PolyPid at Lytham Partners: Strategic Insights on D-PLEX100

On Tuesday, September 30, 2025, PolyPid (NASDAQ:PYPD) took center stage at the Lytham Partners Fall 2025 Investor Conference. CEO Dikla Czaczkes Akselbrad provided a strategic overview of the company’s progress, highlighting promising Phase 3 data for D-PLEX100 in preventing surgical site infections (SSIs) and exploring future market opportunities. While the company is optimistic about its cash runway into 2026 and potential U.S. commercialization, it is still seeking a commercial partner.

Key Takeaways

• D-PLEX100 showed a 60% reduction in SSIs in the SHIELD 2 trial.
• NDA submission for D-PLEX100 is expected in the first quarter of next year.
• PolyPid is actively seeking a U.S. commercial partner for D-PLEX100.
• The company anticipates sufficient cash into 2026.
• Plans for label expansion to other surgical procedures are underway.

Financial Results

• Cost of SSI: In the U.S., the average cost per patient is $25,000.
• Target Market: 7.4 million operations annually, with 4.4 million in the U.S. and 3 million in Europe.
• ENTEP Program: Up to 75% reimbursement for hospitals in the first two to three years post-launch.
• Cash Runway: Sufficient funds expected to last into 2026.

Operational Updates

• D-PLEX100 Development:

- NDA submission is planned for the first quarter of next year.

- A pre-NDA meeting with the FDA is scheduled before year-end.

- Manufacturing has passed inspections by the Israeli Ministry of Health.

- Actively seeking a U.S. commercial partner for D-PLEX100.

- Discussions with the FDA on label expansion are planned around the NDA submission.

• GLP-1 Program:

- Currently in early clinical and preclinical stages.

- Features include zero autokinetic exposure and potential for extended dosing.

- Plans to generate preclinical data for efficacy and pharmacokinetics.

- Collaboration will be sought once more robust data is available.

Future Outlook

• D-PLEX100:

- Anticipates FDA approval following NDA submission.

- Actively seeking a commercial partner for the U.S. launch.

- Pursuing label expansion for other surgical indications.

- Plans to report data in upcoming conferences and publications.

• GLP-1 Program:

- Focus on generating robust preclinical data.

- Seeking collaboration based on preclinical data.

Q&A Highlights

• D-PLEX100 Clinical Data:

- SHIELD 2 trial showed a nearly 40% reduction in infection, mortality, and re-intervention.

- Surgical site infection reduction was significant, dropping from 9.5% to 3.8%.

• FDA Interactions:

- Regular communication with the FDA due to breakthrough therapy designation.

- CMC and preclinical modules for NDA submission are finalized.

• Commercialization Strategy:

- Seeking a partner with a strong sales force to hospitals.

For more details, readers are encouraged to refer to the full transcript below.

Full transcript - Lytham Partners Fall 2025 Investor Conference:

Ben Shanksian, Vice President, Lithuanian Partners: Hello everyone, and thank you all for joining us during the Lithuanian Partners Fall 2025 Investor Conference. My name is Ben Shanksian, Vice President of Lithuanian Partners. During today’s Fireside Chat webcast, we welcome PolyPid, ticker symbol PYPD, on the NASDAQ. Joining us today from the company is Dikla Czaczkes Akselbrad, PolyPid’s Chief Executive Officer. Also joining us today is Chase Richard Knickerbocker, Senior Research Analyst with Craig-Hallum Capital Group LLC, who I’ve asked to moderate today’s Fireside Chat. Chase covers a wide array of specialty pharmaceutical, biotech, and medical technology companies at Craig-Hallum Capital Group LLC, including PolyPid. Chase brings a unique commercial perspective to his coverage as he has held several field sales roles at Stryker early on in his career prior to joining Craig-Hallum Capital Group LLC.

Before I turn it over to Chase, I just want to remind everyone that management is available for one-on-one meetings throughout the conference and in the upcoming weeks. If you have not already signed up and would like to schedule a meeting with the company, please send me an email at shamksian@lithuanianpartners.com. That’s S-H-A-M-S-I-A-N at lithuanianpartners.com. With that, Chase, the floor is yours.

