Morning, everyone, welcome back to Oppenheimer's Annual Healthcare Conference. I'm Jeff Jones. I'm one of the analysts here on the team. I am delighted to welcome the CEO of MediWound, Ofer Gonen, to speak about their story and their programs in NexoBrid and EscharEx. Ofer, I will turn it over to you to give us all an update. Hi, Jeff. Good morning, and thank you for having me. MediWound is a late-stage biologic company with one FDA-approved and profitable drug and a Phase III asset targeting multi-billion dollars market. Our technology has been validated in 14 clinical trials and approved by both the FDA and the EMA, and we are now approaching a meaningful value inflection point. Let me walk through this opportunity. Let me begin with a brief overview of the company. As I said, we have an approved drug. You can see on the left, NexoBrid. It's commercialized in major markets, including the United States, across Europe and Japan. It removes burn eschar within 4 hours, spares healthy tissue, and significantly reduces the need for surgery. It generates revenue, and it is profitable. Our second asset, you can see it below, it's EscharEx, currently in Phase III trial for chronic wounds. It acts in days rather than weeks or months to today's standard of care. It targets an approximately $2.5 billion U.S. debridement market. Importantly, we have established global partnerships with leading wound care companies. You can see on the right. All of them validate both our science and our commercial relevance. We are also supported by a strong balance sheet. We raised $30 million last quarter. We have recently expanded our manufacturing facility. These things position us to support future growth. At the core of MediWound, we have a proprietary enzymatic biologic platform. Our active pharmaceutical ingredient is carefully controlled mixture proteolytic enzymes, which are derived from pineapple stem. Through a complex and very highly specialized manufacturing process, we produce a pharmaceutical-grade biologic that selectively removes devitalized tissue while preserving viable tissue. The results you can see on the right. It's a rapid, predictable, non-surgical approach to tissue removal, avoiding the trauma and all kind of limitations that are associated with traditional surgical debridement. Apologize for the graphic nature of the image here. This clearly illustrates the clinical impact of our technology. In a single 4-hour application, on the left, you can see a burn. You can see how deep it is, you can see how severe it is. If you started treating it with a knife, it would have been a nightmare. With our topical drug, with a single four hour application, NexoBrid removes burn eschar in more than 90% of the patients without the need of surgical excision or general anesthesia. Importantly, the procedure doesn't require any operating room or all kinds of specialized surgeons. By rapidly clearing the devitalized tissue while preserving the viable tissue, our drug, NexoBrid, allows the physicians to assess the wound earlier and to move the patients more quickly to the next phase of treatment. This translates into shorter hospital stays, to reduce blood loss, improve the functional and the cosmesis outcome of the treating of the burn, and of course, it lowers the overall cost of care. Don't forget, the alternative is a surgical debridement, which is invasive, it is resource intensive, and it is associated with significant patient trauma. Our portfolio spans two significant market opportunities. NexoBrid on the left, we just spoke about it's the burn therapy treatment approved in more than 40 countries around the world. It is commercially validated, it generates revenue supported by expanded manufacturing capacity that we have now in order to meet the global demand. NexoBrid validates our enzymatic platform from regulatory and from manufacturing perspective, it definitely de-risks the asset that I will speak from now on. EscharEx, on the right, is the same active pharmaceutical ingredient formulated at approximately half of the concentration of NexoBrid, it is applies the same mechanism of action. It removes the non-viable tissue. For the initial indication, venous leg ulcers, and for the second indication, diabetic foot ulcer, we estimate the addressable U.S. market as $2.5 billion, which is 10 x larger than the chronic than the burns market. If we look at the pipeline, you can see that with NexoBrid, we have reached regulatory approval and commercialization, to the most important indications, burns for adults and pediatric patients. The U.S. government recognized the importance of this capability of early on, for non-surgical burn treatment. For them, it is critical to use in mass casualty burn incidents and in battlefield settings. That recognition from them has translated into $140 million in non-dilutive funding. Now we are working to expand the work with them to expand it for additional two indications for using NexoBrid for battlefield and for blast injuries. EscharEx is the primary focus of the company. The program is currently in phase III. Based on the strength of the data that we have to date, we are evaluating potential label expansion into additional chronic wound indications, such as diabetic foot ulcers and pressure ulcers. We see