PolyPid Ltd. Ordinary Shares Investor Day 2026 & KOL Event

Good day, and thank you for standing by. Welcome to the PolyPid 2030 Virtual Investor Day. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press *11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press *11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Yehuda Leibler. Please go ahead. Good morning, everyone, and welcome to PolyPid's Investor Day.

My name is Yehuda Leibler from Arx Investor Relations. With me on the call today you have Dikla Czaczkes Akselbrad, Chief Executive Officer of PolyPid; Ori Warshavsky, Chief Operating Officer, US of PolyPid; our guest, Dr. Warren Joseph; and joining us on the live Q&A will be Jonny Missulawin, Chief Financial Officer of PolyPid. Earlier this morning, PolyPid issued a press release outlining today's announcements. That release and the presentation you'll see today are available on the Investor section of PolyPid's website. The prepared remarks were recorded ahead of today's event, and the Q&A session you'll see at the end is live. Before we begin, I'd like to remind you that during today's event, management and our guest will make forward-looking statements within the meaning of the Federal Securities Laws. For example, management is making forward-looking statements when it discusses the U.S. Food and Drug Administration's, or FDA's, review of the new drug application, or NDA, for DPEG-100. That includes the priority review designation and the prescription drug user fee act, or PDUFA, GAL date of November 28, 2026. Forward-looking statements also include possible label expansion beyond colorectal surgery, the FDA pre-approval inspection of the company's manufacturing facility, the potential approval of DPEG-100, and the expected commercial launch of DPEG-100 by a Zordi Pharmaceuticals in the United States, in 2027.

They also include the company's exclusive commercialization partnership with a Zordi for the United States and Canada. That covers the partnership's economic structure, potential milestone payments, tiered royalties, and transfer price, and the joint development activities, as well as label expansion programs contemplated under that agreement. The forward-looking statements on this call also cover potential reimbursement for DPEG-100, including the new technology add-on payment, or NTAP, status. Additional forward-looking statements include the European Medicines Agency's, or EMA's, review of the marketing authorization application, or MAA, for DPEG-100, and the anticipated timing of that review. They also include the company's plans for commercialization of DPEG-100 in Europe and other territories, following the reversion of European rights from advanced pharma, including potential partnerships. Forward-looking statements also include the design, development, plan, regulatory pathway, and anticipated timing of the investigational new drug application, and clinical trials of PD-01B, as well as its potential benefits. Finally, they include the company's kinetrics technology and other pipeline programs, including its long-acting metabolic program, and the company's growth strategy and expected milestones through 2030. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond the company's control. These include 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 20F, filed on February 25, 2026. PolyPid disclaims any intention or obligation, except as required by law, to update or revise any forward-looking statements. PD-01B is an investigational product candidate and has not been approved by the FDA or any other regulatory authority. Dr. Joseph's views are his own. This event contains time-sensitive information and speaks only as of today, October 28, 2026. With that, I'd like to turn the event over to Dikla Czaczkes Akselbrad, CEO of PolyPid. Dikla? Thank you, Yehuda, and good afternoon, everyone.

It is great to be here. We are now exactly one month away from our PDUFA date, so it is obviously a very exciting and important time for PolyPid. This is also our first event since we signed our U.S. partnership, other than our quarterly call. For a long time, one of the questions I was asked more often by investors was when are you going to sign a U.S. partnership, and what will that partnership look like? I think we can now say that this question has been fully answered. So today, I would like to move the discussion forward and focus on the next question. What will PolyPid look like in 2030? I will start with a very brief recap of where we are today, and then I will focus on three key growth levers that we believe can drive PolyPid through 2030. We will also introduce our next product candidate, PD-01B, and its potential role in diabetic foot infection. Ori will take you through the program, and then we will hear from Dr. Warren Joseph, who will provide his perspective on the significant unmet need in diabetic foot infection. So let's start with where we are today, because the last six months have been a period of significant progress for the company.

