PolyPid Q1 2025 Earnings Call Transcript

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May 14, 2025

There are 8 speakers on the call.

Operator

and thank you for standing by. Welcome to the Polypede First Quarter twenty twenty five Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. Please be advised that today's conference is being recorded.

Operator

I would now like to hand the conference over to your speaker today, Brian Ritchie. Please go ahead.

Speaker 1

Thank you all for participating in Polypeak's first quarter twenty twenty five earnings conference call. Joining me on the call today will be Dikla Chokshiksz Axelbred, Chief Executive Officer of Polypede Johnny Misilowen, Polypede's Chief Financial Officer and Ori Worshofsky, Chief Operating Officer, U. S. Of Polypede. Earlier today, Polypede released its financial results for the three months ended 03/31/2025.

Speaker 1

A copy of the press release is available in the Investors section on the company's website, www.polyp.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 potential efficacy of DPLEX one hundred and the probability of success of the trial, that the gross proceeds from the company's last financing extend the company's cash runway into the third quarter of twenty twenty five beyond the expected top line results from SHIELD II, the expected timing for top line results from the SHIELD II trial, potential NDA and MAA submissions and the timing thereof, preparations for regulatory submissions, finalization of CMC and nonclinical NDA modules, potential clinical benefits of DPLEX100, potential market size for DPLEX100 in The United States, potential partnership opportunities, the potential to receive up to an additional $27,000,000 from the exercise of the warrants from the recent financing, the company's anticipation that with such additional funding, its runway would be extended beyond anticipated NDA approval, opportunities for the use of DPLEX 100 in additional procedures, and the company's long term prospects. 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.

Speaker 1

The company's 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 annual report on 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. 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.

Speaker 1

This conference call contains time sensitive information and speaks only as of the live broadcast today, 05/14/2025. With the completion of those prepared remarks, it is my pleasure to turn the call over to Diqla Chokshiksa Axelbrad, CEO of Polypede. Diqla?

Speaker 2

Thank you, Brian. On behalf of our team at Polypede, I would like to welcome everyone to our first quarter twenty twenty five earnings conference call. We were thrilled to recently successfully conclude enrollment of the SHIELD II Phase III trial assessing the efficacy of DPX-one hundred for the prevention of surgical site infection in patients undergoing abdominal colorectal surgery. As a reminder, this significant milestone followed an independent Data Safety Monitoring Board, or DSMB, recommendation to conclude the SHIELD II Phase III trial of DPX-one hundred at the lowest sample size reassessment stop, eight hundred patients, after the minimum planned number of patients. We are now rapidly approaching the availability of top line data by the end of next month.

Speaker 2

To reiterate what we have said previously, we view the DSMB's recommendation to conclude Shield-two upon the enrollment of 800 patients as a favorable outcome, as it is suggestive of positive efficacy signals from DPLEX100. Of course, the data generated from Shield two to date remain fully blinded to polypide and others outside of the DSMB until top line results are available. Upon potential positive phase three data, polypide expects to submit a new drug application or NDA with the advantages of the Fast Track and Breakthrough Therapy designations in early twenty twenty six, with a marketing authorization application or MAA submission in The EU anticipated shortly thereafter. Importantly, as a result of our December financing, we are funded into the third quarter of twenty twenty five beyond the expected top line results from SHIELD II. Further, data triggered warrants from this financing, if exercised in full, would result in an additional $27,000,000 We anticipate that with such additional funding, a runway would be extended beyond anticipated NDA approval.

Speaker 2

While we await the SHIELD II trial top line data readout, we are intensely focused on advancing the preparation of our regulatory submission. With the anticipated NDA filing timeline of early twenty twenty six in mind, CMC and nonclinical NDA modules are currently being finalized. Additionally, we continue to progress prelaunch activities and expedite partnership discussions in and outside The United States. Importantly, identifying a U. S.

Speaker 2

Partner is the path we have strategically identified as the most effective commercial course for DPLEX100. Finding the right partner with an existing dedicated hospital product sales force with significant resources will best enable DPLEX100 to maximize its sales potential in The US, which we believe is substantial.

Speaker 3

To this end, as Ori will detail shortly, US partnering interest in DPLEX100 is gaining meaningful momentum amongst multiple parties as we approach our pivotal data readout. With that, I will now turn the call over to Ori to revisit the DPLX100 market potential and review our partnering efforts. Ori? Thank you, Declan. As we get closer to the end of the SHIELD II trial, I would like to reiterate the market potential for DPLEX100 and provide an update on our partnering discussions.

