Good day, welcome to the Delcath Systems fourth quarter and full year 2022 financial results conference call. All participants will be placed 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 your touch-tone phone. To withdraw from the question queue, please press star then two. Please note this event is being recorded. I would now like to turn the conference over to David Hoffman, Delcath's General Counsel. Please go ahead.
Once again, welcome to Delcath Systems fourth quarter and full year 2022 earnings call. With me on the call are Gerard Michel, Chief Executive Officer; Dr. Johnny John, Senior Vice President of Medical Affairs and Clinical Development; Kevin Muir, Vice President of Commercial Operations; John Purpura, Chief Operating Officer; and Anthony Dias, Vice President of Finance. 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 earnings 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. We have had a very productive four months since our last earnings call. Highlights include the resubmission of the HEPZATO NDA on February 14th and the subsequent receipt of the PDUFA date of August 14th from the FDA, the announcement of significant financing with high-quality investors, and the continuation of a steady stream of publication for both commercial usage and clinical investigation of CHEMOSAT in Europe. On February 14th, we filed the NDA resubmission for HEPZATO. And on March 20th, the FDA determined that resubmission constituted a complete Class 2 response and set up the PDUFA date of August 14th. We look forward to working with the FDA through the review process of our resubmission.
Since I know I will be asked, at this time we do not know whether the application will be the subject of an AdCom, but we will continue to prepare for one unless we receive notification otherwise. Obviously, receiving the FDA acceptance was a major milestone for the company, and it represents a culmination of many years of hard work by Delcath employees, our various partners, investigators, and patients. Today, we announced a private investment in public equity, or PIPE, deal with healthcare-focused institutional investors as well as existing investors that will provide up to $85 million in gross proceeds, including $25 million of upfront funding upon closing. The financing was led by Beagle Capital, with participation from Logos Capital, BVF Partners, Stonepine, and Serrado Capital, as well as existing investors, including Rosalind Advisors.
We are grateful for the participation of our existing investors and are delighted to have the financial backing of an additional set of investors. The new investors are well-known, long-term healthcare-focused funds who conducted an extended amount of due diligence on clinical, regulatory, commercial, and other topics before deciding to invest in Delcath. Their support validates the clinical relevance of and the commercial opportunity for HEPZATO in metastatic uveal melanoma. We believe the aggregate funding will fully support the commercial launch of HEPZATO, if approved, and take us to profitability without having to raise additional capital. The structure was designed to remove financing overhang, something that is often an issue in normal economic environments and is greatly exacerbated in the current environment. There is always a trade-off between fully financing a business and dilution.
I think it is important to note that we will manage our business prudently with an eye towards building shareholder value through generating and growing cash flows. Given our likely operating margins and the anticipated uptake of HEPZATO, we likely can generate positive cash flows within a relatively short period after launch. In addition to the press release on this financing, further details of financing, including the impact of on common shares and warrants outstanding upon the conversion of preferred stock, is outlined in our current investor presentation, which can be found on our website. Tony will also cover this in greater detail in his section of the call. On February 16th, we announced that the Board of Directors voted to appoint John Sylvester as a new Chairman of the Board.
Mr. Sylvester has served as Director since July 2019 and has extensive experience in, experience building interventional oncology businesses, including senior commercial roles at BTG and most recently serving as Chief Executive Officer of both Curium SPECT and International business units. Mr. Sylvester will replace Dr. Roger Stoll, who has served as Chairman since October 2015, and will continue to serve as an active member of the Board of Directors and on various committees. We thank Roger for his many years of leadership at the company and are grateful for his continued service with the company. We look forward to Mr. Sylvester's guidance as the company prepares for a possible HEPZATO launch in the U.S. In the U.S., we currently have enrolled three Expanded Access Program treatment sites or EAP.
In addition, we have four more sites reviewing their agreements, and Mayo Jacksonville and Mayo Rochester are undergoing start-up activities. We currently have eight patients at one participating site which has completed 20 cumulative treatments across the patients. While we have not aggressively pursued EAP sites or put in place patient referral networks, we are now in the process of hiring a contract MSL team to support our EAP efforts and start building those referral networks. In February, a publication was presented which updated safety and efficacy results from the phase I portion of the CHOPIN trial. The updated published results for seven patients with advanced uveal melanoma treated with CHEMOSAT and ipilimumab plus nivolumab showed a median progression-free survival of 29.1 months and a median follow-up time of 29.1 months.
