PolyPid Ltd (PYPD) 2026 Q3 法說會逐字稿

Greetings and welcome to the PolyPid Third Quarter 2026 Conference Call. As a reminder, this call is being recorded. I would now like to introduce your host for today's conference, Yehuda Leibler from ARX Investor Relations. Mr. Yehuda Leibler, you may begin.

Thank you, operator, and thank you all for joining Polypid third-quarter 2026 earnings conference call. Earlier today, Polypid released its financial results for the three and nine months ended September 30, 2026. A copy of the press release is available on the Investors section of the company's website at www.polypid.com.

Joining me on the call today are Dikla Czaczkes Akselbrad, Chief Executive Officer of PolyPid, Ori Warshavsky, Chief Operating Officer, US, of PolyPid, and Johnny Miselawchi, Chief Financial Officer of PolyPid.

I'd like to remind you that on this call, management will make forward-looking statements within the meaning of the federal securities laws. These include statements about the FDA's review of the D-PLEX100 NDA, including labeling discussions, the PDUFA goal date, and the FDA pre-approval inspection. They also cover the potential approval of D-PLEX100 and the anticipated timing of the U.S. commercial launch by Advanz Pharma, as well as potential reimbursement for D-PLEX100, including the anticipated timing of a CMS decision on a New Technology Add-on Payment (NTAP). We will also discuss the potential label expansion of D-PLEX100 and planned communications with the FDA, and the EMA's review of the MAA for D-PLEX100, including the anticipated timing of the decision and a potential European launch. In addition, we will refer to the company's plans for Europe, Canada, and other territories, including potential partnerships and their timing.

Finally, these statements include the company's PolyPid 2030 Vision and Leverage for Growth, the development plans and anticipated timing for PD01B and PD03A, and the company's expectation that its cash resources will be sufficient to fund operations into 2028 and through several significant upcoming potential milestones.

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 the company's filings with the Securities and Exchange Commission (SEC).

Accordingly, you should not place undue reliance on these statements. I encourage you to review the company's filings with the SEC, including its Annual Report on Form 20-F, filed on February 25, 2026.

PolyPid disclaims any intention or obligation, except as required by law, to update or revise any forward-looking statements.

This conference call contains time-sensitive information that speaks only as of the live broadcast today, November 11, 2026.With that, it's my pleasure to turn the call over to Dikla Czaczkes Akselbrad, Chief Executive Officer of PolyPid.

Thank you, Yuda, and good morning, everyone. We are now just over two weeks from our PDUFA goal date of November 28, and this is a defining moment for PolyPid.

Let me start with the FDA review.

Our NDA for D-PLEX100 for the prevention of surgical site infections in patients undergoing colorectal surgery is under priority review.

Since the NDA was accepted in July, we have continued to work closely with the agency.

Labeling discussions are underway, and all scheduled FDA interactions are on track and aligned with the PDUFA goal date.

As is standard practice, we will not discuss the contents of the label ahead of an approval decision. In parallel, PolyPid and Azurity Pharmaceuticals are preparing for the U.S. launch of D-PLEX100 in early 2027, subject to FDA approval, and Ori Warshavsky will walk you through that work.

The partnership has already delivered $30 million to PolyPid, and an NTAP application for D-PLEX100 has also been submitted to CMS, with a decision expected in August 2027.

If granted, NTAP would provide additional reimbursement to hospitals of up to 75% of the product's cost above the standard DRG payment. Surgical site infections are not only a colorectal problem, and label expansion is a key growth driver for D-PLEX100.Together with Azurity Pharmaceuticals, our first step is broader abdominal surgery, including GI procedures and hysterectomies, representing approximately 4 million surgeries per year in the U.S., according to IQVIA. Close to half of these are open procedures.

We plan to initiate communications with the FDA on this work in the fourth quarter. Beyond abdominal surgery, we see opportunities in soft tissue and bone surgery. Under our current agreement, Azurity Pharmaceuticals will fund the clinical development once we jointly prioritize the indications

In Europe, we submitted our marketing authorization application to the EMAA on September 14, meeting the third quarter timeline we had communicated. Shortly after quarter end, the EMAA validated the application and began its formal review, with a decision expected in the second-half of 2027 and a potential EU launch in 2028.

At the same time, we mutually agreed with Advanced Pharma to terminate our 2022 agreement for Europe.

And the exclusive European commercialization rights to DFEX 100 have reverted back to us.

