Q2 2025 PolyPid Ltd Earnings Call

Yuda Liebler: Greetings, and welcome to PolyPid's second quarter 2025 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, Yuda Liebler from Arts Capital Market. Mr. Liebler, you may begin.

Speaker #1: And I would now like to introduce your host for today's conference, Yuda Liebler from Arts Capital Markets. Mr. Liebler, you may begin.

Yuda Liebler: Thank you all for participating in PolyPid's second quarter 2025 earnings conference call. Joining me on the call today will be Dikla Akselbrad, Chief Executive Officer of PolyPid Ltd.; Jonny Missulawin, PolyPid's Chief Financial Officer; and Ori Warshavsky, Chief Operating Officer, US of PolyPid Ltd. Earlier today, PolyPid Ltd. released its financial results for the three months ended June 30th, 2025. A copy of the press release is available in the Investors section on the company's website, available at www.polypid.com. I would like to remind you that on this call, management will make forward-looking statements within the meaning of the Federal Securities Law. For example, management is making forward-looking statements when it discusses D-PLEX100's potential benefits, including its potential to address a significant unmet medical need and to substantially reduce the burden of surgical site infections, improve patient outcomes, and generate meaningful healthcare cost savings.

Speaker #2: Thank you all for participating in PolyPid's second quarter 2025 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, U.S. of PolyPid.

Speaker #2: Earlier today, PolyPid released its financial results for the three-month end of June 30, 2025. A copy of the press release is available in the investors' section on the company's website, available at www.polypid.com.

Speaker #2: I'd like to remind you that on this call, management will make forward-looking statements within the meaning of the Federal Securities Law. For example, management is making forward-looking statements when it discusses DPEX 100's potential benefits, including its potential to address a significant unmet medical need, and to substantially reduce the burden of surgical site infections improved patient outcomes and generate meaningful healthcare cost savings.

Yuda Liebler: The expected regulatory submissions and their timing, the aim of the GLP-1 program and its potential to address significant unmet medical needs in the treatment of metabolic diseases, the company's expected cash runway, and the potential partnership opportunities for D-PLEX100. 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 its SEC filings. The company's results may differ materially from these projections. These statements involve material risks and uncertainties that could cause actual results or events to materially differ. Accordingly, you should not place undue reliance on these statements.

Speaker #2: The expected regulatory submissions, and their timing, the aim of GLP-1 program, and its potential to address significant unmet medical needs in the treatment of metabolic diseases, the company's expected cash runway, and the potential partnership opportunities for DPEX 100.

Speaker #2: 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 its SEC filings, the company's results may differ materially from these projections.

Speaker #2: These statements involve material risks and uncertainties that could cause actual results or events to materially differ. Accordingly, you should not place under-reliance on these statements.

Yuda Liebler: I encourage you to review the company's filings with the SEC, including, without limitation, the company's annual report on its Form 20-F filed on February 26th, 2025, which identifies specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements. PolyPid Ltd. disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise. This conference call contains time-sensitive information and speaks only as of the live broadcast today, August 13th, 2025. With the completion of those prepared remarks, it is my pleasure to turn the call over to Dikla Akselbrad, CEO of PolyPid Ltd. Dikla?

Speaker #2: I encourage you to review the company's filings with the SEC, including, without limitation, the company's annual report on its Form 20-F, filed on February 26, 2025, which identified specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements.

Speaker #2: PolyPid disclaims any intention or obligation except as required by law to update or revise any financial projections or forward-looking statements whether because of new information, future events, or otherwise.

Speaker #2: This conference call contains time-sensitive information and speaks only as of the live broadcast today, August 13, 2025. With the completion of those prepared remarks, it is my pleasure to turn the call over to Dikla Akselbrad, CEO of PolyPid.

Speaker #2: Dikla,

Dikla Akselbrad: Thank you, Yuda. On behalf of our team at PolyPid Ltd., I would like to welcome everyone to our second quarter 2025 earnings conference call. The second quarter of 2025 was truly transformational for PolyPid Ltd., marked by the successful results of our Phase III Shield II trial, which demonstrated significant clinical benefits of D-PLEX100 in preventing surgical site infections, or SSI, in abdominal colorectal surgery. As announced in June 2025, the study showed a statistically significant reduction of 38% with a p-value below 0.005 in the primary endpoint, which, as a reminder, is the combination of deep and superficial SSI, all-cause mortality, and surgical reintervention.

Speaker #1: Thank you, Yuda. On behalf of our team at PolyPid, I would like to welcome everyone to our second quarter 2025 earnings conference call. The second quarter of 2025 was truly transformational for PolyPid.

