Q4 2025 PolyPid Ltd Earnings Call

February 11, 2026

Speaker #1: Greetings and welcome to poly s fourth quarter and full year 2025 conference call . At this time , participants are in a listen only mode .

Speaker #1: As a reminder , this call is recorded and I would now like to introduce your host for today's conference , Yehuda Leibler from ARX Investor Mr. Relations .

Yehuda Leibler: Thank you, operator, and thank you all for joining PolyPid's Fourth Quarter and Full Year 2025 Earnings Conference Call. Joining me on the call today will be Dikla Akselbrad, Dikla 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 and 12 months ending 31 December 2025. A copy of the press release is available in the investors section on the company's website at www.polypid.com.

Speaker #1: Liebler, you may begin.

Speaker #2: Thank you . Operator and thank you all for joining PolyPid Ltd. fourth quarter and full year 2025 earnings conference call . Joining call me on the today will be Dikla Akselbrad Chief Executive officer of PolyPid Ltd. .

Speaker #2: Jonny Missulawin Chief Financial Officer and Ori Warshavsky chief Operating officer , US of PolyPid Ltd. . Earlier today , Polypid released its financial results for the three and 12 months ending December 31st , 2025 .

Speaker #2: A copy of the press release is in the section on the company's website at . I'd like to remind this call , management will make forward looking statements within the meaning of the federal securities law .

Yehuda Leibler: 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 the company's regulatory strategy and the anticipated timing and structure of the planned new drug application or NDA submission for D-PLEX 100, including the rolling submission, the potential regulatory and commercial pathways for D-PLEX 100, the company's ongoing partnership discussions, commercialization readiness, transition from a primarily R&D and clinically focused organization into one that is preparing for commercialization, the potential for 2026 to be a transformative year for the company, benefits and advantages of D-PLEX 100, that Kynatrix represents a broader long-term opportunity for PolyPid, and the expectation that current cash resources will be sufficient to fund operations into the second half of 2026.

Speaker #2: For example , management is making forward looking statements when it discusses the company's regulatory strategy and the anticipated timing and structure of the planned new drug Application , or NDA submission for including the Deepccs 100 , rolling submission , the potential regulatory and commercial pathways for DF 100 , the company's ongoing partnership discussions , commercialization readiness , transition from a primarily R&D and clinically focused organization into one that is preparing for commercialization .

Speaker #2: The potential for 2026 to be a transformative year for the company . Benefits and advantages of D plus 100 that cannot represents a broader long term opportunity for Polypid and the expectation that current cash resources will be sufficient to fund operations into the second half of 2026 .

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 SEC filings. The company's results may differ materially from those projections. These statements involve material risks and uncertainties that could cause actual results or events to materially differ. Accordingly, you should not place undue reliance on these statements. I encourage you to review the company's filings with the SEC, including, without limitation, the company's annual report on Form 20-F filed on 26 February 2025, which identifies specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements. PolyPid disclaims any intention or obligation, except as required by law, to update or revise any financial projection or forward-looking statements, whether because of new information, future events, or otherwise.

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 the company's SEC filings .

Speaker #2: The company's results may differ materially from those projections . These statements involve risks and uncertainties that could cause actual results or events to materially differ .

Speaker #2: Accordingly , you should not place undue reliance on these statements . I encourage you to review the company's filings with the SEC , including , without limitation , the company's report on annual 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 .

Speaker #2: PolyPid Ltd. has no 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.

Yehuda Leibler: This conference call contains time-sensitive information and speaks only as of the live broadcast today, 11 February 2026. With the completion of those prepared remarks, 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. 2025 was a pivotal year for PolyPid. Over the course of the year, we successfully completed the SHIELD II phase III trial and announced positive results, with D-PLEX 100 meeting its primary endpoint in all key secondary endpoints and demonstrating a meaningful reduction in surgical site infections. Building on that momentum, we advanced D-PLEX 100 into the final stages of regulatory preparation, marking an important transition point for the company. In parallel, we continue to advance our broader platform efforts, including our long-acting GLP-1 receptor agonist program.

Speaker #2: This conference call contains time sensitive information and speaks only as of the live broadcast today , February 11th , 2026 , with the completion of those prepared remarks , it is my pleasure to turn the call over to The CEO of PolyPid Ltd. .

Dikla Akselbrad: Thank you, Yehuda, and thank you all for joining us today. 2025 was a pivotal year for PolyPid. Over the course of the year, we successfully completed the SHIELD II phase III trial and announced positive results, with D-PLEX 100 meeting its primary endpoint in all key secondary endpoints and demonstrating a meaningful reduction in surgical site infections. Building on that momentum, we advanced D-PLEX 100 into the final stages of regulatory preparation, marking an important transition point for the company. In parallel, we continue to advance our broader platform efforts, including our long-acting GLP-1 receptor agonist program.

Speaker #2: Dikla .

Speaker #3: Thank you . Judah , and thank you all for joining us today . 2025 was a pivotal year for Polypid . Over the course of the year , we successfully completed the shield two , phase three trial and announced positive results with duplex 100 meeting its endpoint primary in all key secondary endpoints and demonstrating a meaningful reduction in surgical site infections .

Speaker #3: Building on that momentum , we advanced duplex 100 into the final stages of regulatory preparation , marking an important transition point for the company .

Speaker #3: In parallel , we continue to advance our broader platform efforts , including our long acting GLP one receptor agonist program , as we continue executing against our strategy .

Yehuda Leibler: As we continue executing against our strategy, our progress is focused on two priorities: advancing the regulatory pathway for D-PLEX 100 and advancing our commercial US partnership discussions. Starting with regulatory progress, we recently received positive written feedback from the FDA following the pre-NDA meeting communication. Importantly, the agencies supported our plan to pursue a rolling NDA review for D-PLEX 100. We expect to begin the rolling NDA submission by the end of Q1 2026. The FDA also agreed that the company's existing clinical data package, including results from the Phase III SHIELD II trial, appears adequate to support NDA submission and review. This feedback provides meaningful clarity on the structure and expectations for our submission and further validates the regulatory pathway we have been preparing for. In parallel with our regulatory efforts, we've made significant progress on the commercial front.

Dikla Akselbrad: As we continue executing against our strategy, our progress is focused on two priorities: advancing the regulatory pathway for D-PLEX 100 and advancing our commercial US partnership discussions. Starting with regulatory progress, we recently received positive written feedback from the FDA following the pre-NDA meeting communication. Importantly, the agencies supported our plan to pursue a rolling NDA review for D-PLEX 100. We expect to begin the rolling NDA submission by the end of Q1 2026. The FDA also agreed that the company's existing clinical data package, including results from the Phase III SHIELD II trial, appears adequate to support NDA submission and review. This feedback provides meaningful clarity on the structure and expectations for our submission and further validates the regulatory pathway we have been preparing for. In parallel with our regulatory efforts, we've made significant progress on the commercial front.

Speaker #3: Our progress is focused on two priorities advancing the regulatory pathway for Deflux 100 and advancing our commercial US partnership . Discussion , starting with regulatory progress .

Speaker #3: We recently received positive recent feedback from the FDA following the Pre-nda meeting . Communication . Importantly , the agency supported our plan to rolling review pursue a for duplex 100 .

Speaker #3: We expect to begin the rolling NDA submission by the end of the first quarter of 2026. The FDA also agreed that the company's existing clinical data package, including results from the Phase 3 SHIELD II trial, appears adequate to support NDA submission and review.

Speaker #3: This feedback provides meaningful clarity on the structure and expectations for our submission and further validates the regulatory pathway we have been preparing for .

Yehuda Leibler: Following our positive Phase III result and the advancement of our regulatory strategy, we have moved into advanced stages of partnership discussions in the United States. These discussions reflect growing recognition of D-PLEX 100's strong clinical profile, its differentiated value proposition, and the significant unmet need it addresses. I'm glad to share that we are very pleased with the progress we made throughout the quarter in our US partnership discussions. These conversations have continued to move forward to advanced stages, which Ori will expand on later in the call. During the quarter, we also participated in a virtual Key Opinion Leader webinar featuring Dr. Steven D. Wexner, a globally recognized leader in colorectal surgery. The discussion focused on the real-life clinical and economic burden of surgical site infections and why prevention remains a major unmet need in abdominal colorectal procedures.

