Good day and welcome to MediWound's 3rd Quarter 2026 Earnings Call, as all participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by 0. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then 1 on your telephone keypad. To withdraw your question, please press star then 2. Please note, this event is being recorded. At this time, I would like to turn the conference over to Gaya Shamis of Lifestyle Advisors. Please go ahead.

Thank you, Sagar, and welcome everyone. Earlier today, before the market opened, MediWound issued a press release announcing financial results for the third quarter ended September 30th, 2026. You may access this press release on the company's website under the Investors tab. I would ask you to review the full text of our forward-looking statements within this morning press release. Before we begin, I would like to remind everyone that statements made during this call, including the Q&A session relating to MediWound's expected future performance, future business prospects, or future events or plans are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. These statements may involve risks and uncertainties that could cause actual results to differ materially from expectations and are described more fully in our filings with the SEC. In addition, all forward-looking statements represent our view only as of today and MediWound assumes no obligation to update or supplement any forward-looking statements, whether as a result of new information, future events, or otherwise. This conference call is the property of MediWound and any recording or rebroadcast is expressly prohibited without the written consent of MediWound. With us today are Ofer Gonen, Chief Executive Officer of MediWound, Hani Luxenburg, Chief Financial Officer, and Barry Wolfenson, Executive Vice President of Strategy and Corporate Development. Following our prepared remarks, we will open the call for Q&A. Now, I would like to turn the call over to Ofer Gonen, Chief Executive Officer of MediWound. Ofer?

Thank you, Gaia, and good morning, everyone. During the third quarter, we advanced SCRx development, supported NexoBridge's commercial growth and government program, and continued preparing our expanded manufacturing facility to meet future demand. Let me start with an update on SCRx. The Global Phase III Value Trial in venous leg ulcers remains our top priority. Enrollment continues and we remain on track to complete the pre-specified interim sample size reassessment in the enrollment by the end of the first quarter of 2027. The current enrollment target is 216 patients across approximately 40 sites in the United States, Europe, and Israel. During the quarter, the Independent Data and Safety Monitoring Board completed its pre-specified periodic review of the value trial, identified no safety concerns, and recommended that the trial continues as planned without modifications. The next DSMB meeting is scheduled for early January 2027. The following meeting is expected at the end of the first quarter of 2027. at which the DSMB will also conduct the interim sample size reassessment. Beyond venous leg ulcers, we continue to advance towards clinical trials in diabetic foot ulcers and pressure ulcers. The diabetic foot ulcer program has received grant funding from the European Innovation Council and is supported by strategic collaborations, while work on pressure ulcer is investigator-initiated. Once final results from the FALU trial are available, we plan to discuss the development pathway for additional chronic wound indications with the FDA. Turning to Nexobrid. The US commercial trajectory continues to strengthen. Paracel reported Nexobrid's strongest quarter since launch, with its highest quarterly revenue to date, driven by the highest number of ordering burn centers and hospital orders ever. More new centers ordered NexoBread in the first nine months of 2026 than in all 2025. More than 80 centers have placed orders to date, with approximately 70 placing repeat orders. Government procurement under Vericel's BARDA contract began in the third quarter, and as Vericel indicated, is expected to continue through the fourth quarter of 2026 and the first quarter of 2027. We continue to collaborate with VeriCell in advancing two NexoBreat development programs under our Master Service Agreement. Indication expansion to acute trauma injuries associated with thermal burns and development of a new stable formulation. Both programs are covered by the contract between VeriCell and BARDA. Separately, the Department of War awarded MediWound an additional $3.3 million in non-dilutive funding to advance the room temperature stable formulation of Nexobrid as a non-surgical debridement solution for battlefield burn care. This brings the program's total budget to $21.8 million and is intended to support the development through submission of an IMD application. Together, these programs are intended to broaden Nexobrid's potential applications in civilian and military burn care. Beyond the United States, demand for NexoBread extends across Europe, Japan, and other markets. However, global demand currently exceeds our manufacturing capacity, limiting our ability to fully meet the needs of these markets. Expanding our capacity is therefore a key priority for us. Let me provide some context on our manufacturing operations. Starting with our current NexoBridge facility. The facility successfully completed routine GMP inspections by the FDA and the Israeli Ministry of Health, with the ministry also conducting its inspection on behalf of the EMA. The facility's GMP certification is valid now for an additional two years. To address the capacity constraints and support the future demands, We are advancing our expanded next of breed manufacturing facility. We are implementing the modification recommended during the previously reported EMA pre-audit and expect to complete this work in the fourth quarter of 2026 as planned. Commercial supply from the expanded facility remains subject to regulatory approval and is expected in the second half of 2027. With that, I will turn the call over to Hani.

