PolyPid Ltd. (PYPD) Q1 2026 Earnings Report, Transcript and Summary

Greetings, and welcome to PolyPid's First Quarter 2026 Earnings 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 First Quarter 2026 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 months ended March 31, 2026. A copy of the press release is available on the Investors section of 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 discussing the company's regulatory strategy, including the expected completion of the rolling New Drug Application or NDA submission for D-PLEX100. Management may also discuss the company's planned engagements with the European Medicines Agency, or EMA, including meetings with the Rapporteur and Co-Rapporteur regarding the planned marketing authorization application, or MAA, and the anticipated timing thereof. In addition, management may discuss the company's ongoing U.S. commercial strategic partnership discussions, its belief that those discussions are in late stages and expected launch plans and timing. Other forward-looking statements may relate to the potential clinical and economic value proposition of D-PLEX100. The company's preparations for potential commercialization, the potential for 2026 to be a transformative year for PolyPid and the expectation that current cash resources will be sufficient to fund operations into the second half of 2026 and from several significant upcoming potential milestones. 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 Securities and Exchange Commission filings. Accordingly, you should not place undue reliance on these statements. I encourage you to review the company's filings with the SEC, including the company's annual report on Form 20-F filed on February 25, 2026. PolyPid disclaims any intention or obligation, except as required by law, to update or revise any forward-looking statements. This conference call contains time-sensitive information and speaks only as of the live broadcast today, May 13, 2026. With that, it is my pleasure to turn the call over to Dikla Akselbrad, the CEO of PolyPid. Dikla?

Thank you, Yehuda, and thank you all for joining us today. The first quarter of 2026 was a defining transition for PolyPid. We moved from late-stage clinical development to final NDA regulatory submission, our U.S. commercial strategic partnership discussion advanced to what we believe are their late stages, and we continue to build the foundation for what we expect will be a transformative year. Our focus remains on two priorities: advancing D-PLEX100 towards potential FDA approval and finalizing a U.S. strategic partnership that will execute commercial launch in the first quarter of 2027. Starting with our regulatory progress. On March 30, 2026, we initiated our NDA submission to the FDA. As a reminder, D-PLEX100 is our lead product candidate for the prevention of surgical site infections, or SSI, in patients undergoing abdominal colorectal surgery. With this initial filing, we submitted the CMC and nonclinical modules as well as other more administrative modules. We expect to submit the remaining components, including the clinical module imminently. This will complete the full NDA submission. Once the FDA accepts our submission and given our Fast Track and breakthrough therapy designation, the product is eligible for priority review. If received, this would shorten the standard review period from 10 months to 6 months. In parallel, in March 2026, we received a small business waiver from the FDA for the PDUFA fee. This waiver was approximately $4.3 million, and it allows us to focus our resources on commercialization preparation as we move closer to potential approval. Turning to Europe. We have scheduled meetings in this quarter with the Rapporteur and Co-Rapporteur, which are the European regulatory authorities designated to lead the assessment of our planned MAA for D-PLEX100. The purpose of these meetings is to align on the content and structure of the submission. Importantly, the MAA will be submitted to the EMA under the centralized procedure on the basis of the therapeutic innovation. The centralized procedures allows the submission of a single marketing application to the EMA that, if approved, enables the product to be marketed in all EU member states. Subject to the outcome of these meetings, we currently plan to submit the MAA in the third quarter of this year. On the commercial front, our strategic partnership discussions with potential U.S. partner have continued to progress. We believe they are now in their late stages as the due diligence and evaluation work that defined earlier phases of this discussion is well behind us, and we are currently focused on the active negotiation of definitive agreement terms. Another important area of commercial readiness is our manufacturing and inspection preparations. Once the FDA accepts our NDA submission, the agency is expected to inspect our manufacturing facility. This is a critical step on the path to potential approval, and we are devoting significant resources to these preparations. We are working closely with experienced external consultants, including industry quality veterans with robust FDA experience who provide us with valuable guidance regarding FDA expectations. We have also conducted multiple mock inspections to ensure our site is ready, the team is prepared and the FDA inspection passes without any major issues. As a reminder, our facility has already passed four consecutive successful GMP inspections, including the most recent one by the Israeli Ministry of Health. We are entering the FDA inspection process from a position of strength, and we are highly focused on getting it right for first time. We have also continued to advance our engagement with the scientific community surrounding the SHIELD II phase III results with two important data presentations this quarter. In early May 2026, at the 45th Annual Meeting of the Surgical Infection Society, we presented an analysis of SHIELD II Asepsis score data, a clinical measure of wound infection severity. The results showed a 64% relative risk reduction in patients with an asepsis score greater than 20, which is the threshold for clinically significant wound infection. What this tells us is that even among patients in the D-PLEX arm who did experience wound events, severity was meaningfully reduced. Ori will speak in a moment to what this potentially means commercially. In April 2026, at the European Society of Clinical Microbiology and Infectious Diseases, also known as ESCMID, we presented new pharmacokinetic or PK data providing further evidence that D-PLEX100 delivers sustained controlled release of doxycycline for approximately 30 days. This result in our largest human data set to date support the core mechanistic premise of our technology. With that, I will now turn the call over to Ori Warshavsky, our Chief Operating Officer, U.S. Ori?

