Delcath Systems, Inc.

and welcome to Delcat Systems' second quarter 2024 earnings conference call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mr. David Hoffman, Delcat General Counsel. Thank you, Mr. Hoffman. You may begin.

Thank you. And once again, welcome to Delcat Systems' second quarter 2024 Earnings and Business Highlights Call. With me on the call are Gerard Nischel, Chief Executive Officer, Sandra Pinnell, Senior Vice President of Finance, Kevin Muir, General Manager, Interventional Oncology, Boyo Vukovic, Chief Medical Officer, and Martha Rook, 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 risk 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. Our press release with our second quarter 2024 results is available on our website, www.dellcalf.com, under the Investors section. and includes additional details about our financial results. Our website also has our latest SEC filing, which we encourage you to review. A recording of today's call will be available on our website. Now, I would like to turn the call over to Gerard Michel. Gerard, please proceed.

Thank you, everyone, for joining. During today's call, we will review Delcab's second quarter financial results, our ongoing commercial activities, including projections for both site activation and average treatment rates for the balance of the year, as well as some important medical and clinical updates. In the second quarter, DELCAP reported $7.8 million in total revenue, including $6.6 million in U.S. revenue from House Auto and $1.2 million in European revenue for ChemoSat. As we have previously described, the key drivers of our revenue ramp in the U.S. are center activation and, once activated, the average number of treatments per center. From a high level, we are thrilled with our overall progress in terms of our ramp, and we're very, very encouraged about what the coming quarters will bring. Now, to be specific, in terms of site activation, we ended the second quarter with seven active sites, and as of today, we have eight active sites. While this fell just below the number we projected in our last call, The treatment rate of just under two per month per center is well ahead of our previously communicated projected rate. I'd like to dig a little deeper into both metrics and turn first to center activation. While activation has been a bit slower at some centers than anticipated, there is no systemic reason for the increase in time for center activation, but instead it's just simply a function of the complexity of activating a center given the number of stakeholders involved. It's important to note that we haven't seen any center in the activation process halt the process. From our ongoing conversations with the centers, we are confident that all the centers that are in process, which today stand at over 20 centers beyond our active, currently active sites, will be active in 2025. The eight active centers include Moffitt Cancer Center, Stanford University Cancer Center, Thomas Jefferson University, University of Wisconsin, Regional One Health or University of Tennessee, UCLA Cancer Center, the University of North Carolina Hospital, and Honor Health Scottsdale. Two additional centers have completed all the required preceptorships and have each scheduled their first treatment this month. Assuming no cancellations, we should end the August with 10 treating centers. An additional four centers have completed the necessary steps to conduct their first commercial treatment under the guidance of Proctor and are currently in the process of identifying and scheduling a patient for proctor treatment with hep-sidal kit. As I've mentioned in the past, that can be a complex scheduling algorithm, given all the proctors that need to arrive, as well as that need to fit with the patient's needs as well. A further eight centers have currently completed a portion of the preceptorship requirement. To date, we have had over 130 perfusionists, anesthesiologists, and interventional radiologists attend preceptorships, representing over 20 institutions in the U.S., with some institutions sending multiple healthcare providers. We are confident that the 12 centers that are currently in the process of activating will successfully activate within the next six months. Now I'd like to dig a little into the second metric, average treatments per center, which has been higher than we projected during our last call. Adjusting for the date of center activation, the average treatment by center was just under two per month in the second quarter. Not surprisingly, some centers have notably greater volumes than others, but given the commitment required to become a REM-certified active treating center, we believe that the vast majority of treatment centers either currently active or undergoing the activation process will become meaningful revenue contributors. We started the third quarter with seven active sites, with eight active sites as of today. As I mentioned before, we anticipate we can end the third quarter with 12 active sites. We expect to reach 15 early in the fourth quarter and anticipate having 20 centers by the end of 2024 or shortly thereafter. While apsile treatments in the second quarter average just under two treatments per month for the active treating centers, adjusted for when centers start treating patients, we estimate treatments will average between one and a half to two treatments per center for the balance of the year, somewhat under the second quarter average, but above what we projected in our last calls. This is based in part on a pattern we are seeing where some centers treat an initial group of patients and then pause for a month or more before treating additional patients. Besides assessing patient outcomes, the pause provides an opportunity for our centers to evaluate the explanation of benefits from payers before approving a study flow of patients. As many of you know, this is a common dynamic for the