Q3 2025 PolyPid Ltd Earnings Call
And welcome to Polly, pad's third quarter 2025 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. UDA Leela from Arts investor relations, Mr. Leela, you may begin
Thank you all for participating in poly pids. Third quarter 2025 earnings conference. Call joining me on the call, today will be Chief Executive Officer of politan. Johnny Malawi pits Chief Financial Officer, and AI workshops Chief Operating Officer us of poly pin.
Earlier today, payid released its Financial results. For the 3 months, ended September 30th 2025
Copy of the press release is available in the investor section on the company's website at www.poly.com. I'd like to remind you that on this call manageable will make forward-looking statements within the meaning of the federal Securities laws.
Company's ongoing partnership discussions market adoption. Reimbursement, assumptions, the company's commercial manufacturing Readiness US market access study. And utilization of deflex 100, regulator, inspection Readiness and the expected cash Runway to fund operations, well, into 20126.
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 20f filed on February 26th 2025, which identifies specific factors that may cause actual results or events to differ materially from those described in the form of these statements.
Polyphen, 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 12th, 2025,
With the completion of those remarks. It is my pleasure to turn the call over to the flats axle, broad CEO of pollyodd.
Thank you Yuda on behalf of our team at policy. I would like to welcome everyone to our third quarter 2025 earning constant score
The first quarter was significant for policy as we progress with our objective to bring District 100. Our late stage product candidate for the prevention of surgical cycling section 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 diplex. 100 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 deep 100.
To successful completion of this inspection ensures we can manufacture commercial products for the European market once DIP 100 is approved in Europe, as well as serve as a real-life test of our readiness.
Or 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 face research to 12 years old and now in the second quarter,
This discussion have progressed during the third quarter.
We also recently completed a new US market access study based on the presentation of the successful sheer to results.
The study provided important validation of duplex 100 Commercial potential.
The results were very encouraging, confirming strong interest from both surgeons and the hospital pharmacy director.
Taken together the third quarter, March continued progress across all forms.
Regulatory commercial and Manufacturing as we move steadily towards the next phase of politics growth, including our Innovative pipeline in oncology, obesity, and diabetes.
With that, I will now turn the call over to Oreo Shiki, our Chief Operating Officer at PolyPid Ltd.
We will provide additional insights on the market access study findings and our commercial readiness efforts.
Thank you, dear.
Noted, this quarter was pivotal in strengthening our commercial readiness for Diplex 100.
The completion of the GMP inspection and our ongoing work with the hospital. Stakeholders brings us closer to launch readiness.
Last month, our medical team participated in and presented data at 2 major US medical conferences.
The 2025 American College of Surgeons clinical Congress, which gathers surgeons for 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 to trial design, and the 58% reduction in surgical site, infection demonstrated by duplex 100.
As the Clam 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 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, Diplex 100 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.
No surgeons indicated that their hospitals are likely to add Diplex 100 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 for 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. Duplex 100.
When asked, if a new technology add-on payment or end up designation, which provides extra reimbursement to hospitals will change the response, the pharmacy directors. Anticipated that the formulary coverage would be even higher and the overall Hospital adoption Outlook. We look even more favorable.
Diplex 100 was widely. Seen as a promising, new SSI, prevention. Agent addressing a significant unmet need.
Altogether. We believe this results are a significant vote of confidence and tangible support for both the clinical and economic potential of duplex 100.
With that, I will now turn the call over to Johnny, Miss allowing our Chief Financial Officer, to review our financial performance.
Thank you, AI. 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 2 phase 3 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 37 cents per share and improvement from the net loss of 7.8 million or 1.22 cents per share in the third quarter of 2024.
looking at the 9 months, ended September 30th 2025
R&D expenses totaled. 17.6 million.
Compared to 15.8 million in the prior year, period.
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 GNA and marketing and Business Development. Expenses were primarily due to non-cash, expenses related to performance-based options or psus.
Following the successful Shield to Phase 3 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 30th 2025 Polly Pete had 18.8 million in cash cash equivalents and short-term deposits up from 15.6 million at your 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 in 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.
Thank you. If you wish to ask a question, you need to press star 1, 1 on your telephone and wait for your name to be announced to withdraw your question. Please press star 1, 1, 1 again.
We will take our first question.
And your first question comes from the line of Chase Knickerbocker from Craig Calum. Please go ahead. Your line is open.
