Q1 2024 PolyPid Ltd Earnings Call
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Operator: Greetings and welcome to the PolyPid first quarter 2024 conference call. At this time, all participants are in a listen only mode. 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.
Speaker Change: Greetings and welcome to the Poly Pete first quarter 2024 conference call. At this time all participants are in a listen only mode. As a reminder, this call is recorded.
I would now like to introduce your host for today's conference Brian Ritchie from lifestyle advises Mr. Ritchie you may begin.
Brian Ritchie: Thank you all for participating in PolyPid's first quarter 2024 earnings conference call. Joining me on the call today will be Dikla Tchotchkes-Akselbrad, Chief Executive Officer of PolyPid, Jonny Missulawin, PolyPid's Chief Financial Officer, and Ori Warshavsky, Chief Operating Officer, U.S. of PolyPid. Earlier today, PolyPid released financial results for the three months ended March 31st, 2020.
Brian Ritchie: Thank you all for participating and poly Pizza first quarter 2024 earnings conference call.
Brian Ritchie: Joining me on the call today will be <unk> actual Brad Chief Executive Officer of Poly, Pete Johnny Michel Aoun, Poly Pizza, Chief Financial Officer, and Ori workshops, keep Chief operating Officer U S. Poly Pete earlier today <unk> released financial results for the three months ended March 30.
Speaker Change: The one 2020 for a copy of the press release is available in the investors section on the company's website www Dot <unk> dot com.
Brian Ritchie: A copy of the press release is available in the investors section on the company's website, 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 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, the strength of the company's intellectual property, the company's expected cash runway, and the potential to receive additional funds if warrants are exercised, forward-looking statements are subject to numerous risks and uncertainty.
Brian Ritchie: Many of these are beyond our control, including the risks described from time to time in our SEC filings. 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 statements. I encourage you to review the company's filings with the Securities and Exchange Commission, including, without limitation, the company's 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.
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. This conference call contains time-sensitive information and speaks only as of the live broadcast today, May 8, 2021. With the completion of these prepared remarks, it is my pleasure to turn the call over to Dikla Tchotchkes Akselbrad, CEO of PolyPid. Dikla?
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 and the <unk>.
Speaker Change: Blinded interim analysis, the planned new drug application submission for duplex 100, the strength of the company's intellectual property. The companys expected cash runway and the potential to receive additional funds if warrants are exercised.
Speaker Change: We're 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.
Speaker Change: 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 statements.
Speaker Change: I encourage you to review the Companys filings with the Securities and Exchange Commission, including without limitation. The Companys 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.
Speaker Change: <unk> disclaims any intention or obligation, except as required by law to update or revise any financial projections or forward looking statements.
Speaker Change: Whether because of new information future events or otherwise. This conference call contains time sensitive information and speaks only as of the live broadcast today may eight 2024.
Speaker Change: With the completion of these prepared remarks, it's my pleasure to turn the call over to <unk> <unk> actual Brad CEO of Poly Pete <unk>.
Dikla Czaczkes Akselbrad: Thank you, Brian. On behalf of our team at PolyPid, I would like to welcome everyone to our first quarter 2024 Earnings Conference. We are excited about the substantial momentum throughout our visit, especially as it relates to enrollment in our ongoing SHIELD 2 pre-result trial for DIPLEX-100 for the prevention of abdominal colorectal surgical site infection. Importantly, this clinical progress is being achieved with a recently fortified balance sheet. Let's begin with the status of Shilpa.
Brad: Thank you Brian on behalf of our team a solid team I would like to welcome everyone to our first.
Brad: First quarter, 'twenty slate or concept.
Brad: We are excited about the substantial momentum throughout our business.
Brad: Most importantly, as it relates to enrollment in our ongoing shift.
Brad: Lasalle trial, so deep dense 100.
Brad: Adventure Domino colorectal surgical site infection importantly, this clinical progress is being achieved with our recently fortified balance sheet.
Brad: Let's begin with the status of shoes.
Dikla Czaczkes Akselbrad: I'm pleased to report today that the study has now enrolled more than 200 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 of 600 subjects complete the 30-day follow-up, which is expected to occur in mid-2024. Top-line results are anticipated in the second half of the year.
Speaker Change: I'm pleased to report today.
Speaker Change: Study is now enrolling more than 200 subjects.
