Q1 2026 PolyPid Ltd Earnings Call

May 13, 2026

Operator 2: Greetings, welcome to PolyPid's Q1 2026 Earnings Conference Call. At this time, participants are in a listen-only mode. 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.

Speaker #1: 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 Akselbrad, Chief Executive Officer of PolyPid; Jonny Missulawin, PolyPid's Chief Financial Officer; and Ori Warshavsky, Chief Operating Officer, US of PolyPid.

Yehuda Leibler: Thank you, operator, and thank you all for joining PolyPid's Q1 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, US of PolyPid. Earlier today, PolyPid released its financial results for the 3 months ended 31 March 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.

Speaker #1: Earlier today, PolyPid released its financial results for the three months ended March 31, 2026. A copy of the press release is available on the Investors section of the company's website, at www.poly-pid.com.

Speaker #1: 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, including the expected completion of the rowing new drug application, or NDA, submission for Duplex 100.

Speaker #1: Management may also discuss the company's plans and engagements with the European Medicines Agency, or EMA, including meetings with the repertoire or co-repertoire regarding the planned marketing authorization application, or MAA, and the anticipated timing thereof.

Yehuda Leibler: Management may also discuss the company's planned engagements with the European Medicines Agency or EMA, including meetings with the rapporteur or co-rapporteur regarding the planned Marketing Authorisation Application, or MAA, and the anticipated timing thereof. In addition, management may discuss the company's ongoing US 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 H2 of 2026 and through several significant upcoming potential milestones.

Speaker #1: In addition, management may discuss the company's ongoing US commercial strategic partnership discussions, its belief that those discussions are in late stages, and expected launch plans and timing.

Speaker #1: Other forward-looking statements may relate to the potential clinical and economic value proposition of Duplex 100, 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.

Speaker #1: 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.

Yehuda Leibler: 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 25 February 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, 13 May 2026. With that, it is my pleasure to turn the call over to Dikla Czaczkes Akselbrad, the CEO of PolyPid. Dikla.

Speaker #1: 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 20F filed on February 25, 2026.

Speaker #1: 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.

Speaker #1: 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.

Dikla Czaczkes Akselbrad: Thank you, Yehuda, and thank you all for joining us today. The Q1 of 2026 was a defining transition for PolyPid. We moved from late-stage clinical development to final NDA regulatory submission. Our US 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 US strategic partnership that will execute commercial launch in the Q1 of 2027. Starting with our regulatory progress. On 30 March 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.

Speaker #1: The first quarter of 2026 was a defining transition for PolyPid. We moved from late-stage clinical development to final NDA regulatory submission. Our US commercial strategic partnership discussion advanced to what we believe are the late stages.

Speaker #1: And we continued to build the foundation for what we expect will be a transformative year. Our focus remains on two priorities: advancing Duplex 100 towards potential FDA approval and finalizing a US strategic partnership that will execute commercial launch in the first quarter of 2027.

Speaker #1: Starting with our regulatory progress, on March 30, 2026, we initiated our NDA submission to the FDA. As a reminder, Duplex 100 is our lead product candidate for the prevention of surgical site infections or SSI in patient undergoing abdominal colorectal surgery.

Speaker #1: 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.

Dikla Czaczkes Akselbrad: 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.

Speaker #1: 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.

Speaker #1: 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.

Speaker #1: 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 repertoire and co-repertoire, which are the European regulatory authorities designated to lead the assessment of our plan, MAA, for Duplex 100.

Dikla Czaczkes Akselbrad: Turning to Europe, we have scheduled meetings in this quarter with the repertoire and corepertoire, 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 Q3 of this year. On the commercial front, our strategic partnership discussion with potential US partner have continued to progress.

Speaker #1: 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 Raporetic Innovation.

Speaker #1: The Centralized Procedures, which 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.

Speaker #1: 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 US partners has continued to progress.

Speaker #1: We believe they are now in their late stages. As the due diligence and evaluation work that defined earlier phases of these discussions is well behind us, and we are currently focused on the active negotiation of definitive agreement terms.

Dikla Czaczkes Akselbrad: 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.

Speaker #1: 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.

Speaker #1: 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.

Speaker #1: 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.

Speaker #1: 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.

Dikla Czaczkes Akselbrad: As a reminder, our facility has already passed 4 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, 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 2 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 show a 64% relative risk reduction in patients with an ASEPSIS score greater than 20, which is the threshold for clinically significant wound infection.

Speaker #1: We have also continued to advance our engagement with the scientific community surrounding the Shield 2 Phase 3 results. With two important data presentations this quarter.

Speaker #1: In early May 2026, at the 45th annual meeting of the Surgical Infection Society, we presented an analysis of Shield 2 asepsis core data. A clinical measure of wound infection severity.

Speaker #1: 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.

