Hi, how are you? Good afternoon, and thanks for joining us to have a conversation with Ofer Gonen, Chief Executive Officer, and Barry. Wolfenson. From MediWound. Well done. MediWound is a global leader in next generation enzymatic therapeutics for tissue repair, built on validated bromelain-based enzymatic platform with approvals from FDA, EMA, and also Japan. The commercial engine today is NexoBrid for eschar removal in severe thermal burns, and has been partnered with Vericel here in the U.S., which has just posted a strong quarter since launch with roughly 80 U.S. burn centers having ordered to date, and which now sits underneath a 10-year BARDA contract, valued at up to $197 million. The long-term VALUE driver is EscharEx now in chronic wounds, now enrolling a global phase III VALUE trial in venous leg ulcers. The study is targeting 216 patients across approximately 40 sites, with pre-specified interim sample size reassessment and completion of enrollment, both expected by the end of early 2027. Behind that also sits a phase II DFU study, under pressure also, investigator initiated trial. Last but not the least, the company's also expanding the manufacturing facility so that it can increase its supply for the demand that it has. To talk about starting off with EscharEx and the NexoBrid franchise, let's get started with Ofer and Barry. Okay. You spoke about everything. I have nothing to add. For people who do not know much about MediWound, what is the long-term strategy here, especially when you have these two pillars, NexoBrid and EscharEx? Hi, thank you for hosting us, and as I said, you summarized quite nicely what we are doing. We have a technology that works. It is validated, published in more than 150 publications. We succeeded in 14 out of 14 clinical trials. We have our first commercial product, which is NexoBrid. It is a drug that removes eschar in severe burns. Our next pipeline product, which is the same technology, it is not only the same technology, it is the same product itself, but with a different concentration, is for a market which is much larger. As for the strategy, I think that it is important to emphasize that we have a company that is not a scientific risk. We are based on something which is approved. We have the first drug that generates revenue, and now we are moving forward to the next challenge, and the exciting milestone is near term. Yeah. One of the questions could be is like, why should the selective enzymatic debridement work better, and why should it become the standard here, especially when surgical debridement has been used for many, many years? This is a great question. We have a technology that, as I said, works. When you apply our enzymes on a tissue, it removes the non-viable tissue, the normal tissue, the one that is not protected by melanin, and it removes it. There are a few indications that can be relevant for that. The first one was the most severe one. You want to get rid as soon as possible from the dead tissue. Indeed, you need to change the strategy of how burns are treated in burn centers. It is not easy. It takes a lot of time in order to change the way how a surgeon works in burn centers. There are additional indications. The one that we are speaking about soon is the chronic wounds, that you just shift a current treatment. It has a lot of advantages, avoid scarring, avoid the pain, very quick, as effective as a knife. You just need to work on the right indications. What are the major catalysts that MediWound has over the next, say, 12- 18 months, and which ones do you think investors are not really paying attention to? I don't think that in MediWound, you need to wait 18 months for catalysts. The main catalyst, by far the most important one, is the phase III VALUE trial that we have. This will determine the real value of the company if it becomes a significant one. As an investor, I will look at the enrollment. I will look at safety. I don't know if you saw the release from today, that the product is actually safe, and no one stops the trial or changes the way we need to handle it. I would watch the top-line data, and after that, everything will speak for itself. What else I would follow is the fact that we are broadening the market or the indication of EscharEx. We want that when the trial will read out, it will be very clear that we have also indications that are very relevant, such as diabetic foot ulcers and pressure ulcers. All of it is going to initiate soon and be available once we have the venous leg ulcers readout. On top of that, we have the commercial asset, which is NexoBrid, keep on generating revenues. All kind of agreements with governments worldwide. Finishing, at last, the manufacturing facility and having it approved in order to be able to support the global demand. I wouldn't wait 18 months. I think the main catalyst is at the end of the first quarter, and the future of the company will be determined by then. Very good. Let's try to expand a little bit on that VALUE study. If you don't mind, describe the study. As you said this morning, you put out the press release saying that the DMC has looked at it and it's safe, and you don't have to increase the patient size. So, what's the study and when should, as you said, first quarter of 2027, what sort of data will we be seeing in there? Okay, so this is the largest study