Dikla Akselbrad: Following our positive Phase III result and the advancement of our regulatory strategy, we have moved into advanced stages of partnership discussions in the United States. These discussions reflect growing recognition of D-PLEX 100's strong clinical profile, its differentiated value proposition, and the significant unmet need it addresses. I'm glad to share that we are very pleased with the progress we made throughout the quarter in our US partnership discussions. These conversations have continued to move forward to advanced stages, which Ori will expand on later in the call. During the quarter, we also participated in a virtual Key Opinion Leader webinar featuring Dr. Steven D. Wexner, a globally recognized leader in colorectal surgery. The discussion focused on the real-life clinical and economic burden of surgical site infections and why prevention remains a major unmet need in abdominal colorectal procedures.

Speaker #3: In parallel with our regulatory efforts , we made significant progress on the commercial front following our positive phase three result and the advancement of our regulatory strategy .

Speaker #3: We have moved into advanced stages of partnership discussions in the United States . This discussions reflect growing recognition of duplex 100 strong clinical profile .

Speaker #3: Its differentiated value proposition and the significant unmet need it addresses . I'm glad to share that we are very pleased with the progress we made throughout the quarter .

Speaker #3: In our US partnership discussions, these conversations have continued to move forward to advanced stages, which Ori will expand on later in the call.

Speaker #3: During the quarter , we also participated in a virtual key opinion Leader webinar featuring Doctor Stephen D Wexner , a globally recognized leader in colorectal surgery .

Speaker #3: The discussion focused on the real life clinical and economic burden of surgical site infections and why prevention remains a major unmet need in abdominal , colorectal procedures .

Yehuda Leibler: Importantly, the conversation reinforced what we believe is the core opportunity of D-PLEX 100: a differentiated, long-acting, localized approach that can significantly reduce infection while fitting naturally into the surgical workflow. As Dr. Wexner noted, this is truly new. This is a paradigm shift for us. We view this type of external clinical engagement as an important part of building awareness and readiness as we prepare the market for approval and launch. A link to the recording of the webinar is on our website under the investors section. I invite all of you to listen to Dr. Wexner's insights. Looking ahead, we believe 2026 has the potential to be a transformative year for PolyPid. With the rolling NDA submission expected to begin by the end of this quarter, partnership discussions continue to advance, and an organization increasingly oriented toward commercial execution, we are entering a new chapter for the company.

Dikla Akselbrad: Importantly, the conversation reinforced what we believe is the core opportunity of D-PLEX 100: a differentiated, long-acting, localized approach that can significantly reduce infection while fitting naturally into the surgical workflow. As Dr. Wexner noted, this is truly new. This is a paradigm shift for us. We view this type of external clinical engagement as an important part of building awareness and readiness as we prepare the market for approval and launch. A link to the recording of the webinar is on our website under the investors section. I invite all of you to listen to Dr. Wexner's insights. Looking ahead, we believe 2026 has the potential to be a transformative year for PolyPid. With the rolling NDA submission expected to begin by the end of this quarter, partnership discussions continue to advance, and an organization increasingly oriented toward commercial execution, we are entering a new chapter for the company.

Speaker #3: Importantly , the conversation reinforced what we believe is the core of opportunity of duplex 100 , a differentiated , long acting , localized approach that can significantly reduce infection while fitting naturally into the surgical workflow .

Speaker #3: As Dr. Wexner noted, this is truly new. This is a paradigm shift for us. We view this type of external clinical engagement as an important part of building awareness and readiness.

Speaker #3: As we prepare the market for approval and launch, a link to the recording of the webinar is on our website under the Investor section.

Speaker #3: I invite all of you to listen to Doctor Wexner Insights . Looking ahead , we believe 2026 has the potential to be a transformative years for PolyPid Ltd. with a rolling NDA submission expected to begin by the end of this quarter .

Speaker #3: Partnership discussions continue to advance , and an organization increasingly oriented toward commercial execution . We are entering a new chapter for the company .

Yehuda Leibler: I also want to highlight an important corporate update. In December 2025, we appointed Ms. Brooke Story as chairman of our board of directors. Brooke brings extensive leadership experience in medical technology and surgical solutions, including a senior executive role at Becton, Dickinson and Medtronic. As we transition toward commercialization and engage with large strategic partners, we believe her background and perspective will be highly valuable in helping guide PolyPid throughout this next chapter. We look forward to providing updates as these developments continue to unfold. With that, I will now turn the call over to Ori Warshavsky, our Chief Operating Officer, US, who will discuss how we are approaching commercialization readiness and partner engagement, our refreshed corporate brand, and the introduction of our Kynatrix technology. Ori? Thank you, Dikla.

Dikla Akselbrad: I also want to highlight an important corporate update. In December 2025, we appointed Ms. Brooke Story as chairman of our board of directors. Brooke brings extensive leadership experience in medical technology and surgical solutions, including a senior executive role at Becton, Dickinson and Medtronic. As we transition toward commercialization and engage with large strategic partners, we believe her background and perspective will be highly valuable in helping guide PolyPid throughout this next chapter. We look forward to providing updates as these developments continue to unfold. With that, I will now turn the call over to Ori Warshavsky, our Chief Operating Officer, US, who will discuss how we are approaching commercialization readiness and partner engagement, our refreshed corporate brand, and the introduction of our Kynatrix technology. Ori?

Speaker #3: I also want to highlight an important corporate update in December 2025 . We appointed Miss Brooks story as chairman of our Board of Directors .

Speaker #3: Brooke brings extensive leadership experience in medical technology and surgical solutions , including senior executive role at Becton , Dickinson and Medtronic . As we transition toward commercialization and engage with large strategic partners , we believe her background and perspective will be highly valuable in helping guide PolyPid Ltd. throughout this next chapter .

Speaker #3: We look forward to providing updates as these developments continue to unfold . With that , I will now turn the call over to Ori Warshavsky , our chief Operating .

Speaker #3: Officer Us who will discuss how we are approaching commercialization readiness and partner engagement . Our refreshed corporate brand and the introduction of our kinetics technology .

Ori Warshavsky: Thank you, Dikla.

Yehuda Leibler: As Dikla mentioned, we've continued to advance discussions during the quarter with potential US commercial partners that have demonstrated experience in hospital-based commercialization and a strong presence within the surgical ecosystem. As these discussions have progressed, they have become increasingly detailed and operational in nature, reflecting both the maturity of the opportunity following our phase III result and the progress we have made on the regulatory front. Turning now to our refreshed corporate brand. As you might have noticed in this morning's press release, PolyPid has a new brand look, which aims to reflect that PolyPid as a company looks different today than it did even a year ago. This rebrand comes at a very intentional moment in the company's lifecycle as we transition from a primarily R&D and clinically focused organization into one that is preparing for commercialization and engaging more broadly with external stakeholders. Our audience is expanding.

Ori Warshavsky: As Dikla mentioned, we've continued to advance discussions during the quarter with potential US commercial partners that have demonstrated experience in hospital-based commercialization and a strong presence within the surgical ecosystem. As these discussions have progressed, they have become increasingly detailed and operational in nature, reflecting both the maturity of the opportunity following our phase III result and the progress we have made on the regulatory front. Turning now to our refreshed corporate brand. As you might have noticed in this morning's press release, PolyPid has a new brand look, which aims to reflect that PolyPid as a company looks different today than it did even a year ago. This rebrand comes at a very intentional moment in the company's lifecycle as we transition from a primarily R&D and clinically focused organization into one that is preparing for commercialization and engaging more broadly with external stakeholders. Our audience is expanding.

Speaker #3: Ori .

Speaker #4: Thank you . Nicola . As mentioned , we continued to advance discussions during the quarter with potential US commercial partners that have demonstrated experience in hospital based commercialization and a strong presence within the surgical ecosystem .

Speaker #4: As these discussions have progressed, they have become increasingly detailed and operational in nature, reflecting both the maturity of the opportunity following our Phase 3 results and the progress we have made on the regulatory front.

Speaker #4: Turning now to our refreshed corporate brand . As you might have noticed in this morning's press release , PolyPid Ltd. has a new brand look which aims to reflect the company .

Speaker #4: look different As a today than it did even a year ago . This rebrand comes at a very intentional moment in the company's lifecycle , as we transition from a primarily R&D and clinically focused organization into one that is preparing for commercialization and engaging more broadly with external stakeholders .

