Q2 2024 PolyPid Ltd Earnings Call

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Hello everyone, welcome to Dikla Akselbrad, Dikla Akselbrad, Jonny Missulawin

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Operator: Raghuram Selvaraju, Brian Ritchie, Dikla Akselbrad Raghuram Selvaraju, Brian Ritchie, Dikla Akselbrad Greetings and welcome to the PolyPid second quarter 2024 conference call. At this time, the participants are in listen-only mode.

Dikla Akselbrad, Jonny Missulawin,

Brian Ritchie: As a reminder, this call is recorded, and I would now like to introduce your host for today's conference, Brian Ritchie from Lifesci Advisors. Mr. Ritchie, you may begin. Thank you all for participating in PolyPid's second quarter, 2020 earnings call. Joining me on the call today will be Dikla Chachkis Akselbrad, Chief Executive Officer of PolyPid. Jonny Missulawin, PolyPid's Chief Financial Officer, and Ori Warshavsky, PolyPid's Chief Operating Officer, here, in the United States of PolyPid.

Brian Ritchie: Earlier today, PolyPid released its financial results for the three and six months ended June 30, [inaudible] The copy of the press release is available in the investors section on the company's website www.polypid.com. I'd like to remind you that on this call, management will make forward-looking statements within the meaning of the Federal Securities, For example, management is making forward-looking statements when it discusses the expected timing for recruitment, number of centers, top-line results from the SHIELD-2 trial and of the unblinded interim analysis, the planned new drug application submission for DPLEX-100, and the company's expected cash runway and the potential to secure additional funds if all the warrants issued to its recent PIPE RFC, forward-looking statements are subject to numerous risks and uncertainty.

Speaker Change: Earlier today <unk> released its financial results for the three and six months ended June 32024.

Speaker Change: A copy of the press release is available in the investors section on the company's website Www Dot <unk>.

Speaker Change: Dot com.

Brian Ritchie: Many of which are beyond our control, including the risks described from time to time in our SCC file. Our results may differ materially from those projected. 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 facts.

Speaker Change: I'd like to remind you that on this call management will make forward looking statements within the meaning of the federal Securities Laws. For example management is making forward looking statements. When he discusses the expected timing for recruitment number of centers topline results from the shield two trial.

Speaker Change: The unblinded interim analysis, the planned new drug application submission for duplex 100, and the Companys expected cash runway and the potential to secure additional funds if all of the warrants issued to its recent pipe are exercised.

Speaker Change: Forward looking statements are subject to numerous risks and uncertainties many of which are beyond our control.

Speaker Change: Including the risks described from time to time in our SEC filings our 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.

Raghuram Selvaraju: Raghuram Selvaraju, Brian Ritchie, Dikla Akselbrad Raghuram Selvaraju, Brian Ritchie, Dikla Akselbrad Greetings and welcome to the PolyPid second quarter, 2024 conference call. At this time participants are in listen only mode.

Speaker Change: <unk> <unk>.

Operator: I encourage you to review the company's filings with the Securities and Exchange Commission, including, without limitation, the company's annual report on Form 20-F, which identifies specific factors that may cause actual results or events to differ materially from those described in the forward-looking form. PolyP 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 others.

Speaker Change: I encourage you to review the company's filings with the Securities and Exchange Commission, including without limitation.

Speaker Change: The company's annual report on form 20-F, which identifies specific factors that may cause actual results or events to differ materially from those described in the forward looking statements <unk> disclaims any intention or obligation except as required by law to update it.

Speaker Change: Or revise any financial projections or forward looking statements, whether because of new information future events or otherwise.

Brian Ritchie: As a reminder this call is recorded and I would now like to introduce your host for today's conference, Brian Ritchie, from Live Side Advisors, Mr. Ritchie, you may begin. Thank you all for participating in PolyPid's second quarter, 2024 earnings conference call.

Operator: This conference call contains time-sensitive information and speaks only as of the live broadcast today, August 14, 2021. With the completion of those prepared, it is my pleasure to turn the call over to Douglas Buchanan, Axelbrett, CEO, PolyPid. Thank you, Brian.

Speaker Change: This conference call contains time sensitive information and speaks only as of the live broadcast today August 14th 2024.

Speaker Change: With the completion of those prepared remarks. It is my pleasure to turn the call over to <unk> CEO <unk> <unk>.

Dikla Akselbrad: On behalf of our team at PolyPid, I would like to welcome everyone to our second quarter 2024 earnings. We are thrilled with the important clinical and operational progress achieved with, most critically, as it relates to continued study enrollment in our ongoing shields to pivotal trial for deep-lex 100 for the prevention of abdominal correctile statric acid. Father, the recent successful financing extends our cash runway through expected entry analysis results in the fourth quarter of this year and the completion of the full planned patient enrollment in early 2020, assuming the full exercise of the warrants for this financing.

Speaker Change: Thank you Brian on behalf of our team at policy I would like to welcome everyone.

Brian Ritchie: Joining me on the call today will be Dikla, Chachkis Akselbrad, Chief Executive Officer of PolyPid, Jonny Missulawin, PolyPid's Chief Financial Officer, and Ori Warshavsky, Chief Operating Officer, United States of PolyPid. Earlier today, PolyPid released its financial results for the three and six months ended June 30th, 2024. A copy of the press release is available in the Investors section on the company's website, www.polyp.com.

Speaker Change: Second quarter 2024 earnings conference call.

Speaker Change: We are thrilled with important clinical and operational progress achieved recently most critically as it relates to continued study enrollment in our ongoing pivotal trial with <unk> 100 for the prevention of abdominal colorectal surgical site infection.

Speaker Change: Further the recent successful financing extends our cash runway throughout expected interim analysis result in the fourth quarter of this year and the completion of the full planned patient enrollment in early 2025.

Brian Ritchie: I'd like to remind you that on this call, management will make forward-looking statements within the meeting of the federal securities laws. For example, management is making forward-looking statements when it discusses the expected timing for recruitment, number of centers, top-line results from the Shield 2 trial, and of the unblinded interim analysis, the planned new drug application submission for Dplex 100, and the company's expected cash runway and the potential to secure additional funds if all the awards issued through its recent type are exercised.

Speaker Change: In addition, assuming the full exercise of the word for this financing.

Dikla Akselbrad: Our cash runway will be further extended into the second quarter of 2025 beyond the anticipated timing of SHIELD 2's top-line release. Let's begin with the status of Shields. I am pleased to report today that the study has now enrolled approximately 327 patients, and approximately 50 centers are currently open in multiple countries around the world, including the U.S., Germany, Italy, Ireland, Portugal, Hungary, and Italy. As a reminder, we intend to conduct an unblinded interim analysis once approximately 400 patients of the planned total of approximately 600 subjects complete the 30-day follow-up, which is expected to occur in the fourth quarter of 2020.

Speaker Change: Cash runway will be further extended into the second quarter of 2025 beyond the anticipated timing of shield to topline results.

Speaker Change: Let's begin with the status of share too I am please to report today.

Speaker Change: It has now enrolled approximately 320 subjects.

Speaker Change: And approximately 50 centers are currently open in multiple countries around the world, including the U S, Germany, Italy, Ireland, Portugal and Israel.

Brian Ritchie: Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond our control, including the risks described from time to time in our SEC filings. Our results made it from 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 I encourage you to review the company's filings with the Securities and Exchange Commission, including without limitation.

