Q1 2025 PolyPid Ltd Earnings Call
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Okay.
Unknown Attendee: Good day and thank you for standing by.
Speaker Change: Good day, and thank you for standing by walking through the Poly Pete first quarter 2025 conference call.
Unknown Attendee: Welcome to the PolyPid First Quarter 2025 conference call. At this time all participants are in a listen-only mode. After the speaker's presentation there will be a question and answer session.
Speaker Change: At this time, all participants southern Edison only language after the speaker's presentation. There will be a question and answer session to ask a question Jobin. This session you will need to press star one one on your telephone you will then have an automated message advice and Johan just raised.
Unknown Attendee: To ask a question during this session you will need to press star 1 1 on your telephone. You will then hear an automated message advising your hand is To withdraw your question please press star 1 1 again. Please be advised that today's conference is being recorded.
Speaker Change: Withdraw your question. Please press star one one again, please be advised that today's conference is being recorded.
Brian Ritchie: I would now like to hand the conference over to your speaker today, Brian Ritchie. Please go ahead.
Speaker Change: Now I'd like to hand, the conference virtual Speaker today, Brian Ritchie. Please go ahead.
Brian Ritchie: Thank you all for participating in PolyPid's first quarter 2025 earnings conference call.
Speaker Change: Thank you all for participating and poly Pizza first quarter 2025 earnings conference call.
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, U.S., of PolyPid.
Speaker Change: Joining me on the call today will be <unk> traffic is actual Brad Chief Executive officer of Poly Pete.
Johnny Miss: Johnny Miss allowing poly pitch, Chief financial Officer, and already workshop sheet, Chief operating Officer U S Poly Pete.
Brian Ritchie: Earlier today, PolyPid released its financial results for the three months ended March 31st, 2021. The copy of the press release is available in the investor section on the company's website www.polypid.com.
Speaker Change: Pete.
Earlier today <unk> released its financial results for the three months ended March 31 2025.
Speaker Change: A copy of the press release is available in the investors section on the company's website www Dot <unk> dot com.
Brian Ritchie: I'd like to remind you that on this call, management will make forward-looking statements within the meaning of the federal securities laws. For example, management is making forward-looking statements when it discusses the potential efficacy of DPLEX-100 and the probability of success of the trial, that the gross proceeds from the company's last financing extend the company's cash runway into the third quarter of 2025 beyond the expected top-line results from SHIELD-2, the expected timing for top-line results from the SHIELD-2 trial, potential NDA and MAA submissions and the timing thereof, preparations for regulatory submissions, finalization of CMC and non-clinical NDA modules.
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 potential efficacy of <unk> 100, and the probability of success of the trial that the gross proceeds from the Companys last Friday.
Speaker Change: It's an extended the company's cash runway into the third quarter of 2025 beyond the expected top line results from shield two you.
Speaker Change: The expected timing with topline results from the shield II trial potential NDA and MAA submissions and the timing thereof.
Speaker Change: Preparations for regulatory submissions.
Speaker Change: Finalization of CMC and non clinical NDA modules protect.
Brian Ritchie: Potential clinical benefits of DeepFlex 100, potential market size for DeepFlex 100 in the United States.
Speaker Change: Potential clinical benefits of duplex 100.
Speaker Change: Central market size for duplex 100 in the United States potential partnership opportunities the potential to receive up to an additional $27 million from the exercise of the warrants from the recent financing.
Brian Ritchie: Potential partnership opportunities.
Brian Ritchie: Unknown Attendee, Raghuram Selvaraju, Brian Ritchie, Dikla Akselbrad, Jonny Missulawin, Ori Warshavsky, PolyPid Unknown Attendee, Raghuram Selvaraju, Brian Ritchie, Dikla Akselbrad, Jonny Missulawin, Ori Warshavsky, PolyPid The company's long-term prospects. 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 filing. The company's results may differ materially from those projected. These statements involve material risks and uncertainties that could cause actual results or events to be materially different. Accordingly, you should not place undue reliance on these.
Speaker Change: The company's anticipation that with such traditional funding its runway would be extended beyond anticipated NDA approval.
Speaker Change: Maturities for the use of duplex 100 in additional procedures in the company's long term prospects.
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.
Speaker Change: The company's results may differ materially from those projections.
Speaker Change: These statements involve material risks and uncertainties that could cause actual results or events to materially differ.
Speaker Change: Accordingly, you should not place undue reliance on these statements.
Brian Ritchie: 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 statement.
Speaker Change: Encourage you to review the company's filings with the Securities and Exchange Commission, including.
Speaker Change: 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 statements.
Brian Ritchie: 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 otherwise.
Speaker Change: <unk> disclaims any intention or obligation, except as required by law to update or revise any financial projections or forward looking statements, whether because of new information future events or otherwise.
Brian Ritchie: This conference call contains time sensitive information and speaks only as of the live broadcast today, May 14th, 2020.
Speaker Change: This conference call contains time sensitive information and speaks only as of the live broadcast today may 14th 2025.
Brian Ritchie: With the completion of those prepared remarks, it is my pleasure to turn the call over to Dikla Tchotchkes-Akselbrad, CEO of PolyPid. Thank you, Brian.