Yehuda Leibler: In addition to clinicians and investigators, we are increasingly engaging with surgeons, pharmacists, hospital administrators, value committee members, and potential commercial partners. The refreshed brand is designed to support these more external-facing conversations and to clearly communicate who we are as a company at this stage. Importantly, the new visual language is meant to convey precision, intention, reliability, and control, core attributes of how our technology is engineered to perform. It reflects a more confident, mature, and credible organization as we move closer to potential commercialization. I encourage investors and partners to visit our new website and review our updated corporate material, which reflects this evolution and our long-term vision. Closely related to this evolution is an important update on our technology. Over the past several years, we have significantly expanded our technological capabilities beyond what the original PLEX platform was designed to do.

Ori Warshavsky: In addition to clinicians and investigators, we are increasingly engaging with surgeons, pharmacists, hospital administrators, value committee members, and potential commercial partners. The refreshed brand is designed to support these more external-facing conversations and to clearly communicate who we are as a company at this stage. Importantly, the new visual language is meant to convey precision, intention, reliability, and control, core attributes of how our technology is engineered to perform. It reflects a more confident, mature, and credible organization as we move closer to potential commercialization. I encourage investors and partners to visit our new website and review our updated corporate material, which reflects this evolution and our long-term vision. Closely related to this evolution is an important update on our technology. Over the past several years, we have significantly expanded our technological capabilities beyond what the original PLEX platform was designed to do.

Speaker #4: Our audience is expanding . In addition to clinician and investigators . We are increasingly engaging with surgeons , pharmacists , hospital administrators , value committee members and potential commercial partners .

Speaker #4: The refreshed brand is designed to support this more external facing conversations and to clearly communicate who we are as a company stage at this .

Speaker #4: Importantly , the new visual language is meant to convey precision , intention , reliability and control for attributes of how our technology is engineered to perform .

Speaker #4: more It reflects a confident , mature and credible organization as we move closer to potential commercialization . I encourage investors and partners to visit our new website and review our updated corporate material , which reflects this evolution in our long term vision .

Speaker #4: related to Closely this , evolution is an important update on our technology . Over the past several years , we have significantly expanded our technological capabilities beyond what the original flex platform was designed to do .

Yehuda Leibler: As a result, we are formally introducing Kynatrix as the name of our next-generation technology. Kynatrix brings together the broader set of controlled release and delivery capabilities, along with the growing intellectual property portfolio we have developed over time. While PLEX remains foundational, our technology is no longer limited to local-to-local delivery of small molecules such as antibiotics. One clear example of these expanded capabilities is our move into metabolic DT, starting with our ultra-long-acting GLP-1 receptor agonist program. This program serves as the first test case for extending our technology beyond localized delivery towards addressing systemic therapeutic needs, and we continue to evaluate additional modalities where these capabilities may be applied. While Kynatrix represents a broad long-term opportunity for PolyPid, it is important to emphasize that D-PLEX 100 remains firmly at the center of our near-term execution and commercial focus.

Ori Warshavsky: As a result, we are formally introducing Kynatrix as the name of our next-generation technology. Kynatrix brings together the broader set of controlled release and delivery capabilities, along with the growing intellectual property portfolio we have developed over time. While PLEX remains foundational, our technology is no longer limited to local-to-local delivery of small molecules such as antibiotics. One clear example of these expanded capabilities is our move into metabolic DT, starting with our ultra-long-acting GLP-1 receptor agonist program. This program serves as the first test case for extending our technology beyond localized delivery towards addressing systemic therapeutic needs, and we continue to evaluate additional modalities where these capabilities may be applied. While Kynatrix represents a broad long-term opportunity for PolyPid, it is important to emphasize that D-PLEX 100 remains firmly at the center of our near-term execution and commercial focus.

Speaker #4: As a result, we are formally introducing Kinetics as the name of our next generation technology. Kinetics brings together the broader set of control, release, and delivery capabilities, along with the growing intellectual property portfolio.

Speaker #4: We have developed over time . While Plex remains foundational , R technology is no longer limited to local to local delivery of small molecules such as antibiotics .

Speaker #4: One clear example of these expanded capabilities is our move into metabolic disease . Starting with our ultra long acting GLP one receptor agonist program , this program serves as the first test case for extending our technology beyond localized delivery towards addressing systemic therapeutic needs .

Speaker #4: And we continue to evaluate additional modalities where these capabilities may be applied . While kinetics represents a broad long term opportunity for PolyPid Ltd. , it is important to emphasize that Deflux 100 remains firmly at the center of our near-term execution , and commercial focus .

Yehuda Leibler: Taken together, our continued progress in partnership discussions, our brand evaluation, the formal introduction of the Kynatrix technology, and growing engagement with clinical leaders all reflect a company that is actively preparing for its next phase of growth. With that, I'll now turn the call over to Jonny to review our financial performance for the quarter and the full year. Jonny? Thank you, Ori. I'll now walk through our financial results for the fourth quarter and full year ended 31 December 2025. Starting with the fourth quarter, research and development expenses were $6.2 million compared to $7 million in the same period last year. This decrease primarily reflects the completion of the SHIELD II phase III trial and our transition toward regulatory submission and preparation activities. General and administrative expenses for the quarter were $1.8 million compared to $1 million in the fourth quarter of 2024.

Ori Warshavsky: Taken together, our continued progress in partnership discussions, our brand evaluation, the formal introduction of the Kynatrix technology, and growing engagement with clinical leaders all reflect a company that is actively preparing for its next phase of growth. With that, I'll now turn the call over to Jonny to review our financial performance for the quarter and the full year. Jonny?

Speaker #4: Taken together , our continued progress in partnership discussions , our brand evaluation , and the formal introduction of the kinetics , technology engagement and growing clinical all leaders with reflect the company that is actively preparing for its next phase of growth .

Jonny Missulawin: Thank you, Ori. I'll now walk through our financial results for the fourth quarter and full year ended 31 December 2025. Starting with the fourth quarter, research and development expenses were $6.2 million compared to $7 million in the same period last year. This decrease primarily reflects the completion of the SHIELD II phase III trial and our transition toward regulatory submission and preparation activities. General and administrative expenses for the quarter were $1.8 million compared to $1 million in the fourth quarter of 2024.

Speaker #4: With that, I'll now turn the call over to Johny to review our financial performance for the quarter and the full year.

Speaker #4: Johnny . Thank you .

Speaker #5: I'll now walk through our financial results for the fourth quarter and full year ended December 31st , 2025 . Starting with the fourth quarter .

Speaker #5: Research and development expenses were $6.2 million , compared to $7 million in the same period last year . This decrease primarily reflects the completion of the phase three trial , and our transition regulatory submission and preparation activities .

Speaker #5: General and administrative expenses for the quarter were $1.8 million , compared to $1 million fourth quarter of 2020 . For marketing and business development , expenses were $0.6 million for the quarter , compared to $0.2 million in the prior year period .

Yehuda Leibler: Marketing and business development expenses were $0.6 million for the quarter compared to $0.2 million in the prior year period. Net loss for the fourth quarter was $8.5 million or $0.41 per share compared to a net loss of $8.5 million or $1.13 per share in the fourth quarter of 2024. Turning to the full year results, research and development expenses for 2025 totaled $23.8 million compared to $22.8 million in 2024. The increase was primarily driven by continued activities related to the completion of the SHIELD II Phase III trial, as well as regulatory preparation, efforts, and advancement of our development programs. General and administrative expenses for the full year were $7.2 million compared to $4.3 million in 2024. This increase was primarily due to non-cash expenses relating to the vesting of performance-based options following the successful completion of the SHIELD II Phase III trial.

Jonny Missulawin: Marketing and business development expenses were $0.6 million for the quarter compared to $0.2 million in the prior year period. Net loss for the fourth quarter was $8.5 million or $0.41 per share compared to a net loss of $8.5 million or $1.13 per share in the fourth quarter of 2024. Turning to the full year results, research and development expenses for 2025 totaled $23.8 million compared to $22.8 million in 2024. The increase was primarily driven by continued activities related to the completion of the SHIELD II Phase III trial, as well as regulatory preparation, efforts, and advancement of our development programs. General and administrative expenses for the full year were $7.2 million compared to $4.3 million in 2024. This increase was primarily due to non-cash expenses relating to the vesting of performance-based options following the successful completion of the SHIELD II Phase III trial.