Dikla Czaczkes Akselbrad: Therefore, SHIELD-2 is now more than half enrolled for the interim analysis, and more than one-third is fully enrolled. Importantly, as the current status would indicate, enrollment is now progressing at a constantly robust rate. With respect to the expected recruitment rate, as we said on our last call, once the site is fully up and running, which takes several weeks following its being formally opened, we anticipate approximately one and a half patients being recruited into this trial per center per month.
Speaker Change: Oximetry 50 centers.
Brad: Currently open in multiple countries around the world, including the U S, Germany, Italy, Ireland, Portugal.
Brad: In Israel.
Brad: Mind, you, we intend to conduct an unblinded interim analysis once approximately 400 patients of the planned total of 600 subjects.
Brad: Complete the 30 day follow up.
Brad: Which is expected to occur in mid 2024.
Brad: Top line results are anticipated in the second half of this year.
Brad: Therefore, <unk> two is now more than half enrolled for the interim analysis and more than one third fully invoked.
Brad: Importantly at the current status with indicate enrollment is now progressing constantly robust phase, which.
Brad: With respect to the expected recruitment rate.
Brad: We said on our last call. What's the science is fully up and running which takes several weeks following being formally open we anticipate approximately one and a half stations being recruited into the trial.
Dikla Czaczkes Akselbrad: And we expect to have a total of approximately 60 centers opened to recruit patients. So, at the peak of the enrollment period, we anticipate recruiting 90 patients per month, similar to the enrollment rate we had in children.
Brad: 10 months and we expect to have a total of approximately 60 centers opened in recruiting patients.
Brad: So at the peak of the enrollment period.
Brad: Dissipate recruiting 90 patient per month.
Brad: Similar to the environment rate, we had in shield one.
Dikla Czaczkes Akselbrad: With that said, having crossed the important 200 subject threshold, we thought we'd provide some color on several encouraging enrollment trends we are seeing. Of note, the median age, male-female split, and percentage of enrolled cancer patients in SHIELD2 are similar to the patient population in the SHIELD1 large incision pre-specified sample. This is significant because we are thus far observing similar demographics in this more focused patient population for which we have already generated highly positive data in SHIELD1.
Brad: With that said, having crossed the important 200 subjects thresholds, we thought we'd provide some color on several encouraging enrollment trends we are seeing.
Brad: Of note the median age.
Brad: Female split percentage of cancer patients in Q2.
Brad: Similar to the patient population in the shield, one large infusion prespecified Chuck this.
Brad: This is significant because we are thus far observing similar demographics in this more focused patient population.
Brad: We have already generated highly positive data in shield one.
Dikla Czaczkes Akselbrad: This is yet another reason we continue to strongly believe that CHIL-2 is a de-risk phase retrial, along with the fact that SHIELD 2 is not being conducted within the tight COVID-related restrictions that were in place during the pandemic and throughout the duration of SHIELD. Of course, we are also leveraging key learning from SHIELD-1 related to the sites involved. To this end, while we are targeting approximately 60 centers for SHIELD-2, around the same number as for SHIELD-1, we have firm knowledge of the best performing sites from SHIELD-1 in terms of recruitment, patient monitoring, and good clinical performance.
Brad: This is yet another reason we continue to strongly believe.
Brad: <unk> is a derisked phase III trial.
Brad: Along with the fact that Q2 is not being conducted within the tight coffee related restriction, that's what I mean.
Brad: In place during the pandemic and throughout the duration of shared one.
Brad: Of course, we are also leveraging key learnings from shield one related to the sites involved into step.
Brad: And while we are targeting approximately 60 centers.
Brad: Q2 around the same number one we have knowledge of the best performing sites.
Brad: Sure.
Brad: In terms of recruitment patient monitoring and good clinical practice, we believe this to be essential in the execution of shifts. We have also enhanced our clinical operations team and another step towards supporting a successful study.
Dikla Czaczkes Akselbrad: We believe this to be essential in the execution of shield. We have also enhanced our clinical operations team, another key step towards supporting a successful. Moreover, the Data Safety Monitoring Committee in charge of the review of accumulated safety data and study conduct for the SHIELD2 study has twice recommended to continue the study without modification, meaning that no safety issues related to Deflect 100 have been observed in Shield 2.
