PolyPid - Earnings Call - Q2 2025

Transcript

Speaker 6

Greetings and welcome to PolyPid's second quarter 2025 conference call. At this time, 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, Yehuda Leibler from ARX Capital Markets. Mr. Leibler, you may begin.

Speaker 4

Thank you all for participating in PolyPid's second quarter 2025 earnings conference call. Joining me on the call today will be Dikla Akselbrad, Chief Executive Officer of PolyPid, Jonny Missulawin, PolyPid's Chief Financial Officer, and Ori Warshavsky, Chief Operating Officer, US of PolyPid. Earlier today, PolyPid released its financial results for the three months ended June 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, management will make forward-looking statements within the meaning of the Federal Securities Law.

For example, management is making forward-looking statements when it discusses D-PLEX100's potential benefits, including its potential to address a significant unmet medical need, 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 the GLP-1 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 D-PLEX100. 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.

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 February 26, 2025, which identifies specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements. PolyPid disclaims any intention or obligation, except as required by law, to update or revise any financial 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, August 13, 2025. With the completion of those prepared remarks, it is my pleasure to turn the call over to Dikla Akselbrad, CEO of PolyPid. Dikla.

Speaker 6

Thank you, Yehuda. On behalf of our team at PolyPid, I would like to welcome everyone to our second quarter 2025 earnings conference call. The second quarter of 2025 was truly transformational for PolyPid, marked by the successful results of our Shield II Phase III trial, which demonstrated significant clinical benefits of D-PLEX100 in preventing surgical site infections, or SSI, in abdominal colorectal surgery. 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 SSIs, all-cause mortality, and surgical reintervention.

In addition, we demonstrated a robust 58% reduction in the rate of surgical site infections in patients treated with D-PLEX100 versus standards of care, with a p-value below 0.005, including a significant reduction in deep surgical site infections, with five cases of deep SSIs representing approximately 14% out of all SSIs in the standards of care arm versus zero in the D-PLEX100 arm, with a p-value below 0.05. Importantly, we also saw in the study a clear and statistically significant 62% 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. D-PLEX100 not only markedly decreased the rate of superficial and deep SSIs, but even when SSIs occurred in the D-PLEX100 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 D-PLEX100's 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. All recognize D-PLEX100's 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 events between patients treated with D-PLEX100 versus standards of care. This safety profile further supports the D-PLEX100 potential as a well-tolerated prophylactic treatment option for patients undergoing major abdominal surgeries. Following this positive Phase III data, we are on track with our New Drug Application or FDA 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. We anticipate submitting the NDA to the FDA in early 2026 and Marketing Authorization Application or MAA submission in Europe shortly thereafter. Shifting gears, we recently made significant progress on our GLP-1 program, which leverages the company's extensive long-term experience. This initiative aims to deliver approximately 60 days no-burst GLP-1 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 in the fast-growing metabolic disease market. Following the end of the quarter, yesterday we announced the appointment of Dr.

Nurit Zachs, MD, MBA, as Chief Medical Officer of the company, transitioning from her role on PolyPid's board of directors. Dr. Zachs brings extensive medical R&D and business development expertise to this executive position, strengthening the company's leadership team as it advances towards NDA submission and commercial preparation following the positive Phase III Shield II results. From a financial perspective, we have significantly strengthened our balance sheet through a successful warrant exercise inducement transaction, extending our cash runway well into 2026. With that, I will now turn the call over to Ori, our COO, to provide more details on our commercial preparation and partnering efforts for D-PLEX100. Ori?

Speaker 3

Thank you, Dikla. Following the successful completion of the Phase III Shield II trial auditing efficacy data, we have intensified our commercial preparation activities and partnership discussions. We believe that the positive Phase III results have validated the substantial market opportunity for D-PLEX100. To reiterate, based on accurate data we believe the total addressable market for D-PLEX100 in the U.S. is just over 12 million total surgeries annually, with approximately 4.4 million of those being abdominal surgeries and an additional 2.1 million abdominal procedures, principally in gynecology and urology. The 58% reduction in SSI demonstrated in our Phase III trial is particularly significant when considering the substantial costs associated with SSI. As a reminder, SSIs are estimated to cost the U.S.

healthcare system up to $10 billion annually, extend hospital length of stay by 7 to 9 days on average, and increase hospitalization costs by more than $20,000 per patient admission. D-PLEX100's potential ability to significantly reduce these infection rates represents a compelling value proposition for the healthcare system, payers, and most importantly, for patients. With respect to our partnership strategy, we continue to believe that identifying a U.S. partner with a dedicated hospital-focused set of significant resources will enable D-PLEX100 to maximize its sales potential in the U.S. Following the positive Phase III data announcement, we have seen increased interest from potential partners, and we are currently evaluating that development opportunity. We will, of course, provide updates on these discussions as appropriate. For the European market, as we mentioned previously, we already have an exclusive licensing agreement in place with Advanced Pharma to commercialize D-PLEX100 across European countries.