Speaker #5: Net loss for the fourth quarter was $8.5 million , or $0.41 per share , compared to a loss net of $8.5 million , or $1 .

Speaker #5: $0.13 per share , in the fourth quarter of 2020 . For . Turning to the full year results . Research and development expenses for 2025 totaled $23.8 million , compared to $22.8 million in 2020 .

Speaker #5: For the increase was primarily driven by continued activities related to the completion of the shield two phase as three trial , well as regulatory preparation advancement of our development programs .

Speaker #5: General and administrative the expenses for full year were $7.2 million , compared to $4.3 million in 2020 . For . This increase was primarily due to non-cash expenses relating to the vesting of performance based options .

Yehuda Leibler: Marketing and business development expenses for the year were $2 million compared to $0.9 million in 2024, reflecting increased business development and commercial preparation efforts as we move closer to potential commercialization. Net loss for the full year ended 31 December 2025 was $34.2 million or $2.09 per share compared to a net loss of $29 million or $4.91 per share in 2024. From a balance sheet perspective, as of 31 December 2025, PolyPid had $12.9 million in cash, cash equivalents, and short-term deposits. Subsequent to the end of the quarter, several long-time shareholders exercised warrants ahead of their expiration at prices ranging between $3.61 and $4.50 per share, generating $3.7 million in additional gross proceeds, further strengthening our balance sheet.

Jonny Missulawin: Marketing and business development expenses for the year were $2 million compared to $0.9 million in 2024, reflecting increased business development and commercial preparation efforts as we move closer to potential commercialization. Net loss for the full year ended 31 December 2025 was $34.2 million or $2.09 per share compared to a net loss of $29 million or $4.91 per share in 2024. From a balance sheet perspective, as of 31 December 2025, PolyPid had $12.9 million in cash, cash equivalents, and short-term deposits. Subsequent to the end of the quarter, several long-time shareholders exercised warrants ahead of their expiration at prices ranging between $3.61 and $4.50 per share, generating $3.7 million in additional gross proceeds, further strengthening our balance sheet.

Speaker #5: Following the successful completion of the shield two phase three trial . Marketing and business development expenses for the year were $2 million , compared to $0.9 million in 2020 for reflecting increased business development and commercial preparation efforts .

Speaker #5: we move As closer to potential commercialization . Net loss for the full year ended December 31st , 2025 was $34.2 million , or $2.09 per share , compared to a net loss of $29 million , or $4.91 per share , in 2020 .

Speaker #5: For from a balance sheet perspective , as of December 31st , 2025 , PolyPid Ltd. $12.9 million in cash , cash equivalents , and short term deposits .

Speaker #5: Subsequent to the end of the quarter , several long time shareholders exercised warrants ahead of their expiration at prices ranging between $3.61 and four and a half dollars per share , generating $3.7 million in additional gross proceeds .

Yehuda Leibler: Based on our current plans and assumptions, we believe that our existing cash resources will be sufficient to fund operations into the second half of 2026 and through several significant upcoming milestones. With that, we will now open the call for questions. Operator? Thank you. As a reminder, to ask a question, you will need to press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. We will take our first question. And the question comes from the line of Chase Knickerbocker from Craig-Hallum Capital Group. Please go ahead. Your line is open. Good morning. Thanks for taking the questions. Maybe just a couple around the pre-NDA minutes that you received in December.

Jonny Missulawin: Based on our current plans and assumptions, we believe that our existing cash resources will be sufficient to fund operations into the second half of 2026 and through several significant upcoming milestones. With that, we will now open the call for questions. Operator?

Speaker #5: Further strengthening our balance sheet . Based on our current plans and assumptions , we believe that our existing cash resources will be sufficient to fund operations into the second half of 2026 and through several significant upcoming milestones .

Operator: Thank you. As a reminder, to ask a question, you will need to press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. We will take our first question. And the question comes from the line of Chase Knickerbocker from Craig-Hallum Capital Group. Please go ahead. Your line is open.

Speaker #5: With that, we will now open the call for questions. Operator.

Speaker #1: Thank you . As a to ask reminder a question , you will need to press star one one on your telephone and wait for your name to be announced .

Speaker #1: To withdraw your question , please press star one . One again . We will take our first question , and the question comes from the line of Chase Knickerbocker from Craig-hallum .

Chase Knickerbocker: Good morning. Thanks for taking the questions. Maybe just a couple around the pre-NDA minutes that you received in December.

Speaker #1: Please go ahead . Your line is open .

Speaker #6: morning . Good Thanks for taking the questions . Maybe just a couple on around the pre NDA minutes that you received in December .

Yehuda Leibler: Dikla, would you be willing to share kind of how those discussions around the scope of the label sort of progressed, and just kind of generally what your current expectations are as you kind of look to your proposed label as far as what we're thinking around kind of colorectal kind of specific versus a broader kind of abdominal label? And then kind of the same question around what kind of investor expectations should be potentially for some sort of risk factor or size of incision that could be on a proposed label. Thanks. Thank you. Thank you. And good morning, Chase. With regards to label, based on our discussion with the FDA, we are targeting an initial label for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery.

Chase Knickerbocker: Dikla, would you be willing to share kind of how those discussions around the scope of the label sort of progressed, and just kind of generally what your current expectations are as you kind of look to your proposed label as far as what we're thinking around kind of colorectal kind of specific versus a broader kind of abdominal label? And then kind of the same question around what kind of investor expectations should be potentially for some sort of risk factor or size of incision that could be on a proposed label. Thanks.

Speaker #6: Would you be willing to share kind of how those discussions are on the scope of the label . Sort of progressed . And just kind of generally what are your current expectations are as you kind of look to your proposed label as far as , you know , what we're thinking around , kind of colorectal , kind of specific versus a broader kind of abdominal label .

Speaker #6: And then kind of the question around same what kind of investor expectations should be potentially for , you know , some sort of risk factor or size of incision that could be on a proposed label ?

Dikla Akselbrad: Thank you. Thank you. And good morning, Chase. With regards to label, based on our discussion with the FDA, we are targeting an initial label for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery.

Speaker #6: Thanks .

Speaker #3: Thank you . Thank you , and good morning . Chase . With regards to to label based on our discussion with the FDA , we are targeting an initial label for the prevention of surgical site infections in prevention in patients undergoing abdominal colorectal surgery .

Yehuda Leibler: This indication is directly supported by the SHIELD II phase III data and is also our breakthrough therapy designation. We also expect that there may be an opportunity to evaluate potential label expansion into broader abdominal surgical application as we go through the review process in parallel. The main rationale around it is colorectal is the worst SSI prevalence in abdominal surgery. Obviously, there are other, but that's just as a high level. That's our baseline assumption. This is how we build all of our planning and models. We do not expect on that regard anything that will narrow this. We think that this is a very conservative assumption, and this is why this is our baseline assumption. As you referred to, we also met the FDA towards the end of last year as part of an NDA process.

Dikla Akselbrad: This indication is directly supported by the SHIELD II phase III data and is also our breakthrough therapy designation. We also expect that there may be an opportunity to evaluate potential label expansion into broader abdominal surgical application as we go through the review process in parallel. The main rationale around it is colorectal is the worst SSI prevalence in abdominal surgery. Obviously, there are other, but that's just as a high level. That's our baseline assumption. This is how we build all of our planning and models. We do not expect on that regard anything that will narrow this. We think that this is a very conservative assumption, and this is why this is our baseline assumption. As you referred to, we also met the FDA towards the end of last year as part of an NDA process.

Speaker #3: This is the indication is directly supported by the shield two phase three data and is also our breakthrough therapy designation . We also expect there expect that there may be an opportunity to evaluate potential label expansion into broader abdominal surgical application .

Speaker #3: As we pursue , as through we go the review process in a parallel and the main rationale around it is as colorectal is the worst SSI prevalence in abdominal surgery and obviously there are other , but that's just as a high level .

Speaker #3: So that's that's our baseline assumption . This is how we build all of our of our planning and models . We do not expect on that regards any .

Speaker #3: Anything that will narrow this . We think that this is very conservative assumption . And this is why this is our our baseline assumption .

Speaker #3: And as you refer to , we also met the FDA towards the end of last year as part of an process . had Actually an pre-ind communication with the FDA where the purpose of this communication was really to align the requirement around the NDA submission .

