in order to fund Shear 2 to its successful completion. With that said, we are grateful for the continued support shown by our largest institutional shareholders, as well as our new investor who participated in the March public offering. Moving on, we also continue to advance our business development initiatives. As a reminder, we are focused on two key areas. First, we are targeting additional strong partners for D-Plex 100 in different geographies like the US and Asia. Second, we are pursuing Plex platform-related collaboration that are becoming more focused in nature in specific therapeutic areas such as oncology. As we said on our last call, our planned objective is to formalize two partnerships in 2023. although the exact pace of partnership discussion is inherently difficult to predict. With that, it is my pleasure to turn the call over to Johnny to review our current financials. Johnny?