Hello, and welcome to PolyPid's Company Webcast. My name is Ben Shamsian, Vice President of Lytham Partners, and today we have Dikla Czaczkes Akselbrad, CEO of PolyPid, who will be taking us through a brief slide presentation followed by a fireside chat moderated by me. PolyPid trades under PYPD on the Nasdaq. With that, let's get started. Dikla, welcome.
Thank you, Ben, and welcome everyone to our presentation. If I dive directly into who we are and what is our mission statement, so PolyPid is developing a unique platform technology that can support prolonged local delivery on a linear manner with late-stage asset that is about to have an NDA this coming year. We have more than 170 patents covering our platform technology, as well as headquartered in New Jersey and Israel. Without further ado, if I need to kind of exemplify on a very high level what the magic is all about and how is it that we are supporting this weeks of constant linear release of the drug, this is by combining two very well-established technologies, polymer and lipids, by a self-assembly manner. We are creating this matrix of thousands of alternate layers supporting weeks of delivering of the drug exactly where care begins.
Once the drug is administered at the tumor site, at the incision, as a depot for incretin, body fluids create what we call surface degradation, which supports this linear release. Our pipeline is today consisting of our late-stage phase three asset, well, actually our lead asset, which is about to be submitted for an NDA. This is the D-PLEX 100. Just towards the end of last year, early December, we reported our pre-NDA meeting with the FDA, getting an alignment around the approval process and the submission process. I will share with you today in some of the results. Then we have a younger program with GLP-1.
D-PLEX 100 is approaching the surgical site infection market when, if you look at the number of surgeries that can benefit from an additional prevention drug for surgical site infection, we're looking at a large market of 12 million procedures just in the U.S. The product has breakthrough therapy designation, fast track, and QIDPs with the FDA. Now, I was kind of describing the platform, I was describing the product, but what exactly does it mean, this approach of prolonged local delivery in a linear manner? So if you look at one of our early phase two studies in open heart surgery, you can see how the product is actually being used in the clinics. Here you have the last few steps for CABG surgery. The surgeon reconstitutes the drug. Once it's reconstituted, it becomes like a paste applied all over the sternum bone along the incision.
Dosing is based on the length of the incision, varying from one to three vials. From this minute, this patient here has 30 days coverage of antibiotic all along the incision. Now, the timing is crucial because the CDC defines surgical site infection in most of the surgeries as infection that occurs within 30 days from the surgery. With this approach, we are giving the surgeon an additional tool into the toolkit to cover the window of opportunity for the infection to occur at the right time that is needed. In addition to that, this approach supports very significant, or I would even say high local concentration with minimal to no systemic exposure, which is really what makes the difference in our clinical data. This is really what makes this approach potentially transformational in terms of reducing the risk for surgical site infection.
The best way to exemplify it is our recent phase three. This was published on the second, early, or I would say mid last year, 2025, with the model for approval being a patient undergoing colorectal resection. The primary endpoint was to show reduction of infection, mortality, and re-intervention within 30 days from surgery. Overall, close to 1,000 patients in 60 centers in the U.S., EU, and Israel. The study was very well balanced between the two arms, with most of the patients also reported in literature that are undergoing this type of surgery being cancer patients, more than 85% of the patients. And without further ado, here is the actual data. So you can see that we have reduced by 40% the level of incidence of mortality, surgical site infection, and re-operation from 18% - 9.9%.
And maybe equally important, this was done in a very robust statistical manner, P-value, which is lower than 0.005. Obviously, the most important point for us was to see what is the exact effect on surgical site infection. And this was also our key secondary endpoint. We had a total of three key secondary endpoints. We met all of them, the first one being surgical site infection alone. You can see here that in this study, we had around 10% infection rate with patients only getting the standard of care versus 3.8% infection rate with patients getting the standard of care plus D-PLEX 100. Again, this was very meaningful statistically, P-value, which is lower than 0.005.
The other two points of the study, the other two key secondary points of the study, were looking at the overall patient population in addition to the intention to treat population that added an additional 200 patients undergoing minimally invasive procedure. Also here, study results were very meaningful, maintained the same trend with a P-value lower than 0.005. And the last key secondary endpoint being measuring the sepsis score, a score that is designed to assess the severity of the infection and the clinical consequences of it. These being additional hospitalization days, IV antibiotic treatment in IV antibiotics, re-hospitalization, re-operation. And here again, 60% reduction between the percentage of patients that had over 20 scoring versus with the treated arm. With these strong results, we reach out, as I said before, to the FDA for a pre-NDA meeting.
And now that we have an alignment with the agency, the plan is to submit the NDA early this year with the breakthrough therapy designation, which makes us eligible for the priority review. We expect a six-month review time, which practically means we will be looking at an approval towards the end of 2026, early 2027. Just a word about our commercial plan. So we are, we've said publicly that we are in discussion to find a partner in the U.S., and those discussions are going right on plan. And I'm sure we'll be able to elaborate about that in the Q&A portion.