Yehuda Leibler: Actually, we had a pre-IND communication with the FDA where the purpose of this communication was really to align the requirement around the NDA submission, both in terms of timeline as well as in terms of having the FDA agree that the phase III data is adequate for NDA submission, both in terms of efficacy and safety. Got it. Maybe just align those lines. This may be somewhat dependent on kind of partnership discussions as well, but any kind of formal thoughts on kind of plans as far as what may be required for a broader label and/or kind of further expansion opportunities for D-PLEX 100 specifically? Maybe a little bit too early for that question, but any additional thoughts? Yeah. Yeah. I think what I can say is that we have, as part of our planning timeframe, that we plan to meet with the FDA to discuss this. Got it.

Dikla Akselbrad: Actually, we had a pre-IND communication with the FDA where the purpose of this communication was really to align the requirement around the NDA submission, both in terms of timeline as well as in terms of having the FDA agree that the phase III data is adequate for NDA submission, both in terms of efficacy and safety.

Speaker #3: Both in terms of timeline as well as in terms of having the FDA agree that the phase three data is adequate for NDA submission , both in terms of efficacy and safety .

Chase Knickerbocker: Got it. Maybe just align those lines. This may be somewhat dependent on kind of partnership discussions as well, but any kind of formal thoughts on kind of plans as far as what may be required for a broader label and/or kind of further expansion opportunities for D-PLEX 100 specifically? Maybe a little bit too early for that question, but any additional thoughts?

Speaker #6: Got it . Maybe just along those lines , this may be somewhat dependent on kind of partnership discussions as But well . any kind of formal thoughts on kind of plans as far as what may be required for a broader label and or kind of further expansion opportunities for 100 .

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

Speaker #6: Specifically , you know , maybe a little bit too early for that question . But any additional thoughts ?

Speaker #3: I what Yeah , think I can say is that we have , as part of our planning time frame , that we plan to meet with to discuss this .

Chase Knickerbocker: Got it.

Yehuda Leibler: Just maybe the last one from me on kind of future applications for the platform. Can you kind of help shape our thinking a little bit for kind of where you may go next? Obviously, you've announced that metabolic program and how these kind of future formulations may differ from what we've seen you do thus far. Thanks. So first, as you rightly referred to, we have the opportunity to expand D-PLEX into other indications, and that's the first and probably the most advanced pipeline expansion that we'll look, which is specifically on D-PLEX. But with regards to other pipelines, so I'm saying that because it's important for investors to understand that our near-term focus remains firmly on execution, the regulatory and commercialization pathway of D-PLEX. So that is where the vast majority of our attention, our resources are directed.

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

Speaker #6: Got it . And just maybe the last one for me on kind of future applications for the platform . Can you kind of help shape our thinking a little bit for kind of go where you may next ?

Speaker #6: You've obviously you've you've announced that metabolic program , but you know , and how these kind of future formulations may differ from what we've seen .

Dikla Akselbrad: So first, as you rightly referred to, we have the opportunity to expand D-PLEX into other indications, and that's the first and probably the most advanced pipeline expansion that we'll look, which is specifically on D-PLEX. But with regards to other pipelines, so I'm saying that because it's important for investors to understand that our near-term focus remains firmly on execution, the regulatory and commercialization pathway of D-PLEX. So that is where the vast majority of our attention, our resources are directed.

Speaker #6: You do seen this you do far . Thanks .

Speaker #3: So first , as you rightly refer to , we have the opportunity to expand deeper into other indications . And that's the first probably the most advanced pipeline expansion that we look , which is specifically on duplex , but with regards to other that So I'm saying pipelines .

Speaker #3: because it's important for , for investors to understand that our near-term focus remain firmly on execution , the regulatory and commercialization pathway of duplex .

Yehuda Leibler: But as we move forward with the NDA submission and approval, we are expanding into specifically, as you all know, around the GLP-1 and metabolic health. I expect that we will see during this year, we'll get additional data. I would even say around mid-year. This program is still at preclinical development, but with the underlying technology platform that provides long-term opportunity sorry, long-term exposure of 60+ or around 60 days and the ability to support it in a linear way, this is very lucrative in this area. Thank you. Thank you. We will take our next question. The next question comes from Jason Butler at Citizens. Please go ahead. Your line is open. Hi. Thanks for taking the questions and congrats on the progress.

Dikla Akselbrad: But as we move forward with the NDA submission and approval, we are expanding into specifically, as you all know, around the GLP-1 and metabolic health. I expect that we will see during this year, we'll get additional data. I would even say around mid-year. This program is still at preclinical development, but with the underlying technology platform that provides long-term opportunity sorry, long-term exposure of 60+ or around 60 days and the ability to support it in a linear way, this is very lucrative in this area.

Speaker #3: So that is where the vast majority of our intention , our resources are directed . But as we move forward with with the NDA submission and approval , we are expanding into specifically , as you all know , around the GOP , one and metabolic health .

Speaker #3: I expect that we will see during this year . We'll get additional data . I would even say around mid-year this program is still at preclinical development , but with the underlying technology platform that provides long term opportunity , sorry , long term beyond exposure of 60 plus or around 60 days .

Chase Knickerbocker: Thank you.

Speaker #3: And the ability to support it in a linear way . This is very lucrative in this area .

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

Speaker #6: Thank you .

Speaker #1: Thank you . We will take our next question . The next question comes from Jason Butler at Citizens . Please go ahead . Your line is open .

Jason Butler: Hi. Thanks for taking the questions and congrats on the progress.

Yehuda Leibler: Dikla, can you just talk about the work that you're doing or will be doing this year to get ready for a potential approval of D-PLEX 100, both in terms of building awareness as well as getting ready with payers, just the work that needs to be done before approval? Thank you. Sure. Sure. So some of it we've shared in previous calls, and some of it is also all we refer to in our new branding and website. This is all part of getting ready for the commercial stage. Some of it is already out there, like the website and the new branding. But also, there is work that is done around packaging for D-PLEX, its commercial name that we will obviously expose later on once we are in the approval process.

Jason Butler: Dikla, can you just talk about the work that you're doing or will be doing this year to get ready for a potential approval of D-PLEX 100, both in terms of building awareness as well as getting ready with payers, just the work that needs to be done before approval? Thank you.

Speaker #7: Hi . Thanks for taking the questions and congrats on the progress . Can you just talk about the work that you're doing or will be doing this year to get ready for a potential approval of duplex 100 , both but in terms of building awareness as well as getting ready with payers .

Dikla Akselbrad: Sure. Sure. So some of it we've shared in previous calls, and some of it is also all we refer to in our new branding and website. This is all part of getting ready for the commercial stage. Some of it is already out there, like the website and the new branding. But also, there is work that is done around packaging for D-PLEX, its commercial name that we will obviously expose later on once we are in the approval process.

Speaker #7: Just , just just the work that needs to be done . You know , before approval . Thank you .

Speaker #3: Sure , sure . So some we've of it shared we've with the with in in previous calls and some of it is also or we refer to in our new branding and website .

Speaker #3: This is all part of getting ready for the commercial stage. Some of it is already out there, like the new website and the branding, but also there is work that is done around packaging for Deep Plex.

Speaker #3: It's commercial name that we will obviously expose later on . Once we are in the approval process and in addition to that , we have been doing a lot of work , not just now , but in the last few years , and already please feel free to add to that .

Yehuda Leibler: And in addition to that, we have been doing a lot of work not just now but in the last few years. Ori, please feel free to add to that, whether it is in terms of market research, of pricing, creating awareness. You'll start to see many more abstracts and articles coming from our front during this year, building a KOL network. Just the beginning of it was with our KOL event; it was actually our KOL event, but Roth Group's KOL event with Professor Steven D. Wexner. Ori, do you want to add anything to that? I will just add that the main work right now is really, like you said, Jason, kind of putting the data out there and making sure that people are aware of the data, of the product. So conferences will be a big part of it.

Dikla Akselbrad: And in addition to that, we have been doing a lot of work not just now but in the last few years. Ori, please feel free to add to that, whether it is in terms of market research, of pricing, creating awareness. You'll start to see many more abstracts and articles coming from our front during this year, building a KOL network. Just the beginning of it was with our KOL event; it was actually our KOL event, but Roth Group's KOL event with Professor Steven D. Wexner. Ori, do you want to add anything to that?