Thank you, Ofer, and good morning, everyone. Before I walk through the numbers, let me put our result in context. Our revenue is heavily weighted toward development services for U.S. government programs. Product sales, meanwhile, are constrained by supply rather than demand. We are selling every unit we can manufacture. On the expense side, our main investment is in R&D, mainly the SCRX Phase III value trial. We expect spending on that trial to decline substantially as it reaches completion. Now turning to our financial result for the third quarter of 2026. Revenue for the quarter was $3.6 million compared with $5.4 million in the third quarter of 2025. The decrease was primarily attributable to lower revenue from development services related to the U.S. government. Gross profit was $1 million, representing a gross margin of 28.5% compared with gross profit of $0.9 million or 16.5% in the prior year period. The margin improvement primarily reflected higher contribution from royalty revenue Research and development expenses were $6.2 million compared with $3.5 million in the third quarter of 2025, primarily reflecting increased investment in the S-Correct Phase 3 value trial. SG&A expenses totaled $3.4 million compared with $4 million in the same period last year. The decrease primarily reflected lower marketing expenses. Operating loss was $8.5 million compared with $6.5 million in the third quarter of 2025. Net loss was $6 million or $0.47 per share compared with a net loss of $2.7 million or $0.24 per share in the prior year period. The year-over-year change primarily reflected lower non-cash financial income from revaluation of warrants. Adjusted EBITDA loss was $7.4 million compared with a loss of $5.4 million in the third quarter of 2025. Turning to our results for the first nine months. Revenue for the first nine months of 2026 was $8.1 million compared with $15.1 million in the first nine months of 2025. primarily attributable to lower revenue from development services related to U.S. government. Cross-profit of $3 million or 19.7% in the prior year period, the margin improvement primarily reflected a higher contribution from royalty revenue. Research and development expenses were $17.3 million compared with $9.8 million in the first nine months of 2025. primarily reflecting increased investment in the S-Correct Phase 3 value trial. SG&A expenses totaled $10.8 million compared with $10.6 million in the same period last year. Operating loss was $26 million compared with $17.5 million in the first nine months of 2025. Net loss was $16.3 million or $1.27 per share compared with a net loss of $16.7 million or $1.53 per share in the prior year period. The change primarily reflected non-cash warrant revaluation income of $10.3 million in 2026 compared with $1.8 million in 2025. Adjusted EBITDA loss was $22.7 million compared with a loss of $13.8 million in the first nine months of 2025. Turning to our balance sheet. As of September 30, 2026, we had $28.4 million in cash, cash equivalents, and deposits compared with $53.6 million at year-end 2025. Cash burn during the first nine months of 2026 totaled $28.3 million. Warrant exercises generated $2 million during the first nine months and we received an additional $1.1 million after quarter end. Those exercising warrants included all board members who held warrants, the company's founder and our CEO, each of whom also agreed to lock up restrictions. In addition, in November 2026, we closed an underwritten public offering, including the full exercise and shoe option for gross proceeds of $17.25 million. This concludes my review of our financial results offer. Back to you.