Thank you, Dikla. I would like to spend a few minutes on the broader commercial readiness work underway. Alongside the partnership process and manufacturing readiness, we are continuing with our commercial readiness activities across several other fronts. Picking up on the asepsis data Dikla just referenced, those results have meaningful potential commercial implications. A 64% relative risk reduction with a P value of 0.0103 in severe wound events translates directly to fewer wound complications, less reliance on intravenous antibiotics, the potential for earlier hospital discharge and lower hospital resource utilization. That is exactly the language hospital P&T committees and payers respond to, and we believe that this is central to the health economics work we are now accelerating. Alongside this, we are expanding our presence at major surgical and infectious disease conferences, advancing additional planned scientific publications and continuing to engage leading clinical voices in the field. As part of these efforts, we hosted a roundtable discussion with KOLs earlier this month at the Surgical Infection Society annual meeting, which was chaired by the president of the society. There were a lot of good insights during that meeting, including an open discussion on the fact that infection rates are often underreported to avoid penalties and that growing obesity rates are impacting infection rates in abdominal surgeries. At the general assembly of the conference, there was a call from the stage to see how the society can, and I quote, "Help move practice forward with a really novel product." Together, these efforts build the awareness and the evidence base that will support a successful launch. I would also like to briefly address the broader environment in which D-PLEX100 would be launched. Two converging trends are shaping that environment in important ways. The first is the growing focus across U.S. hospital systems on infection prevention, antimicrobial stewardship and reducing the use of systemic antibiotics. The second is the evolving reimbursement landscape. Under Medicare's new Transforming Episode Accountability model known as TEAM, hospitals are now financially accountable for inpatient and outpatient complications occurring throughout the 30 days following certain surgical procedures, including colorectal surgery. This represents a significant shift as the 30-day window for SSI is no longer just a clinical concern, it is increasingly tied to how hospitals are reimbursed. We believe D-PLEX100 is well-aligned with both trends. By delivering high concentration of broad-spectrum antibiotic directly at the surgical site rather than relying on systemic antibiotic load, D-PLEX100 supports the same antimicrobial stewardship goals hospital systems are increasingly being asked to advance. Just as important, D-PLEX100 is designed to provide antibiotic protection for approximately 30 days, the same window which hospitals are now financially accountable for. We expect this convergence, clinical data on one side, policy-driven economic incentives on the other to be an increasingly important part of D-PLEX's position with hospital system and payers as we move towards potential commercialization. With that, I will now turn the call over to Jonny to review our financial performance for the quarter. Jonny?

Thank you, Ori. I will now walk through our financial results for the first quarter ended March 31, 2026. Starting with operating expenses, research and development expenses for the first quarter of 2026 were $5.8 million compared to $6.1 million in the first quarter of 2025. This decrease primarily reflects the completion of the SHIELD II phase III trial and our ongoing transition towards regulatory submission and commercial readiness activities. General and administrative expenses for the quarter were $1.6 million compared to $1.2 million for the same period in 2025. Marketing and business development expenses were $0.4 million compared to $0.3 million in the prior year period. Net loss for the first quarter of 2026 was $7.7 million or $0.35 per share compared to a net loss of $8.3 million or $0.70 per share in the first quarter of 2025. Turning to the balance sheet, as of March 31, 2026, PolyPI'd had $10.9 million in cash -- cash equivalents and short-term deposits compared to $12.9 million on December 31, 2025. The modest decrease approximately $2 million reflects continued operating activities, partially offset by proceeds from warrant exercises during the quarter. Subsequent to quarter end, our balance sheet has been further strengthened by an additional development. In early May 2026, we completed the full repayment of our remaining loan facility originally entered into in April 2022. As a result, the company has fully repaid its outstanding debt obligations and has no remaining loan-related liabilities as of the date of today's earnings release, further strengthening our balance sheet ahead of potential commercialization. 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 potential milestones. With that, we will now open the call for questions. Operator?