several catalysts ahead. Let's start with the primary value driver, EscharEx. We have an interim phase III readout expected by year-end 2026. This readout is designed to provide a clear signal regarding the study's success. If it is positive, it positions us for a BLA submission thereafter. In parallel, we are preparing for DFU and pressure ulcer clinical trial. We want to expand the label as much as we can. NexoBrid, we are working on FDA and EMA approval from the new manufacturing facility. It is expected around mid-2026. It is anticipated to remove the current supply constraint that we have and support the global demand growth. We also expect a significant government-related agreements. Probably we'll speak about it when they become more relevant. Before discussing the program more in detail, let me briefly address the financial position. We have $54 million dollars in cash, no debt, we have a long-standing collaboration with the US government, which funds a significant portion of our operations. This balance sheet allows us to execute the strategy without any near-term financing pressure. If we look 2026 to 2028, the NexoBrid revenue growth is driven by expanding manufacturing capacity. It is also driven by broader geographic penetration and additional go-government contracts. As previously noted, the facility expansion is expected to be completed in 2026. It will support the increased global demand for NexoBrid. With respect to EscharEx, subject to successful Phase III results and the regulatory progress that is associated with this, we anticipate the potential for initial revenue as early as 2028. Everything you have seen so far demonstrate our technology works in the challenging settings, the most challenging setting, which is severe burns. Now, I'd like to show you how the same technology scales to a larger market, which is chronic wound. Chronic wound market, you can see we are speaking about four million patients, give or take, every year, venous leg ulcers and diabetic foot ulcers. The first thing that the patient needs to do when he sees his physician, when he has such an ulcer, he needs to debride it, and we are there to do that. Today, unlike burns, that the only modality that is used in burn centers is a knife. For wound care, there are multiple debridement modalities. Surgical debridement is effective, but invasive, it requires only trained specialists. It is effective, but it is either painful or expensive or you need highly trained physicians. The only FDA-approved enzymatic option currently on the market was introduced to the market in the 1960s. While it's very easy to apply, it is very slow, and it often requires a prolonged treatment, frequently combined with a knife. EscharEx, our drug, is designed to combine the speed of a surgical debridement, should be active within days, and with the ease of use of enzymatic therapy. We demonstrated these attributes that I was speaking about in the previous slide in three Phase II studies across venous leg ulcers, diabetic foot ulcers, and trauma wounds. Results were consistent across all the studies. EscharEx achieved rapid and complete debridement, effectively prepared wounds for closure, and reduced biofilm and bacterial burden, and maintained a strong safety and tolerability profile. The data that we collected with those dozens of patients supported our decision to advance EscharEx into Phase III study. As I said two slides ago, the only one FDA-approved enzymatic debridement therapy is called SANTYL, currently generating around $302 million a year. I think this year the numbers will be higher. We'll know them soon. EscharEx raises the performance standard for this specific category. What typically requires four to eight weeks of treatment with SANTYL, often combined with a sharp scalpel, can be achieved with NexoBrid topical application alone in three to five days. Importantly, this acceleration of healing is achieved with a comparable safety profile. We did a Phase II study, and you can see that in our study, look on the left, 63% of the patients treated with EscharEx achieved the debridement endpoint. Look at Santyl, Zero. It's not a mistake, because we measured the debridement after two weeks, and Santyl doesn't debride wounds in two weeks. None of the Santyl-treated patients achieved complete debridement with this timeframe. EscharEx also prepared the wound for closure much rapidly, much quicker than Santyl, and without any associated pain or safety concern. Wound bed preparation, you see we've done that in 10, 11 days, while Santyl didn't achieve it even after 100 days. This is a critical milestone enabling progressing of the wounds to other advanced therapies and ultimately, wound closure. Now we are hopefully replicating and scaling these findings into a fully Phase III trial. The study involves 216 patients, VLU patients, across give or take 40 sites in the United States and Europe. We have two co-primary endpoints here: complete debridement and facilitation of wound closure. An interim analysis is planned as approximately 65% of the patients finishes enrollment. It is expected in late 2026. Importantly, for this high-profile trial, we have established research collaboration agreement with leading wound care companies like Solventum, SCT, Mölnlycke, and