MediWound Ltd. H.C. Wainwright 28th Annual Global Investment Conference
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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 to 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.
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