Good day, and welcome to the Delcath Systems reports third quarter fiscal year 2023 financial results. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then one on a touch-tone phone. To withdraw your question, please press star, then two. Please note this event is being recorded. I would now like to turn the conference over to David Hoffman, General Counsel. Please go ahead, sir. Thank you. And once again, welcome to Delcath Systems 2023 third quarter earnings and business update call. With me on the call are Gerard Michel, Chief Executive Officer, Sandra Pennell, Senior Vice President of Finance, Kevin Muir, General Manager, Interventional Oncology, Vojo Vukovic, the Chief Medical Officer, and John Purpura, Chief Operating Officer. I'd like to begin the call by reading the Safe Harbor statement. This statement is made pursuant to the Safe Harbor for forward-looking statements described in the Private Securities Litigation Reform Act of 1995. All statements made on this call, with the exception of historical facts, may be considered forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Although the company believes that expectations and assumptions reflected in these forward-looking statements are reasonable, it makes no assurance that such expectations will prove to have been correct. Actual results may differ materially from those expressed or implied in forward-looking statements due to various risks and uncertainties. For a discussion of such risks and uncertainties, which could cause actual results to differ from those expressed or implied in the forward-looking statements, please see risk factors detailed in the company's annual report on Form 10-K, those contained in subsequently filed quarterly reports on Form 10-Q, as well as in other reports that the company files from time to time with the Securities and Exchange Commission. Any forward-looking statements included in this call are made only as of the date of this call. We do not undertake any obligation to update or supplement any forward-looking statements to reflect subsequent knowledge, events, or circumstances. Now, I would like to turn the call over to Gerard Michel. Gerard, please proceed. Thank you, everyone, for joining today. Since the FDA approval of HEPZATO KIT on August 14 for patients with metastatic uveal melanoma, we have been focused on outreach to potential treating sites and building our commercial team in preparation for commercial launch, which is now anticipated for January. While it's taken slightly longer than expected to work with our CMOs to finalize and produce QC-released, labeled, and packaged melphalan specific to HEPZATO, we have been productively using the time between approval and launch to expand the number of treatment teams that have undergone didactic training and attended a preceptorship, both of which require before a new treating team can perform their first proctored case. In HEPZATO KIT's FDA approval, we have been encouraged by both the medical oncologist and interventional radiology communities, motivation and stated commitment to incorporate HEPZATO KIT into their practices treating patients with metastatic uveal melanoma. While we are fielding interest from more than 20 sites, we are primarily focused on a subset of these to ensure that we achieve our planned activation targets throughout the year. In conjunction with the local medical oncologists at each of our target sites, we have been working with the site's interventional radiologists to identify and train HEPZATO KIT treatment teams. In addition to training the treatment teams at each site, we are also working to get HEPZATO KIT approved through the various traditional hospital formularies and value analysis committees, and we have started that process in 13 hospitals. Currently, we have three EAP sites, Moffitt Cancer Center, Duke University, and the University of Tennessee, which are fully trained and can start treating commercial patients upon the availability of commercial product. In addition, we now have a further four sites, Mayo Clinic, Thomas Jefferson, Ohio State University, and Stanford University, that have completed the necessary steps to conduct their first commercial treatment under the guidance of a proctor, once commercial product is available and Formulary and Value Analysis Committee approvals are obtained. Beyond those seven sites, another four sites, UCLA, Providence Saint John's, Mass General, and Piedmont Hospital, currently have their preceptorship scheduled in November or December. In total, we expect at least 10 sites will have completed the required training to treat a commercial case by the end of January, contingent on scheduling a proctor team for that first case and a successful completion of the various value analysis committee processes. Given the need for the first case to be proctored and the required committee approvals, I don't expect all of the 11 previously mentioned sites to be actively treating patients in the first quarter. However, based on interest and progress to date, I am confident that we will achieve at least five active treatment sites sometime in the first quarter, 10 by the end of the second quarter, and 15 treating centers by the end of 2024. We expect treatments per site to start out at approximately one per month and end the year at approximately two per month. Since HEPZATO KIT is a liver-directed interventional