PolyPid Q1 2026 Earnings Call - NDA Submission Advances, U.S. Partnership in Late Stages

Operator: Greetings, welcome to PolyPid’s first quarter 2026 earnings conference call. At this time, participants are in a listen-only mode. 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.

Yehuda Leibler, Investor Relations, Arx Investor Relations: 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 31st, 2026. A copy of the press release is available on the investor 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 repertoire or co-repertoire regarding the planned Marketing Authorisation 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 through 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 25th, 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 13th, 2026. With that, it is my pleasure to turn the call over to Dikla Czaczkes Akselbrad, the CEO of PolyPid. Dikla.

Dikla Czaczkes Akselbrad, Chief Executive Officer, PolyPid: Thank you, Yehuda. 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 continued 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 filings, we submitted the CMC and non-clinical 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 designations, 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 plan 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 therapeutic innovation. The centralized procedure 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 discussion 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 preparation. 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 at 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 core data, a clinical measure of wound infection severity.

The results show 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 control 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.

Ori Warshavsky, Chief Operating Officer, U.S., PolyPid: 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 payer respond to. 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 system 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 toward potential commercialization. With that, I will now turn the call over to Jonny to review our financial performance for the quarter. Jonny.

Jonny Missulawin, Chief Financial Officer, PolyPid: Thank you, Ori. I will now walk through our financial results for the first quarter ended March 31st, 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 toward 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 31st, 2026, PolyPid had $10.9 million in cash equivalents and short-term deposits, compared to $12.9 million on December 31st, 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 earning 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: Thank you. If you wish to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. We will take our first question. The first question comes from the line of Chase Knickerbocker from Craig-Hallum. Please go ahead. Your line is open.

Chase Knickerbocker, Analyst, Craig-Hallum: Good morning. Thanks for taking the questions. Maybe just to start, you know, 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? Maybe just speak to, kind of the work you’ve done with consultants and the confidence you’ve gained there. Secondly, I’ll just ask both up front. As you think about kind of the inspection readiness, you’ve had several mock audits at this point.

Maybe just, talk to us a little bit about how those have progressed or your findings from those have progressed, and again, kind of increase your confidence in the positioning of your filing. Thank you.

Dikla Czaczkes Akselbrad, Chief Executive Officer, PolyPid: Thank you, Chase. Good morning. I’ll start with the first portion on the CMC. Obviously, there is the aspect of consultants and regulatory consultants, 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. 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 NDA. We did that. Yes, there is the portion of getting advice and reviews, and we have very experienced team in the CMC aspect, from the development stage up to the actual operational aspects.

We also used communicate with the FDA multiple times to make sure that we are aligned with what they are expecting to see. 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. It’s not a CMO. We have full control of the processes on the method regulation, or all the implementation methods internally, both in terms of our employees as well as the 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. This is why we were able to pass this inspection, which are also, by the way, qualified for the European authorities. Now, as we get closer to the pre-approval inspection, obviously we are, you know, even tightening those processes, even tightening what is needed, working with very veteran quality persons that really been 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 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 on the go to do that, but nothing that we viewed as major. Also for the matter of the Israeli Ministry of Health did not see those as major or critical.

Chase Knickerbocker, Analyst, Craig-Hallum: Very helpful, guys. Thank you.

Dikla Czaczkes Akselbrad, Chief Executive Officer, PolyPid: Thank you.

Operator: Thank you. We will take our next question. Your next question comes from Jason Butler from Citizens JMP. Please go ahead. Your line is open.

Jason Butler, Analyst, Citizens JMP: Hi. Thanks for taking the questions. First one from me. 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?

Dikla Czaczkes Akselbrad, Chief Executive Officer, PolyPid: As we shared previously, again. Not something formal. Nothing formal at this stage, but we’ve not completed the NDA submission. 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.

Jason Butler, Analyst, Citizens JMP: Great. Then you’ve spoken in the past about what you’re looking for from a commercial partnership or collaboration. Can you just, like, speak to, you know, as you continue those discussions, have those priorities shifted at all or are your goals the same out of any partnership? Thank you.

Dikla Czaczkes Akselbrad, Chief Executive Officer, PolyPid: No, they’ve not shifted. We are still focused. 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.

Jason Butler, Analyst, Citizens JMP: Great. Thanks for taking the questions.

Dikla Czaczkes Akselbrad, Chief Executive Officer, PolyPid: Thank you, Jason.

Operator: Thank you. We will take our next question. Your next question comes from the line of Boobalan Pachaiyappan from Roth Capital Partners. Please go ahead. Your line is open.

Boobalan Pachaiyappan, Analyst, Roth Capital Partners: Hi. Good morning, and thanks for taking our questions. 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?