Speaker #1: Marked by the successful results of our Q2 phase 3 trial, which demonstrated significant clinical benefits of DPEX 100 in preventing surgical site infections or SSI in abdominal colorectal surgeries.

Speaker #1: As announced in June 2025, the study showed a statistically significant reduction of 38% with a p-value below 0.005 in the primary endpoint, which, as a reminder, is the combination of deep and superficial SSIs, all-cause mortality, and surgical reinterventions.

Dikla Akselbrad: In addition, we demonstrated a robust 58% reduction in the rate of surgical site infection in patients treated with D-PLEX100 versus standards of care, with a p-value below 0.005, including a significant reduction in deep surgical site infection, with five cases of deep SSI representing approximately 14% out of all SSIs in the standards of care arm versus zero in D-PLEX100 arm, with a p-value below 0.05. Importantly, we also saw in the study a clear and statistically significant 62% reduction of patients with an asepsis score over 20. The asepsis score reflects the severity of the wound infection appearance and the clinical consequences of the infection. D-PLEX100 not only markedly decreased the rate of superficial and deep SSIs, but even when SSIs occurred in the D-PLEX100 arm, they were less severe and caused less medical burden, such as prolonged hospitalization or use of IV antibiotics.

Speaker #1: In addition, we demonstrated a robust 58% reduction in the rate of surgical site infections in patients treated with DPEX 100 versus standards of care with a p-value below 0.005.

Speaker #1: Including a significant reduction in deep surgical site infection with five cases of deep SSIs representing approximately 14% out of all SSIs, in the standards of care arm versus zero in DPEX 100 arm, with a p-value below 0.05.

Speaker #1: Importantly, we also saw in the study a clear and statistically significant 62% reduction of patients with an asepsis score over 20, the asepsis score reflects the severity of the wound infection appearance and the clinical consequences of the infection.

Speaker #1: So, DPEX 100 not only markedly decreased the rate of superficial and deep surgical site infections (SSIs), but even when SSIs occurred in the DPEX 100 arm, they were less severe and caused less medical burden, such as prolonged hospitalization or use of IV antibiotics.

Dikla Akselbrad: These robust results validated our conviction in D-PLEX100's potential to address a significant unmet medical need and have generated substantial interest from potential commercial partners. We are extremely encouraged by the enthusiastic reception from healthcare professionals, lead surgeons in different types of surgeries, as well as thought leaders in the field of surgical site infections. All recognize D-PLEX100's potential to substantially reduce the burden of surgical site infections, improve patient outcomes, and generate meaningful healthcare cost savings. In addition, further analysis of the Phase III Shield II trial safety data revealed a good safety profile with no difference in serious treatment emergent adverse events between patients treated with D-PLEX100 versus standards of care. This safety profile further supports D-PLEX100's potential as a well-tolerated prophylactic treatment option for patients undergoing major abdominal surgeries. Following these positive Phase III data, we are on track with our New Drug Application, NDA, preparation.

Speaker #1: This robust result validated our conviction in DPEX 100 potential to address a significant unmet medical need and have generated substantial interest from potential commercial partners.

Speaker #1: We are extremely encouraged by the enthusiastic reception from healthcare professionals, lead surgeons in different types of surgeries, as well as thought leaders in the field of surgical site infections.

Speaker #1: All recognize DPEX 100's potential to substantially reduce the burden of surgical site infections, improve patient outcomes, and generate meaningful healthcare cost savings. In addition, further analysis of the phase 3 Q2 trial safety data revealed a good safety profile, with no difference in serious treatment-emergent adverse events between patients treated with DPEX 100 versus standards of care.

Speaker #1: This safety profile further supports DPEX 100 potential as a well-tolerated prophylactic treatment option for patients undergoing major abdominal surgeries. Following these positive phase 3 data, we are on track with our new drug application for NDA preparation.

Speaker #1: Our next steps include a pre-NDA meeting with the FDA planned by the end of this year, leveraging our Fast Track and Breakthrough Therapy Designation to facilitate regulatory review.

Dikla Akselbrad: Our next steps include the pre-NDA meeting with the FDA, planned by the end of this year, leveraging our fast-track and breakthrough therapy designation to facilitate regulatory review. We anticipate submitting the NDA to the FDA in early 2026 and Marketing Authorization Application, or MAA, submission in Europe shortly thereafter. Shifting gears, we recently made significant progress on our GLP-1 program, which leverages the company's extensive long-term experience. This initiative aims to deliver approximately 60 days no-burst GLP-1 receptor agonist peptides for improved patient compliance and enhanced therapeutic outcomes in the rapidly growing weight loss and diabetes market. We have formally unveiled this program early in the current quarter, and we believe it represents an exciting opportunity to expand our therapeutic footprint into the fast-growing metabolic disease market. Following the end of the quarter, yesterday, we announced the appointment of Dr.

