PolyPid Ltd (PYPD) 2025 Q4 法說會逐字稿

Greetings and welcome to PolyPid's fourth quarter and full year 2025 conference call. (Operator Instructions) As a reminder, this call is recorded, and I would now like to introduce your host for today's conference, Yehuda Leibler from ARX Investor Relations. Mr. Leibler, you may begin.

Thank you, operator, and thank you all for joining PolyPid's fourth quarter and full year 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 3 and 12 months ending December 31, 2025. A copy of the press release is available in the investors section on the company's website at 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 law. For example, management is making forward-looking statements when it discusses the company's regulatory strategy and the anticipated timing and structure of the planned new drug application or NDA submission for D-PLEX100. Including the rolling submission, the potential regulatory and commercial pathways for D-PLEX100, the company's ongoing partnership discussions, commercialization readiness, transition from a primarily R&D and clinically focused organization into one that is preparing for commercialization, the potential for 2026 to be a transformative year for the company, benefits and advantages of D-PLEX100, that Kinnatrix represents a broader long-term opportunity for PolyPid. And the expectation that current cash resources will be sufficient to fund operations into the second half of 2026.

Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond the company's control, including the risks described from time to time in the company's 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 SEC, including, without limitation, the company's annual report on form 20 filed on February 26, 2025, which identifies specific factors that may cause actual results or events to differ materially from those described in the forwarding statements. PolyPid disclaims any intention or obligation, except as required by law to update or revise any financial projection 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, February 11, 2026. With the completion of those prepared remarks, it is my pleasure to turn the call over to Diklatchake Axel, CEO of PolyPid. Dikla.

Thank you, Yehuda, and thank you all for joining us today. 2025 was a pivotal year for PolyPid.

Over the course of the year, we successfully completed the Shield 2 Phase 3 trial and announced positive results with D-PLEX100 meeting its primary endpoint in all key secondary endpoints and demonstrating a meaningful reduction in surgical site infection.

Building on that momentum, we advance D-PLEX100 into the final stages of regulatory preparation, marking an important transition point for the company. In parallel, we continue to advance our broader platform efforts, including our long acting GLP-1 receptor agonist program.

As we continue executing against our strategy, our progress is focused on two priorities: advancing the regulatory pathway for D-PLEX100 and advancing our commercial US partnership discussion.

Starting with regulatory progress, we recently received positive written feedback from the FDA following the pre-NDA meeting communication. Importantly, the agency supported our plan to pursue a rolling NDA review for D-PLEX100. We expect to begin the rolling NDA submission by the end of the first quarter of 2026. The FDA also agreed that the company's existing clinical data package, including results from the Phase 3 Shield 2 trial, appears adequate to support NDA submission and review. This feedback provides meaningful clarity on the structure and expectations for our submission and further validates the regulatory pathway we have been preparing for.

In parallel with our regulatory efforts, we made significant progress on the commercial front. Following our positive Phase 3 result and the advancement of our regulatory strategy. We have moved into advanced stages of partnership discussions in the United States. These discussions reflect growing recognition of D-PLEX100's strong clinical profile, its differentiated value proposition, and the significant unmet need it addresses.

I'm glad to share that we are very pleased with the progress we made throughout the quarter in our US partnership discussions. These conversations have continued to move forward to advanced stages which Ori will expand on later in the call.

During the quarter we also participated in a virtual key opinion leader webinar featuring Dr. Stephen D. Wexner, a globally recognized leader in colorectal surgery. The discussion focused on the real-life clinical and economic burden of surgical site infections and why prevention remains a major unmet need in abdominal colorectal procedures.

Importantly, the conversation reinforced what we believe is the core opportunity of D-PLEX100. A differentiated, long-acting, localized approach that can significantly reduce infection while fitting naturally into the surgical workflow.

As Dr. Wexner noted, this is truly new. This is a paradigm shift for us. We view this type of external clinical engagement as an important part of building awareness and readiness as we prepare the market for approval and launch. A link to the recording of the webinar is on our website under the investors section. I invite all of you to listen to Dr. Wexner's insights.

Looking ahead, we believe 2026 has the potential to be a transformative year for PolyPid. With a rolling NDA submission expected to begin by the end of this quarter, partnership discussions continue to advance, and an organization increasingly oriented toward commercial execution, we are entering a new chapter for the company.