radiology procedure and not an infused drug, we are focused on medical centers, as currently mentioned, that currently offer liver-directed therapies for metastatic uveal melanoma patients and currently treat a meaningful number of patients with liver-directed therapy. Noteworthy centers include Thomas Jefferson University, led by uveal melanoma oncologist thought leader Marlana Orloff, and interventional radiologist David Eschelman, a leader in liver-directed therapy. Thomas Jefferson, by far, treats the largest number of metastatic uveal melanoma patients in the country. Other noteworthy centers include UCLA, with uveal melanoma thought leader, medical oncologist Bartosz Chmielowski, and interventional radiologist Sid Padia. Mayo Clinic, with medical oncologist Roxana Dronca and Yiyi Yan, interventional oncologist Charles Ritchie, and Beau Toskich. Moffitt Cancer Center, with the FOCUS trial principal investigator, Jon Zager, and Stanford University, with medical oncologist Sunil Reddy and interventional radiologist, Gloria Hwang. Since approval, Kevin Muir, Delcath's general manager in interventional oncology, has been busy building the commercial organization. Kevin has made a point of bringing on team members that have deep experience in launching complex therapies that require multiple stakeholders in the hospital setting. For example, our new director of sales, Zach McLagan, comes from Boston Scientific and has over 20 years experience leading teams and bringing new liver-based interventional procedures to market. Under Zach's guidance, we have divided the U.S. into four regions, each of which will be served by a commercial team comprised of a liver-directed therapy representative and two oncology managers. The liver-directed therapy representative will manage the hospital approval process and ensure that the HEPZATO KIT procedure team is trained and supported while performing the procedure. The oncology managers will engage community-based medical oncologists outside of our treating centers, with the goal of building referral networks to the oncologists within the treating centers. In addition, each team will be supported by a clinical specialist, who will support the treatment teams in preparation for and during the treatment, with the goal of ensuring patient safety and improving patient outcomes. To ease patient access, Kevin's team has been working with market access consultants to submit the required applications to obtain the C code, J code, and NTAP from CMS. Given the nature of HEPZATO KIT, we anticipate all codes and add-on payments to be granted. We are in the final stages of designing a patient access program called HEPZATO KIT Access, designed to assist patients and hospitals in numerous aspects of treatment planning, including prior authorization. We are working with a well-established hub service with significant experience in both ultra-orphan diseases and oncology, designed to design and manage this program. We continue to support both internal and external efforts to add to a growing body of evidence that the PHP procedure, whether utilizing melphalan delivered by Delcath's CHEMOSAT or the HEPZATO KIT, is an important treatment option for patients with liver-dominant uveal melanoma. We recently announced the publication of results from a retrospective comparative study of CHEMOSAT and selective internal radiation, or SIRT, published in the Journal of Cancers. The independent investigator study from the University Hospital Tübingen, Germany, compared two liver-directed therapies: multiple cycles of SIRT versus two treatments of percutaneous hepatic perfusion with CHEMOSAT in patients with liver-dominant metastatic uveal melanoma. Median overall survival was 301 days for the 34 patients treated with SIRT, and 516 days for the 28 patients treated with CHEMOSAT. In an adjusted Cox regression model, there was a significant difference between SIRT and CHEMOSAT, with a hazard ratio of 0.32, an associated 95% confidence interval of 0.14-0.73, and a P value of 0.006. The overall survival results clearly demonstrate the positive impact of treating liver metastases on patient outcomes with CHEMOSAT. As a reminder, there is an ongoing investigator-initiated, randomized, phase II trial in Europe, the CHOPIN trial, evaluating the effect of adding immunotherapy to CHEMOSAT liver-directed therapy. The trial has enrolled 55 of the planned 76 patients, and the investigators expect the trial to be fully enrolled mid-2024. The primary objective of the trial is to determine the efficacy of combination treatment of immunotherapy with ipilimumab and nivolumab with CHEMOSAT treatment versus CHEMOSAT alone, defined by progression-free survival at one year. Secondary objectives include overall survival and overall response rate. An interim futility analysis conducted in September resulted in the Independent Data Monitoring Committee recommending the continuation of the study without modification. As mentioned earlier, we now expect to start commercial sales in January 2024. We have been utilizing the time between approval and launch to increase the number of trained treating centers and initiating the formulary approval process in numerous institutions. The feedback and progress to date gives us confidence that HEPZATO KIT will become the standard of liver-directed therapy care for metastatic uveal melanoma patients quickly after launch. I will