Speaker #1: We anticipate submitting the NDA to the FDA in early 2026 and marketing authorization application or MAA submission in Europe shortly thereafter. Shifting gears, we recently made significant progress on our GLP-1 program, which leverages the company's extensive long-term experience, this initiative aims to deliver approximately 60 days no-burst GLP-1 receptor agonist peptide for improved patient compliance and enhanced therapeutic outcomes in the rapidly growing weight loss and diabetes market.

Speaker #1: We have formally unveiled this program early in the current quarter and we believe it represents an exciting opportunity to expand our therapeutic footprint into the fast-growing metabolic disease market.

Speaker #1: Following the end of the quarter, yesterday, we announced the appointment of Dr. Norit Tyler-Dux, MD, MBA, as Chief Medical Officer of the company's transitioning from a role on PolyPid's board of directors.

Speaker #1: Dr. Tyler-Dux brings extensive medical, R&D, and business development expertise to this executive position, strengthening the company's leadership team as it advances towards NDA submission and commercial preparations following the positive phase 3 Q2 result.

Dikla Akselbrad: Nourit Tizer-Zakh, MD, MBA, as Chief Medical Officer of the company, transitioning from her role on PolyPid's Board of Directors. Dr. Tizer-Zakh brings extensive medical R&D and business development expertise to this executive position, strengthening the company's leadership team as it advances towards NDA submission and commercial preparations following the positive Phase III Shield II result. From a financial perspective, we have significantly strengthened our balance sheet through a successful warrant exercise inducement transaction, extending our cash runway well into 2026. With that, I will now turn the call over to Ori Warshavsky, our US COO, to provide more details on our commercial preparations and partnering efforts for D-PLEX100. Ori?

Speaker #1: From a financial perspective, we have significantly strengthened our balance sheet through a successful warrant exercise inducement transaction, extending our cash runway well into 2026.

Speaker #1: With that, I will now turn the call over to Ori, our CEO of US, to provide more details on our commercial preparations and partnering efforts for DPEX 100.

Speaker #1: Ori?

Speaker #3: Thank you, Dikla. Following the successful completion of the Phase 3 Q2 trial and the positive efficacy data, we have intensified our commercial preparation activities in partnership discussions.

Speaker #3: We believe that the positive phase 3 results have validated the substantial market opportunity for DPEX 100. To reiterate, based on our QBA data, we believe the total addressable market for DPEX 100 in the US is just over 12 million total surgeries annually, with approximately 4.4 million of those being abdominal surgeries and an additional 2.1 million abdominal procedures principally in gynecology and urology.

Ori Warshavsky: Thank you, Dikla. Following the successful completion of the Phase III Shield II trial positive efficacy data, we have intensified our commercial preparation activities and partnership discussions. We believe that the positive Phase III results have validated the substantial market opportunity for D-PLEX100. To reiterate, based on the QBR data, we believe the total addressable market for D-PLEX100 in the U.S. is just over 12 million total surgeries annually, with approximately 4.4 million of those being abdominal surgeries and an additional 2.1 million abdominal procedures, principally in gynecology and urology. The 58% reduction in SSI demonstrated in our Phase III trial is particularly significant when considering the substantial costs associated with SSI. As a reminder, SSIs are estimated to cost the U.S. healthcare system up to $10 billion annually, extend hospital length of stay by 9.7 days on average, and increase hospitalization costs by more than $20,000 per patient admission.

Speaker #3: The 58% reduction in SSI demonstrated in our phase 3 trial is particularly significant when considering substantial costs associated with SSI. As a reminder, SSIs are estimated to cost the US healthcare system up to $10 billion annually, extend hospital and stay by 9.7 days on average, and increase hospitalization costs by more than $20,000 per patient admission.

Speaker #3: DPEX 100's potential ability to significantly reduce these infection rates represents a compelling value proposition for healthcare systems, payers, and most importantly, for patients. With respect to our partnership strategy, we continue to believe that identifying a US partner with a dedicated hospital-focused sales force and significant resources will enable DPEX 100 to maximize its sales potential in the US.

Speaker #3: Following the positive Phase 3 data announcement, we have seen increased interest in potential partners, and we are currently evaluating relevant opportunities. We will, of course, provide updates on these discussions as appropriate.

