Earnings Call Transcript - PYPD Q4 2025

Operator, Operator

Greetings and welcome to PolyPid's Fourth Quarter and Full Year 2025 Conference Call. As a reminder, this call is recorded. I would now like to introduce your host for today's conference, Yehuda Leibler from ARX Investor Relations. Mr. Leibler, you may begin.

Yehuda Leibler, Investor Relations

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, U.S. 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 laws. 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 Kynatrix 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-F filed on February 26, 2025, 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, February 11, 2026. With the completion of those prepared remarks, it is my pleasure to turn the call over to Dikla Czaczkes Akselbrad, the CEO of PolyPid. Dikla?

Dikla Akselbrad, CEO

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 II Phase III trial and announced positive results with D-PLEX100 meeting its primary endpoint and all key secondary endpoints, demonstrating a meaningful reduction in surgical site infection. Building on that momentum, we advanced 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 U.S. partnership discussions. 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 III SHIELD II 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 III results 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 U.S. 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. Steven 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 and 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 the rolling NDA submission expected to begin by the end of this quarter, partnership discussions continuing to advance and an organization increasingly oriented towards 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 a 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, our Chief Operating Officer, U.S., who will discuss how we are approaching commercialization readiness and partner engagement, our refreshed corporate brand, and the introduction of our Kynatrix technology. Ori?

Ori Warshavsky, COO, U.S.

Thank you, Dikla. As Dikla mentioned, we continue to advance discussions during the quarter with potential U.S. 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 III results and the progress we have made on our 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 that PolyPid as a company looks different today than it did even a year ago. The brand comes at a very intentional moment in the company's lifecycle 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. Our audience is expanding. In addition to clinicians and investigators, we are increasingly engaging with surgeons, pharmacists, hospital administrators, value committee members, and potential commercial partners. The refresh brand is designed to support the more external safety 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 and our long-term vision. Closely related to this evolution is an important update on our technology. Over the past several years, we have significantly expanded our technological capabilities beyond what the original PLEX platform was designed to do. As a result, we are formally introducing Kynatrix as the name of our next-generation technology. Kynatrix brings together the broader set of controlled release and delivery capabilities along with the growing intellectual property portfolio we have developed over time. While PLEX remains foundational, our technology is no longer limited to localized delivery of small molecules such as antibiotics. One clear example of these expanded capabilities is our move into metabolic disease, starting with our ultra-long-acting GLP-1 Receptor Agonist program. This program serves as the first step 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 Kynatrix represents a broad long-term opportunity for PolyPid, 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 Kynatrix technology, and growing engagement with clinical leaders all reflect a 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 and the full year. Jonny?

Jonny Missulawin, CFO

Thank you, Ori. I'll now walk through our financial results for the fourth 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 II Phase III trial and our transition towards 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 SHIELD II Phase III trial as well as regulatory preparation efforts 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 noncash expenses relating to the vesting of performance-based options following the successful completion of the SHIELD II Phase III 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 31, 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, cash equivalents, and short-term deposits. Subsequent to the end of the quarter, several long-time 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 sheet. 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?

Operator, Operator

We will take our first question, which comes from Chase Knickerbocker from Craig-Hallum.

Chase Knickerbocker, Analyst

Maybe just a couple around the pre-NDA minutes that you received in December. Would you be willing to share kind of how those discussions around 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 what you're thinking around kind of colorectal versus a broader abdominal label? And then kind of the same question around what kind of investor expectations should be potentially for some sort of risk factor or size of incision that could be on a proposed label.