Speaker #1: What this tells us is that even among patients in the Duplex arm, who did experience wound events, severity was meaningfully reduced. Ori will speak in a moment to what this potentially means commercially.

Dikla Czaczkes Akselbrad: 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, US. Ori.

Speaker #1: 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 DuoPlex 100 delivers sustained, controlled release of doxycycline for approximately 30 days.

Speaker #1: These results in our largest human dataset 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 US.

Speaker #1: 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.

Ori Warshavsky: Thank you, Dekel. 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 Dekel 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.

Speaker #1: 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.

Speaker #1: That is exactly the language hospital P&T committees and payer respond to. And we believe that this is central to the health economics work we are now accelerating.

Speaker #1: 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.

Ori Warshavsky: 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.

Speaker #1: 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.

Speaker #1: 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.

Speaker #1: At a 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.

Speaker #1: I would also like to briefly address the broader environment in which Duplex 100 would be launched. Two converging trends are shaping that environment in important ways.

Ori Warshavsky: 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 US 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.

Speaker #1: The first is the growing focus across US hospital systems on infection prevention, antimicrobial stewardship, and reducing the use of systemic antibiotics. The second is the evolving reimbursement landscape.

Speaker #1: Under Medicare's new transforming episode accountability model, known as TIM, hospitals are now financially accountable for inpatient and outpatient complications occurring throughout the 30 days following certain surgical procedures, including colorectal surgery.

Speaker #1: 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.

Speaker #1: We believe Duplex 100 is well aligned with both trends. By delivering high concentration of broad-spectrum antibiotic directly at a surgical site, rather than relying on systemic antibiotic load, Duplex 100 supports the same antimicrobial stewardship goals hospital systems are increasingly being asked to advance.

Ori Warshavsky: 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 Johnny to review our financial performance for the quarter. Johnny.

Speaker #1: Just as important, Duplex 100 is designed to provide antibiotic protection for approximately 30 days. The same window which hospitals are now financially accountable for.

Speaker #1: We expect this convergence, clinical data on one side, policy-driven economic incentives on the other, to be an increasingly important part of Duplex's position with hospital systems and payers as we move toward potential commercialization.

Speaker #1: With that, I will now turn the call over to Johnny to review our financial performance for the quarter. Johnny?

Speaker #2: 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.

Jonny Missulawin: Thank you, Ori. I will now walk through our financial results for Q1 ended 31 March 2026. Starting with operating expenses, research and development expenses for Q1 2026 were $5.8 million compared to $6.1 million in Q1 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.

Speaker #2: This decrease primarily reflects the completion of the Shield 2 Phase 3 trial and our ongoing transition toward regulatory submission and commercial readiness activities. General and administrative expenses for the quarter were $1.6 million.

Speaker #2: 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.

Speaker #2: Net loss for the first quarter of 2026 was $7.7 million, or 35 cents per share. Compared to a net loss of $8.3 million, or 70 cents per share in the first quarter of 2025.

Jonny Missulawin: Net loss for Q1 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 Q1 2025. Turning to the balance sheet, as of 31 March 2026, PolyPid had $10.9 million in cash equivalents, and short-term deposits compared to $12.9 million on 31 December 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.

Speaker #2: Turning to the balance sheet, as of March 31st, 2026, PolyPid had $10.9 million in cash cash equivalents and short-term deposits. Compared to $12.9 million, on December 31st, 2025.

Speaker #2: 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.

Speaker #2: 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 had fully repaid its outstanding debt obligations and has no remaining loan-related liabilities as of the date of today's earning release.

Jonny Missulawin: 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 H2 2026 and through several significant upcoming potential milestones. With that, we will now open the call for questions. Operator.

Speaker #2: 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.

Speaker #2: With that, we will now open the call for questions. Operator?

Speaker #3: 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.

Operator 2: 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.

Speaker #3: We will take our first question. And the first question comes from the line of Chase Nickerbuckle Farm, Craig Hallam. Please go ahead. Your line is open.

Operator 2: 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.

Speaker #4: Good morning. Thanks for taking the questions. 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.

Chase Knickerbocker: 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 upfront. As you think about kind of the inspection readiness, you've had several mock audits at this point.

Speaker #4: 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?

Speaker #4: So maybe just speak to kind of the work you've done with consultants and the competence you've kind of gained there. And then secondly, I'll just ask both up front, as you think about kind of inspection readiness, you've had several mock audits at this point.

Speaker #4: 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.

Chase Knickerbocker: 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.

Speaker #4: Thank you.

Speaker #5: Thank you, Chase. Good morning. So 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 of the NDA with the FDA on different processes, on different methods, as well as submitting the development report.

Dikla Czaczkes Akselbrad: 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 a 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.