Thank you, Dikla, for that presentation. We have time for a few questions here. Can you speak about the current standard of care, its limitations, and why hospitals and surgeons are excited about the D-PLEX 100?
Sure. So the standard of care varies from type of surgery to type of surgery and from hospital to hospital. But in all of those centers and procedures, there is a very detailed list of things that are being done prior to the surgery, during the surgery, and post-surgery. Many of these steps have little to no clinical proof that they actually help. And there is quite a lot of burden around all these steps. And obviously, the data that I've just shared takes this into consideration, meaning all of these patients got all the steps, and still they had a 10% infection rate. One thing that is, I would say, common to all of the procedures and all of the hospital patients will get prophylactic antibiotics, systemic, of course, usually IV, prior to the surgery, half an hour to an hour prior to the surgery.
So if a patient is undergoing an emergency surgery, they won't be able to give it to them. And those procedures have got us as far as feasible. We've kind of got to this glass ceiling in terms of the level of infection. So we need a different approach, and this is what we're bringing, a different approach, not another antibiotic that is a bit different, but a totally different approach covering the incision for 30 days at site, avoiding the systemic exposure, which is jeopardized when you have such a large procedure cutting the vein to the area.
Okay. As you go commercial, we want to look at this the same way that hospitals would look at a new product. So weighing the cost of SSIs or surgical site infections and the rates versus how D-PLEX 100 can sort of save some of those costs. Can you talk about some of the thought processes that go into those calculations?
Sure. And Ori, please feel free to jump in. So the way that the hospital is looking at it is from a couple of points. First, there is the overall cost of the surgical site infection. And you can see that this is a direct cost that is borne by the hospital because they are getting a total DRG payment for the surgery. So they're getting the same payment if the patient had a successful surgery, went home, and never came back, versus if they stayed for an additional week, two weeks because of an infection. And this is borne by the hospital. The other thing, the CMS also imposes penalties on hospitals that are related to hospital-acquired conditions, such as surgical site infection. And here we are coming.
The last point, which is beneficial on our approach, on top of the actual saving, the direct saving, the hospital will also be benefiting in the first 2-3 years of launch from the NTAP program that we are eligible to.
Okay. Thank you. Can you walk us through sort of the path to commercialization? You had a successful pre-NDA meeting. What are sort of the next steps here?
Sure. So as we said, we are going to submit the NDA early this year. We are eligible for the priority review as well as the rolling submission. So the plan is to submit the NDA in a matter of weeks. And at that point, the expectation is to start rolling. That is, that within two months or so, we will be finalized with the submission. And then there is another 60 days that the FDA takes to review and say that the submission is completed, that they accept the NDA submission. And from that point, we're looking at six months review time due to the priority. So if you take these all into consideration, we are looking at PDUFA Day towards the end of this year, early next year.
As I said, in terms of partnership, we are in discussion, and we think that the best path forward is to find a partner in the U.S. that has a robust presence in the hospital space, and specifically in the surgery suite, and partner around this indication. This is what we're doing right now.
Okay, great. So you mentioned the partner that you're looking at for U.S. When can investors hear some more specifics as to the name of the partner and sort of the terms and things like that?
The minute we sign, everything will be public. It is as easy as that. Now, seriously, I think that the kind of color that we are giving in terms of the type of partner that can support a successful launching on that, examples that are out there on very successful launches of prevention of infection products that were introduced in the U.S. to the market in the last two years, these are the kind of, I think, inspiration that investors can take at this stage to understand what to expect, what is the potential. But the actual specific, it makes those processes do take time from both sides. Both sides want to make sure that this is the right decision. But I expect that around the time that we will be submitting the NDA, we should be close to announcing this.
Okay, great. So what makes D-PLEX exciting for investors is sort of the platform mechanism, right? Meaning you can add more indications going forward without a lot of work. Current indication is for colorectal just because it's a large area. And you speak about other indications, and you've talked about things such as GLP-1 delivery. When can we hear more about other indications that you're working on?
So definitely, this is on the objective for 2026, both in terms of the expansion to other surgeries in the abdominal space, as well as the GLP-1. Towards the end of last year, we, for the first time, shared this program, although we've been working on it for over a year. And the plan is to be able to share additional preclinical data, some PK data, as well as efficacy data later this year. All of this is already in progress. So we expect to share this as we progress.
Okay. And we're almost out of time. So a final question here. The company has obviously many transformational milestones in 2026 and 2027. You have great healthcare funds as investors and supporters and partners. What does the balance sheet look like today, and how do you expect to fund the growth going forward?
So as we've indicated, our cash position, which last reported was close to $20 million, is sufficient to take us well into 2026. We've also indicated with this ongoing discussion, we think we have sufficient cash to get to the approval process, assuming those discussions mature, as I described. So we are in a very strong financial position today.
Okay. Thank you, Dikla, and thank you, everyone, for watching. If you have any questions or would like to schedule a meeting with PolyPid, please send me an email at shamsian@lythampartners.com. We have additional presentations and fireside chats coming up, so please stick around for more. Thank you, and have a great rest of the day.