in wound care that was conducted in the last two decades. Very sick population. They suffer from venous leg ulcers. They are divided. The bar is relatively low. We need to beat placebo head-to-head. One arm is treated with EscharEx, the second one is treated with placebo for the first two weeks. After that, they're treating with standardized treatment in the best centers that are available in the world. It's a very robust study. It's an expensive study. Every patient costs around $100,000. Most of the sites are already actively recruiting patients, and we are in a good place now. The data that we should expect after recruiting 65% of the patient, which is ballpark of 140, after they're being treated, we are looking at a committee that is not related to the company, is looking at the data and see if the assumptions that we started the trial, that the study is powered for 85%-90% probability of success, if the assumptions are still there. Many things can happen. The previous trial was finished three years ago. Many things could have happened. We want to make sure that the probability of success is 90%. So in this interim, we can see three options. We can say that the study is ended because we finished the recruitment and still there is 85%-90% probability of success. We can extend the number of patients by around 50, and it can be extended by around 120 more patients. These are the numbers. The thing that we will report will be only when the recruitment finishes. Currently, we are speaking about Q1 2027. If there is an increase of the sample size, let's say by 50 patients, it is another quarter. Yeah. If it is by 100 patients, by two quarters. I would say that everything, if you told me today, increase it by 50 patients, I would sign. Why? Because it means that another $6 million and another three months, you have 90% of a blockbuster in hand. This is what we are focusing on, making sure that we execute the trial and that the results are positive. Okay. In terms of the timing of the final data, once you recruit it, once you complete the recruitment, how long does it take for us to see the final results? The top line results will be only three months after the interim. There are all kind of data that will be collected later on, all kind of follow-up data that is very important for the BLA, but it is not important for understanding if the trial succeeded or not. Okay. In the phase II study, the ChronEx VLU trial, complete debridement within two weeks, that was 63% for EscharEx, versus 30% placebo. In the head-to-head, EscharEx beat SANTYL with a statistical significance as well. How much of that phase II effect size actually are you carrying into the expectations for VALUE? We do not need to have such an effect size. As I said, we did not disclose the exact gap between us and placebo, but the bar is very low because no one to date was proven to be better than placebo in a head-to-head trial. We just need to have a marginal advantage over placebo. Of course, the numbers that we got in the phase II are excellent, but even if we get worse than that, we are in a good place. Okay. Moving on to the competition and SANTYL. Competition is buried. On the second quarter call, Smith & Nephew characterized SANTYL as not really being a good debridement option at this point, and they are trying to develop a second-generation product. What are your thoughts on that? Not only the statement, but also what Smith & Nephew is trying to do, and what kind of a competition would that set up for you? SANTYL is a $400 million a year product in the U.S., which makes it one of the biggest brands in wound care in the U.S., and it is a legacy monopoly product. It was approved in the 1960s, ultimately acquired by Smith & Nephew somewhere around 2010-ish. It is written by physicians day in and day out, and not one of them would say that they think that it is a particularly efficacious drug. It literally is a monopoly. It is the only drug really ostensibly available specifically in wound care. It takes, call it, four to eight plus weeks to completely debride a wound. Our drug takes around, on average, four to five days. There is a meaningful difference. This has always been our thesis as to why the market is so robust of an opportunity. Having the CEO of Smith & Nephew state that he feels the drug is slow and that they need to make a second new product to replace that just validates our thinking. It does not really change the market from our perspective, it just validates it. Okay. Let us say they get into a clinical trial and say three years down the line or four years down the line, the product is out there. Would that pose any threat to your product or by that time you would have had enough market share? Well, I'm not entirely sure that it could possibly be three-plus years. Right now, as far as what we know publicly, because we've been tracking this for several years, this is a burn-focused drug to really compete with NexoBrid. But when you get into the specifics of how they're organizing the phase I study, it seems like even they are somewhat backing away from saying that it could really compete with NexoBrid. There isn't anything public with regard to going into chronic wound care. Even if they were to start tomorrow, it probably would take the better part of 10 years or so. We'll have a significant advantage as far