Speaker Change: As a reminder, we intend to conduct an unblinded interim analysis once approximately 400 patients of the planned total of approximately 600 subject complete 30 days follow up which is expected to occur in the fourth quarter of 2020 for top line results are anticipated in the <unk>.

Dikla Akselbrad: Top-line results are anticipated in the first quarter of next year. Therefore, SHIELD-2 is now three quarters enrolled for the interim analysis and more than halfway to full plant enrollment. Importantly, enrollment is progressing at a consistent and robust rate.

Speaker Change: First quarter of next year there.

Speaker Change: Therefore, <unk> two is now three quarters enrolled for the interim analysis and more than halfway to full plant enrollment.

Brian Ritchie: The company's annual report on Form 20F, which identifies specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements. PolyPid displays 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 Change: Importantly, enrollment is progressing at a consistent and robust base.

Dikla Akselbrad: Of significance, the key patient enrollment trends we identified on our last call have continued. The median age, male-female split, and percentage of enrolled patients suffering from cancer in SHIELD 2 are all similar to those in the SHIELD 1 large incision pre-specified subgroup. This is important because these similar demographics are being observed in the more focused patient population for which we have already generated highly positive data in SHIELD1. We continue to strongly believe that CHIR-2 is a de-risk phase 3. Unlike SHIELD-1, the currently enrolling SHIELD-2 is not being conducted under the tight COVID-related restrictions that were in place during the pandemic.

Speaker Change: All significant key patient enrollment trends, we identified on our last call has continued.

Speaker Change: H male female fleet and percentage of enrolled patients suffering from cancer in Q2.

Brian Ritchie: This conference call contains time-sensitive information and speaks only as of the live broadcast today, August 14, 2024.

Speaker Change: All similar to the patient in the shield, one large anesthesia prespecified subgroup.

Speaker Change: This is important because these similar demographics are being observed in the more focused patient population in which we have already generated highly positive data in Q1.

Brian Ritchie: With the completion of those prepared remarks, it is my pleasure to turn the call over to Dikla Chachis Akselbrad, CEO, PolyPid. Dikla? Thank you, Brian.

Speaker Change: We continue to strongly believe that Q2 is a derisk phase III trial.

Dikla Akselbrad: On behalf of our team at PolyPid, I would like to welcome everyone to our second quarter's 2024 earnings conference call. We are thrilled with the important clinical and operational progress achieved recently. Most critically, as it relates to continued study enrollment in our ongoing shields to pivotal trials for Dikla X100 for the prevention of abdominal-correctal surgical site injection. Father, the recent successful financing extends our cash runway throughout expected entry analysis results in the fourth quarter of this year and the completion of the full planned patient enrollment in early 2025. In addition, assuming the full exercise of the warrants for this financing, our cash runway will be farther extended into the second quarter of 2025, beyond the anticipated timing of shield-to-top line results.

Speaker Change: Unlike Q1. The currently enrolling Q2 is not being conducted under the tight COVID-19 related with kitchen that were in place during the pandemic.

Dikla Akselbrad: Later in the call, Ori will further discuss the surgical site infection risk currently being observed in the clinic as viewed by a key opinion leader in the field. Of course, we are also leveraging key learning from Shields I related to the sites involved in the, and discuss on prior earnings call while we are targeting approximately 60 centers for shield 2 around the same number in shield 1 we identified the best performing sites in countries from shield 1 in terms of recruitment, patient monitoring and good clinical process, and have focused on these sites and countries in sheer We believe this to be essential in the execution of shield, More offers, the DASA Safety Monitoring Committee in charge of the review of accumulating safety data and study conduct for SHIELD 2 has recommended three times to continue the study without modification, meaning that no safety issues related to the flex 100 have been observed in shift 2.

Speaker Change: Later in the call <unk> will further discuss the surgical site infection with currently being observed in the clinic is viewed by a key opinion leader in the field.

Speaker Change: Of course, we are also leveraging key learning from shield one related to the sites involved in the study.

Speaker Change: As discussed on prior earnings call. While we are targeting approximately 60 centers for shell to around the same number in shield one.

Speaker Change: Despite the best performing sites and countries functions one in terms of recruitment patient monitoring and good clinical practices and have focused on these sites and countries in Q2.

We believe this to be essential in the execution of shield two.

Dikla Akselbrad: Let's begin with the status of shield-to. I am pleased to report today that the study has now enrolled approximately 320 subjects, and approximately 50 centers are currently open in multiple countries around the world, including the U.S., Germany, Italy, Ireland, Portugal, Hungary, and Israel. As a reminder, we intend to conduct an unblinded interim analysis, once approximately 400 patients of the planned total for approximately 600 subjects complete the 30-day follow-up, which is expected to occur in the fourth quarter of 2024.

Speaker Change: Moreover, the data safety monitoring committee in charge of the review of accumulating safety data and study conduct for shield. Two has recommended three times to continue the study without modification, meaning that no safety issues related to duplex.

Speaker Change: It has been observed in Q2 to date.

Dikla Akselbrad: Moving on, to reiterate what we have said previously, we have a clear regulatory pathway for the potential NDA submission for DIPLEX-100 in the U.S. Last year, the FDA acknowledged not only that SHIELD-1 results may provide supportive evidence of the safety and efficacy of DUPLEX-100 in patients with large surgical incisions but also confirmed that, if successful, SHIELD-2 is sufficient to support a potential NDA submission. Shifting gears, we were pleased to recently fortify our balance sheet by successfully closing a financing of $8.1 million in gross. The fine syndicate was comprised of a few and existing investors, including participation from multiple top-tier U.S. Light Sciences.

Speaker Change: Moving on to reiterate what we have said previously we have a clear regulatory pathway for the potential NDA submission for <unk> 100 into Europe.

Speaker Change: Last year, the FDA acknowledge not only that shield. One result may provide supportive evidence of the safety and efficacy of <unk> 100 in patients with large surgical incision, but also confirm that it's successful tier two is sufficient to support a potential NDA submission.

Dikla Akselbrad: Subline results are anticipated in the first quarter of next year. Therefore, shield-to is now three quarters enrolled for the interim analysis and more than halfway to full planned enrollment. Importantly, enrollment is progressing at a consistent and robust pace. Of significance, the key patient enrollment trends we identified on our last call have continued. The median age, male, female, street, and percentage of enrolled patients suffering from cancer in shield-to are all similar to the patient in the shield-one, large, infusion, pre-specified cancer.

Speaker Change: Shifting gears, we were pleased to recently fortified our balance sheet by successfully closing of financing of $8 $1 million of cross property.

Speaker Change: The bank Syndicate was comprised of new and existing investors, including participation from multiple top tier U S lifestyles.

Speaker Change: Questions.

Dikla Akselbrad: The PIPE extends the company's cash runway into the first quarter of 2025, beyond expected interim analysis results and the completion of enrollment of approximately 600 patients. Additionally, PolyPid has the potential to secure an additional $6.1 million if the unblinded interim analysis of its SHIELD-2 Phase 3 trial of BPEX100 results in either the stopping of the trial due to positive efficacy or a continuation to planned patient recruitment of up to If all warrants issued in this recent financing are exercised, the company will be funded beyond top-line results and into the second quarter of 2021. In addition, the company announced that it has restructured its existing secured loan agreement with Grails with over $2 million of deferred repayment, which will be paid from April 2025 onward.