Speaker #3: For the European market, as we've mentioned previously, we already have an exclusive licensing agreement in place with Advanced Pharma to commercialize DPEX 100 across European countries. We are actively working together to plan and implement pre-launch activities to maximize DPEX 100's anticipated launch in Europe.

Ori Warshavsky: D-PLEX100's potential ability to significantly reduce these infection rates represents a compelling value proposition for healthcare systems spared and, most importantly, for patients. With respect to our partnership strategy, we continue to believe that identifying a U.S. partner with a dedicated hospital-focused sales force and significant resources will enable D-PLEX100 to maximize its sales potential in the U.S. Following the positive Phase III data announcement, we have seen increased interest in potential partners, and we are currently evaluating relevant opportunities. We will, of course, provide updates on these discussions as appropriate. For the European market, as we have mentioned previously, we already have an exclusive licensing agreement in place with Advanced Pharma to commercialize D-PLEX100 across European countries, and we are actively working together to plan and implement pre-launch activities to maximize D-PLEX100's anticipated launch in Europe.

Speaker #3: With that, I will now turn the call over to our CFO, Jonny, to review our financial results. Jonny?

Speaker #4: Thank you, Ori. We are pleased to report our financial results for the second quarter of 2025. Which reflect our continued investment in advancing our pipeline while maintaining fiscal discipline.

Speaker #4: Starting with our balance sheet, as of June 30, 2025, the company had cash and cash equivalents of $17.4 million and short-term deposits of $12 million.

Speaker #4: For a total of $29.5 million. This represents a significant improvement from our cash position of $15.6 million as of December 31, 2024. The increase was primarily driven by the successful warrant exercise inducement transaction that Dikla mentioned earlier.

Speaker #4: We expect that our current cash balance will be sufficient to fund operations well into 2026. Now turning to our income statements for the three months ended June 30, 2025, research and development expenses were $6.2 million compared to $4.8 million in the same period of 2024.

Ori Warshavsky: With that, I will now turn the call over to our CFO, Jonny, to review our financial results. Jonny?

Jonny Missulawin: Thank you, Ori. We are pleased to report our financial results for the second quarter of 2025, which reflect our continued investments in advancing our pipeline while maintaining fiscal discipline. Starting with our balance sheet, as of June 30, 2025, the company had cash and cash equivalents of $17.4 million and short-term deposits of $12 million for a total of $29.5 million. This represents a significant improvement from our cash position of $15.6 million as of December 31, 2024. The increase was primarily driven by a successful warrant exercise inducement transaction that Dikla mentioned earlier. We expect that our current cash balance will be sufficient to fund operations well into 2026. Turning to our income statement for the three months ended June 30, 2025, research and development expenses were $6.2 million compared to $4.8 million in the same period of 2024.

Speaker #4: The increase was primarily due to activities related to the completion of the Q2 phase 3 trial and preparation for regulatory submissions. General and administrative expenses were $2.5 million compared to $1.1 million for the same period of 2024.

Speaker #4: The increase was primarily due to non-cash expenses related to performance-based options or PSUs. Following the successful Q2 phase 3 trial, which triggered the vetting of the PSUs, marketing and business development expenses were $0.7 million compared to $0.3 million for the same period of 2024.

Speaker #4: For the second quarter of 2025, the company had a net loss of $10 million or $0.78 per share. Compared to a net loss of $6.3 million or $1.25 per share in the second quarter of 2024.

Speaker #4: For the six months ended June 30, 2025, R&D expenses were $12.3 million compared to $9.8 million for the same six-month period of 2024. G&A expenses were $3.7 million compared to $2.1 million for the same period of 2024.

Speaker #4: Marketing and business development expenses were $1 million compared to $0.5 million for the same period of 2024. The company had a net loss of $18.2 million or $1.48 per share compared to a net loss of $12.7 million or $2.62 per share.

Jonny Missulawin: The increase was primarily due to activities related to the completion of the Shield II Phase III trial and preparation for regulatory submissions. General and administrative expenses were $2.5 million compared to $1.1 million for the same period of 2024. The increase was primarily due to non-cash expenses related to performance-based options, or PSUs, following the successful Shield II Phase III trial, which triggered the vesting of the PSUs. Marketing and business development expenses were $0.7 million compared to $0.3 million for the same period of 2024. For the second quarter of 2025, the company had a net loss of $10 million or $0.78 per share, compared to a net loss of $6.3 million or $1.25 per share in the second quarter of 2024. For the six months ended June 30, 2025, R&D expenses were $12.3 million compared to $9.8 million for the same six-month period of 2024.

Speaker #4: In the six-month period ended June 30, 2024, with that, we want to open the call to your questions. Operator,

Speaker #1: Thank you. If you wish to ask a question, please press star one, when on your telephone, and wait for your name to be announced.

