PolyPid Ltd. Ordinary Shares Lytham Partners Fall 2026 Investor Conference

Hello everyone, and thank you all for joining us during the Lytham Partners Fall 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. Let's get started. Dikla, welcome, and I will turn the floor over to you for your presentation.

Thank you, Ben. Good day everyone. Happy to be here, and introduce you to PolyPid. PolyPid is a biopharmaceutical company in a very interesting time in the life of the company. We have a PDUFA date, very soon, November 28, for our lead product, and a pipeline of products based on our proprietary technology, called Kinetrix, that allow for long-acting control release of a drug. The technology can be customized to any API, and we have started with surgical site infection, which are elaborate in a minute, more than 170 patents already granted and approved, around the platform and the pipeline product, close to 90 employees. And as Ben mentioned, we are traded under the symbol PYPD. So what's the magical is all about what is this Kinetrix platform. So we are taking advantage of two very well-established technologies, polymer and lipid, which have been established for many years. They are drug-based on polymer, they are drugs that are based on lipids, but up until now, no one has done or combined the two in the way that we have done under a self-assembly condition, a self-assembly manner, we are creating a matrix of thousands of alternate layers. Think about the structure of an onion or a book where the polymer are the backbone of this matrix, and in between you have the drugs surrounded by lipids, no chemical bond between the compounds, just a matrix organized into the structure.

And once the drug is released, or applied in the tumor site and the incision site, gradually the drug is released, layer by layer, at the site, covering the area in our case, the incision, for 30 days, of antibiotic, of protection of the drug, from infection. And this is really our laggard ship product, a drug that is curing our platform, our Kinetrix platform, with doxycycline, covering the incision for 30 days. The 30 days is pre-designed to meet CDC definition of surgical site infection, which in most of the surgery referred to 30 days infection that can occur post-surgery. You could look at areas in this case in abdominal surgery, with incident rate of 15%, 25% incision risk, surgical site incision infection, and this is now in 2026, so there is a huge unmet need, and we are there to get this percentage closer to zero. The product has breakthrough therapy designation, FASTPREP, 3QIDPs, and it's under the 505(b)(2) path, and that is now in the motion with a PDUFA date, for the end of November. A briefing to the drug, how it's actually being used, what is this matrix looks like, and the patient in the clinic.

So we are talking about, in this case, an abdominal surgery, colorectal open colorectal, surgery. Most of the these patients are cancer patients, they did their routine colonoscopy, the doctor identified something that requires additional biopsy post this biopsy, once this there is a tumor, usually the first step is resection of the tumor, resection of part of the colon, resecting part of the colon, and in many of these cases, based on the size of the tumor, the patient condition, those could be with a relatively large incision. Whether it's starting from 7 centimeter and even going up to an open procedure with 10 plus centimeters, and those of our drug is based on the length of the incision. So up to 10 centimeter, one vial will be sufficient; 10 to 20, the surgeon will apply two vials, and over 30 centimeter, the surgeon will apply three vials. Each clinical vial product candidate contain about half an oral pill of oral antibiotic, and you could say, how could half an oral pill that is released over 30 days make a difference? But this is really the power of what we do. The drug is applied all along the incision, from all the abdominal wall, from the fascia to the skin, covering the incision, and due to our Kinetrix platform, we are supporting 30 days of coverage of the incision all along the abdominal wall, covering the incision. 30 days, this meets the CDC definition of surgical site infection.

The way that the drug is presented to the site, covering at the site, creates a relatively high minimal inhibitory concentration. High MIC at the site. And this is really what empowers us to see this level of result. This is a phase 3 pivotal study, 1,000 patients, global study, showing prevention of surgical site infection in patient undergoing colorectal resection. This data was first published about a year ago, and after submitting an NDA package, to the FDA, several months ago, we are now with a PDUFA date, approval date, by the end of November. And what we have here, we first have here on the left side, the primary efficacy endpoint. What the FDA required in order for the study to be successful, and what we are sharing or what we are comparing here is the standard of care arm, patient that got what is now customary, systemic antibiotics, mechanical bowel prep, there is a list of things that are done on a day-to-day basis with these patients, still getting us to 10% infection rate. We've also counted mortality, and reoperation. And you can see how this product got all of these parameters 40% lower, from 18% to 10.9%.