At the time of publication, all patients were still alive, three of four patients who subsequently experienced progressive disease continued with treatment in the form of repeated melphalan PHP treatments delivered by CHEMOSAT. The ongoing randomized phase II portion of the CHOPIN trial, comparing melphalan PHP alone with melphalan PHP plus Ipi/Nivo, which will include another 76 patients, 38 per arm, is approximately 50% or more enrolled. We eagerly await the publication of interim results potentially late this year from the phase II portion of this study. This should provide critical information about the potential utility of CHEMOSAT or HEPZATO used in sequence with immune checkpoint inhibitors. Finally, in December, the results of a single-center study in the treatment of cholangiocarcinoma were published in the journal Clinical and Experimental Metastasis.
The study was a retrospective analysis of 17 patients who underwent a total of 42 procedures in CHEMOSAT and melphalan between October 2014 and September 2020 at the Hannover Medical School in Germany. The aim of the retrospective monocentric study was to analyze PHP with CHEMOSAT as a palliative treatment for unresectable liver dominant cholangiocarcinoma. Based on the results of the study, the authors concluded that percutaneous PHP- CHEMOSAT is an effective and safe treatment option for patients with advanced cholangiocarcinoma and has the potential to prolong life in patients with inoperable treatment-refractory liver metastases.
The authors highlighted the increasing importance of locoregional forms of therapy in the treatment of cholangiocarcinoma and that the new addition of the German S3 cancer guidelines, diagnostics, and therapy of pancreatic adenocarcinoma and biliary carcinomas now includes PHP with melphalan for the treatment of both inoperable intrahepatic cholangiocarcinoma and extrahepatic cholangiocarcinoma liver metastases. That completes my prepared remarks. I look forward to taking questions after Tony reviews the financials. Tony?
Thank you, Gerard. Product revenues for the three months ended December 31st, 2022, was approximately $639,000, compared to $246,000 for the prior year quarter from the sales of CHEMOSAT in Europe. In the fourth quarter of 2022, the company was selling direct, it's not comparable to the fourth quarter of 2021, in which we generated product revenues with our European distributor on a revenue share arrangement. Other income of $1.9 million for the fourth quarter of 2021 was related to the acceleration of the amortization of the license agreement with medac, which ended in December 2021.
Research and development expenses for the quarter increased to $4.4 million, compared to $3.6 million in the prior year quarter, primarily due to higher professional service costs relating to the preparation of our NDA resubmission, which occurred on February 14, 2023. Selling, general, and administrative expenses for the quarter was approximately $3.8 million compared to $3 million in the prior year quarter. The increase was primarily due to high headcount-related costs, such as share-based compensation expense. On December 31, 2022, the company had cash equivalents and restricted cash totaling $11.8 million as compared to cash equivalents and restricted cash totaling $27 million on December 31, 2021.
During the year ended December 31, 2022 and December 31, 2021, we used $25 million and $22.6 million, respectively, of cash in our operating activities. Use of cash and operating activities partially offset by two private placements during 2022, resulting in net proceeds of $10.9 million. On March 15, 2023, we returned to Avenue the $4 million held in restricted cash to pay down a portion of our outstanding loan balance. On December 13, 2022, the company closed a private placement for the issuance and sale of approximately 1.5 million shares of common stock and approximately 692,000 shares of pre-funded warrants to purchase common stock at market price. The company received gross proceeds from this private placement of approximately $6.2 million before deducting offering expenses.
Today, we announced that the company has signed a securities purchase agreements with healthcare-focused institutional investors that will provide up to $85 million in gross proceeds to Delcath through a private placement that includes initial upfront funding of $25 million. The company will issue approximately $25 million in shares of Series F convertible preferred stock and two tranches of warrants that are exercisable for shares of Series F convertible preferred stock. The Series F convertible shares are convertible into approximately 7.6 million common shares, and has an effective price per share of $3.30. The first tranche of warrants has an aggregate exercise price of approximately $35 million, or $4.50 per share, and exercisable until the early of March 31, 2026, or 21 days following the company's announcement and receipt of FDA approval for HEPZATO.
