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PolyPid Ltd.
5/12/2021
Greetings and welcome to the PolyPID first quarter 2021 conference call. At this time, participants are in listen-only mode. As a reminder, this call is recorded. And I would now like to introduce your host for today's conference, Mr. Bob Yadid from LifeSci Advisors. Mr. Yadid, you may begin.
Thank you. And thank you all for participating in PolyPID's first quarter 2021 earnings conference call. Joining me on the call today will be Amir Weisberg, Chief Executive Officer, and Dikla Chavka-Oxobrod, Executive Vice President and Chief Financial Officer of PolyPID. Earlier today, PolyPID released financial results for the three months ended March 31, 2021. A copy of the press release is available in the Investors section of the company's website, www.polypid.com. I'd like to remind you on this call, management will make forward-looking statements within the meaning of the Federal Securities Law. For example, management is making forward-looking statements when it discusses the expected recruitment for trials, timing of trials and release of trial results thereof, the capacity of the company's manufacturing facility, the potential benefits of PLEX and Oncoplex, and the sufficiency of the company's cash, to fund future operations. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond our control, including the risks and uncertainties described from time to time in our filings with the Securities and Exchange Commission. Our results may differ materially from those projections. These statements involve material risks and uncertainties that can cause actual results or events to materially differ. Therefore, you should not place undue reliance on these statements. I encourage you to review the filings with the SEC, including without limitation, the company's forms 20F and 6K, which identifies specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements. PolyPede 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 12, 2021. With the completion of those prepared remarks, it's my pleasure to turn the call over to Amir Weissberg, CEO. Amir?
Thank you, Bob. On behalf of our team at Polypeed, I would like to welcome everyone to our first quarter 2021 earning call. I will begin today with some brief introductory comments and then Dikla will provide a little update on our business and we'll review our financial results after which we will open the call for questions. I'm very pleased with the recent progress we have achieved in advancing our development programs and in continuing our evolution toward becoming a commercial company. As you know, we are currently in a large phase three program with our lead asset, D-Plex 100, for the prevention of surgical site infection, or SSI. DECLA will provide further details on this program shortly. but I am excited to report today that our ongoing SHIELD1 trial is proceeding as planned, and we are having great success accelerating enrollment into this study. Moreover, our second Phase III trial in abdominal surgery, SHIELD2, is also advancing as expected with new site opening at a robust phase. As a reminder, this two phase three trial will serve as a basic for polypid first new drug application submission and we believe will contribute to support a broad level for the prevention of SSI. Importantly, our broad DPLEX-100 development program is supported by a vast patent portfolio. In fact, we now have 101 patents granted and allowed worldwide for our platform and products. I am also pleased to report today that our manufacturing facility is now fully scaled up. This facility will be able to support the first 30 months of product demand worldwide. As you can see, Polypid has recently achieved important progress in all aspects of its business. We also continue to be supported by a strong balance sheet, which we expect to be sufficient to complete the Shield 1 study, to conduct Shield 2, and prepare for the submission of NDA, as well as further advance our on-copy development platform with cash on hand. I will now turn the call over to Dikla to provide you with some further details on our business. Dikla, please take it from here.
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