Dikla Akselbrad: Group. This is important because these similar demographics are being observed in the more focused patient population in which we have already generated highly positive data in SHIRD-1. We continue to strongly believe that SHIRD-2 is a de-risk phase 3 trial. Unlike SHIRD-1, the currently enrolling SHIRD-2 is not being conducted under the tight COVID-related restriction that were in place during the pandemic.

Speaker Change: The pipe extends the company's cash runway into the first quarter of 2025 beyond expected interim analysis result, and the completion of enrollment of approximately 600 patients.

Speaker Change: While it has the potential to secure an additional $6 1 million.

Speaker Change: If the unblinded interim analysis of <unk>.

Speaker Change: Two phase III trial of <unk> hundred, resulting in either the stocking of the trial to positive efficacy or continuation to plant patient recruitment of up to 630 subjects.

Dikla Akselbrad: Later in the call, Ori will further discuss the surgical sizing section with currently being observed in the clinic as viewed by a key opinion leader in the field. Of course, we are also leveraging key learning from SHIRD-1 related to the sites involved in this study. And discuss on prior earnings call while we are targeting approximately 60 centers for SHIRD-2 around the same number in SHIRD-1, we identify the best performing sites in countries from SHIRD-1 in terms of recruitment, patient monitoring, and good clinical practice, and have focused on these sites and countries in SHIRD-2.

Speaker Change: If all warrants issued in this recent financing exercised the company will be funded beyond topline results and into the second quarter of 2025.

Speaker Change: In addition, the company announced that it has restructured its existing secured loan agreement with <unk> with over $2 million of deferred repayment.

Speaker Change: Which will be paid from April 2025 onwards.

Dikla Akselbrad: I'd like to take the opportunity to thank all the investors who participated in the financing for their confidence and support. Finally, I am pleased to announce today that Ms. Dalit Hazan, our EVP R&D Clinical and Regulatory Affairs, has been promoted to the role of Deputy CEO, R&D Clinical and Regulatory Affairs. Dalit has been instrumental in the planning and execution of our clinical strategy, R&D, and the company's strategy with the FDA and European regulatory authorities.

Speaker Change: I'd like to take the opportunity to thank all the investors who participated in the financing for their confidence and support.

Speaker Change: Finally, I am pleased to announce today that Mr. Li Zhang.

Dikla Akselbrad: We believe this to be essential in the execution of SHIRD-2. Moreover, the DASA Safety Monitoring Committee in charge of the review of accumulating safety data and study conduct for SHIRD-2 has recommended three times to continue the study without modifications, meaning that no safety issues related to the complex 100 have been observed in SHIRD-2 today.

Speaker Change: Our ECP R&D clinical and regulatory affairs has been promoted to the role of Deputy CEO, EVP R&D clinical and regulatory affairs.

Speaker Change: It has been instrumental in the planning and execution of our clinical strategy.

Speaker Change: And the company's strategy with the FDA and European regulatory authorities and we look forward to her continued contributions to the advancement of policies as we approach.

Dikla Akselbrad: And we look forward to her continued contributions to the advancement of PolyPid as we approach the potential commercialization of DPLX-100. Now, I'd like to turn the call over to Ori to review the recent KOL event PolyPid hosted with Professor Charles Edmiston. Okay, Ori?

Dikla Akselbrad: Moving on, to reiterate what we have said previously, we have a clear regulatory pathway for the potential NDA submission for DIPLEX-100 in the US. Last year, the FDA acknowledged not only that SHIRD-1 result may provide supported evidence of the safety and efficacy of DIPLEX-100 in patients with large surgical incision, but also concern that it's successful SHIRD-2 is sufficient to support a potential NDA submission.

Speaker Change: <unk> commercialization of <unk> 100.

Speaker Change: Now I'd like to turn the call over to <unk> to review the recent Kols event polyphase posted with professor Charles Edmiston.

Speaker Change: Sorry.

Ori Warshavsky: Thank you, Dikla. This last June, we hosted a Key Opinion Leader webcast and conference call featuring Professor Charles E. Edmiston, Emeritus Professor of Surgery, Division of Vascular Surgery, Medical College of Wisconsin, on several key topics surrounding the prevention of surgical site infections. A replay of this virtual event can be found on the events and presentation page under the investor heading of the company's website. Key takeaways from this call include, One, an increase in surgical site infections back to pre-COVID rates due to a rebound in the number of elective surgeries conducted and the surgical environment normalizing to that found prior to 2020.

Speaker Change: Thank you <expletive>.

Speaker Change: This last June we hosted a key opinion leader webcast and conference call featuring <unk> <unk> com.

Speaker Change: Home and weakest potential surgery division vascular surgery Medical College of Wisconsin, We discussed several key topics surrounding the prevention of surgical patent infections.

Dikla Akselbrad: Shifting yields, we were pleased to recently fortify our balance sheet by successfully closing a financing of $8.1 million of growth process. The PIEC syndicate was comprised of new and existing investors, including participation for multiple top-tier U.S, lifestyle service investors. The PIEC extends the company's cash runway into the first quarter of 2025 beyond expected intraminalysis results and the completion of enrollment of approximately 600 patients in SHIRD-2. Polybid has the potential to secure an additional $6.1 million if the unblinded intraminalysis of the SHIRD-2 phase 3 trial of DIPLEX-100 results in either the stopping of the trial due to positive efficacy or a continuation to plan patient recruitment of up to 630 subjects. If all the worrying issues in this recent financing are exercised, the company will be funded beyond top-line results and into the second quarter of 2020. 25.

Speaker Change: A replay of this virtual event can be found on the events and presentations page under the Victor hedging of the company's website.

Speaker Change: Key takeaways from this call include group.

One the increase in surgical packing picture back to Greek corporate rates due to a rebound in the number of electric surgeries conducted and the surgical environment normalizing for that client prior to <unk>.

Speaker Change: Too wide.

Ori Warshavsky: Two, Wide Scrains, and Underreporting of Surgical Sacking, with up to 30 to 35% of colorectal infections missed due to suboptimal surveillance. Three procedural and patient-related risk factors significantly heightened the possibility of developing a surgical patent. And this increased possibility is compounded when patients have multiple miscarriages, for the long-term cost to commercial payers of the single Colorado surgical tag-in session event over a period of 24 months will remain sustained, ranging from $44,000 in superficial income.

Speaker Change: Widespread underreporting of surgical patent protection with up to 30% to 35% of our coli infection missed due to sub optimal surveillance strategy.

Speaker Change: Procedural and patient related factors significantly heightened the possibility of developing a surgical site infection and this increased our community is compounded when patients have multiple of these taxes.

Speaker Change: For the long term cost to commercial payers for the single colorectal surgical packing pension events over a period of 24 months remains substantial.

Dikla Akselbrad: In addition, the company announced that it has restructured its existing secured loan agreement with wealth with over $2 million of the third repayment, which will be paid from April 2025 or more.

Speaker Change: <unk> from $44000 in superficial infection to $64000 deep infection, and the cost for Medicare ranging from $20000.

Jonny Missulawin: $64,000 in deepening, and the cost for Medicare ranging from $20,000 to $45,000. The fifth and final takeaway is that the risk of surgical satisfaction is reduced when using surgical care bundled in patients undergoing colorectal surgery. Dr. Edmondson commented that the 30-day high-concentration release of antibiotics achieved with DPLX-100 has the potential to add additional clinical and economic benefits to infection prevention. With that said, it is my pleasure to turn the call over to Jonny to review the financials.

Speaker Change: $245000 in recycling.