In the second tranche of warrants has an aggregate exercise price of approximately $25 million or $6 per share, and exercisable until the early of March 31, 2026, or 21 days following disclosure of the company's public announcement of recording of at least $10 million in quarterly U.S. revenues from the commercialization of HEPZATO. As Gerard mentioned, these details are contained in our corporate presentation, which is on our website and has been filed as an 8-K. That concludes my financial remarks, and I ask the operator to open the phone lines for Q&A. Can you please check for questions?
Thank you. 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're using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster. Our first question comes from Scott Henry with ROTH Capital. Please go ahead.
Thank you. Good afternoon, and congratulations for just a lot going on, in the past day or so, or the past few days. A couple questions I had. First, with regards to the PDUFA date, if you did get approval on that date, about how long would it take between approval and product availability?
I think the fastest would be about three weeks, and it might take as long as six. You know, the gating item, I think you know this pretty well, Scott, is not necessarily having product per se, but having labeled product on hand. We can do that pretty quickly at our site in Queensbury, but our partner, Neopharma, who manufactures the melphalan, they'll need to label that with the FDA-approved label, get it through their QC processing, and give it to us. John Purpura, our COO, has already negotiated with them for them to hold some, I think it's called bright stock, in hand, a broken sublot which they normally wouldn't do, so we can do that quickly. I think three to six weeks is probably the range that we'll shoot for.
Okay, great. When product is available on the market, would you expect to book revenue simultaneous with product usage? Sometimes there's a lag, and just trying to get a think of how we should think about potentially late 2023 revenues.
Sure. We're gonna sell direct. We're not gonna go through AmerisourceBergen or Cardinal. There won't be any stock in to the wholesalers or anything like that. You know, given the specialty product and the volumes we're talking about, that wouldn't make much sense. I think, really, the revenue is gonna be one of two models. One is it's gonna be on consignment, and then when they use it, we'll book it. Alternatively, you know, they won't be on consignment, and we'll book it as soon as it's shipped to them, and they buy it. Either way, I think the revenue-- I don't think any hospital's ever gonna be carrying a lot of inventory of this. I think the booking the revenue is gonna track very closely with the actual usage or procedures with the patients.
You know, unlike, you know, a more typical, infused therapy or a pill where, you know, you have a fair amount of inventory purchased and held by wholesalers.
Okay, great. With regards to build out of reps, could you give us a sense of, you know, when you would start to hire people and approximately how much, you know, reps or marketing liaisons or, you know, how many employees would you expect to have in that unit?
Yeah. In terms of the overall field force, you know, Kevin Muir and I have been talking about probably something in the range of eight reps. The current thinking is, you know, four of those, roughly. A gain, this could evolve, will be more focused on medical oncologists and kind of pulling patients into or pushing patients into the referral networks. Then for medical device types, we're very familiar with interventional oncology, and they'll be kind of centered around the actual treating centers. Then those two reps will kind of partner together to help develop referral networks as well as open new sites. I think all told about eight of those. We're just recently signed a contract with a company to help us build a modest-sized medical science liaison sales force.
I'm hoping to have the first of them out there in, well, this is like kind of an estimate, maybe as soon as two months, hopefully sooner. They'll start calling on medical oncologists' pre-approval to try to establish those referral networks, so maybe two or three of those. All told, you know, even taking into account training, et cetera, I don't see having more than, let's say, 12 to 15 people in the field upon launch.
Okay, great. I'll just finish it up with a couple modeling questions. First, a lot of moving levers, shares outstanding. It looks like it'll be about 10.1 million in Q1, jump up to 18-ish in 2Q, and then, you know, we'll deal with the warrants when that stuff happens. Is that assumption correct?
Yeah. If you take a look at the, I think slide 36 of the investor presentation we just updated today and it's on the website-- O n an as converted basis, you know, the Series E and E1s and the pre-funded warrants, all of which are just plain vanilla. They're there simply as blockers for Rosalind, who doesn't wanna go over 9.9%. That totals about $12.7 million equivalent common. The deal we did today, if those preferred or announced today, when those Series Fs convert, that'll be about another $7.6 million shares. In total, a bit over $20 million, about $20 million shares.