Poly Pete: With the completion of those prepared remarks. It is my pleasure to turn the call over to <unk> CEO Poly Pete.
Speaker Change: Okay.
Dikla Akselbrad: On behalf of our team at PolyPid, I would like to welcome everyone to our first quarter 2025 Earnings Conference.
Poly Pete: Thank you Brian on behalf of our teammates quality I would like to welcome everyone to our first quarter 2025 earnings conference call.
Dikla Akselbrad: We were thrilled to recently successfully conclude enrollment of the SHIELD-2 Phase III trial assessing the efficacy of DIPLEX-100 for the prevention of surgical site infection in patients undergoing abdominal colorectal As a reminder, this significant milestone followed an independent Data Safety Monitoring Board, or DSMB, recommendation to conclude the SHIELD2 phase 3 trial of DIPLEX-100 at the lowest sample size reassessment. 800 patients. After the minimum planned number of. We are now rapidly approaching the availability of top-line data by the end of next month. To reiterate what we have said previously, we view the DSMB's recommendation to conclude Shield 2 upon the enrollment of 800 patients as a favorable outcome.
Poly Pete: We were thrilled to recently successfully conclude enrollment of the shield two phase III trials assessing the efficacy of.
Poly Pete: <unk> 100 for the prevention of surgical site infection in patients undergoing abdominal colorectal surgery.
Poly Pete: As a reminder, this significant milestone followed an independent data safety monitoring board or DSP. The commendation to conclude this year to phase III duplex 100 at the lowest sample size reassessment stock.
Poly Pete: 800 patients.
Poly Pete: After the minimum plan number of patient.
Poly Pete: We are now rapidly approaching the availability of topline data by the end of next month.
Poly Pete: Reiterate what we have said previously we view the D smbs recommendation to conclude shoot to occur.
Poly Pete: The environment of 800 patient as a favorable outcome.
Dikla Akselbrad: as it is suggestive of positive efficacy signals from DIPLEX-100. Of course, the data generated from SHIELD2 to date remain fully blinded to PolyPid and others outside of the DSMB until top line results are available.
Poly Pete: As it is suggestive of positive efficacy signals from duplex 100.
Poly Pete: Of course, the data generated from shield two to date, we remain fully blinded to qualified and others outside of the SMP until topline results.
Dikla Akselbrad: Upon potential positive phase three data, PolyPid expects to submit a new drug application, or NDA, with the advantages of the fast track and breakthrough therapy designations in early 2020. with a Marketing Authorization Application or MAA submission in the EU anticipated shortly thereafter.
Doug.
Poly Pete: Upon potential positive phase III data publicly and expect to submit a new drug application or NDA with the advantages of the fast track and breakthrough therapy designation in early 2026, with a marketing authorization application or MAA submission in the EU.
Poly Pete: Anticipated shortly thereafter.
Dikla Akselbrad: Importantly, as a result of our December 2024 $15 million financing, we are funded into the third quarter of 2020. beyond the expected top line results from Shield. Further, data-triggered warrants from this financing, if exercised in full, would result in an additional $27 million. We anticipate that with such additional funding, a runway would be extended beyond anticipated NDA approaches.
Poly Pete: Importantly, as a result of our December 2020 for $15 million financing, we are funded into the third quarter of 2025.
Poly Pete: Beyond the expected top line results from shield two.
Poly Pete: The data tweak it words from this financing if exercised in full would result in an additional $27 million.
Poly Pete: We anticipate that with such additional funding a runway would be extended beyond the anticipated NDA approval.
Dikla Akselbrad: While we await the SHIELD-2 trial top-line data readout, we are intensely focused on advancing the preparation of our regulatory submission. With the anticipated NDA filing timeline of early 2026 in mind, CMC and non-clinical NDA modules are currently being filed. Additionally, we continue to progress pre-launch activities and expedite partnership discussions in and outside the United States.
Poly Pete: While we await the <unk> two trial topline data readout.
Poly Pete: We are intensely focused on advancing the preparation of our regulatory submission.
Poly Pete: With the anticipated NDA filing timeline early 2026 in mind CMC and non clinical NDA modules are currently being finalized at.
Poly Pete: Additionally, we continue to progress prelaunch activities and expedite partnership discussion.
Poly Pete: And outside the United States.
Dikla Akselbrad: Importantly, identifying a U.S. partner is the path we have strategically identified as the most effective commercial course for the Plex 100. Finding the right partner with an existing dedicated hospital product sales force with significant resources will best enable DIPLEX-100 to maximize its sales potential in the US, which we believe is substantial. To this end, as Ori will detail shortly, US partnering interest in DPLEX-100 is gaining meaningful momentum amongst multiple parties as we approach our pivotal data reach.
Poly Pete: Importantly, identifying a U S partner is the path, we have strategically identified as the most effective commercial costs for the next 100.
Poly Pete: Finding the right partner with an existing dedicated hospital product sales force with significant resources.
Poly Pete: Best in April duplex 100 to maximize sales potential in the U S, which we believe is substantial.
Poly Pete: To this end as already will detail shortly U S. Partnering interest in duplex 100 is gaining meaningful momentum.
Poly Pete: Multiple parties as we approach our pivotal data readout.