Uh, good morning, thanks for taking the questions. Maybe just first on the, uh, on the Israeli Ministry of Health, um, successful inspection, uh, can you maybe just walk us through? Um, any findings, uh, that you did see there? Um, and I would just like, you know, kind of to get your thoughts on, on your general confidence. Uh,
Heading into that, you know, likely FDA inspection next year. Um, now that you've you know, had success multiple successful um inspections from from several regulatory bodies. I mean, just kind of walk us through kind of your confidence and any additional items that you uh do need to address before the FDA inspection or anything else that they would look for. Um that that wouldn't be a part of these prior inspections.
Good morning, Chase. Thank you. Uh, so yes. We've passed this. Uh,
Ministry of Health inspection actually, this was the fourth consequence of, uh, inspection that we had uh, the Israeli Ministry of Health is recognized by the European authorities. So this is also service commercial, validation for the European authorities and once we'll get the approval, we can start selling as as in every GMP inspection. Obviously, there are always comments and things that are suggesting for improvement and this is as this has been and this is an ongoing um
Focus of us to always improve our facility. Always improve our uh, QC laboratory and and the way that we are managing this process, and there isn't anything that I can point out specific that I can point out that uh,
You know, we were, we got a comment in in specific area, it was an ongoing uh discussion. Nothing that is critical of the uh 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 uh GMP facilities, in aseptic facilities. But, you know, to be honest, having confident in this uh aspect
And from that, there is a list of things that the team is working on to make sure that we pass this at first. Uh, and this is a real important effort for us. So, we are highly confident but you know, this is a, an ongoing effort. We have to maintain this high standard all along not just for the inspection, but also afterwards for, for the actual commercial Manufacturing.
Helpful. Thanks um maybe just ahead of that FDA uh the pre-nda meeting uh in December uh any specific items that you call out that are particularly
Does this make sense?
Yep. Connection might be bad. Sorry.
Please continue to stand by your conference will resume shortly. Okay, Jay Jay say I can hear you. I'm taking the call from a different location. Please ask again, you're asking about the you're asking about the pre and the a meeting.
Yeah, just ahead of the pre-nda meeting, uh, anything anything. Can you recap your question because we weren't able to hear it. So, if you can
Civic that you're, uh, um, this particular is particularly crucial to reach alignment with with the agency ahead of that ahead of the NDA filing. Um, 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 uh, agreement with the um
With the current clinical CMC data support, NDA filing. And
Clarity on any remaining requests before, uh, the rolling submission.
Um, a successful meeting will set the stage for an early 2026 submission.
Uh obviously uh, with priority review potential under our designation. So there's nothing specific. But the regular uh, clearance that you would want to get from uh, from the FDA for an NDA.
Got it. And then just last for me, um, now that you've been able to do quite a bit more survey work. Um,
And, uh, speak with relevant stakeholders in the market. Um, any additional thoughts on pricing? Um,
As we, uh, as we look forward.
Yeah, I can I can I can take that 1. So we we've done over over the last 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 in the conferences and really across the board. It's very strong interest in, uh, in the product
From the point of view that they really there's, there's a need. There's a need for Innovation. There's a need for something new to, 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, uh, on formulary and stalked or not stocked, and the impact on end up and across the board. It sounds like um,
Premium pricing is is uh is something that we can uh reach reach to. I I I don't want, I don't want to give a specific numbers because we are in in discussion with with partners. And this is all kind of part of part of the the activities that are ongoing on the on the partnership front. But
No, from from the prices that we tested before. And we've seen we we we we we see now that we can stretch that that the even even higher there is room.
And willingness to use this, there's a very strong understanding of the of the impact of of SSI. What it does from a
From just the direct cost of length of stay, I heard recently of surgeons that have in their annual review and in the kind of the bonus payment, infections as a reduction in infection as part of it. So, there's really a nice driver there which will allow us to.
To, to stretch higher, the the pricing piece.
Got it. Thank you.
Thank you, Chase.
Thank you.
We will take our next question.
Your next question comes from the line of Brandon, folks from HC Wayne Wright, please go ahead, your line is open.
Hi. Thanks for taking my questions, and congrats on the progress. Um, maybe just sort of at a high level post a partnership, how quickly do you expect to grow the PolyPid pipeline? Um, you know, with you being, well, we can discuss manufacturing defects. Can you just help us think through the evolution of PolyPid in 2026 and 2027 through being, you know, a manufacturing partner, but then also redeploying capital into the pipeline going forward? And maybe just one more from me, um, in terms of the FDA filing in early 2026.
