PolyPid Ltd (PYPD) 2025 Q1 法說會逐字稿

Good day and thank you for standing by. Welcome to the PolyPid first quarter 2025 conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. (Operator Instructions) I would now like to hand the conference over to your speaker today, Brian Ritchie. Please go ahead.

Thank you all for participating in PolyPid's first quarter 2025 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 its financial results for the three months ended March 31, 2025. A copy of the press release is available in the investor section on the company's website www. Polypide.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 D-PLEX 100 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 2025 beyond the expected top line results from Shield 2.

The expected timing for topline results from the SHIELD 2 trial, potential NDA and MAA submissions, and the timing thereof, preparations for regulatory submissions, finalization of CMC and non-clinical NDA modules, potential clinical benefits of D-PLEX 100, potential market size for D-PLEX100 in the United States, potential partnership opportunities. The potential to receive up to an additional $27.0 million 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 D-PLEX 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.

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, 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 14, 2025.

With the completion of those prepared remarks, it is my pleasure to turn the call over to Dikla Czaczkes Akselbrad, CEO of PolyPid. Dikla?

Thank you, Brian. On behalf of our team at PolyPid, I would like to welcome everyone to our first quarter 2025 earnings conference call.

We were thrilled to recently successfully conclude enrollment of the Shield 2 phase 3 trial assessing the efficacy of D-PLEX 100 for the prevention of surgical site infections 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 2 phase 3 trial of D-PLEX 100 at the lowest sample size reassessment stop 800 patients. After the minimum planned number of patients, we are now rapidly approaching the availability of topline data by the end of next month. To reiterate what we have said previously, we view the DSMB's recommendation to conclude Shield 2 upon the enrollment of 800 patients as a favorable outcome.

As it is suggestive of positive efficacy signals from D-PLEX100. Of course, the data generated from Shield 2 to date remain fully blinded to PolyPid and others outside of the DSMB until top line results are available. Upon potential positive phase 3 data, PolyPid expects to submit a new drug application or NDA with the advantages of the fast track and breakthrough therapy designations in early 2026.

With a marketing authorization application or MAA submission in the EU anticipated shortly thereafter. Importantly, as a result of our December 2024 $15 million dollar financing, we are funded into the third quarter of 2025 beyond the expected topline results from Shield 2.

Further, data triggered warrants from this financing, if ex exercised in full, would result in an additional $27 million. We anticipate that with such additional funding, a runway would be extended beyond anticipated NDA approval. While we await the Shield 2 trial hotline data readout, we are intensely focused on advancing the preparation of our regulatory submission.

With the anticipated NDA filing timeline of early 2026 in mind, CMC and non-clinical NDA models are currently being finalized. Additionally, we continue to progress pre-launch activities and expedite partnership discussions in and outside the United States. Importantly, identifying a US partner is the path we have strategically identified as the most effective commercial course for D-PLEX00.

Finding the right partner with an existing dedicated hospital product sales force with significant resources will best enable D-PLEX 100 to maximize its sales potential in the US, which we believe is substantial to this end, as all we will detail shortly, US partnering interest in D-PLEX 100 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 deepest 100 market potential and review our partnering efforts. Ori.

Thank you Dikla. as we get closer to the end of the SHIELD II trial, I would like to reiterate the market potential for D-PLEX 100 and provide an update on our partnering discussions. To begin, as we discussed previously and as it relates to Shield 2. A CDC report published in November 2024 tracking hospital acquired infections in over 3,000 hospitals showed an increase of 3% 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 I study.

From a commercial perspective, as I reviewed on our last quarterly conference call, based on our QVR data, we believe the total addressable market for D-PLEX 100 in the US is just over 12 million total surgeries annually, with approximately 4.4 million of these being abdominal soft tissue surgeries, an additional 2.1 million abdominal procedures, principally in gynecology and neurology. I would like to dive a bit deeper into these surgeries.