now hand the call over to Sandra to share some details on our financial position. Sandra? Thank you, Gerard. We ended Q3 with $40.5 million in cash. Cash used in operations was approximately $9.2 million in the third quarter and $23.1 million for the first nine months of the year. The increase in cash is due to the funding received as part of the Tranche A warrant exercise. Specifically, the Tranche A warrants were exercised for $35 million, for the equivalent of 7.5 million in common stock. The $35 million should be sufficient to fund the company until another 4.1 million shares of common stock equivalents are issuable at a strike price of $6 as part of the Tranche B warrant... without having to issue additional equity capital. The Tranche B warrants would result in $25 million of gross proceeds upon the company achieving $10 million in quarterly revenue. Current shares outstanding is 22.1 million and 40.5 million on a fully diluted basis. Revenue from our sales of CHEMOSAT was $0.4 million for the three months ended September 30, 2023, compared to $0.9 million for the three months ended September 30, 2022. For the three months ended September 30 this year, R&D expenses were $4.7 million, compared to $4.1 million for the three months ended September 30, 2022. The increase is due to activities related to the FDA inspection and other requests in advance of the approval of HEPZATO. For the three months ended September 30, 2023, compared to the same period in 2022, selling general and administrative expenses have increased from $4.8 million to $6.2 million due to activities to prepare for commercial launch. That concludes our earnings and business update, and I'd ask the operator to open the line for Q&A. Can you please check for questions? We will now begin the question-and-answer session. To ask a question, you may press star, then one on your touch-tone phone. 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 and then two. Our first question comes from Bill Maughan with Canaccord Genuity. Please go ahead. Hi, good afternoon, and thank you. So, I have two questions. So you talk about getting sites up and running, and the last hurdles to go through being product availability and site Value Analysis Committee approvals. On the site Value Analysis Committee approvals, how active is Delcath in that process? Or is that generally an internal hospital process? And how much, you know, how certain is the outcome of those processes? In other words, is it sort of a check-the-box operation, or is there any uncertainty in that approval? Second question is, how do you see this, how do you see HEPZATO being used post-KIMMTRAK? Are those patients simply too far along to be an addressable market? Thanks. All right. Yes. Let me start with the first question, Bill. Good to hear from you. And I think, Kevin, you can probably add some color to this, but I think I wouldn't go as far as to say it's check -the- box. But I would also say, and Kevin could add some color to this, that we have a lot of sites. There's no place that we're moving forward and aggressively where we aren't confident of support. But David... Kevin can give some color there. And we certainly support the sites to some extent, but I think the days of the company going and presenting are long gone. But you do have to support them to some extent. But, Kevin, can you add some color? Yeah, Gerard, thank you. It's far from check -the -box. You know, it's a formal process within each facility. And they're basically looking for, if we code this procedure, will we get paid? Will we get reimbursed? And so we are asked to provide a limited amount of information, and then the hospital makes its decision on itself. We feel confident with our hub services, Gerard mentioned earlier in the call, and they're assisting with the coding, the kind of the coding forecast for the facilities, and then it's up to them to see if that's beneficial to them. And the feedback that we've had to this point in time has been very good. We're confident that, out of the 11 sites that Gerard mentioned, that we'll have five of them that will perform procedures by the end of January. Kevin, I think it's fair to say that we haven't... There have been a number of these meetings already, and it's usually not just one meeting, but a number- Yeah ... of these meetings have started, and we've yet to have any, "Geez, this isn't going to happen," type reactions. Is that correct? Yeah, it's entirely correct. We've been overwhelmed by the response that we've had and the two-way communications that we've had with each hospital to this point in time. As Gerard mentioned, we've had several of these calls and presentations that we've made to the hospitals, and we anticipate most, if not all of these, coming back with the value analysis committee in our favor. Now, Bill, in terms of your second question, are patients who are post-tebentafusp, will they be too far gone, too far progressed? And I think, you know, the answer is some may be, some may not be. I think if we take a step back, the first question really is, should you use liver-directed first? There are certainly some oncologists out there who believe that in many cases, many cases, liver-directed first makes sense. There are others that want to go to systemic first, so it's not going to be everyone automatically going to tebentafusp first. I think one of the points we're going to