MediWound at H.C. Wainwright Conference: Strategic Growth and Challenges

On Monday, 08 September 2025, MediWound Ltd (NASDAQ:MDWD) presented at the H.C. Wainwright 27th Annual Global Investment Conference, outlining its strategic initiatives and addressing both opportunities and hurdles. The company highlighted its advances in biologic technology, while also acknowledging supply chain challenges affecting its flagship product, NexoBrid.

Key Takeaways

• MediWound is advancing its Phase 3 study for EscharEx, targeting a $2.5 billion market.
• The company is expanding manufacturing capabilities to address NexoBrid supply constraints.
• Strong collaborations with BARDA and the DOD support future growth.
• Financially stable with $33 million in cash reserves and potential additional funds from warrants.
• A new US-based facility is planned to support EscharEx commercialization.

Business Strategy and Overview

MediWound, a biotech company, has developed a validated biologic technology with its FDA and EMA-approved product, NexoBrid, which is used for severe burns in over 40 countries. This enzymatic technology offers an alternative to surgery by removing eschar in just four hours. The company is also progressing with EscharEx, aimed at treating venous leg ulcers, currently in Phase 3 trials with a market potential of $2.5 billion. Collaboration with major wound care companies is a cornerstone of its strategy, aiming to establish EscharEx as a standard of care.

Near-Term Catalysts

Key upcoming catalysts include:

• Potential awards from a ten-year BARDA contract.
• Completion of a new manufacturing facility by year-end to ease NexoBrid production bottlenecks.
• An interim analysis of the Phase 3 EscharEx study by the end of 2025 or mid-2026, crucial for determining its market success.

Financial Status

MediWound reported a cash position of $33 million, with the possibility of an additional $30 million from warrant exercises. While clinical trial costs are around $25 million, the company remains profitable outside these expenses, indicating a solid financial footing.

Operational Updates

The company is addressing NexoBrid supply issues, prioritizing the US and Israeli markets. A new manufacturing facility, once approved in Europe, is expected to nearly double revenue. MediWound is also considering a US-based facility, potentially funded by the government, to support both EscharEx and NexoBrid production.

Future Outlook

MediWound’s relationship with the US government, through BARDA and DOD contracts, is a significant growth driver. The upcoming BARDA RFP, expected in Q4 2025, includes programs for stockpiling NexoBrid, developing treatments for blast injuries, and creating a room temperature stable formulation, which could be vital for military applications.

Conclusion

For a deeper dive into MediWound’s strategic plans and detailed discussions from the conference, please refer to the full transcript below.

Full transcript - H.C. Wainwright 27th Annual Global Investment Conference:

Unidentified speaker: Just BARDA under DOD. In in February, the company initiated a pivotal phase three study with EscharEx, a biologic for debridement of chronic wounds for treating venous leg leg ulcers. To discuss the company’s wound care portfolio, let’s get started with Ofer. Ofer, thanks for joining us, and I appreciate you accepting our invitation to talk to our audience today.

Ofer Gonen, MediWound: The pleasure, and thank you for inviting me.

Unidentified speaker: So so briefly, if you can discuss a little bit about the business strategy of MediWound and also give us an overview of your long term strategy, and how the enzyme debridement products are different from other wound health products.

Ofer Gonen, MediWound: Okay. So, first of all, you presented the company so well so you can replace me. But, we are a biotech company. We have a biologic technology, which is validated in 14 clinical trials. Actually, our, first product is approved by both FDA, EMA, and it is approved in more than 40 countries.

We have, an enzymatic technology that replaces surgeries across a few indications. The first one is already approved. It’s for severe burns, eschar removal for dead tissue. He does it in four hours. It’s instead of a surgery.

The second indication is currently in phase three studies. It’s a much larger indication. The addressable market is considered to be something like $2,500,000,000. And currently, we’re in a pivotal phase three study, and the recruitment is ongoing. As a small company, we, enjoy collaborations with the largest, companies in their field.

And so we feel, very comfortable with our technology, making sure that we can assist as many patients as possible.

Unidentified speaker: Perfect. So just to get started off, you know, what sort of catalyst do investors should be on the lookout for, especially, I would say, next six to twelve months? Because I know quite a few things are happening right now.