Ori Warshavsky: With that, I will now turn the call over to Ori to revisit the DeepLabs 100 market potential and review our partnering efforts. Ori? Thank you, Dikla. As we get closer to the end of the SHIELD 2 trial, I would like to reiterate the market potential for Deeplex 100 and provide an update on our partnering Thank you, Dikla. To begin, as we discussed previously, and as it relates to SHIELD 2, a CDC report published in November 2024 tracking hospital-acquired infections in over 3,000 hospitals. showed an increase of 3% in SSIs across all surgeries in 2023 as compared to 2022.
Poly Pete: With that I will now turn the call over to Ali to revisit the deepest 100 market potential and we view our partnering efforts.
Speaker Change: Thank you <unk>.
Speaker Change: As we get closer to the end of the shoot to try I would like to reiterate the market potential for <unk> 100, and provide an update on our partnering discussions to begin.
Speaker Change: As we discussed previously and as it relates to shale to a <unk>.
Speaker Change: <unk> reports published in November 2020 for tracking hospital acquired infections in over 3000 hospitals showed an increase of 3% in ssi across all surgeries in 2023 as compared to 2022.
Ori Warshavsky: This important data confirms the increase in SSIs post-COVID following the decrease in SSIs during the COVID years that we observed in the SHIELD1. From a commercial perspective, as I reviewed on our last quarterly conference. Based on our QVR data, we believe the total addressable market for DPLEX-100 in the U.S. is just over 12 million total surgeries annually, with approximately 4.4 million of these being abdominal soft tissue surgeries and additional 2.1 million abdominal procedures, principally in gynecology and urology.
Speaker Change: These important data confirms the increase in exercise post coffee following the decreasing exercised during the COVID-19 years that we observed in the shield one study.
Speaker Change: From a commercial perspective as I reviewed on our last quarterly conference call.
Speaker Change: Based on <unk> data, we believe the total addressable market for <unk> 100 in the U S is just over 12 million total surgeries annually with approximately $4 4 million of these being abdominal soft tissue surgeries and additional $2 1 million abdominal procedures principally in Guyana.
Speaker Change: Technology and urology.
Ori Warshavsky: I would like to dive a bit deeper into this surgery. Our recent market research flagged four groups of surgeons as potential users for DPLX-100 beyond colorectal surgery. These are general surgeons, hepato-pancreatobiliary surgeons, urology surgeons, and oncogenicology. The surgeons who took part in the research were many clinical department heads and have flagged several high-risk procedures, including exploratory laparotomy and mastectomy in general surgery. Whipple Procedure in Hepato-Pancreatobiliary Surgery, Thystectomy and Nephrectomy in Neurology Surgery, and C-section, Hysterectomy and Ovarian Tumor Removal in the Oncogyn. These eight surgical procedures represent an area of great unmet need with a total of close to 1.5 million inpatient open procedures per year in the U.S.
Speaker Change: I would like to dive a bit deeper into these surgeries.
Speaker Change: Our recent market research flagged for groups of surgeons, it's potential users for duplex 100 beyond colorectal surgeries. These are general surgeons.
Speaker Change: Part of pancreatic beta resurgence urology surgeons and encore gynecology surgeons.
Speaker Change: The surgeons, who took part in the research were mainly clinical department heads and flagged several high risk procedures, including exploratory laparotomy and mastectomy in general surgery.
Speaker Change: Bill procedure in Hepatopancreatic auxiliary surgery.
Speaker Change: Cystectomy and nephrectomy in urology surgery, and C section hysterectomy and ovarian tumor removal in the encore Gyn's space.
Speaker Change: These eight surgical procedures represent an area of great unmet need with a total of close to $1 5 million in patient open procedures per year in the U S and can serve as a starting point for piloting and championing duplex 100 post launch in major hospitals across the country.
Ori Warshavsky: and can serve as a starting point for piloting and championing DPLX-100 post-launch in major hospitals across the globe. We are optimistic that the U.S. market is substantial and that it represents a viable and attainable commercial opportunity for Deeplex 100. The larger global market offers additional room for growth and, if approved, DIPLEX-100 could potentially significantly transform the surgical landscape.
Speaker Change: We are optimistic that the U S market is substantial and that it represents a viable and attainable commercial opportunity for <unk> 100.
Speaker Change: The larger global market offers additional room for growth and if approved duplex 100 could potentially significantly transformed the surgical landscape, where post operative Ssi remains a burden on the health care system as well as on patients.
Ori Warshavsky: where post-operative SSI remains a burden on the healthcare system as well as on Moving to our partnering discussions, we continue to intensively seek partners to support commercialization efforts of DPLEX-100 with the U.S. market being our main priority. The upcoming top-line results of SHIELD 2 represent a major milestone, and it creates a healthy competition among potential partners to be ready to advance into further negotiation and dealmaking once the study outcomes are known. As a result, we are in advanced discussions and due diligence stage with multiple potential partners in the U.S. and expect others to join the process once the top-line data is released.
Speaker Change: Moving to our partnering discussions we continue to intensively seek partners to support commercialization efforts of duplex 100, with the U S market being our main priority.
Speaker Change: The upcoming topline results of shield to represent a major milestone and it creates a healthy competition among potential partners to be ready to advance into further negotiation and dealmaking. Once the study outcomes are unknown.