Speaker #1: To withdraw your question, please press star one, when again. We will take our first question. The first question comes from the line of Chase Nickerbocker from Craig Callum.

Speaker #1: Please go ahead, your line is open.

Speaker #5: Good Good morning. Thanks for taking the questions. Maybe just on the NDA filing. So if I think about what is kind of left to be done between now and one Q, can you kind of, you know, walk us through the larger items?

Speaker #5: And then, you know, particularly, obviously on the CMC side, can you talk about your preparations as they continue progress on mock audits, et cetera?

Speaker #5: As it relates to preparing for that one Q filing?

Speaker #1: Sure. Hi, good morning, Chase. We are in the finalization stages of the CMC and the preclinical model. Those will be the first that we will submit.

Speaker #1: There are some data points that are still being collected, and obviously the preparation itself and the finalization of the document is taking time. But those documents have already been reviewed by our external FDA consultants as a first step.

Jonny Missulawin: G&A expenses were $3.7 million compared to $2.1 million for the same period of 2024. Marketing and business development expenses were $1 million compared to $0.5 million for the same period of 2024. The company had a net loss of $18.2 million or $1.48 per share, compared to a net loss of $12.7 million or $2.62 per share in the six-month period ended June 30, 2024. With that, we will now open the call to your questions. Operator?

Speaker #1: And we are now preparing first of all the CSR and all the package for pre-NDA meeting. Meaning that, and we would like to meet with the FDA before the end of this year for pre-NDA meeting.

Speaker #1: To get an agreement, while we are prior to submitting the NDA, and then early 2026, the first quarter to submit the NDA. In parallel to that, obviously, we are in preparation for the GMP PLI review, this is something that is ongoing.

Speaker #1: The facility has been reviewed a couple of times already, both by the Israeli Ministry of Health and the European QP. But still, there is always room to prepare further for an FDA review and get the facility ready for the commercialization stage.

Operator: Thank you. If you wish to ask a question, please press star one, one on your telephone, and wait for your name to be announced. To withdraw your question, please press star one, one again. We will take our first question. The first question comes from the line of Chase Nichabaka from Craigallen. Please go ahead. Your line is open.

Speaker #1: So if to summarize, we will be submitting in the next few weeks a pre-NDA meeting request which we expect that will occur later in the year.

Speaker #1: And early Q and early next year, Q1, we will submit the NDA.

Speaker #5: Got Got it. Maybe just one on, can you talk about kind of the path forward for the GLP-1 program as far as when we might see some data there?

Chase Nichabaka: Good morning. Thanks for taking the questions. Maybe just on the NDA filing. If I think about what is kind of left to be done between now and Q1, can you kind of walk us through the larger items? Then, particularly, obviously, on the CMC side, can you talk about your preparations as they continue progress on MACAT, etc., as it relates to preparing for that Q1 filing?

Speaker #5: And kind of, you know, early stage plans in that program. And then just second, last for me, if we think about the advance partnership, when should we expect some potential milestones from that kind of post-data?

Speaker #5: Is that mainly going to be regulatory or will there be anything that triggers from the data itself, from the phase three?

Speaker #1: Sure. So the GLP-1, which is a program that we are very excited both because of the broader consequences of having a peptide that is released injected in a form that supports an average of 60 or above 60 days of constant and linear release, but also has been seeing a field with some unmet need and patients that still do not benefit from the current medication and endurance being quite harsh on these medications.

Dikla Akselbrad: Sure. Hi. Good morning, Chase. We are in the finalization stages of the CMC and the preclinical module. Those will be the first that we will submit. There are some data points that are still being collected. Obviously, the preparation itself and the finalization of the document is taking time. Those documents have already been reviewed by our external FDA consultants as a first step. We are now preparing, first of all, the CSR and also package for a pre-NDA meeting. We would like to meet with the FDA before the end of this year for a pre-NDA meeting to get an agreement while we are prior to submitting the NDA. Then early 2026, the first quarter, we will submit the NDA. In parallel to that, obviously, we are in preparation for the GMP PLI review. This is something that is ongoing.

Speaker #1: So what we think is our main benefit is from both the prolonged, both the aspect that we can have a relatively longer than what is out there drug.

Speaker #1: And also the aspect of avoiding the burst that is characterizing current measurement of treatment. In terms of the timeline, we are now going into more robust preclinical studies where what we would like to show is both this in PK to support the release profile as we see in cells in PK studies in the bloodstream.

Speaker #1: This is also a very important for potential partners. And at this stage, we see this program as a blue tide started with the GLP-1, but this could be extended being pursued into the clinic with collaboration.