[Operator Instructions] We will take our first question and the first question comes from the line of Chase Knickerbocker from Craig-Hallum.

Maybe just to start, a couple on the filing. Just as we kind of think about that CMC module, maybe talk about the work that you've done with consultants internally to kind of submit that module with confidence, I think, particularly around kind of the process validation portions with your differentiated drug product, which obviously also comes with some novel aspects being that it is differentiated, right? So maybe just speak to kind of the work you've done with consultants and the confidence you've kind of gained there. And then secondly, I'll just ask both upfront. As you think about kind of the inspection readiness, you had several mock audits at this point. Maybe just talk to us a little bit about how those have progressed, how your findings from those have progressed and again, kind of increase your confidence in the positioning of your filing.

Thank you, Chase. So I'll start with the first portion on the CMC. Obviously, there is the aspect of consultants and regulatory consultant. But I think the most reassuring portion here is that we took advantage of -- or we used the Breakthrough Therapy Designation, which allows us to have more frequent communication with the FDA. And we really communicate prior to submission the NDA with the FDA on different processes on different methods as well as submitting the development report and everything that we thought could be risky, and we wanted the agency feedback ahead of submitting an NDA, we did that. So yes, there is a portion of getting advised and reviews, and we have a very experienced team in the CMC aspect from the development stage up to the actual operational aspect. But we also used -- communicate with the FDA multiple times to make sure that we are aligned with what they are expecting to see. So that's on the module -- the CMC module. On the preparation for the inspection, there are a couple of things that I think we've done from the start. The first one being the fact that we have built our own manufacturing facility. So it's not a CMO. We have full control of the processes on the method, regulation, all the implementation methods internally, both in terms of our employees as well as our QA. It's all internal. And that's, I think, a good thing and strengthen our position. The other thing is really working from day one with the eyes to the FDA expectation, always staying up to date to see what is the FDA expectation, what is the most recent expectation -- and this is why we were able to pass this inspection, which are also, by the way, qualified for the European authorities. So that's an ongoing. And now as we get closer to the pre-approval inspection, obviously, we are even tightening those processes, even tightening what is needed, working with very veteran quality person that really been on almost on a weekly basis part of FDA inspection, so we could really know what the FDA is focusing on these days. Now you were asking about specifically if anything came out of this mock inspection that can put this in danger. I'm very freely, I can say that we don't think so that obviously, there is -- when there is an inspection, there are comments, there are suggestions, there are reviews, but all of it is things that either have already been implemented and corrected or things that are ongoing, but nothing that we viewed as major. And also the -- for the matter of the Israeli Ministry of Health did not see those as major or critical.

Your next question comes from Jason Butler from Citizens JMP.

First one for me. Just can you speak to any dialogue that you've had with FDA since submitting the first modules of the NDA? Have you had any questions or information requests from FDA yet?

So as we showed previously -- again. So not something formal, nothing formal at this stage, but we've not completed the NDA submission. So we don't really expect to get anything. But the NDA submission is -- or the completion is expected imminently. So I'm sure we'll start to get that immediately after.

Great. And then you've spoken in the past about what you're looking for from a commercial partnership or collaboration. Can you just speak to -- as you continue those discussions, have those priorities shifted at all? Or are your goals the same out of any partnership?

So no, they have not shifted. We are still focused and we think that the main objective is to have a partner with good presence in the hospital and capabilities to build and expand on a sales force that is in the hospital. That's what we are looking at. And we're very pleased so far.

Your next question comes from the line of Boobalan Pachaiyappan from ROTH Capital Partners.

A couple from us. Maybe to start with, I was wondering if you could talk about the tariff rate for drugs that are manufactured in Israel and commercialized in the U.S. and other countries. Is it like a flat tariff rate regardless of indications? Any color on that, please?

Ori, do you want to take this one regarding the U.S.?