Speaker Change: As a result, we are in advanced discussions and due diligence stage with multiple potential partners in the U S and expect others to join the process once the top line data is weak.
Ori Warshavsky: Regarding Europe, as a reminder, we already have an exclusive licensing agreement in place with Advanced Pharma to commercialize Deeplex 100 in all European countries, and we are currently actively working together to plan and start implementing pre-launch activities to maximize Deeplex 100 anticipated launch in Europe.
Speaker Change: Regarding Europe as a reminder, we already have an exclusive licensing agreement in place with advanced farmer Mac to commercialize duplex 100 in all European countries and we are currently actively working together to plan and start implementing prelaunch activities to maximize duplex 100 <unk>.
Speaker Change: A beta launch in Europe.
Jonny Missulawin: With that, it is my pleasure to now turn the call over to Jonny to review the Thank you, Ori. We are pleased to be in a solid financial position as we await the top-line results of the SHIELDS-II trial. expected by the end of the current quarter. As of March 31, 2025, the company had cash and cash equivalents of $8 million. We expect that our current cash balance will be sufficient to fund operations into the third quarter of 2025.
Speaker Change: With that it is my pleasure to now turn the call over to Johnny to review the financials Johnny.
Johnny Miss: Thank you Laurie we are pleased to be in a solid financial position as we await the top line results of the shield two trial expected by the end of the current quarter.
Johnny Miss: As of March 31, 2025, the company had cash and cash equivalents of $8 million.
Johnny Miss: We expect that our current cash balance will be sufficient to fund operations into the third quarter of 2025.
Jonny Missulawin: Now, let's turn to our income state. Research and development expenses for the three months ended March 31, 2025 were $6.1 million compared to $5.1 million in the same three-month period of 2024. R&D expenses in the most recently completed quarter were driven by the ramp-up of the ongoing SHIELD 2 Phase 3 trial. Marketing and business development expenses for the first quarter of 2025 were $0.3 million compared to $0.2 million during the prior year period. General and administrative expenses for the first quarter of 2025 were $1.2 million compared to $1 million recorded in the same three-month period of 2024.
Johnny Miss: Now, let's turn to our income statement research and development expenses for the three months ended March 31, 2025 were $6 1 million compared to $5 1 million in the same three months period of 2024.
Johnny Miss: R&D expenses in the most recently completed quarter was driven by the ramp up of the ongoing <unk> phase III trial.
Johnny Miss: Marketing and business development expenses for the first quarter of 2025 or zero point $3 million compared.
Johnny Miss: Compared to zero point $2 million during the prior year period.
Johnny Miss: General and administrative expenses for the first quarter of 2025 were $1 2 billion.
Johnny Miss: Impaired to $1 million recorded in the same three months period of 2024.
Jonny Missulawin: For the first quarter of 2025, the company had a net loss of $8.3 million, as compared to $6.4 million in the first quarter of 2024.
Johnny Miss: For the first quarter of 2025, the company had a net loss of $8 $3 million as compared to $6 $4 million in the first quarter of 2024.
Unknown Attendee: With that, we will now open the call to your questions. Operator. Thank you. As a reminder, to ask a question, you will need to press star 1 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1, 1 again.
Johnny Miss: With that we will now open the call to your questions operator.
Johnny Miss: Thank you as a reminder to ask a question you will need to press star one on your telephone and wait for your name to be announced to withdraw your question. Please press star one.
Johnny Miss: One again.
Chase Knickerbocker: We will take our first question and the first question comes from the line of Roy Buchanan from JMP Securities. Please go ahead, your line is open. Hey, great. Thanks for taking the questions.
Johnny Miss: We will take our first question.
Speaker Change: On the first question comes from the line of will it be come in from JMP Securities. Please go ahead. Your line is open.
Speaker Change: Hey, great. Thanks for taking the questions I guess to start can you just discuss how youre thinking about.
Chase Knickerbocker: I guess to start, can you just discuss how you're thinking about the price per vial for dPlex 100? Because I think it's substantially above our model today. And then just remind me the vials per procedure. And how did you arrive at the price that you're at today?
The price per vial for duplex 100, because I think it's substantially above.
Speaker Change: Our model today, and then just remind me the vials per procedure.
Speaker Change: And how did you arrive at the price that youre at today. Thanks.
Dikla Akselbrad: So first, we have not finalized the pricing strategy and pricing steps. Good morning, guys. I will start with that. And thank you for the question. We have not finalized the pricing strategy at this stage. And we did some preliminary research along the development stages, and we will do another study once we have the top line data in the very near future, as we would want to refine things. Pricing has changed, indexes changed, and having on hand the actual efficacy on SSI, on mortality, and on reintervention could affect the pricing here. Also, I think that as we've developed the product and started to get results and speaking with more and more surgeons, we have a better understanding of the target market opportunity.
Speaker Change: So first we have not finalized the pricing strategy and pricing Scott.
Speaker Change: Morning Glory.
I'll start with that and thank you for the question.
Speaker Change: We have not finalized our pricing strategy at this stage.
Speaker Change: We did some preliminary research along the development stages, and we will do another study once we have the topline data.
Speaker Change: In the very near future as we would want to refine things the pricing has changed indexes change.