rollout of premium innovative new procedures and therapies within hospitals. even in situations such as ours, where the product has the benefit of a product-specific J-code, which greatly reduces risk of underpayment. Some of you may have seen this morning's press release, in which we shared that on August 1st, we were informed by CMS that we were granted new technology add-on payment status for HPSADA, effective for starting October 1st, 2024. This additional payment under NCAP designation will help cover the costs associated with the treatment for the small percentage of Medicare patients that might require an inpatient stay. As a reminder, most patients do not end up being billed as inpatient, and thus for those Medicare billed patients in an outpatient basis, the product is reimbursed to the hospital under J code at ASP plus 6%. Given the pace of revenue ramp, we continue to expect that we will achieve $10 million in quarterly U.S. revenue by the fourth quarter of this year. which is expected to trigger approximately $25 million in cash proceeds from the exercise of the remaining tranche of warrants that were issued as part of our financing in March 2023. Chemo set sales in Europe have increased over 100% over the same period prior year. The majority of the growth was from Germany and is a result of having a dedicated commercial presence in the market for over a year. We're in the process of submitting for reimbursement in the UK, and we now understand that that review will take place next year. While we estimate approximately 40% of all metastatic UV melanoma patients in the Netherlands are being treated with ChemoSat, those patients are almost all being treated as part of the ongoing Chopin trial. We have started commercial sales in Sweden, but expect most patients to enroll in an IIT we are sponsoring there, looking at sequencing if and even with ChemoSat, which I will describe in greater detail in a moment. We are early in the process of identifying and opening commercial centers in France, Italy, and Spain. We believe it is important to have multiple treating centers in all major European markets. But as I've mentioned before, we are being measured in our investment, given the low price point in Europe, and have chosen to manage the EU market on a break-even basis. Recall that ChemoSat has a broader pan-solid tumor device label, and some of our European sites have over a decade's worth of experience with ChemoSat. The value of Europe in the short to medium term is as trial sites and a source of publications. both in metastatic uveal melanoma and other tumor types. These activities can support both EU and U.S. adoption. In addition to the significant commercial activity, we continue to support both internal and external efforts to add to the growing body of evidence that the PHC procedure, whether utilizing melphalan delivered by Delcath Chemostat or the Hepsado kit, is an important treatment option for patients with liver-dominant uveal melanoma, as well as potentially other liver-dominant cancers. In the second quarter, we announced the publication of key results from the Pivotal Phase 3 Focus Trial Hepatokit in patients with unresectable metastatic uveal melanoma in the journal's Annals of Surgical Oncology. We expect additional results from the focus study to be presented and published in the coming months. For example, an efficacy analysis in clinically important subgroups of patients in the focus study has been accepted as a poster presentation at the upcoming ESMO conference in September. As we continue to roll out commercial use of Hepsado in the U.S., we are also engaging medical oncologists in the U.S. and EU to discuss integration of Hepsado into treatment algorithms and combination sequencing with available treatment options in metastatic uveal melanoma. There is significant interest in the medical community to evaluate Hepsado in different treatment settings. As an example, I would like to point to a recent single-case publication published in Frontiers in Oncology, on successful treatment of a metastatic UV melanoma patient with chemosat following failure on immune checkpoint inhibitors and cadentifus. As I mentioned a moment ago, we're expecting a new IIT to enroll and start treatments of patients in Sweden this quarter. This IIT will evaluate sequencing of immune checkpoint inhibitors, ipilimumab and nivolumab, or ipinivo, followed by chemosat treatment and compare against therapy with ipinugo as the control. This IIT is the second IIT, the first being Chopin, which evaluates ifadivo first in sequence with chemoset, with chemoset as a control. In discussions with medical oncologists, we are aware that physicians and patients are very interested in exploring epsodart or chemoset in combination with immunotherapy, based on a body of published evidence of possible synergies between chemotherapy and immune therapy in solid tumors. We have heard multiple anecdotal reports of physicians utilizing chemostat and immunotherapy in combination or sequence without waiting for the completion and publication of the Chopin study results. On that note, the Chopin study continues to progress with 70 of the total planned 76 patients enrolled. Currently, the investigators are anticipating final analysis of the primary endpoint to occur in mid-2025 with presentation of results in the second half of 2025. As a reminder, the primary endpoint of the Chopin trial is progression-free survival at one year. This analysis depends on collecting the appropriate number of events, so the timelines for data readout by definition are somewhat uncertain. We continue to plan to initiate one or more clinical studies of hepatochemostat in an additional indication over the next six months and recently conducted two scientific advisory boards focused on colorectal and breast cancer to better define the development path. We will provide updates on our clinical development plan later this year.