Dikla Akselbrad: The facility has been reviewed a couple of times already, both by the European Ministry of Health and European QP. Still, there is always room to prepare further for an FDA review and get the facility ready for the commercialization stage. To summarize, we will be submitting in the next few weeks a pre-NDA meeting request, which we expect will occur later in the year. Early next year, Q1, we will submit the NDA.

Speaker #1: It's one of the large players in this field.

Speaker #5: And then just on the advanced partnership.

Speaker #1: Yes, yes, thank you. Thank you, yes. Ori, you want to go first?

Speaker #3: I just wanted to add some housekeeping. We're getting some messages that the line is not great, so please tell us if we need to repeat any pieces here or anything that was said earlier.

Speaker #1: So So regarding the assigned partnership, we are in active and continue, the partnership is active and continuous both through the clinical stage as well as now in preparation from the MAA submission as part of the relationship advance will also be reviewing.

Chase Nichabaka: Got it. Maybe just one on, can you talk about the path forward for the GLP-1 program as far as when we might see some data there and early-stage plans in that program? Then just second and last for me, if we think about the Advanced Pharma partnership, when should we expect some potential milestones from that kind of post-data? Is that mainly going to be regulatory, or will there be anything that triggers from the data itself from the Phase III?

Speaker #1: The MAA submission and the question was, where should we expect milestones? So definitely there is a milestone that is expected and the more than three years has passed since we've signed with Advanced.

Speaker #1: Both Advanced and us think that there are some adjustments that need to be assessed and this is what we are doing now. I don't expect it to take too long.

Speaker #1: And once there is anything to announce around that, we will obviously announce that. As I said before, we are very pleased with the relationship.

Dikla Akselbrad: The GLP-1, obviously, is a program that we are very excited about because of the broader consequences of it, of having peptides that are released injected in a form that supports an average of 60 or above 60 days of constant and linear release. This is also being a field with so much unmet need and patients that still do not benefit from the current medication and endurance being quite harsh on these medications. What we think is our main benefit is from both the prolonged, both the aspect that we can have a relatively longer than what is out there drug, and also the aspect of avoiding the burst that is characterizing the current regimen of treatment.

Speaker #1: I think there is a trust that has been built during the years and appreciation. And Advanced are now starting to put more effort into the pre-launch activities.

Speaker #1: So both parties have an interest to finalize this as soon as possible.

Speaker #5: Thank you, Dikla.

Speaker #1: Thank you. Thank you. Thank you. We will take our next question. Please stand by. Please continue to stand by. Your conference will resume shortly.

Speaker #1: Your next question comes from the line of Roy Buchanan from Citizens. Please go ahead, your line is open.

Speaker #6: Okay, great. Thanks for the line. Sounds much better now. I got I'm not sure if she's on the call or not, but I had a couple for Dr. Gleiser Sachs.

Speaker #6: If so, is she here? Do you guys hear me?

Dikla Akselbrad: In terms of the timeline, we are now going into more robust preclinical studies where what we would like to show is both based in MPK to support the release profile that we see in cells in MPK studies in large stream. This is also very important for potential partners. At this stage, we see this program as we started with the GLP-1, so it is going to be extended being pursued into the clinic with collaboration with one of the large players in this field.

Speaker #1: Please repeat the question.

Speaker #6: Oh, the line's bad again. Yeah, I'll try to repeat it. So if Dr. Tweider Sachs is on, I was going to ask I guess the most compelling reason for joining the company is chief medical officer DPEX 100 or the broader PLEX platform, if you could just comment on that.

Speaker #6: And then what she's going to focus on, I guess most intently for the next 12 to 24 months.

Speaker #1: Sure. So first of all, I think this is really a nice addition to our management team, and it's nice because Dr. Rita Gleiser Sachs was on our board for almost two years.

Speaker #1: So she knows the team intimately. She knows the programs intimately. She knows the good and the bad and everything. And still, obviously she keeps her results.

Speaker #1: So other position, but she decided to join us and we're very pleased and I think she's going to be a great addition to the team.

Chase Nichabaka: On the Advanced Pharma partnership, Dikla?

Dikla Akselbrad: Yes, yes. Thank you, thank you. Ori, you went to bed? I just wanted to come up to you. We are getting some messages that the line is not great. Please tell us if you need to repeat any issues or anything that was said earlier. Regarding the Advanced Pharma partnership, we are in active and continuous. The partnership is active and continuous both through the clinical stage as well as now in preparation for the MAA submission. As part of the relationship, Advanced Pharma would also be reviewing the MAA submission. The question was, where should we expect milestones? Definitely, there is a milestone that is expected. As more than three years have passed since we signed with Advanced Pharma, both Advanced Pharma and us think that there are some adjustments that need to be assessed, and this is what we are doing now.