I also want to highlight an important corporate update. In December 2025, we appointed Ms. Brooke Story as Chairman of our board of directors. Brooke brings extensive leadership experience in medical technology and surgical solutions, including senior executive role at Becton Dickinson and Medtronic. As we transition toward commercialization and engage with large strategic partners, we believe her background and perspective will be highly valuable in helping guide PolyPid throughout this next chapter. We look forward to providing updates as these developments continue to unfold.

With that, I will now turn the call over to Ori Warshavsky, Chief Operating Officer US, who will discuss how we are approaching commercialization readiness and partner engagement. A refreshed corporate brand and the introduction of our Kinnatrix technology. Ori.

Thank you, Dikla. As Dikla mentioned, we've continued to advance discussions during the quarter with potential but commercial partners that have demonstrated experience in hospital-based commercialization and a strong presence within the surgical ecosystem. As these discussions have progressed, they have become increasingly detailed and operational in nature, reflecting both the maturity of the opportunity following our Phase 3 results and the progress we have made on a regulatory front.

Turning now to our refreshed corporate brand, as you might have noticed in this morning's press release, PolyPid has a new brand look which aims to reflect the PolyPid as a company looks different today than it did even a year ago. This rebrand comes at a very intentional moment in the company's life cycle as we transition from a primarily R&D and clinically focused organization into one that is preparing for commercialization and engaging more broadly with external stakeholders. (inaudible)

In addition to clinicians and investigators who are increasingly engaging with surgeons, pharmacists, hospital administrators, value committee members, and potential commercial partners. The refresh brand is designed to support these more external facing conversations and to clearly communicate who we are as a company at this stage.

Importantly, the new visual language is meant to convey precision, intention, reliability, and control. Core attributes of how our technology is engineered to perform. It reflects a more confident, mature, and credible organization as we move closer to potential commercialization. I encourage investors and partners to visit our new website and review our updated corporate material which reflects this evolution in our long-term vision.

Closely related to this evolution is an important update on our technology. Over the past several years we have significantly extended our technological capability beyond what the original Flex platform was designed to do. As a result, we are formally introducing Kinnatrix as the name of our next generation technology.

Kinnatrix brings together the broader set of control release and delivery capabilities along with the growing intellectual property portfolio we have developed over time. While D-Plex remains foundational, our technology is no longer limited to local-to-local delivery of small molecules such as antibiotics. One clear example of these extended capabilities is our move into metabolic disease, starting with our ultra long acting GLP-1 receptor agonist program.

This program serves as the first test case for extending our technology beyond localized delivery towards addressing systemic therapeutic needs, and we continue to evaluate additional modalities where these capabilities may be applied. While Kinnatrix represents a broad long-term opportunity for politics, it is important to emphasize that D-PLEX100 remains firmly at the center of our near-term execution and commercial focus.

Taken together, our continued progress in partnership discussions, our brand evaluation, the formal introduction of the Kinnatrix technology, and growing engagement with clinical leaders all reflect the company that is actively preparing for its next phase of growth.

With that, I'll now turn the call over to Jonny to review our financial performance for the quarter in the full year. Jonny.

Thank you, Ori. I'll now walk through our financial results for the forth quarter and full year ended December 31, 2025.

Starting with the fourth quarter, research and development expenses were $6.2 million compared to $7 million in the same period last year. This decrease primarily reflects the completion of the Shield 2 Phase 3 trial and our transition toward regulatory submission and preparation activities. General and administrative expenses for the quarter were $1.8 million compared to $1 million in the fourth quarter of 2024.

Marketing and business development expenses were $0.6 million for the quarter compared to $0.2 million in the prior year period. Net loss for the fourth quarter was $8.5 million or $0.41 per share compared to a net loss of $8.5 million or $1.13 per share in the fourth quarter of 2024. Turning to the full year results, research and development expenses for 2025 totaled $23.8 million compared to $22.8 million in 2024. The increase was primarily driven by continued activities related to the completion of the SIELD 2 Phase 3 trial. As well as regulatory preparation, effort, and advancement of our development programs.

General and administrative expenses for the full year were $7.2 million compared to $4.3 million in 2024. This increase was primarily due to non-cash expenses relating to the vesting of performance-based options following the successful completion of the Shield 2 Phase 3 trial.