as time to market. We have no idea what their clinical efficacy profile will be. We understand that it's something that's under development, but it's not anything that we're currently concerned about from a commercial perspective. Okay. Moving on to NexoBrid. Vericel has said that there are about 80 centers having ordered the drug since launch. In your thinking, what needs to happen for that to grow into a higher number of centers and also it's not just the number of centers, but also the depth of utilization in each center. Where do you think they stand and how do you think that they are going to develop that end? I think that Vericel is doing outstanding work. In order to penetrate the burn center, changing the protocol, the SOP, how you treat patients. In burn, forget what you see in the kitchen. It's not that you have a small burn. There is a life at risk, and those physicians or those surgeons are treating burns. They can't just replace what they do with the nurse applying a drug. It takes a lot of time. They take one case and see that it works, and then another one, and then there is something on the hand. You don't want to start working with a knife on palms. They try it there. We see how it happened in Israel. In Israel today, even if you have something which is not a burn, but remotely remind a burn, the physicians are using it because they got used to it. It's gradually, and it takes time. As for the number of centers, I cannot disclose what the target of Vericel is, but 80 is not far away for the number of centers. But there will be centers, and there should be more centers that are using it more frequent. For us, since we have a limitation of the ability to manufacture, we are satisfied from the pace. Mid-2027, when we have the new facility up and running, I hope that they will sell much more. Okay. Talking about the 2027 time point for expanding the facility, what needs to happen from here to get to that? In terms of not only the EMA inspection, but also the FDA. Should we be concerned at all in terms of getting FDA to inspect the facility? The only thing you should be concerned about is that we make sure that the VALUE trial of EscharEx meets the endpoints. This will determine the value of the company. As for the facility, it will be ready. We got some comments from the European inspectors. All of them were operational. You need to clean it like this. You need to move this here, this there. We needed to change some things in the facility in order for it to be acceptable by them. We will finish that by the end of the year, and then we start manufacturing NexoBrid in the new facility. After three months and after six months, we can call for inspections from European Union and from the FDA. Our expectation that the first approval will be from Europe, and it will be around mid-2027. Okay. Regarding the BARDA 10-year contract, even though Vericel, it is supported and awarded to Vericel, you also are part of that contract. Which parts go to Vericel, which parts go to you? I know it is a multi-component contract. Can you explain, at least give us the highlights of that? I will give you a highlight of what I can share. First of all, it is an agreement between Vericel and the U.S. government. We are considered, I do not remember the exact terminology, but we are a prime subcontractor or something like that. The $200 million-ish agreement is divided to procurement, so Vericel buys from us. Development of indications, you can understand alone who is the majority of the development, and all kind of other aspects. I cannot say things that are not agreed with Vericel about how this money is split, but I read that the CEO of Vericel said that two-thirds of the agreement are revenue to Vericel. You can do the math by yourself. Very good. A part of that is also trying to get a manufacturing facility in the United States. What changes for you when that happens? Not only operationally, but also on the revenue side of things. The U.S. government decided that for them, it is a priority to have a backup facility in the United States. For us, it will not impact the revenue at all because in the new manufacturing facility, we have capacities to support all the global demand. If we get it is four years until we get it, so it will not impact MediWound at the short time. Having said that, we have EscharEx. We want to be able to manufacture EscharEx as well. It is revenue from development services. We have a strong interest that it will happen. But currently, we are focused on executing on what we have the control on. Okay. I know we are almost at the end of time here. I know your hands are full with EscharEx, but as investors, we are hungry. What else could we see come down from the pipeline? Again, Barry should answer that, but I don't want him to answer. The risk that was enormous before NexoBrid was approved, seems not to be there anymore because the manufacturing process of such an active product, is approved and validated. We are in discussions with many large companies, about all kind of indications that are very close to eschar removal in burns and in wounds. But when times come, we will share additional information. Currently, other than Barry, the company is focused on succeeding in the VALUE trial. Thank you very much. Thank you for your time. Thank you for your time. Thanks, Barry. Thank you.