Brad: More of the data safety monitoring Committee Shawn just a review of accumulated safety data and study conduct for shield. Two study has twice recommended to continue the study without modification.
Brad: Meaning that no safety issues related to deploy 100 have been upset in Q2.
Dikla Czaczkes 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. I'd like to take a moment to acknowledge an often overlooked key aspect of the compelling DPREX-100 product profile, and that is its substantial Intellectual Property Foundation.
Brad: Just today.
Brad: Moving on to reiterate what we have said previously we have a clear regulatory pathway for the potential NDA submission.
Brad: 100 in the U S last year, the FDA acknowledged not only that shield. One results may provide supportive evidence of the safety and efficacy of duplex 100 in patients with large surgical incision.
Brad: But also confirmed that if successful should help too is sufficient to support a potential NDA submission.
Brad: I'd like to take a moment to acknowledge an often overlooked aspect of the compelling duplex 100 products qualified.
Brad: And that is it substantial intellectual property Foundation spitz.
Dikla Czaczkes Akselbrad: Specifically, we are fast approaching 175 granted and pending patents for the PLEX platform and its users for the treatment of different indications. Among those method-of-use patents is a significant number of patents with long-term protection for DPLEX-100 for the prevention of surgical site infections. For example, our DIPLEX-100 SSI patent is expected to remain in effect until 2035 in more than 40 countries worldwide.
Brad: Specifically, we are fast approaching 175 granted and pending applications patch at the flex platform and its users for the treatment of different indications.
Brad: And now those method of use patents.
Brad: A significant number of patents with long term protection for duplex 100 for the prevention of surgical site infection.
Brad: For example, our duplex 100 S. Aside patent is expected to remain in effect until 'twenty 35, even more than 40 countries worldwide.
Dikla Czaczkes Akselbrad: This incredibly strong IP position only enhances the value of this promising late-stage product candidate. Shifting gears, we continue to advance Shield 2 from a strengthened financial position following our January 2024 private placement financing or PIPE for $16 million in gross profit. Importantly, our Cash One Way now extends into the fourth quarter of this year and beyond the anticipated timing of Shield 2's planned unblinded interim announcement. Moreover, the company has the potential to secure an additional $19 million if the results of the unblinded interim analysis are positive and all warrants issued in the financing are exercised, which would fund PolyPid through the start of a planned rolling NDA submission for Dikla.
Brad: This incredibly strong IP position only enhances the value of these promising late stage product candidate for us shifting gears, we continue to advance <unk> two from our strengthened financial position following our January 2024, private placement financing.
Brad: It was $16 million of gross proceeds.
Brad: Importantly, our cash runway now extends into the fourth quarter of this year and beyond the anticipated timing of tier twos plant on blinded interim analyses.
Brad: The company has the potential to secure an additional $19 million is the result of the unblinded interim.
Brad: These are positive and all warrants issued in the financing of exercise.
Brad: Which would fund policies to the start of a plant rolling NDA submission for <unk> 100.
Dikla Czaczkes Akselbrad: As a reminder, the PIPE syndicate was comprised of new and existing investors, including participation from U.S. life science focused investors, DAFNA Capital Management and Rosalind Advice. Before I turn the call over to Jonny for his review of the financials, I'd like to let you all know that we have recently posted a newly revamped corporate presentation on our IR website. We would encourage all of you to take a look at your convenience. With that, it is my pleasure to now turn the call over to Jonny. Jonny? Thank you, Dikla.
Brad: As a reminder, the syndicate was comprised of new and existing investors.
Brad: <unk> participation.
Brad: The us lifestyle focused investors Dafna capital management at <unk> advisors.
Brad: Before I turn the call over to John <unk> for his review of the financials I'd like to let you. All know this we have recently posted a newly revamped corporate presentation on our IR website, we would encourage all of you to take a look at your convenience.
Brad: With that it is my pleasure to now turn the call over to John.
Jonny Missulawin: Thank you, Dikla. As of March 31, 2024, the company had cash and short-term deposits of $14.5 million, as compared to $5.3 million at the end of 2022. This includes the net proceeds of approximately $15 million generated from the Pi financing closed in January 2021. We expect that our cash balance will be sufficient to fund operations into the fourth quarter of 2024.
Brad: Ronnie.
