PolyPid Ltd.

all for participating in PolyPede's fourth quarter and full year 2022 financial results conference call. Joining me on the call today will be Dikla Chachkis-Axelbred, Chief Executive Officer of PolyPede, Ori Warshawski, Chief Operating Officer for PolyPede's U.S. Operations, and Johnny Misalawan, PolyPede's SVP Finance. Earlier today, PolyPede released financial results for the three and 12 months ended December 31st, 2022. A copy of the press release is available in the investor section on the company's website, www.polyped.com. I'd like to remind you that on this call, management will be making forward-looking statements within the meaning of the federal securities laws. For example, management is making forward-looking statement when it discusses the regulatory pathway for the potential NDA submission for DPLEX 100, including the potential of the Shield 1 results and Shield 2 study to provide support, the potential for wide use of DPLEX 100, the timing of resumption, completion of patient recruitment, the design and top line results of the revised Shield 2 study, the company's expectations regarding its cash runway and financing opportunities, goals for 2023, including with respect to interactions with European regulatory authorities, its ability to attract additional partners and enter collaborations and the potential timing thereof and the expected timing for the commercial manufacturing process and packaging validation for DPLEX-100. 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 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, February 8th, 2023. With the completion of those prepared remarks, it is my pleasure to turn the call over to Dikla. Dikla?

Thank you, Brian. On behalf of our team at PolyP, I would like to welcome everyone to our fourth quarter and full year 2022 earning call. Before discussing the details of our clinical program, I would like to reiterate how thrilled we are to now have a clear regulatory pathway for the potential NDA submission for DIPLEX-100 in the U.S., following a positive type D meeting communication with the U.S. FDA on the SHIELD-1 phase 3 data. As a reminder, in advance of the type D meeting, we provided the FDA currently available data from the SHIELD-1 study evaluating DIPLEX-100 in abdominal colorectal surgery. Based on these data, particularly the 54% reduction observed in the primary endpoint in a pre-specified subgroup analysis of 423 patients with surgical incisions greater than 20 centimeters compared to standards of care, which represented a p-value of 0.0032, the FDA acknowledged that the SHIELD1 result may provide supportive evidence on this population. The agency also recommended that the company conducted an additional study to support a potential NDA submission. The FDA confirmed that the ongoing SHIELD2 study, which to date has enrolled approximately 40 patients with the appropriate large surgical incision, could potentially serve as such a study. Importantly, the FDA also recognized that since DIPLEX-100's proposed indication is for the prevention of infection, it has potential for wide use. While we are currently working expeditiously to finalize the design of the revised CHILD2 trial and expect to resume patient recruitment next quarter, we wanted to take the opportunity today to provide some color around what this study will look First, 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 SHIELD1 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 SHIELD1. Moreover, we have the opportunity to leverage the key learnings from the SHIELD-1 study, notably with regard to countries and specific sites and patient profiles. In order to ensure we are appropriately leveraging these key learnings, we conducted a clinical advisory board meeting late last year to gather clinical feedback from key U.S. opinion leaders specialized in SSI including both surgeons and infectious disease specialists. We intend to recruit a total of approximately 600 patients for an additional 550 subjects behind 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 next quarter. Topline results are expected mid-next year, three months from completion of enrollment. I would highlight that this anticipated timeline is similar to the one seen in Shield 1. We also plan to conduct an unblinded interim analysis once a total of approximately 400 patients complete their 30 days follow-up. To put this in context, You will recall that it took us 22 months to recruit 977 patients into SHIELD1, and it was during the most challenging period of the COVID pandemic. Importantly, the ability to leverage the ongoing SHIELD2 study will significantly reduce the time and resources needed as compared to having to initiate a new trial. The design of the SHIELD2 trial will be very similar to the SHIELD1 study in terms of primary and secondary endpoints with patient intervention arm receiving DIPLEX-100 on top of standards of care and subject in the control arm receiving standards of care alone. The primary endpoint of the trial will be a combination of SSI reintervention and mortality rate at 30 days post-index surgery as defined in the CDC SSI guidelines. Patient safety will be monitored for an additional 30 days. The study will take place in the US, EU, and Israel. In Europe, as we have done with the FDA in the US, we are also preparing for expected near-term interactions anticipated in the first half of this year with the European regulatory authorities regarding DICTEX 100. I should add that we are working closely with our European partner, Advanced Pharma, with regards to the EU pathway and are fully aligned on the regulatory strategy for this region. In regard to our financial position, we continue to expect our current cash runway to extend well into the third quarter of this year. With that said, we anticipate having a number of compelling financing opportunities to enhance our balance sheet in 2023 and to fund CHILD II to a successful completion. We are grateful for the continued support shown by our largest institutional shareholders. Moving on, we have a number of operational goals in 2023. I will now ask Ori to review those.

Thank you, Dikla. We view 2023 as a potentially transformational year, not only in the clinical and regulatory areas, but also on business development and manufacturing fronts. From a business development perspective, first, we intend to focus on attracting additional strong partners for DIPLEX 100 in different geographic territories, like U.S. and China. Second, ShieldOne validated the Plex technology platform in a large clinical trial, providing local and controlled release of drug molecules directly at the disease target organ over a predetermined period of time. This validation of the platform can serve as a starting point for platform-related collaborations. Importantly, we have in-house research, development, and GMP manufacturing that can support various potential partnership opportunities. Using our in-house capabilities, it is a matter of only months to encapsulate new API into the Plex platform and achieve proof of concept. Plex platform collaborations will be focused on two key areas. The first, the delivery of innovative drug specifically local delivery, where systemic delivery is either not effective enough or too toxic, for example, in oncology. Second, the lifecycle management of an approved drug where prolonged local delivery provides significant clinical benefit. Specialty companies are always looking to differentiate their existing product portfolios, and leveraging the Plex technology is an excellent way to accomplish this. Our planned objective is to formalize two partnerships in 2023, although the exact pace of partnership discussion is inherently difficult to predict. On the operations side, we expect to complete the commercial manufacturing process validation and packaging validation for DPLEX-100 in the first half of this year. We plan on having the CMC and preclinical data needed to support an NDA submission by the end of the year. With that, it is my pleasure to turn the call over to Johnny to review our current financials. Johnny? Thank you, Ori.