Gerard: month or two. Um, the average pace has been a little over since we've launched has been, I think about 1.1, 1.2, uh, per month. Um, but if I don't see, um, sites, you know, ready to treat a patient or having one scheduled, then I say, all right, I'm going to have another dry month or two. And I pull that out. Um, so, you know, under that framework, I'm saying that's more likely will be 37. Could it be 38 or 39? Yeah. Um, But I think 37 is probably, you know, a more likely number. And it's as simple as that. But don't see anything in the next month or so, so I kind of reduce it.
John Noonan: Okay, great. And then one quick follow-up. On the SHOPAN data, which I think are really fantastic and should be really beneficial, I'm curious if you're seeing most of the new sites that you're in discussion with, kind of citing that as a factor for their enthusiasm, or if it's sort of balanced between new and old sites. I'm just curious if perhaps you're seeing kind of the new sites pick up on this in terms of wanting to get on board with the product, or is it kind of balanced across older existing sites and the new sites?
Gerard: All right, so if you're asking, you know, the level of enthusiasm from Chopin, I think it's both new and existing. There are some existing sites that have been doing a Chopin-like protocol from day one, when they became active. And there are others that have moved over to that, given the data. I would argue that probably most new sites are planning to do a Chopin-like protocol. a combination of immunotherapy and PHP. But Kevin, why don't you chime in? You're a little closer to it than I am in terms of would you say almost all the new sites are going with the Chopin or is it more 50-50?
Kevin: I would say that the majority of them will be going with the Chopin-like protocol. We hear a lot about just combination treatments in general. but Chopin specifically. Now, it is kind of important to note the new sites we've been engaged with for months. As you just pointed out, the site opening process takes a considerable amount of time. So... when we talk with these sites as they're bringing us on there are many conversations between you know peer-to-peer groups as well as our medical and clinical team as well so uh everyone is well versed in the chopin type protocol and so i would anticipate the majority of them that are coming on in the future will embrace that right thanks great thank you
Moderator: Thank you.
Conference Operator: The next question comes from Sudan Loganathan with Stevens. Please go ahead.
Sudan Loganathan: Hi, good morning, Gerard and Sandra. My first question is regarding the ESMO breast cancer data that you also provided. I noticed that the adverse event profile showed some grade three, four adverse events in about 80% of patients. Additionally, the median overall survival was around six months when untreated. never met metastatic breast cancer patients or maybe around the four to five month range. So just kind of curious on how you're viewing this first set of data for this indication and how this kind of dictates how you go forward.
Gerard: Yeah, these were all very heavily pretreated patients. And I think probably one of the most important parts of the data is um although you know the average event profile you mentioned may seem high to be untutored to oncologists these events are easily managed and and all are resolvable um i think there's not much that can be done for these these days these types of patients that were treated um so i think we're quite happy with the data and glad it's there to help improve recruitment, site activation and recruitment in the clinical trial. I'll ask Voyo, is there any other commentary you want to add regarding those results?
Voyo: Yes, sure. So, thanks for the question. In addition to the comments that Gerard made, I'd like to point out that the patients who were treated with Hepstato in this data review, received the median of four prior systemic treatments. That means they have been receiving multiple chemotherapies, and many, if not most, of the patients have residual toxicities. So these are not the patients that we have treated before in the FOCUS or SHPEN trial, which are typically very little pretreatment or no pretreatment at all. So the safety profile depends also on the line of treatment in which you administer PHB. And regarding your comment about the survival, these are patients with breast cancer, and they develop liver metastases. Typically, that's the final stage of the disease where patients have just a few months of life left. So seeing six months is actually, you know, in that context, not so bad. And the doctors expressed a great deal of satisfaction when we talked to them about being able to manage this very difficult stage of the disease.
Moderator: Thank you, I appreciate the details.
Sudan Loganathan: And then additionally, just wanted to ask, even as we go into the second half of this year, could we still anticipate a few other data readouts or just other updates on either breast cancer or colorectal cancer indications going forward?
Gerard: Thanks. Yeah, there's not going to be any data readouts. I mean, we'll keep you apprised of how the trials are proceeding in terms of open sites and patients. but there won't be any from us, any data readouts. As you know, the product's been on the market as a standalone device in Europe for over a decade. And often data comes out that we don't know that investigators or clinicians have submitted it as a poster presentation or a publication. So could something else come out?