MiMedx. All of them are interested to be associated with this trial, associated with, hopefully, the success of EscharEx. Now, I'll give you a very short video that illustrates what we believe should happen in the Phase III trial. It's based on the Phase II study that we already completed and what we aim to confirm in the Phase III. Look at it. I will stop it and then come back. Here you see, here you see two wounds. It's the median wound of the Phase III trial. On the bottom, you can see stickers with days. This is how we're treating the left wound with EscharEx and the right wound with placebo. Look what happened after Day nine. EscharEx wound is completely debrided. Placebo, nothing yet. Day 11, EscharEx wound is ready to be closed, while the placebo still hanging there. You can see that we closed the wound mechanically. It can be either by a surgery, an autograft, or by a cellular tissue product of MiMedx. We are closing it. The placebo is still in the process of trying to be debrided by all kind of treatments that are non-surgical ones. Only Day 63, and we are measuring Day 14. Only Day 63, the placebo wound is typically debrided. Look at Day eight, Day 85. EscharEx wound is already closed. Only now, the placebo is ready to be closed. The study finishes at 100 days, the two endpoints, we have a clear advantage of EscharEx on top of the placebo. As I said, the previous drug was approved in the 1960s, the bar for approval now is extremely low. FDA wants us to beat a placebo in a clinical trial, a trial that SANTYL didn't make it until today. I'm getting closer to finishing my presentation. Just a couple of words of the market. If the phase III is successful, a substantial opportunity lies ahead. Independent market research that was done by Alira and then verified by L.E.K. suggests that the enzymatic debridement usage could increase from approximately 80% today to 30% roughly with a product profile such as EscharEx. Much of this incremental share is expected to come from a surgical procedure. Based on the projected share, and the treated population, and the validated pricing assumptions, we estimate a peak sale revenue of approximately $831 million across the two first indications, venous leg ulcers and diabetic foot ulcers. This is a commercial opportunity that being reflected in a very strong strategic interest in MediWound, and we see that from leading wound care companies. To conclude, MediWound has proven its technology in one of the most demanding clinical setting, which is severe burns. NexoBrid continues to grow while validating the non-surgical approach. EscharEx applies the same platform to a significantly larger market, with a clear unmet need. With manufacturing expansion and a late-stage clinical catalyst ahead, we believe that MediWound is positioned for a meaningful value creation going forward. Thank you. I hope I was very clear. Thank you very much, Ofer. Couple of questions for you in the time we have remaining. You talked a little bit about the new manufacturing capacity coming online for NexoBrid, and NexoBrid's traditionally been capacity constrained. What recollection is that you need to have a couple of regulatory inspections for to be able to use the materials coming out of that facility? Can you just give us an update on timing expectations for those inspections? Actually, we are now manufacturing NexoBrid for inventory, okay? Definitely after we are done with the inspections, this inventory can be deployed to the market. Regarding the timeline, we already announced that the facilities are operational. We are able to manufacture it. There are some regulatory requirements, such as stability of the products, making sure that the same NexoBrid that we manufacture in the new facility is stable after three and six months. Only after those stability testing, we are able to call for inspections. Our assumption is that after mid-2026, we will be able to call for the first agency for inspection, which is the EMA, and after that, we will be able to call the FDA. Okay. All right. I know when you announced, you know, updates in January, you know, there wasn't the BARDA contract was still outstanding. BARDA obviously represents a big sort of base of your revenue. You know, you were impacted, obviously, by the US government shutdown late last year. Can you just speak to what the BARDA funding supports for you, and, you know, just any updates on expectations around timing? What we said in the previous announcement that we expect that the BARDA agreement will be concluded in the Q1 of 2026. The contract is going to be between BARDA and Vericel. The contract will include three main components. The first one is stockpiling, the second one is development, room temperature stable indication, in order to support first of all, to support all kind of the US Army around the world. They don't have. We saw in the recent conflict here in Israel that NexoBrid is extremely helpful to treating soldiers. The difference, the distance between a soldier that is wounded in Gaza to a hospital is something like one hour. If a U.S. soldier is injured in, I don't know, Afghanistan or Iraq or Iran, it takes something like 72 hours before he goes to a burn center in the United States. One of the indications that is being, and that the U.S. government