I will now hand the call over to Sandra to share some details on our financial position. Sandra?

Thank you, Gerard. Revenue from our sales with Hepsado were $6.6 million and ChemoSat were $1.2 million for the three months ended June 30th, 2024, compared to $0.5 million for ChemoSat during the same period in 2023. Our gross margins were 80% in the second quarter. For the three months ended June 30th, 2024, research and development expenses were $3.4 million compared to $3.6 million for the three months ended June 30th, 2023. The change in research and development expenses is primarily due to a decrease in clinical trial activities offset by an increase in personnel-related expenses in medical affairs and regulatory costs associated with an approved product. For the three-month end in June 30th this year, compared to the same period in 2023, selling, general, and administrative expenses increased to $6.8 million from $4.8 million. The increase is due to activity for commercial launch, including marketing-related expenses and additional personnel on the commercial team. We ended Q2 with $19.9 million in cash and investments, and cash use and operations was approximately $4.5 million in the second quarter. On August 1st, the loan with Avenue fully matured and final payment was made. We believe that our current financial resources are adequate to fund operations until the company achieves $10 million in U.S. quarterly revenue, which would likely trigger a warrant exercise resulting in $25 million in proceeds. This $25 million should be sufficient to fund the company until we become cash flow positive under current levels of research and development expenses. As Gerard previously mentioned, we remain confident we will achieve $10 million in U.S. quarterly revenue by the fourth quarter of this year. That concludes our prepared remarks, and I'd ask the operator to open the phone line for Q&A. Can you please check for questions?

Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. you may press star two if you would like to remove your questions from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. The first question comes from the line of John Newman with Canaccord Generity. Please go ahead.

Hi there. Congratulations on the quarter, and thank you for taking my question. You know, I know it's still a bit early in the launch, but could you comment on what you're seeing in terms of the mean number of treatments for Hepsado? And just kind of curious as to how you would expect that trend to progress over the next, say, 12 to 24 months. Thanks.

Thanks. Sure. So it's anecdotal at best, given we're really getting this from the reps and the clinical support specialists who are in most of the procedures. But it seems like most patients are progressing on to two, three, four, five, or more. It's too early now to say whether or not it'll match what we saw in the trial, which was 4.1 on average. But I suspect we'll do at least that well over time. But, you know, no indication that it'll be lower than that at this point.

Okay, great. If I could sneak in one additional question. It seems like there's a lot of potential for Hepsado beyond the additional approval. You spoke a bit about additional trials beyond Schopen. Just curious, do you expect that those trials would be sort of smaller single-arm studies, or would you expect that maybe some of those studies might also have control arms? Thanks.

Yeah, I think we're going to do a mix of things. So, Voya right now is working with both advisory committees to think through larger randomized studies with control arms, as well as single and multicenter investigator-initiated trials And those would probably more likely be single arm, although some of those have a control as well. So I think you'll see a mix of things from this, ranging from sponsor trials that are randomized and have a control arm. We might do some trials. We have some trials in mind that would look at historical data. So a single arm with a control arm being pre-specified, sort of like a registry data, for example. So it'll be a mix of things. And the goal, again, will be a mix as well. The goal will be ranging from giving adequate data so physicians can make an informed judgment for certain patients, whether or not they want to treat and try to get reimbursed for the patients, to informing potential guidelines down the road, all the way to trying to expand the label.

So it will be a mix. Great. Thank you.

Thank you. Next question comes from the line of Mari Thibault with BDIG. Please go ahead.

Hi, Gerard. Hi, Sandra. Very nice quarter, this quarter. I wanted to dig a little bit on the average treatments per center metric. Thank you for giving us that detail. If we were to strip out, you know, the highest volume center, I don't know if it's still Moffitt. I know it was last quarter. Is there a way to think about the average for kind of that... that remaining group. And you mentioned that they are pausing just to check on billing and things. Is everything going smoothly on that front? I know with the J code going into effect, that was, of course, supposed to help quite a bit.