We now fully control our European strategy and we are in active discussions with potential commercial partners. In Canada, part of the Azurity collaboration, a new drug submission is planned for 2027.

At our Investor Days 2 weeks ago, we laid out the vision for Pplypid 2030 and our three levels of growth: maximizing DPLEX 100 through Azurity , including label expansion beyond colorectal surgery, taking DPLEX 100 into new territories, starting with Europe, and expanding our kinetics pipeline, beginning with PD-01B for the treatment of moderate to severe diabetic foot infections, or DFI.

Diplex 100 was always meant to be our first product, not our only one. To summarize the milestone ahead, our PDUFA goal date in two weeks' time on November 28.

The start of FDA communications on broader abdominal surgery this quarter, the U.S. Launch of DUPLEX 100 in early 2027, subject to approval, the NTAP decision in August 2027, and in the second-half of 2027, the EMAA decision, as well as the PD01B pre-IND meeting and first-in-human study.

With a committed US partner preparing for launch, full commercialization rights for Europe, a growing pipeline, and a strong balance sheet, we believe Polypid is well-positioned for this next stage. With that, I will turn the call over to Ori.

Thank you, Dikla.

I will cover our launch preparation with Azurity, new DPlex 100 data in our pipeline. Azurity is an established specialty pharmaceutical company with more than 70 medicines across 11 therapeutic areas, and we believe it is the right partner for Diplix 100.

It brings reach, more than 10 hospital-administered products, more than 200 U.S. Commercial-facing colleagues, and the GPO contracting and institutional relationships that reach more than 1,700 leading U.S. Hospitals and academic centers.

It also brings relevance, a hospital-prescribed antibiotic on the market that gives it credibility with infectious disease specialists and bowel preparation products used by the same colorectal surgeons Diplex 100 will initially serve. And it brings commitment to invest in and expand the product over time.

Since we signed the agreement in July 2026, the work has moved from planning to execution.

Azurity is building out its sales force, national accounts, market access and medical affairs team and our companies meet in joint forms across medical, regulatory, supply chain and commercial functions.

We see the commercial launch of Diplex 100 as a process that will build over several months starting in early 2027. Subject to approval, Azurity medical teams will start working with target hospitals, engaging surgeons and infectious disease specialists who can bring DPLEX100 to the hospital's Pharmacy and Therapeutics, or PMT, committee for review in addition to formulary. Each hospital reviews new products on their own schedule, so access will grow account by account over several months.

After the quarter, we also presented DPLEX 100 microbiology data at the ID Week 2026 conference.

In a late-breaking oral presentation by Dr. George Viola of MD Anderson Cancer Center, an exploratory pooled microbiology analysis of our clinical data covering 2,185 patients looked at infections that occurred despite prevention. The finding from the abstract added microbiologic context to the SHIELD 2 results. Finally, we introduced PD01B for the treatment of moderate to severe diabetic foot infections at our recent Investor Day.

It is our first step in extending kinetrics from preventing infections to treating them. Diabetic foot infections are among the most serious and costly complications of diabetes, and current treatment relies on debridement and systemic antibiotics, which can struggle to reach adequate concentration in the infected tissue with poor blood supply.

PD01B is designed to be applied directly into the wound and to sustain hyperlocalized high doxycycline levels in the infected tissue over weeks. It builds on the same active ingredient, manufacturing site, and established safety database of Diplex 100, and PolyPid holds worldwide commercial rights for it.

We expect to hold a pre-IND meeting with the FDA and begin a first-in-human study in the second-half of 2027. Our long-acting obesity program, PD03A, continues in early preclinical development.

With that, I will turn the call over to Jonny to review our financial results.

Thank you, Ori. I will now review our financial results for the third quarter ended September 30, 2026.

Research and development expenses for the third quarter of 2026 were $6.5 million compared to $5.3 million in the third quarter of 2025. The increase was primarily due to ongoing NDA-related activities and continued commercial readiness preparation. General and administrative expenses were $1.5 million compared to $1.8 million in the prior year period.

The decrease was primarily due to lower non-cash expenses related to performance-based options following the positive Phase III Shield II top-line results. Which triggered the vesting of those options. Marketing and business development expenses were $0.4 million in line with the prior year period.

Net loss for the third quarter of 2026 was $5.8 million or $0.24 per share, compared to a net loss of $7.5 million or $0.37 per share in the third quarter of 2025. For the first nine months of 2026, net loss was $21.3 million or $0.94 per share, compared to $25.7 million or $1.72 per share in the same period of 2025.