Speaker 3

To begin, as we discussed previously, and as it relates to Shield two, a CDC report published in November 2024, tracking hospital acquired infections in over 3,000 hospitals, showed an increase of three percent in SSIs across all surgeries in 2023 as compared to 2022. This important data confirms the increase in SSIs post COVID following the decrease in SSIs during the COVID years that we observed in the SHIELD-one study. From a commercial perspective, as I reviewed on our last quarterly conference call, based on IQVIA data, we believe the total addressable market for DPLEX100 in The US is just over twelve million total surgeries annually, with approximately four point four million of these being abdominal soft tissue surgeries, and additional two point one million abdominal procedures, principally in gynecology and urology. I would like to dive a bit deeper into these surgeries. Our recent market research flagged four groups of surgeons as potential users for DeepLex 100 beyond colorectal surgeons.

Speaker 3

These are general surgeons, hepatopancreatobiliary surgeons, urology surgeons, and oncogenecology surgeons. The surgeons who took part in the research were mainly clinical department heads and have flagged several high risk procedures, including exploratory laparotomy and mastectomy in general surgery, Whipple procedure in hepatopancreatobiliary surgery, cystectomy and nephrectomy in urology surgery, and C section, hysterectomy, and ovarian tumor removal in the onco GYN space. These eight surgical procedures represent an area of great unmet need, with a total of close to 1,500,000 inpatient open procedures per year in The US, and can serve as a starting point for piloting and championing DPLEX100 post launch in major hospitals across the country. We are optimistic that The US market is substantial and that it represents a viable and attainable commercial opportunity for DPLEX100. The larger global market offers additional room for growth, and if approved, DPLEX100 could potentially significantly transform the surgical landscape, where post operative SSI remains a burden on the healthcare system as well as on patients.

Speaker 3

Moving to our partnering discussions, we continue to intensively seek partners to support commercialization efforts of DPLEX100, with The U. S. Market being our main priority. The upcoming top line results of SHIELD II represent a major milestone, and it creates a healthy competition among potential partners to be ready to advance into further negotiation and deal making once the study outcomes are known. As a result, we are in advanced discussions and due diligence stage with multiple potential partners in The US and expect others to join the process once the top line data is released.

Speaker 3

Regarding Europe, as a reminder, we already have an exclusive licensing agreement in place with Advanced Pharma to commercialize DPLX-one hundred in all European countries, and we are currently actively working together to plan and start implementing pre launch activities to maximize DPLX-one hundred anticipated launch in Europe. With that, it is my pleasure to now turn the call over to Johnny to review the financials. Johnny?

Speaker 4

Thank you, Ori. We are pleased to be in a solid financial position as we await the top line results of the SHiELD-two trial expected by the end of the current quarter. As of 03/31/2025, the company had cash and cash equivalents of $8,000,000 We expect that our current cash balance will be sufficient to fund operations into the third quarter of twenty twenty five. Now let's turn to our income statement. Research and development expenses for the three months ended 03/31/2025 were $6,100,000 compared to $5,100,000 in the same three month period of 2024.

Speaker 4

R and D expenses in the most recently completed quarter were driven by the ramp up of the ongoing SHiELD II Phase III trial. Marketing and business development expenses for the first quarter of twenty twenty five were $300,000 compared to $200,000 during the prior year period. General and administrative expenses for the first quarter of twenty twenty five were $1,200,000 compared to $1,000,000 recorded in the same three month period of 2024. For the first quarter of twenty twenty five, the company had a net loss of $8,300,000 as compared to $6,400,000 in the first quarter of twenty twenty four. With that, we will now open the call to your questions.

Speaker 4

Operator?

Operator

Thank you. We will take our first question. And the first question comes from the line of Roy Buchanan from JMP Securities. Please go ahead. Your line is open.

Speaker 5

Hey, great. Thanks for taking the questions. I guess to start, can you just discuss how you're thinking about the price per vial for the plex 100? Because I think it's substantially above our model today and then just remind me the vials per procedure and how did you arrive at the price that you're at today? Thanks.

Speaker 2

So, we have not finalized the pricing strategy and pricing. Good morning, Roy. I will start with that and thank you for the question. We have not finalized the pricing strategy at this stage. We did some preliminary research along the development stages, and we will do another study once we have the top line data in the very near future, as we would want to refine things, pricing has changed, index has changed, and having on hand the actual efficacy on SSI, on mortality, and on reintervention could affect the pricing here.

Speaker 2

Also, think that as we've developed the product and started to get results and speaking with more and more surgeons, we have a better understanding of the target market opportunity. This is what Ori was elaborating on, so we can better identify those specific patients and surgeries that are at most need of a product like ours. Saying all of that, and maybe adding to that the dosing, the dosing is between one to three vials, depending on the length of the incision, where minimal invasive surgeries will need one vial and larger surgeries will need between two to three vials. Our assumption is that in average we will see 2.5 vials. If again, going to the model, I think that, you know, for the purpose of the modeling at this stage, we are looking at the pricing of $600 per vial.

