PolyPid Ltd. (PYPD) Q3 FY2025 Earnings Call Transcript & Summary

Greetings, and welcome to PolyPid's Third Quarter 2025 Conference Call. [Operator Instructions] As a reminder, this call is recorded. And I would now like to introduce your host for today's conference, Yehuda Leibler from ARC Investor Relations. Mr. Liebler, you may begin.

Thank you all for participating in PolyPid's Third Quarter 202 Earnings Conference Call. Joining me on the call today will be Dikla Czaczkes 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 its financial results for the 3 months ended September 30, 2025. A copy of the press release is available in the Investors section on the company's website 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 laws. For example, management is making forward-looking statements when it discusses the anticipated timing of the pre-new drug application or NDA meeting of the U.S. Food and Drug Administration or FDA, the planned NDA submission for D-PLEX100, the expected submission of the European marketing authorization application, the potential regulatory and commercial pathways for D-PLEX100, including leveraging its fast track and breakthrough therapy designations, the company's ongoing partnership discussions, market adoption, reimbursement assumptions, the company's commercial manufacturing readiness, U.S. market access studies and utilization of D-PLEX100, regulatory inspection readiness and the expected cash runway to fund operations well into 2026. 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 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. I encourage you to review the company's filings with the SEC, including, without limitation, the company's annual report on 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, November 12, 2025. With the completion of those remarks, it is my pleasure to turn the call over to Dikla Czaczkes Akselbrad, CEO of PolyPid. Dikla?

Thank you, Yehuda. On behalf of our team at PolyPid, I would like to welcome everyone to our Third-Quarter 2025 Earnings Conference Call. The past quarter was significant for PolyPid as we progress with our objective to bring D-PLEX100, our late-stage product candidate for the prevention of surgical site infection, to the market. We are pleased to report that our pre-NDA meeting with the FDA is scheduled for early December and is expected to be held as an in-person meeting at the FDA office. This important meeting is designed to align with the agency on the data package format and requirements for our NDA submission, representing a key milestone in our path to regulatory approval. We remain on track to submit the NDA for D-PLEX100 in early 2026, leveraging both our Fast Track and breakthrough therapy designation. In parallel, we are preparing for submission of the European marketing authorization application, which is expected to follow the NDA. During the quarter, we successfully completed the Israeli Ministry of Health Good Manufacturing Practice, or GMP inspection, marking our fourth consecutive successful inspection and an important step forward in achieving commercial manufacturing readiness for D-PLEX100. The successful completion of this inspection ensures we can manufacture commercial products for the European market once D-PLEX100 is approved in Europe, as well as serve as a real-life test of our readiness for an FDA inspection of our facility, which we expect will follow the NDA submission. We continue to advance our strategic discussions with potential U.S. partners with an established hospital sales infrastructure, building also on the strong momentum of our positive Phase III SHIELD II trial results announced in the second quarter. These discussions have progressed during the third quarter. We also recently completed a new U.S. market access study based on the presentation of the successful SHIELD II results. The study provided important validation of D-PLEX100's commercial potential. The results were very encouraging, confirming strong interest from both surgeons and hospital pharmacy directors. Taken together, the third quarter marked continued progress across all fronts, regulatory, commercial, and manufacturing, as we move steadily towards the next phase of PolyPid's growth, including our innovative pipeline in oncology, obesity, and diabetes. With that, I will now turn the call over to Ori Warshavsky, our Chief Operating Officer, U.S., who will provide additional insights on the market access study findings and our commercial readiness efforts.

