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spk02: Greetings and welcome to the Polypeed third quarter 2024 conference call. At this time, all 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 LifeSci Advisors. Mr. Ritchie, you may begin.
spk06: Thank you all for participating in Polypeed's first quarter 2024 earnings conference call. Joining me on the call today will be Dikla Tchotchkes-Axelbrad, Chief Executive Officer of Polypeed, Johnny Misalawin, Polypeed's Chief Financial Officer and Ori Warshawski, Chief Operating Officer, US of Polypeed. Earlier today, Polypeed released financial results for the three months ended March 31st, 2024. A copy of the press release is available in the Investor section on the company's website, .polypeed.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 the expected timing for recruitment, number of centers, top-line results from the SHIELD II trial and of the unblinded interim analysis, the planned new drug application submission for Deplex 100, the strength of the company's intellectual property, the company's expected cash runway and the potential to receive additional funds if warrants are exercised. 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. Poly P 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 8th, 2024. With the completion of these prepared remarks, it is my pleasure to turn the call over to Dikla, Czasky Axelbrad, CEO of Polypeed. Dikla?
spk04: Thank you, Brian. On behalf of our team at Polypeed, I would like to welcome everyone to our first quarter 2024 earning conference. We are excited about the substantial momentum throughout our business. Most importantly, as it relates to enrollment in our ongoing SHIELD II pivotal trials for DIPLEX-100 for the prevention of abdominal colorectal surgical site infection. Importantly, this clinical progress is being achieved with a recently fortified balance sheet. Let's begin with the status of SHIELD II. I'm pleased to report today that the study has now enrolled more than 200 subjects and approximately 50 centers are currently open in multiple countries around the world, including the US, Germany, Italy, Ireland, Portugal, Hungary, and Israel. As a reminder, we intend to conduct an unblinded interim analysis once approximately 400 patients of the planned total of 600 subjects complete the 30-day follow-up, which is expected to occur in mid 2024. Top line results are anticipated in the second half of this year. Therefore, SHIELD II is now more than half enrolled for the interim analysis and more than one third fully enrolled. Importantly, as the current status would indicate, enrollment is now progressing at a constantly robust pace, with respect to the expected recruitment rate. As we said on our last call, once the science is fully up and running, which takes several weeks following it being formally open, we anticipate approximately one and a half patients being recruited into the trial per center per month, and we expect to have a total of approximately 60 centers opened and recruiting patients. So, at the peak of the enrollment period, we anticipate recruiting 90 patients per month, similar to the enrollment rate we had in SHIELD I. With that said, having crossed the important 200-subject threshold, we thought we'd provide some color on several encouraging enrollment trends we are seeing. Of note, the median age, male-female split, and percentage of enrolled cancer patients in SHIELD II are similar to the patient population in the SHIELD I large incision pre-specified sample. This is significant because we are, thus far, observing similar demographics in this more focused patient population, in which we have already generated highly positive data in SHIELD I. This is yet another reason we continue to strongly believe that SHIELD II is a de-risk phase retrial, along with the fact that SHIELD II is not being conducted within the tight COVID-related restrictions that were in place during the pandemic and throughout the duration of SHIELD I. Of course, we are also leveraging key learning from SHIELD I related to the sites involved in the study. To this end, while we are targeting approximately 60 centers, or SHIELD II, around the same number as SHIELD I, we have firm knowledge of the best performing sites from SHIELD I in terms of recruitment, patient monitoring, and good clinical practice. We believe this to be essential in the execution of SHIELD II. We have also enhanced our clinical operations team, another key step towards supporting a successful study. Moreover, the Data Safety Monitoring Committee, in charge of the review of accumulated safety data and study conduct for SHIELD II study, has twice recommended to continue the study without modification, meaning that no safety issues related to DIPLAC 100 have been observed in SHIELD II to date. Moving on, to reiterate what we have said previously, we have a clear regulatory pathway for the potential NDA submission for DIPLAC 100 in the US. Last year, the FDA acknowledged not only that SHIELD I results may provide supportive evidence of the safety and efficacy of DIPLAC 100 in patients with large surgical incisions, but also confirmed that if successful, SHIELD II is sufficient to support a potential NDA submission. I'd like to take a moment to acknowledge an often overlooked key aspect of the compelling DIPLAC 100 product profile, and that is its substantial intellectual property foundation. Specifically, we are fast approaching 175 granted and pending applications patented for the PLEX platform and its users for the treatment of different indications. Among those method of use patents are a significant number of patents with long-term protection for DIPLAC 100 for the prevention of surgical site infection. For example, our DIPLAC 100 SSI patent is expected to remain in effect until 2035 in more than 40 countries worldwide. This incredibly strong IP position only enhances the value of this promising late-stage product candidate for us. Shifting gears, we continue to advance SHIELD II from a strengthened financial position following our January 2024 private placement financing or PIPE for $16 million of gross profit. Importantly, our cash one way now extends into the fourth quarter of this year and beyond the anticipated timing of SHIELD II's planned unlined interim analysis. Moreover, the company has the potential to secure an additional $19 million if the results of the unlined interim analysis are positive and all warrants issued in the financing of SSI, which would fund polypeed to the start of a planned rolling NDA submission for DIPLAC 100. As a reminder, the PIPE syndicate was comprised of new and existing investors, including participation from US Life Science focused investors, DAFNA Capital Management and Roslyn's advisors. Before I turn the call over to Johnny for his review of the financial, I'd like to let you all know that we have recently posted a newly revamped corporate presentation on our IR website. We would encourage all of you to take a look at your convenience. With that, it is my pleasure to now turn the call over to Johnny. Johnny?
