Delcath Systems, Inc.

Good day and welcome to the DELCAS 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, DelCast General Counsel. Please go ahead.

Thank you. And once again, welcome to DelCast 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 Diaz, 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. I'd like to conclude the resubmission of the Hesado NDA on February 14th. and the subsequent receipt of the DUCA 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 from both commercial usage and clinical investigation of chemosat in Europe. On February 14th, we filed the NDA resubmission for Hipsado, and on March 20th, the FDA determined the resubmission constituted a complete class 2 response and set up the DUCA 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, many years of hard work by Delcat 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 in upfront funding upon closing. The financing was led by Bevo Capital, with participation from Logos Capital, BBF Partners, Stone Pine, and Serato Capital, as well as existing investors, including Roslyn 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 DELCAT. Their support validates the clinical relevance of and the commercial opportunity for Hepsado and metastatic ophthalm melanoma. We believe the aggregate funding will fully support the commercial launch of Pepsado, 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 Hubsado, 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 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 their new chairman of the board. Mr. Sylvester has served as director since July 2019 and has extensive experience building interventional oncology businesses, including senior commercial roles at BTG, and most recently serving as Chief Executive Officer of both Kiram Spec 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 actor member of the Board of Directors and on various committees. We thank Roger for his many years of leadership of the company and are grateful for his continued service with the company. And we look forward to Mr. Sylvester's guidance as the company prepares for a PASO-Hexato launch in the U.S. In the U.S., we currently have enrolled three expanded access program treatment sites, or EAPs. In addition, we have four more sites reviewing their agreements, and Mayo-Jacksonville and Mayo-Rochester are undergoing startup 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 one portion of the Chopin trial. The updated published results for seven patients with advanced serial melanoma treated with chemosat and ipilimumab plus nivolumab showed a median progression pre-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, and 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 two portion of the CHOPAN trial comparing melphalan-PHP alone with melphalan-PHP plus ipinivo, 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 two portion of this study. This should provide critical information about the potential utility of chemoset or Hepsado 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 of chemosat and melatonin between October 2014 and September 2020 at the Hanover 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 with 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 local regional forms of therapy in the treatment of cholangiocarcinoma and that the new addition of the German S3 cancer guidelines, Diagnostics and Therapy of Hepatocytic Carcinoma and Biliary Cancer Carcinomas, now includes PHC with melform for the treatment of both inoperable intrahepatic cholangiocarcinoma and extrahepatic cholangiocarcinoma liver metastases. That completes my prepared remarks, and I look forward to taking questions after Tony reviews the financials. Tony?

Thank you, Gerard. Product revenues for the three-month end of December 31, 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, and it's not comparable to the fourth quarter of 2021. which we generated product revenues with our European distributor on a revenue share arrangement. Another income of $1.9 million for the fourth quarter of 2021 was related to the acceleration of amortization of a 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 high professional service costs relating to the preparation of INDA 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 higher headcount-related costs, such as share-based compensation expense. On December 31, 2022, the company had cash, cash equivalents, and restricted cash, totaling $11.8 million, as compared to cash, cash equivalents and restricted cash, totaling $27 million in December 31st, 2021. During the year ended December 31st, 2022, and December 31st, 2021, we used $25 million and $22.6 million, respectively, of cash in our operating activities. The use of cash in operating activities is partially offset by two private placements during 2022, resulting in net proceeds of $10.9 million. Also, 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 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 agreement with healthcare-focused institutional investors. They'll provide up to $85 million in gross proceeds to DELCAS through 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 31st, 2026, or 21 days following the company's announcement of the receipt of FDA approval for Exato. And the second tranche of warrants is an aggregate exercise price of approximately $25 million, or $6 per share, and exercisable until the early of March 31st, 2026, or 21 days following disclosure of the company's public announcement a recording of at least $10 million in quarterly U.S. revenues from the commercialization of EBSATO. As Gerard mentioned, these details are contained in our corporate presentation, which is on our website and has been filed as an AK. That concludes my financial remarks, and I ask the operator to open the phone lines for Q&A. And 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, and 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. And, you know, the gating item, I think you know this pretty well, Scott, is not having, not necessarily having product per se, but having label product on hand. We can do that pretty quickly at our site in Queensberry, but our partner in your pharma who manufactures the milk blend, they'll need to label that with the FDA-approved label, get it through their QC processing, and give it to us. John Prafar, our COO, is already in the negotiated with them to hold some, I think it's called Brightstock, in hand, a sub-lot, which they normally wouldn't do, so we can do that quickly. But I think three to six weeks is probably the range that we'll shoot for.

Okay, great. And 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. So we're going to sell direct. We're not going to go through Ms. Kessinger or Cardinal. So there won't be any stock in to the wholesalers or anything like that. You know, given this specialty product and the volumes we're talking about, that wouldn't make much sense. So I think really the revenue is going to be one of two models. One is it's going to be on consignments. And when they use it, we'll book it. Or 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 is ever going to be carrying a lot of inventory of this. So I think the booking the revenue is going to track very closely with the actual usage or procedures with the patients. You know, unlike, you know, a more typical situation, infused therapy or a pill where you have a fair amount of inventory purchased and held by wholesalers.