Turning to the balance sheet, as of September 30, 2026, PolyPid had cash equivalents and short-term deposits of $15.5 million compared to $12.9 million at December 31, 2025.

Our cash at September 30 does not yet include the $15 million milestone payments from Azurity for the NDA acceptance, which is recorded as a receivable on the balance sheet and was received in earlier October.

Our plans for PD01B over the next 18 months involve relatively modest spending and are reflected in this outlook. Based on our current plans and assumptions, we believe that our existing cash resources, together with the expected proceeds from our commercialization agreement with the Azurity, as well as future potential proceeds, will be sufficient to fund operations into 2028.

And through several significant upcoming potential milestones.

With that, we will now open the call for questions. Operator.

(Operator Instructions) Chase Knickerbocker, Craig-Hallum.

Good morning. Thanks for taking the progress. Thanks for taking the questions and congrats on the progress.

On the label, I respect that you're not going to talk about specifics, but can you just confirm for us that labeling discussions themselves have occurred with FDA? Thanks.

Hi, Chase. Good morning. So yes, and we said that in the press release that we are at the stage of the label discussion with everything that is coming with it.

Got it. Thanks.

And then just a second, as we think about, physician feedback from what we've disclosed on PD01B.

Anything else you've kind of gotten from the clinician community, whether it's your outreach or their outreach as far as what kind of the product profile that they would look for here? I think particularly just around as we think about this product potentially fitting into kind of current standard of care and how these patients are treated, particularly around kind of bandage changes, et cetera. Thanks.

Feel free to add to that also based on the latest conference. A couple of things that we are hearing from colorectal surgeons in particular, and those are very detailed into the data that we show on our phase three.

And what they really get from this data is obviously the 60% reduction of infection. That's obvious, that's the key secondary and this is easy for them to know that they have a certain percentage of surgical type infection in this patient. It is shown to be reduced by 60%. The other thing that they do, they look at, they also look at the, and those are of course open procedure.

The other thing that they mentioned to us, and this was coming almost from everyone that we spoke with, is the fact that the bottom line of our incident of surgical site infection with Diplex was lower than what they see in their minimally invasive business. And this is really encouraging. The other thing that is a focal point for all of the discussion is the understanding. Then when you look at the infection that are still there after the reduction that we've done, and you compare the complexity of those patients and those infection between the two arms, you see the same level of reduction in complexity.

So that implies that patients are not just having fewer events, but also. That they have the same level of complexity, maybe even less complexity in the fewer infections that are out there. So these are two major, I think, focal points.

Ori, anything you want to add to it?

Sorry, I was on mute.

I was on mute. I would just add that surgeons, when they, before they go into these procedures, they assess the patient based on risk, and again, what (Diplik) does is help.

Reduce some of this risk and mitigate this risk. This is kind of how they triage the patient and this is how they prepare. And I think this is what they will gain most from or when they think of where to apply or where to use the product is really based on the risk assessment. We know from literature, we know from data that risk factors, smokers, diabetics, IBMI.

Older patients have a higher risk for infection, and this will be kind of the target for the problem.

Got it. Maybe just last for me.

Any kind of conversations as part of this review that kind of give you a sense for how FDA is thinking about kind of the bar for you on label expansion, particularly into broader abdominal surgeries? Thanks.

So we discussed this.

Briefly on our R&D days about two weeks ago, but also in our prepared remarks today, this is ongoing. So the expansion from colorectal to abdominal, this is a work that is internally.

On the motion, and we said that we plan to initiate those discussions with the FDA this quarter. So, you can imagine that the package to the FDA is up and ready. We will be submitting it this quarter. I think it's premature to. Discuss what the requirement will be before we actually hear from the FDA. But we think we have a very good case to expanding from colorectal and specifically from the broad phase three data to abdominal.

But let's wait until we hear from the agency.

Thank you.

Jason Butler, Citizens.

Hi. Thanks for taking the questions and congrats on the progress.

Two questions. A quick follow-up to the label extension question.

Given the funding commitment for Missouri, how quickly do you think you can start to look at surgeries beyond abdominal surgery? Is that something that could even happen in parallel or do you expect it to be a sequential process? And then second question, can you maybe just comment a little bit more about your expectations for the ramp and adoption throughout 2027 and to what extent is the, or how important will the NTAP be to. Driving adoption.