Speaker #5: 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 the portion of getting advice and reviews, and we have very experienced teams in the CMC aspect from the development stage up to the actual operational aspect.

Speaker #5: But we also used communicate with the FDA multiple times to make sure that we are aligned with what they are expecting to CMC module.

Dikla Czaczkes Akselbrad: 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 our QA. It's all internal, and that's, I think, a good thing and strengthen our position.

Speaker #5: 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.

Speaker #5: So it's not a CMO. We have full control on the processes. On the method, regulation, all the implementation, method, internally, both in terms of our employees as well as our QA, it's all internal.

Speaker #5: And that's, I think, a good thing and strengthened 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.

Dikla Czaczkes Akselbrad: 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. That's an ongoing. 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 on a, almost on a weekly basis, part of FDA inspections, 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.

Speaker #5: 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 persons that really been on almost on a weekly basis part of FDA inspections so we could really know what the FDA is focusing on these days.

Speaker #5: Now you were asking about specifically if anything came out of these mock inspections 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 on the go to do that, 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.

Dikla Czaczkes Akselbrad: 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 on the go to do that, but nothing that we viewed as major. For the matter of the Israeli Ministry of Health did not see those as major or critical.

Speaker #5: Or critical.

Speaker #4: Very helpful, guys. Thank you.

Chase Knickerbocker: Very helpful, guys. Thank you.

Speaker #5: Thank you.

Dikla Czaczkes Akselbrad: Thank you.

Speaker #3: 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.

Operator 2: 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: Hi. Thanks for taking the questions. First one from 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?

Speaker #6: Hi. Thanks for taking the questions. First one from me. Just can you speak to any dialogue that you've had with FDA since submitting the first modules of the NDA?

Speaker #6: Have you had any questions or information requests from FDA yet?

Dikla Czaczkes Akselbrad: 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, or the completion, is expected imminently, so I'm sure we'll start to get that immediately after.

Speaker #5: So, as we shared previously, it's 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.

Speaker #5: But the NDA submission is or the completion is expected imminently. So I'm sure we'll start to get that immediately after.

Speaker #4: Great. And then you spoke 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?

Jason Butler: 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.

Speaker #4: Thank you.

Speaker #5: 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.

Dikla Czaczkes Akselbrad: No, they have 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. We're very pleased so far.

Speaker #5: And we're very pleased so far.

Jason Butler: Great. Thanks for taking the questions.

Speaker #4: Great. Thanks for taking the questions.

Speaker #5: Thank you, Jason.

Dikla Czaczkes Akselbrad: Thank you, Jason.

Speaker #3: Thank you. We will take our next question. Your next question comes from the line of Bhubalan. Pasha Yapin from Roth Capital Partners. Please go ahead.

Operator 2: 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.

Speaker #3: Your line is open.

Boobalan Pachaiyappan: 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 US and other countries. Is it like a flat tariff rate regardless of indications? Any color on that, please.

Speaker #7: 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.

Speaker #7: On commercialized in the US and other countries, is it like a flat tariff rate regardless of indications, any color on that, please?

Dikla Czaczkes Akselbrad: Ori, you wanna take this one regarding the US?

Speaker #5: Or you want to take this one? Regarding the US?

Speaker #4: Yes. So the question, just so I understand, is regarding tariffs on products from Israel to the US?

Ori Warshavsky: Yes. The question, just so I understand, the question is regarding tariffs on products from Israel to the US?

Speaker #7: Yes. For drug products that are manufactured in Israel. On commercialized in the US and other countries.

Boobalan Pachaiyappan: Yes. For drug products that are manufactured in Israel and commercialized in the US and other countries.

Speaker #4: Yeah. 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 US and Israel on all incoming goods coming from Israel to the US.

Ori Warshavsky: That's a good question. As far as I know, and we can follow up on this later, there's a flat tariff rate prenegotiated between the government of the US and Israel on all incoming goods coming from Israel to the US.

Speaker #4: We can follow up on this with the rates.

Boobalan Pachaiyappan: All right.

Ori Warshavsky: We can follow up on this with the rates.

Speaker #7: All right. Thank you. That's helpful. And in light of the ongoing conflict in the geo in the Middle East area, region, can you maybe talk about the timeline or the impact of this conflict on the inspection procedure to be conducted by the FDA?

Boobalan Pachaiyappan: All right. Thank you. That's helpful. In light of the ongoing conflict in the Middle East 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 H2 2026?

Speaker #7: How are you thinking about it? And if you expect the inspection timeline 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 the second half of '26?

Dikla Czaczkes Akselbrad: Thank you for this question, Boobalan Pachaiyappan. 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 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 find ways to get drugs approved. We do not expect it to change anything. We are operating in a normal course of business.

Speaker #5: So, thank you for this question, Bhubalan. Obviously, if we knew this answer, we could use it in many, many other aspects.