In July, we signed an exclusive licensing agreement with a Zordi pharma covering U.S. and Canada. Under the agreement, we received $30 million upfront payment, and we are eligible for an additional over $290 million in development, regulatory, and sales milestone. We are also entitled to tiered royalties on net sales, ranging from the mid-teens to mid-twenties, and we have a pre-negotiated transfer price for each vial that we will manufacture and supply to a Zordi pharma. Another important compound of our agreement is label expansion. A Zordi pharma will found the clinical development for label expansion. Since signing the agreement, our working relationship with a Zordi has been excellent. A Zordi is bring building out its sales force, national accounts, market access, and medical affair team, ahead of potential launch in 2027, with a hospital footprint that reaches more than 1,700 leading U.S. hospitals and academic centers. Our teams meet regularly, across medical, regulatory, supply chain, and commercial functions, and we are working closely together to prepare for day one of launch. On the regulatory front, the NDA that we submitted earlier this year is under priority review, with a target PDUFA date of November 28, 2026, and all scheduled FDA interactions on track and aligned with DPEG-100's PDUFA goal date.

In addition, an application for a new technology add-on payment, or NTAP, was submitted to CMS in October this year, with a decision expected next August. If approved, NTAP would provide additional hospital reimbursement for DPEG-100 in the inpatient setting. In Europe, we submitted our marketing authorization application to the EMAA in September, and it was validated at the end of that month. So DPEG-100 is now under formal review by the EMA. And earlier this month, we regained full European commercial right to DPEG-100, which I will come back to in a moment. The bottom line of this: over the past six months, we told you what we would do, and we did it. So why hold this event now? From day one, we built PolyPid to be a platform company. DPEG-100 was always meant to be our first product, not our only one. Our technology delivers a drug at high concentration over a controlled period of time, and the value of that goes well beyond colorectal surgery and well beyond surgical site infections. So why now? With DPEG-100 approaching potential approval and with a commercial committed partner, funding the U.S. launch and label expansion, we are now in a position to move forward on several fronts at once.

DPEG-100 has demonstrated what our technology can do. Now we are putting the platform to work. We think about value creation over the next several years through three key levers: spending from near, mid, and long term. First, maximize the potential of DPEG-100 throughout our U.S. partnership, including label expansion beyond colorectal surgery. Second, bringing DPEG-100 to additional territories starting with Europe. And third, build a pipeline based on our technology platform, beginning with PD-01B. Our base case is the DPEG-100, subject to approval, will be approved for patient undergoing colorectal surgery with large incision. That is the patient population covered by our initial U.S. application. But surgical site infection isn't only a colorectal problem. It is a surgical problem, and it carries a significant burden both clinical and economically across many different surgeries. Our first step is to expand into broader abdominal surgery, including GI procedures, and hysterectomies. This represents around $4 million surgeries each year in the U.S., with close to half of them being open procedures. We plan to initiate discussions with the FDA in the fourth quarter of this year. Beyond that, we see additional opportunities in soft tissue surgeries, such as breast reconstruction and post-waist last body contouring.

This is a fast-growing segment as more patient experience significant weight loss, with GLP-1 therapies. These are also procedures involving very large incisions. And then there are opportunities in bone-related surgeries, including trauma and fracture fixation, as well as lumbar fusion. Importantly, under our agreement, a Zordi funds the clinical development of the label expansion programs that we pursue together while PolyPid retained clinical and scientific role. This makes label expansion one of the most capital-efficient growth opportunities available for us. The product is already developed and manufactured, and it is already in the hands of a commercial partner that is funding the clinical development work. The decision on which indication to prioritize will be made jointly with a Zordi following potential approval and we will update you as those plans take shape. Our second lever is geography. In the U.S., launch is expected in 2027, subject to approval, and in Canada, we plan to submit a new drug submission in 2027. With the EMAA validated and under EMA review, and full European right now back with PolyPid, we control our European strategy. We are evaluating how to maximize the value of DPEG-100 in Europe, including active partnership discussions. I would also say that having the U.S. partnerships gives us a strong template to what such a collaboration should look like, what are the key elements that need to be agreed on, and we can leverage this into a European agreement.