Speaker Change: And having on has the actual efficacy on Ssi on mortality and on re intervention could affect the pricing here.
Speaker Change: So I think that as well.
Speaker Change: We've developed the product and.
Speaker Change: Started to get result in speaking with more and more strategy, we have a better understanding of the target market opportunity. This is worth all we.
Dikla Akselbrad: This is what Ori was elaborating on. So we can better identify those specific patients and surgeries that are at most need of a product like ours. Saying all of that, and maybe adding to that the dosing, the dosing is between one to three vials, depending on the length of the incision, where minimally invasive surgeries will need one vial and larger surgeries will need between two to three vials. Our assumption is that in average, we will see two and a half vials. If again, going to the model, I think that, you know, for the purpose of the modeling at this stage, we are looking at the pricing of six hundred dollars per vial.
Speaker Change: Was elaborating on so we can better identify specific patient and surgeries that are it's most needed.
Speaker Change: A product like ours.
Thank all of that and maybe adding to that the dosing. The dosing is between one to three file depending on the length of the seizure.
Speaker Change: Sure.
Speaker Change: Minimally invasive surgeries will need one vial and larger surgeries will need between two to three file our assumption is that in average we will see two and a half miles.
Speaker Change: Again going to the model I think that the.
Speaker Change: For the purpose of the modeling at this stage, we are looking at the pricing of 600 dollar profile, but as I've said before this is something that is on the go and in process to be refined and also since we are planning to commercialize the product with a partner obviously this.
Chase Knickerbocker: But as I said before, this is something that is on the go and in process to be refined. And also, since we are planning to commercialize the product with a partner, obviously, this will also be a discussion that we will have with the potential partner. OK, great, that makes sense.
Speaker Change: It will also be a discussion that we will have with the potential partner.
Speaker Change: Okay, Great that makes sense and then just a follow up I guess.
Dikla Akselbrad: And just to follow up, I guess that for SHIELD-2, was there a strict requirement for the number of vials used per procedure? And I know you're looking at incisions over 20 centimeters, but it seems like maybe, you know, things might change during the surgery.
Speaker Change: For shield two.
Speaker Change: Was there a strict requirement.
Speaker Change: The number of vials used per procedure, and I know youre looking at and decisions over 20 centimeters, but it seems like maybe things.
It might change.
Dikla Akselbrad: So, will you have any subjects, I guess, with smaller incisions, or were there absolutely none? There was a strict requirement on the... on the incision test? Thanks.
Speaker Change: During the surgery.
Speaker Change: What do you have any subjects I guess with smaller incisions are where theyre absolutely none and there is a strict requirement on the.
Speaker Change: And then so yes, well the patient population that is combining the ITT and the primary endpoint and all the statistical analysis for that.
Dikla Akselbrad: Well, the patient population that is combining the ITT and the primary endpoints and all the statistical analysis for that are part of those are very restrict. All of them are with long incision and with three vials. Exactly.
Speaker Change: A lot of those are very very strict all of them are with long incision and with three vial exactly we had a handful of patient around 170 patients that were recruited for other purposes safety and expansion of indication in those.
Chase Knickerbocker: We had a handful of around 170 patients that were recruited for other purposes, safety and expansion of indication, and those combined minimal invasive and other, but they are not part of the primary end. So all the statistical analysis for the sake of the primary end point doesn't take them into account. They are on top of the eight hundred. Okay, great. Thank you. Come back in queue. Thank you.
Speaker Change: By minimal invasive and other but they are not part of the primary endpoint.
Speaker Change: So all the statistical analysis for the sake of the primary endpoint that they would take them into account.
Speaker Change: On top of the 800.
Speaker Change: Okay, great. Thank you jump back in queue.
Speaker Change: Thank you. Thank you.
Chase Knickerbocker: We will take our next question. And the next question comes from the line of Chase Knickerbocker from Craig Hallam. Please go ahead, your line is open. Good morning and good afternoon, guys. Thanks for taking the questions. Maybe just first on kind of NDA filing timing, I mean, looking farther ahead.
Speaker Change: We will take our next question.
Speaker Change: And the next question comes from the line of Chase Knickerbocker from Craig Hallum. Please go ahead. Your line is open.
Chase Knickerbocker: Good morning, and good afternoon, guys. Thanks for taking the questions.
Maybe just first.
Chase Knickerbocker: So kind of the NDA filing timing I mean looking farther ahead.
Dikla Akselbrad: Can you just walk us through what will be required between data and NDA filing that, you know, leads to the expectation that it takes a couple of quarters to prepare the filing? Thanks. Sure, sure. Good morning and good day, Chase. Thank you for that. So the NDA is composed, or there are three modules that are part of the NDA submission. Two of them are more technical. The other three are the CMC, the preclinical data and the clinical data. As we said in today's call, we are in finalization stages of the CMC and the preclinical. And once we'll have the top line, we'll start working on the clinical module.
Chase Knickerbocker: Can you just walk us through what will be required.
Chase Knickerbocker: Between data and NDA filing.
Chase Knickerbocker: But.
Chase Knickerbocker: Leads to the expectation that takes a couple of quarters to prepare the filings. Thanks.