Our recent market research flagged 4 groups of surgeons as potential users for D-PLEX 100 beyond colorectal surgeons. These are general surgeons, hepato pancreato biliary surgeons, neurology surgeons, and oncogynecology 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 hepato pancreato biliary surgery, cystectomy and nephrectomy in neurology surgery, and C-section, hysterectomy, and ovarian tumor removal in the oncologist surgeons . These eight surgical procedures represent an area of great unmet need, with a total of close to 1.5 million inpatient open procedures per year in the US and can serve as a starting point for piloting and championing D-PLEX 100 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 D-PLEX 100. The larger global market offers additional room for growth, and if approved, Duplex 100 could potentially significantly transform the surgical landscape where postoperative SSI remains a burden on the healthcare system as well as on patients.

Moving to our partnering discussions, we continue to intensively seek partners to support commercialization efforts of D-PLEX 100, with the US market being our main priority. The upcoming top line results of SHIELD 2 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. Regarding Europe as a reminder, we already have an exclusive licensing agreement in place with Advanced Pharma to commercialize D-PLEX 100 in all European countries, and we are currently actively working together to plan and start implementing pre-launch activities to maximize D-PLEX 100 anticipated launch in Europe.

With that, it is my pleasure to now turn the call over to Johnny to review the financials. Jonny.

Thank you, Ori. We are pleased to be in a solid financial position as we await the topline results of the SHIELD 2 trial, expected by the end of the current quarter.

As of March 30, 2025, the company had cash and cash equivalents of $8 million. We expect that our current cash balance will be sufficient to fund operations into the third quarter of 2025.

Now let's turn to our income statements. Research and development expenses for the three months ended March 30, 2025 were $6.1 million compared to $5.1 million in the same three month period of 2024. R&D expenses in the most recently completed quarter were driven by the ramp up of the ongoing SHIELD 2 phase 3 trial.

Marketing and business development expenses for the first quarter of 2025 were $0.3 million compared to $0.2 million during the prior year period. General and administrative expenses for the first quarter of 2025 were $1.2 million compared to $1 million recorded in the same three month period of 2024.

For the first quarter of 2025, the company had a net loss of $8.3 million as compared to $6.4 million in the first quarter of 2024.

With that we will now open the code to your question, operator.

Thank you. (Operator Instructions) Roy Buchanan from JMP Securities.

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 D-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.

So first we have not, finalized the pricing strategy and pricing, start. Good morning. 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 is. Change indexes change and having enhanced the actual efficacy on SSI, on mortality and on reintervention could affect the pricing here. Also, I 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 we. I was elaborating on so we can better identify those specific patients and surgeries that are in most need of a product like ours, saying all of that and maybe adding to that the dosing. The dosing is between 1 to 3 vials depending on the length of the incision where Minimally invasive surgeries will need 1 vial, and larger surgeries will need between 2 to 3 vials. Our assumption is that on average we will see 2.5 vials again going to the model. I think that, for the purpose of the model.

At this stage we are looking at the pricing of $600 per vial, but as I said before, this is something that is on the go and in the process to be refined and also since we are planning to commercialize the product with a partner, obviously this will also be a discussion that we will have with the potential partner.

Okay, great. That makes sense. And then just to follow up, I guess that for shield 2, was there a strict requirement for the number of vials used per procedure? 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, and there's a strict requirement on the incisions. thanks

So yes for the patient population that is combining the ITT and the primary endpoint and all the statistical analysis for that are part of those are very restrict. All of them are with long incision and with 3 vials, exactly. We had a handful of patients around 170 patients that were recruited for other purposes, safety and expansion of vindication, 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. They are on top of the 800.

Okay, great. Thank you. Jump back into you. Thanks.

Chase Knickerbocker from Craig-Hallum.

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

Sure. Good morning and good day. Thank you for that. So the NDA is composed or there are 3 modules that are part of the NDA submission, 2 of them are more technical, the other 3 are the CMC, the pre-clinical 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 a pre-NDA meeting. 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.