make to oncologists is that you can tell after two treatments from us whether or not you're getting a benefit. With tebentafusp, they recommend treating through progression because of pseudo progression with immuno-oncology agents. So you run the risk of going too long with tebentafusp before you really know whether it's working or not. So it may make sense to start with us from that rationale. The third thing I'll say is we have seen patients post-tebentafusp. So we've seen patients that are applicable for tebentafusp coming with us first, and we've seen patients post-tebentafusp. So clearly it's going to be a mix, but we think we have a sound argument because the liver is usually the life-limiting organ site of metastases, and you can get a quicker read on whether you're getting efficacy when you go with us first. We think we have a good argument to go with us first, but if not, I think we'll still get a fair number of those tebentafusp patients that unfortunately eventually progress. Got it. Thank you very much. The next question comes from Scott Henry with Roth Capital. Please go ahead. Thank you, and good afternoon. Just had a couple questions. You know, first, as far as I'm just thinking about the launch metrics you sort of laid out, Gerard. When we think about one per month moving to two per month, do you think about that as an average, or do you think about as a high volume location? Or just trying to get a sense, because I know, you know, obviously some people will do more, some will do less, how you try to put that one to two in reference? Yeah, I think here's what we have. Before we really get out there and get moving, I'm kind of averaging it maybe down, who knows? I do know I'm confident there'll be some sites that are doing, you know, one a week. But I think there are others as they get started, and we're building the referral networks, they might be doing one every two months. You know, eventually, my hope is that sites do at least one a week, you know, out some time over the horizon. And that's what we need to do to, you know, get to peak share. But it's definitely an average, and it's really thinking there's one or two sites doing most of those and the new ones that have recently come on board, they're building their referral networks. Okay, great. And when we think about cycles per patient, how would you think about the average cycle, number of cycles a patient would have, and how much time between cycles should we expect in utilization? Well, we saw in the FOCUS trial, I think, as you know, it was 4.1, so we're kind of, for our own modeling purposes, assuming four. In the FOCUS trial, we allowed patients to go up to eight weeks between cycles. Six was the recommended. I think what we're seeing, you know, what we've seen in other settings, Europe, is that some docs, more in compassionate use settings, earlier in the U.S., some docs choose to do two quickly together, let's say six to eight weeks apart, and then do watchful waiting. Others follow the protocol perfectly. So I think, my guess is we're gonna have a subset that do, you know, two, eight weeks apart and then wait. Others are gonna go straight through. One thing I am certain of is patients that we, you know, lost in the trial, that withdrew because their blood counts had not risen to the level or was appropriate to retreat them. We won't lose those likely in a commercial setting because the docs will just wait a few extra weeks. So when we- So on average, I think it'll be... Go ahead. I was gonna say, so when we think about cycles per quarter as we model out expectations for the launch, you know, obviously everyone doesn't come in the first day of the quarter. It sounds like we should think about it as one to two cycles per quarter, depending when the- One to two, yeah, one, you know, one, one on an average, kind of starting out early in the first quarter, you know, one treatment a month per site, ending two. And then when I say treatment, I mean a cycle or a treatment. It could be, and we're not really counting patients right now because, you know, we're just scratching the surface at these levels in terms of the TAM. You know, at some point, we'll have to start talking about number of patients on therapy, but right now we're just focused on treatments or cycles. Okay. And Gerard, you know, maybe it'd be for the typical hospital, maybe if you could just walk through how that hospital, you know, gets paid with this product, you know, what is the procedure, and how we should think about that? Yeah. So for the typical hospital, you know, there will be three components of payments. All right? We're gonna talk about an outpatient because the majority of these patients will be outpatients. They're gonna put in a set of CPT codes for a facility fee. They're gonna put in a set of CPT codes for the procedure for the doctor's time. Now, most of these doctors are on salary, so it's not a direct incentive to them, but they do care. And the third reimbursement component will be, putting in for reimbursement for the drug itself, HEPZATO KIT. That will initially be with a C code, and then eventually we will get a J code, but that's a pass-through payment, so the hospital would get paid, you know, whatever, whatever we charge them, plus 6%. Let me just pause there and see if there's any more detail or any particular part of that process that you'd like to hear about. No, I think