Chase Richard Knickerbocker, Senior Research Analyst, Craig-Hallum Capital Group LLC: Thanks, Ben. Hi, Dikla. Thanks for taking the time. Maybe just to start, for those who are less familiar with PolyPid, maybe just a little bit of background on the company and kind of catching us up to date.

Dikla Czaczkes Akselbrad, Chief Executive Officer, PolyPid: Sure. PolyPid has developed over a decade a unique platform technology that allows for prolonged delivery, constant linear delivery of drugs, where initially we were focusing, we are focusing on surgical site infection, on prevention of surgical site infection, hoping to bring more product, utilizing our platform technology. Our lead product, the D-PLEX100, which is pairing our PLEX technology platform with doxycycline for 30 days coverage of the incision, just recently, a few months ago, has published a positive Phase 3 data, pivotal study, and we are now in the process of submitting the product for an NDA application.

Chase Richard Knickerbocker, Senior Research Analyst, Craig-Hallum Capital Group LLC: Maybe just to start on the pivotal data that you released a couple of months ago, can you talk about what you learned in SHIELD 1, how that informed SHIELD 2, and then walk us through the data? We can jump back and forth a little bit there, but obviously very strong results, nearly 40% reduction on the composite primary, over 50% reduction in surgical site infections. Maybe talk through the specifics of the data as well.

Dikla Czaczkes Akselbrad, Chief Executive Officer, PolyPid: Sure. The study is in prevention of infection in patients undergoing abdominal surgery, specifically open colorectal, where infection rates are quite high. In this type of patient, you would expect to see double-digit infection rate. This model was chosen for the very obvious reason of being a case where in an elective surgery, there is a very high infection rate. I would like there to say unacceptable infection rate. This is how we conducted the study. We started with SHIELD 1, which was a study that was run through COVID. 100% of the patients of this Phase 3 were recruited during the COVID time, which I must admit that at the time of the design and the initial running of the study, we didn’t give this too much thought in the sense that we thought that it’s more of an operational challenge.

As times went by and as we started to see the data coming out and in parallel to that, a peer review journal came out, we started to see hospital reporting that there was a reduction in surgical site infection during the COVID time. For all the obvious reasons, people were not going to the hospital as much. The hospital had much more robust hygiene processes. This jeopardized, or I would say, this had an impact on the robustness of the overall data. Within that, we had, with half the patient population in the study, about 500 patients, very robust data with patients that were more complex, the ones that are having multiple comorbidities, and the procedure is much more complex. We went to meet the FDA with that.

The FDA recommended that we repeat this group, saying that if the data is robust, this should be sufficient for an NDA. This is what we’ve done. This was exactly two years ago. We initiated the study. The study was conducted in patients undergoing open colorectal resection, specifically the more complex patients, the ones with the larger incision, with the larger tumor. As you said, in this data, where the primary endpoint was to show reduction of infection, mortality, and re-intervention based on the instruction of the agency, we had almost 40% reduction, with very statistically meaningful data, a p-value that is lower than 0.005, better than what is needed, reducing the incidence of the combination of these events from 18% to 10.9%. Also, maybe more important for us is our effect on surgical site infection, where we saw a 60% reduction from almost 10%, 9.5% to 3.8%.

Again, very robust in terms of statistical meaningful. What’s interesting here, and this is something that we’ve been hearing from surgeons post-publishing the data, now that we have some discussions with surgeons, they have indicated to us two points that I think are important in this data, at least 9.5% to 3.8%. The one thing that they are saying, we see in our practice a higher incidence rate than the 9.5%. To that, my answer is this makes perfect sense because in a study, you do not recruit some of the patients that you have in real life. For example, patients undergoing emergency surgery or those that are very unstable because you can’t randomize them, because that’s the common practice. The other thing that they’re saying, you have reduced the infection rate to 3.8%, which is better than what we see in the laparoscopy procedure in this patient population.