Dikla Akselbrad: I'd like to take the opportunity to thank all the investors who participated in the financing for their confidence and support.

And the fifth and final takeaway the risk of surgical packing picturing is reduced when using surgical care bundled in patients undergoing colorectal surgery.

Dikla Akselbrad: Finally, I am pleased to announce today that Ms. Dalit Hazan, our EVP R&D Clinical and Regulatory Affairs, has been promoted to the role of Deputy CEO EVP R&D Clinical and Regulatory Affairs. Dalit has been instrumental in the planning and execution of our clinical strategy R&D and the company strategy with the FDA and European Regulatory Authority. And we look forward to her continued contributions to the advancement of polypid as we approach potential commercialization of DX100.

Speaker Change: Dr. Edmonson commented that they're taking day high concentrations of need for antibiotics achieved with deep looks 100 has the potential to add additional clinical and economic benefits to infection prevention.

Speaker Change: With that because my pleasure to turn the call over to John to review the financials.

Jonny Missulawin: Thank you Ori. As of June 30, 2024, the company had cash, cash equivalents, and short-term deposits of $9.3 million. This does not include the gross proceeds of approximately 8.1 million dollars generated from the type financing.

John: Thank you Laurie as of June 32024, the company had cash cash equivalents and short term deposits of $9 3 million.

This does not include the gross proceeds of approximately $8 $1 million generated from the pipe financing closed in August.

Ori Warshavsky: Now, I'd like to turn the call over to Ori to review the recent KOE-ELEvent polypid hosted with Professor Charles Edwiston. Ori? Thank you, Dikla.

Jonny Missulawin: Robert N. Ard, We expect that our performer cash balance will be sufficient to fund operations into the first quarter of 2025, not including a potential additional $6.1 million. All warrants from the recent financing are expired. Now let's turn to our income. Research and development expenses for the three months ended June 30, 2024 were $4.8 million, compared to $4 million in the same three-month period of 2020. The increase in R&D expenses in the most recently completed quarter The increase in R&D expenses in the most recently completed quarter, Unknown Attendee, Brian Ritchie, Dikla Akselbrad, Jonny Missulawin, Ori Warshavsky, PolyPid General and administrative expenses for the three months ended June 30, 2024 were $1.1 million, compared to $1.5 million recorded in the same three-month period of 2020. This decrease For the three months ended June 30, 2024, the company had a net loss of $0.3 million compared to $5.8 million in the second quarter of 2020.

John: We expect that our pro forma cash balance will be sufficient to fund operations into the first quarter of 2025, not including a potential additional $6 $1 million, if all warrants from the recent financing or exercise.

Ori Warshavsky: This last June, we hosted a key opinion leader in webcast and conference calls featuring Professor Charles Edwiston and Rita's Professor of Surgery, the Vision of Vascular Surgery Medical College of Wisconsin. We discussed several key topics surrounding the prevention of surgical site infections. A replay of this virtual event can be found on the event and presentation page under the investor heading of the company's website.

John: Now, let's turn to our income statement.

John: Research and development expenses for the three months ended June 32024.

John: Our $4 8 million.

John: Compared to $4 million in the same three months period of 2023.

Ori Warshavsky: Key takeaways from this call included one, the increase in surgical site infections back to pre-corbit rates due to rebound in the number of elective surgeries conducted and the surgical environment normalizing to that found prior to 20 points. Two, widespread underreporting of surgical site infections with up to 30 to 35% of color cell infections missed due to sub-optimal surveillance strategies. Three, procedural and patient-related risk factors significantly heightened the possibility of developing a surgical site infection.

John: The increase in R&D expenses in the most recently completed quarter was driven by the ramp up of the ongoing shield II phase III trial marketing and business development expenses for the three months ended June 32024 or 265000.

Ori Warshavsky: And this increased possibility is compounded when patients have multiple risk factors. Four, the long-term cost to commercial payers of the single color cell surgical site infection event over a period of 24 months remains substantial ranging from $44,000 in superficial infection to $64,000 in deep infection in the cost for Medicare ranging from $20,000 to $45,000 in a second. And the fifth and final takeaway, the risk of surgical site infection is reduced when using surgical care bundled in patients undergoing color cell surgery.

John: Compared to $357000 during the prior year period general and administrative expenses for the three months ended June 32024.

John: $1 1 million compared.

John: Compared to one 5 million recorded in the same three months period of 2023. This decrease reflects our ongoing cost containment efforts.

John: The three months ended June 32024, the company had a net loss of $6 3 million as compared to $5 $8 million in the second quarter of 2023.

Operator: With that, we will now open the call to your questions, operator. Thank you. To ask a question, please press star one-and-one on your telephone and wait for your name to be announced. To withdraw your question, please press star one-and-one again. Once again, please press star one-and-one on your telephone and wait for your name to be announced.

Speaker Change: With that we will now open the call to your questions operator.

Speaker Change: Thank you.

Operator: To withdraw your question, please press star one-and-one again. Thank you. We are now going to proceed with our first question. The questions come from the line of Roy Buchanan from JMP.

Speaker Change: To ask a question. Please press star one and one on your telephone and wait for your name to be announced two weeks ago. Your question. Please press star one and one again once again, please press star one and one on your telephone and wait for Vietnam.

Ori Warshavsky: Dr. Edson commented that the 30-day high-concentration release of antibiotics achieved with deep-lexal 100 as the potential to add additional clinical and economic benefits to infection prevention bundled.

Speaker Change: Question. Please press star one and one again.

Speaker Change: Thank you.

Speaker Change: We are now going to proceed with our first question.

Jonny Missulawin: With that, it is my pleasure to turn the call over to Johnny to review the financials. Johnny Thank you, Lord. As of June 30, 2024, the company had cash, cash equivalents and short-term deposits of $9.3 million. This does not include the gross proceeds of approximately $8.1 million generated from the pipe financing closed in August. We expect that our performer cash balance will be sufficient to fund a paration into the first quarter of 2025, not including a potential additional $6.1 million if all warrants from the recent financing are exercised.

ROI: Our question comes from the line of ROI.

ROI: From JMP. Please ask your question.

Unknown Attendee: Please ask your question. Hey, thanks for taking the questions. I guess the first one, just the interim analysis coming up in the next quarter, just what are the options of what you can announce? What should we expect? I guess if the trial continues to the final result, are you going to disclose the infection rate? So, hi, good morning, boy.

ROI: Hey, thanks for taking the questions I.

ROI: I guess the first one just.

ROI: The interim analysis coming up in the next quarter, just what are the options.

Speaker Change: Can announce what should we expect.

Speaker Change: I guess, if the trial continues to the final results are you going to disclose the infection rate.

Speaker Change: Okay.

Speaker Change: Hi, good morning.

Dikla Akselbrad: So... First of all, I'll start with the letter. We will not be aware of it. We will only get the study. So the options of the interim, the DSMB, who is also monitoring the safety data, will come back to us with several, one of three options. I know they can say that.

Speaker Change: First of all I'll start with a letter we will not be aware of the infection that we will only get the.

Speaker Change: And point of the study so the auctions of the entry at the SMB, who is also monitoring the safety data, we'll come back to us with that for a lot of AV three auction.

Jonny Missulawin: Now let's turn to our income statement. Retrition development expenses for the three months ended June 30, 2024, were $4.8 million compared to $4 million in the same three month period of 2023. The increase in R&D expenses in the most recently completed quarter was driven by the ramp up of the ongoing Shield 2 Phase 3 trial. Marketing and business development expenses for the three months ended June 30, 2024, were $265,000 compared to $357,000 during the prior European period.