Okay, great. Just the final question, could you just give me a estimate of pro forma cash and debt after everything kinda has went through the system here?
Okay. Knew someone would have to ask me a hard question. I think about $23.5 million came in, will come in net from the deal we did today. We were on, you know, getting kind of low, but and we paid back $4 million of Avenue debt. This is probably about, I'd say, let's call it about $24 million on the balance sheet now. In terms of overall debt, there is probably about, I'll call it $9 million of debt that we still owe Avenue. And there's another maybe $2 million or so of that that is owed to Rosalind. That, the Rosalind convertible debt is essentially equity, and that'll convert at about $11 per share.
That's probably about the best way to think of that, it's about another 200,000 shares there. In terms of debt that we really have to pay back, it's roughly $9 million right now.
Okay, great. Thank you for taking the questions.
Sure.
Our next question comes from William Maughan with Canaccord Genuity. Please go ahead.
Hi, good afternoon. Congrats on the acceptance. Now with some more clarity on your financial outlook for the next few quarters, does that update your plans for your EAP? If you could just run through those numbers in terms of how many patients you expect to have on around the time of launch and how many sites you expect to have up and running at that point.
Yeah, I hesitate to... I can tell you what I, you know, what I'd like to see happen with the EAP. It really is we're gonna really start testing it once we get some people out in the field, talking to these treating centers that, from which we want to have patients referred to our treating sites. In terms of how many sites we have now, we have three that are open, really just one enrolling. The other two, we're trying to get them coordinated to get trained, but if a patient shows up, they will be trained. Then we have another three, Thomas Jefferson, Stanford, Ohio, you know, we're having discussions with. The Mayo Clinic has two sites, and they're probably the most aggressive in terms of trying to get themselves up and running.
I'd say on the conservative side, it would be five EAPs up and running at launch, and probably on the more aggressive side, up to eight or nine. In terms of, you know, how many patients we'd like to see in the network, I mean, ideally, we'd be getting maybe one patient every other week, which is not a lot, but, you know, I think it'll take approvals before we start getting it flooded. If we had one patient every other week, let's say at six centers, you know, that would be a run rate of about, I don't know, $10 million if they, if that ran right into, you know, as soon as we launched, they became paying customers, $10 million a quarter.
Yeah, that's, we'll have to see how it, how it proceeds. Again, I think, you know, one way to look at it, I think is, you know, count the number of centers we have. I think a good healthy clip, probably not out of the gate, would be one a week. Then eventually we try to peak towards, you know, 20 centers and, you know, one to two a week, as we ramp up.
Thanks. Now looking just over at the overall, you know, MoM market, there is a convenient, you know, comp in, you know, a competitive launch that's going on now. When you look at, you know, HEPZATO versus KIMMTRAK, you know, is there a drawback that says that the kind of numbers that KIMMTRAK is putting up are out of reach for you guys? Or do you think that what they're putting up is, you know, the kind of blue sky for HEPZATO?
Yeah. I think a couple of dynamics at play there. The first is what they did in the fourth quarter was $38 million in the U.S., $50 million globally. In the U.S., we just focused on that, they're doing at about $152 million or so, I think, or $174 million in revenue, which is fantastic for them on an annualized basis in the U.S. That probably represents 1/2 of the market that they have available. It's a little hard to tell. They have about 350 patients, we estimate, available to them. We have about 800 because of the specific HLA phenotype.
If we did, you know, if we were priced exactly equivalently, you know, we could do slightly under 1/2 the penetration in our TAM as them and get the same type of revenue. We're not saying we're gonna price exactly the same. I think many of you heard me just throw out $150 as $ 100K a kit as a placeholder, which is probably about 3/4 of the price point, give or take. We'll just leave that as a placeholder for the time being. It's clear that, you know, what they need to do is get product into, I don't know how many centers they have, but let's call it 100 centers and patients.
Most patients will be able to drive and get their treatment, and their, you know, medical oncologist who's managing them probably doesn't really need to send them anywhere too far. The difference with us is we're gonna have to get patients, most of them are gonna have to get on an airplane, and we're gonna have to get their medical oncologist to refer them out. It is not always so easy to get docs to refer patients out. you know, we have to, at least on their own, we have to get in front of those docs and get them aware of HEPZATO and get them plugged into a referral network with one of, you know, a number of the treating centers.