Moderator: Yes, but not from the company. Thank you.
Conference Operator: The next question comes from Chase Knickerbocker with Craig Hellam. Please go ahead.
Jake: Good morning, everyone. This is Jake on for Chase. First, regarding the goal of 40 sites by the first quarter of 2027, for the incremental 11 sites, how much are you relying on the three new sales territories, and what are you seeing from the funnel there?
Gerard: Yeah, the territories are not new geographies, OK? So we're just slicing the existing territories from four to six to nine into smaller territories so there's more concentrated effort. So there's no particular territory. I think the reason to increase, there's no particular region where we're going to get more business. As sites are open, it takes effort to manage open sites. So to maintain the same level of effort in terms of activating new sites and the same pace of activating new sites, we have to put more bodies in the field. Now these are very experienced reps, I'll just call them bodies, but we have to put more experienced people out there to manage the existing accounts and to maintain the same level of site activation efforts.
Jake: Okay, thanks for that. And then on guidance, just on a run rate basis, you're already at the $100 million floor just with this quarter. What are your assumptions for the remaining three quarters for revenue?
Gerard: Yeah, well, the assumptions, as I mentioned before, are that we will see the same seasonal impact we saw in the third and fourth quarter of last year. Now, we could be wrong there. In hindsight, It could very well be that we're being overly conservative, but we have a very small N in terms of understanding to what extent seasonality will impact things. There are certain aspects of the seasonality that we think we can address and are trying to address. The specific one that we are trying to handle is if we have a treatment team, if at an important center there is only one full treatment team, Let's say there's only one IR or there's only one anesthesiologist who's trained. If they go on vacation, by definition, the capacity has dropped at that center. So, you know, we have implemented a special incentive to the sales force. If you get a second treatment team trained up and going, there will be something in it for the rep. That is yielding some additional backup treatment teams. And I'm hopeful that will offset some of the seasonality we saw. There's also seasonality, I think, by patients deciding at certain times of year they would rather not be treated. They'll postpone treatment or postpone getting started. That is difficult for us to impact. But for those aspects we can impact, specifically maintaining capacity in terms of trained teams, we're doing what we can. But again, getting back to the core of your question, what assumptions are we utilizing given we're already at a run rate to hit to hit guidance, we're assuming we see the same level of seasonality as last year. And again, that might be overly conservative, but I think it's best to guide that way and also be clear about our assumptions underlying the guidance.
Moderator: Appreciate that, Keller. Thank you. Thank you. Thank you.
Conference Operator: The next question comes from John Noonan, please go ahead.
John Noonan: Hi. Thanks for taking my follow-up. I had a question about the recent data that you were just discussing earlier on the breast cancer work that was done in Europe. It was interesting. I noticed that the median number of cycles was one, and I'm wondering if if you think that's representative of what we'll see going forward when you test this treatment in perhaps a different set of breast cancer patients, and also whether that median one cycle may have just been limited by either patient survival or just physicians that maybe hadn't had a lot of experience with the treatment.
Gerard: Thanks. Yeah, I will note that the clinical protocol calls for two. treatments, so I would think that would be the median when the trial reads out. In terms of why they only received one, I have some theories, but let me ask Goliath a comment.
Goliath: Yeah.
Voyo: As Gerard mentioned, this was not a prospect with Kyle. This is basically reflecting data from real-world clinical practice. And the practicing physicians were probably making decisions which they thought in the absence of any guiding data are the best for the patients. And just to remind you, these were heavily pre-treated patients with a median of four prior treatments, quite exhausted with lots of residual toxicities. And I think physicians were probably being cautious and trying to manage the disease, perhaps not to achieve the best possible efficacy, but rather to control the disease and prolong patients' lives, which would be typical of the treatment goal, you know, after first or second line. So I think that the median number cycle simply reflects the different treatment objectives compared to if you treat patients at an earlier stage in the patient journey.
Moderator: Great. Thank you. Thank you.
Conference Operator: The next question comes from Yale Jen with Lido and Company. Please go ahead.
Yale Jen: Good morning, and thanks for taking the questions. You refer in the press release that you have 36% volume growth year-over-year of the same quarter. I just wonder whether if you compare to the fourth quarter of last year, what that readout might be, and then I have a follow-up.