Speaker Change: Either they can say that which we.

Dikla Akselbrad: Nobody in the audience is going to say that we need to stop because the study is futile or will not reach the end point. They can say, which is obviously what we are hoping, that we need to stop the study at 400 due to efficacy, that we reach the point, or they can send us to the end of the study, the lower end of the study, which is expected to be below 630.

Speaker Change: We do not expect that they can say that we need to stop because the study is futile will not reach the endpoint. They can say which is obviously.

Speaker Change: What we are hoping that we need to stop the study at the 400 due to the efficacy that we reached a point or they can send us too.

Speaker Change: And of the study the lower end of the study, which is expected to be below 630 <unk>.

Dikla Akselbrad: And they also have a fourth option of upscaling the study. And then they will tell us just the overall lectures on Biolitics and Computational Science. Okay, great. That's helpful. Thanks. I guess, still on that point, the warrants, are they eligible for exercise if they recommend that the trial size goes above the 630? And can you remind us any potential advanced milestones on the interim? So, so the

And they also have a phone option.

Jonny Missulawin: General administrative expenses for the three months ended June 30, 2024, were $1.1 million compared to $1.5 million recorded in the same three month period of 2023. This decrease reflects our ongoing cost-containment efforts. For the three months ended June 30, 2024, the company had a net loss of $6.3 million as compared to $5.8 million in the second quarter of 2023.

Speaker Change: Upscaling the study.

Speaker Change: And then they will tell us just the overall patient number that is required at no point before on blinding. The data we will actually know the infection rate.

Speaker Change: Okay, Great that's helpful. Thanks.

Speaker Change: I guess still on that point that the warrants are they eligible for exercise.

Speaker Change: If they recommend that the trial size goes above the $6 30 and.

Speaker Change: Can you remind us any potential advance a milestone by the interim.

Operator: With that, we will now open the call to your questions. Operator? Thank you. Do ask a question. Please press star one and one on your telephone and wait for your name to be announced. Do we draw your question? Please press star one and one again. Once again, please press star one and one on your telephone and wait for your name to be announced. Do we get a question? Please press star one and one again. Thank you.

Speaker Change: Okay.

Speaker Change: So the.

Dikla Akselbrad: Warrants are sizable at any time within the coming two years. There is a triggering event that shortens the time for exercise if we are either stopping the study early due to efficacy or if we are sent to the minimum sample size, which is the end of the study, which is up to 630. If we extend to a lower number, there will be... Okay, great. And then any advance?

Speaker Change: Warrants are exercisable at any time within the coming two years.

Speaker Change: There is a triggering event that shortened the time for exercise if we are either stopping the study.

Speaker Change: Early due to efficacy.

Speaker Change: If we are sent to the minimum sample size, which is at the end of the study which is.

Speaker Change: Up to 630 were sent to a lower number there will be excess.

Operator: We are now going to proceed with our first question.

Speaker Change: Within 10 days from that point.

Roy Buchanan: The questions come from the line of Roy Buchanan from JMP.

Speaker Change: Okay, Great and then any add Brian.

Roy Buchanan: Please ask your question. Okay, thanks for taking the questions. I guess the first one, just the interim analysis coming up in the next quarter. What are the options or what you can announce? What should we expect? I guess if the trial continues to the final result, are you going to disclose the infection rate?

Dikla Akselbrad: You were asking about advance, yes. So, advance has several development milestones in the agreement, and the first one being positive topics. Okay, great. And then last one for me, I guess I know you guys are 110% focused on SHIELD2 in the interim, but just anything you can say about progress with partnering D-PLEX in additional geographies or with the broader platform. Thanks.

Speaker Change: About advanced yet so it does that have several development milestones in the women and the first one being positive top line results.

Speaker Change: Okay, Alright, and then last one for me I guess I know you guys are one.

Speaker Change: 110% focused on <unk> two in the interim but just anything you can say about.

Roy Buchanan: So, hi, good morning, Roy. So, first of all, start with the letter. We will not be aware of the infection rate. We will only guess the end point of the study. So, the options of the interim, the DSMB, who is also monitoring the safety data, will come back to us with several, one of three options. Pachaiyappan, the lower end of the study, which is expected to be below 630, and they also have a fourth option of upscaling the study, and then they will tell us just the overall patient number that is required at no point before unblinding the data we will actually know the fiction Okay great, that's a couple of things, and I guess still not point to the warrants, are they eligible for exercise if they recommend that the trial size goes above the 630, and can you remind us any potential advance milestones on the interim?

Speaker Change: Progress with partnering deeply and additional geographies or with the broader platform.

Speaker Change: So.

Dikla Akselbrad: As part of being 100% and more than 100% focused on deep legs, we are also progressing on commercialization. We said early in the year that we expected to see a commercialization deal coming this year and we are focusing on that, geographies in Europe where we already have an agreement. We've also indicated that in the previous quarter. I can say that we are in discussions on that. We still expect to sign before the deadline.

Speaker Change: As part of being a 100% and more than hunting sustained focus on deep links.

Speaker Change: Also progressing on commercialization discussions we said this early in the year that we expect to see commercialization deal coming this year and we are focusing on that different geographies in Europe that we have already.

Speaker Change: Have an agreement.

Speaker Change: We've also indicated that in previous quarter I can say that we are in discussions on that and something that has been sometimes and we still expect to sign before the data.

Dikla Akselbrad: You are also asking about the platform deal; this is another point, another aspect of our business development activities that is progressing. Again, I would expect to see a deal before the end of the year, as we said in our objection. Okay, thank you. Thank you. Once again, to ask a question, please press star 1 and 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 and 1 again. We are now going to proceed with our next question. The questions come from the line of Ram Selvaraju from HC Wainwright.

Speaker Change: You were also asking on platform deal. This is another another aspect of our business development activities. This is progressing again I would expect to see a deal before the end of the year.

Speaker Change: We said in our objective.

Speaker Change: Okay. Thank you.

Thank you once again to ask a question. Please press star one and one on your telephone and wait for your name to be announced until we've drilled your question. Please press star one and one again.

Speaker Change: We are not going to proceed with our next question.

Ron said: Two questions come from the line of Ron said, if I read you from H C. Wainwright. Please ask your question.

Operator: Please ask your question. Thank you very much for taking my questions. Can you hear me?

Ron said: Thank you very much for taking my questions can you hear me.

Roy Buchanan: So the warrants are sizable at any time within the coming two years. There is a triggering event that shorten the time for exercise if we are either stopping the study early due to efficacy, or if we are sent to the minimum sample size, which is the end of the study, which is up to 630, we are sent to a lower number, there will be exercise within 10 days from the point. Okay great, so we are asking about advance yet, so advance has several development marks on the agreement, and the first one being positive supply results.

Raghuram Selvaraju: Yeah, we owe you a good morning. Good morning.

Ron said: Yes, we hear you well good morning Graham.

Raghuram Selvaraju: So, I wanted to first of all ask if you could provide a little bit more granularity around the timing of the completion of the interim analysis. So, once you are in a position to conduct the interim analysis, can you share with us approximately how long you expect that process to take? And if you have a sense at this juncture, depending on when you start that process, when you might have the results in the first quarter of 2025, would it be earlier in the quarter or later in the quarter? So, let me try to clarify some of the points. You raised some very, very good points.