Speaker Change: Sure sure good morning, and good day. Thank you for that so the NDA is composed though there are three modules that are part of the NDA submission.
Chase Knickerbocker: Two of them are more technical the other three are the.
Chase Knickerbocker: The CMC preclinical data and the clinical data as we said in today's call. We are in Finalization stages of the CMC and preclinical and whilst we will have the top line will start working on the clinical module obviously.
Dikla Akselbrad: Obviously, We are not standing by and waiting. We are starting to prepare an outline of that and working on everything else that is needed that is coming from SHIELD-1 or previous studies. We are planning to meet the FDA for a pre-NDA meeting. We think that this is the right course. It's not a must, but we think that this is the right course in order to get to an agreement with the FDA on how we're going to submit some questions that we want to ask prior to submission to really maximum the chances to have it right at first time.
Chase Knickerbocker: We are not.
Chase Knickerbocker: Standing by and waiting.
Chase Knickerbocker: Starting to prepare.
Chase Knickerbocker:
Chase Knickerbocker: Outline of that and working on everything else that is needed that is coming from shield, one or previous studies.
Chase Knickerbocker: We are planning to meet the FDA for pre NDA meeting, we think that this is the right course, it's not lost but we think that this is the right course in order to get to an agreement with the FDA on.
Chase Knickerbocker: How we're going to submit some questions that we want ask prior to submission to really maximum the chances to have it.
Dikla Akselbrad: And the thinking is that we will be able to meet the FDA with top line by the end of June, before the end of this year.
Chase Knickerbocker: Right the first time.
Chase Knickerbocker: And the thinking is that we will be able to meet the FDA.
Chase Knickerbocker: With top line by the end of June before the end of this year and immediately after meeting the FDA and implementing whatever comments. They will start submitting early 2026 first quarter 2026.
Dikla Akselbrad: And immediately after meeting the FDA and implementing whatever comments they will have, start the meeting early 2026, first quarter of 2021. Got it.
Dikla Akselbrad: And then just on the CMC module, can you remind us kind of your plans to prepare there? Unknown Attendee, Raghuram Selvaraju, Brian Ritchie, Dikla Akselbrad, Jonny Missulawin, Of course, of course. So once we submit the NDA, the FDA will come and inspect our facility. This is standard and we are in process of having exactly what you referred to, having several mock inspections done by external ex-FDA advisors that can prepare us.
Speaker Change: Got it and then just on the CMC module can your remind us kind of your plants to prepare there.
Speaker Change: What's kind of the work that with the consultants that you plan to do some mock audits.
Speaker Change: Yeah and months after data et cetera.
Speaker Change: Of course of course, so once.
Speaker Change: Once we submit the NDA the FDA will come and inspect our facility. This is standard and we are.
Speaker Change: In process of having exactly what you referred to having several mock inspection done by external ex FDA advisor that can prepare us well, we actually met yesterday someone who has a really.
Dikla Akselbrad: Well, we actually met yesterday, someone who is really. probably one of the most, if not the most, experience in the country in FDA's reviews with hundreds of reviews on his shoulder, with several decades of work around QA in the pharmaceutical industry, and we are aligning all the team to get to that. We have a detailed plan on that in terms of what we need to do in preparation, how we can best prepare for this.
Speaker Change: Probably one of the most if not the most experience in the country in Fda's reviews with.
Speaker Change: <unk> hundred refuse on on his shoulder.
Speaker Change: Several decades of work.
Speaker Change: Around QA in the pharmaceutical industry and we are aligning.
Speaker Change: All of the team to get to that.
Speaker Change: A detailed plan on that in terms of what will be need to what we need to do it.
Speaker Change: Perforation, how we can best prepare for this this is.
Dikla Akselbrad: Post-submitting the NDA, this is the most important thing or the most important milestone prior to commercialization in the continuous development on bringing DeepLex into the market.
Speaker Change: Post submitting the NDA. This is the most important.
Think of the most important milestone prior to commercialization.
Speaker Change: The continuous development.
Speaker Change: <unk> duplex into the market.
Dikla Akselbrad: And then just a little on kind of what we should expect from top-line data in coming weeks, months. Should we be just expecting kind of top-line data? Are we going to get some of the key secondaries? Are we going to get some of the, you know, obviously specific drivers within the primary? Are we going to see some data from the smaller incisions too?
Speaker Change: And then just a little on kind of what we should expect.
Speaker Change: From topline data.
Speaker Change: In coming weeks months.
Speaker Change: Should we be just expecting kind of topline data are we going to get some of the key secondaries.
Speaker Change: Are we going to get some of the obviously specific drivers within the primary or are we going to see some data from the smaller and so some steel I mean, just kind of walk us through.
Dikla Akselbrad: I mean, just kind of walk us through, you know, what we should expect from that release when it comes. Sure, sure.
Speaker Change:
Speaker Change: What we should expect from that release when it comes.
Poly Pete: Sure sure. So first I must tell you that everyone here at polyp paid are super excited getting to this point this is really the.
Dikla Akselbrad: So first, I must tell you that everyone here at PolyPid are super excited getting to this point. This is really the something we've been working towards for four years. And now that things are coming in together in terms of getting to finalizing day 60 of all patients and getting to the point when we lock the data, and soon we will be able to unblind the data and share it with investors as well as with all of our external partners and the discussions that we have. We expect to have top lines and key secondaries endpoints. and expect to share these with investors once we get it.