John: Thank you.
John: As of March 31, 2024 at the company had cash and short term deposit.
John: $14 $5 million.
John: As compared to $5 3 million at the end of 'twenty to 'twenty three.
John: This includes the net proceeds of approximately $58 million.
John: Generated from the pipe financing closed January 28.
John: We expect that our cash balance will be.
John: Be sufficient to fund the observation.
John: The fourth quarter 'twenty plenty, Florida.
Jonny Missulawin: Now let's turn to our income statement. Research and development expenses for the three months ended March 31, 2024 were $5.1 million compared to $3.8 million in the same three-month period of 2024. The increase in R&D expenses in the most recently completed quarter was driven by the ramp-up of the ongoing Shield 2 faith retrial. Marketing and business development expenses for the three months ended March 31, 2024 were $236,000, compared to $385,000 during the prior year period.
John: Now, let's turn to our income statement.
John: Search and development.
John: The three months ended March 31 2024.
John: Like $1 billion a pair.
John: $3 $8 million in the same three months period of 2023.
John: The increase in R&D expenses in the most recently completed quarter.
John: That's driven by the ramp up of the ongoing shield two phase III trial.
John: Marketing and business development expenses for the three months ended March 31 2024.
John: $236000.
John: Q3 hundred $85000 during the prior year period.
Jonny Missulawin: General and administrative expenses for the three months ended March 31, 2024 were $1 million, compared to $1.6 million recorded in the same three-month period of 2021. This decrease reflects our ongoing cost containment efforts. For the three months ended March 31, 2024, the company had a net loss of $6.4 million, as compared to $6.1 million in the first quarter of 2020. With that, we will now open the poll to your questions. Operator?
John: General and administrative expenses for the three months ended March 31, 'twenty 'twenty four.
John: 1 million.
John: Tears to one 6 million recorded in the period 2023.
John: This decrease reflects our ongoing cost containment efforts.
John: For the three months ended March 31, 2024, the company had a net loss of $6 4 million.
John: As compared to $6 1 billion in.
John: With first quarter of 2021.
Speaker Change: With that we will now open the call to your questions operator.
Operator: Thank you. If you wish to ask a question, you will need to 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 will take our first question, and your first question comes from the line of Roy Buchanan from Citizens JMP. Please go ahead, your line is open. Hey, thanks for taking the questions. I appreciate all the comprehensive updates. A couple just quick ones on Shield 2.
Speaker Change: Thank you.
Speaker Change: If you wish to ask a question you would need to press star one and one on your telephone and wait for your name to be announced.
Speaker Change: To withdraw your question Please press star one.
Speaker Change: One again.
John: We will take our first question on your first question comes from the line of Voip Buchanan from citizens J M. P. Please go ahead. Your line is open.
Roy Buchanan: Hey, thanks for taking the questions. I appreciate all the comprehensive updates. A couple quick ones on SHIELD-2. I guess, Dikla, can you just review in a little bit more detail the timeline for the NDA submission and the expected review? Now, with the 505B2, you have breakthrough designation. What can we expect as far as the timeline is concerned? Then, what are the plans for Europe, assuming SHIELD-2 is successful?
Voip Buchanan: Hey, Thanks for taking the question I appreciate all their comprehensive updates on a couple.
Voip Buchanan: Just a quick one.
Voip Buchanan: Two I guess.
Voip Buchanan: Can you just review in a little bit more detail I guess, the timeline for the NDA submission and the expected review now, let's say a 505 Btu you have breakthrough designation.
Voip Buchanan: What can we expect as far as the timeline.
Voip Buchanan: And then what's what are the plans for Europe, I'm, assuming shale to a successful.
Operator: You may be on mute, or I may have dropped. Yeah, now we are not on mute. Sorry. Can you hear me?
Speaker Change: You may be on mute or I may have dropped.
Speaker Change: Yes, I can.
Speaker Change: Yeah, No we are not on mute sorry can you hear me.
Dikla Czaczkes Akselbrad: Hi, good morning. Thank you. Thank you for the question. So SHIELD 2 is expected to finalize the 400 patients for the interim analysis this, mid this year, with a readout for that and around the fall. And assuming we are stopping there, or maybe I should say assuming we are, we will need to continue to the 600 patients, which is the minimum for the study design, it is another quarter for recruitment.