Okay, great. And then with regards to build out of reps, could you give us a sense of when you would start to hire people and approximately how much reps or marketing liaisons or how many employees would you expect to have in that unit?

Yeah, so in terms of the overall field force, Kevin and I have been talking about probably something in the range of eight reps. And the current thinking is four of those, roughly, and this could evolve, will be more focused on medical oncologists and kind of pulling patients in or pushing patients into the referral networks. And then four medical device types who are very familiar with interventional ontology, and they'll be kind of centered around the actual treating centers. And then those two reps will kind of partner together to help develop referral networks as well as open new sites. So I think all told about eight of those. We just recently signed a contract with a company to help us build a modified medical science liaison sales course. I'm hoping to have the first of them out there, and this is kind of an estimate, maybe as soon as two months, hopefully sooner. And they'll start calling on medical oncologists pre-approval to try to establish those referral networks. So maybe two or three of those. But 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. And 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 Q2, and then we'll deal with the warrants when that stuff happens. Is that assumption correct?

Yeah, if you take a look at the – slide 36 of the investor presentation we just updated today and from the website. On an as-converted basis, you know, series preferred E and E1s and the pre-funded warrants, all of which are just plain vanilla. They're there simply as blockers for Roslyn who doesn't want to go over 9.9%. That totals about $12.7 million equivalent common. The deal we did today, if those are announced today, When those preferred Fs convert, that'll be about another 7.6 million shares. So in total, a bit over 20 million shares.

Okay, great. And then just the final question, could you just give me an estimate of pro forma cash in debt after everything kind of has went through the system here?

Okay, some would have to ask me a hard question. So 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 we paid back $4 million of Avenue debt. So 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 Roslyn. But the Roslyn convertible debt is essentially equity. And that will convert it to about $11 per share. So that's probably about the best way to think of that. It's got another 200,000 shares there. So 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.

Our next question comes from Bill Mahe with Kinecord Genuity.

Please go ahead.

Hi. Good afternoon, and congrats on the acceptance. So now with some more clarity on your financial outlook for the next few quarters, does that update your plans for your EAP? And 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 can tell you what I'd like to see happen at the EAP. We're going to really start testing it once we get some people out in the field talking to these treating centers from which we want to have patients referred to our treating sites. But 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, and the Mayo Clinic has two sites, and they're probably the most aggressive in terms of trying to get themselves up and running. So 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 how many patients would we like to see in the network, ideally we'd be getting maybe one patient every other week, which is not a lot, but I think it'll take approval before we start getting it flooded. But if we had one patient every other week, let's say at six centers, that would be a run rate of about oh, I don't know, $10 million, if that ran right into, you know, as soon as we launched, that became paying customers, $10 million and a quarter. Yeah, we'll have to see how it proceeds. But 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. And then eventually we try to peak towards, you know, 20 centers, and, you know, one to two a week as we wrap up.

Thanks. And 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, Hepsado versus KimTrack, you know, is there a drawback that says that the kind of numbers that KimTrack is putting up are out of reach for you guys? Or do you think that what they're putting up is is the kind of blue sky for Hepsado.

Yeah, I think there are 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. But in the U.S., we just focused on that. They're doing at about $152 million or so, I think, or $174 million globally. in revenue, which is fantastic for them on an annualized basis in the U.S. That probably represents half 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 this specific HLA phenotype. So if we did, you know, if we were priced exactly equivalently, you know, we could do slightly under half the penetration RTEMs them and get the same type of revenue. Now, we're not saying we're going to price exactly the same. I think many of you have heard me just throw out 150 as a placeholder, which is probably about three-quarters of the price point, give or take. We'll just leave that as a placeholder for the time being. It's clear that 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. Most patients will be able to drive and get their treatment, and their medical oncologist who's managing them probably doesn't really need to send them anywhere too far. The difference with us is we're going to have to get patients, most of them are going to have to get on an airplane, and we're going to have to get the medical oncologist to refer them out. It is not always so easy to get docs to refer patients out, so we have to, at least on their own, we have to get in front of those docs and get this. get them aware of EPSADO, and get them plugged into a referral network with one of, you know, a number of the treating centers. So 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 going to be bunted 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 we'll have to build the referral networks. And so I do think on a patient volume basis, it'll be slower. But I also believe on a TAM basis, we have pretty much twice as much as what they have. And 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, to the liver mets. The 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. So 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 Ramakant with HC Wainwright. Please go ahead.

Thank you. Good afternoon, Gerard, and congratulations. Thank you, Gerard. One quick question for me. With Hapsado, the surgeon or the physician needs to learn the procedure as well. So how easy is it to learn the procedure and 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?