I expect the uptake from that perspective to be slower in terms of patient build, but I don't think the ultimate peak sales are gonna be blunted whatsoever from that process. I think the data we have is quite strong. The need to get on an airplane or drive a long ways, every two months, I don't think it's really that much different than having weekly to go get an infusion. I think the issue will be, you know, we'll have to build the referral networks. I do think on a patient volume basis, it'll be slower, but I also believe on a TAM basis, you know, we have pretty much twice as much as what they have. Lastly, I'll say, I don't think the business they're getting is dramatically reducing the potential for us.
I think these products are complementary. Patients who get this disease, eventually, in most cases, succumb to liver failure. They're liver mets. Systemic mets do show up. I think patients will sequence through both of these therapies. It's a good thing for patients that they're both available. I don't know if that fully answers your question, Bill, or not.
It does. I appreciate it. Thank you.
Our next question comes from Ramakanth Swayampakula with H.C. Wainwright & Co. Please go ahead.
Thank you. Good afternoon, Gerard, and congratulations.
Thank you RK .
One quick question from me. With HEPZATO, the surgeon or the physician needs to learn the procedure as well. How, you know, how easy is it to learn the procedure? Also, would you be having any training centers so that you can increase that option beyond the initial centers who are involved in the study?
Yeah. Thanks for that question, RK. You know, no particular step in this procedure is technically difficult for the interventional radiologist or the anesthesiologist who's there or the perfusion technician. What's important is that these things are done in a coordinated fashion. That really is, will be the focus of training. It doesn't make sense for us to put together a, you know, a training center because I don't think we'll have that volume of doctors who need to be trained. You know, I know when I was at Vericel, we would do, for lack of a better phrase, you know, pop-up training centers where we would bring in a bunch of, you know, cadaver knees for, you know, to use the cell therapy product, that CartiLife unit, and we'd have, you know, 40 docs come in.
I don't think that type of thing will work here. I think what we will do is, have didactic training, online that they can go through, and it'll be broken up by a team member. They will either attend the case, either directly or virtually watch a case. We'll set up probably both of those mechanisms for them. We will have, a proctor come in, and the first case that is done will have someone proctor it. We will likely have our own person who's capable of proctoring as well to augment that. It'll be a mix of all of those. It'll start with didactic training.
We will have them do it virtually or see a case or travel to see a case, we'll have a proctor sit through the initial case for the team. We will have somebody pretty much in every procedure until we're confident that the team has it down. Again, we don't need to do any technical type, those very difficult technical portion of this. It's really a matter of making sure that the filters come out at the right time, the balloons go out at the right time, the blood pressure is managed in the right way at the right time. Again, it's a matter of coordination, not technical difficulty.
Okay. Thank you for that. The second question is, in terms of the CHOPIN study, you know, you said there will be an update later this year. That's an IIT at this point. Would you take it under your wing once you get the approval for HEPZATO?
I think we hadn't really considered transitioning, and I don't know I've never been involved where you actually transition an IIT. In terms of a sponsored trial for a combination of immuno-oncology agents and HEPZATO or CHEMOSAT, that's definitely something that we're very interested in doing, whether or not it's in this particular indication, metastatic ocular melanoma, or another indication where IO is reviewed. I think it's definitely top of the list. On the top of, you know, top two or three things that we want to do is to continue to explore, you know, immuno-oncology agents in combination with HEPZATO. I've talked about this before, you know, there's a compelling rationale for that.
You know, a side effect of the product, which, you know, one could say was a bad thing, is actually a good thing, and that's the local hepatic myeloablative effect that really resets the tumor microenvironment in the liver that ends up having probably systemic effects. Yeah, we will definitely take under our wing the idea or of some type of trial or trials combining our treatment with combination immunotherapy.
Very good. Thank you. Thank you for taking my questions.
Thank you.
Our next question comes from Yale Jen with Laidlaw & Company. Please go ahead.
Good afternoon and congrats on all the developments recently.
Sure.
Just a couple of quick ones. The first one is that, in terms of the financing, the remaining, committed of $65 million or $60 million, what sort of milestone that is, was anticipated, and, expected so they will move the, those, funding forward?