Speaker Change: Yes, hi.
Speaker Change: Hi, good morning, Thank you as well alright. Thank you for the question. So shaft two is expected to finalize a 400 patient for the interim analysis.
Speaker Change: This mid this year with the Readouts for for that around the <unk>.
Speaker Change: Paul.
Speaker Change: And assuming we are stopping there or maybe I should say, assuming we are we will need to continue to the 600 patient which is the minimum for the study design. It is another quarter for recruitment so towards the end of the year, we expect to.
Dikla Czaczkes Akselbrad: So towards the end of the year, we expect to get that done as well. And the understanding that we have is that during 2025, the first half of 20, at the end of the first half of 2025, we should be submitting NDAs, which means that towards the end of 2025, we will get the result. This assumes that we are continuing recruitment, and this is our assumption. If we decide to stop recruitment, then, well... Let's leave it this way.
Speaker Change: Get the.
Speaker Change: That done as well.
Speaker Change: The spending that we have is that during 2025.
Speaker Change: At the first half of 'twenty at the end of the first half 'twenty four 'twenty five we should be submitting NDA, which means the towards the end of 2025, we will get.
Speaker Change: The result, this assumes that we are continuing recruitment and this is our assumption.
Speaker Change: If we decided to stop the recruitment then well.
Dikla Czaczkes Akselbrad: So this assumes continuing recruitment up to 600 patients, and this takes us into the end of 2025 for the NDA. With regard to Europe, we are looking at it as a powerless strategy. It takes a bit longer to get approval in Europe, although we are entitled to the centralized procedure, so we can submit once and get an approval for all of Europe, which is very beneficial. We will be making a more, let's say, tactical decision as we get to the readout to see whether we want to have the end-of-phase 3 meeting with the FDA before we submit to Europe. But these are really tactical. So our assumption is that Europe will shortly follow after the US in terms of end-of-phase 3.
Speaker Change: That's let's say it this way so there's a few of them continuing to equipment up to the 600 patient and this takes us into the end of 2025 for the did.
Speaker Change: With regards to Europe, we are looking.
Speaker Change: Looking at it as a part of the strategy.
Speaker Change: Uh huh.
Speaker Change: It takes a bit longer to get the approval in Europe, although we are entitled to the centralized procedure. So we can submit once and get an approval for all of Iraq, which is very beneficial we will be making a more let's say tactical.
Speaker Change: Decision as we get to the readout to see whether we want to get a.
Speaker Change: Before we submit to Europe to have the end of phase II meeting with the FDA, but these are really tactical so so.
Speaker Change: Our assumption is that Europe will shortly follow after you asked in terms of M D.
Speaker Change: Okay.
Dikla Czaczkes Akselbrad: Okay, great. And then just one on the sites. I guess, can you provide a bit more detail on the geographic breakdown of the current 50 sites? I know the countries are listed in the press release, but, you know, those predominantly in the U.S. or elsewhere, Western Europe, etc. And then for the additional 10 sites, where are those expected to be?
Speaker Change: Okay, Great and then just one on the.
Speaker Change: The sites I guess can you provide a bit more detail on the geographic breakdown of the <unk>.
Speaker Change: 55, and other countries are listed in the press release, but those predominantly in the U S or elsewhere, Western Europe et cetera.
Speaker Change: Then for the additional 10 sites where are those expected to be added.
Dikla Czaczkes Akselbrad: So, we actually related a little bit to that in the press release, listing the list of countries that are examples of countries that have participated. We listed U.S. [inaudible] Italy, Ireland, Portugal, Hungary, and Israel. We have some additional countries, Eastern European countries, that are also being added. Overall, I would say that in European countries there are around between three to five centers per country. In the U.S., we have a bit more, and that's about how it's widespread. Many countries that were in Shield 1 are also in Shield 2. We didn't have that much Western Europe in Shield 1. We have a little bit more of Western Europe now, which, which we, we.
Speaker Change: Sure so.
Speaker Change: Actually related a little bit to that in the press really lifting the list. The countries that are example of countries that are sophisticated.
Speaker Change: We left the U S.
Speaker Change: Germany.
Speaker Change: Italy, Ireland, Portugal, Hungary, and Israel, we have some additional countries eastern European country.
Speaker Change: Also being added.