Dikla Akselbrad, CEO

Thank you. Regarding the label, based on our discussions with the FDA, we are aiming for an initial label that targets the prevention of surgical site infections in patients undergoing abdominal colorectal surgery. This indication is directly supported by the SHIELD II Phase III data and aligns with our breakthrough therapy designation. We believe there may be a possibility to explore label expansion into broader abdominal surgical applications as we navigate the review process concurrently. The primary reasoning for this is that colorectal surgery has the highest prevalence of surgical site infections among abdominal surgeries. While there are other types of surgeries, this represents our fundamental assumption. All of our planning and models have been developed with this in mind. We do not anticipate anything that would limit this assumption. We consider it to be a very conservative estimate, which is why it serves as our baseline. As mentioned, we also met with the FDA toward the end of last year as part of the NDA process and had a pre-IND communication with them. The goal of this communication was to ensure alignment on the requirements for the NDA submission, including timelines and confirmation that the Phase III data is sufficient for NDA submission concerning both efficacy and safety.

Chase Knickerbocker, Analyst

Got it. Maybe just along those lines, it may be somewhat dependent on partner 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 further expansion opportunities for D-PLEX100 specifically. Maybe a little bit too early for that question, but any additional thoughts?

Dikla Akselbrad, CEO

Yes. I think what I can say is that we have as part of our planning timeframe that we plan to meet with the FDA to discuss this.

Chase Knickerbocker, Analyst

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

Dikla Akselbrad, CEO

So first, as you rightly referred to, we have the opportunity to expand D-PLEX into other indications, and that's the first and probably the most advanced pipeline expansion that we look at, which is specifically on D-PLEX. But with regards to other pipelines, 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 and 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 additional data during this year, probably around midyear. This program is still in preclinical development but with the underlying technology platform that provides long-term exposure of around 60 days and the ability to support it linearly. This is very lucrative in this area.

Operator, Operator

The next question comes from Jason Butler at Citizens.

Jason Butler, Analyst

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, both in terms of building awareness and getting ready with payers? Just the work that needs to be done before approval.

Dikla Akselbrad, CEO

Sure. Some of it, we've shared in previous calls, and some of it is also Ori 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 has been done around packaging for D-PLEX, its commercial name that we will expose later on once we are in the approval process. In addition to that, we have been doing a lot of work, not just now, but in the last two years. And Ori, please feel free to add to that, whether it is in terms of market research of pricing, creating awareness, you will start to see many more abstracts 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 Wexner.

Ori Warshavsky, COO, U.S.

I would just add that the main work right now is really about 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 economics piece is something that is kicking off now because, as you said, for market access, this is a driver. But also some of the on-the-ground, boots-on-the-ground market preparation will be dependent on the partner. We are expecting that the partner will have sufficient time, which is why our conversations are with experienced global partners that can get running immediately after signing and start doing all the prior approval meetings in the hospitals, and really get the access piece going almost immediately.

Jason Butler, Analyst

Great. And then just one more for me. On the GLP-1 program, how do you think about strategically when and 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?

Dikla Akselbrad, CEO

Sure. Our GLP-1 program leverages our new Kynatrix 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 are more robust preclinical efficacy and pharmacokinetic sets of data that support this attribute of sustained release. We are targeting to have this more robust efficacy and PK studies. We are already advancing in the development of this program and have been speaking with different groups, but we believe that once we have this set of data, this could be of great interest to partners, especially since we have this coming after a validated program. D-PLEX100 has validated our approach in a very robust way, both in terms of manufacturing, CMC, and our ability to deliver and develop our technology forward into drugs.

Operator, Operator

We will take our next question, which comes from Boobalan Pachaiyappan at ROTH Capital Partners.

Boobalan Pachaiyappan, Analyst

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

Dikla Akselbrad, CEO

Great. Thank you for that. So I'll start with the first portion. In terms of other geographies, we are very focused now on the U.S. We think that's our highest priority. That said, there might be interest in other geographies as part of those discussions and other discussions that we have. But our first priority is the U.S. As for the timeline, when you look at our NDA submission, that is expected by the end of this quarter, and the European submission is expected approximately a quarter later after we finalize the FDA submission. It makes more sense this way. Your second portion was?

Boobalan Pachaiyappan, Analyst

I was asking about what factors might play a role in identifying the final partner.

Dikla Akselbrad, CEO

So Ori, feel free to add to that. But we have been saying for quite some time that the ideal partner, and also the partner that we are discussing with, are those with broad hospital-based capabilities and presence in the surgical suite within the hospital. This is what's really needed to market a product like D-PLEX100. So I do not see what could go wrong in that respect because I think that the interest aligns between the need and our offering. Ori, do you want to add to that?