Speaker 2

But as I said before, this is something that is on the go and in process to be refined. And also, since we are planning to commercialize the product with a partner, obviously, would also be a discussion that we will have with the

Speaker 5

Okay, great. That makes sense. Then just to follow-up, I guess, for Shield two, was there a strict requirement for the number of vials used And I know you're looking at incisions over 20 centimeters, but it seems like maybe things might change, during the surgery. So, will you have any subjects, I guess, with smaller incisions or were there absolutely none?

Speaker 5

There a strict requirement on the on the incision?

Speaker 2

Yes, it's for the patient population that is combining the ITT and the primary endpoints and all the statistical analysis for that are part of those are very restrict. All of them are with long incision and with three vials exactly. We had a handful of patients, around 170 patients, that were recruited for other purposes, safety and expansion of indication, and those combined minimal invasive and other, but they are not part of the primary endpoint. So all the statistical analysis for the sake of the primary endpoint doesn't take them into account. Are on top of the 800.

Speaker 5

Okay. Great. Thank you. Jump back in queue. Thanks.

Operator

Thank you. Thank you. We will take our next question. And the next question comes from the line of Chase Knickerbocker from Craig Hallum. Please go ahead.

Operator

Your line is open.

Speaker 6

Good morning and good afternoon, guys. Thanks for taking the questions. Maybe just first on kind of NDA filing timing, I mean, looking farther ahead, can you just walk us through what will be required between data and NDA filing that, you know, you leads to the expectation that takes a couple quarters to to prepare the filing? Thanks.

Speaker 2

Sure, sure. Good morning and good day, Chase. Thank you for that. So the NDA is composed or there are three modules that are part of the NDA submission. Two of them are more technical.

Speaker 2

The other three are the CMC, the preclinical data, and the clinical data. As we said in today's call, we are in finalization stages of the CMC and the preclinical, and once we'll have the top line, we'll start working on the clinical module. Obviously, we are not standing by and waiting. We are starting to prepare outline of that and working on everything else that is needed that is coming from SHIELD-one or previous studies. We are planning to meet the FDA for pre NDA meeting.

Speaker 2

We think that this is the right course. It's not a must, but we think that this is the right course in order to get to an agreement with the FDA on how we're going to submit some questions that we want to ask prior to submission to really maximum the chances to have it right the first time. And the thinking is that we will be able to meet the FDA with top line by the June, before the end of this year, and immediately after meeting the FDA and implementing whatever comments they will have, submitting early twenty twenty six, first quarter of '20 '20 '6.

Speaker 6

Got it. And then just on the CMC module, can you remind us kind of your plans to prepare there? You know, what what's kind of the work then with consultants? Are you planning to do some mock audits? In months after data, etcetera?

Speaker 2

Of course, of course. So once we submit the NDA, the FDA will come and inspect our facility. This is standard, and we are in process of having exactly what you referred to, several mock inspections done by external ex FDA advisors that can prepare us. We actually met yesterday someone who is really probably one of the most, if not the most, experienced in the country in FDA's reviews with hundreds of reviews on his shoulder, with several decades of work around QA in the pharmaceutical industry, and we are aligning all the team to get to that. We have a detailed plan on that in terms of what we need to do in preparation, how we can best prepare for this.

Speaker 2

Post submitting the NDA, is the most important thing or the most important milestone prior to commercialization in the continuous development on bringing Diplex into the market.

Speaker 6

And then just a little on kind of what we should expect from top line data in coming weeks, months. Should we be just expecting kind of top line data? Are we going to get some of the key secondaries? Are we going to get some of the obviously specific drivers within the primary? We gonna see some data from the smaller incisions too?

Speaker 6

I mean, just kinda walk us through, you know, what we should expect from that release when it comes.

Speaker 2

Sure. Sure. So first, must tell you that everyone here at Polypede are super excited getting to this point. This is really something we've been working towards for years. And now that things are coming in together in terms of getting to finalizing day 60 of all patients and getting to the point when we lock the data and soon we will be able to unblind the data and share it with investors, as well as with all of our external partners and the discussions that we have, we expect to have top line and key secondary endpoints and expect to share these with investors once we get it.

Speaker 2

Obviously, we will not have all the data, but we do expect to have top line as well as secondary endpoints.

Speaker 6

Great. Thanks. Thank

Speaker 2

you.

Operator

We will take our next question. Your next question comes from the line of Bibalan Pashayyapin from ROTH Capital. Please go ahead. Your line is open.

Speaker 7

Good morning, Tim. Thanks for taking my questions and congratulations in completing the Shield two enrollment. This is an important milestone. So a few questions from us. So I wanted to follow-up on the expectations or the top line for the SHIELD-two data.