And this was with a relative risk reduction p-value of 0.0039, so very robust data. We also checked, and this was the most important thing for us, is to see what are the level of surgical site infection. On the standard of care arm, on the control arm, we had 10%. And we've reduced this to 60%. Again, very strong statistical data, with a p-value which is 0.0013. The FDA wants to see data in order for it to be considered a successful study. That is, with a p-value lower than 0.05. So this is much lower than that, and the feedback that we've been getting from surgeons since we got this study is that we are taking an open colorectal resection operation, which they usually see 11, 12% infection rate, and we are getting it below the 5% that they expect to see in the minimal invasive procedure. So this is better than what they see in the minimal invasive procedure. A bit about the market opportunity, and our recent collaboration with Azurity Pharmaceutical. So if you look at the overall relevant addressable market, we're looking at 12 million procedure in the US, those are procedure that have some considerable level of surgical site infection, and also once an infection occurred, the clinical and disability meaning of it could be quite crucial for the patient.

And we're looking at starting with abdominal surgery, those are about 4 million procedure in the US alone. Our collaboration, we've been saying all along that our strategy for this product is to find a partner that will market the product in the US, we had several months procedure of finding this partner, and getting into an agreement, this was a competitive process, and we chose to sign with Azurity Pharmaceutical, Azurity is a fully privately owned company, that is focusing on drugs that are used in the hospital, that's their main focus, and this is very synergistic with the sales force that is required to sell Duplex. The deal structure, was around US and Canada only, all other territories are returning by PolyPid, Azurity is responsible for commercializing Duplex in the US, and we are responsible for manufacturing, we have our own GMP manufacturing facility, and we will jointly pursue expanding the label behind colorectal and abdominal surgery. So as I mentioned, just before, you could see this going into other surgery, like hip, knee, like women that are undergoing breast mastectomy and reconstruction, and many more surgeries where there is a high amplitude. So those will be pursued together, and Azurity will be funding these experiments.

Financially wise, we received $30 million in upfront and near-term milestone, those were already secured based on the acceptance of the NDA, we have more than $190 million of development and sales milestones, with indicated that the development milestone are all relatively near-term, and could be achieved in the first two years of the agreement, and we have tiered royalties starting from mid-teens into mid-20s on each vial that is sold. The manufacturing that I've mentioned that we are the supplier, is also part of the agreement, and there is a pre-negotiated transfer price or sales price for each vial. All of these different compounds, the upfront, the development milestones, the sales milestone, and the supply agreement, in addition to the royalties, create what we believe is a very strong financial economics for this transaction, and we look forward to start seeing sale in 2027. Azurity is indicated that they're looking to launch the product early 2027. Some views about how this product will be fit, or what's the demonstrated economic incentive to adopt a product like Duplex. So there are many around the patient, around the data, just the data around the prevention of the infection, makes a huge difference for an hospital that is getting paid on a total DRG, and most of these patients that I've shown you are getting around 40,000 dollar their total DRG for the sale, but there is also another incentive and this is the enter program.

The enter program that stands for new technology add-on payment, allows for the hospital to get up to 75% reimbursement on the cost of the drug for the first two to three years, and this could be an additional driver for adoption, early on. Before I turn the call back to Ben, I just want to mention that as part of the deal, we're very proud with our manufacturing facility, that has been established to support both the development and the commercial activity, this is part of the strong economics that we presented in the licensing deal. So to summarize where are we in terms of the development, earlier this year, we have submitted the NDA in July the NDA was accepted, and we got a PDUFA date for November 28. We are going to submit the enter, this October, it's on the go, and we have submitted with the EU for approval in Europe, approval in Europe takes about a year, so our expectation is that this will be around a year from now. So a lot to expect, both in terms of approval in the US and in Europe, and also in terms of additional expansion of the label to other territories, and to other surgery.

We look forward to catching up with you later this year, and early next year. Ben, I will turn the floor again to you.

All right. Thank you, Dikla. And thank you to 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 at lithampartners.com. If you'd like to learn more about Litham Partners, you can visit our website, lithampartners.com, or follow us on LinkedIn, or YouTube, to stay connected about future events.