Thank you, Dikla. As Dikla noted, this quarter was pivotal in strengthening our commercial readiness for D-PLEX100. The completion of the GMP inspection and our ongoing work with hospital stakeholders brings us closer to launch readiness. Last month, our medical team participated and presented data in 2 major U.S. medical conferences, the 2025 American College of Surgeons Clinical Congress, which gathers surgeons from multiple disciplines across the U.S. and internationally; and IDWeek, the key annual conference for infectious disease specialists. The response from both surgeons and infectious disease specialists was remarkably consistent. Both groups expressed the need for innovation and new tools to prevent SSI and were impressed by the SHIELD II trial design and the 58% reduction in surgical site infection demonstrated by D-PLEX100. As Dikla mentioned, we also recently completed a new U.S. market access study that included both surgeons and hospital pharmacy directors from leading academic and community hospitals who are contributing members or heads of the Pharmacy and Therapeutic Committee, also known as P&T Committee review process at their respective hospitals. The results were very encouraging and in line with our expectations in terms of both clinical perception and commercial potential. I'd like to share a few key highlights from the study. Among surgeons, D-PLEX100 was viewed as more valuable than currently available SSI prevention measures, primarily due to its strong efficacy, safety profile, and ease of use in the operating room. Most surgeons indicated that their hospitals are likely to add D-PLEX100 to formulary at launch, with 80% saying they are extremely likely to use it for their next eligible patients once available, and an average expected utilization of approximately 6 out of every 10 eligible cases, particularly for high-risk patients undergoing colorectal or abdominal surgeries or those with comorbidities like obesity or diabetes. Hospital pharmacy directors echo this enthusiasm. Based on the clinical profile, 70% reported a high likelihood to add and stop D-PLEX100. When asked if a new technology add-on payment or NTAP designation, which provides extra reimbursement to hospitals, would change their response, the pharmacy directors anticipated that the formulary coverage would be even higher, and the overall hospital adoption outlook will look even more favorable. D-PLEX100 was widely seen as a promising new SSI prevention agent addressing a significant unmet need. Altogether, we believe these results are a significant vote of confidence and tangible support for both the clinical and economic potential of D-PLEX100. With that, I will now turn the call over to Jonny Missulawin, our Chief Financial Officer, to review our financial performance.

Thank you, Ori. Turning to our financial results for the third quarter of 2025. Research and development expenses totaled $5.3 million, down from $6.2 million in the second quarter of 2025 and $6 million in the same quarter last year. This decrease reflects the completion of the SHIELD II Phase III trial. General and administrative expenses came in at $1.8 million compared to $1.2 million in the third quarter of 2024, while marketing and business development expenses were $0.4 million, up from $0.2 million in the same period last year. The net loss for the quarter was $7.5 million or $0.37 per share, an improvement from the net loss of $7.8 million or $1.22 per share in the third quarter of 2024. Looking at the 9 months ended September 30, 2025, R&D expenses totaled $17.6 million compared to $15.8 million in the prior year period. G&A expenses increased to $5.4 million from $3.3 million last year, and marketing and business development expenses rose to $1.4 million from $0.7 million last year. The increase in G&A and marketing, and business development expenses were primarily due to noncash expenses related to performance-based options or PSUs, following the successful SHIELD II Phase III trial, which triggered the vesting of the PSUs. Net loss for the 9-month period was $25.7 million or $1.72 per share compared to $20.5 million or $3.82 per share for the same period in 2024. From a balance sheet perspective, as of September 30, 2025, PolyPid had $18.8 million in cash, cash equivalents, and short-term deposits, up from $15.6 million at year-end 2024. We continue to expect that our current cash balance will fund operations well into 2026. Notably, during the quarter, we made significant progress reducing our debt by decreasing current maturities from $6.5 million to $2.4 million. We remain focused on maintaining financial discipline while advancing our key strategic initiatives towards NDA submission and commercial readiness. With that, we will now open the call to your questions. Operator?

[Operator Instructions] And your first question comes from the line of Chase Knickerbocker from Craig-Hallum.

Maybe just first on the Israeli Ministry of Health's successful inspection. Could you maybe just walk us through any findings that you did see there? And I would just like kind of to get your thoughts on your general confidence heading into that likely FDA inspection next year, now that you've had multiple successful inspections from several regulatory bodies. I mean, just kind of walk us through kind of your confidence in any additional items that you do need to address before the FDA inspection, or anything else that they would look for that wouldn't be a part of these prior inspections?