In this type of procedure, we would expect to see a 5% infection rate in laparoscopy colorectal resection, and you’ve shown 3.8%. This is kind of implying to them, or at least this is how we interpret their comment, that these are very robust results, very significant clinical added value. What we are hearing is that they expect that in real life, it will even have a better, an even better effect or a broader effect because of additional patients that will be part of the treatment.

Chase Richard Knickerbocker, Senior Research Analyst, Craig-Hallum Capital Group LLC: As we start to think about the product, now finally commercially, with the great data, as we’re marching toward FDA approval, with the submission in the first quarter of next year, can you just help characterize for investors how much preventing one infection saves the hospital? Then, two on that front, just kind of how you see the market opportunity in this initial indication for D-PLEX100 from a, you know, overall patient and dollars perspective.

Dikla Czaczkes Akselbrad, Chief Executive Officer, PolyPid: The cost of SSI per patient on average is $25,000 in the U.S. That’s the cost, and this is not being reimbursed because the hospital gets a total DRG, and this is what they get per patient, whether it’s a colorectal, for example, with the most complex colorectal resection with different multiple comorbidities. The total DRG will be $40,000, and it could be as minimal as $10,000 in the less complex and the most easiest procedures and patients. When a hospital has, on average, a $25,000 expense on these patients, they probably lose money on these patients. That’s one thing that I think is the most important. Obviously, the most important thing is to save life and to help patients, but this is really very easy to measure. The other thing is that our product has breakthrough therapy designation and three different Qualified Infectious Disease Product (QIDP) designations.

This makes us eligible for the ENTEP program, which means that the hospital could get up to 75% reimbursement on the cost of the drug in the first two to three years from launch. These are the first two economical drivers. In addition to that, as you were asking about the way we look at it, D-PLEX100 should be in the lifecycle management. The thinking is that the product could be expanded to many surgeries and many applications. The initial application that we are looking at is the abdominal one, which in the U.S., it is about 4.4 million procedures a year in abdominal surgeries. In Europe, additional 3 million. We’re talking on the initial target market opportunity of 7.4 million operations. Obviously, later on, we expect to see ourselves going into areas like open heart surgery, CABG, breast mastectomy and reconstruction, orthopedics.

There are many more areas where we can help the patient and the hospital.

Chase Richard Knickerbocker, Senior Research Analyst, Craig-Hallum Capital Group LLC: If we think about those future indications, you know, millions of more procedures, obviously, do you have any thought on kind of your path there as far as what kind of studies would be required? Is it going to be, you know, incrementally simpler studies than what we had to run in SHIELD 2? How should investors think about kind of the path forward and other indications as well?

Dikla Czaczkes Akselbrad, Chief Executive Officer, PolyPid: We believe, and we also see real-life evidence in other products, that those should be incrementally much smaller than the D-PLEX100. It’s not a pivotal study. The way we look at it and what we expect to see, we are going to submit the NDA, as you said, early next year in the first quarter of next year. We also plan to meet the FDA before the end of this year for a pre-NDA meeting. The thinking is that around the same time that we submit the NDA, we should be meeting the FDA for a label expansion discussion. This is part of our plan, and we can discuss then with the FDA specifically what the requirements are. I can give you examples. We’ve seen products that are in the surgery suite for management of post-surgical pain, for example.

We’ve seen many products that we can learn from that are under the 505(b)(2) pathway, where the presence of PK data, of safety data, of Phase 2 data was everything that was needed in order to support this broader of the label. I think the orthopedic is something that we will need to discuss in more detail with the FDA. The other parts are something that we feel very strongly that this should be supportive and sufficient.

Chase Richard Knickerbocker, Senior Research Analyst, Craig-Hallum Capital Group LLC: Got it. Maybe just on the path forward with the FDA towards the NDA submission, it sounds like everything’s on track for an early submission next year. Maybe just talk through any incremental conversations you’ve had with the agency, incremental things to do as far as what’s left to do for the filing and the final package.