We are actively working together to plan and implement pre-launch activities to maximize D-PLEX100's anticipated launch and role. With that, I will now turn the call over to our CFO, Jonny, to review our financial results. Jonny?

Speaker 4

Thank you, Ori. We are pleased to report our financial results for the second quarter of 2025, which reflect our continued investment in advancing our pipeline while maintaining fiscal discipline. Starting with our balance sheet, as of June 30, 2025, the company had cash and cash equivalents of $17.4 million and short-term deposits of $12 million for a total of $29.5 million. This represents a significant improvement from our cash position of $15.6 million as of December 31, 2024. The increase was primarily driven by the successful warrant exercise inducement transaction that Dikla mentioned earlier. 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 June 30, 2025, research and development expenses were $6.2 million compared to $4.8 million in the same period of 2024.

The increase was primarily due to activity related to the completion of the Shield II Phase III trial and preparation for regulatory submissions. General and administrative expenses were $2.5 million compared to $1.1 million for the same period of 2024. The increase was primarily due to non-cash expenses related to performance-based awards or PSUs, following the successful Shield II Phase III trial, which triggered the vesting of the PSUs. Marketing and business development expenses were $0.7 million compared to $0.3 million for the same period of 2024. For the second quarter of 2025, the company had a net loss of $10 million or $0.78 per share compared to a net loss of $6.3 million or $1.25 per share in the second quarter of 2024. For the six months ended June 30, 2025, R&D expenses were $12.3 million compared to $9.8 million for the same six-month period of 2024.

G&A expenses were $3.7 million compared to $2.1 million for the same period of 2024. Marketing and business development expenses were $1 million compared to $0.5 million for the same period of 2024. The company had a net loss of $18.2 million or $1.48 per share compared to a net loss of $12.7 million or $2.62 per share in the six-month period ended June 30, 2024. With that, we want to now open the call to your questions. Operator?

Speaker 5

Thank you. If you wish to ask your question, please press star one, one on your telephone, and wait for your name to be announced. To withdraw your question, please press star one, one again. We will take our first question. The first question comes from the line of Chase Richard Knickerbocker from Craig-Hallum Capital Group LLC. Please go ahead. The line is open.

Speaker 0

Morning. Thanks for taking the questions. Maybe it's on the NDA filing. If I think about what is kind of left to be done between now and 1Q, can you walk us through the larger items? Particularly, obviously, on the CMC side, can you talk about your preparations as they continue to progress on knockout products, etc.? That's always too preparing for that 1Q filing.

Speaker 1

Sure. Good morning, Chase. We are in the finalization stages of the CMC and the clinical module. Those will be the first that we will submit. Throughout them, data points that are still being collected. Obviously, the preparation itself and the finalization of the document is taking time. The document has already been reviewed by our external FDA consultant as a first step. We are now preparing, first of all, the CMC CSR and all the packets for pre-NDA meetings. Meaning that we would like to meet with the FDA before the end of this year for pre-NDA meetings, create an agreement while we are prior to submitting the NDA. Early 2026, the first quarter, to submit the NDA. In parallel to that, we are in preparation for the GMP PR review. This is something that is ongoing.

The facility has been reviewed a couple of times already, both by the U.S. Ministry of Health and European QP. There is always room to prepare further for an FDA review and get the facility ready for the commercialization stage. To summarize, we will be submitting in the next few weeks a pre-NDA meeting request, which we expected to have early this year. Early next year, Q1, we will submit the NDA.

Speaker 0

Got it. Maybe just one on, can you talk about kind of the path forward for the GLP-1 program as far as when we might do some data there and kind of, you know, early-stage plans in that program? If we think about the Advanced Pharma partnership, when should we expect some potential milestones from that kind of post-data? Is it mainly going to be regulatory, or will there be anything that triggers from the data itself from the Phase III?

Speaker 1

Sure. For the GLP-1 program, which is a program that we're very excited about because of the broader consequences of it, of having the time that it released. They injected in a form that supports an average of 60 or about 60 days of constant and linear release, but also as it's being a field with so much unmet need and patients that still do not benefit from the current medication and endurance being quite harsh on these medications. What we think is our main benefit is from both the prolonged, both the aspect that we can have a relatively longer than what's out there drug and also the aspect of avoiding the burst that is characterizing the current regimen 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 release profile that we see in cells, in PK studies, in bloodstream. This is also very important for potential partners. At this stage, we see this program, the 20-glucide, started with the GLP-1 as this could be extended being pursued into the clinic with collaboration with one of the large players in this field.

Speaker 0

Regarding the Advanced Pharma partnership, Dikla.

Speaker 1

Yes, thank you. Yes, you want to add?