Thank you. So yes, we've passed this Ministry of Health inspection. Actually, this was the fourth consequence of inspection that we had. The Israeli Ministry of Health is recognized by the European authorities. So this is also served as commercial validation for the European authorities. And once we'll get the approval, we can start selling. As in every GMP inspection, obviously, there are always comments and things that are suggesting for improvement. And this is -- this has been, and this is an ongoing focus of us to always improve our facility, always improve our QC laboratory, and the way that we are managing this process. There isn't anything that I can point out specific that I can point out that we were -- we got a comment in specific area. It was an ongoing discussion, nothing that is critical, obviously, otherwise, we wouldn't have passed. But we are very confident on our ability to pass. We have here people with overall years of experience working in GMP facilities, in aseptic facilities. But to be honest, having confidence in this aspect [Audio Gap] and from that, there is a list of things that the team is working on to make sure that we pass this at first. And this is a really important effort for us. So we are highly confident, but this is an ongoing effort. We have to maintain this high standard all along, not just for the inspection, but also afterwards for the actual commercial manufacturing.

Maybe just ahead of that FDA, the pre-NDA meeting in December, any specific items that you can call out there, particularly?

Chase, I can hear you. I'm taking the call from a different location. Please ask again, you were asking about the pre-NDA meeting?

Yes, just out of the pre-NDA meeting, anything--

Can you recap your question because we weren't able to hear it? So if you can ask it again, please?

Yes. Just anything specific that you're -- is particularly crucial to reach alignment with the agency ahead of that -- ahead of the NDA filing that you'd call out for investors?

So we expect to review the data package, the submission format, the label scope. And our goal is to get agreement with the current clinical CMC data support NDA filing and clarity on any remaining requests before the rolling submission. A successful meeting will set the stage for an early 2026 submission, obviously, with priority review potential under our designation. So there's nothing specific, but the regular clearance that you would want to get from the FDA for an NDA.

And then just last for me. Now that you've been able to do quite a bit more survey work. and speak with relevant stakeholders in the market. Any additional thoughts on pricing as we look forward?

Yes, I can take that one. So we've done -- over the last month or so, we had quite a lot of touch points with stakeholders, both formally to market research and less formally in the conferences, and really across the board, very strong interest in the product from the point of view that they really -- there's a need. There's a need for innovation. There is a need for something new to reduce the infection rates from where they are. We tested -- as I mentioned before, we tested both the willingness to prescribe, the willingness to put product on formulary, whether it's on formulary and stocked, or not stocked, and the impact on NTAP. And across the board, it sounds like premium pricing is something that we can reach to. I don't want to give specific numbers because we are in discussion with partners, and this is all kind of part of the activities that are ongoing on the partnership front. But from the prices that we tested before and we've seen, we see now that we can stretch that even higher. There is room and willingness to use this. There's a very strong understanding of the impact of SSI, what it does from just direct cost of length of stay, but also I heard recently of surgeons that have in their annual review and in the kind of the bonus payment infections or reduction in infection as part of it. So there's really a nice driver there, which will allow us to stretch higher the pricing piece.

Your next question comes from the line of Brandon Folkes from H.C. Wainwright.

Congrats on the progress. Maybe just sort of at a high level, post the partnership, how quickly do you expect to grow the PolyPid pipeline with you being -- well with your manufacturing D-PLEX, can you just help us think through the evolution of PolyPid in 2026 and 2027 through being a manufacturing partner, but then also redeploying capital into the pipeline going forward? And maybe just one more for me. In terms of the FDA filing in early 2026, anything that you need or any sort of answers coming out of that -- the pre-NDA meeting that could extend that timeline? Just sort of how are you feeling about that meeting, and sort of anything that may come out of that versus that guidance?

Thank you, Brandon. So I'll start with the -- with your second question. In terms of our readiness for submission and where we stand, so all the modules are ready for submission. The CMC and the nonclinical modules are finalized, and the clinical modules is -- we are integrating SHIELD II and trial data to bring complete -- to being completed. We will incorporate, obviously, any FDA feedback after the December meeting and then start the rolling submission early 2026. Do not expect anything in particular. I can tell you that in the last year or so, we had a handful of correspondents with the FDA on specific aspects that we wanted to clear specific questions that we wanted to make sure that we are on the right path. But obviously, having the meeting early December and us wanting to submit in early 2026, there will be some things that will need to be incorporated based on the feedback and the meeting, but we do not expect this to be substantial. We will obviously update once we get the FDA minutes that on the actual meeting, whatever we can update at this point. But there's nothing that we expect on that. As to your question on -- I would even broaden it a little bit our vision for PolyPid and our vision for the PLEX platform. The way we see it, obviously, a U.S. partner on the abdominal indication is very important. But our platform and our SHIELD II is a validation to our approach and to our ability to bring product in that format. We have our younger program, which obviously will need to accelerate on this, and we've already been working on them, whether it's in the oncology space or in the obesity diabetes space. But we also see D-PLEX growing further behind the abdominal indication. And that's also something that is a potential growth.