Yes. So the question -- just so I understand the question is regarding tariffs on products from Israel to the U.S.

Yes, for drug products that are manufactured in Israel and commercialized in the U.S. and other countries.

That's a good question. As far as I know, and we can follow up on this later, there's a flat tariff rate be negotiated between the government of the U.S. and Israel on all incoming goods coming from Israel to the U.S. We can follow up on this with the rates.

All right. That's helpful. And in light of the ongoing conflict in the Middle East area region, can you maybe talk about the time line or the impact of this conflict on the inspection procedure to be conducted by the FDA? How are you thinking about it? And if you expect the inspection time line to be sort of -- is there -- at what point do you think you will have more clarity on whether or not the inspection will take place in second half of '26?

So thank you for this question, Boobalan. Obviously, if we knew this answer, we would have been -- we could use it in many, many other aspects. But seriously, we know that the FDA was inspecting two facilities in Israel this last March. Obviously, since March, they were not here. We do not expect this to have an effect. The FDA has many means to inspect the facility, either from -- COVID was here 2 years almost and drugs were approved. So I think both companies and the agency find ways to get drugs approved. So we do not expect it to change anything. We are operating in a normal course of business. You can see both in terms of the time line, we were committed to submitting the NDA before the end of the first quarter, which was done. We are now very shortly, we'll finalize this submission. And the team here is fully committed to all of these processes. And on a personal note, I hope that it will come and there won't be any issues.

All right. Maybe one last one. I understand D-PLEX100 will be commercialized by the strategic partner. So just curious, I mean, do you still need to hire some employees to sort of internally track the progress? And can you also talk about the impact of this on G&A spend?

So I'll let Jonny add on that. But specifically on G&A, I don't see any major impact. We do think that there will be some increase later on as we expand the commercialization and sales increase, we'll need more employees on the operational front, obviously. And once we can discuss more clearly on next step, we will also lay out the development plan as we see it.

No, I agree. So for the whole G&A part, we wouldn't expect such a big increase, but there will be some increase. And as Dikla said, the bigger increase will be in the operational part.

[Operator Instructions] We will take our next question, and the question comes from Brandon Folkes from H.C. Wainwright.

Congrats on the progress. Maybe just two for me. Can you talk about how broad of a development pipeline you would consider once you do execute on a commercial transaction? Are you envisioning a singular product development focus going forward? Or could we sort of see a pretty broad pipeline? And then secondly, you remain very disciplined on the SG&A line. So can you just talk about if you envision PolyPid itself doing any market awareness this year ahead of an approval and ahead of a potential partnership?

Thank you. Thank you, Brandon. So I'll start with the first portion of your question. In terms of -- or maybe let's start with the latter. We do see PolyPid doing some prelaunch activities. Everything that was done up until now was done by us, whether it is around packaging names, scientific conference, all of that is done with us, and we'll see some of it also continues. We are hoping to publish the manuscript of the SHIELD I -- the SHIELD II data in a peer-reviewed journal soon. All of this is the more scientific clinical assets are managed by us and we'll be able to again say more how much of it will be managed by us or the partner. On other geographies, it's to be seen depending on the arrangement that we will get to. But generally, for D-PLEX, we do not see ourselves marketing the product on our own. In terms of our pipeline, this is a very important question. We envision the pipeline, and this is work that is done already and some of those are communicated to investors, but I think once we have a partner that could be even further reassessed and strengthened, we envision three paths. One is obviously -- and this was discussed quite intensively expanding D-PLEX behind abdominal indication. There is a high need in many other surgeries, and this will be done with the partner. The other is expanding our PLEX platform to other indications. And we also have our younger program in the metabolic health. So I envision and we envision multiple products that some are late stage and some are more early stage.

There seems to be no further questions. I will now hand the call back to Dikla for closing remarks.

Thank you all for joining us today. The first quarter of 2026 marked a critical transition for PolyPid. Our rolling NDA submission is well underway with completion expected imminently. Our U.S. strategic partnership discussions are in their late stages. Our European regulatory strategy is advancing toward an MAA submission later this year, and our balance sheet has been meaningfully strengthened. Together, these milestones mark what we believe is the most consequential phase in our company's history. We continue to believe that 2026 has the potential to be a transformative year for PolyPid, and we look forward to providing further updates as these milestones unfold. Thank you. Operator, you may now close the call.

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