Thank you, Hani. We are advancing SCRX, supporting Nextoblitz commercial growth, and expanding our manufacturing facility. Our recent public offering strengthens our balance sheet, giving us additional financial flexibility through and beyond the value data readout. We continue to work with the U.S. government to secure funding for our planned US-based manufacturing facility. A substantial portion of our anticipated 2026 revenue is tied to development services for this project. We do not yet know when or whether funding will be secured, and as a result, our 2026 revenue outlook depends on these ongoing discussions. Our priorities are clear. First, complete the value interim assessment and enrollment by the end of the first quarter of 2027. Second, support NexoBit continued commercial growth. We'll do that by bringing our expanded facility into operation and by advancing new indications. With that, we are ready to take your questions. Operator?

Thank you. We will now begin the question and answer session. To ask a question, you may press star then one on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star, then 2. At this time, we will pause momentarily to assemble our roster. Your first question comes from Josh Jennings. with GD Koven. Please go ahead.

Hi, Ofer, Hani, and Barry. Thanks for taking the questions and appreciate the download today and the update. I wanted to just ask on about value trial enrollment. You reiterated expectations for the completion of enrollment by the end of 1Q. It's great to hear, but maybe if you could just help us better understand your confidence in achieving that milestone within the next four to five months. Any more granularity you can provide just on recent enrollment velocity?

Hi, Josh. Good to speak to you. As for the value, we feel very comfortable. We had some hiccups in the past, as you know, especially about opening sites in Europe. Currently, we feel comfortable. 95% of the sites are open. To protect the study integrity, we are not sharing patient enrollment numbers. or more enrollment trends during the conduct of the study. Having said that, if we plan on the 216 patients with the roughly 40 sites that are open, we are very comfortable in this guidance of the end of the first quarter of 2027.

And just wanted to just better understand or maybe you could just map out potential timing for The protocol includes pre-specified interim sample size reassessment after we finish the treatments.

of 140-ish patients. This is in order to confirm the targeted 85% statistical power. Based on that assessment, we will either finish the enrollment of the 216 patients or increase the sample size. Under the current 216 patient design, We expect to finish the enrollment, as I said, by the end of the first quarter. After that, we have around three months of treatment, another couple of weeks of aggregating the data. So I would expect the top line results in mid-2027.

Actually, maybe just one more. Sorry for adding another question under my session here. I just wanted to talk about the commercial strategy for S-Corrects and partnership versus independent launch as you're moving value advances toward the pivotal readout. How are your discussions with potential commercial partners evolving? Are they waiting for the phase three results or could a transaction or partnership occur ahead of the readout? Thanks for taking all the questions.

So I don't want to comment on discussions with specific companies or on whether any are taking place right now. But what I can do is to explain why we believe that the SKRX is a strategic asset for the large wound care companies. First, the market has shifted after the CMS cuts of the Skin Staptitude reimbursement. companies with large wound care sales force now looking for product approved through BLA, NDA, or PMA with an established reimbursement path. To our knowledge, S-Corex is the only late-stage BLA candidate of its kind. So this is, I think, the main reason for attractiveness of S-Corex. Second, the product profile. If S-Corex is approved, If you compare it to against the single decades old Santil, which has more than $400 million in annual sales, and it takes four to eight plus weeks to achieve what F-Corex has shown in four to five days on average, it is considered very significant in wound care. And third, the size of the opportunity. We project approximately $1 billion in US peak sales across venous leg ulcers, diabetic foot ulcers, and pressure ulcers, the three largest chronic wound categories. And we believe that this is an opportunity that no major wound care company can ignore. You can see that by the engagement of our collaborators. We have eight out of the nine larger wound care companies that are collaborating with us. Our focus is delivering on the value data, and I think after that we have the flexibility to get a decision on our own timeline. I hope I answered your question.

Yes, understood. Thank you, Ofer. Thank you.

Thank you.

Thank you. The next question comes from Soyambakula Ramakant with HC Wainwright. Please go ahead.

Thank you. Good afternoon, Ofer, Hani, and good morning, Barry. A couple of questions on the expanded facility. After the modifications that you need to do during the fourth quarter, what is left in terms of validation for the inspection and release milestones that you're expecting for the second half 27 commercial supply. And also, is there any timing cushion that you have included into it so that if things get shifted, you still could achieve that milestone of second half 27?