Marketing and business development expenses for the year were $2 million compared to $0.9 million in 2024, reflecting increased business development and commercial preparation efforts as we move closer to potential commercialization. Net loss for the full year ended December 30, 2025 was $34.2 million or $2.09 per share. Compared to a net loss of $29 million or $4.91 per share in 2024.

From a balance sheet perspective, as of December 31, 2025, PolyPid had $12.9 million in cash equivalents, and short-term deposits. Subsequent to the end of the quarter, several longtime shareholders exercised warrants ahead of their expiration at prices ranging between $3.61 and $4.5 per share. Generating $3.7 million in additional gross proceeds, further strengthening our balance sheets.

Based on our current plans and assumptions, we believe that our existing cash resources will be sufficient to fund operations into the second half of 2026 and through several significant upcoming milestones. With that, we will now open the call for questions, operator.

Thank you. (Operator Instructions) Chase Knickerbocker, Craig Hallen.

Good morning. Thanks for taking the questions. Maybe just a couple around the pre-NDA minutes that you received in December. Dikla, would you be willing to share kind of how those discussions are on the scope of the label sort of progressed and just kind of generally what your current expectations are. As you kind of look to your proposed label as far as you know what we're thinking around kind of colorectal kind of specific versus a broader kind of abdominal label and then kind of the same question around what kind of investor expectations should be potentially for you know some sort of risk factor or size of incision that you know could be on a proposed label. Thanks.

Thank you and good morning, Chase. With regards to label, based on our discussion with the FDA, we are targeting an initial label for the prevention of surgical site infections and prevention in patients undergoing abdominal colorectal surgery.

This indication is directly supported by the Shield 2 Phase 3 data and is also our breakthrough therapy designation. We also expect that there may be an opportunity to evaluate potential label expansion into broader abdominal surgical application as we pursue, as we go through the review process in a parallel.

And the main rationale around it is as colorectal is the worst SSI's prevalence in abdominal surgery, and obviously there are others, but that's just as a high level. So that's our baseline assumption. This is how we build all of our planning and models. We do not expect on that regards any anything that will narrow this. We think that this is a very conservative assumption and this is why this is our baseline assumption and as you referred to, we also met the FDA.

Towards the end of last year, as part of an NDA process, actually had a pre-IND communication with the FDA where the purpose of this communication was really to align the requirement around the NDA submission, both in terms of timeline as well as in terms of having The FDA agreed that the Phase 3 data is adequate for NDA submission both in terms of efficacy and safety.

Got it maybe just along those lines. This may be somewhat dependent on kind of partnership discussions as well, but any kind of formal thoughts on kind of plans as far as what may be required for a broader label. And or kind of further expansion opportunities for D-PLEX100 specifically, maybe a little bit too early for that question, but any additional thoughts.

Yeah, maybe I think what I can say is that we have as part of our planning. Time frame that we plan to meet with the FDA to discuss this.

Got it. And just maybe a last one for me on, kind of future applications for the platform. Can you kind a help shape our thinking a little bit for kind of where you may go next? You've obviously, you've announced that metabolic program. But you know, how these kinds of future formulations may differ from what we've seen you do this far. Thanks.

So first, as you rightly referred to, we have the opportunity to expand D-PLEX into other indication, and that's the first and probably the most advanced pipeline expansion that we look, which is specifically on D-PLEX, but with regards to, other pipelines, so I, I'm saying that because it's important for investors to understand that our near term focus remains firmly on execution, the regulatory and commercialization pathway of D-PLEX. So that is where the vast majority of our intention, our resources are directed, but as we move forward with the NDA submission.

And approval. We are expanding into specifically, as you all know, around the GLP-1 and metabolic health. I expect that we will see, during this year, we'll get additional data, I would even say around mid-year. This program is still a pre-clinical development. But with the underlying technology platform that provides long-term opportunity. Long-term exposure of 60 plus or around 60 days and the ability to support it in a linear way, this is very lucrative in this area.

Thank you.

Jason Butler, Citizens.

Hi, thanks for taking the questions and congrats on the progress. Dikla, can you just talk about the work that you're doing or will be doing this year to get ready for a potential approval of D-PLEX100, but both in terms of building awareness as well as getting ready with payers, just the work that needs to be done, before approval. Thank you.