Moderator: Sandra, do you have the quarter-on-quarter growth off the top of your head? Volume growth? Sandra, you might be on mute.
Sandra: Apologies, you're correct. I was on mute. I want to say we're mid-20% volume growth from Q1 2026 over Q4 2025.
Yale Jen: Okay, great. That's very helpful. Maybe just a follow-up here that we know that the referral obviously is the long-term sort of expansion sources. So we know that you guys already started the process. And just curious, what would be the measurement or other sort of follow-up to track how the referral practice being done and, you know, improvements if needed, so on and so forth? So any colors on that front? And thanks.
Gerard: Yeah, it's interesting that you asked that question because it's something I've grappled with Kevin. Because what we want to do is incentivize our oncology managers to get the referrals going. It is somewhat difficult to know when a patient shows up at a center because obviously we have to be HIPAA compliant. You can't exactly quiz the doctor on where did this patient come from, that sort of thing. And so it's difficult to know, hey, did our referral process lead to this specific patient? We definitely know of cases, many, many cases, where the work of the oncology manager resulted in a patient ending up at one of our treating centers. So it is working. In terms of measuring it on a specific metric, you know, we're grappling with an accurate metric. We're grappling with that ourselves. How do we follow that? We have some ideas, but right now I can't point to a specific way we're going to measure that. And it's unlikely that we're going to be able to tell you, you know, ever get to the point where we can say, hey, if X percent of our patients or the rate of referral is Y per site, I don't think we'll ever get there. Because, again, it's HIPAA compliant. You know, you can't quiz the docs. But we're focused very, very much on it.
Yale Jen: Okay, great. That's very helpful and thanks and congrats.
Conference Operator: Thank you. The next question comes from Charles Wallace with HCW. Please go ahead.
Charles Wallace: Hi, this is Charles on for RK from HCW. Thanks for taking my questions. So the first question I have is I was curious for the Chopin publication ESMO clinical practice guidelines. Are you seeing these two publications translate into increased physician adoption in Europe? I know it's a little early, but should we expect kind of ChemoSat to grow in 2026 from these?
Gerard: Yeah, I think the European growth is significantly hampered by reimbursement issues. I think many centers in Europe, you know, are doing, you know, a combination type regime. Um, but to be frank, a lot of European centers are, a lot of European oncologists are less aggressive than they are in the U S. Um, But I can't really comment as to whether or not I think it's going to grow to increase revenue in Europe in the long term. Certainly for this particular year, I think we just have to assume that we're going to see probably modest single digit growth in Europe. What will change that is getting reimbursement in the UK, which we've been working on for quite a while. as well as, you know, establishing commercial businesses in Spain, France, and Italy, and we're working hard on that as well. In terms of the overall impact on the business, given the price point in Europe, I wouldn't call it a rounding error, certainly, but, you know, it's a plus or minus 10% thing on EBITDA for the business. It's not a huge driver, but we're focused on Europe, as I've mentioned before, primarily, at least for the short to medium term, as areas where we can generate data. The device is approved to deliver melphalan to the liver. It is not tied to a specific tumor type. Now, most of the usage is in uveal melanoma because that's where most of the data is. But it's a great place to generate, run IITs and generate data in other tumor types. So right now, Europe's importance is generation of data. We manage it on a break-even basis. At some point, we may relaunch the product as a combination drug device, as a Hepsado, and try to reset the price point, but that's many, many years down the road.
Charles Wallace: Yeah, thank you for all the color. I guess one more follow-up from me. So on the pipeline for NCRC, I think you mentioned that there's 13 sites, but it's been slower than expected enrollment with, I think you said, seven patients. So I was just curious when you expect enrollment to pick up and ultimately complete for this study. Thank you.
Moderator: Sure. Boyo, do you mind taking that?
Goliath: Sure.
Voyo: You're correct. We have opened 13 sites, and we have enrolled thus far seven patients. Based on the momentum that we've observed over the last several months, we feel confident that the momentum both in terms of site openings and patient screening and enrollment is picking up. So, we believe that enrollment will proceed in this year and next year, and that we'll be able to share interim results publicly by the end of next year, 27.
Moderator: Great. Thank you for taking my questions. Thank you.
Conference Operator: We have reached the end of the question and answer session, and this concludes today's conference, and you may now disconnect your lines. Thank you all for your participation.