Poly Pete: Something we've been working towards for four years.
Poly Pete: And now that things are coming together in terms of getting to.
Poly Pete: Finalizing day 60 of all patient.
And getting to the point when we lock the data and soon we will be able to unblinded data and share it with investors.
Poly Pete: Well as with.
Poly Pete: All of our external partners and the discussions that we have we expect to have top line and key secondary endpoint.
Poly Pete: And expect to share this.
Bhubalan Pashayappan: Obviously, we will not have all the data, but we do expect to have top line as well as secondary. Great, thanks. Thank you. Once again, if you wish to ask a question, please press star 1, 1 on your telephone. We will take our next question.
Poly Pete: With investors once we get it obviously, we will not have all the data, but we do expect our topline as well as secondary endpoint.
Poly Pete: Great. Thanks.
Poly Pete: Thank you once again, if you wish to ask a question. Please press star one on your telephone.
Poly Pete: We will take our next question.
Bhubalan Pashayappan: Your next question comes from the line of Bhubalan Pashayappan from Roth Capital.
Poly Pete: Our next question comes from the line of people on Pasha <unk> from Roth Capital. Please go ahead. Your line is open.
Bhubalan Pashayappan: Please go ahead, your line is open. Good morning, Tim. Thanks for taking my questions and congratulations in completing the SHIELD 2 enrollment. This is an important milestone. So a few questions from us. So I wanted to follow up on the expectations or the top line for the SHIELD 2 data. And when you report your top line, so will you report a composite endpoint comprising SSI reduction, reinfection, and readmission for both placebo and duplex group patients? And also in that regard, can you remind us if an efficacy threshold of 30% or above in all three metrics is necessary to consider this trial a success?
Speaker Change: Good morning, Tim Thanks for taking my questions and congratulations on completing the sale to enrollment. This is there is an important milestone so a few questions from us.
Speaker Change: So I wanted to follow up on the expectations on the topline for the shield two data.
Speaker Change: When you report your topline.
Speaker Change: So will you report a composite endpoint comprising ssi reduction the infection and readmission for both placebo and duplex drove patients and also in that regard can you remind us if an efficacy threshold of 30% or above in all three metrics is necessary to consider this trial.
Speaker Change: Our success.
Dikla Akselbrad: Okay, so we will report the primary endpoint and the primary endpoint is the combination of SSI, mortality and re-intervention. We are counting all of these events. This is how the primary is composed and this is obviously we will report the primary as a whole. We will also report the secondary. Secondary relates to surgical site infection alone. So you could see how we've met the baseline requirement of having an alpha level below 0.05 with the primary as well as some of the effects. We'll need to see, you know, our plan is to report the data as soon as possible after we are unblinded.
Speaker Change: Okay. So we will report the primary endpoint and the primary endpoint is the combination of.
Speaker Change: Ssi mortality and we intervention we are counting all of these events. This is how the fiber is composed of and this is obviously we will report it.
Speaker Change: Primarily as a whole.
Speaker Change: We will also report the secondary secondary relates to surgical site infection alone. So you could see how we've met the baseline requirement of having an alpha.
Speaker Change: 0.05, with the primary as well as some of the effects will need to see you know.
Speaker Change: Plan is to report the data as soon as possible. After we are blinded, we will need to see how much of this can be.
Dikla Akselbrad: We will need to see how much of this can be digested in a way and presented in a meaningful way within hours from getting the data. But the plan is to share as much as possible, have an investor, an analyst call, post the data, and then as we get more and more data, obviously find a venue to share additional data.
Speaker Change: Digest it in a way and presented in a meaningful way.
Speaker Change: Within hours from getting the data, but the plan is to share as much as possible have a an investor and analyst call posted data and then as we get more and more data obviously find a venue to share additional data.
Bhubalan Pashayappan: All right, that's very helpful.
Speaker Change: Alright, that's very helpful. And then switching to commercial manufacturing. So let's assume you are getting the priority review.
Dikla Akselbrad: And then switching to commercial manufacturing. So let's assume you are getting the priority review. So what are your preliminary thoughts with regards to inspection readiness? And also, with respect to your capacity, can you give us some idea, you know, what's your how do you expect to, you know, assess the demand, at least for a couple of years? And how do you expect the capacity to satisfy those demands? Sure, so with regards to the inspection, this is our top priority these days. We are in the process of getting ready for this inspection, including having in place a detailed plan of things that will be need to be doing timeline for mock inspection.
Speaker Change: So what are your preliminary thoughts with regards to inspection readiness and also with respect to your capacity can you give us some idea you know.
Speaker Change: What's your how do you expect to assess the demand at least for a couple of years and how do you expect the capacity to satisfy those demands.
Speaker Change: Sure So with regards to the inspection and this is our top priority. These days we are in the process of getting ready for this inspection, including having in place a detailed plan of things that will need to be doing timeline for <unk>.