Hi RK, and thank you for joining. As for the expanded facility, as I mentioned in my prepared remarks, we expect the work that the recommendation that we got in the pre-audit to do some operational changes. We expect to finish that work in the fourth quarter of this year. Once that work is complete, We will start manufacturing NexoBread at the new facility. Then we will need to submit it. There is a review process. There is an in-site inspection. And then we can sell that specific commercial supply for the expanded facility. We are targeting a second half. The second half is a six-month period. There is some cushion there, but we do not expect it to be earlier.

Very good. With 70 repeat ordering centers in the U.S. and also the BARDA procurement has started, so what are the constraints now for incremental supply, especially before you can get that expansion approved? And congratulations on the current facility going through all the recent inspections. Is that facility have enough capacity to handle what is happening or what the demand is asking for here in the U.S.? And is that all included into your guidance at this point?

So as I said in the call, we are quite limited in our ability to manufacture. We have no issues in demand. We need to prioritize who we sell next of breed and when. The United States market gets the priority. We are in a position to give the supply that is required to various sales for the commercial use and also for the procurement of BARDA. This is our top priority.

So the last question is on the revenue outlook. I understand the inability with regards to the separate US facility and why you cannot get the proper guidance as it. However, what is already included into your previous guidance? In terms of how much of the executable work in that project has been included or not included, and is there any additional color you can provide around that?

So our revenue is heavily weighted toward development services for the U.S. government programs, as you know.

and it has a few pillars.

Under the agreement with VeriCell, we continue to support two next of redevelopment programs. Both of them are covered by the contract with VeriCell and BARDA. It's the indication expansion to acute trauma injuries and the development of new stable formulation. Separately, we have income from the Department of War. They're awarded us an additional $3.3 million. to develop the room temperature stable formulation through the IND. As I said in the product size side, sorry, next of which says are constrained by supply. So we have one, we have visibility towards what we can generate revenues there. We are selling every unit that we can manufacture, including all the products. I'm referring to previous questions, including products for the government procuring procurement under the Varicell-Barda contract. The key uncertainty, and we highlighted this, is the U.S.-based manufacturing facility. We are substantial portion of our anticipated 26 revenues tied to that. We are still in ongoing discussions with them, all kind of funding discussion that I cannot get into details now, and I don't know when it will be secured.

Thank you. Your next question comes from Meera Sharma with Oppenheimer. Please go ahead.

Hi, this is Meera on for Jeff. Thank you for taking our question. We were just wondering if you could give a bit more guidance on how you think 2026 and 2027 will shake out. for U.S. government and Barrio Revenue. And how will we see the first curve of 2027 to be impacted, especially for the SCRX VLU trial timelines and for the other two indications as well for DFU and pressure ulcers? Thank you.

Hi. As for the SCRX, as I said, the guidance is very clear. Interim Assessment First Quarter. Assuming the base case happens, we expect top line results mid-2027. We will start in parallel. We are finishing the preparations for both pressure ulcers and diabetic foot ulcers. We will give a color when we initiate the trials and I guess it will be, at least the first one will be in the next few weeks. So in S-Correct, I think the guidance is quite clear. Did you also ask about Nextogrid?

No, thank you, that's it.

Okay, thank you.

Thank you. Your next question comes from the line of Chase Knickerbocker with Greg Allum. Please go ahead.

Hey guys, this is Nick Mattiacci on for Chase. Thanks for taking our questions. So I think you guys mentioned in the prepared remarks that there will be a couple additional data safety and monitoring board meetings for value in the first quarter. Can you just walk us through what will be assessed at those meetings and how those reviews relate to the sample size reassessment and What information we should be looking out for from those meetings?