Thank you.

Sure. Hi, good morning, Jason. So we are prepared and ready and label expansion is very important both for authority and to us. This is one of our major level of growth. We've discussed this.

Very detailed looking at polyPid into 2030, we view this as the most, or I wouldn't, maybe I shouldn't say the most, but one of the most rewarding expansion that we could pursue around the Plex 100. And this is the same way that Azurity looks at it and it was important for them. To have the ability to expand to other surgery. This is why it is covered with our mutual agreement.

To tell you whether things could be running in parallel or one after the other, it won't be smart to go into that when we have an FDA discussion.

Or we are initiating a discussion very soon. I think this is something we'll need to comment once we hear the feedback, but presumably there are specific surgery that goes specific area that could be done in parallel. I'm not sure if this is the best way.

To do things in parallel. It could be in a specific area within the area of abdominal and soft tissue, but maybe there are areas where we first need to see or to build a strategy with the FDA to convince them that after having additional safety data, additional proof, this could be done. And we'll also need to see. How this is adopted in the market to the sense that, we'll hear from surgeons, we'll hear from a hospital where they want to see this next.

So I think this is also something that is important. Ori, you want to touch the second question about NTAP.

Yeah, I'll take it. So Jason, good morning. You had two questions on RampUp and NTAP. So first on the ramp up, the plan is really once the product is approved, early 2027 to start with launch activities. And launch activities mean that MSLs are out there to the target hospitals, finding those champions, the surgeons that can bring the product to P&T.

Then a PMT needs to review, get additional input from their economic assessment, from the quality folks, from the infectious diseases specialists.

And then after this review, an update to the electronic systems to be added to formulary. So it's a process that takes a little bit of time. And it's a process that is done really account by account. So some hospitals.

I reviewed the PNTs convened every month and some every quarter. Some of the IDNs review hospital by hospital and some do one review for the entire network. So we will see over the next several months the accounts coming in.

In a sense in a stepwise approach, one quarter there will be a set and then the next quarter will be either more or less depending on the cadence within the hospital.

So without really giving, I know I'm not giving you a specific date, but it will a process that will take several months until we start really seeing traction.

And it connects also to the NTAP when we ask in the market research, we ask pharmacists that lead P&T committees about the willingness to put the product on formulary and in stock.

It was very high, close to 90% willingness to put the product on formulary, and then we asked them, okay, how would the NTAP change your answer? And the answer was, okay, from 90%, this would go to 100%. They would want to see the.

The data holds without NTAP, meaning the pharma economics data holds without NTAP. And then NTAP comes in as an addition, just coming to make the decision easier to accept. And timing wise, it'll be so if the NTAP application was submitted, it will be approved in August, and in effect next October. So really as PNTs. Complete their assessment and ready to put the product on the formulary and for surgeon to use it, NTAP will be there active and ready to go.

Great.

Thank you.

Boobalan Pachaiyappan, Roth Capital .

Good morning, Tim. Thanks for taking our questions. So obviously, the PDFA date is just three weeks away. So can you explicitly confirm whether the pre-approval manufacturing site inspections have been completed and is there any like unresolved.

Observation, for example, form 483, something like that. Are there any compliance issues? Are there any other deficiencies that were sort of unearthed during this time? If you can confirm that.

Thank you. That's the first.

Hi, good morning.

Thank you for that.

So I would say like that.

Obviously, as a matter of practice, the FDA is part of the NDA review. It is a standard process that the FDA conducts a pre-approval inspection of our manufacturing facility. But I think that at the stages we are, as a matter of practice, we should not comment on any specific labeling and timing status of pre-approval inspection. We said in the press release that everything has been either set to support the regulatory milestone or has already been done.

PDUFA is in just about two weeks. I think we have to be patient.

We are standing behind everything that we said, both in terms of the timing and the label discussions. That are underway, that by itself is a strong signal to where the review process is, but we will need to be patient a little bit more.

That's super helpful. Thanks for that. And then, in terms of, trying to do all the pre-launch activities, so I'm just curious, whether they are finding out hospitals where there's very low base level -- baseline infection rates are offered with more intensive prevention protocols, because in those cases, the economy case for duplex use could be, a little bit more challenging. So, I'm just curious if you can comment, maybe you'll explain what you are.

Sure. The hospital economic evidence.

