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. Leibler, you may begin.
Thank you, operator. Thank you all for joining PolyPid's 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 investor 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 U.S. of PolyPid, and Jonny Missulawin, 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 its U.S. commercial launch by Azurity Pharmaceuticals, as well as potential reimbursement for D-PLEX100, including the anticipated timing of a CMS decision on a New Technology Add-on Payment, or 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 U.S. 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 levers 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. 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. Dikla?
Thank you, Yehuda, and good morning, everyone. We are now just over two weeks from our PDUFA goal date of November 28th, 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 infection 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 content of the label ahead of an approval decision. In parallel, PolyPid and Azurity are preparing for the U.S. launch of D-PLEX100 in early 2027, subject to FDA approval, and Ori will walk you through that work.
The partnership has already delivered $30 million to PolyPid, and 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 hospital of up to 75% of the product 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, our first step is broader abdominal surgery, including GI procedures and hysterectomies, approximately 4 million surgeries a year in the U.S. according to IQVIA. Close to half of them 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 with Azurity will fund the clinical development once we jointly prioritize indications.
In Europe, we submitted our marketing authorization application to the EMA on September 14, meeting the third quarter timeline we had communicated. Shortly after quarter end, the EMA 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 ADVANZ PHARMA to terminate our 2022 agreement for Europe, and the exclusive European commercialization rights to D-PLEX100 have revert 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 two weeks ago, we laid out the vision for PolyPid 2030 and our three levers of growth: maximizing D-PLEX100 through Azurity, including label expansion beyond colorectal surgery, taking D-PLEX100 into new territories, starting with Europe, and expanding our Kynatrix pipeline, beginning with PD01B for the treatment of moderate to severe diabetic foot infections, or DFI. D-PLEX100 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 28th, the start of FDA communications on broader abdominal surgery this quarter, the U.S. launch of D-PLEX100 in early 2027, subject to approval, the NTAP decision in August 2027, and in the second half of 2027, the EMA decision, as well as the PD01B pre-IND meeting and first-in-human study.
With a committed U.S. 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. Ori?
Thank you, Dikla. I will cover our launch preparation with Azurity, new D-PLEX100 data, and 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 D-PLEX100. 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 D-PLEX100 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 forums across medical, regulatory, supply chain, and commercial functions. We see the commercial launch of D-PLEX100 as a process that will build over several months, starting in early 2027. Subject to approval, Azurity's medical teams will start working with target hospitals, engaging surgeons and infectious disease specialists who can bring D-PLEX100 to the hospital's Pharmacy and Therapeutics, or P&T, committee for review and 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 D-PLEX100 microbiology data at the IDWeek 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 II results. Finally, we introduced PD01B for the treatment of moderate to severe diabetic foot infections at our recent R&D Day. It is our first step in extending Kynatrix 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 hyper-localized, high doxycycline levels in the infected tissue over weeks.
It builds on the same active ingredient, manufacturing site, and established safety database of D-PLEX100, 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. Jonny?
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 payment from Azurity for the NDA acceptance, which is recorded as a receivable on the balance sheet and was received in early 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 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?
Thank you. We will now begin the question-and-answer session. If you wish to ask a question, please press star, one on your telephone and wait for your name to be announced. To withdraw your question, please press star, one again. We will take our first question. Your first question comes from Chase Knickerbocker from Craig-Hallum. Please go ahead. Your line is open.
Good morning. Thanks for taking the questions, and congrats on the progress. On the label, I respect that you are 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. 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. Then just second, as we think about physician feedback from what we have disclosed on PD01B, anything else you have kind of gotten from the clinician community, whether it is 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. Couple of things that we are hearing from colorectal surgeons in particular, and those are very detailed into the data that we show in our phase III. What they really get from this data is obviously the 60% reduction of infection. That is obvious. That is the key secondary, and this is easy for them to know that they have a certain percentage of surgical site infection in these patients. It is shown to be reduced by 60%. The other thing that they do, they look at, they also look at the. 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 D-PLEX was lower than what they see in their minimally invasive business. This is really encouraging. The other thing that is a focal point for all of the discussion is the understanding that when you look at the infection that are still there after the reduction that we have 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. That imply that patients are not just having fewer event, but also that they have the same level of complexity, maybe even less complexity in the fewer infection that are there. 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, before they go into these procedures, they assess the patient based on risk. Again, what D-PLEX 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. I think this is what they will gain most from, or when they think of where to apply or where to use the product, it is really based on the risk assessment. We know from literature, we know from data that risk factors, smokers, diabetics, high BMI, older patients have higher risk for infection, and this will be kind of the target for the product.
Got it. Maybe just last from 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.
We discussed this briefly on our R&D Day about two weeks ago, but also in our prepared remark 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 discussion 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 requirements 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 these broad phase III data to abdominal. But let's wait until we hear from the agency.
Thank you.
Thank you. We will take our next question. Your next question comes from Jason Butler from Citizens. Please go ahead. Your line is open.
Hi. Thanks for taking the questions, and congrats on the progress. Two questions. Maybe a quick follow-up to the label expansion question. Given the funding commitment from Azurity, 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? Then second question, Dikla, can you maybe just comment a little bit more about your expectations for the ramp in 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 Azurity and to us. This is one of our major levers of growth. We've discussed this very detailed, looking at PolyPid into 2030. We view this as the most, or maybe I shouldn't say the most, but one of the most rewarding expansion that we could pursue around D-PLEX100. 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 surgeries or 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 area 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. 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 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
Yeah
question about the NTAP?