Sure. So some of it we've shared with in in previous, calls and some of it is also or we referred to in our, new branding and website. This is all part of getting ready for the commercial stage.

Some of it is already out there like the website. And the new branding, but also there is work that is done around packaging for D-PLEX. It's commercial name that we will obviously expose later on once we are in the approval process.

And in addition to that, we have been doing a lot of work, not just now but in the last few years. And Ori, please feel free to add to that, whether it is in terms of market research of pricing. Aware creating awareness you'll start to see many more abstract and articles coming from our front during this year.

Building a KOL network, just the beginning of it was, with our KOL event with Doctor. Or well, it wasn't actually our KOL event, but, Roth Group's KOL event with Doc Professor Steven D. Wexner. Ori do you want to add anything to that?

I would just add that the there's the main work right now is really like you said Jason. Kind of putting the data out there and making sure that people are aware of the data of the product, so conferences will be a big part of it publication will be a big part of it, a lot of the health economic space is something that's is kicking off now because as you said for market access this is a driver.

But also, some of the on the ground, kind of boots on the ground market preparation will be dependent on the partner. And we are expecting that that the partner will have sufficient time and that's where our conversations are with kind of experience global partners that will kind of get the running immediately after signing can go on and start doing all the prior approval meetings in the hospitals and really get the axis piece going almost immediately.

Great, thank you. And then just one more for me, on the GLP-1 program, how do you think about strategically when and you know what data you can generate yourself versus when a partner might make sense to bring on board and just, longer-term how you think about positioning and differentiation in this market.

Sure. So, our GLP-1 program leverages our new Kinnatrix technology for approximately 60 days of sustained release. And we are targeting improved patient compliance.

Our vision for this program is to partner at a relatively early stage. What we are building now is a more robust pre-clinical efficacy NPK sets of data that support this attribute, this sustained release, no spike as you see. The burst release that you see, that is seen with current weekly delivered molecules. So we are targeting to have this more robust efficacy and NPK studies.

We are already along the development of this program, have been speaking with different groups, but we believe that once we have these sets of data, this could be very interesting for partners, especially since we have. This is coming after a validated program. D-PLEX100 has validated our approach in a very robust way, both in terms of manufacturing, CMC, as well as PK and our ability to deliver and develop our technology forward into drugs.

Great. Thank you.

Boobalan Pachaiyappan, Roth Capital Partners.

Good morning to you, and thanks for taking my questions. So first, I wanted to talk about the progress you highlighted in the press release about the potential US partnership. So, without getting into the confidential information, is it reasonable to assume the potential partner shall also have a presence in ex US regions, and also assuming the significant interest post the NDA filing, what factors could play a pivotal role in closing in the partnership? And I have some follow-ups.

Great. So, good morning and thank you for that. So I'll start with the first portion.

In terms of other geographies, so we are very focused now on US we think that's our highest priority. That said, there might be interest to other geographies as well as part of those discussions and other discussions that we have.

But our first priority is US. Also, since you know in terms of the timeline, when you look at our NDA submission that is expected by the end of this quarter. And European submission is expected later on, about a quarter, around the quarter after we finalized the FDA submission, so it makes more sense. And your second portion was?

So I was asking about, what factors might play a role in identifying the final total.

So, Ori feel free to add to that, but we've been saying for quite some time that, the ideal partner and also the partner that we are discussing with are with broad hospital-based capabilities. And presence in the surgical suite in the hospital, and this is what's really needed to market a product like D-PLEX100.

So, I don't see what could go wrong in that respect, because I think that the interest and there is an alignment between the interest and the need, Ori you want to add to that?

I would just said that we're in, we keep saying we're advancing, but we are advancing, from a high-level discussion, the due diligence is going on and becomes more and more. In the details, and I think that's a sign that we're heading in the right direction here.

All right, that's helpful. And then, you mentioned about the call. Obviously, during my call with Dr. Wexner, she mentioned that the Phase 3 study was well designed, adequately controlled with balanced characteristics, and the patients they reflect the real world scenario. So, I was wondering if you could comment on whether the FDA took a similar view based on your pre-NDA meeting communications.

I think the fact that the positive, the feedback was positive and there is an alignment on that. And the FDA, confirmed both the NDA pathway as well as indicated that the existing clinical data package is sufficient to support an NDA submission. I think that's, it says it all.