that's a good... So these three codes that all come into place, are all of them necessary to start the process? Or, you know, is there a sequence that hospitals will want as they utilize this? Yeah. So let me, Kevin, why don't you explain the availability of, you know, how the CPT codes work in terms of being a portfolio of codes you're going to use, and then, you know, when, when the—what they'll do initially, and then when the C code comes on board, then the J codes? Yeah. So thanks, Gerard. So CPT codes are nothing more than codes that describe what the physicians are doing during the procedure. So when they go through the step, there will be... Or when they go through the procedure, they will record what they do. The CPT codes will match what they do. They're presented to CMS, and the payment comes back. So there, there's going to be two payments, one for the hospital, one for the physicians. We've gone through a number of coding exercises to ensure both ourselves and our hospital partners that this will be—there are codes in place, and if they code them correctly or if they do the procedure, then the hospital will be reimbursed fully for what they are doing. Physicians, the same thing. Their codes will pay them adequately for their time. So those are the two main concerns when you really come down to it. This is a lot of what's done from the earlier question on the Value Analysis Committee. Make sure the CPT codes are there for the hospital and the physician. And then the final part of that is the product. And we should anticipate hearing very soon back from CMS on our C code, or it's called, actually called a TPT, Transitional Pass-Through, application, which results in a C code. We're anticipating hearing on that shortly. Those usually go into effect on January first, but sometimes they drag into January. So that should, as Gerard mentioned, be a pass-through payment for the hospital, and they get a 6% administration fee on top of that. Again, from the customers, from the hospitals that we've talked to at this point in time, there seems to be more than adequate reimbursement for them to move forward. Okay, great. That's helpful. Gerard, that should do it for me. Thank you. All right. Thanks so much, Scott. The next question comes from Marie Thibault with BTIG. Please go ahead. Hey, good afternoon. This is Sam Eiber on for Marie. Thanks for taking the questions, and congrats on the progress getting through some of those treatment sites. Maybe I can use my first question here on the work with the CMOs. I think I caught your comments earlier on the call that it's taking a bit longer than expected. Just wanted to get any additional color on maybe some of the bottlenecks or work that's going on behind the scenes there. Thanks. Sure. So, you know, we've known for quite a while that we'd like to work more directly, you know, with a CMO for melphalan. You know, given that series of acquisitions, based on who we initially signed up with for melphalan, I won't go through all the details. We're ended up in a situation where Mylan holds the ANDA, and they use a CMO, NerPharMa in Italy, and NerPharMa uses a set of CMOs or contract labelers to make the various labels and such. We have tried prior to approval and post-approval to take some of that work on ourselves, saying, "You know, ship us naked vials, we'll label it, we'll make the labels and ship them out to Italy," anything we can to accelerate this. Unfortunately, since we're a very small player for this generic product and these nested manufacturers, we really are having difficulty, you know, moving, you know, getting them to move off of what they say is basically: Here's your contracted lead times. Now, there really was no way in our position to, you know, write a large check or even guess what the final label would be to get way ahead of this. This is an unusual situation, again, where we're using a generic product, and we're getting them to carve out, you know, a small run for us. And that's really what the bottom line is. You know, could it have been a little smoother? Perhaps, but, you know, at the end of the day, we've got to work with what I'm calling these nested CMOs. This won't be a problem longer term. We've already got an order in for a second full batch, you know, which will be delivered probably shortly after the first batch. And so that will be, you know, well supplied going forward. We wouldn't have these bottlenecks anymore. But again, it's kind of a situation where we're never really in a position to fund our own ANDA for this type of thing. So we just kind of have to live with this situation. And as we go forward, you know, we're going to focus a lot on making sure the supply chain is as robust as possible, and we don't have any you know, we're never at a stock out situation or a slowdown situation. Okay. Yeah, that all makes sense. I appreciate the added color there. Maybe I could use my follow-up here on some of the VAC approval process questions. How long do these usually take? I mean, we hear for other products, they could take six to 12 months. You know, I assume that it's probably a bit quicker here. Recognize it's not just a check-the-box kind of item, but just wondering your thoughts on how long those VAC approvals you expect to take. Yeah, I think what's unique about this is... Well, this is not another antibiotic, you know, to for a hospital-acquired, you