Hi. So as we guided in the past, we have a DSMB that will be unblinded and look at the data once 140 patients finish the treatment. But separately, we have this DSMB review safety, at pre-specified points during the clinical study. At each review, the DSMB has all kind of option of recommendations, such as continuous plan, continue but make some protocol changes, a temporary hold until the changes are made, or they can even stop the trial if they see all kinds of major safety concerns. As we reported previously, the most recent DSMB recommendation was everything looks great, continuous plan without making any modification. The next DSMB review is expected in early January, the first week of January. And then the following meeting is expected to be at the end of the first quarter and the DSMB there will also conduct the interim sample size reassessment as we discussed earlier. I hope it was clear.

Yeah, got it. Thanks for that. And then I think this was already touched on a little bit, but Just as we think about the top line and the previous range you guys provided for 2027, are you just able to share any color on what portion of that range was hinged on the progress with the US manufacturing facility?

As we said, it's a major part of the, it's a significant part of the 24 to 26 million dollar guidance. We are not prepared now to say how we break out this component of the guidance, only to share that the substantial portion is tied to development services for the planned US-based facility.

Understood. Thanks for taking our questions. Thank you.

Thank you. The next question comes from Michael Okunovic with Maxim Group. Please go ahead.

Hey guys, good morning. Thank you for taking my questions. Good morning. I wanted to ask just a little bit about the value study, the upcoming DSMB review, and in particular, what change in the incidence of complete debridement or wound bed prep is the study powered for under the current target enrollment of 216 patients? So,

The value trial is very similar to a trial that we did, which was called Chronex, which is a phase two trial. There are some differences that we believe fit better the ability to demonstrate SCRx advantage over placebo. All the power calculation were based on the previous trial. The changes that were made in this trial hopefully make the probability of success better based on the fact that we standardized the treatment, all the patients are getting identical treatments across many sites, and based on the fact that we removed patients from the trial that are too easy to treat or very complicated to heal. We believe that it will increase substantially the gap between the active SCRx to a placebo. But the 216 patients calculation is based on the previous phase two trial.

All right, thank you.

And then for the DSM-D, how do they look at the co-primer endpoints, right? Because you have both complete debridement and wound closure. Will they base their sample size recommendations on the probability of succeeding in both endpoints, or is it an either-or situation where probability of success in one or the other would lead them to recommend you unmodify the study?

Okay, this is a great question. So we have two primary endpoints. The first one is the incidence of complete debridement. In order to prove that SCRx is better than placebo in debridement, You don't need 216 patients. According to our calculations, you need less than 20 in order to show that it is much better because basically if you recruit the right patients, and this is what we are focusing on this trial, the gap between the two arms should be significant. So no one is looking at the placebo assuming the 216 patients is 99.9% powered to beat this specific endpoint. The only thing that the DSMB are looking at is the difference in the time to facilitate wound closure. And this is what they're looking at. Only that.

All right. Thank you. I really appreciate that clarity. And then one last one from you before I hop back into the queue. Could you provide just an update on your plans for the pressure ulcer study and the DFUs? Previously, those were expected to launch this year. Just an update on your development plans for X-CREPs before, or

Beyond Value.

So, as I said, the Phase III value study in VLU, this is our primary focus on escorex. We are conducting, beyond VLU, we see escorex addressing diabetic foot ulcers and pressure ulcers. And together with VLUs, these are the three largest chronic wounds categories. and the market size that we discussed last time was around $1 billion potential pixels or potential opportunity. We are now preparing for the broad development of the program. Both of the studies are getting ready for initiation. We will have some news about it in the next, I guess, Next call or next few weeks. The first trial is the pressure ulcer, which is an investigator initiated. It means that it is not directly run by us. It will be a small open label trial. And the second one is the DFU, 50 patient study supported by the European Innovation Council. And this will be a larger trial. Double-blinded, this specific trial is supported by some of the large collaborators that we discussed in the prepared remarks. I hope it was clear.

Thank you very much, and I appreciate the additional clarity. Thank you.

Thank you.

At this time, there are no further questions in the queue. I would like to turn the conference over to the management for closing remarks.

Thank you everyone for joining us today.

We look forward to updating you again on our next quarterly call.