Speaker Change: Overall, I would say that it is a little bit.
Speaker Change: Tween.
Speaker Change: In the European countries around between.
Speaker Change: Three to five.
Speaker Change: Centers per country in the U S. We have a bit more.
Speaker Change: <unk>.
Speaker Change: And that's that's about that's it's quite spread similar many countries that we're in shield. One I'll also ensures two we didn't have.
Speaker Change: That's much.
Speaker Change: You as well.
Speaker Change: Western Europe in shield, one we have a little bit more of Western New York now.
Speaker Change: Which which we see as a good thing because we see this as data is more clean and and.
Speaker Change:
Speaker Change: Repeats itself.
Roy Buchanan: Okay, great. That's helpful. Thank you. And then, maybe one last one, if I can. Assuming SHIELD 2 is successful, how soon?
Speaker Change: Okay. Great. That's helpful. Thank you and then maybe one last one if I can.
Speaker Change: Assuming shield two successful.
Speaker Change: How soon do you think you can pivot or not pivot, but advanced the pipeline uncle Plex.
Speaker Change: And I guess in the waiting what what are the plans how fast can we get that going thank you.
Dikla Czaczkes Akselbrad: So this is something that we are actually putting a lot of effort now into. Obviously, our top priority right now is DIPLEX-100. But, as we previously said, we are looking into the pipeline. The second-in-line priority is the oncology program, the Oncoplex, which remains a priority for us. If you remember, we had a successful pre-IND meeting with the U.S. FDA supporting phase 1-2 clinical trials, so this is our first priority, but we are also looking at potential broadening of that, a more strategic pipeline prioritization, looking also in some additional directions in order to be prepared with this for the time of the top line.
Speaker Change: So this is something that we are actually putting a lot of the effort now into so obviously, our top priority right now.
Dikla Czaczkes Akselbrad: We want to make sure that once we are past this very important milestone of phase 3 in SHIELD 1, sorry, in SHIELD 2, in DPLEX-100, we are ready for expansion of the pipeline. So I think after the top line, we will also have some news to share there. This is something we are looking at very in-depth these days.
Speaker Change: 100 <unk>.
Speaker Change: Right.
Speaker Change: But as we previously said we are looking into the pipeline.
Speaker Change: The second priority is the oncology program Bill Quirk.
Speaker Change: It remains a priority for us.
Speaker Change: Remember, we had a successful pre IMD meeting with the U S. FDA supporting a phase one two clinical trial. So this is our first priority, but we are also looking on potential broadening of that are more strategic pipeline prioritization looking wholesaling.
Speaker Change: Some additional direction in order to be prepared with this.
Speaker Change: Time of the top line, we want to make sure that once we are past this very important milestone of our phase III in shield, one and sorry in two <unk> 100, we are ready for expansion of the pipeline. So I think.
Speaker Change: After the top line. We will also have some news to share. There. This is something we are looking at very in depth.
Speaker Change: Right.
Speaker Change: Okay.
Speaker Change: Okay. Thank you.
Operator: Thank you. There seem to be no further questions. I would like to hand it back for closing remarks.
Speaker Change: Thank you that seems to be no further questions I would like to hand back for closing remarks.
Dikla Czaczkes Akselbrad: Thank you for joining PolyPid's first quarter 2024 Earnings Conference. We remain highly confident in our long-term prospects, especially the potential of our promising late-stage product candidate, DIPLEX-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 toward our goal of bringing DPLX-100 to health care providers and patients as quickly as possible. We look forward to speaking with you again on our next conference call.
Speaker Change: Thank you for joining politics first quarter 2020 for earning conference call.
Speaker Change: We remain highly confident in our long term prospects, especially the potential of a promising late stage product candidate <unk> 100 is always well.
Speaker Change: Wasteful to our team members shareholder and all external partners for their commitment to our <unk>.
Speaker Change: Mission and support and continuing to advance toward our goal of bringing the plus 100 to health care providers and patient as quickly as possible. We look forward to speaking with you again on our Netcom and our next conference call.
Operator: Thank you. This concludes today's conference call. Thank you all for participating. You may now disconnect.
Speaker Change: Thank you. This concludes today's conference call. Thank you all for participating you may now disconnect.
Speaker Change: Okay.
Speaker Change: [music] okay.
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: [music].