know, infection or another stent. This is a product where there is nothing else like it for this patient set. And you know, our interventional radiologists and medical oncologists are very happy to champion this and push this forward outside the regular scheduled meetings. Now, what I'm doing here is I'm repeating what Kevin has told me, but Kevin, is there anything I left out—in terms of the process or any further color? ... No, but to add a little color to the question, you're right. I mean, you know, throughout my entire career, I've budgeted nine months for one of these Value Analysis Committees. And again, it's kind of been what has been so encouraging about this, is that we have, you know, it's ultra-rare disease. It's, you know, lack of a standard of care for some of these patients, and we're also at the right hospitals. And so they recognize the need for the product that we're bringing, and we're kind of moved outside of that nine months, and we're probably closer to three months, and even in some scenarios, maybe shorter than that. So it's been very encouraging from the response that we've received from these committees. Okay, really helpful. Maybe just a clarification question. How many of the proctor sites do you have in the U.S. that could essentially do the proctor cases, or that you expect to have? Kevin? Yeah, looking at my list right now, we have the three EAP sites that are ready to go. The rest of the FOCUS trial sites have abbreviated training requirements, so that would be another one, two, three, four. So we'll have seven. Kevin, in terms of proctor teams ready to go, it's Moffitt, right? Oh, proctor team. Yeah. Yeah. Yeah. I'm sorry, I misunderstood the question. Yeah, it's Moffitt, and that's one of the reasons it's going to be a bit slow. Yeah. But, you know, we'll have another team, you know, two or three teams up and going within a few months, and we have a number of teams in Europe who are more than happy to fly over and proctor. So that's. We're probably going to end up relying on some European teams as well. Got it. Okay, thanks for taking the questions. Yeah. The next question comes from Yale Jen with Laidlaw & Company. Please go ahead. Good afternoon, and thanks for taking the questions, and congrats on all the progress. Thank you, Yale. Good evening. Just quick, couple quick ones. First one is that, in terms of your inventory preparation for the launch, by end of this year or beginning of next year, what do you think your inventory level might be, and how would that be, you know, how adequate to supply the anticipated, potential anticipated use over the subsequent quarters? Okay, I got the first question, the inventory level, I'll answer, and that is, we're trying to maintain at least a year's worth of inventory. I think once, and so that'll be a rolling, you know, demand forecast looking forward. I think once we get past the $10 million revenue milestone, that'll bring more cash to the balance sheet. We'll be just short of being break even then on an EBITDA basis. I think we'll probably increase safety stock beyond a year on certain components, just to be careful, because it's not always easy to switch out components if suppliers change. So that's the answer to your first question. What was the second, Yale? When you start to launch the product, you have adequate, or how do you see that preparation at that time? So, do we have adequate? I think we will probably, based on orders coming in this year, and once the melphalan shows up, we'll have every component. We will have at least a year's worth of stock. Okay, great. That's helpful. And my second question here is that, given you indicated there's roughly 10 sites ultimately will be in the queue for the, I guess, first half of next year. What is your estimate or the total potential patient size or procedure number of all those 10 combined? So are you asking what I think the volume will be for the full year? For the full year, from those 10 target hospitals and sites. Yeah, let me stick with what I've said before, and then if there's, I mean. And that is, and I think you can probably do the math, and that is, with a little bit of range, which is I'm trying to ensure here, is, you know, five. By the end of the quarter, we'll definitely have five sites up and running, and I think at ending the quarter, they'll be doing at least one a month. Middle of the year, at least 10 sites up and running. End of the year, at least 15 sites up and running, and they should end the year doing at least two a month, you know, exiting the year. You can get to, you know, fairly wide range, ±30% in terms of volume, depending on when you assume they get there within the quarter. In terms of how many patients that represents, whatever number you have divided by four. Okay, sounds good. Okay. Maybe the last question here is that, is there any patient you anticipated or to be in the procedures when, you launch the product? In other words, they become patients, presumably, you know, people call them- Yeah. -growing fruit. You know, any number and the colors on that? Yeah. So if we are having the conversations with sites or have had the conversation with sites, it varies by site, that we plan, we'd like to transition EAP patients over to commercial patients once commercial supply is available. With the exception, of course, if a patient doesn't have coverage, we wouldn't stop treating