PolyPid Q2 2025 Earnings Call Transcript

Quartr
Provided by Quartr
August 13, 2025

Key Takeaways

  • Positive Sentiment: Phase III SHIELD II trial results showed a 38% reduction in the primary endpoint, a 58% drop in surgical site infections, and a 62% decrease in severe infections with DPLEX100 versus standard of care.
  • Positive Sentiment: DPLEX100 demonstrated a good safety profile with no increase in serious treatment-emergent adverse events compared to standard of care.
  • Positive Sentiment: Management is on track for a pre-NDA meeting with the FDA by year-end and plans to submit the DPLEX100 NDA in early Q1 2026, followed by a European MAA shortly thereafter.
  • Neutral Sentiment: The company advanced its GLP-1 program, developing a ~60-day release GLP-1 receptor agonist for metabolic diseases, now entering robust preclinical studies and partnership discussions.
  • Positive Sentiment: Polypeed strengthened its balance sheet via a warrant exercise, ending Q2 with $29.5 million in cash and deposits, extending its cash runway well into 2026.
AI Generated. May Contain Errors.
Earnings Conference Call
PolyPid Q2 2025
00:00 / 00:00

There are 7 speakers on the call.

Operator

Greetings, and welcome to Polypeed's Second Quarter twenty twenty five Conference Call. At this time, 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, Juda Liebla from ARTS Capital Markets. Mr.

Operator

Liebla, you may begin.

Speaker 1

Thank you all for participating in Polypid's second quarter twenty twenty five earnings conference call. Joining me on the call today will be Diklat Tatis Axelbrod, Chief Executive Officer of Polypid Johnny Mislawyn, Polyped's Chief Financial Officer, and Ori Warchavsky, Chief Operating Officer, US of Polyped. Earlier today, Polyped released its financial results for the three months ended 06/30/2025. A copy of the press release is available in the Investors section on the company's website available at www.polypid.com. I'd like to remind you that on this call, will make forward looking statements within the meaning of the federal securities law.

Speaker 1

For example, management is making forward looking statements when it discusses DPLEX100's potential benefits, including its potential to address a significant unmet medical need and to substantially reduce the burden of surgical site infections, improve patient outcomes and generate meaningful healthcare cost savings, the expected regulatory submissions and their timing, the aim of GLP-one program and its potential to address significant unmet medical needs in the treatment of metabolic diseases, the company's expected cash runway and the potential partnership opportunities for DPLEX one hundred. Forward looking statements are subject to numerous risks and uncertainties, many of which are beyond the company's control, including the risks described from time to time in its SEC filings. The company's results may differ materially from these projections. These statements involve material risks and uncertainties that could cause actual results or events to materially differ. Accordingly, you should not place undue reliance on these statements.

Speaker 1

I encourage you to review the company's filings with the SEC, including without limitation, the company's annual report on its Form 20 F filed on 02/26/2025, which identifies specific factors that may cause actual results or events to differ materially from those described in the forward looking statements. Policies 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, 08/13/2025. With the completion of those prepared remarks, it is my pleasure to turn the call over to Dikla Chavchkas Axelbrot, CEO of Polypid. Dikla?

Speaker 2

Thank you, Iuda. On behalf of our team at Polypede, I would like to welcome everyone to our second quarter twenty twenty five earnings conference call. The 2025 was truly transformational for Polyped, marked by the successful results of our SHIELD II Phase III trial, which demonstrated significant clinical benefits of DPLEX100 in preventing surgical site infections or SSI in abdominal colorectal surgeries. As announced in June 2025, the study showed a statistically significant reduction of 38% with a p value below 0.005 in the primary endpoint which, as a reminder, is the combination of deep and superficial exercise, all cause mortality and surgical reintervention. In addition, we demonstrated a robust fifty eight percent reduction in the rate of surgical site infections in patients treated with DIPLEX100 versus standard of care with a p value below 0.005, including a significant reduction in deep surgical site infection with five cases of deep exercise representing approximately fourteen percent out of all exercise in the standard of care arm versus zero in DPX-one 100 arm, with a p value below 0.05.

Speaker 2

Importantly, we also saw in the study a clear and statistically significant sixty two percent reduction of patients with an asepsis score over 20. The asepsis score reflects the severity of the wound infection appearance and the clinical consequences of the infection. So DPLEX100 not only markedly decreased the rate of superficial and deep exercise, but even when exercise occurred in the DPLEX100 arm, they were less severe and caused less medical burden such as prolonged hospitalization or use of IV antibiotics. These robust results validated our conviction in DPLX-one 100 potential to address a significant unmet medical need and have generated substantial interest from potential commercial partners. We are extremely encouraged by the enthusiastic reception from healthcare professionals, lead surgeons in different types of surgeries, as well as thought leaders in the field of surgical site infections.