Sure. We just got a $25 million, or right now it's as we speak, it's being wired in, a $25 million financing. The first warrant tranche will be for about 7.8 million warrants that are exercisable at $4.50, which is about $35 million. Those are three-year warrants. However, the expiry of the warrant gets accelerated once we're approved to 21 days after approval. Essentially, the warrant holders need to exercise that warrant once we're approved. That's the first milestone should yield $35 million in gross financing. Once we achieve $10 million in gross revenue in a quarter, that will trigger a second accelerated expiry to within 21 days of us announcing that.
That will yield a little under 4.2 million warrants priced at exercisable at $6 a share, and that's another $25 million to the business. That's why we think in aggregate, if things go according to plan, and we know things don't always go according to plan. If things go according to plan, and we have a bit of cushion here, we should be able to get to cash flow positive without having to do any more financing.
Okay, great. That's very helpful. The next question is that you and I talked about beforehand that, you know, talk about the pipeline development and given what the cash you may have going forward, certainly many of those can be executed. Have you sort of set up some sort of priority and, you know, the region, the area to explore in terms of the pipeline development, other indications, for example?
Yeah. We, we have, you know, three areas that we're very interested in. ICC, because there's tremendous interest in investigators, especially in Europe for that, it's really the large unmet need there. That's another orphan indication. Colorectal because it's the number one, metastatic, you know, liver metastatic cancer. There are a number of settings we can go with there. The third is kind of a more of a basket area of liver mets, where the primary cancer is being treated, with IO agents. Now, in terms of how quickly we can get to that, our hands are rather, you know, rather full at the moment, prepping for an AdCom, answering or being ready to answer FDA information requests, as well as prepping for launch overall.
I think we'll have to build out the team with all that on our plate before we can aggressively pursue other indications. With that said, we will do work such as advisory committees, exploring some of these ideas, trying to write some protocols, get those down on paper. Even if we move with reasonable speed, it probably would be a good one year or so before we could spend any significant amount of monies on that from where we are right now. I think the shorter answer is we'll be planning and planning for one or all of those three areas I just discussed. In terms of actual impact on, you know, our P&L and increasing our burn in the R&D area, it would be at least one year out.
Okay, great. That's very helpful. Maybe the last question is that given that you take back the European sales, do you anticipate with the potential approval in the United States going forward, you may be able to increase the price for the product and maybe just increase the revenue in that regard as well? Thanks.
Yeah. Yeah, I think as you probably know, it's tough to move prices up in Europe once they're set. You know, we're not approved yet, excuse me, for reimbursement in the U.K. We're new there. That'll probably be the first test to see how far we can move things up from where it is now. Germany, the price is set. It would be kinda hard to move it up too much. It is a very difficult situation that the price will be, not surprisingly, quite a bit lower for the device standalone in Europe versus the combination drug device in the U.S. There are advantages for how we're approved in Europe, given that it's a CE Mark, and the CE Mark is for the use of CHEMOSAT to deliver melphalan delivered.
It is tumor agnostic, and that gives us a bit more flexibility in terms of developing the product and doing smaller trials and such, and letting investigators use it on their own where they think it's applicable, and having open conversations about it. It's, you know, you've noted the amount of data coming out of Europe, without us really doing much besides supplying product. That will likely continue to happen in a variety of different cancer types, which might yield benefits in the U.S. given that, you know, small publications, although they're not gonna get you labeled for use, and we are not going to promote based on small publications, doctors do note it, and it can lead to reimbursement if the doctor believes it's worth a shot.
You know, we have ICC publications that come out because of the independent work of investigators. Again, that's partly driven by the CE Mark used for in any cancer, and you know, we've had usage in breast cancer and a number of other things that look promising. It may be that that is just a source of publications for us despite the low price. You know, we may end up being very happy with just the data that's getting generated, you know.
Okay, great. again, congrats and great job so far.
All right. Thank you very much. You're welcome for the questions.
This concludes our question and answer session. I would like to turn the conference back over to Gerard Michel for any closing remarks.
Yeah, thank you. I appreciate everyone's questions and attention today. I'd like to thank our existing and new investors who've gotten involved with the business. You know, without those folks, we'd be nowhere. I look forward to speaking to everyone in about two and a half months with another update. Have a good evening.
The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.