them. That, the way we set up the protocol is it's not an automatic, we can't force that, and there are some important reasons why we chose not to set it up so that we could force it. But I don't know whether or not it'll be a third or half, but there'll be some meaningful percentage of the patients that we'll treat in the first quarter will be patients who switch over from EAP. Okay, that's very helpful. And, thanks a lot for the details and, congrats again. Congrats on all the progress. Thanks so much, Yale. The next question comes from Swayampakula Ramakanth with H.C. Wainwright. Please go ahead. Thank you. This is RK from H.C. Wainwright. You know, in terms of getting centers ready, when you start launching the drug, the kit, in January. As you're preparing some of these hospitals, are you getting a feel for, like, how long it's taking for some of these doctor teams or the surgery teams, you know, in terms of training and so that they can start doing their surgeries? And do you see that, and also, how do you think, you know, that training time is gonna evolve, as you launch and more of the physician teams start treating? Yeah. So in terms of how long, it really varies. We, we have one site that, you know, immediately jumped on it and got their preceptorship done, within a month or so of having a discussion with maybe a month or two, having a discussion with them. We have other sites that, again, I've used the term on multiple calls or one-on-ones, herding cats, where it's been very difficult to get, you know, an interventional radiologist, an anesthesiologist, and, a perfusionist, you know, all attending a case at the same time, you know, which requires an airplane flight, et cetera. So I think that's the reason why, one of the reasons why I'm saying, look, we'll, we'll probably have 11 sites. Well, we're planning on having 11 sites preceptored, hopefully within about two months plus. But of those, I think five will end up getting proctored because then we have to look at a team of experienced docs, and right now that's just Moffitt, 'cause we have, we have a requirement that they need to have done a certain number in the recent past, and Moffitt's the only one that checks off that box, as well as some European sites. You know, we expect there'll be some, some issues with experienced sites, with getting an experienced site to a precepted sites. So that will be the second, you know, gating item. Again, it's gonna be... it's tough to predict. That's where we're saying out of the 11 that we think will have attended preceptorships, maybe five will get on board. And we can't really decide which five. We don't know exactly which five it'll be. Thereafter, you know, as more sites do more cases and more sites get beyond the, I think it's 10 cases they have to do before they can be a proctor. Once they get beyond the 10 cases, all of a sudden, we'll have multiple experienced sites that can proctor. And I think towards the back end of next year, that's when it'll really accelerate, and it'll be a lot simpler to get sites up and running. So varied, hard to predict. It'll take much longer in the beginning of this year than it will towards the end, beginning of next year, as than it will take towards the end of next year, as more and more sites are available to be proctors. So hopefully that answers the question, RK, which is basically it depends. Yeah. No, got that. And then, in terms of how do you see hospitals and even docs act trying to get on treatment treating with HEPZATO KIT versus KIMMTRAK. And, you know, when you go in to have some of these conversations, you know, what sort of conversations do you end up having? And, or do you think you will be able to, you know, get any of the teams to move from KIMMTRAK to the kit? Yeah, I think... Well, Kevin, why don't, Kevin, why don't you give an example? From a commercial rep perspective, what will the conversation be? Yeah, I don't think that we will replace KIMMTRAK with HEPZATO KIT. You know, the conversations that we've had in the field right now have revolved around, you know, potential to use these two therapies in sequence. What's the best sequence? How can they complement each other? You know, ultimately, these patients are probably gonna go at least on twp lines of treatment, if not three. So what is the order that is going to provide these patients with the best options and ultimately the longest overall survival? So that's where the conversations have been really focusing around. Not so much on the either/or between HEPZATO KIT or KIMMTRAK. Very good. That's good to hear. Thank you. Thank you. Yeah, I think it's also also important to remember, and I think everyone on this call does remember this, but that KIMMTRAK is, you know, indicated for about 40%-45% of the overall population. So this is a subset of the patients that we, you know, this conversation is pertinent to, but I think everybody knows that, but worth highlighting. Thanks, Gerard. Thanks for taking my questions. All right. This concludes our question and answer session. I would like to turn the conference over to Gerard Michel for any closing remarks. Okay. Well, I want to thank everyone for taking the time this afternoon. I look forward to providing future updates regarding the launch and subsequent to that, commercial uptake. Thank you, everyone, and have a good evening. The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.