Speaker 2

All recognize DPLEX100 potential to substantially reduce the burden of surgical site infections, improve patient outcomes and generate meaningful healthcare cost savings. In addition, further analysis of the Phase III SHIELD II trial safety data revealed a good safety profile with no difference in serious treatment emergent adverse event between patients treated with DPX-one hundred versus standard of care. This safety profile further supports DPLX-one hundred potential as a well tolerated prophylactic treatment option for patients undergoing major abdominal surgeries. Following these positive Phase III data, we are on track with our new drug application or NDA preparation. Our next steps include a pre NDA meeting with the FDA planned by the end of this year, leveraging our Fast Track and Breakthrough Therapy Designation to facilitate regulatory review.

Speaker 2

We anticipate submitting the NDA to the FDA in early twenty twenty six and Marketing Authorization Application or MAA submission in Europe shortly thereafter. Shifting gears, we recently made significant progress on our GLP-one program, which leverages the company's extensive long term experience. This initiative aims to deliver approximately sixty days no burst GLP-one receptor agonist peptide for improved patient compliance and enhanced therapeutic outcomes in the rapidly growing weight loss and diabetes market. We have formally unveiled this program early in the current quarter, and we believe it represents an exciting opportunity to expand our therapeutic footprint into the fast growing metabolic disease market. Following the end of the quarter, yesterday we announced the appointment of Doctor.

Speaker 2

Nuit Tyser Zacks MD MBA as Chief Medical Officer of the company transitioning from a role on Polypie's Board of Directors. Doctor. Tyser Zlach brings extensive medical, R and D, and business development expertise to this executive position, strengthening the company's leadership team as it advanced towards NDA submission and commercial preparation following the positive Phase three Shield two results. From a financial perspective, we have significantly strengthened our balance sheet through a successful warrant exercise in human transaction, extending our cash runway well into 2026. With that, I will now turn the call over to Ori, our COO of US, to provide more details on our commercial preparations and partnering efforts for DPLEX 100.

Speaker 2

Ori?

Speaker 3

Thank you, Dipla. Following the successful completion of the phase three trial positive efficacy data, we have intensified our commercial preparation activities in partnership discussions. We believe that the positive Phase three results have validated the substantial market opportunity for DPLEX one To reiterate, based on IQVIA data, we believe the total addressable market for DPLEX one hundred in The US is just over twelve million total surgeries annually, with approximately four point four million of those being abdominal surgeries, and an additional two point one million abdominal procedures principally in gynecology and urology. The fifty eight percent reduction in SSI demonstrated in our Phase III trial is particularly significant when considering the substantial cost associated with SSI. As a reminder, SSI's are estimated to cost The U.

Speaker 3

S. Health system up to $10,000,000,000 annually, extend hospital length of stay by nine to seven days on average, and increase hospitalization by more than $20,000 per patient admission. The LX100's potential ability to significantly reduce these infection rates represent a compelling value proposition for healthcare systems, payers, and most importantly, patients. With respect to our partnership strategy, we continue to believe that identifying a US partner with a dedicated hospital focused sales force and significant resources will enable Diflex one hundred to maximize its sales potential in The US. Following the positive phase three data announcement, we have seen increased interest from potential partners, and we are currently evaluating the relevant opportunities.

Speaker 3

We will, of course, provide updates on these discussions as appropriate. For the European market, as we've mentioned previously, we already have an exclusive licensing agreement in place with advanced pharma to commercialize DPLEX100 across European countries. And we are actively working together to plan and implement pre launch activities to maximize DLS 100 and launch annual. And with that, I will now turn the call over to our CFO, Johnny, to review our financial results. Johnny?

Speaker 4

Thank you, Lori. We are pleased to report our financial results for the 2025, which reflect our continued investments in advancing our pipeline, while maintaining fiscal discipline. With our balance sheet. As of 06/30/2025, the company had cash and cash equivalents of $17,400,000 and short term deposits of $12,000,000 for a total of $29,500,000 This represents a significant improvement from our cash position of 15,600,000 as of 12/31/2024. The increase was primarily driven by the successful warrant exercise inducement transaction that Nicolas mentioned earlier.