Ofer Gonen, MediWound: Yeah. Many things happened in the past few quarters. We’re very good for our company. Since we initiated the trial, we met all the expectation in our revenue. Unfortunately, we cannot meet the real demand of the first product.

We have three times more demand than we can actually manufacture our first drug for severe burns. So if we look forward, we have, I think, three very significant catalysts that are coming in the next few months. The first one, recently, there was published an RFP for BARDA. Mhmm. And we expect to get a significant portion of it.

It’s a ten year contract, and I guess we’ll speak about it later on. The second thing is that we are going to complete and finish building our manufacturing facility. We should be completing all the operational activities by the end of the year, and only regulatory activities that will take a few months, and then everything will be approved. And the bottleneck of being able to manufacture NexoBrid will eventually will be relieved. And finally, by the end of next year and mid twenty twenty six, we are going to have our interim look in the face we study.

And this is a very major catalyst, and it will tell us if we have a drug that targets 700,000,000 in peak sales or we do not succeed. So it’s a very important few months for us now.

Unidentified speaker: So let’s start with the the the last one, which is the the the big catalyst of of EscharEx.

Ofer Gonen, MediWound: Yeah.

Unidentified speaker: So since you already gave us a little bit on the on the market opportunity, when you started this study in February, you know, what you initially had three or four partners, you know, in terms of connecting the phase three studies of recently, you added additional collaborators. Right. So what’s the what what is the rationale there to have, almost four or five partners now within that study?

Ofer Gonen, MediWound: So so the value phase three study is, is the largest, most significant clinical trial in venous leg ulcers in a few decades. And it’s very clear that if the if we meet the endpoint and if the study is a success, the all the treatment scheme of venous leg ulcers is going to be changed. And the first step will be the same as NexoBrid is using our product. We had we’ve we felt that there is a lot of pressure from large players to collaborate with us on this trial, And we wanted to make sure that the patients in this trial are getting the best the best ancillaries possible in the treatment because the success in the trial, this is how a treatment in VLU will look like down the road, and we want them to get the best the best ancillaries. So we collaborated with Solventum around the compression therapy.

We with Molnicki around the dressings, Mimedix around the cellular tissue products, recently with SCT Mhmm. Around compression after the wound is closed. And if I forgot part, also forgive me about it. But, again, if you look at the list of collaborators, they’re not only around this trial. We are doing we’re having additional indications.

Seven out of the largest seven wound care companies are with us in those trials. And what they enjoy is being part of the treatment that is going to be the standard of care. Correct.

Unidentified speaker: No. That’s, that’s a telling, you know, especially with those those those larger cap companies wanting to work with you. But in terms of the data itself, as you said, there’s gonna be an interim assessment done going to be done once you reach about sixty five percent of the 216 enroll enrollment that you need to achieve. So what what would we see in this interim assessment? And, you know, is this gonna be simple efficacy I mean, simple futility, or will we see some efficacy data as well?

Ofer Gonen, MediWound: So the reason for us to have, an interim look in this, trial is to minimize the risk and maximize the potential success. It’s a relatively small trial. 216 patient for a phase three trial. It’s a small trial. And on top of that, what we are saying, that, it is powered for ninety percent success.

It’s a very high power to begin with. And our aim in the interim look is to make sure that this ninety percent probability of success is maintained. So what we are doing in this interim look is seeing that it is still ninety percent probability of success. We are looking at the blinded, of course, just making sure that we are on the right direction. And if this is the case, there are only two outcomes.

One of them that we are stopping the recruitment, finishing the the the follow-up period and and seeing the result, it means that we are 90% or more. The probability is 90% or more for succeeding. And there is another scenario in which we see that we need to add additional patients. Let’s say we have eighty seven percent probability of success. Probably, we need to add additional 10 patients in the in in order for this trial to be to be a successful one.

As I said earlier, we succeeded in all the trials that we conducted, 14 out of 14 across a few indications. Three of them were almost identical to the current trial, so we have no intention to miss this opportunity as well.

Unidentified speaker: So the API is the same as NexoBrid, which is already approved. So what is the real risk in this study, or is there one?

Ofer Gonen, MediWound: So we are again, we succeeded in three studies that looks almost the same, according to the endpoint that are required by the FDA, which are incidents of complete debridement in two weeks and facilitation of wound closure. We saw in the previous trials that it that the gap between us and the placebo, which is the requirement of the FDA, the gap is huge. What can happen is that we do something wrong. So we are trying to take the previous trial, make sure that now it is better standardized for us not to have all kind of mistakes. Ninety percent is ninety percent.