spk07: Thank you, Nikla. As of March 31, 2024, the company had cash and short-term deposits of $14.5 million. As compared to $5.3 million at the end of 2023. This includes the net proceeds of approximately $15 million generated from the PIE Finance enclosed in January 2024. We expect that our cash balance will be sufficient to fund operations into the fourth quarter 2024. Now let's turn to our income statements. Research and development expenses for the three months ended March 31, 2024, were $5.1 million compared to $3.8 million in the same three-month period of 2023. The increase in R&D expenses in the most recently completed quarter was driven by the ramp-up of the ongoing Shield 2 phase retrial. Marketing and business development expenses for the three months ended March 31, 2024, were $236,000 compared to $385,000 during the prior year period. General and administrative expenses for the three months ended March 31, 2024, were $1 million compared to $1.6 million recorded in the same three-month period of 2023. This decrease reflects our ongoing cost containment efforts. For the three months ended March 31, 2024, the company had a net loss of $6.4 million as compared to $6.1 million in the first quarter of 2023. With that, we will now open the call to your question. Operator?
spk02: Thank you. If you wish to ask a question, you will need to press star 1 and 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 and 1 again. Thank you. We will take our first question. And your first question comes from the line of Roy Buchanan from Citizens JMP. Please go ahead. Your line is open.
spk01: Thanks for taking the questions. Appreciate all the comprehensive updates. A couple just quick ones on Shield 2. I guess, Sikla, can you just review in a little bit more detail, I guess, the timeline for the NDA submission and the expected review? Now, we're at 505B2, you have breakthrough designation. What can we expect as far as the timeline? Then what are the plans for Europe,
spk03: assuming Shield 2 is successful? You may be on mute, or I may have dropped. No, I can hear you.
spk05: Now we are
spk04: not on mute. Sorry. Can you hear me?
spk03: Yes.
spk04: Hi. Good morning. Thank you, Roy. Thank you for the question. So Shield 2 is expected to finalize the 400 patients for the interim analysis mid-this year with readouts for that around the fall. And assuming we are stopping there, or maybe I should say assuming we will need to continue to the 600 patients, which is the minimum for the study design, it is another quarter for recruitment. So towards the end of the year, we expect to get that done as well. And the understanding that we have is that during 2025, at the first half of 20, at the end of the first half of 2025, we should be submitting NDA, which means that towards the end of 2025, we will get the result. This assumes that we are continuing recruitment, and this is our assumption. If we decide to stop the recruitment, then, well, let's leave it this way. So this is continuing recruitment up to the 600 patients, and this takes us into the end of 2025 for the NDA. With regards to Europe, we are looking at it as a powerless strategy. It takes a bit longer to get the approval in Europe, although we are entitled to the centralized procedure, so we can submit once and get an approval for all of Europe, which is very beneficial. We will be making a more, let's say, tactical decision as we get to the readout, see whether we want to get, before we submit to Europe, to have the end of phase three meeting with the FDA, but these are really tactical. So our assumption is that Europe will shortly follow after US in terms of NDA.
spk03: Okay, great. And then just one
spk01: on the sites. I guess, can you provide a bit more detail on the geographic breakdown of the current 50 sites? I know the countries are listed in the press release, but those predominantly in the US or elsewhere, Western Europe, et cetera, and then for the additional 10 sites, where are those expected to be added?
spk04: Sure. So we actually related a little bit to that in the press release, listing the list of countries that are, example of countries that are participated. We listed US, Germany, Italy, Ireland, Portugal, Hungary, and Israel. We have some additional countries, Eastern European countries that are also being added. Overall, I would say that it is about between, in the European countries, around between three to five centers per country. In the US, we have a bit more. And that's about that. It's quite spread, similar. Many countries that were in Shield 1 are also in Shield 2. We didn't have that much Western Europe in Shield 1. We have a little bit more of Western Europe now, which we see as a good thing because we see that the data is more
spk05: clean and repeats itself.
spk03: Okay, great, that's helpful. Thank
spk01: you. And then maybe one last one, if I can.
spk03: I guess,
spk01: assuming Shield 2 is successful, how soon do you think you can pivot, or not pivot, but advance the pipeline? You have Oncoplex, and I guess in the waiting, what are the plans? How fast can you get that going? Thank you.
spk04: So this is something that we are actually putting a lot of effort now into. So obviously our top priority right now is DIPLEX-100. But as we previously said, we are looking into the pipeline. The second in line priority is the oncology program, the Oncoplex, which remains a priority for us. If you remember, we had a successful pre-IND meeting with the US FDA supporting the phase 1-2 clinical trials. So this is our first priority, but we are also looking on potential broadening of that, a more strategic pipeline prioritization, looking also in some additional direction in order to be prepared with this for the time of the top line. We wanna make sure that once we are past this very important milestone of phase 3 in Shield 1, sorry, in Shield 2, in DIPLEX-100, we are ready for expansion of the pipeline. So I think after the top line, we will also have some news to share there. This is something we are looking at
spk05: very
spk04: in depth these
spk05: days. Okay, thank you.
spk02: Thank you. There seems to be no further questions. I would like to hand back for closing remarks.
spk04: Thank you for joining Polypeed's first quarter 2024 earning conference call. We remain highly confident in our long-term prospects, especially the potential of our promising late stage product candidate, DIPLEX-100. As always, we are grateful to our team members, shareholders, and all external partners for their commitment to our mission and support in continuing to advance toward our goal of bringing DIPLEX-100 to healthcare providers and patients as quickly as possible. We look forward to speaking with you again on our
spk05: next conference call. Thank you. This concludes today's conference call. Thank you all for participating.
spk02: You may now disconnect.
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