Your next question comes from the line of Boobalan Pachaiyappan from ROTH Capital.

So firstly, with respect to market research, you just described, it's pretty exciting. And I just need some additional thoughts on that. So firstly, can you talk to us what's the sample size of your market research study? And then in that specifically, what percentage of those who participated in the research, they were involved in the decision-making process? And within that market research question, I also wanted to know whether you had an option to sort of assess the preliminary thoughts on utilizing D-PLEX100 to the gynecology and urology. Yes. And then what pricing point would make them comfortable to utilize D-PEX100 in the U.S. formulary? That's the first question.

Yes. So -- thanks, Boobalan. All good questions. So in terms of the study itself, first, it's a qualitative study. The study was split into 2. There were 10 surgeons, general surgeons, colorectal and gynecology surgeons. That's one. And then there were 10 pharmacy directors, both from a stand-alone hospital and network hospitals. All of them -- everyone participated in the study was either running the PMT process or contributing member to the process. So that was by design. The purpose of the study was to have people who are on formulary. And then you were asking about -- sorry, you're asking about the -- ask the second part again. I lost my thought.

Maybe before that, I would just add that, that this is not our first market access study. We've done several in the past. And besides for the pricing that was -- we saw a higher price in this and a premium and reference to the NTAP, all were much in line. Now it is very detailed. It's actually -- we use the actual data that we saw in SHIELD II. Obviously, everything is blinded. They did not know the actual product, but it was very detailed in terms of referring to the specific product and the specific results that we had in SHIELD II.

And then second, I understand you are advancing your partnership discussions in the U.S., and this may be some sort of hypothetical questions, or sort of I'm just thinking out loud. So I wanted to know, let's just say there's a global firm, they want to commercialize D-PLEX100 in the U.S. as well as in the ex-U.S. regions. And obviously, your an existing arrangement with Advanced Pharma. So I wanted to know if this existing arrangement would, in any way, provide some sort of barriers or impediments for a partnership with a global player? And will there be any sort of like a buyback clause with the Advanced Pharma agreement?

So no, there's nothing in the advanced agreement. Advance is our exclusive partner for Europe, but nothing out of that is part of this arrangement. U.S. Canada, all the rest of the world, it's not covered by this arrangement. If one of the partners, if it's a global partner that would want to include Europe as part of the discussion, we'll need to see if this is feasible. But it's not something that we plan on pursuing at this stage.

And one final question from us. Obviously, D-PLEX100 will be manufactured in Israel. And as you are well aware, there is a push within the U.S. for domestic manufacturing and also its connection with most-favored-nation pricing. So maybe can you talk to us potential challenges or barriers that PolyPid needs to overcome to commercialize D-PLEX100 in the U.S.

So yes, first, I should mention that our current facility, and we've indicated this along the years, is not our end goal facility. This will -- it will not be sufficient for the peak sales. We -- this facility is built in a way that it should be sufficient for the first 5 years of commercial launch -- from commercial launch. And we've already started planning and evaluating what should be our next facility or expanded facility, and we're taking this into consideration. So the trend in the U.S. around local manufacturing is something that we are taking into consideration. We're thinking about the expansion of the facility.

There seems to be no further questions. I will now hand back to Dikla for closing remarks.

Thank you for joining PolyPid's Third Quarter 2025 Earnings Conference Call. This has been a highly productive period as we execute on our regulatory strategy and move closer to our goal of bringing D-PLEX100 to patients and clinicians worldwide. With our pre-NDA meeting scheduled for early December and our NDA submission on track for early 2026, we are confident in our path forward. At the same time, we are making important progress in partnership discussions and commercial partnerships while advancing our manufacturing readiness to support a successful launch upon approval. We look forward to sharing further updates on our regulatory and commercial milestones in the months ahead. As always, we thank our team members, partners, and shareholders for their ongoing support and commitment to our--