Speaker Change: Good morning, So I wanted to first of all ask if you could provide a little bit more granularity around the timing of the.

Speaker Change: The completion of the interim analysis.

Speaker Change: Once you are in a position to conduct the interim analysis can you share with us approximately how long do you expect that process to take and if you have a sense at this juncture depending on when you start that process when in the first quarter of 2025, you might have the result.

Speaker Change: Would it be earlier in the quarter or later in the quarter.

Speaker Change: Yeah.

Speaker Change: So.

Speaker Change: Let me try to clarify some some of the points you raised a very very good point.

Dikla Akselbrad: The interim is based on 400 patients. So once, and I expect that we will announce that we've reached 400. Once we reach 400 patients, it takes about two months until we get the DSMB recommendation, or once we get the full 400, approximately 400 patients for the interim at that point. It's 30 days for follow-up, and another 30 days for cleanup of the data and then getting the top-line data to the DSMB and a recommendation. So that that would give you.

Roy Buchanan: Okay great, and then last one for me I guess I know you guys are 110% focused on shield 2 in the interim, but just anything you can say about progress with partnering deplex and additional geographies are with the broader platforms. So as part of being 100% and more than 100% focused on deep legs, we are also progressing on commercialization discussion. We said this early in the year that we expect to see commercialization deals coming this year, and we are focusing on that different geographies in Europe that we've already have an agreement.

Speaker Change: <unk> is based on 400 patient so one and I expect that we will announce that we've reached 400 patient.

Speaker Change: Once we reach 400 patient it is about two months until we get the data SMB recommendation or once we get the full 400, approximately 400 patients for the interim for that point. It's two months, it's 30 days for follow up.

Speaker Change: And another 30 days for cleanup or cleanup of the data and then getting the <unk>.

Speaker Change: Top line data to the SMB and a recommendation.

Speaker Change: That would give you.

Dikla Akselbrad: Special Clarity on Timeline. This is why we said that we expected that the interim data would be in the fourth quarter of this year. With regard to the top line, since we are continuing to recruit patients, towards the end of the year, we should also be in a position where we've raised the full 600 pages. And then the top line is taking a little bit longer in terms of cleaning data and getting the unblinded data because you close the data. You cannot go back to the data after that. It's unblinding.

Speaker Change: Better clarity on time and this is why we said that we expect that the interim data will be at the fourth quarter of this year.

Roy Buchanan: We've also indicated that in previous quarter I can say that we are in discussions on that and something that has been sometimes, and we still expect to sign before the data. You are also asking on platform deal. This is another aspect of our business development activities that is progressing. Again, I would expect to see a deal before the end of the year, as we said in our objectives.

Speaker Change: With regards to the top line since we are continuing to recruit the patient.

Roy Buchanan: Okay, thank you. Thank you.

Speaker Change: Towards the end of the year, we should also be in a position that we've raised the full 600 patients.

Speaker Change: And then top client is taking a little bit longer in terms of cleaning data and getting the unblinded data because you've closed the data you cannot go back to the data after that it's on lighting. There is no going back to the data so it's a bit longer than that it's more of a in a quarter.

Dikla Akselbrad: There's no going back to the data, so it's a bit longer than that. It's more often a quarter.

Operator: Once again, to ask a question please press 121 on your telephone and wait for your name to be announced. Do we draw your question please press 121 and 1 again?

Speaker Change: And this is why we said the first quarter.

Speaker Change: Next year.

Operator: We are now going to proceed with our next question.

Dikla Akselbrad: And this is why we said the first quarter of, Okay, no, that's very helpful. Thank you. The second question I had was with respect to the underlying market dynamics for the shield to target indication and if you could maybe comment on what you are seeing specifically with respect to a return to the pre-COVID environment and the extent to which you expect that to persist going forward. In other words, you know, should we assume at this point that, for all intents and purposes, if nothing changes from a market environment perspective, that, you know, essentially, you will be reporting your top line data into a situation that, for all intents and purposes, in every way resembles the pre-COVID-19 market situation?

Speaker Change: Okay No that's very helpful. Thank you.

Speaker Change: The second question I had was with respect to the underlying market dynamics for the fields to target indication and if you can maybe comment on.

Dikla Akselbrad: And what are the implications of that for the market demand for a product like this? So, This is part of the reason that we wanted to hold a KOL event with Professor Richard Edmstone to really not give our opinion, but rather someone with a surgical site infection specialist working with hospital, working, teams within the hospital to try to reduced infection rate and try to educate teams on how to lower the surgical site infection rate and give his perspective on what, was the baseline prior to COVID, what happened during COVID, and what he's seeing these days when we are out of COVID.

Raghuram Selvaraju: The questions come from the line of Raghuram Selvaraju from H.C. Wainwright, please ask a question. Thank you very much for taking my questions. Can you hear me? Yeah, we are you well, good morning, Graham. Morning, so I wanted to first of all ask if you could provide a little bit more granularity around the timing of the completion of the interim analysis. So once you are in a position to conduct the interim analysis, can you share with us approximately how long you expect that process to take and if you have a sense of this juncture depending on when you start that process, when in the first quarter of 2025, you might have the results. Would it be earlier in the quarter or later in the quarter?

Speaker Change: What you are seeing specifically with respect to our return to the pre COVID-19 environment and the extent to which you expect that to persist going forward in other words should.

Speaker Change: Could we at this point assume that for all intents and purposes, if nothing changes from a market environment perspective that essentially you will be reporting your topline data into a situation that effectively for all intents and purposes in every way.

Speaker Change: Or is that both the pre COVID-19 market situation and what are the implications of that for.

The market demand for a product like this.

Speaker Change: So.

Raghuram Selvaraju: So let me try to clarify some of the points. You raised very, very good points. The interim is based on 400 patients. So once and I expect that we will announce that we've reached 400 patients. Once we reach 400 patients, it is about two months until we get the DSMB recommendation. Or once we get the full 400 approximately 400 patients for the interim for that point, it's two months. It's 30 days for follow-up and another 30 days for cleanup of the data and then getting the top line data to the DSMB and a recommendation. So that would give you better clarity on time.

Speaker Change: This is part of the reason that we wanted to hold a carryover real event with professor Richard Ed and stone to really not give our opinion, but rather as someone who is a surgical site infection, especially working with hospitals working with.

Speaker Change: Teams within the hospital.

Speaker Change: To.

Speaker Change: Try to.

Richard Edstone: Reduced infection rates and try to educate teams on how to lower the surgical site infection rate and give his perspective.

Richard Edstone: What was the baseline prior to call it would have been doing coffee and what he's seeing.

Speaker Change: These days when when we are out of coffee to be more specific on your question, we do assume that when we publish the data.

Dikla Akselbrad: To be more specific, on your question, we do assume that when we publish the data, we will be similar to what we are now, and what is being observed now, that we will be closer to the baseline infection rate prior to COVID. Obviously, with regard to the study itself, we are blinded, so we are not exposed to the data.

Raghuram Selvaraju: And this is why we said that we expect that the interim data will be at the fourth quarter of this year. Which regards to the top line since we are continuing to recruit the patient. Towards the end of the year, we should also be in a position that we raised the full 600 patients. And then top line is taking a little bit longer in terms of cleaning data and getting the underlying data because you close the data. You cannot go back to the data after that. It's unlining. There's no going back to the data. So it's a bit longer than that. It's more for in a quarter.

Speaker Change: Will be similar to what we what is.