Speaker #5: 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.

Speaker #5: The FDA has many means to inspect the facility. Either from a COVID was here two years almost and drugs were approved. So I think both companies and the agency find ways to get drugs approved.

Speaker #5: 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 timeline.

Dikla Czaczkes Akselbrad: You can see both in terms of the timeline, we were committed to submitting the NDA before the end of Q1, 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.

Speaker #5: 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.

Speaker #5: And the team here is fully committed to all of these processes. And from a personal note, I hope that they will come and there won't be any issues.

Speaker #7: All right. Maybe one last one. I understand Duplex 100 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?

Boobalan Pachaiyappan: 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.

Speaker #7: And can you also talk about the impact of this on GNA spend as GNA spend? Thank you. That's all.

Dikla Czaczkes Akselbrad: I'll let Jonny add on that. 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 Xtant, we will also lay out the development plan as we see it.

Speaker #5: So unless Jonny add on that, but specifically on GNA, 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.

Speaker #5: We'll need more employees on the operational front, obviously. And once we can discuss more freely on next steps, we will also lay out the development plan as we see it.

Jonny Missulawin: No, I agree. For the whole G&S and G&A part, we wouldn't expect such a big increase, but there'll be some increase. As Dixit said, the bigger increase will be in the operational part.

Speaker #4: No, I agree. So for the whole GNA part, increase. But there'll be some increase. And as Dikla said, the bigger increase will be in the operational part.

Speaker #7: All right. Thank you.

Boobalan Pachaiyappan: All right. Thank you.

Speaker #3: 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.

Operator 2: 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, and the question comes from Brandon Folkes from H.C. Wainwright. Please go ahead. Your line is open.

Speaker #3: And the question comes from Brandon Folks from HC Wainwright. Please go ahead. Your line is open.

Brandon Folkes: Hi. Thanks for taking my questions and congrats on the progress. Maybe just two from me.

Speaker #8: Hi. Thanks for taking my questions, and 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?

Brandon Folkes: 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.

Speaker #8: 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.

Speaker #8: So 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?

Speaker #8: Thank you.

Speaker #5: 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.

Dikla Czaczkes Akselbrad: Thank you. Thank you, Brandon Folkes. I'll start with the first portion of your question. 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 I, 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.

Speaker #5: 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 and we'll see some of it also continues.

Speaker #5: We are hoping to publish the manuscript or the shield two data in a peer-reviewed journal soon. All of this is the more scientific, clinical aspects are managed by us.

Speaker #5: And we'll be able to, again, say more how much of it will be managed by us or the partner. On other geography, it says to be depending on the arrangement that we will get to.

Dikla Czaczkes Akselbrad: 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 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 it was communicated to investor, but I think once we have a partner, this could be even further reassessed and strengthened. We envision three 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 a partner. The other is expanding our PLEX platform to other indication. We also have our younger program in the metabolic health.

Speaker #5: But generally, for Duplex, we do not see ourselves marketing the product on our own. In terms of our pipeline, this is a very important question.

Speaker #5: We envision a pipeline, and this is work that is done already, and some of it was communicated to investors. But I think once we have a partner, this could be even further reassessed and strengthened.

Speaker #5: We envision three paths. One is obviously and this was discussed quite intensively, expanding Duplex behind abdominal indication. There is a high need in many other surgeries and this will be done with the partner.

Speaker #5: 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.

Dikla Czaczkes Akselbrad: I envision, and we envision multiple products that some are late stage and some are more early stage.

[Company Representative] (PolyPid): Once a year, as we've said, we expect most patients.

Speaker #8: One year at least that we expect most patients. Great. Thank you so much.

Brandon Folkes: Great. Thank you very much.

Speaker #5: Thank you.

Dikla Czaczkes Akselbrad: Thank you.

Speaker #3: Thank you. There seems to be no further questions. I will now hand the call back to Dikla for closing remarks.

Operator 2: Thank you. There seems to be no further questions. I will now hand the call back to Dikla for closing remarks.

Speaker #5: Thank you all for joining us today. The first quarter of 2026 marked a critical transition for PolyPid. A rolling NDA submission is well underway with completion expected imminently.

Dikla Czaczkes Akselbrad: Thank you all for joining us today. The Q1 of 2026 marked a critical transition for PolyPid. Our rolling NDA submission is well underway, with completion expected imminently. Our US 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.

Speaker #5: Our Euro 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.

Speaker #5: Together, these milestones mark what we believe is the most consequential phase in our company's history. We continue to believe the 2026 has the potential to be a transformative year for PolyPid.

Speaker #5: And we look forward to providing further updates. As these milestones unfold. Thank you. Operator, you may now close the call.

Operator 2: This concludes today's conference call. Thank you for participating. You may now disconnect.