Yahoo Finance PolyPid Ltd. (NASDAQ:PYPD) Q1 2024 Earnings Call Transcript
PolyPid Ltd. (NASDAQ:PYPD) Q1 2024 Earnings Call Transcript May 9, 2024
PolyPid Ltd. isn't one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).
Operator: Thank you all for participating in PolyPid's First Quarter 2024 Earnings Conference Call. Joining me on the call today will be Dikla Czaczkes Akselbrad, Chief Executive Officer of PolyPid; Jonny Missulawin, PolyPid's Chief Financial Officer and Ori Warshavsky, Chief Operating Officer, US of PolyPid. Earlier today, PolyPid released financial results for the three months ended March 31, 2024. A copy of the press release is available in the Investors section on the Company's website, www.polypid.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 D-PLEX100, 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 20-F, which identifies specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements. PolyPid 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 08, 2024. With the completion of these prepared remarks, it is my pleasure to turn the call over to Dikla Czaczkes Akselbrad, CEO of PolyPid. Dikla?
Dikla Czaczkes Akselbrad: Thank you, Brian. On behalf of our team at PolyPid, 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 enrolment in our ongoing SHIELD II pivotal trial for D-PLEX100 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, enrolment is now progressing at a constantly robust pace. With respect to the expected recruitment rate, as we said on our last call, once the site is fully up and running, which takes several weeks following its 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 enters opened and recruiting patients.
So at the peak of the enrolment period, we anticipate recruiting 90 patients per month, similar to the enrolment 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 enrolment trends we are seeing. Of note, the median age, male female sleep, and percentage of enrolled cancer patients in SHIELD II are similar to the patient population in the SHIELD I large incision, pretty specified subgroup. 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 III trial, 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 modifications, meaning that no safety issues related to D-PLEX100 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 D-PLEX100 in the US. Last year, the FDA acknowledged not only that SHIELD I results may provide supportive evidence of the safety and efficacy of D-PLEX100 in patients with large surgical incision, but also confirm 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 D-PLEX100 product profile, and that is its substantial intellectual property foundation. Specifically, we are fast approaching 175 granted and pending applications patent 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 D-PLEX100 for the prevention of surgical site infection. For example, our D-PLEX100 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 proceeds. Importantly, our cash runway now extends into the fourth quarter of this year and beyond the anticipated timing of SHIELD II's planned unblinded interim analysis. Moreover, the company has the potential to secure an additional $19 million if the result of the unblinded interim analysis are positive and all warrants issued in the financing are exercised, which would fund PolyPid to the start of a planned rolling NDA submission for D-PLEX100.
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 Roseline Advisors. Before I turn the call over to Jonny for his review of the financials, 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 Jonny. Jonny?
Jonny Missulawin: Thank you, Dikla. 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 pipe financing closed 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 II Phase III trial. 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 questions. Operator?
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