Alright, maybe one final question from us. So we have done some research. It looks like there's approximately 900 integrated delivery networks in the US, and they manage roughly 6,000 to 7,000 hospitals. So I was wondering, assuming this is indeed the case, what percentage of potential target IDNs would reasonably be likely to include D-PLEX on formulary within the first 12 months after approval? Thank you.

Ori you want to take?

Yes, I can take this. I think, the process, the first I would say that of course this would be a mission for the for the US commercial partner. And this is the reason why we are discussing the commercialization activities with the partners that understands the ins and outs of the IDNs that have relationship. From the surgeon to the pharmacist to the IDN level to the GPOs, to really ensure uptake as fast as we can.

Specifically, about one month, I think it really depends on it's by hospital or by network decision. There are a number of steps and I think we discussed this in the past. There are a number of steps to get the product used in the hospital.

Starts with, finding the right champions, which this is a process that will be done even before launch to start an educating from a medical perspective, educating the surgeons on the needs. Then the product needs to come to PNT review. And then this PNT review there'll be discussions both on the clinical benefits, and the economic benefits. All of that are topics that we have strong information on, and the partners will have all the tools they will need to make the case.

And then likely the hospital, the IDN will ask for some sort of maybe a small pilot study a handful of patients just really to see how this product works in their operating room and then an update to the electronic systems within the hospital.

So, all to take a little bit of a long answer to say that it's the uptake will take a little while it's not a day one peak of sales. Probably a few months before we'll start seeing a meaningful update. But I think the flip side of that is once there is, once the product is on the formulary. And there is usage, it's a relatively sticky process, meaning the products are rarely getting taken off formulary, assuming the product works and there are no issues. So we can see what once the product is on formulary a volume growing steadily and the usage growing steadily month after month.

All right, thanks for taking your questions and congratulations.

Brandon Folkes, H.C. Wainwright.

Hi, thanks for taking my questions and congrats on all the progress. Maybe just two from me. Maybe, firstly, any color and when you expect to complete the rolling submission, And then maybe secondly, can you just elaborate on the differences between the Kinnatrix platform and the D-PLEX technology platform? And just, how much early stage work do you need to do on the Kinnatrix platform or how much can you leverage from your experience with D-PLEX? I'm just thinking about sort of how we should think about timing of moving products forward on the new platform. Thank you.

Thank you, Brandon. So, with regards to the timeline, as we said, we expect to submit the NDA by the end of the 1st quarter. We will first submit the CMC, a non-clinical module, followed by the clinical module. And the gap between those two submissions is not more than a couple of months. It is very close to one another. From that point, since we have a fast track and breakthrough therapy designation that supports the use of a rolling submission priority review, we expect that the NDA review will be shortened to 6 months from the regular 10 months.

And Ori, do you want to give a bit of the difference?

Yes, I can take the question. So hi, Brandon. First, I think it's important to understand that it's not that one day we were on D-PLEX and the next day it was a Kinnatrix. Kinnatrix really is collecting under one umbrella a lot of the work that that has been done over the past several several years that was not under D-PLEX.

And under the D-PLEX umbrella, meaning to say there's not, there's no gap here. The work has been going on, for as for as a continuous work. What you see under Kinnatrix is now a way for us to collect some of the IP on peptide release, on, intra tumoral injection, on the sting agonist partnership that we had. All these activities coming under this umbrella and helping us, build new, IP and in a way allowing us to discuss this more freely without the limitations of D-PLEX. So it's a new name, but the work in the R&D team and the development has been going on, continuously forever. Now, does that make sense, Brandon?

Yes, very helpful. I appreciate it, and congrats again. Thank you.

Thank you, this concludes today's question-and-answer session. I will now hand the call back for closing remarks.

Thank you all for joining us today. 2025 marked an important turning point for PolyPid, and we enter 2026 with momentum across regulatory, commercial, and organizational fronts. With the rolling NDA review expected to begin shortly, continued progress in partnership discussion, and a clear strategic vision for the company's future, we believe PolyPid is well positioned for the next phase of growth.

We appreciate the continued support of our shareholders, partners, and employees, and we look forward to providing further updates as the year progresses. Thank you, and operator. You may now close the call.

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