Yeah, I'll take it. Jason, good morning. You had two questions on ramp-up and NTAP. First on the ramp-up, the plan is really once the product is approved early 2027 to start with launch activities. Launch activities mean that the MSLs are out there to the target hospitals, finding those champions, the surgeons that can bring the product to P&T. Then P&T needs to review, get additional input from their economic assessment, from the quality pay folks, from the infectious diseases specialists. Then after this review, an update to the electronic systems to be added to formulary. It's a process that takes a little bit of time, and it's a process that is done really account by account. Some hospitals are reviewed, the P&Ts convened every month, and some every quarter.
Some of the IDNs review hospital by hospital, and some do one review for the entire network. We will see over the next several months, accounts coming in a sense, in a stepwise approach. One quarter there'll be a set, and then the next quarter will be either more or less, depending on the cadence within the hospital. Without really giving a 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. It connects also to the NTAP. When we ask in market research, we ask pharmacists that lead P&T committees about the willingness to put the product on formulary and in stock, there was very high, close to 90% willingness to put the product on formulary.
Then we asked them, "Okay, how would the NTAP change your answer?" The answer was, "Okay, from 90% this would go to 100%." They would want to see the data holds without NTAP, meaning the pharmacoeconomic data holds without NTAP, and then NTAP comes in as an addition just kind of to make the decision easier to accept. Timing-wise, it'll be, so if the NTAP application was submitted, it will be approved in August, so and in effect next October. Really, as P&Ts 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.
Thank you. We will take our next question. Your next question comes from Boobalan Pachaiyappan from Roth Capital. Please go ahead. Your line is open.
Good morning, team. Thanks for taking our questions. So obviously the PDUFA date is just three weeks away. Can you explicitly confirm whether the preapproval manufacturing site inspections have been completed, and is there any unresolved observation, for example, Form 483, something like that? Are there any compliance issues? Are there any other deficiencies that were unearthed during this time? If you can confirm that. Thank you. That's the first.
Hi. Good morning. Thank you for that. 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 conduct a preapproval inspection of our manufacturing facility. But I think that at the stage that we are, as a matter of practice, we should not comment on any specific labeling and timing status of preapproval 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.
We'll need to be patient a little bit more.
That is super helpful. Thanks for that.
Thank you.
In terms of Azurity, trying to do all the pre-launch activities. I am just curious whether they are finding out hospitals where there is very low baseline infection rates or operatives with more intensive prevention protocols, because in those cases, the economic case for D-PLEX use could be a little bit more challenging. I am just curious if you can comment, maybe you just mentioned that you are-
Sure
the hospital economic evidence.
Sure. I will start, and Ori, please add on. They are looking first on First, you need to remember that Azurity has a pipeline of products around mechanical bowel prep. They are speaking with the colorectal surgeon now on a daily basis, and they have their 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. They are the first candidate for approaching. Those are the ones that they are looking at to reach out to first. Ori, you want to add to that something?
Yes, I think, that is the first step. The second step is, and this is really in line with how we saw the market, is really to go to the academic centers where guidance are written. What I heard when I spoke to some of the surgeons in the academic centers is really, it is almost kind of a race to who has the best technology. If you do not adopt a new technology and your peer across the street does, and they now show better results, or they have something that is more interesting that patients coming in, they kind of compete on the same patient.
Although in some of these academic centers, the infection rates are maybe lower than in some of, let us say, general hospitals or community hospitals, they do have interest to bringing the newest technology, the most effective one, and they are competing between themselves on what to use and how they are measured compared to other top hospitals. That is the kind of the next level of target hospitals that Azurity is looking at.
All right. That is very helpful. Thanks for taking our questions.
Thank you. We will take our next question. Your next question comes from Jeevan Larsen from Oppenheimer. Please go ahead. Your line is open.
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? Then, follow-up is, does FDA approval alone trigger the Azurity milestone, or are there other label conditions attached to that? When would the cash be received, and when would that revenue be recognized?
Hi, Les. Sorry, Jeevan. Welcome. 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've 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. Ori, you want to add anything to that?
No, that's how it is. The pricing will be decided ultimately by Azurity.
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 million between the three. What we did say is that the development and regulatory milestone are all relatively in the short term. Other than that, I can't really add much to that.
Thank you. Once again, if you wish to ask a question, please press star one on your telephone. We will take our next question. Your question comes from Brandon Folkes from H.C. Wainwright. Please go ahead. Your line is open.
Hi, thanks for taking my question, and congrats on the progress. Maybe just 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? Along those lines, do you expect some of the hospitals to run their own experience trials before broad adoption? How large of an investment into post-approval real-world data are you and Azurity contemplating? Thank you.
Ori, you want to take this one?
Yes, I'll take it. Hey, Brandon. The data that we have, we believe is sufficient for launch. This is from our conversations. We've shown, just as Dikla mentioned earlier, we've shown a reduction in the severity of infection, a reduction in, or a delay in the onset of breakthrough infection, which is very important to the hospitals, 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 for what is needed to demonstrate the economic case in front of P&T. Now, we also had conversations with a number of hospitals regarding your question on, let's call it, the pilot study.
The overall consensus is that if there will be a need for a pilot study, it will be a small handful of patients, seven to 10 patients, something on this level, really to check how the surgeons are comfortable with the product. 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. Beyond that, the post-approval kind of real-world data, I think it's a little bit early to discuss. In any case, it will be part of the tactics of Azurity on how they drive 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.