And our third lever, and the one we are focusing on today, is the pipeline. Kinetrix allows us to do three things with a drug. First, improve its efficacy. By achieving a high concentration exactly where it's needed. Second, extend the release of the molecule over time. And third, minimize systemic side effect and toxicity. We apply these capabilities across three therapeutic areas: surgical site infection, where DPEG-100 sits, infectious treatment, where PD-01B sits, and metabolic disease, including obesity. Here is how that all comes together. One platform covering both prevention and treatment. DPEG-100 in colorectal surgery with our PDUFA date on November 28, 2026, our EMAA under review in Europe, and Canadian submission planned for 2027, followed by label expansion into additional surgeries. In infection treatment, we have PD-01B, which is moving toward a pre-I&D meeting, and a first-in-human study. And in metabolic disease, we have PD-03A, our long-acting GLP-1 program, where early preclinical work is ongoing. It is encouraging to see how much interest there is across the industry in long-acting delivery for these drugs. Our nearest and most mature opportunity for a new product is in infection treatment. With that, I will hand over to Ori to introduce you to PD-01B.

Thank you, Dikla. So why did we choose this indication? There are over 40 million people with diagnosed or undiagnosed diabetes in the U.S. And close to a third of those will develop a diabetic foot ulcer, at some point in their lifetime. We know that 50% of ulcers can be infected. And from literature, we see that 1.5 to 1.6 million people live with diabetic foot infection every year. When we look at complications, in diabetes, the number one complication that leads to hospitalization is an infection. Looking at severe and moderate, DFIs, up to 20% of those with diabetic foot infections will end up with some level of amputation, whether it's a toe or a foot or maybe a larger part of the leg. So the implications are huge, in terms of time with the doctors, surgery time, surgeon time, and even downstream after an amputation, quality of life implications, and implication on caregivers and the patient itself. So why did we choose this indication? It's a big market with great unmet need. It's a space where both physicians and investors know very well. There have been attempts in the past to apply local antibiotic to treat the infections.

And I think more important, diabetic foot infection is a local problem. It's a problem of poor blood flow and it's a problem that systemic antibiotic does not solve completely. Very similar to what we saw with SSI, where Kinetrix managed applying locally, managed to impact infection rates. And this is what we plan to do, taking Kinetrix, apply local high-concentration for a long enough duration of time to close that gap in current infection treatment. So what is PD-01B? It's a hyperlocal, high-concentration doxycycline released in the diabetic foot wound for several weeks. The indication would be treatment of moderate to severe diabetic foot infection after wound debridement, and it will be developed under a new NDA under the 505(b)(2) pathway. So let's talk about what PD-01B is and what it isn't. What it isn't, it's clear. It is not DPEG-100. The two products have different goals, different indications, they'll be prescribed by different physicians in different settings. So while DPEG-100 is designed for prevention of surgical site infections after colorectal surgery, PD-01B is for treatment of moderate to severe diabetic foot infection. It will be prescribed by podiatrist and wound care specialist in the wound clinic as opposed to surgeons applying DPEG-100 in the operating room.

The two products have different release profiles, and PD-01B will have its own intellectual property portfolio. And just recently, we applied for a patent application for a new patent from PD-01B. In terms of commercial rights, we own all the worldwide rights for PD-01B, while Azurity maintains the rights for DPEG-100 in the U.S. and Canada for surgical site infections. So in short, we have a platform, Kinetrix, with two distinct products coming out of it. Now, the fact that we do share the platform means that we are not starting the development of PD-01B from zero. We can leverage a lot of the experience and the knowledge that was gained over the years to really hit the ground running. So first, Kinetrix, as a technology, is a validated technology. It's been proven in a large phase three. Also, doxycycline abroad spectrum antibiotics is well known. It's been on the market for many years. It's well characterized with a clear safety record. The formulation design is relying on what was done with DPEG-100, as well as the CMC and manufacturing processes. We will be using the same manufacturing site that is used for DPEG-100. Now, that is not to say that there's no work to be done.

There's adaptations that need to happen. Some of the methods, some of the testing need to be designed, but we are not starting from scratch. Even more specifically, in the preclinical work, over the years, we've generated a lot of information, preclinical safety information, toxicity information, microbiology information, all that work will serve as the base for the new development. Some of it will need to be adjusted, some of that will need to be done based on the DFI indication, but we're not starting from zero. In terms of timeline, we are expecting to meet the FDA for pre-I&D meeting in the second half of '27, and also have a first inhuman trial also in the second half of 2027. And with that, it is my pleasure to introduce Dr. Warren Joseph to talk about the clinical need in diabetic foot infection and the place in therapy of locally applied antibiotics. Dr. Warren, please, and if you don't mind, just introducing yourself as you start your presentation.