Yeah, let me answer the second question first. I have heard of no fundamental problem with reimbursed at the hospitals when they do things right. I have heard of a couple of cases where they've done things wrong and they've had to go back and fix it. and then get paid. But if they do things right, they get paid. And if they don't, they always have the opportunity to go back, which takes a little bit longer. So no fundamental issue there that I've seen at all. Everything's been very positive. In terms of the average treatment rates, I'm going to hesitate from breaking it down to that level. I will say if you stripped out the Moffitts and the Thomas Jeffersons, yeah, the average treatment per week would drop. But I do think most centers will eventually do at least two a month, and many will be more than that. Thomas Jefferson and Moffitt, you know, clearly are bringing the averages up. In addition, as new centers come on, not all of them, but many of them seem to do a couple patients, then wait, and then start, and then hit the gas. So those newer centers really will drive, I think, the average rate be down with pressure on the average, but maturing centers will keep the average kind of flat. So net-net, that's why I think it'll be somewhere between one and a half, two for the balance of the year.

Okay, that's really helpful. For a follow-up here, wanted to underscore how good your margins were this quarter, both gross margins and OpEx control. Help us think about the sustainability of some of that. Are you needing to add more sales reps to kind of keep up with your launch plans? Was there a reason the control is so good on the operating spend side? Just any more detail you can give us there. And thanks for taking the questions.

Sure. I think we're fairly disciplined on the OpEx side. A lot of the players here have come from another similar company who kind of know, spend money wisely. We don't need a huge sales force to reach all the centers. This is going to be a specialty product that is small number centers. I think in the past I talked about maybe getting to 25 to 30. Our thinking is evolving there. We might decide to get to more like 35 or 40. That might have a marginal increase on SG&A relative to where we are now, but not a huge increase. In terms of cost of goods, we're great for three, four years before we'd have to do any meaningful type of CapEx, I believe. So we're in good shape there. So I think the biggest variable really is, and I might be preempting a question, is R&D spend. How much do we decide that we want to invest into R&D? And we're going to be very thoughtful about that, but there's no doubt we will increase R&D at some point for some additional trials. It would just be... We'd be remiss if we didn't because this product has tremendous potential in many other much larger indications. But I'm not going to forecast what that's going to be a year and a half out from now. I'll just say, look, we're going to try to be very prudent. And, you know, we understand there's, you know, an E in EPS. I mean, an S in EPS, excuse me, in terms of number of shares. So we're going to be very prudent. try to keep the cost down so we really don't have to raise much more money going forward.

Very good. Thank you.

Thank you. Next question comes from the line of Sven Bukula-Ramkant with HC Wainwright. Please go ahead.

Thank you. Good afternoon. Regarding the center activations, now that you have eight centers activated, or almost 10 by the end of this month. What are the learnings from the, if there's any push or pull on it, and how is that helping you not only educate internally, but also the preceptors so that the next set of activations goes smooth?

Yeah, I don't think there's any dramatic learnings aside from we need to address, you know, approach stakeholders kind of in parallel and really help try to educate some of the stakeholders in the hospitals and get ahead of kind of the various committee approvals and stuff. The preceptorship training stuff is really just a Rubik's Cube of scheduling. You know, as we get further along and we have more proctors available and people who can do preceptorships, it'll get a little bit easier. But right now, it's just difficulty in scheduling. Kevin, I don't know if you want to chime in about any learnings in terms of site activation, preceptorship, or anything like that.

Sure. Thanks, Gerard. Gerard, I like the analogy, the Rubik's Cube of scheduling. And so the more sites that we have active and the more procedures that we have, it lessens the, or it increases, I should say, it increases the opportunities for preceptorships and proctorships. So in that respect, it should make the account activation cycle a bit easier. The other thing are 8 to 10 centers that we're working with right now. It allows for peer-to-peer conversations that kind of happen organically behind the scenes. So physicians call each other and hospitals do for some manner of checking on reimbursement and understanding how to set things up. So the net-net of all of this is that when these centers will help us and should kind of streamline the activation process as we go forward with the second half of the year.

Thank you. Regarding the NTAP that you received, the HEP-SATA kit received just earlier this month. How does that benefit in terms of adoption and would that help in any ways in terms of increasing the number of procedures per center?

I don't think getting NTAP is going to make much of a difference in terms of uptake. I think it is helpful for the hospitals when they have the infrequent inpatients. It will lessen the financial burden on the hospital. It's a rather complex formula. They have to have a certain loss amount, and it covers a certain percentage up to a certain percentage, which I don't think it's worth going into that level of detail because I don't think it's that critical. I think the most important thing or telling thing is it's more of a sign of how innovative this therapy truly is. You know, people look at, it's melphalan, it's a device, et cetera, but the bar to get the new technology add-on payment is pretty high. You really do need to prove that you're an innovative therapy doing something that nothing else does is out there. And I think it's fantastic that we got it. And I think although it seems unrelated, the physician reaction we're getting from the radiologists and oncologists who are using the product and the response rate they're seeing, they're incredibly positive. So it shows that, yeah, this is a filter. It's old-school chemo. It is truly something new that's making a real difference for patients. And I think that's why we got the NTAP. It is a modest tailwind, but it's not that big of a deal. We really don't need it.

