PolyPid Ltd (PYPD) 2025 Q3 法說會逐字稿

Greetings and welcome to PolyPid's Third quarter 2025 conference call. (Operator Instruction) I would now like to introduce your host for today's conference, • Yehuda Leibler from ARX Investor Relations. Mr. Liebler, you may begin.

Thank you all for participating in PolyPid's Third quarter 2025 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 US of PolyPid.

Earlier today, Polypid released its financial results for the three months ended September 30th, 2025. A copy of the press release is available in the investors section on the company's website. At www.polifid.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 US 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, US market access study, 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 risk 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 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 projection 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 Poly.

Thank you, Yehuda. On behalf of our team at Poly, I would like to welcome everyone to our Third quarter 2025 earnings conference call.

The past quarter was significant for policies as we progressed 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 submissions, 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 Goods 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 US partners with an established hospital sales infrastructure, building also on the strong momentum of our positive phase three shield to trial results announced in the second quarter.

These discussions have progressed during the third quarter.

We also recently completed a new US market access study based on the presentation of the successful SHO 2 results.

The study provided important validation of D-PLEX100 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 quality growth, including our innovative pipelines in oncology, obesity, and diabetes.

With that, I will now turn the call over to Ori Warshavsky, our Chief Operating Officer US, 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 two major US medical conferences.

The 2025 American College of Surgeons Clinical Congress, which gathers surgeons from multiple disciplines across the US and internationally. And ID Week, 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 2 trial design and the 58% reduction in surgical site infection demonstrated by D-PLEX100.

As Dilka mentioned, we also recently completed a new US 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 PNT 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 echoed this enthusiasm.

Based on the clinical profile, 70% reported a high likelihood to add and stopD-PLEX100.

When asked if a new technology add-on payment or NTA 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 would 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 two phase three trial.

General 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 nine 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 non-cash expenses related to performance-based options or PSUs.

Following the successful Shield two phase three trial, which triggered the vesting of the PSUs.

Net loss for the nine 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 30th, 2025, Polyfeed had $18.8 million in cash cash equivalent 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 debts 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 Instruction) Chase Knickerbocker, Craig Hallum.

Good morning. Thanks for taking the questions. Maybe just first on the Israeli Ministry of Health, 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 from several regulatory bodies. I mean, just kind of walk us through kind of your confidence and any additional items that you do need to address before the FDA inspection or anything else that they would look for that that wouldn't be a part of these prior inspections.

Good morning, Chase.

Thank you. So yes, we've passed this, Ministry of Health inspection. Actually, this was the Fourth consequence of the inspection that we had.

The Israeli Ministry of Health is recognized by the European authorities, so this is also serving. 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 a 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 is.

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 you know 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.

Got it. Helpful, thanks. Maybe just ahead of that FDA, the pre-NDA meeting, in December, any specific items that you call out that are particularly.

Is, does this make sense?

Yes, connection might be bad, sorry.

(Operator Instruction).

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.

Yeah, just out of the pre-NDA meeting. Anything.

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

Yeah, just anything specific that you're. This particular, 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 an agreement with the with the current clinical CMC data support NDA filing and Clarity on any remaining request 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 from the FDA for an NDA.

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

Yeah I can take that one so we've done over over the last over the last month or so we have quite a lot of touch points with the stakeholders both formally to market research and less formally in the conferences and really across the board very strong interest in the in the product.

From the point of view that there really there's there's a need, there's a need for innovation, there's 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 end up and across the board it sounds like.

Premium pricing is something that we can reach reach to I don't want to give a specific numbers because we are in discussion with with partners and this is all kind of part of the the activities that are ongoing on the partnership front but.

From the prices that we tested before and we've seen now that we can stretch that that day even even higher there is room.

And willingness to use this, there's a very strong understanding of the impact of the SSI, what it does from a, 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 bonus payment infections as a reduction in infection is part of it. So there's really a nice driver there. Which will allow us to stretch higher the the pricing piece.

Got it thank you.

(Operator Instruction) (Inaudible).

Hi, thanks for taking my questions and congrats on the progress. Maybe just sort of at a high level, post the partnership, how quickly do you expect to grow the Polypit pipeline, with you being, or with your manufacturing duplex, can you just help us think through the evolution of PolyP, in 2026 and 2027 through being, a manufacturing partner, but then also redeploying capital into the pipeline going forward. And maybe just one more from me, in terms of the FDA filing in early 2026, any, anything that you need or any sort of answers coming out of that, the pre-NDA meeting that could extend that that timeline, just sort of how you're feeling about that meeting.

And sort of anything that may come out of that versus that guidance.

Thank you.

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 non-clinical modules are finalized, and the clinical modules is, we are integrating Shield two and prior data to bring complete, to being completed.

We We'll incorporate obviously any FDA feedback after the December meeting and then start the rolling submission early 2026.

Did not expect anything in particular. I can tell you that in the last year or so we had.

Handful of correspondence 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 (inaudible) and our vision for the (Inaudible)platform. The way we see it, obviously a US partner on the abdominal indication is very important, but our platform and our shield tool 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 duplex growing farther beyond the abdominal indication, and that's also something that is a potential growth.

(Operator Instruction) (Inaudible).

Good morning everyone and thanks for taking your questions and free from us. So firstly, with respect to market research you guys 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.

Can you hear me?

Yes, we can

yeah, go ahead.

Up, yeah. And then, what pricing point would make them comfortable to utilize D-PLEX100 in the US formulary? That's the first question.

Yeah, so, all, thanks, Dikla and, all good questions. So in terms of the study itself, first, it's a qualitative study. The study was, split into two. There were, 10 surgeons, general surgeons, colorectal and gynecology surgeons. That's one. And then there were 10 pharmacy directors both from a standalone hospital and network network hospitals.

All of them, all everyone participated in this study in the study was, either running the PNT process or, contributing member to the process.

So that was by design the.

The purpose of the study was to to have people who are who are on the formulary, and then you were asking about, so you're asking about the.

At the second part again. I lost.

My thought.

Maybe before that I would just add 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 the premium and reference to the end up all were much in line now it is very detailed it's actually we use the actual.

Data that we saw in Shield two, 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 result that we had in in shield two.

All right, that's very helpful. And then second, I understand you're advancing your partnership discussions in the US, 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 US as well as in the XS regions, and obviously your own 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 to forge 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. US, 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, they 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.

All right, great. And one final question from us. Obviously Duplex 100 will be manufactured in Israel, and as you're well aware, there is a push in the US 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 US?

Thank you.

So yeah, 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, this facility is built in a way that it should be sufficient for the First Five 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 aspect, the trend in the US around local manufacturing is something that we're taking into consideration. We're thinking about the expansion of the facility.

All right. Congratulations again. Thanks for your time.

(Operator Instruction).

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 mission.

Operator, you may now close the call.

(Operator Instruction).