Dikla Czaczkes Akselbrad, Chief Executive Officer, PolyPid: Sure. First, we along the way have been in quite, and this is also thanks to the breakthrough therapy designation, which allows us to have more frequent communication with the FDA. We’ve been submitting along the way things that we wanted to pre-agree on with the FDA, whether this is some CMC processes, some validation processes, everything that in our eyes is questionable, we’ve asked and we are asking. I think we probably had in the last year or so, dozens of back-and-forth communication with the FDA on things that we wanted to clear and make sure that we are on the right path. This is also the purpose of the pre-NDA meeting. We are not leaving things for the NDA. Whatever we can hear from and get to an agreement prior to the NDA, we try to do it.

Not everything, obviously, we can because some things we need to wait for the data. Whatever is finalized, we try to submit it. I must say that we get more and more confidence based on these responses and the type of requests that we get. That’s one important thing. We are not leaving things to the end of it. The other thing is that we’ve been in the process of preparing the modules and the package for the last year, even before we got the data. We sense that we are at the final review and final processes of at least the first modules that we plan to submit, the CMC and the preclinical. Those are pretty much finalized and are in good shape. The clinical module is in work, and it will be ready as well.

Maybe one thing that is also important, being an Israeli company gets us to be inspected by different regulatory authorities prior to the FDA inspection, which is not the case in U.S.-based facilities that are being inspected once they submit the NDA. We’ve been inspected by the European authorities, by the Israeli Ministry of Health. Just recently, we reported that we passed a commercial inspection and routine commercial inspection. We are in that state of mind. That said, a lot of work is being done to be prepared. We have a whole team that is dedicated to that. There is a lot of work that is being done to be prepared in the best way possible for the inspection. Once we submit the NDA, we expect that the FDA will come to inspect the facility shortly after that, in a matter of months.

Chase Richard Knickerbocker, Senior Research Analyst, Craig-Hallum Capital Group LLC: For that inspection from the Israeli Ministry of Health, are their standards fairly similar to that of what the FDA will hold you to, and can you speak to the confidence that that gives you in that ultimate FDA inspection when it happens during the NDA process?

Dikla Czaczkes Akselbrad, Chief Executive Officer, PolyPid: It’s very much on the same standard, and there is some mutual recognition for the stage of the clinical stage, and it’s a very high standard, all done under GMP requirement. I would say on that, and something that I think the team is also telling me, the worst thing that you could do in preparation for inspection is to feel too confident. Yes, the answer to your question is that the standards are very similar. Those are high standards. Every inspection, every mock inspection that we are doing with an external advisor, and every inspection that we’re doing, for example, with the Israeli Ministry of Health, is helpful in getting us better. I don’t think this is something that we can say, "Okay, we’re good to go." We need to be prepared for that.

A lot of work needs to be done in order to really pass this in the best way possible. Those are the kinds of standards that we put to ourselves and to our team. We hope to be.

Chase Richard Knickerbocker, Senior Research Analyst, Craig-Hallum Capital Group LLC: Got it. Yeah. You’ve been fairly clear and open post-data that you’re likely to seek a commercial partner in the U.S. Can you speak to how those conversations are going? Obviously, as you look to maximize value in those conversations, speak to how you see the overall opportunity from a revenue perspective for D-PLEX100 that you’re expecting these potential partners to value for you.

Dikla Czaczkes Akselbrad, Chief Executive Officer, PolyPid: I must say that I’m very pleased with all those discussions, with the level of interest, with the type of companies that are interested in the product. Those are companies that have a robust sales force to the hospital. I see that as a very good fit. Also, the kind of interest that they have in the product, how they view the product, how they view the potential to grow this product. Those are very good discussions. Obviously, you can’t time those discussions, and it takes time. We are pleased with the way that those discussions are going.

Chase Richard Knickerbocker, Senior Research Analyst, Craig-Hallum Capital Group LLC: Got it. To shift gears just a little bit, you guys have recently announced a GLP-1 program that’s in, you know, call it early clinical, preclinical stages. Can you just speak to kind of when we could see data from that program and exactly what you’re looking to prove and kind of what profile you’re looking to deliver in that?