Speaker 7

When you report your top line, so will you report a composite endpoint comprising SSI reduction, reinfection, and readmission for both placebo and Diplex group patients. And also in that regard, can you remind us if an efficacy threshold of thirty percent or above in all three metrics is necessary to consider this trial a success?

Speaker 2

Okay, so we will report the primary endpoint. And the primary endpoint is the combination of SSI, mortality, and reintervention. We are counting all of these events. This is how the primary is composed, and this is obviously we will report the primary as a whole. We will also report the secondary.

Speaker 2

Secondary relates to surgical site infection alone. So, you could see how we've met the baseline requirement of having an alpha level below 0.05 with the primary, as well as some of the effects. We'll need to see, you know, plan is to report the data as soon as possible after we are unblinded. Will need to see how much of this can be digested in a meaningful way within hours from getting the data. But the plan is to share as much as possible, have an investor and analyst call, post the data, And then as we get more and more data, obviously, find the venue to share additional data.

Speaker 7

Alright. That's very helpful. And then switching to commercial manufacturing. So let's assume you are getting the priority review. So what are your preliminary thoughts with regards to inspection readiness?

Speaker 7

And also with respect to your capacity, can you give us some idea, you know, what's your how do you expect to, you know, assess the demand at least for the couple of years? And how do you expect the capacity to satisfy those demands?

Speaker 2

Sure. So with regards to the inspection, this is our top priority these days. We are in the process of getting ready for this inspection, including having in place a detailed plan of things that we'll need to be doing, timeline for mock inspection. We plan to do several mock inspection prior to FDA review. We also are engaging a consultant ex FDA, that can help us and guide us through the process with really reaching or outreaching this process in the mind of getting it right at first time.

Speaker 2

So that's in terms of all the preparation for the CMC. The fact that the CMC pack modules is in finalization mode is very helpful, because a lot of the actual work needed for the submission in terms of stability and all the rest of it is in finalization mode. As for overall capacity, we did not disclose the capacity of the facility because this is, at this stage, we believe is an information that should be kept in house, especially since we are in commercialization discussions in different geographies. But we did say that our assumption is that the facility will be sufficient for the first four to five years from launch, which gives us sufficient time to expand or to build an expansion elsewhere once we see that there is

Speaker 7

a need for that. Okay. That's very helpful. I know, Orey, you mentioned about the November 2024 SSI data. Can you maybe provide that in context with what the SSI was observed pre COVID?

Speaker 7

So essentially, wanted to see if you can compare the SSI pre COVID versus the number 2024 data.

Speaker 3

Yes. So just just to clarify, the the data that I cited was CDC data that is comparing twenty twenty three to twenty twenty two, and that showed a three percent increase in infection. I don't have off the top of my head the number of pre COVID, but what we know is there was a steady decline in steady to flat rate of SSI before COVID and then a significant drop 2021, '20 '20 '2 and really 2023 is the first time that we see an uptick reported and it is reported. So the three percent is really across all procedures that the CDC tracks. So if you can, obviously there's some that jumped quite a lot.

Speaker 3

Some of them that did not jump at all. So on average, it's quite a large increase over the COVID time.

Speaker 7

All right. That's it from me. Thank you very much for taking my questions.

Operator

Thank you. There seems to be no further questions. I would like to hand back for closing remarks.

Speaker 2

Thank you for joining Polypede's first quarter twenty twenty five earnings conference call. We remain highly confident in our long term prospects, especially the potential of our promising late stage product candidate, DPLEX100, and look forward to reporting the top line results of the SHIELD II Phase III trial in the very near future. 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 towards our goal of bringing DPLEX100 to healthcare providers and patients as quickly as possible. We look forward to speaking with you again on our next conference call.

Operator

This concludes today's conference call. Thank you for participating. You may now disconnect.

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Key Takeaways

  • Polypede has completed enrollment of the SHIELD II Phase III trial at 800 patients on a Data Safety Monitoring Board recommendation, with top-line efficacy data expected by the end of next month.
  • The company plans to submit a New Drug Application in early 2026 (leveraging Fast Track and Breakthrough designations) and follow with a EU MAA, while finalizing CMC and nonclinical submission modules.
  • Following its December financing, Polypede’s cash runway extends into Q3 2025, and the exercise of data-triggered warrants could raise up to $27 million to support operations beyond anticipated NDA approval.
  • Polypede is intensively advancing prelaunch activities and is in advanced partnering discussions in the US market, with an existing exclusive licensing agreement in Europe with Advanced Pharma.
  • The addressable US market for DPLEX100 exceeds 12 million surgeries annually—4.4 million abdominal soft-tissue cases plus 2.1 million gynecology and urology procedures—with eight high-risk surgery types accounting for ~1.5 million open inpatient procedures per year.
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