PolyPid Ltd.

The conference will begin shortly. To raise your hand during Q&A, you can dial star 1 1. Greetings and welcome to the Polypedes second quarter 2022 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, Bob Yedid from LifeSci Advisors. Mr. Yedid, you may begin.

Thank you all for participating in Polypedes Second Quarter 2022 Earnings Conference Call. Joining me on the call today will be Dikla Chachkas-Aksobrad, Chief Executive Officer of PolyPede, and Orr Wachowski, Chief Operating Officer for PolyPede's U.S. Operations. Earlier today, PolyPede released financial results for the three and six months ended June 30th, 2022. A copy of the press release is available in the Investors section on the company's website. 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 our ongoing clinical trials, our expectations regarding the timing of top-line results from the Shield 1 study and potential NDA submission and MAA filings, potential milestone payments under the licensed agreement with Advanced Pharma, potential future additional commercial partners, and our ability to maximize the value of D-Plex 100, the commercial potential for D-Plex 100, market opportunity in Europe, the strength of our financial position, and our expectation that our cash balance, together with the upfront payment from Advanced Pharma and the proceeds from the Krios loan, will be sufficient to fund operations through the end of the second quarter of 2023. Forelook and 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 can cause actual results or events to differ materially. Accordingly, you should not place undue reliance on these events. I encourage you to review the company's filings with the SEC, 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. The conference call contains time-sensitive information and speaks only as of the live broadcast today, August 10, 2022. With the completion of those prepared remarks, it's my pleasure to turn the call over to Dikla, CEO of PolyPete. Dikla?

Thank you, Bob. On behalf of our team at PolyPID, I would like to welcome everyone to our second quarter 2022 earning call. I'm thrilled to have the opportunity to provide you with a corporate update today during such a truly exciting time for PolyPID. I will begin with the recent exclusive license agreement we signed with Advanced Pharma for the commercialization of D-Plex 100 for the prevention of surgical site infections or SSI in abdominal and cardiac surgeries in Europe, which provide further validation for the significant cells potential of Dplus100 and represent substantial value for PolyPID. Under the terms of the agreement, PolyPID is entitled to receive an upfront payment immediately upon signing of the agreement and additional potential development-related milestones for a total of up to $23.5 million and up to $89 million in sales-related milestones. We will also supply DPLEX 100 to Advanced Pharma for a negotiated transfer price and receive royalties on net sales in double-digit percentages of up to the mid-20s. Advanced Pharma is backed by Nordic Capital. one of the most active and experienced private equity investors in healthcare. Advanced pharma expertise in marketing hospital-based therapies, mainly after the recent acquisition of Intercept, that more than doubled their commercial and medical teams across major EU countries and the UK, will prove invaluable in expanding access to the DPLEX-100 and delivering this much-needed therapy. if approved to patients. To understand our excitement for this licensing agreement, it is important to put in perspective the opportunity of DPLEX-100 in Europe. Surgical site infections represent a major unmet medical need in Europe. SSIs are one of the most common hospital-acquired infections and occur in up to 15 to 20% of major surgical procedures, such as open colorectal resections. We are also talking about a very significant market opportunity. According to Acuvia, the addressable market opportunity in selected abdominal surgeries in the big five European countries represent approximately 3 million annual surgeries. Moreover, there are an additional estimated 450,000 open heart surgeries in the big five EU countries every year. As a result, it is not surprising that the World Health Organization estimates the significant economic burden SSI represents. The WHO estimates that SSI results in up to 11 billion euros of additional hospital costs per year in Europe. This deal is the first step in our strategic approach to commercialize DIPLEX-100. In terms of additional potential collaborations in the US and rest of the world, We remain in dialogue with several other large and mid-sized pharmaceutical companies that we believe would be ideal commercial partners. Like Advanced Pharma, these companies are leading in selling pharmaceutical products to hospitals, often with a current portfolio of marketed products have strong established commercial infrastructures, exhibit a deep understanding of clinical benefits and health economics in the hospital channel, and maintain strong relationship with the hospital medical and administrative staff. Importantly, there continues to be a high level of interest in DPLEX 100 from additional potential partners. While there is currently no formal timeline related to executing any additional potential collaborations in the US or rest of the world, our most critical objective is to maximize the value of DPLEX-100 in any potential transaction, as we believe we have done in the Advanced Pharma Agreement. If and when we do finalize additional collaboration agreements, maximizing the value of DPLEX-100 will be the key determining factor. With that, I will now provide a brief update on the status of our pipeline. Let's begin with Shield 1, our Phase 3 study evaluating DIPLEX-100 for the prevention of abdominal soft tissue SSI. As we announced in May this year, the Independent Data Safety Monitoring Board, or DSMB, recommended concluding this trial subsequent to the enrollment of 950 patients. which is the minimum number of targeted patients in the study protocol. This recommendation was based on the unblinded interim analysis by the independent DSMB of efficacy data from the first 750 enrolled patients. The enrollment of the last patient subsequently was announced in late May 2022. As a reminder, the SHIELD-1 study of DIPLEX-100 in the prevention of SSI in abdominal tissue surgery is designed to demonstrate at least a 50% reduction in incisional SSI in the DPLEX-100 treatment arm compared to the control arm, with 90% power to detect the difference between the two arms and an alpha level of less than 0.05. Patients in the study have been enrolled across approximately 60 centers in the United States, Europe, and Israel. Importantly, field one is the largest infection prevention trial in colorectal surgery conducted in more than a decade, which we believe only enhanced the importance of this data. Full top line results are anticipated by the end of the current quarter. followed by potential NDA submission to the FDA and European Union MAA filing. Resulting from the breakthrough therapy designation, DPLEX-100 is eligible for rolling NDA submission targeted to start early 2023. Before we provide an update on OncoPlex and PolyPIDS Financial, Ori will provide color on key takeaways for market research we recently completed for DPLEX-100 in the U.S., and how this work was further supported by the real-world commentary provided by 2KOL at a recent webinar focused on managing the cost of SSI. Ori?