Speaker Change: Being able to serve now that we will be at a more close to baseline infection rate prior to COVID-19.

Speaker Change: With regards to the study itself. We are blinded. So we are not exposed to the data.

Dikla Akselbrad: And we cannot, the only thing that we can say is, and we said this in today's formal presentation, that the key patient enrollment trend that we identified on our last call is continuing. We see, and a comparability between shield 1 and shield 2 in the demographics and the patient population, obviously comparing the large incision to the large incision.

And we cannot the only thing that we can say is and we said this in this are in todays formal presentation that the key patient enrollment trends.

Speaker Change: That we identified on our last call are continuing we see.

Speaker Change: Permeability between shield, one in Q2, and the demographic and the patient population, obviously, comparing the larger decision to the larger decision and for US. This is very encouraging.

Raghuram Selvaraju: And this is why we said the first quarter of next year. Okay. No, that's very helpful. Thank you.

Dikla Akselbrad: And for us, this is very encouraging. We view this as the de-risking of... Okay, great.

Raghuram Selvaraju: The second question I had was with respect to the underlying market dynamics for the Shield2 target indication. And if you can maybe comment on what you are seeing specifically with respect to a return to the pre-COVID environment and the extent to which you expect that to persist going forward. In other words, should we at this point assume that for all intents and purposes if nothing changes from a market environment perspective, that essentially you will be reporting your top line data into a situation that effectively for all intents and purposes in every way resembles the pre-COVID-19 market situation. And what are the implications of that for the market demand for a product like?

Speaker Change: We view this as derisking of the study.

Raghuram Selvaraju: And then the last question for me is, assuming a hypothetical situation, which I think obviously we all are expecting, that the interim analysis is positive, can you give us a sense of how you expect your DNA spending to evolve from that point? In other words, are you going to engage in any additional market preparation activity prior to the release of the final top line data but after the release of positive interim analysis results, or are you going to effectively keep G&A expenses at a more modulated run rate until after the top line analysis? In other words, what I'm really asking is, when do you expect G&A spending to ramp up as you contemplate the possibility of introducing the product into the market?

Speaker Change: Okay, Great and then the last question from me is.

Speaker Change: A hypothetical situation.

Speaker Change: I think obviously, we all are expecting that the interim analysis is positive.

Can you give us a sense of how you expect your G&A spending to evolve from that point in other words.

Speaker Change: Are you going to engage in any additional market preparation.

Speaker Change: Activity.

Speaker Change: Prior to the release of the final top line data, but after release of positive interim analysis results or are you going to effectively keep G&A expenses at a more modulator run rate until after the topline analysis in other words, what I'm really asking it.

Raghuram Selvaraju: So, this is part of the reason that we wanted to hold a K.O.E, event with Professor Richard Edimstone to really not give our opinion but rather someone with a surgical site infection specialist working with hospitals, working with teams within the hospital to try to reduce infection rate and try to educate teams on how to lower the surgical site infection rate and give his perspective on what was the baseline prior to COVID, what happened during COVID and what he's seeing these days when we are out of COVID. To be more specific on your question, we do assume that when we publish the data, we will be similar to what we are being observed now, that we will be at more close to baseline infection rate prior to COVID, obviously with regards to the study itself, we are blinded so we are not exposed to the data and we cannot, the only thing that we can say is, and we said this in today's the formal presentation that the key patient enrollment trends that we identified on our last goal are continuing.

Speaker Change: When do you expect G&A spending to ramp up as you contemplate the possibility of introducing the product into the market.

Dikla Akselbrad: This is a very good point. I would start by saying that from our perspective and also the investor that participated in the last round, a positive interim will be either stopping at the interim or going to the minimum size. Both, in our view, are good income at the interim, and this is why this is how the triggering event is defined for the warrant. With regard to DNA, we do not foresee a substantial increase and an extended chair there.

Speaker Change: This is a very good point I would start by saying that from our perspective and also the investor that participated in the last call a positive into them will be either stopping.

Speaker Change: At the interim or going to the minimum size of the 600 patient both.

Speaker Change: Our view is a good income with the increment. This is why this is how the triggering event as defined for them.

Speaker Change: Sure.

Speaker Change: Hum.

Speaker Change: We got to the G&A.

Speaker Change: We do not see we do not foresee.

Speaker Change: Potential increase.

Speaker Change: AMD extended share there.

Dikla Akselbrad: Obviously, there will be some modification as we grow and as we continue to sign additional collaboration deals around D-PLEX, but again, looking at the agreement that we have with ADDVANCE, most of the... responsibility for marketing, on the medical affairs, on reaching the hospital is on the part of the part. So there will be some increase, but we do not foresee anything that will immediately change significantly RPM.

Speaker Change: Obviously, there will be some modification as we grow and as we continue to sign additional collaborations.

Speaker Change: Collaboration deal around duplex, but again looking at the agreement that we have with advance.

Speaker Change: Most of the responsibility on the marketing on the medical affair.

Speaker Change: On reaching out to the hospital is on the partners.

Speaker Change: It will be some increase but we do not foresee something that.

Speaker Change: Well immediately changed significantly our P&L.

Raghuram Selvaraju: We see a comparability between shield one and shield two in the demographic and the patient population, obviously comparing the large incision to the large incision and for us this is very encouraging and we view this as the risking of the study.

Raghuram Selvaraju: Thank you very much. Thank you. We have no further questions at this time. I want to hand back to Dikla Akselbrad for closing remarks. Thank you for joining PolyPid in second quarter 2024. We remain highly confident in our long-term prospects, especially the potential of our promising late-stage products candidate, Douglas Buchanan.

Speaker Change: Thank you very much.

Speaker Change: Okay.

Thank you we have no further questions at this time I will now hand back to Declaw Jetskis Axa, Brian for closing remarks.

Speaker Change: Thank you for joining policies second quarter 2024 earnings conference call.

Raghuram Selvaraju: Okay, great, and then the last question for me is, assuming a hypothetical situation, which I think obviously we all are expecting, that the interim analysis is positive. Can you give us a sense of how you expect your DNA spending to evolve from that point? In other words, are you going to engage in any additional market preparation activities prior to the release of the final top line data, but after release of positive interim analysis results, or are you going to effectively keep DNA expenses at a more modulated run rate until after the top line analysis? In other words, what I'm really asking is, when do you expect DNA spending to ramp up as you contemplate the possibility of introducing the product into the market?

Speaker Change: We remain highly confident in our long term prospects, especially the potential of a promising late stage product candidates.

Speaker Change: 100, <unk> as always we are grateful to our team members shareholders and all external partners for their commitment to our mission and support and continuing to advance toward our goal of bringing <unk> 102 health care providers and patients as quickly as possible.