Dikla Czaczkes Akselbrad, Chief Executive Officer, PolyPid: Maybe just to say what we see our benefit in this, because this is a very crowded area, and what’s the added value that we are bringing to this area. The two things that we are bringing that are quite unique are our ability to have this drug, the GLP-1, or the amyline, or the GIP. We started with GLP-1, but later on, with the right partner, this could be also expanded, is that we allow for zero autokinetic exposure to the drug. There’s no spike. All the drugs that are out there today are suffering from an initial spike. People have different PK, different exposure to the drug at the beginning of the week versus the end of the week. We are offering a zero autokinetic exposure of the drug. That’s one thing.

We expect that this will have an impact on the adverse event and the tolerability of the drug. The other thing is our ability to have it on a much extended time. Today, the drugs that are approved are for a weekly injection. We’ve published that we’re looking at 50 to 60 days, which is obviously much more. The endurance of this could be much better. It’s early, as you said. The next step is preclinical data that will show both efficacy as well as PK of the drug. I expect that this program, once we have this more robust preclinical data, will be a subject to some sort of a collaboration.

Chase Richard Knickerbocker, Senior Research Analyst, Craig-Hallum Capital Group LLC: The thought is not only to deliver a better dosing regimen, but also that there could be some benefit from that more smooth PK profile on the side effects that plague the class.

Dikla Czaczkes Akselbrad, Chief Executive Officer, PolyPid: Exactly.

Chase Richard Knickerbocker, Senior Research Analyst, Craig-Hallum Capital Group LLC: Do you think that preclinical data, as far as demonstrating that product profile, is sufficient to then kind of engage with partners? Do you think you’ll need some clinical data before you generate that interest?

Dikla Czaczkes Akselbrad, Chief Executive Officer, PolyPid: I think we, depending obviously on the actual data, and this is not just from me thinking that, but also from discussions that we have with the big players in this area, the first thing that they want to see is PK data. From their perspective, if they see PK data, knowing what they know on the drug and the indication, they can extract from that very, very nicely what will be the effect. That’s the first thing that they want to see. We also want to see some actual efficacy data. I think this will also have an impact. If the data is compelling, I think this should be sufficient. We’ve seen different deals that were signed, you know, just in a matter of, I think it’s two months that Eli Lilly signed a huge deal on a platform, on a delivery capability.

I think this should be sufficient, not because of the actual sufficiency of the data, but because this is based on a Phase 3, on a pre-approval drug. This is a pre-approval technology. It’s not something that is new. We are utilizing things that we’ve developed over a decade. We’re bringing a much more stable approach.

Chase Richard Knickerbocker, Senior Research Analyst, Craig-Hallum Capital Group LLC: Got it. Maybe just to finish, maybe just a quick lap around the financial position from a cash perspective, and then any other kind of near or medium-term catalysts that we should be watching for the company before the NDA submission in Q1?

Dikla Czaczkes Akselbrad, Chief Executive Officer, PolyPid: Sure. We have reported that we have sufficient cash into 2026. This is sufficient, obviously, post-submission of the NDA. In terms of additional milestones, we will be reporting as we progress on commercial, which is quite important to us. You would expect, I would expect to be able to report some publication of the data in different conferences. Probably the article will take a little bit longer because of the type of magazines that we are hoping to be at.

Chase Richard Knickerbocker, Senior Research Analyst, Craig-Hallum Capital Group LLC: Great. With that, thank you for your time, Dikla. I’ll pass the floor back to Ben.

Ben Shanksian, Vice President, Lithuanian Partners: All right. Chase and Dikla, thank you very much for your time today. Certainly found this very informative, and I believe our audience found it informative as well. Before we wrap up, a quick reminder. Again, anyone who would like to schedule a meeting with PolyPid, please send me an email: shamksian@lithuanianpartners.com, S-H-A-M-S-I-A-N at lithuanianpartners.com. Chase, Dikla, once again, thank you for your time, and we hope everyone enjoys the rest of the conference.

Chase Richard Knickerbocker, Senior Research Analyst, Craig-Hallum Capital Group LLC: Thank you, Ben.

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