Speaker #1: With regards to how we view the CMO position and what is going to be a role going forward, specifically looking at the coming two years or so, we are now in the position that we start to do some pre-launch activities, some pre-commercialization activities as well as support all the regulatory efforts.

Speaker #1: We have great safety data that we want to have in front of as many surgeons as possible. The data will obviously like to be published in the best peer-reviewed journal.

Speaker #1: As part of the preparation, maintaining a robust clinical advisory board to support broadening the label as well as the pre-launch activities is essential. We have the pipeline, which is another point that we would like our assistant in directing our research team to always allow other doctors, and quite experienced as she is, to lead this program.

Speaker #6: Okay, great. Thank you. Thank you.

Speaker #7: You know, heading into the likely approval and launch next year, undoubtedly you’d like to bolster the balance sheet further. I guess do you just have a preferred way?

Dikla Akselbrad: I do not expect it to take too long. Once there is anything to announce around that, we will obviously announce. As I said before, we are very pleased with the relationship. I think there is a trust that has been built during the years and appreciation. Advanced Pharma is now starting to put more effort into the pre-launch activities. Of course, it is in the interest to finalize this as soon as possible.

Speaker #7: Maybe you've answered this with the advanced response, but do you have a preferred way to do that non-dilutive by partnering or something else? Can you just comment on that?

Speaker #1: Sure, sure, sure, sure. Please continue to stand by. Your conference will resume shortly.

Chase Nichabaka: Thank you, Dikla.

Dikla Akselbrad: Thank you.

Operator: Thank you. We will take our next question. Please stand by. Please continue to stand by. Your conference will resume shortly. Your next question comes from the line of Roy Buchanan from Citizens. Please go ahead. Your line is open.

Speaker #6: Consequences of this review.

Speaker #1: Please continue to stand by. Your conference will resume shortly.

Roy Buchanan: Okay, great. Thanks. My line sounds much better now. I guess I am not sure if she is on the call or not, but I had a couple for Dr. Nourit Tizer-Zakh. If so, is she here? Can you guys hear me?

Dikla Akselbrad: Please repeat the question.

Roy Buchanan: The line is bad again. I will try to repeat it. If Dr. Nourit Tizer-Zakh is on, I was going to ask the most compelling reason for joining the company as Chief Medical Officer, D-PLEX100 or the broader PLEX platform, if you could just comment on that. Then what she is going to focus on most intently for the next 12 to 24 months.

Speaker #7: Hi, can you hear us?

Speaker #1: Hello, this is yes, I am able to hear you now.

Speaker #7: Hello, can you hear us?

Speaker #1: This is the operator. You can be heard.

Dikla Akselbrad: First of all, I think this is a really nice addition for our management team. It is nice because Dr. Nourit Tizer-Zakh was on our board for almost two years. She knows the team intimately. She knows the programs intimately. She knows the good and the bad and everything. She came to a lot of other positions, but she decided to join us. We are very pleased. I think she is going to be a great addition to the team. With regards to how we view the Chief Medical Officer position and what is going to be her role going forward, specifically looking at the coming two years or so, we are now in the position that we start to do some pre-launch activities, some pre-commercialization activities, as well as support all the regulatory effort.

Speaker #7: Okay. Let's go back.

Speaker #6: I can hear you. We can hear you now.

Speaker #7: Okay, okay.

Speaker #1: Great. Sorry for that. I hope I heard just most of the question, but please feel free to ask it again if I missed any of the portions.

Speaker #1: So, with regard to the NDA submission and funding the NDA through the NDA submission, as we indicated in today's press release, we have sufficient funds to take the company well into 2026.

Speaker #1: And post-NDA submission, so we are very confident on that. And this is based on the cash we have on hand. It doesn't take into consideration any other upfront and milestone payment that we expect we'll get.

Speaker #1: What was the second portion of the question?

Speaker #6: Just if you had a preferred way for bolstering the balance sheet beyond that, you know, for the launch and all of those expensive things.

Speaker #1: So as we said for quite some times, we are also looking to collaborate around that. So portion of obviously of the effort will be financed and taken by our partner.

Dikla Akselbrad: We have great Phase III data that we want to have it all in front of as much urgent as possible. The data will obviously we would like to put it in the best peer-reviewed journal as part of the preparation. Maintaining a robust clinical advisory board to support broadening the label as well as the pre-launch activities. We have the pipeline, which is another point that we would like her assistance in directing our research team. We will always love another doctor and quite experienced as she is to lead this program.