Okay. Thank you. One last question from me on the UK reimbursement since the couple hospitals, if I remember correctly, from the UK that have used ChemoSat for a longer time than others. How is that going to play into the reimbursement review when it comes time?

Yeah, I have no doubt we're going to get reimbursement. They went from a, you know, A semi-annual review to an annual review, that was a surprise to us. That's what pushed it back into next year. That just was a recent change in how often they do the review. But we'll get reimbursement. I have no doubt about that. The question is, what will the reimbursement be? I don't have high hopes that it'll be, you know, a significant step up from where we are right now. But again, as I mentioned before, we're going to manage Europe on a kind of roughly break-even basis. But we're going to continue to invest in there on a measured basis because I think it's, as clinical sites and as sources generate publications, it's a very, very important strategic asset to the company.

Perfect. Thank you very much, Gerard.

Thank you. Next question comes from the line of Sudan Loganichan with Stephen Inc. Please go ahead.

Hi, Gerard, Sandra, and Delcat team. Congrats on a great quarter. I have two questions. My first one is regarding the marketing strategy. Is the main focus geared towards selling the kit to hospitals to bring on more additional sites or trying to, you know, focus that more towards the patient and physician awareness? And then as you go into next year and progress this launch, you know, will there be any changes to that marketing strategy? And then secondly, at what quarterly and yearly revenue run rate and off-ex range do you anticipate you need to be at to achieve a break-even or a positive EPS? I understand you might also have aspirations and other indications for a hips etiquette, but is getting to break-even or casual pause really a track towards that, a potential goal to achieve prior to taking on new clinical endeavors?

Sure. I think, Sandra, why don't you pick up where you think we need to be at to hit break-even? okay, on a quarterly basis, you know, under current R&D spend?

Yeah, you know, currently, probably around the 60 to 80 KIS, just depending, a quarter in order to be break-even or cash flow positive. You know, obviously dependent on additional SG&A, marketing spend, and R&D that will be incurred the rest of this year. But, you know, I think we're well on the course of becoming cash flow positive, you know, hopefully by Q1 of 2025.

And that's about $13 million a quarter in revenue.

Yep.

All right. Now, in terms of the focus on marketing, right now, I think, you know, Kevin Chiman, if you disagree, we're probably focused 80% site activation, you know, 20% trying to, you know, get, Get patients to the sites. That'll switch over time. But, you know, all elements of the marketing mix are important at the moment. Kevin, maybe I don't know if you want to give a couple sentences about, you know, our priorities now and how that might evolve over the next year, year and a half.

Sure. And I think with the patient population that we have right now, one of our main goals is to that 20% is to drive awareness and increase patient access to what we think is a wonderful option for these patients. And while Opening sites is important. It's not our main goal. Our main goal is not to open as many sites as we can. As Gerard pointed out in his remarks, we've started with a goal of 20 and with our ultimate goal of probably roughly around 40 sites. And it's more the quality of sites. Are we going to the correct sites? Are we giving patients access at these sites? So that's been our focus, opening the right sites and getting patients access to those sites.

Thanks, I appreciate it.

Thank you. A reminder to all the participants that you may press star and one to ask a question. Next question comes from the line of Chase Knickerbocker with Craig Helm Capital Group. Please go ahead.

Good afternoon, everyone. Thanks for taking the questions. Just first from me, are there any other high end early adopters in the pipeline, kind of like Moffitt or Thomas Jefferson? Or should we think of kind of everyone else from here as those that maybe pause a bit after a couple patients and kind of generally drag down that average kits per center per month number over the first quarter or so of them being active?

I think there's a third surprise center to us, but I wouldn't say that they're at that level, but might approach it given some recent activity. And I think there'll be a number of others that will reach that level. I think some of the centers we're opening that weren't at that level in terms of a book of business, once they have our treatment, they will increasingly become kind of a destination for a lot of patients. So I don't think that I don't think we're going to have a ton of centers doing six a week. But will we end up having quite a few centers that are doing maybe one a week and quite a few centers being more than four or five? Yeah, I think so, eventually. So if you look at the Pareto analysis of centers, those are the big guys who you mentioned. But I think a lot of centers, once they have our therapy, will end up treating patients maybe that aren't appropriate for our therapy, but they're going to start bringing them in, so they'll start becoming destinations.