We topline by the end of June before the end of this year, and immediately after meeting the FDA and implementing whatever comments they will have start submitting early 2026, first quarter of 2026.

Got it. And then just on the CMC module, can you remind us kind of your plans to prepare their, you know what kind of the work done with consultants so you planning to do some mock audits, in months after data, etc.

Of course. So, once we submit the NDA, the FDA will come and inspect our facility. This is standard, and we are in the process of having exactly what you refer to having several mock inspections done by external ex-FDA advisor that can prepare us. Well, we actually met yesterday, someone who is a really probably one of the most, if not the most experienced in the country in FDA 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 will be what we need to do in preparation, how we can best prepare for this. This is post-submitting the NDA. This is the most important thing or the most important milestone prior to commercialization in the continuous development on bringing the into the market.

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? Are we going to see some data from the smaller incisions too? I mean, just kind of walk us through, you know what we should expect from that release when it comes.

Sure. So, first time I tell you that everyone here at PolyPid are super excited getting to this point. This is really the 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 where we lock the data and soon we will be able to online the data and share it with investors as well as with our all of our external partners and the discussions that we have. We expect to have top line and key secondaries end points.

And expect to share these with investors once we get it. Obviously, we will not have all the data, but we do expect to have top line as well as secondary endpoint.

Great thanks.

Thank you. (Operator Instructions) Boobalan Pachaiyappan from Roth Capital.

Good morning, Team. Thanks for taking my questions and congratulations on completing the Shield 2 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 2 data, and when you report your top line. So will you report a composite in point comprising SSI reduction, reinfection, and remission for both placebo and D-PLEX group patients? And also in that regard, can you remind us if an efficacy threshold of 30% or above in all three metrics is necessary to consider this trial a success?

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 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 our plan is to report the data as soon as possible after we are blinded, we will need to see how much of this can be digested in a way. And presented in a meaningful way within hours from getting the data, but the plan is to share as much as possible, have an investor, an analyst call, post the data, and then as we get more and more data, obviously find the venue to share additional data.

Alright, that's very helpful. And then switching to commercial manufacturing, so let's assume you're getting the priority review. So, what are your preliminary thoughts with regards to inspection readiness and also with respect to your capacity, can you give us some idea, what's your, how do you expect to access the demand at least for a couple of years and how do you expect the capacity to satisfy those demands?

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 need to be doing, timeline for inspection, we plan to do several mock inspection prior to FDA review. We also are engaging consultants, ex-FDA that can help us and guide us through the process with really.

Reaching outreaching this process in the mind of getting it right at the first time, so that's in terms of all the preparation for the CMC. The fact that the CMC pack module 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 can, 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 4 to 5 years from launch, which gives us sufficient time to expand or to build an expansion elsewhere once we see that there is a need for that.

Okay, that's very helpful. I know, Ori, you mentioned about the number 2024 SSI data. Can you maybe provide that in context with what the SSI was observed pre-COVID? So essentially I wanted to see if you can compare the SSI pre-COVID versus the number 2024 data.

Yes, so just to clarify, the data that I cited was CDC data that is comparing 2023 to 2022, and that showed the 3% increase in 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 all steady to flood the rate of SSI before COVID and then a significant drop 2021, 22, and really 2023 is the first time that we see anaptic reported and it is reported so the 3% is really across all procedures that the CDC tracks. So if you can, obviously there's some that jumped quite a lot, some of them that they that did not jump at all. So on average it's quite a large increase over the COVID time.

All right, that's it from me. Thank you very much for taking my question.

there seems to be no further questions, I would like to hand back for closing remarks.

Thank you for joining PolyPid's first quarter 2025 earnings conference call. We remain highly confident in our long-term prospects, especially the potential of our promising late stage product candidate, D-PLEX100, and look forward to reporting the top line results of the Shield 2 phase 3 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 D-PLEX 100 to healthcare providers and patients as quickly as possible. We look forward to speaking with you again on our next conference call.

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