Hello, everyone, and thank you all for joining us during the Lytham Partners Spring 2026 investor conference. My name is Ben Shamsian, Vice President at Lytham Partners, and today, Dikla Czaczkes Akselbrad, CEO of PolyPid, will be taking us through a brief slide presentation. PolyPid trades under PYPD on the Nasdaq. With that, let's get started. Dikla, welcome. I will turn the floor over for your presentation. Thank you, Ben. Thank you everyone for joining us. The last few months and 2026, in general, is going to be a real transformative year for PolyPid. Looking at our upcoming milestone, you could see that just in the first quarter, we initiated our NDA submission towards the end of the quarter, March 30th, under the rolling submission. We are about to finalize the submission shortly. Within 74 days from that point, we expect to get the FDA acceptance. Our lead product, D-PLEX100, is eligible for priority review, which will mean six months of review. PDUFA date is expected early 2027. In parallel to that, this quarter, we're going to meet the European authorities, the rapporteur and co-rapporteur, for what could be described as the equivalent to pre-NDA meeting, to align on the MAA submission, both in terms of timeline and scope. Shortly after that, a quarter after, we plan to submit with the MAA. Many milestones that are ahead of us, ahead of an approval, and I hope you all keep watching as we go towards our approval in the U.S. Going a bit high level in terms of where we are, the company, PolyPid is utilizing its unique core technology, called PLEX, which allows for long-acting control release of drug over time in the body. When we are talking about long-acting, we are referring to timeframe that starts from weeks and can continue even to several months. This is a very unique capabilities that we have developed for over a decade. More than 170 patent are already covering this approach. Our lead product, the D-PLEX100, is the first and the leading product to show this. Just to give you a sense on the platform, it is agnostic to the specific, to the molecule, both in terms of size and characteristic. We have small molecule in our lead product that is about to be approved within several months, and we also have peptide in our more younger pipeline programs. We have zero burst, which is a key component in many of the indication that we are targeting, and minimal systemic exposure where it's needed. This was the basis for a lead product, which is the D-PLEX100, a 30 days broad-spectrum antibiotics for prevention of surgical site infection. We specifically have shown in phase III in abdominal colorectal, the prevention of surgical site infection. This was published in the last few months. We're looking at specifically in abdominal colorectal, you expect to see double-digit infection rate, which is really unacceptable in 2026. Once the drug is administered at the end of the surgery, applied all over the incision, the abdominal incision in this case, although easily applied in any surgical site infection, the patient has coverage for 30 days of antibiotic at the incision. The 30 days is coming from our PLEX technology, which support this, but it's also very important in the way the CDC looks at surgical site infection. Surgical site infection in this surgery is defined as infection that occurs within 30 days from the surgery. Here you have a patient that has a gatekeeper for the bacteria to grow in. The surgeon has another tool, another shield, for the patient to cover the incision. This is exactly what we've shown in our last phase III study. This was an 800-patient, multinational, multi-center study looking at patient undergoing colorectal surgery, specifically open, large colorectal surgery. You can see here on the left side that in our primary endpoint, we've shown 40% reduction in a very robust statistical manner. Primary endpoint, based on the request of the FDA, was a combination of infection, mortality, and reoperation. All were accounted, and it's obvious that in the standard of care arm, there were about 18% occurrence of either mortality, reoperation or infection versus 10% in the treated arm. Drilling down into the key secondary endpoint, and the first one and the most important one is obviously looking at surgical site infection in more detail. Here you can see that patient that were mostly cancer patient, this is important to mention, had, without D-PLEX, about 10% infection rate, and this was reduced to 3.8%, 60% relative risk reduction with a P value of 0.001. Very robust. We believe this should be sufficient for an approval within a matter of months. I would also point out to another key secondary endpoint, which was looking. By the way, we met all key secondary endpoint, which was recently published in a conference that we were participating in, the SIS, the Surgical Infection Society. Here what you see is in addition to looking on the