Speaker 3

I just wanted to add in some housekeeping because we're getting some messages that the line is not great. Please tell us if we need to repeat anything or any of those earlier.

Speaker 1

Regarding the sample partnership, we are in active and continuous. The partnership is active and continuous both through the clinical stage as well as now in preparation for the MAA submission. As part of the relationship, Advanced would also be reviewing the MAA submission. The question was, where should we expect milestones? There is definitely a milestone that is expected. As more than three years have passed since we've signed with Advanced, both Advanced and us think that there are some adjustments that need to be assessed. This is what we are doing now. I don't expect it to take too long. Once there is anything to announce around that, we will obviously announce. As I said before, we are very pleased with the relationship.

There is a trust that has been built during the years and appreciation and Advanced on how strategies to put more effort into the freedom of subjectivity. Both parties have an interest to finalize this as soon as possible.

Speaker 0

Thank you, Dikla.

Speaker 1

Thank you.

Speaker 5

Thank you. We will take our next question. Please stand by. Please continue to stand by. Your conference will resume shortly. Your next question comes from the line. Over, Douglas Royal Buchanan from PolyPid Ltd. Please go ahead. Your line is open.

Speaker 2

Okay. Great. Thanks. The line sounds much better now. I'm not sure if she's on the call or not, but I had a couple for Dr. Nurit Zachs. Is she here?

Speaker 1

Hello. Can you hear me? Could you please repeat the question?

Speaker 2

No. The line's back again. I'll try to repeat it. If Dr. Nurit Zachs is on, I was going to ask the most compelling reason for joining the company as a Medical Officer, you know, D-PLEX100 or the broader PLEX technology platform, if she could give a comment on that. What she's going to focus on most intensely for the next 12 to 24 months.

Speaker 1

Sure. First of all, I think this is a really nice addition to our management team. It's nice because Dr. Nurit Zachs was on our board for almost two years. She knows the team intimately. She knows the programs intimately. She knows the good and the bad and everything. Obviously, she could choose also other positions, but she decided to join us. We're very pleased. I think she is going to be a great addition to the team. With regards to how we view the Chief Medical Officer position and what is going to be our role going forward, specifically looking at the coming two years or so, we are now in a position to start to do some pre-launch activities and pre-commercialization activities as well as support all the regulatory efforts.

We have great Phase III data that we want to have all in front of as much third-party as possible. Data will obviously like to put it in the best peer-reviewed journal as far as the preparation and maintaining a robust clinical advisory board to support broadening the label as well as the next launch activity. We have a pipeline, which is another point that we would like her assistance in directing our research team. We'll always allow another doctor and quite the experience that she has to lead this program.

Speaker 2

Great. Thank you. I'm James Seebach. We're heading into the likely approval and launch next year. Undoubtedly, you'd like to bolster the balance sheet further. I guess, do you just have a preferred way? Maybe you've answered this with the advanced response, but do you have a preferred way to do that non-dilutive via partnering or something else? Can you just comment on that?

Speaker 1

Sure.

Speaker 6

We expect it will get. What was the second portion of the question?

Speaker 1

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

Speaker 6

As we said for quite some time, we are also looking to collaborate around that. A portion of, obviously, the effort will be financed and taken by our partner. 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 1

Okay. Perfect. Thank you.

Speaker 6

Thank you.

Speaker 5

Thank you. We will take our next question. Your next question comes from the line of Brandon Foulks from H.D. Wainwright. Please go ahead. Your line is open. Brandon Foulks, your line is open. Please ask your question. We shall move to the next question. Please stand by. The question comes from the line of Bublan Pashayev from Roth Capital. Please go ahead. Your line is open.

Speaker 3

I think it looks like the line will be muted.

Speaker 5

Please stand by. Please continue to stand by. Brandon Foulks from HD Wing Light. Your line is open. 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 star one, one on their telephones if you wish to ask a question. Brandon Foulks, your line is open. Please ask your question. Please continue to stand by. Your conference will resume shortly. Please continue to stand by. Your conference will resume shortly. Please continue to stand by. Your conference will resume shortly. Apologies. We do seem to be having technical issues. If I could hand back for closing remarks.

Speaker 6

Truly apologizing for that. Thank you for joining PolyPid's second quarter 2025 earnings conference call. The second quarter of 2025 was a pivotal period for PolyPid. The positive Shield II Phase III result represents a significant milestone in our journey to bring D-PLEX100 to market. We are now focused on preparing our regulatory submissions, advancing our commercial preparations, and exploring partnership opportunities to maximize the value of D-PLEX100. We are also excited about the progress we have made in extending our pipeline with the GLP-1 program, which leverages our extensive long-term experience to address significant unmet needs 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.

If anyone wants to further ask questions that were not asked on the call, please reach out to us.

Speaker 5

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