Always, there is a chance of the ten percent. Nothing that we can point out now.

Unidentified speaker: Okay. So in terms of the program itself, I believe there are a couple additional studies that you’re doing. So what are these studies, and do you think they will be all completed by the time you get to the end of the phase three study?

Ofer Gonen, MediWound: Oh, yeah. Yeah. For sure. We are we we have all kind in order to have this product approved, we have additional small studies or not significant studies that we are planning in order to have a full package to submit for the BLA. Let’s start with the two trivial ones.

One of them is a PK study. Just make we did something the same with NexoBrid, which are much larger burns are much larger than wounds, so we don’t see any risk in doing that because venous leg ulcers are smaller ones. It’s a very small study, something like 20 patients. The second study will be, a human factor study. Mhmm.

EscharEx is is not going to be used only in the clinics or at hospitals, also at home. This is a very small and very cheap study that makes sure that people are reading the instructions for use and knowing how to apply it to themselves. And lastly, we are doing a kind of a head to head study versus collagenase. In The United States, it’s Santyl, and in Europe, it’s Eruxol. This is more a kind of a safety study and us collecting some data that we will be able to use it down the road and making sure that we can charge the right price for EscharEx, hopefully, significantly higher than the current Santil.

Unidentified speaker: Okay. So the last question on on on EscharEx is, you know, since the market is big and, you know, we have seen some supply chain issues on NexoBrid, which we’ll talk about in a minute. For for when when you’re planning for commercialization of EscharEx, how are you thinking about manufacturing, supply chain, and other things?

Ofer Gonen, MediWound: So we announced a few months ago that we are in discussions with the US government for them funding us a facility in The United States. We already got some funding from BARDA to plan the facility and to start locating an ideal place for that. We’re in the process of finalizing it and securing the full funding. And between the current facility in Israel, the new facility in Israel that we are going to complete by the end of this year and the new facility in The United States, we will have enough capacity to secure a successful launch in EscharEx, and we appreciate the fact that the amount of units for EscarX are extremely higher than the ones relatively to NexoBrid. Okay.

Unidentified speaker: So going back to NexoBrid now. Since the NexoBrid was launched in ’24 in The US, what how how how do you think it’s tracking against your internal expectations? And, also, what what sort of lessons are you learning from commercializing NexoBrid that you would want to take it to EscharEx?

Ofer Gonen, MediWound: So so let’s start with the with the first question. I think that Vericel is doing a great job. What we see first of all, we had an experience in launching such a product in Europe. It’s a dramatic paradigm shift. Totally different different treatment than the than the previous one for the for the burn units, and they need to adjust.

And I think Vericel is doing its great job. They just reported a 52% increase comparing to the previous quarter last year. They reported a record month in June. And when they reported, they said that July was even stronger in revenue. What we hear is the also the feedback from the KOLs and from the burn centers, and we hear that the the the the adoption if of this product is outstanding.

So I don’t they don’t need me to give them grades, but I think that they’re doing a great job. And let’s see if this growth is continuing as as they did. As for lessons to EscharEx, it’s a different, totally different market, different patient population. And unlike unlike in NexoBrid where you needed to educate the burnt units how to work and change SOPs and to go through all kind of hurdles in order to get used to working with it. With EscharEx, it’s just replacing the current enzymatic debridement that is already available on the market.

Nothing other than showing them the data that we do in a few days what Santill does in two months is required. So we think that the uptake of EscharEx will be significantly quicker.

Unidentified speaker: Okay. So we we talked a little bit about how to manage supply chain. So two questions on that. One is how even though you already have collaborations with Japan and other parts of Asia as well as Europe. So how are you managing in terms of inventory of NexoBrid between The US and the rest of the geographies?

And the second part of that question is when you get your facility commissioned in by the end of this year, where would, you know, the the bulk of the material go to on the commercial side? But is it gonna come to The US, or is it gonna be to the rest of the geographies?

Ofer Gonen, MediWound: So our currently, our priority is to support The US commercial markets and the Israeli market. The US commercial market, we believe it is our largest market, and it will impact quite substantially, the value the value of of MediWound down the road. The Israeli market, Israel is under a a war now, so I don’t need to give further explanations why we give a priority to the soldiers that we saved quite a few in the past couple of years. We now control the the internally, the commercialization in Europe. So in Europe, we are not disappointing any partner.