Speaker #3: Whether it is in terms of market research or pricing aware , creating awareness , you'll start to see many more abstract and article coming from our front .

Speaker #3: During this year . Building a coal network just the beginning of it was a with coal event with doctor or . Well , it was actually our coal event , but rock groups coal event with doc professor Stephen D Wexner or do you want to add anything to that ?

Ori Warshavsky: I will just add that the main work right now is really, like you said, Jason, kind of putting the data out there and making sure that people are aware of the data, of the product. So conferences will be a big part of it.

Speaker #4: I would just add that there's there's the main the main work right now is really , like you said , Jason a , a kind putting , of putting the data out there and making sure that people are aware of the data of the product .

Yehuda Leibler: Publication will be a big part of it. A lot of the health economics piece is something that is kicking off now because, as you said, for market access, this is a driver. But also, some of the on-the-ground kind of boots-on-the-ground market preparation will be dependent on the partner. We are expecting that the partner will have sufficient time. That's why our conversations are with kind of experienced global partners that will kind of get running immediately after signing, can go on and start doing all the prior approval meetings in the hospitals, and really get the access piece going almost immediately. Great. Thank you. And then just one more for me. On the GLP-1 program, how do you think about strategically when and what data you can generate yourself versus when a partner might make sense to bring on board?

Ori Warshavsky: Publication will be a big part of it. A lot of the health economics piece is something that is kicking off now because, as you said, for market access, this is a driver. But also, some of the on-the-ground kind of boots-on-the-ground market preparation will be dependent on the partner. We are expecting that the partner will have sufficient time. That's why our conversations are with kind of experienced global partners that will kind of get running immediately after signing, can go on and start doing all the prior approval meetings in the hospitals, and really get the access piece going almost immediately.

Speaker #4: So conferences will be a big part of it . Publication will be a big of . A lot of the health something economics piece is that's is is kicking off now because , as you said , for market access , this is a driver .

Speaker #4: But also some of the some of the on the ground kind of boots on the ground market preparation will be dependent on , on the partner .

Speaker #4: And we are a expecting that that , that the partner will have sufficient sufficient time . And we are and that's where our conversations are with kind of experienced partners that will kind of get a running immediately after signing .

Speaker #4: Can can go on and start doing all the the prior approval meetings in , in the hospitals and really get the , the access piece going almost immediately .

Jason Butler: Great. Thank you. And then just one more for me. On the GLP-1 program, how do you think about strategically when and what data you can generate yourself versus when a partner might make sense to bring on board?

Speaker #7: Great . Thank you . And then just one more for me on the Glp1 program . How do you think about strategically when and you know , what data you can generate yourself versus when a partner might make sense to bring on board and and just longer term , how you think about positioning and and differentiation in , in this market .

Yehuda Leibler: And just longer term, how you think about positioning and differentiation in this market? Sure. Sure. So our GLP-1 program leverages our new Kynatrix technology for approximately 60 days of sustained release. And we are targeting improved patient compliance. Our vision for this program is to partner at a relatively early stage. What we are building now is more robust preclinical efficacy NPK sets of data that support this attribute, this sustained release, no spike, as you see the burst release that is seen with current weekly delivered molecules. So we are targeting to have these more robust efficacy NPK studies. We are already along the development of this program, have been speaking with different groups. But we believe that once we have these sets of data, this could be very interesting for partners, especially since this is coming after a validated program.

Jason Butler: And just longer term, how you think about positioning and differentiation in this market?

Dikla Akselbrad: Sure. Sure. So our GLP-1 program leverages our new Kynatrix technology for approximately 60 days of sustained release. And we are targeting improved patient compliance. Our vision for this program is to partner at a relatively early stage. What we are building now is more robust preclinical efficacy NPK sets of data that support this attribute, this sustained release, no spike, as you see the burst release that is seen with current weekly delivered molecules. So we are targeting to have these more robust efficacy NPK studies. We are already along the development of this program, have been speaking with different groups. But we believe that once we have these sets of data, this could be very interesting for partners, especially since this is coming after a validated program.

Speaker #3: Sure , sure . So so our GLP one program leverages our new kinetics technology for approximately 60 days of sustained release . And we are targeting improved patient compliance .

Speaker #3: Our vision for this program is to partner at a relatively early stage . What we are building now is a more robust pre-clinical efficacy and PK sets of data that support this attribute .

Speaker #3: This sustained release—no spike, as you see. The burst release that you see is what is seen with current weekly delivered molecules. So we are targeting to have this more robust efficacy and PK.

Speaker #3: Studies . We are already along the development of this program , have been speaking with different groups , but we believe that once we have these sets of data very , this could be interesting for partners , especially since we have this is coming after a validated program .

Yehuda Leibler: 100 has validated our approach in a very robust way, both in terms of manufacturing, CMC, as well as PK, and our ability to deliver and develop our technology forward into drugs. Great. Thank you. 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. Good morning, Dikla. Thanks for taking my questions. So first, I wanted to talk about the progress you highlighted in the press release about the potential US partnership. So without getting into the confidential information, is it reasonable to assume the potential partner shall also have a presence in ex-US regions? And also, assuming the significant interest post-NDA filing, what factors could play a pivotal role in closing in the partnership? And I have some follow-ups. Great. So good morning, and thank you for that.

Dikla Akselbrad: 100 has validated our approach in a very robust way, both in terms of manufacturing, CMC, as well as PK, and our ability to deliver and develop our technology forward into drugs.

Speaker #3: Deep flex 100 is validated . Our approach in a very robust way , both in terms of manufacturing , CMC as well as PK and our ability to deliver and develop our technology forward into drugs .

Jason Butler: Great. Thank you.

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

Speaker #7: Great . Thank you .

Speaker #1: Thank you . We will take our next question . Your next question comes from the line of Rasha from Roth Capital Partners . Please go ahead .

Boobalan Pachaiyappan: Good morning, Dikla. Thanks for taking my questions. So first, I wanted to talk about the progress you highlighted in the press release about the potential US partnership. So without getting into the confidential information, is it reasonable to assume the potential partner shall also have a presence in ex-US regions? And also, assuming the significant interest post-NDA filing, what factors could play a pivotal role in closing in the partnership? And I have some follow-ups.

Speaker #1: Your line is open .

Speaker #8: Good morning , and thanks for taking my questions . So first I wanted to talk about the progress you highlighted in the press release about the potential use partnership .

Speaker #8: So without getting into the confidential information , is it reasonable to assume the potential partner shall also have a presence in US regions and also assuming the significant interest post NDA filing ?

Dikla Akselbrad: Great. So good morning, and thank you for that.

Speaker #8: What factors could play a pivotal role in closing in the partnership ? And I have some follow ups .

Yehuda Leibler: So I'll start with the first portion. In terms of other geographies, so we are very focused now on US. We think that's our highest priority. That said, there might be interest to other geographies as well as part of those discussions, and other discussions that we have. But our first priority is US. Also, in terms of the timeline, when you look at our NDA submission, that is expected by the end of this quarter, and European submission is expected later on, around the quarter after we finalize the FDA submission, so it makes more sense. And your second portion was? So I was asking about what factors might play a role in identifying the final partner. So Ori, feel free to add to that.

Dikla Akselbrad: So I'll start with the first portion. In terms of other geographies, so we are very focused now on US. We think that's our highest priority. That said, there might be interest to other geographies as well as part of those discussions, and other discussions that we have. But our first priority is US. Also, in terms of the timeline, when you look at our NDA submission, that is expected by the end of this quarter, and European submission is expected later on, around the quarter after we finalize the FDA submission, so it makes more sense. And your second portion was? So I was asking about what factors might play a role in identifying the final partner. So Ori, feel free to add to that.

Speaker #3: Great . So , so good morning and thank you for that . So I'll I'll start with the first portion in terms of other geographies .

Speaker #3: So we are very focused now on us that's . We think our highest priority . That said be , there might interest to other geographies as well as part of those discussions and other discussions that we have .

Speaker #3: But our first priority is us also know , in since , you terms of the timeline , when you look at our NDA submission , that is expected by the end of the this quarter and European submission is expected later on , about a quarter around the quarter after we we finalize the FDA submission .

Speaker #3: So it makes more sense . And your second portion was .

Speaker #8: So I was asking about what factors might play a role in identifying the final partner .