Any anything that you need or any sort of answers coming out of that? Uh, the pre-nda meeting that could extend that 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.
Thank you Brandon. So I'll start with the with your second question. Um,
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 module are finalized and the clinical modules is, uh, we are integrating CO2 and prior data to bring complete to being completed.
We?
Will incorporate obviously, any FDA feedback after the December meeting? Uh, 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 um,
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. Right tests have but obviously, you know, having the, the meeting early December, uh, and US wanting to submit in early 2026, there will be some things that will need to be incorporated based on the, the feedback and and the meeting. But we do not expect
This to be substantial. Um we will obviously update once we get the FDA minutes um that on the actual meeting, whatever we can update at this point. Um, 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, for poly paid and our vision for for the Plex platform.
The way we see it, obviously a US partner on the abdominal indication is, is very important, but our platform and our Shield, too is a validation to our approach, and to our, uh, ability. Uh, to bring product in that format, we have our younger program, which obviously will need to accelerate on this. And, and we've already been working on them, whether it's in the oncology space or in the um obesity uh diabetes space.
but we also see duplex growing further behind the abdominal indication and that's also something that uh
Is a potential growth.
Thank you.
Once again, if you wish to ask a question please press star 1 1 on your telephone.
We will take our next question.
Your next question comes from the line of ban from Roth Capital. Please go ahead, your line is open
00 to the Gynecology and Urology area. Can you hear me?
Yes, we can. I can I can I can hear you. Yeah.
Go ahead. Okay. Yeah, yeah. And then um what pricing point would make them comfortable to utilize TX 100 in the US. Formulary, that's the first question.
Yeah, so, so, uh, all all thanks Google and all, all good questions. So in terms of the, the study itself,
First it's it's a it's a qualitative, it's a qualitative study. The the the study was the split into 2 there were a 10
Surgeons general, general surgeons, colorectal and gynecologic surgeons—that's one. And then there were 10: pharmacy directors, both from a standalone hospital and a network.
Network network hospitals, all of them, both all everyone participated in in this in the study in the study was uh either running the pnt process or uh contributing member to the, to the, to the process. So that's that, that was by Design. The the the
the the the purpose of the study was to, to have people who are who are on
Were on a formulary, and then you were asking about... Sorry, you're asking about the...
at the second part. Again, I uh, I lost my thought.
Maybe before that I was just I would just add that element that this is not our first uh Market access study. We've done several in the past and besides for the pricing that was uh um
We saw a higher price in this and a premium and reference to the end up. Um, all were much in line. Now, it is very detailed. It's actually we use the actual, um,
Data that we saw in Shield to obviously everything is blinded. They did not did not know the actual product but it was very detailed detailed in terms of
Referring to the specific product and the specific results that we had in in Shield too. Yeah.
All right, that's very helpful. And then second, I understand your 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. Um, so I wanted to know, let's just say there's a global firm. They wanted commercialized reflex 100 in the US, as well as
The exos regions and obviously your own existing arrangement with Advanced Pharma. Um, 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 know the there's nothing in the advanced agreement.
For Europe but nothing out of that uh is is part of this Arrangement US Canada, all the rest of the world. It's it's not covered by this Arrangement. If uh 1 of the partner if it's a global partner that would want to to
Include Europe. As part of the discussion, we'll need to see if this is visible but uh, it's not it's not something that we plan on pursuing.
At this stage.
All right, great. And 1, final question from us. Obviously, duplex 100 will be manufactured in Israel. And, um, as you're well, aware there is a push within 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? But uh, poly pin needs to overcome to commercialize defects 100 in the US. Thank you.
So yeah, um first I should mention that our current facility and we've indicated this along the years is not our uh end goal facility. This will it will not be sufficient uh for uh the peak sales. We this facility is built in a way that it should be sufficient for the first 5 years of commercial launch, 1 commercial launch and we've already started planning and evaluating. What should be our next uh
Facility or expanded facility, and we take this into consideration though. The the aspect, the, the trend in the US around.
Is something that we are taking into consideration. We're thinking about the expansion of the facility.
All right. Congratulations again. Thanks for your time.
Thank you. There seems to be no further questions. I will now hand back to declare foreclosing remarks.
Thank you for joining poly. Pits 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 the products 100 to patient and clinicians worldwide.
With our free, NDA meetings 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.
This concludes today's conference call, thank you for participating. You may now disconnect