Speaker 4

We expect that our current cash balance will be sufficient to fund operations well into 2026. Now turning to our income statement for the three months ended 06/30/2025, research and development expenses were $6,200,000 compared to $4,800,000 in the same period of 2024. The increase was primarily due to activities related to the completion of the SHiELD II Phase III trial and preparation for regulatory submission. General and administrative expenses were $2,500,000 compared to $1,100,000 for the same period of 2024. The increase was primarily due to non cash expenses related to performance based options or PSC use, following the successful Shield two Phase three trial, which triggered the vesting of the PSC use.

Speaker 4

Marketing and business development expenses were $700,000 compared to $300,000 for the same period of 2024. For the 2025, the company had a net loss of $10,000,000 or $0.78 per share compared

Speaker 2

to

Speaker 4

a net loss of $6,300,000 or $1.25 per share in the 2024. For the six months ended 06/30/2025, R expenses were $12,300,000 compared to $9,800,000 for the same six month period of 2024. G and A expenses were $3,700,000 compared to $2,100,000 for the same period of 2024. Marketing and business development expenses were $1,000,000 compared to $500,000 for the same period of 2024. The company had a net loss of $18,200,000 or $1.48 per share compared to a net loss of $12,700,000 or $2.62 per share in the six month period ended 06/30/2024.

Speaker 4

With that, we will now open the call to your questions. Operator?

Operator

Thank We will take our first question. The first question comes from the line of Chase Nicolauskas from Craig Hallum. Please go ahead. Your line is open.

Speaker 5

Good morning. Thanks for taking the questions. Maybe just on the NDA filing. So if I think about what is kind of left to be done between now and 1Q, can you kind of walk us through the larger items? And then particularly obviously on the CMC side, can you talk about your preparations as they continue to progress on mock up products etcetera as it relates to preparing for that 1Q filing?

Speaker 2

Sure. Good morning, Jack. We are in the finalization stages of the CMC and the clinical module. So, those will be the first approval to meet. There are some points that are being collected And obviously the preparation itself and the finalization of the document is taking time.

Speaker 2

But the document has already been reviewed by consultant as a first step. And we are now preparing, first of all, this and all the package for pre NDA meeting. Meaning that we would like to meet with the FDA for the end of this year for pre NDA meeting.

Speaker 3

We have

Speaker 2

an agreement while we are prior to submitting the NDA and then early twenty twenty six, the first quarter to submit the NDA. In parallel to that, obviously, we are in preparation for the GMP. Is something that is ongoing. The facility has been reviewed a couple of times already, both by the Israeli Ministry of Health and European QP, but still there is always the room to prepare further for FDA review and get the facility ready for the commercialization stage. So, summarize, we will be submitting in the next few weeks a pre NDA meeting request, which we expect that will early in the year and early next year, Q1, we will submit the NDA.

Speaker 5

Got it. Maybe just one on, can you talk about kind of the path forward for the GLP-one program as far as when we might see some data there and kind of early stage plans in that program? And then just second last for me, if we think about the ADVANCE partnership, should we expect some potential milestones from that kind of post data? Is that mainly going be regulatory or there'll be anything that triggers from the data itself from the Phase three?

Speaker 2

Sure. So the GLP-one, which is a program that we're very excited both because of the broader consequences of having a child that is released, injected in a form that supports an average of sixty or about fifty days of content and linear release, but also as it's being a field with so much unmet need and patients still do not benefit from the current medication endurance being quite harsh on this medication. So, what we think is our main benefit from both the prolonged, both the aspect that we can have relatively longer than without the Drugs and also the aspect of avoiding the first is characterizing current regiment of treatment. In terms of the timeline, we are now going into more robust preclinical studies where what we would like to show is both based in PK to support the risk profile that we see in cells in PK studies in bloodstream. This is also, I think, very important for potential partners.

Speaker 2

And this stage, we see these programs started with the GLP-one, but it's going be extended, being pursued into the clinic with collaboration. One of the large players in this field.

Speaker 5

And then just on the advanced partnership.

Speaker 3

Yes.

Speaker 2

You. Thank you. Yes. All you want to

Speaker 3

know, I just wanted to come out because we're getting some messages that the line is not great. So please tell us if we need to repeat any or any that was in there earlier.