Yehuda Leibler: But we've been saying for quite some time that the ideal partner and also the partner that we are discussing with are with broad hospital-based capabilities and present in the surgical suite, in the hospital. And this is what's really needed to market a product like D-PLEX 100. So I don't see what could go wrong in that respect because I think that there is an alignment between the interest and the need. Ori, you want to add to that? I would just add that we keep saying we're advancing, but we are advancing from high-level discussion. The due diligence is going on and becomes more and more in the details. And I think that's a sign that we're heading in the right direction here. All right. That's helpful. And then you mentioned about the KOL call. Obviously, during my call with Dr.

Dikla Akselbrad: But we've been saying for quite some time that the ideal partner and also the partner that we are discussing with are with broad hospital-based capabilities and present in the surgical suite, in the hospital. And this is what's really needed to market a product like D-PLEX 100. So I don't see what could go wrong in that respect because I think that there is an alignment between the interest and the need. Ori, you want to add to that?

Speaker #3: So I feel free to to add to that . But we've been saying for for quite some time that the ideal partner and also the partner that we are discussing with are with broad hospital based capabilities and presence in the in the surgical suite in the hospital .

Speaker #3: And this is what's really needed to market a product like reflex 100 . So I don't see the what could go wrong in that respect , because I think that the interest and there is an alignment between the interest and the need , or you that want to .

Ori Warshavsky: I would just add that we keep saying we're advancing, but we are advancing from high-level discussion. The due diligence is going on and becomes more and more in the details. And I think that's a sign that we're heading in the right direction here.

Speaker #4: would just add I in that , you know , we're we're we keep saying we're advancing , but we are advancing from , from high level discussion a the due diligence is going on and becomes more , more and more , you know , in the details .

Boobalan Pachaiyappan: All right. That's helpful. And then you mentioned about the KOL call. Obviously, during my call with Dr.

Speaker #4: And I think that's that's a sign that we're we're heading in the right direction here .

Yehuda Leibler: Wexner, she mentioned that the phase three study was well designed, adequately controlled, with balanced characteristics, and the patients, they reflect the real-world scenario. So I was wondering if you could comment on whether the FDA took a similar view based on your pre-NDA meeting communications. I think the fact that the feedback was positive and there is an alignment on that, and the FDA confirmed both the NDA pathway as well as indicated that the existing clinical data package is sufficient to support an NDA submission. I think it says it all. All right. Maybe one final question from us. So we have done some research. It looks like there's approximately 900 integrated delivery networks in the US, and they manage roughly 6,000 to 7,000 hospitals.

Boobalan Pachaiyappan: Wexner, she mentioned that the phase three study was well designed, adequately controlled, with balanced characteristics, and the patients, they reflect the real-world scenario. So I was wondering if you could comment on whether the FDA took a similar view based on your pre-NDA meeting communications.

Speaker #8: All right . That's helpful . And then you mentioned about the cable call , obviously , you know , during my call with Doctor Wexner , he mentioned that the phase three study was well designed , adequately controlled with balanced characteristics .

Speaker #8: And the patients , they reflect the real world scenario . So I was wondering if you could comment on whether the FDA took a similar view based on your Pre-nda meeting communications .

Dikla Akselbrad: I think the fact that the feedback was positive and there is an alignment on that, and the FDA confirmed both the NDA pathway as well as indicated that the existing clinical data package is sufficient to support an NDA submission. I think it says it all.

Speaker #3: I think the fact that the the positive , the feedback was positive and there is an alignment on on that , and the confirmed both the NDA pathway as well as indicated that the existing clinical data package is sufficient to support an NDA submission .

Boobalan Pachaiyappan: All right. Maybe one final question from us. So we have done some research. It looks like there's approximately 900 integrated delivery networks in the US, and they manage roughly 6,000 to 7,000 hospitals.

Speaker #3: I think that's it says it all .

Speaker #8: All right . Maybe from one final question us . So we have done some research . It looks like there's approximately 900 integrated delivery networks in the US .

Yehuda Leibler: So I was wondering, assuming this is indeed the case, what percentage of potential target IDNs would reasonably likely include D-PLEX on formulary within the first 12 months after approval? Thank you. Ori, you want to take? Yes. I can take this. I think the process first. I would say that, of course, this would be a mission for the US commercial partner. And this is the reason why we are discussing the commercialization activities with partners that understand the ins and outs of the IDNs that have relationship from the surgeon to the pharmacist to the IDN level to the GPOs to really ensure kind of uptake as fast as we can. Specifically, about 1 month, I think it really is it depends. It's a hospital-by-hospital or network-by-network decision. There are a number of steps. And I think we discussed this in the past.

Boobalan Pachaiyappan: So I was wondering, assuming this is indeed the case, what percentage of potential target IDNs would reasonably likely include D-PLEX on formulary within the first 12 months after approval? Thank you.

Speaker #8: And they manage roughly 6000 to 7000 hospitals . So I was wondering , you know , assuming this is indeed the case , what percentage of potential target .

Dikla Akselbrad: Ori, you want to take?

Speaker #8: Idns would reasonably likely to include deflux on formulary within the first 12 months after approval ? Thank you .

Ori Warshavsky: Yes. I can take this. I think the process first. I would say that, of course, this would be a mission for the US commercial partner. And this is the reason why we are discussing the commercialization activities with partners that understand the ins and outs of the IDNs that have relationship from the surgeon to the pharmacist to the IDN level to the GPOs to really ensure kind of uptake as fast as we can. Specifically, about 1 month, I think it really is it depends. It's a hospital-by-hospital or network-by-network decision. There are a number of steps. And I think we discussed this in the past.

Speaker #3: Or do you want to .

Speaker #4: Take . Yeah , I can take this . I think the process , the first first I would say that of course , this would be this would the be a mission for the for the commercial US partner .

Speaker #4: And this is the reason why we are discussing the commercialization activities with partners that understands the ins and outs of the idns that have relationship from the from the surgeon to the pharmacist to the IDN level to the gpos to really ensure ensure a kind of uptake as fast as we can .

Speaker #4: Specifically , about one month , I think , I think it really is . It depends . It's it's a hospital by hospital or network by network .

Yehuda Leibler: There are a number of steps to get the product used in the hospital. It starts with finding the right champions, which this is a process that will be done even before launch to start from a medical perspective, educating the surgeons on the need. Then the product needs to come to a P&T review. And in this P&T review, there'll be discussions both on the clinical benefits and the economic benefits. All of that are topics that we have strong information on, and the partners will have all the tools they will need to make the case. And then likely, the hospital, the IDN, will ask for some sort of maybe a small pilot study, a handful of patients just really to see how this product works in their operating room, and then an update to the electronic systems within the hospital.

Ori Warshavsky: There are a number of steps to get the product used in the hospital. It starts with finding the right champions, which this is a process that will be done even before launch to start from a medical perspective, educating the surgeons on the need. Then the product needs to come to a P&T review. And in this P&T review, there'll be discussions both on the clinical benefits and the economic benefits. All of that are topics that we have strong information on, and the partners will have all the tools they will need to make the case. And then likely, the hospital, the IDN, will ask for some sort of maybe a small pilot study, a handful of patients just really to see how this product works in their operating room, and then an update to the electronic systems within the hospital.

Speaker #4: A decision . There are a number of steps and I think we discussed this in the past . There are of a number steps to get the product used in the hospital .

Speaker #4: Starts with finding the right champions , which this is a process that will will be done even before launch to to start an educating a from a medical perspective , educating the the surgeons on the need .

Speaker #4: product needs to Then the come to to a PA review and then this review , there'll be discussions both on the clinical benefits , the A and the economic benefits .

Speaker #4: All of that are are topics that we have strong information on . And the partners will have all the all the tools they will need to to make the case .

Speaker #4: And then and then likely the , the hospital , the IDN will will ask for some sort of maybe a small pilot study , a handful of patients just really to see how this works product in their operating room .

Yehuda Leibler: So all to take a little bit of a long answer to say that the uptake will take a little while. It's not a day-one peak of sales. Probably a few months before we'll start seeing a meaningful uptake. But I think the flip side of that is once the product is on a formulary and there is usage, it's a relatively sticky process, meaning products are rarely getting taken off formulary, assuming the product works and there are no issues. So we can see once the product is on formulary, volume growing steadily and usage growing steadily month after month. All right. Thanks for taking your questions, and congratulations. Thank you. We will take our next question. And the question comes from the line of Brandon Folkes from H.C. Wainwright. Please go ahead. Your line is open. Hi. Thanks for taking my questions, and congrats on all the progress.

