PolyPid Ltd. (NASDAQ:PYPD), a specialty pharmaceutical company, announced its first-quarter financial results for 2024, highlighting significant progress in its SHIELD II pivotal trial for D-PLEX100. The company is actively enrolling patients, with over 200 subjects across approximately 50 centers in multiple countries. PolyPid anticipates an unblinded interim analysis after 400 patients complete a 30-day follow-up, with top-line results expected in the latter half of the year. The company's strong intellectual property position is reflected in its 175 granted and pending patents for its proprietary PLEX platform. PolyPid's current cash balance is projected to sustain operations until the fourth quarter of 2024, with the potential for an additional $19 million in funding through warrant exercises.
Key Takeaways
- PolyPid is advancing the SHIELD II trial for D-PLEX100, with over 200 patients enrolled.
- The company expects interim analysis and top-line results in the second half of 2024.
- PolyPid has a robust intellectual property portfolio with 175 patents for the PLEX platform.
- The company's cash reserves should support operations into Q4 2024, with additional funding possible.
- Recruitment for the D-PLEX100 trial is projected to reach 600 patients by the end of 2025.
- PolyPid plans to submit a New Drug Application in the US and seek approval in Europe.
- The trial is currently conducted in the US, several European countries, and Israel, with plans to expand to Eastern Europe.
- The company is prioritizing the D-PLEX100 program but also advancing the OncoPLEX oncology program.
Company Outlook
- PolyPid remains focused on the D-PLEX100 program and is planning for submission of the New Drug Application after reaching enrollment goals.
- The company is confident in its long-term prospects and is committed to market introduction for D-PLEX100.
Bearish Highlights
- There are no specific bearish highlights mentioned in the provided context.
Bullish Highlights
- The company's intellectual property portfolio is a strong asset, with a significant number of patents granted and pending.
- PolyPid is confident in the potential of its PLEX technology platform and its application in multiple therapeutic areas.
Misses
- The provided context does not indicate any specific misses or setbacks in the company's operations or financial performance.
Q&A Highlights
- The summary does not provide details of the Q&A session from the earnings call, so no specific highlights can be reported.
PolyPid's continued progress in the pivotal trial of D-PLEX100 and its strategic focus on expanding its pipeline, particularly in oncology with OncoPLEX, showcases the company's commitment to innovation and patient care. The company's robust patent portfolio and financial position support its ongoing operations and future development plans. With a clear strategy for regulatory submissions in the US and Europe, PolyPid is poised to make significant strides in the pharmaceutical industry.
InvestingPro Insights
PolyPid Ltd. (PYPD) has shown a dedication to advancing its pharmaceutical trials, particularly with the SHIELD II trial for their leading candidate D-PLEX100. As investors consider the potential of PolyPid, it is essential to observe both the company's strategic movements and its financial health.
InvestingPro data indicates a market capitalization of $21.95 million, which, while modest, reflects the current scale of the company's operations. The stock's recent performance has seen a significant downturn, with a one-week total return of -8.9%. Over a broader timeframe, the one-year price total return stands at -63.41%, suggesting that the market has had a bearish view on the stock's prospects. This aligns with the InvestingPro Tip that the stock has taken a substantial hit over the last week, which could be a point of concern for potential investors.
Furthermore, the company's operating income, as of the last twelve months ending Q1 2024, shows a loss of $23.38 million USD. This financial metric complements the InvestingPro Tip that analysts do not anticipate the company will be profitable this year. It also underscores the importance of the company's cash reserves, which are projected to sustain operations until the fourth quarter of 2024.
For investors seeking a deeper analysis, there are additional InvestingPro Tips available for PolyPid. These tips include insights on the company's cash burn rate and gross profit margins, which are crucial for understanding the financial sustainability of PolyPid as it progresses through its trials. To access these insights, investors can visit the InvestingPro platform at https://www.investing.com/pro/PYPD. For those interested in a subscription, use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, which includes a total of 7 additional InvestingPro Tips for PolyPid.
PolyPid's journey through the SHIELD II trial and its financial stability are closely intertwined. As the company continues to invest in its PLEX technology platform, these InvestingPro Insights and Tips may help investors make more informed decisions about the company's future prospects.
Full transcript - PolyPid (PYPD) Q1 2024:
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?
Operator: [Operator instructions] And your first question comes from the line of Roy Buchanan from Citizens JMP. Please go ahead. Your line is open.
Roy Buchanan: Hey, thanks for taking the questions. I appreciate all the comprehensive updates. Just quick ones on SHIELD II, I guess Dikla, can you just review in a little bit more detail, I guess the timelines for the NDA submission and the expected review? I would say 505(b)(2), you have breakthrough designation. Just what can we expect as far as the timeline? And then what are the plans for Europe assuming SHIELD II is successful? You may be on mute or I may have dropped.
Dikla Czaczkes Akselbrad: I can hear you now. We are not on mute.
Ori Warshavsky: Roy. Thank you for the question. So SHIELD II is expected to finalize the 400 patients for the interim analysis mid this year with the readout for that and around the fall and assuming we are stopping there, or maybe I should say assuming we are -- we will need to continue to the 600 patient, 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 '25, 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 assumes continuing recruitment up to the 600 patient and this takes us into the end of 2025 for the NDA. With regards to Europe, we are looking at it as a parallel 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 and 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 to see whether we want to get, before we submit to Europe to have the end of Phase III meeting with the FDA. But these are really tactical. So our assumption is that Europe will shortly follow after US in terms of NDA. Okay, great.
Roy Buchanan: And then just one 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, etcetera and then for the additional 10 sites where those expected to be added.
Ori Warshavsky: Sure. So we actually related a little bit to that. In the press release listing the list that the 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 widespread. Similar many countries that were in SHIELD I are also in SHIELD II. We didn't have that much Western Europe in SHIELD I. 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 clean and repeats itself.
Roy Buchanan: Okay, great. That's helpful. Thank you. And then maybe one last one to say, if I can, I guess, assuming SHIELD II is successful, how soon do you think you can pivot or not pivot, but advance the pipeline? You have OncoPLEX, kind of, I guess, in the waiting. What are the plans? How fast can you get that going? Thank you.
Ori Warshavsky: So this is something that we are actually putting a lot of effort now into. So obviously, our top priority right now is D-PLEX100, but as we previously said, we are looking into the pipeline. The second in line priorities 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 I, Phase II 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 want to make sure that once we are past this very important milestone of Phase III in SHIELD I, sorry, in SHIELD II in D-PLEX100, 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 very in depth these days.
Operator: Thank you. There seems to be no further questions. I would like to hand back for closing remarks.
Ori Warshavsky: Thank you for joining PolyPid's first quarter 2024 earnings conference call. We remain highly confident in our long term prospects, especially the potential of our promising late stage product candidate, D-PLEX100. 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 D-PLEX100 to healthcare providers and patients as quickly as possible. We look forward to speaking with you again on our next conference call.
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