is interested in developing, is making sure that EscharEx can be treated at a room temperature setting. On top of that, they are interested in developing another indication for blast injuries. Again, from the recent war in Israel, we saw that in Israel, it became literally standard of care. Soldiers that are being injured by blast, it's a very complicated injury, and the NexoBrid is now the standard of care or the first treatment for those soldiers. It's shown to be very, very, very effective. Okay, that's helpful. I guess with NexoBrid, again, you were capacity-constrained, so as you were saying, using it frequently on blast injuries for personnel, in Israel, Yeah that's not something you would expect to see a revenue impact for its use in those scenarios? There was also a drama or a crisis or a disaster in Switzerland recently, around New Year. Dozens of patients were treated with NexoBrid, because in Switzerland, NexoBrid is available, and for some of the patients that were Italians or German, they were transported to their countries, and they were treated with NexoBrid as well. It won't impact our revenue since we used all the inventory for that. Currently, I hope no one gets burned in Europe because the inventory there is zero, at least for the next month or two. It doesn't impact the revenue, but it definitely shows the potential going forward. Okay, very helpful. Talking about EscharEx and the interim readout in the VLU setting, Yeah the two endpoints you talked about, the complete debridement and then facilitating wound closure, obviously very different from a timing perspective. When you look at that interim readout, I believe you're talking about 65% of patients enrolled. Is there an opportunity to accelerate things just based on the complete debridement versus following for several more months? Just thinking about, you know, is there an opportunity to accelerate timelines based on that interim analysis, or is it just something that gives you greater confidence in the ultimate outcome? It's a great question. We are not concerned about the debridement. Debridement is very, very, the effect of debridement is very strong. After four days, if you take six patients, you can have a win in this clinical trial, EscharEx versus placebo. Placebo does nothing. EscharEx is very effective. We are not concerned about that. We saw in every study that we did, even in small studies, even if in a 20-patient study, we saw a very significant effect. We are only looking at the facilitation of wound closure. This is the benefit for the patient, this is the benefit for the physician, because he can start treating the patient with additional advanced a product. We cannot just based on the quick debridement endpoint accelerate the registration. What we are looking at, we are looking only about the facilitation of the wound closure. We know that the debridement will be fine, therefore, I don't anticipate any acceleration of the timelines. Okay. The what will you have visibility to at that interim analysis? In that interim analysis, the only thing that we will know is whether to change the sample size of the study. The study currently is planned for around 85% power, which means that the probability of success is very high, 85%. We would like to maintain a 90% power after the interim assessment. After 140 patients that were treated, we want to make sure that we still have 90% of success on this trial. Even 80 was great, but we decided 90 because we saw that it doesn't require from us to increase the number of patient substantially. The information that we will know is a number of patient we need to increase the study. It will be bulk of 20, 30, 40, 50 patients, and then we will know how close we are to success. If we don't touch the sample size, it means, great, we have 90% of success. If we need to increase the sample size by 20 patients, it means, great, probably the probability is 82%. With additional 20 patients, we are getting to the 90%. Those outcomes are great. If we need to increase the sample size by 120 patients, I wouldn't be so happy. Sure. Sure. That makes a lot of sense. Really for you guys, obviously, manufacturing NexoBrid right now, capacity or ability to use that material then for commercial supply later this year, as you have, your regulatory inspections driven by, stability data, update on BARDA contract, hopefully in the very near term, which funds those additional indications and facility for SR-X. Meanwhile, that study continues to enroll, and, really, the gating item then, sort of nearest term is manufacturing in terms of the revenue story, and of course, you know, government funding coming from BARDA. You defined it, super. You're right. Government funding, manufacturing facility, and then the phase III readout, these are the items this year that will keep us busy. Hopefully, we'll be able to execute as we did previously. Wonderful. All right, Ofer, thank you very much for the update. It has been a pleasure. Thank you. I hope you have some great meetings, over the course of the conference, and we look forward to your four-key update, in a few weeks. Thank you so much. Next week. Next week? Yeah. Next week. It was a pleasure. Let's be in touch. Let's speak next week again. Thank you so much. All right. Take care.