Dikla Czaczkes Akselbrad, Chief Executive Officer, PolyPid: Ori, you wanna take this one regarding the U.S.?

Ori Warshavsky, Chief Operating Officer, U.S., PolyPid: Yes. The question, just so I understand, the question is, regarding tariffs on products from Israel to the U.S.?

Boobalan Pachaiyappan, Analyst, Roth Capital Partners: Yes, for drug products that are manufactured in Israel and commercialized in the U.S. and other countries.

Jonny Missulawin, Chief Financial Officer, PolyPid: That’s a good question. As far as I know, and we can follow up on this later, there’s a flat tariff rate pre-negotiated between the government of the U.S. and Israel on all incoming goods coming from Israel to the U.S. We can

Boobalan Pachaiyappan, Analyst, Roth Capital Partners: All right.

Jonny Missulawin, Chief Financial Officer, PolyPid: We can follow up on this with the rates.

Boobalan Pachaiyappan, Analyst, Roth Capital Partners: All right. Thank you. That’s helpful. In light of the ongoing conflict in the Middle East area or region, can you maybe talk about the timeline or the impact of this conflict on the inspection procedure to be conducted by the FDA? How are you thinking about it? If you expect the inspection timeline to be, you know, sort of, at what point do you think you will have more clarity on whether or not the inspection will take place in the second half of 2026?

Dikla Czaczkes Akselbrad, Chief Executive Officer, PolyPid: Thank you for this question, Balanel. Obviously, if we knew this answer, we would have been, we could use it in many, many other aspects. 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. You know, the FDA has many means to inspect the facility, either from, COVID was here two years almost, and drugs were approved. I think both companies and the agency have found ways to get drugs approved, 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 timeline, we were committed to submitting the NDA, before the end of the first quarter, which was done. We are now, very shortly will finalize this submission, and the team here is, fully committed to all of these processes. From a personal note, I hope that they will come and there won’t be any issues.

Boobalan Pachaiyappan, Analyst, Roth Capital Partners: All right. Maybe one last one. I understand D-PLEX100 will be commercialized by the strategic partner. Just curious, I mean, do you still need to hire some employees to sort of internally track the progress? Can you also talk about the impact of this on G&A spend? Thank you. That’s all.

Dikla Czaczkes Akselbrad, Chief Executive Officer, PolyPid: 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. Once we can discuss more freely on X-Step, we will also lay out the development plan as we see it.

Jonny Missulawin, Chief Financial Officer, PolyPid: No, I agree. For the whole G&A part, we wouldn’t expect such a big increase, but there’ll be some increase. As Dikla said, the bigger increase will be in the operational part.

Boobalan Pachaiyappan, Analyst, Roth Capital Partners: All right. Thank you.

Operator: Thank you. Once again, if you wish to ask a question, please press star one one on your telephone. We will take our next question. The question comes from Brandon Folkes from H.C. Wainwright & Co. Please go ahead. Your line is open.

Brandon Folkes, Analyst, H.C. Wainwright & Co: Hi. Thanks for taking my questions and congrats on the progress. Maybe just two from me. Can you talk about how broad of a development pipeline you would consider once you do execute on a commercial transaction? You know, are you envisioning a singular product development focus going forward, or could we sort of see a pretty broad pipeline? Secondly, you know, you remain very disciplined on the SG&A line. Can you just talk about if you envision PolyPid itself doing any market awareness thing this year ahead of an approval and ahead of a potential partnership? Thank you.

Dikla Czaczkes Akselbrad, Chief Executive Officer, PolyPid: Thank you. Thank you, Brandon. I’ll start with the first portion of your question. In terms of, maybe let’s start with the latter. We do see PolyPid doing some pre-launch 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, we’ll see some of it also continues. We are hoping to publish the manuscript of the SHIELD II data in a peer-review journal soon. All of this is the more scientific clinical aspects are managed by us, we’ll be able to again say more how much of it will be managed by us or the partner.

On other geography, it’s to be seen, depending on the arrangement that we will get to. Generally for D-PLEX, we do not see ourself 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 it was communicated to investor. I think once we have a partner, this could be even further reassessed and strengthened. We envision 3 paths. One is obviously, and this was discussed quite extensively, 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 indication. We also have our younger program in the metabolic health.

I envision, and we envision multiple products that some are late stage and some are more early stage.

Jonny Missulawin, Chief Financial Officer, PolyPid: Once a year, at least, that we expect most patients.

Brandon Folkes, Analyst, H.C. Wainwright & Co: Great. Thank you much.

Dikla Czaczkes Akselbrad, Chief Executive Officer, PolyPid: Thank you.

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

Dikla Czaczkes Akselbrad, Chief Executive Officer, PolyPid: 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.

Operator: This concludes today’s conference call. Thank you for participating. You may now disconnect.