Should we think of kind of a max level kind of per week treatments that, you know, some of those high adopters could do? I mean, any way for us to kind of think about that, of kind of what the constraint is on the high end? And then second, of the centers that are kind of awaiting that initial commercial treatment scheduling, do we get a sense of kind of how long it takes to activate those patients? I know we kind of gave a lot of numbers on the call, so forgive me if I'm making you, you know, repeat yourselves, but just kind of those four, for example, that we're just kind of awaiting the schedules to line up. Do we have a kind of a general kind of feel for how long that takes?

No, it's been all over the map and that's why, you know, I was, I was off of it in my projections. I thought we'd have, you know, 10 by the end of last quarter and we didn't, we had, you know, Now we're at eight, and in about three or four weeks, we should be at two or three weeks, we should be attentive. If nobody, you know, patient doesn't get a cold and all the proctors can show up, et cetera. It really is all over the map. In terms of what you think of, you know, what is a max or a run rate, you know, we have a couple centers in Europe that, if it's not summer vacation, you know, are doing pretty regularly one a week. and that seems to be kind of a natural high-volume rate for centers, although we had one center recently do three in one day, believe it or not. So that center may end up being a six-a-month, seven-a-month type place. So I think as people get used to this or are willing to train a second team or have a couple backup people, they might end up doing six or seven a month. But right now, I think four months will likely be what the high end does for a bit, and others are going to be one or two a month. I think eventually we'll see some sites that regularly do one to two a week. That'll take a bit of time. And again, we saw a center just the other, I think, two weeks ago that did, or last week, they did three in one day. So they were able to push them through.

Got it. That's helpful, Culler. And then just last for me, just maybe speak to a little bit about, I know it's early, but the progress that you're having in the community, you know, kind of driving referrals to, you know, some of these centers, and then maybe kind of an early look at how your therapy is going to interact with with those patients that are eligible for tabentafust. Are those kind of patients who are eligible getting tabentafust first, or is this something where physicians are viewing it kind of in line treatment? Just kind of give me an early look there.

We've had patients before Tebby, and we've had patients after Tebby. And it really has more to do with whether the doc believes that liver-directed therapy should go first because this Liver mets are usually what these patients succumb to. So if they're going to prioritize treatment, some docs want to prioritize liver-directed therapy. So it's all over the map, and it'll settle out over time probably one way or another. But most patients do live long enough to get more than one line of therapy. So whether they go first on Tevi or first on us, I think, Patients who are HLA-2 positive should get both. It's probably the right thing for the patients. In terms of referrals, it's still early days. Boyo's team and Kevin's team are both working on, Boyo's medical affairs team and Kevin's commercial team are both working on setting up referral patterns. We've had, I don't know, quite a few referrals to date. They're usually peer-to-peer referrals. So a lot of times we've been getting referrals from centers that are waiting to finish their preceptorships or finishing up their, you know, the various approval committees they need to have. They have a patient they want to have treated. They send them to another site, knowing the patient's going to come back to them, hopefully, you know, once the fall, the approvals occur at their center. So we've seen those peer-to-peer referrals. And we've also, you know, sent, some patients directly due to phone calls we've made and such on the training sites. In terms of a good well-oiled machine referral process, we're developing that right now. That's something that will become increasingly important. We're confident we can do it. It's going to involve a lot of direct patient things, work through advocacy centers. The advocacy groups are very excited about the product, so we'll work with them so the patients know where this is available. We have reasonable data as to who's treating these patients, so we know who has just one of them, just two of them, just three of them. And we have developed a process where through emails, phone calls, perhaps surprise visits, we try to get in front of these docs to tell them about Hepsado kits. you know, because each of these patients is so valuable, it makes sense to, you know, hunt down to that level of N equals one, N equals two or three. But we recognize the importance of that. We're also developing programs where the patient has a reason to get directly in touch with a third party that we work with. Maybe it's help with co-pays, travel, et cetera. But through that process, we'll probably get involved with docs who have smaller numbers of patients and that'll help us with referrals there. So it's going to be a kind of a multi-spoke effort. Still early days to declare, you know, say how well it's working, but we are going to be focused on that.

Got it. Thanks, Gerard. And congrats again on the great early progress here. Thank you.

Thank you. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.