Thanks for that question, Arte. No particular step in this procedure is technically difficult for the interventional radiologist or the anesthesiologist who's there or the perfusionist technician. What's important is that these things are done in a coordinated fashion and that really will be the focus of training. It doesn't make sense for us to put together a training center because I don't think we'll have that volume of doctors who need to be trained. I know when we were at, when I was at Veracel, we would do the lack of a better phrase, you know, pop-up training centers where we would bring in a bunch of, you know, cadaverities for, you know, to use the cell therapy project, cartilage 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, and then They will either attend the case either directly or virtually watch a case. We'll set up probably both of those mechanisms for them. And then we will have a proctor come in and the first case that is done, we'll have someone proctor. We will likely have our own person who's capable of proctoring as well to augment that. So it'll be a mix of all of us. It'll start with didactic training. Then we will have them do the virtually or see a case or travel to see a case, and then we'll have a proctor sit through the initial case for the team. And then 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, very difficult technical portion of this. It's really a matter of making sure that the filters come on at the right time, The balloon pump, the balloons go out at the right time. The blood pressure is managed in the right way at the right time. So again, it's a matter of coordination, not technical difficulty.

Okay, thank you for that. And then the second question is, in terms of the show-up and stay, you know, you said there will be an update later this year. That's an IIT at this point. So would you... Would you take it under your wing once you get the approval for Hepsado?

Yeah, I think we had really considered transitioning, and I don't know, I've never been involved where you actually transition in IIT. In terms of a sponsored trial for a combination of immuno-oncology agents and Hepsado or ChemoSat, That's definitely something that we're very interested in doing, whether or not it's in this particular indication, metastatic ochromellonella, or another indication where IO agents are used. So I think it's definitely top of the list, on the top of the top two or three things that we want to do is to continue to explore, you know, immuno-oncology agents in combination with Epsado. And I've talked about this before, you know, this 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 myoblastic effect that really resets the tumor microenvironment in the liver that ends up having probably systemic effects. So, yeah, we will definitely take under our wing the idea or some type of trial or trials combining our treatment with combination immunotherapies.

Very good. Thank you. Thank you for taking my questions.

Thank you.

Our next question comes from Yael Jin with Laidlaw & Company.

Please go ahead.

Good afternoon and congrats on all the developments recently. Just a couple of quick ones. The first one is that in terms of the financing, the remaining submitted of, I guess, $65 million or $60 million. What sort of milestone that was anticipated and expected so they will move those funding forward?

Sure. So we just got a $25 million arm. Right now, as we speak, it's being wired in, a $25 million financing. The second, the first warrant tranche will be for about $7.5 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. So essentially, the warrant holders need to exercise that warrant once we're approved. So that's the first milestone that 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 within 21 days of us announcing that. And that will yield a little under $4.2 million in warrants priced at $6 this year, and that's another $25 million to the business. So that's why we think in aggregate, if things go according to plan, and we know things don't always go according to plan, But if things go according to plan and we have a bit of cushion here, we should be able to get the cash flow positive without having to do any more financing.

Okay, great. That's very helpful. And the next question is that you and I talked about beforehand that you talk about the pipeline development and giving what the cash you may have going forward. Certainly many of those can be So, have you sort of set up some sort of priority and, you know, the areas to explore in terms of the pipeline development, other indications, for example?

Yeah, 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, and it's really the large FME there. That's another orphan area. And colorectopagus is the number one metastatic, you know, liver metastatic cancer. And there are a number of settings we can go with there. And then the third is kind of more of a basket area liver mess where the primary cancer is being treated with IL agents. Now, in terms of how quickly we can get to that, our hands are rather know we're rather full at the moment um 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 up 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. So even if we move with reasonable speed, it probably would be a good year or so before we could spend any significant amount of monies on that from where we are right now. So I think the short answer is we'll be planning, and planning for one or all of those three areas I just discussed. But in terms of actual impact on our P&L and increasing our burn in the R&D area, it will be at least a year out.

Okay, great. That's very helpful. And 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? And 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 for reimbursement in the UK. We're used there. That will 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 kind of hard to move it up too much. And 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 direct 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 melt from the liver. 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. So 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 going to 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 leaves. It's worth a shot. So, you know, we have ICC publications that come out because of the independent work of investigators. And, again, that's partly driven by the CE mark used for in any cancer. And, you know, we've had uses for breast cancer and a number of other things that look promising. So it may be that that's just a source of publication for us. Despite the low price, you know, we may end up being very happy with just the data that's getting generated here.

Okay, great. Again, congrats and a great job so far.

All right, thank you very much. You're welcome for questions.

This concludes our question and answer session. I'd like to turn the conference back over to Gerard and Michelle for any closing remarks.

Thank you. I appreciate everyone's questions and attention today, and I'd like to thank everyone are existing and new investors who've gotten involved with the business. You know, without those folks, we'd be nowhere. And 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.