overall infection rate in those patient, we wanted to get a sense of the severity of the infection. From the first key secondary endpoint, it is obvious that we are reducing the prevalence of infection substantially. That's obviously the treated arm, where we had fewer infection versus the standard of care arm. You might ask, these 15, are they as severe as these 36? Maybe they are more severe, maybe they are less severe. This measurement, which is a numerical measurement, is called an ASEPSIS score, and the surgeon is giving score to the severity of the infection and the consequences. If a patient is being treated with IV antibiotic, if a patient is being readmissioned or reoperated, all of these points are getting a score, and over 20 is considered the threshold for severe infection. We're looking at the two arm, you can see 64% reduction, again, statistically robust, and the number and percentage of patient that had severe infection. Looking in that, it is obvious that once D-PLEX is used in the hospital, in the clinic, we would expect to see fewer infections and fewer patients with severe infections. This is very exciting for us. I'm moving on a little bit for the last few minutes to share with you how we view the market opportunity. Overall, when looking at the U.S. market, we are analyzing and looking at about 12 million procedures that are inpatient surgical procedures that have either high prevalence or relatively high prevalence of infection, or the consequences of an infection could be leading to disability or even mortality. This all sums to 12 million procedures. Out of these 12 million procedures, 4.4 are abdominal procedures, including colorectal, and some other abdominal. This is our first target market opportunity. We view this study, this robust 800-patient study, as the first entry to the abdominal surgery, with the expectation to expand behind abdominal to other surgery as well. It's not just the clinical benefit that we bring to the patient, which is obviously the most important thing. There is also here an opportunity to save money to the hospitals and to the American health system. Not just by reducing direct cost of the surgical site infection, which can be an average $30,000 that can be saved. It is also an indirect cost. For example, CMS penalties, it could be between 1%-3% on a yearly. In addition to that, D-PLEX100 is eligible for the NTAP program, which means that the hospital could get up to 75% reimbursement of the cost of the drug in the first two to three years of commercialization. Many incentive from that point to the hospital, and this was very nicely demonstrated in a recent market research that we've done post the result when both surgeon and hospital administrator saw the exact data that was gathered in the phase III. What you can see here, that surgeon were very willing or likely to prescribe D-PLEX to prevent surgical site infection. Here you can see that 80% were extremely likely to prescribe. This is encouraging for us. In addition to the surgeon, we also looked at pharmacy directors, as they are likely to look at the expense and to look at the cost. Here again, they were very likely to prescribe. When you add the NTAP component, the likelihood is 90%. This is where we are in terms of the positioning of the product within the hospital. As a company, we recently shared that we are in discussion to commercialize D-PLEX in the U.S. with a U.S. partner with good presence in the hospital space, and looking forward to launching the product early 2027 together with a partner. I will just close my remark today by mentioning that the product is being manufactured in our own GMP facility. That was precisely built for the Kynatrix platform. Very unique aseptic manufacturing facility that is going to be part of this partnership and part of this partnership to commercialize D-PLEX in the U.S. To summarize where we stand in terms of the milestone. As I said before, Q1, we initiated the NDA submission. During the second half of the year, this summer, we expect to get FDA acceptance letter and PDUFA date. Again, in the second half of this year, we will apply for the NTAP program In this second half of the year, EU submission, looking for an approval in Q1 2027 for the FDA, and in the second half of 2027, an approval in the EU. Very exciting year, very transformative. Looking forward to 2027, where we will actually start selling in the U.S. Thank you all. This is our financial highlight. All right. Well, thank you. Thank you, Dikla. Thanks 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, S-H-A-M-S-I-A-N @lythampartners.com. If you'd like to learn more about Lytham Partners or any of our clients, please visit our website at lythampartners.com. Follow us on LinkedIn to stay connected about future events. We hope you enjoy the rest of the conference, and have a great day.
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