Speaker 2

So, the partnership, we are in active and continue the partnership is active and continuous both through clinical stage as well as now in preparation for the submission and as part of the relationship advance, we'll also be reviewing the submission. The question was where should we expect milestones? So definitely, there is a milestone that is expected. And the more than three years have passed since we've signed with Vance, both advanced and I think that there are some adjustments that needs to be assessed and this is what we're doing now. I don't expect it to take too long.

Speaker 2

And once there is anything to announce around that, we will obviously announce. But as I said before, we are very pleased with the relationship. There is a trust that has been built during the years and appreciate. Advance are now starting to put more effort into the prelaunch activities. So both parties have an interest to finalize this as soon as possible.

Speaker 3

Thank you, Diqua.

Speaker 2

Thank you.

Operator

Thank you. We will take our next question. Your next question comes from the line of Roy Buchanan from Citi. Please go ahead. Your line is open.

Speaker 6

Okay. Great. Thanks. The line is much better now. I'm not sure if she's on the call or not, but I had a couple for doctor Klasers.

Speaker 6

So, is she here?

Speaker 3

Can you repeat

Speaker 2

the question?

Speaker 6

Oh, the line is bad again. Yeah. I'll try to repeat it. So if if doctor Twizer's is on, I was gonna ask, I guess the most compelling reason for joining the company as Chief Medical Officer, DPX100 or the BroaderPlex platform, if you could just comment on that. And then what she's gonna focus on, I guess, most intently for the next twelve to twenty four months.

Speaker 2

Sure. So, I think this is a really nice addition and our management team. And it's nice because Doctor. On board for almost two years. So she knows the team intimately.

Speaker 2

She knows the programs intimately. She knows the good and the bad and everything. And still, obviously, could choose also other positions, but she decided to join us and we're very pleased. And I think she is going to be a great addition to the team. With regards to how we view the CMO position and what is going to be a role going forward, specifically looking at the coming years or so.

Speaker 2

We are now in the position to start to do some prelaunch activity, some pre commercialization activities as well as support all the regulatory efforts. We have a great data that we want to have it all in front of as much as possible data. We'll obviously like to put it in the best peer reviewed journal. Part of the preparation and maintaining robust clinical advisory board to support broadening label as well as the launch activity. We have pipeline, which is another point we would like for assisting directing the team.

Speaker 2

Doctors and quite the experience that she has to lead this program.

Speaker 6

Okay, great. You. I'm feedback. Heading into the likely approval and launch next year, undoubtedly you'd like to bolster the balance sheet further. I guess, you just have a preferred way I may answered this with advance response, but do you have a preferred way to do that non dilutive via partnering or something else?

Speaker 6

Can you just comment

Speaker 2

What was the second portion of the question?

Speaker 6

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

Speaker 2

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

Speaker 6

Okay, perfect. Thank you. Thank you.

Operator

Thank you. We will take our next question. Your next question comes from the line of Brandon Folkes from H. C. Wainwright.

Operator

Please go ahead. Your line is open. Brandon Folkes, your line is open. Please ask your question. We shall move to the next question.

Operator

Please stand by. And the question comes from the line of Bhublan Pashejapin from ROTH Capital. Please go ahead. Your line is open.

Speaker 3

And it looks like the panel is muted.

Operator

Please stand by. Please continue to stand by. Brandon Folkes from H. C. Wainwright, your line is open.

Operator

Please ask your question. Unfortunately, we do seem to have some technical issues. Please continue to stand by. If I could ask participants to please press 11 on their 10 phones, if you wish to ask a question. Brandon Folkes, your line is open.

Operator

Please ask your question. Please continue to stand by. Your conference will resume shortly. Please continue to stand by. Your conference will resume shortly.

Operator

Apologies. We do seem to be having technical issues. If I could hand back for closing remarks.

Speaker 2

Truly apologizing for that. Thank you for joining PolyPeak's second quarter twenty twenty five earnings conference call. The 2025 was pivotal period for polypede. The positive SHOE-two Phase III results represent a significant milestone in our journey to begin to bring DPLX-one hundred to market. We are now focused on preparing our regulatory submissions, advancing our commercial preparations and exploring partnership opportunities to maximize the value of DPLEX-one hundred.

Speaker 2

We are also excited about the progress we have made in extending our pipeline with the GLP-one program, which leverages our extensive long term experience to address significant unmet need in the treatment of metabolic disease. As always, we are grateful to our team members, shareholders, and all external partners for their commitment to our mission. We look forward to speaking with you again on our next conference call. And if anyone wants to further ask questions that were not asked on the call, please reach out to us.

Operator

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

Powered by Quartr