PolyPid Ltd.

greetings and welcome to the polypete third quarter 2023 conference call at this time participants are in listen only mode as a reminder this call is recorded and i would like now to introduce your host for today's conference brian ritchie from life science advisors mr ritchie you may begin

Thank you all for participating in PolyPete's third quarter 2023 earnings conference call. Joining me on the call today will be Dikla Chachkis-Axelbrad, Chief Executive Officer of PolyPete, Johnny Misalawan, PolyPete's Chief Financial Officer, and Ori Warshawski, Chief Operating Officer of PolyPete. Earlier today, PolyPete released financial results for the three and nine months ended September 30th, 2023. A copy of the press release is available in the Investors section on the company's website, www.polyp.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 therefrom. It's intention to conduct an unblinded interim analysis once a total of approximately 400 patients complete their 30 day follow up the potential new drug application submission for deplex 100 in the US and EU marketing authorization application regulatory filings. It's expectation to have 40 centers open by the end of 2023. Factors essential in the execution of Shield 2. The potential of D-Plex 100 in addressing the persistent challenge of surgical site infections. D-Plex 100's potential to provide prophylactic efficacy benefits in patients with increased SSI risk factors. The company's competitive advantages. Potential clinical evaluation of D-Plex 100 in the pediatric population. potential commercial demand for DPLEX 100, 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 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, November 8th, 2023. With the completion of these prepared remarks, it is my pleasure to turn the call over to Dikla Chachkis-Axelrod, CEO of PolyP. Dikla?

Thank you, Brian. On behalf of our team at PolyPEED, I would like to welcome everyone to our third quarter 2023 earning goals. To begin, I would like to extend our gratitude to so many of you who have continued to reach out to us to express your concern regarding the health and safety of our employees and their families, given the horrible acts of violence that took place in Israel on October 7th. Despite the terrible news over the last few weeks, we at PolyPID remain focused on ensuring the uninterrupted progress of our ongoing SHIELD2 pivotal trial for DPEX100 for the prevention of abdominal colorectal surgical site infection, or SSI. To date, there has been no material impact on our operations and specifically on SHIELD2. In fact, As we said would be the case by this time, we currently have approximately 20 centers open, the majority of which are outside of Israel. The vast majority of these 20 centers have opened only in the last few weeks. Therefore, while we currently have approximately 50 patients recruited into the SRIL2 trial, we expect enrollment to ramp up shortly. To this end, we anticipate having approximately 40 centers open by the end of 2023. To give you a better sense of the expected pace of enrollment, once the site is fully up and running, which takes several weeks following its being formally open, we expect approximately 1.5 patients to be recruited into the trial per center per month. We intend to conduct an unblinded interim analysis once a total of approximately 400 patients complete their 30-day follow-up, and top-line results are expected in the second half of 2024. I should also add that while surgical incision length is widely known independent procedural risk factor for SSI and abdominal surgeries, it is not the only one. In the SHIELD-1 study, we also observed a positive effect of DIPLEX-100 in postdoc analysis of subgroup of patients with patient-specific risk factors, such as obesity, diabetes, hypertension, and COPD. Based on these results, we believe DIPLEX-100 has the potential to provide prophylactic efficacy benefits in patients with increased SSI risk factors, both procedural and patient-specific. Patients in either of these risk categories are relatively easily identified by the surgeon in the pre- and intraoperative periods and could be ideal candidates for DPLEX-100 at the time of incision closure, particularly when there is a need for enhanced SSI antimicrobial prophylaxis. Moving on. As you know, 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 the SHIELD-1 result may provide supportive evidence of the safety and efficacy of DPLEX-100 in patients with large surgical incisions, but also confirmed that if successful, SHIELD-2 is sufficient to support a potential NDA submission. We continue to strongly believe that SHIELD2 is a de-risk phase retrial, 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. We are also leveraging key learnings from SHIELD1 related to the sites 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 and countries 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. While we focus on enrollment into SHIELD2, we have also recently achieved several key DPLEX100 manufacturing-related milestones that have helped evolve PolyPIT into a fully integrated biopharmaceutical company. First, we successfully completed the production and release of three process validation batches of DPLEX100. This significant accomplishment completes a substantial requirement towards our planned submission of DPLEX 100 NDA and EU marketing authorization application regulatory filing. I should highlight that the successful validation of the production process at commercial scale is the result of a significant facility expansion and scale-up that's more than tripled the company's capacity to manufacture DPLEX 100 for the US, EU, and global markets. Our in-house state-of-the-art good manufacturing practice, or GMP, sterile production facility, provides us with full control of Duplex 100 manufacturing from clinical stage to commercial supply and serve as a key competitive advantage going forward. Most recently, we completed a successful GMP audit by the Israeli Ministry of Health of our manufacturing facility without any critical or major findings. This audit is also valid for European regulators. Importantly, we can now produce Duplex 100 at scale in order to fulfill the expected commercial demand for the product. Moving on, we also continue to augment the published and presented research in support of Duplex 100. To this end, a paper highlighting positive preclinical results that demonstrated for the first time the safety profile of DPLEX-100 and the Plex technology platform in juvenile animals, was published in the peer-reviewed journal, International Journal of Toxicology. These results have the potential to support the clinical evaluation of DPLEX-100 in the pediatric population. In addition, we recently presented the result of the SHIELD-1 phase 3 trial for the first time at a medical meeting the American College of Surgeons Clinical Congress 2023, which took place last month in Boston. I am pleased to report that polypid's progress in the advancement of DIPLEX-100 has not gone unnoticed. Last month, DIPLEX-100 was selected as the winner of the 2023 Overall Biopharma Solution of the Year as part of the third annual Biotech Breakthrough Awards which recognize the world's best biotech and life science companies, products, and services. Shifting gear, I'd like to highlight that we recently regained compliance with NASDAQ's minimum closing bid price rule. Also, while Johnny will review our current financials momentarily, I'd like to emphasize the ongoing cost containment efforts throughout our business, including in clinical operations, GNA, and manufacturing. For the first nine months of 2023, our net cash used in operating activities decreased by 56% as compared to the first nine months of 2022. Finally, I would like to take this opportunity to welcome Dr. Nuit Tweezer-Zachs, who was recently appointed to Polyped's Board of Directors. Dr. Tweezer-Zachs is a biopharmaceutical industry veteran with extensive executive business development, clinical, and R&D expertise. She is an experienced sector investor and was a practicing physician for nearly 15 years. We look forward to leveraging her vast expertise across the BD, clinical, R&D, and financial functions. As we approach critical, clinical, and regulatory months, as well as potential commercialization of LIPLEX 100. On behalf of everyone at Polipede, I would also like to express my thanks to Anat Sursegal, who is retiring from our board following 15 years of distinguished service. Mr. Sursegal has provided critical counsel over the years that has helped grow and advance our business. We wish her the best in all our future initiatives. With that, I am pleased to turn the call over to Johnny. Johnny?