Sure. I'll start and Ori please add on. They are looking first on first and you need to remember that the Azure has a pipeline of products around mechanical valve print. So they are speaking with the colorectal surgeon now on a daily basis. And they have the KOLs and the surgeon that they are frequently in contact with. They also have our KOL that has been with us along the development and during the clinical studies. So they are the first candidate for approaching.

And those are the ones that they are looking at to reach out to first. Or you want to add to that something?

Yes, I think so that's the first step. The second step is, and this is really in line with how we saw the market is really to go to a. The academic centers where guidance are written and what I heard when I spoke to some of the surgeons in the academic centers is really it's almost kind of a race to who has the best technology and so if you don't adopt a. A new technology and your peer across the street does, and they now show better results. So they have, a more, something that's more interesting that patients coming in, they kind of compete on the same patient. So although in some of these academic centers, the infection rates are maybe lower than in some of, let's say, general hospitals or community hospitals.

They do have interest to bringing the newest technology, the most effective one, and they're competing between themselves on what to use and how they're measured compared to other top hospitals. So that's the kind of the next level of target hospitals that ASRUTI is looking at.

All right, that's very helpful. Thanks for taking your questions.

Jeevan Larson, Oppenheimer.

Hey, thanks. This is Jeevan on for Les.

Thanks for taking our questions.

First one is, when should we expect pricing disclosure? What net cost per procedure are you discussing with the hospitals and maybe how that compares with the expected savings from preventing infections?

Follow-up is, does FDA approval alone trigger the Azurity milestone or are there other, label conditions attached to that? And, when would the cash be received and when would that revenue be recognized?

Hi, Liz. Well, sorry, John, welcome. So, in terms of the pricing, Azurity will share the pricing at the launch. This is obviously their decision. I can say that up until now, everything that they have learned is very much in line with what we have seen. We obviously shared with them our past market research, some of the highlights of those were disclosed by us in the past. But this will be their part to disclose, or you want to add anything to that?

No, that's how it is. It's the pricing will be decided ultimately by authority.

And as for the second part around milestone around approval, so. As everyone probably recall, we received already $30 million, and there are over $290 million in development, regulatory, and sales milestone. We did not disclose the breakdown of these over $290 between the three.

What we did say is that the development and regulatory milestone are all relatively in the short-term.

So other than that, I can't really add much to that.

(Operator Instructions) Brandon Folkes, H C Wainwright.

Hi, thanks for taking my question and congrats on the progress.

Maybe just sort of one multi-part from me.

How much health economic benefit data do you envision hospitals to require for uptake initially?

I know you had generated some good health economic data in the past. So does that still hold for launch or do you anticipate having to generate new or updated data for the hospitals?

And then along those lines, do you expect some of the hospitals to run their own experience trials before broad adoption? And how large of an investment into post-approval real-world data are you and Azurity contemplating?

Thank you.

Or do you want to take this one?

Yes, I'll take it. Hey, Brandon. So the data that we have, we believe is sufficient for launch. This is from our conversations. We've shown, just as (inaudible) shared earlier, we've shown a reduction in the severity of infection. Or a delay in the onset of breakthrough infection, which is very important to the hospital because if the patient is discharged, then the whole economics change.

We've shown a reduction in length of stay overall for the hospital. So we believe we have sufficient data to. For what is needed to demonstrate the economic case in front of PNT. Now, we also had conversations with a number of hospitals regarding your question on, let's call it a pilot study. And the overall consensus is that if there will be a need for a pilot study, it will be a small.

Handful of patients, 7 to 10 patients, something on this level really to check how the surgeons are comfortable with the product, that it wouldn't be an efficacy study, but more really to understand the usability and how it works with the workflow of the operating room. So that is something that is expected, that is something that Azurity is looking for and beyond that, the post-approval kind of real-world data, I think it's a bit early to discuss. And in any case, it will be part of the tactics of Azurity on how they drive the demand in the market.

But of course we will support them with our data as needed.

Great, thank you very much.

Thank you. This concludes today's question-and-answer session. I will now hand back for closing remarks.

Thank you all for joining us today and for your questions. With our PDUFA goal date fast approaching, Azurity preparing for launch, our MAA under review in Europe, and advancing PD01 development, we look forward to updating you on our progress in the weeks and months ahead. As always, we are grateful to our team, our partners, and our shareholders for their continued support.

Operator, you may now close the call.

This concludes today's conference call.

Thank you for participating. You may now disconnect.