Speaker #1: And in terms of other activities, again, we do rely on payments that we expect will be coming both from our existing partners as well as new partners.

Speaker #6: Okay, perfect. Thank you.

Speaker #1: Thank you. Thank you. We will take our next question. Your next question comes from line of London folks from HC Wainwright. Please go ahead, your line is open.

Speaker #1: Brandon Fox, your line is open. Please ask your question. We shall move to the next question. Please stand by. And the question comes from the line of Dublin Perche Yappen from Ross Capital.

Roy Buchanan: Okay, great. Thank you. I am going to change feedback. Heading into the likely approval and launch next year, undoubtedly, you would like to bolster the balance sheets further. I guess, do you just have a preferred way? Maybe you have answered this with the Advanced Pharma response, but do you have a preferred way to do that, non-dilutive by partnering or something else? Can you just comment on that?

Speaker #1: Please go ahead, your line is open.

Speaker #8: I think it looks like the line will be muted.

Speaker #1: Please stand by. Please continue to stand by. Brandon Fox from HC Wainwright, your line is open. Please ask your question. Unfortunately, we do seem to have some technical issues.

Operator: Please continue to stand by. Your conference will resume shortly. Please continue to stand by. Your conference will resume shortly.

Speaker #1: Please continue to stand by. If I could ask participants to please press star one, when on their telephones. If you wish to ask a question.

Speaker #1: Brandon Fox, your line is open. Please ask your question. Please continue to stand by. Your conference will resume shortly. Please continue to stand by.

Roy Buchanan: Can you hear us?

Operator: Hello. Yes, I am able to hear you now.

Roy Buchanan: Hello. Can you hear us?

Operator: This is the operator. You can be heard.

Roy Buchanan: Okay. Let's go back. I think we can hear you. We can hear you now.

Dikla Akselbrad: Okay. Great. Sorry for that. I hope I heard at least most of the question, but please feel free to ask it again if I missed any of the portions. With regards to the NDA submission and funding through the NDA submission, as we have indicated in today's press release, we have sufficient funds to take the company well into 2026 and post-NDA submission. We are very confident on that. This is based on the cash we have on hand. It does not take into consideration any other upfront and milestone payments that we expect we will get. What was the second portion of the question?

Roy Buchanan: Just if you had a preferred way for bolstering the balance sheet beyond that, you know, for the launch and all of those expensive things.

Dikla Akselbrad: As we said for quite some time, we are also looking to collaborate around that. A portion of, obviously, the effort will be financed and taken by our partner. In terms of other activities, again, we do rely on payments that we expect will be coming both from our existing partners as well as new partners.

Roy Buchanan: Okay. Perfect. Thank you.

Dikla Akselbrad: Thank you.

Operator: Thank you. We will take our next question. Your next question comes from the line of Brandon Fox from HC Wainwright. Please go ahead. Your line is open. Brandon Fox, your line is open. Please ask your question. We shall move to the next question. Please stand by. The question comes from the line of Dublin Pache Yapen from Ross Capital. Please go ahead. Your line is open.

Roy Buchanan: I think it looks like it's under the PolyPid.

Operator: Please stand by. Please continue to stand by. Brandon Fox from HC Wainwright, your line is open. Please ask your question. Unfortunately, we do seem to have some technical issues. Please continue to stand by. If I could ask participants to please press star one, one on their telephones if you wish to ask a question. Brandon Fox, your line is open. Please ask your question. Please continue to stand by. Your conference will resume shortly. Please continue to stand by. Your conference will resume shortly. Please continue to stand by. Your conference will resume shortly. Apologies. We do seem to be having technical issues. If I could hand back for closing remarks.

Dikla Akselbrad: Truly apologizing for that. Thank you for joining PolyPid's second quarter 2025 earnings conference call. The second quarter of 2025 was a pivotal period for PolyPid. The positive Shield II Phase III result represents a significant milestone in our journey to bring D-PLEX100 to market. We are now focused on preparing our regulatory submissions, advancing our commercial preparations, and exploring partnership opportunities to maximize the value of D-PLEX100. We are also excited about the progress we have made in extending our pipeline with the GLP-1 program, which leverages our extensive long-term experience to address significant unmet needs in the treatment of metabolic disease. As always, we are grateful to our team members, shareholders, and all external partners for their commitment to our mission. We look forward to speaking with you again on our next conference call.

Dikla Akselbrad: If anyone wants to further ask questions that were not asked on the call, please reach out to us.

Operator: This concludes today's conference call. Thank you for participating. You may now disconnect. Speakers, please stand by.