Dikla Akselbrad: As always, we are grateful to our team members, shareholders, and all external partners for their commitment to our mission and support in continuing to advance toward a goal of bringing DIPLEX-100 to healthcare providers and patients as quickly as possible. We look forward to speaking with you again on our next call. This concludes today's conference call. Thank you all for participating. You may now disconnect your lines. Thank you. Music Music, [music] Raghuram Selvaraju, Brian Ritchie, Dikla Akselbrad Brian Ritchie, Dikla Akselbrad, Jonny Missulawin, Brian Ritchie, Dikla Akselbrad Brian Ritchie, Dikla Akselbrad, Jonny Missulawin, Brian Ritchie, Dikla Akselbrad, Jonny Missulawin, Brian Ritchie, Dikla Akselbrad Brian Ritchie, Dikla Akselbrad, Jonny Missulawin, Brian Ritchie, Dikla Akselbrad, Jonny Missulawin Brian Ritchie, Dikla Akselbrad, Jonny, Raghuram Selvaraju, Raghuram Selvaraju, Raghuram Selvaraju Raghuram Selvaraju, Raghuram Selvaraju, BOOBALAN PACHAIYAPPAN, Raghuram Selvaraju, Brian Ritchie, Dikla Akselbrad, Jonny Missulawin, Ori Warshavsky, PolyPid BOOBALAN PACHAIYAPPAN, Raghuram Selvaraju, Brian Ritchie, Dikla Akselbrad, Jonny Missulawin, Ori Warshavsky, PolyPid BOOBALAN PACHAIYAPPAN, Raghuram Selvaraju, Brian Ritchie, Dikla Akselbrad, Jonny Missulawin, Ori Warshavsky, PolyPid BOOBALAN PACHAIYAPPAN, Raghuram Selvaraju, Brian Ritchie, Dikla Akselbrad, Jonny Missulawin, Ori Warshavsky, PolyPid BOOBALAN PACHAIYAPPAN, Raghuram Selvaraju, Brian Ritchie, Dikla Akselbrad, Jonny Missulawin, Ori Warshavsky, PolyPid BOOBALAN PACHAIYAPPAN, Raghuram Selvaraju, Brian Ritchie, Dikla Akselbrad, Jonny Missulawin, Ori Warshavsky, PolyPid BOOBALAN PACHAIYAPPAN, Raghuram Selvaraju, Brian Ritchie, Dikla Akselbrad, Jonny Missulawin, Ori Warshavsky, PolyPid, Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music, Raghuram Selvaraju, Brian Ritchie, Dikla Akselbrad Jonny Missulawin Selvaraju, Brian Ritchie, Dikla Akselbrad, Jonny Missulawin Selvaraju, Brian Ritchie, Dikla Akselbrad, Jonny Missulawin Selvaraju Brian Ritchie, Dikla Akselbrad, Jonny Missulawin Selvaraju, Brian Ritchie, Dikla Akselbrad, Jonny Missulawin Selvaraju

Speaker Change: Look forward to speaking with you again on our next conference call.

Speaker Change: Okay.

Speaker Change: This concludes today's conference call. Thank you all for participating you may now disconnect your lines. Thank you.

Speaker Change: Okay.

Speaker Change: [music].

Raghuram Selvaraju: So, this is a very good point. I would start by saying that from our perspective and also the investor that participated in the last round, a positive interim will be either stopping at the interim or going to the minimum size of the 600 patients, both on our view is a good income at the interim. And this is why this is how the triggering event is defined for the warrant, which regards to the DNA, we do not foresee a substantial increase in the expenditure there.

Raghuram Selvaraju: Obviously, there will be some modification as we grow and as we continue to sign additional collaboration deal around deplex, but again, looking at the agreement that we have with and most of the responsibility on the marketing, on the medical affairs, on reaching how to the hospital is on the part, so there will be some increase but we do not foresee something that will immediately change significantly on P&L.

Raghuram Selvaraju: Thank you very much.

Dikla Akselbrad: Thank you, we have no further questions on this time, I will now hand back to Dikla, Judge Gis, Akselbrad, Focusing Remarks. Thank you for joining PolyPid's second quarter, 2024 and its conference hall. We remain highly confident in our long-term prospects, especially the potential of our promising late-stage product candidate, Dikla's 100. As always, we are grateful to our team members, shareholders and all external partners for their commitment to our mission and support in continuing to advance for a goal of bringing Dikla's 100 to healthcare providers and patients as quickly as possible. We look forward to speaking with you again on our next conference call.

Speaker Change: Okay.

Speaker Change: Sure.

Speaker Change: [music].

Operator: This concludes today's conference call. Thank you all for participating in our Disconnect Your Lines. Thank you.

Yes.

Speaker Change: [music].

Speaker Change: Yeah.

Speaker Change: [music].

Unknown Attendee: [inaudible] Thank you all for joining us today, thank you all for joining us today[inaudible] us today, thank you all for joining us today, thank you all for joining us today[inaudible] Thank you all for joining us today, thank you all for joining us today[inaudible] Raghuram Selvaraju, Raghuram Selvaraju, Raghuram Selvaraju, Raghuram Selvaraju, Raghuram Selvaraju, Raghuram Selvaraju, Raghuram Selvaraju, Raghuram Selvaraju, Raghuram Selvaraju,[inaudible] Raghuram Selvaraju, Raghuram Selvaraju, Raghuram Selvaraju, Raghuram Selvaraju, Raghuram Selvaraju, Raghuram Selvaraju, Raghuram Selvaraju, Raghuram Selvaraju, Raghuram Selvaraju, Raghuram Selvaraju, Raghuram Selvaraju, Raghuram Selvaraju,[inaudible] Raghuram Selvaraju[inaudible] Raghuram, Raghuram[inaudible] Raghuram, Raghuram Selvaraju, Dr. Ritchie, Dr. Ritchie, Dikla Akselbrad, Jonny Missulawin, Ritchie, Dikla Akselbrad Dr. Ritchie, Dr. Ritchie, Dikla Akselbrad, Jonny Missulawin, Ritchie, Dikla Akselbrad Ritchie, Dikla Akselbrad, Jonny Ritchie, Dikla Akselbrad

Speaker Change: Okay.

Speaker Change: [music].

Speaker Change: Okay.

Speaker Change: Perfect.

[music].

Speaker Change: Okay.

Speaker Change: [music].

Speaker Change: Okay.

Speaker Change: Thank you.

Speaker Change: [music].

Speaker Change: Yes.

Speaker Change: [music].

Speaker Change: Thank you.

Speaker Change: [music].

Speaker Change: Yes.

Speaker Change: [music].

Speaker Change: Okay.

Speaker Change: [music].

Speaker Change: Yes.

[music].

Speaker Change: Yes.

Speaker Change: [music].

Speaker Change: Okay.

Speaker Change: Sure.

Speaker Change: Yes.

Speaker Change: Yes.

Speaker Change: Yes.

Speaker Change: [music].

Speaker Change: Okay.

Speaker Change: Okay.

Speaker Change: Okay.

[music].

Speaker Change: Sure.

Speaker Change: [music].

Speaker Change: Okay.

Speaker Change: [music].

Speaker Change: Okay.

Speaker Change: Yes.

Speaker Change: Okay.

Yes.

Speaker Change: [music].

Speaker Change: Yes.

Speaker Change: Yes.

Speaker Change: Yes.

Yes.

Speaker Change: [music].

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Speaker Change: [music].

Speaker Change: Sure.

Speaker Change: Okay.

Speaker Change: Okay.

Speaker Change: Yes.

Speaker Change: [music].

Speaker Change: Okay.

Speaker Change: Okay.

Speaker Change: Okay.

Speaker Change: [music].

Speaker Change: Okay.

Speaker Change: [music].

Speaker Change: Yes.

Speaker Change: [music].

Speaker Change: Yes.

Speaker Change: Okay.

Speaker Change: [music].

Speaker Change: Yes.

Speaker Change: [music].

Okay.

Speaker Change: [music].

Speaker Change: Yes.

Speaker Change: Great.

Speaker Change: [music].

Speaker Change: Okay.

Speaker Change: Okay.

Speaker Change: [music].