We’re not sending some materials. There is much more demand than there that we can manufacture. We have also shortages in Japan and in other countries. The bottleneck will be resolved once we get the first approval, which we believe will be the European approval for the facility. Immediately, we can almost double the revenue there.

And after that, I think we will start we will we will really start the commercialization efforts. We didn’t do anything till now.

Unidentified speaker: Okay. And then in terms of the expanding beyond, you know, the the current one, when you when when you were talking about The US facility in terms of EscharEx, will that facility also produce NexoBrid, or is it is it mostly on EscharEx?

Ofer Gonen, MediWound: We are speaking it’s the same. Again, it’s the same API, almost the same manufacturing process. We have a lot of flexibility where to manufacture. Once we have three facilities, the old one in Israel, the new one in Israel, and the new one in The United States, we will have flexibility. I’m not sure what we will manufacture where, but probably EscharEx and NexoBrid will be manufactured in United States.

Unidentified speaker: Very good. So talking about the contracts. Right? You you always had a good relationship with BARDA and DOD that, you know, has helped you get NexoBrid as well, you know, in in through the through the FDA that you had worked with BARDA previously. So the the new RFP, how different is that from the one that that you you you just got to the end of?

Ofer Gonen, MediWound: Yeah. So indeed, we have a very good relationship with the US government. We were afraid in the beginning of the year that under the new administration, there will be different priorities, and our programs will be deprioritized. But what we saw in the second quarter that the outcome is totally different, we got two additional incremental budget from both BARDA and the DOD, BARDA for the manufacturing facility in The United States, and the DOD for a room temperature stable formulation. The new RFP of BARDA is very comprehensive.

It speaks about three main programs. One of them is stockpiling. Stockpiling, of course, the main address the the the the main the the the entity that has the commercial rights in The United States is Vericel. So these are stockpiling discussion between Vericel and BARDA, and we are the supplier of the of of the NexoBrid. And the second two components, both of them, I think, are I think the motivation was after seeing what NexoBrid is actually doing in the field.

One of them is to develop NexoBrid for the scenario of blast injuries.

Unidentified speaker: Mhmm.

Ofer Gonen, MediWound: And the second one is to develop NexoBrid for a room a formal a new formulation for NexoBrid that will be stable in a room temperature. So these are very heavy development programs, a few tens of millions of dollars each. And I guess NexoBrid, they show they saw the US government saw what NexoBrid is doing in in real time, and they decided to invest further.

Unidentified speaker: So do do you know when the RFP will be decided on and will be awarded?

Ofer Gonen, MediWound: The plan is that it will be that the kickoff will be in q four twenty twenty five. I hope this will be the case. I know that very cell who leads who leads the discussions with BARDA. And the only thing I can share with you that they submitted a very comprehensive proposal.

Unidentified speaker: So in terms of that room stable temperature room temperature stable NexoBrid, outside of the military interest, is there a market for it? And if there is, what sort of a market is it?

Ofer Gonen, MediWound: Yeah. It’s it’s for for for the for the field in the army, it’s clear. You don’t you cannot you cannot have a a serious cool chain process. But, also, if you think about burn mass casualty incidents, you have an event in a remote city in The United States. You don’t have, all it’s very complicated to ship all the things to the place when you need to maintain a cool chain.

The second thing is even for the commercial market, if you remove all the hurdles of being it of it being refrigerated, etcetera, it just increases the reach the outreach of the for the relevant centers.

Unidentified speaker: So the last question from me is on the on the balance sheet. You know, what’s what’s your current cash position? And, you know, in terms of runway, what commentary can you give?

Ofer Gonen, MediWound: So we have last quarter, we had $33,000,000 in the bank. Every now and then, we have additional $30,000,000 in warrants that are deep in the money. So every now and then, there is a bulk of a few millions that are being exercised. On top of that, our our operation other than the clinical trial is profitable, and the clinical trial cost is around 25,000,000. So we are in a relatively good situation.

Not great. I would be be happy if you I had additional $200,000,000 in the bank, but it is what it is. Thank you. Thank you for time. Thank you.

Thank you.

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