Ori Warshavsky, COO, U.S.

I would just add that we are advancing, but we are advancing from a high-level discussion. The due diligence is ongoing and becoming more and more detailed. I think that's a sign that we're heading in the right direction here.

Boobalan Pachaiyappan, Analyst

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

Dikla Akselbrad, CEO

I think the positive feedback we received indicates that there is an alignment, and the FDA has confirmed both the NDA pathway and indicated that the existing clinical data package is sufficient to support an NDA submission. I believe that says it all.

Boobalan Pachaiyappan, Analyst

All right. Maybe one final question from us. We have done some research. It looks like there are approximately 900 integrated delivery networks in the U.S., managing roughly 6,000 to 7,000 hospitals. I was wondering, assuming this is indeed the case, what percentage of potential target IDNs would be reasonably likely to include D-PLEX on formulary within the first 12 months after approval?

Dikla Akselbrad, CEO

Ori, do you want to take this?

Ori Warshavsky, COO, U.S.

Yes, I can take this. First, I would say that, of course, this will be a mission for the U.S. commercial partner. This is the reason why we are discussing the commercialization activities with partners that understand the ins and outs of the IDNs and have relationships from the surgeon to the pharmacist to the IDN level to the GPOs to ensure uptake as fast as we can. Specifically about 1 month, I think it really depends on a hospital-by-hospital or network-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, starting with finding the right champions. This is a process that will be done even prior to launch to start educating from a medical perspective and educating the surgeons on the need. The product then needs to go to a P&T review, where discussions will be held on both 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 need to make the case. Finally, the hospital or IDN will likely ask for some sort of small pilot study to see how this product works in the operating room, which will be followed by an update to their electronic systems. To sum up, the uptake will take some time, and it is not a day one peak of sales. It will likely take a few months before we start seeing meaningful uptake. However, once the product is on formulary and usage starts, it usually becomes quite sticky, meaning products are rarely taken off formulary assuming they work without issues. So we can anticipate steady volume growth and usage growth month after month.

Operator, Operator

We will take our next question, which comes from the line of Brandon Folkes from H.C. Wainwright.

Brandon Folkes, Analyst

Congrats on all the progress. Maybe just two from me. For starters, any color on when you expect to complete the rolling submission? And then secondly, can you just elaborate on the differences between the Kynatrix platform and D-PLEX technology platform? How much early-stage work do you need to do on the Kynatrix platform? Or how much can you leverage from your experience with D-PLEX? I'm just thinking about timing of moving products forward on the new platform.

Dikla Akselbrad, CEO

Thank you, Brandon. So regarding the timeline, we expect to submit the NDA by the end of the first quarter. We will first submit the CMC and nonclinical module followed by the clinical module. The gap between those two submissions will not exceed a couple of months; they are very close to one another. Given that we have Fast Track and breakthrough therapy designations supporting the use of a rolling submission and priority review, we expect that the NDA review period will be shortened to six months from the regular ten months. Ori, do you want to clarify?

Ori Warshavsky, COO, U.S.

Yes, I can address that question. It's important to understand that it's not the case that we suddenly transitioned from PLEX to Kynatrix. Kynatrix is effectively collecting under one umbrella the extensive work that has been done over the past several years, including developments that were not part of the original PLEX IP umbrella. What you see under Kynatrix is a way for us to collate some of the intellectual property on peptide release and intratumoral injection that we have developed. All these activities are helping us build new intellectual property and allowing us to discuss this more freely without the limitations of PLEX. It’s a new name, but the work in our R&D team and development has been ongoing continuously.

Brandon Folkes, Analyst

Yes. Very helpful, I appreciate it and congrats again.

Operator, Operator

This concludes today's question-and-answer session. I'll now hand the call back for closing remarks.

Dikla Akselbrad, CEO

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 discussions, 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.

Operator, Operator

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