Ori Warshavsky: So all to take a little bit of a long answer to say that the uptake will take a little while. It's not a day-one peak of sales. Probably a few months before we'll start seeing a meaningful uptake. But I think the flip side of that is once the product is on a formulary and there is usage, it's a relatively sticky process, meaning products are rarely getting taken off formulary, assuming the product works and there are no issues. So we can see once the product is on formulary, volume growing steadily and usage growing steadily month after month.

Speaker #4: And then an update and then an update to the the electronic systems within the hospital . So all to say a little bit of a long answer to say that it's the , the uptake will will take a little while .

Speaker #4: It's not a day . One peak of sales , probably a few a few months before we'll start seeing meaningful uptake . But I think the the flip side is of that once the once is once the product is , is on the formulary and there is usage , it's a relatively sticky , sticky process , meaning there products are rarely getting taken off formulary , assuming the product works and there are no issues .

Speaker #4: So we can see once the product is on formulary volume growing steadily and usage growing steadily month after month .

Boobalan Pachaiyappan: All right. Thanks for taking your questions, and congratulations.

Operator: Thank you. We will take our next question. And the question comes from the line of Brandon Folkes from H.C. Wainwright. Please go ahead. Your line is open.

Speaker #8: All right . Thanks for taking your questions and congratulations .

Speaker #1: Thank you . We will take our next question . And the question comes from the line of Brandon Foulkes from H.C. Wainwright . Please go ahead .

Brandon Folkes: Hi. Thanks for taking my questions, and congrats on all the progress.

Yehuda Leibler: Maybe just two from me. Maybe firstly, any color and when you expect to complete the rolling submission? And then maybe secondly, can you just elaborate on the differences between the Kynatrix platform and the D-PLEX technology platform? And just how much early-stage work do you need to do on the Kynatrix platform, or how much can you leverage from your experience with D-PLEX? I'm just thinking about sort of how we should think about timing of moving products forward on the new platform. Thank you. Thank you. Thank you, Brandon. So with regards to the timeline, as we said, we expect to submit the NDA by the end of Q1. We will first submit the CMC, a non-clinical module, followed by the clinical module. And the gap between those two submissions is not more than a couple of months. It is very close to one another.

Speaker #1: Your line is open .

Speaker #9: Hi . Thanks for taking my questions and congrats on all the progress . Maybe two from just me . Maybe . Firstly , any color and when expect to rolling complete the submission and maybe .

Speaker #9: then Secondly , can you just elaborate on the differences between the kinetics platform and the duplex technology platform and just , you know , how much early stage work do you need to do on the platform , or how much can you leverage from your experience with duplex ?

Dikla Akselbrad: Thank you. Thank you, Brandon. So with regards to the timeline, as we said, we expect to submit the NDA by the end of Q1. We will first submit the CMC, a non-clinical module, followed by the clinical module. And the gap between those two submissions is not more than a couple of months. It is very close to one another.

Speaker #9: I'm just thinking about, sort of, how we should think about the timing of moving products forward on the new platform. Thank you.

Speaker #3: Thank you , thank you , Brendan . So with regards to the timeline , as we said , we expect to submit the the NDA by the end of the first quarter .

Speaker #3: We will first submit the CMC and non-clinical module , followed by the clinical module and the the gap between those two . Submission is not more than a couple of months .

Yehuda Leibler: From that point, since we have a Fast Track and Breakthrough Therapy designation that support the use of a rolling submission priority review, we expect that the NDA review will be shortened to six months from the regular 10 months. And Ori, do you want to give a bit of the difference? Yes. I can take the question. So hi, Brandon. First, I think it's important to understand that it's not that one day we were on PLEX and the next day it was Kynatrix. Kynatrix really is collecting under one umbrella a lot of the work that has been done over the past several years that was not under PLEX and under the PLEX IP umbrella. Meaning to say, there's no gap here. The work has been going on as a continuous work.

Dikla Akselbrad: From that point, since we have a Fast Track and Breakthrough Therapy designation that support the use of a rolling submission priority review, we expect that the NDA review will be shortened to six months from the regular 10 months. And Ori, do you want to give a bit of the differen

Speaker #3: It is very close to one another from that point have . Since we a fast track and breakthrough therapy designation that support the use of a rolling submission , priority review , we expect that the NDA review will be shortened to six months from the regular ten months .

Ori Warshavsky: e? Yes. I can take the question. So hi, Brandon. First, I think it's important to understand that it's not that one day we were on PLEX and the next day it was Kynatrix. Kynatrix really is collecting under one umbrella a lot of the work that has been done over the past several years that was not under PLEX and under the PLEX IP umbrella. Meaning to say, there's no gap here. The work has been going on as a continuous work.

Speaker #3: And Ari , do you want to give a bit of the difference ?

Speaker #4: Yes , I can take I can take the , the the question . So hi Brendan . First , I think it's important to , to understand that it's not that one day we were on Plex and the next day it was a kinetics .

Speaker #4: Kinetics really is collecting under under one umbrella . A lot of the work that that has been done over the past several , several months , several years , that is not a that was not under Plex and under the Plex Plex IP umbrella , meaning to say there's not there's there's no here .

Speaker #4: The been has work has been going on for as for for as a continuous work what what you see under kinetics is now a way for us to a collect some of the the IP on , on peptide release on , on intratumoral injection on the sting agonist that that partnership we had all all these activities coming under this umbrella and helping us build new IP and in a way allowing us to to discuss this more freely without without the limitations of of Plex .

Yehuda Leibler: What you see under Kynatrix is now a way for us to collect some of the IP on peptide release, on intratumoral injection, on the STING agonist partnership that we had. All these activities coming under this umbrella and helping us build new IP and, in a way, allowing us to discuss this more freely without the limitations of Plex. So it's a new name, but the work in the R&D team and the development has been going on continuously forever. Does that make sense, Brandon? Yes. Very helpful. I appreciate it. And congrats again. Thank you. Thank you. Thank you. This concludes today's question-and-answer session. I'll now hand the call back for closing remarks. Thank you all for joining us today. 2025 marked an important turning point for PolyPid, and we enter 2026 with momentum across regulatory, commercial, and organizational fronts.

Ori Warshavsky: What you see under Kynatrix is now a way for us to collect some of the IP on peptide release, on intratumoral injection, on the STING agonist partnership that we had. All these activities coming under this umbrella and helping us build new IP and, in a way, allowing us to discuss this more freely without the limitations of Plex. So it's a new name, but the work in the R&D team and the development has been going on continuously forever. Does that make sense, Brandon?

Speaker #4: So , so it's it's a new name , but the work in , in the R&D team and the development has been going on continuously forever is that does that make sense ?

Brandon Folkes: Yes. Very helpful. I appreciate it. And congrats again. Thank you.

Dikla Akselbrad: Thank you.

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

Speaker #4: Brendan .

Speaker #9: Yes . Very helpful . I appreciate it . And congrats again .

Speaker #3: you . Thank you Thank .

Dikla Akselbrad: Thank you all for joining us today. 2025 marked an important turning point for PolyPid, and we enter 2026 with momentum across regulatory, commercial, and organizational fronts.

Speaker #1: Thank you . This concludes today's question and answer session . I'll now hand the call back for closing remarks .

Speaker #3: Thank you all for joining us today , 2025 marked an important turning point for PolyPid Ltd. , and we enter 2026 with momentum across regulatory , commercial and organizational fronts with the rolling NDA review expected to begin shortly .

Yehuda Leibler: With the rolling NDA review expected to begin shortly, continued progress in partnership discussion, and a clear strategic vision for the company's future, we believe PolyPid is well positioned for the next phase of growth. We appreciate the continued support of our shareholders, partners, and employees, and we look forward to providing further updates as the year progresses. Thank you. Operator, you may now close the call. This concludes today's conference call. Thank you for participating. You may now disconnect.

Speaker #3: Continued progress in partnership discussion and a clear strategic vision for the company's future . We believe Polypid is well positioned for the next phase of growth .

Speaker #3: We appreciate the continued support of our shareholders , partners and employees , and we look forward to providing further updates as the year progresses .

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

Speaker #3: Thank you . And operator , you may now close the call . .

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