Dikla Akselbrad: We plan to do several mock inspection prior to FDA review. We also are engaging a consultant, ex-FDA, that can help us and guide us through the process. We do really Richie or outreaching this process in the mind of getting it right at first time. So that's in terms of. all the preparation for the CMC. The fact that the CMC packet modules is in finalization mode is very helpful because a lot of the actual work needed for the submission in terms of stability and all the rest of it is in finalization mode. As for overall capacity, we did not disclose the capacity of the facility because this can, this is, at this stage we believe is an information that should be kept in-house, especially since we are in commercialization discussions in different geographies.
Speaker Change: Inspection, we plan to do several mock inspection prior to FDA.
Speaker Change: We view, we also are engaging.
Speaker Change: And consultants ex FDA that can help us and guide us through the process.
Speaker Change: It really.
Reaching out reaching this process in the mind of getting it right. The first time.
Speaker Change: So that's in terms of.
All the preparation for the CMC.
Speaker Change: Fact that the CMC package modules is.
Speaker Change: And final ejection Mod is very helpful. Because a lot of the actual work needed for the submission in terms of stability.
Speaker Change: And all the rest of it is is in Finalization mode as for our overall capacity, we did not disclose the capacity of the facility. Because this can this is a at this stage.
Speaker Change: Believe that is an information that should be kept in house, especially since we are in commercialization discussions in different geographies.
Dikla Akselbrad: But we did say that our assumption is that the facility will be sufficient for the first four to five years from launch, which gives us sufficient time to expand or to build an expansion elsewhere once we see that there is a need.
Speaker Change: We did say that our assumption is that the facility will be sufficient for the first.
Speaker Change: Four five years from launch, which gives us sufficient time to expand or to build and expansion elsewhere. Once we see that there is a need for that.
Ori Warshavsky: OK, that's very helpful. I know, Ori, you mentioned about the November 2024 SSI data. Can you maybe provide that in context with what the SSI was observed pre-COVID? So essentially, I wanted to see if you can compare the SSI pre-COVID versus the November 2024 data. Yes, so just to clarify, the data that I cited was CDC data that is comparing 2023 to 2022, and that showed a 3% increase in infection. I don't have off the top of my head the number of pre-COVID, but what we know is there was a steady, steady decline in, or steady to flat rate of FSI before COVID, and then a significant drop 2021-22, and really 2023 is the first time that we see an uptick reported.
Speaker Change: Okay. That's very helpful. I know Ara you mentioned about the number 2020 for Ssi data can you maybe provide that in context with what the Ssi was observed pre COVID-19.
Speaker Change: Actually I wanted to see if you can compare the ssi pre COVID-19 versus the number 2024 data.
Speaker Change: Okay.
Speaker Change: Yes, so just just to clarify.
Speaker Change: The data that I cited was CDC data that is comparing.
Speaker Change: 2023 to 2022.
Speaker Change: That shows a 3% increase in infection.
Speaker Change: I don't I don't have off the top of my head.
Speaker Change: The number of pre Covid, but what we know is there was a.
Speaker Change: Steady steady declining in a steady two flat day rate of Ssi before Covid and then a significant drop 2021 'twenty two and really 2023 is the is the first time that we see.
Speaker Change: We see an uptick reported it as well.
Ori Warshavsky: And it is reported, so the 3% is really across all procedures that the CDC tracks. So if you can, obviously there's some that jumped quite a lot. Some of them that did not jump at all. So on average, it's quite a quite a large increase over the COVID time.
Speaker Change: Reported so the 3% is really across all procedures that the CDC tracks. So if you. If you can obviously there is some that jumped quite a lot.
Speaker Change: Some of them that they did not jump in also on average it's quite a quite a large a increase over the coffee time.
Bhubalan Pashayappan: All right, that's it from me. Thank you very much for taking my question. Thank you.
Speaker Change: Alright, that's it from me. Thank you very much for taking my questions.
Unknown Attendee: There seems to be no further questions.
Speaker Change: Thank you that seems to be no further questions I would like to hand back for closing remarks.
Brian Ritchie: I would like to hand back for closing remarks. Thank you for joining PolyPid's first quarter 2025 earnings conference. We remain highly confident in our long-term prospects, especially the potential of our promising late-stage product candidate, DIPLEX-100, and look forward to reporting the top-line results of the SHIELD 2 Phase 3 trial in the very near future. As always, we are grateful to our team members, shareholder, and all external partners for their commitment to our mission and support in continuing to advance towards our goal of bringing DIPLEX-100 to health care providers and patients as quickly as possible. We look forward to speaking with you again on our next conference.
Speaker Change: Thank you for joining policies first quarter 2025 earnings conference call. We remain highly confident in our long term prospects, especially the potential of a promising late stage product candidate <unk> 100, and look forward to reporting the top line results of the <unk>.
Speaker Change: Two phase III trials in the very near future.
Speaker Change: As always we are grateful to our team members shareholder and all external partners for their commitment to our mission and support and continuing to advance towards our goal of bringing deep X 100 to health care providers and patient as quickly as possible we look.
Speaker Change: Forward to speaking with you again on our next conference call.
Speaker Change: Yeah.
Unknown Attendee: This concludes today's conference call. Thank you for participating.
Speaker Change: This concludes today's conference call. Thank you for participating you may now disconnect.
Unknown Attendee: You may now disconnect.
Speaker Change: Okay.
Speaker Change: [music].