Delcath Systems, Inc. Q1 FY2021 Earnings Call

Good morning, everyone. Welcome to Delcath's First Quarter 2021 Earnings Event. I am now pleased to introduce your host, James Carbonara from Investor Relations. The floor is yours, James.

Thank you. And once again welcome to Delcath Systems first quarter 2021 earnings call. With me on the call are Gerard Michel, Chief Executive Officer; John Purpura, Chief Operating Officer; Dr. Johnny John, VP Medical Affairs; Christine Padula, Interim Principal Accounting Officer; and Kevin Muir, Vice President, Commercial Operations. 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 assurances 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. Our last quarterly call was just over a month ago, given the typical compressed timeframe between filing the annual 10-K and the first quarter 10-Q. The focus of that recent call was the release of the preliminary results from the FOCUS trial. Given the importance of those data, and frankly in the misinterpretation by some investors regarding the results; I believe a recap of the data is warranted on this call. Most importantly, the preliminary FOCUS trial results are unambiguously positive. The primary endpoint, overall response rate as determined by the independent review committee exceeded the pre-specified threshold for success by a very wide margin. We powered the study to demonstrate superiority over checkpoint inhibitors used to treat metastatic ocular melanoma. To demonstrate superiority, the lower bound of the overall response rate in the ITT population needed to exceed 8.3%. We reported an overall response rate of 29.2%, the lower bound of which was just over 20%, greatly exceeding the pre-specified 8.3% threshold for success. While the data is based on 87% of treated patients, it is mathematically impossible to have the lower bound of our efficacy calculation fall below the pre-specified success criterion of 8.3% regardless of the response outcome of the remaining patients. We can unequivocally state we have met the pre-specified overall response rate endpoint based on these data, and that this cannot change regardless of results for the few remaining patients. Additionally, pre-specified comparative analyses against the best alternative care arm, including overall response rate, disease control rate, and progression-free survival, all demonstrated clinically meaningful and statistically significant improvements. This was not expected given the small sample and the best alternative care arm. In the per protocol population, the overall response rate was 32.9% in the HEPZATO arm versus 13.8% for the Best Alternative Care arm, median progression-free survival was minus nine months for the HEPZATO arm versus 3.1 months for the Best Alternative Care arm, and a disease control rate was 70.9% for HEPZATO versus 37.9% for the Best Alternative Care arm. Since most of the patients in the Best Alternative Care arm were treated with TACE, this trial provides a strong signal that HEPZATO may have advantages over both the checkpoint inhibitors used in the trial and TACE in the treatment of metastatic ocular melanoma patients. Since TACE and checkpoint inhibitors represent the bulk of current treatments utilized for metastatic ocular melanoma, these data may result in HEPZATO becoming the standard of care for metastatic melanoma patients. While these comparative results against best alternative care are preliminary, we are confident these preliminary data will not significantly change upon evaluation of the full data set. More importantly, the safety profile was consistent with the safety profile of CHEMOSAT treatment described in previous European single-center and multi-center publications, with no new safety signals observed in this patient population and no treatment-related deaths. A critical objective of the FOCUS trial was to maintain or improve the efficacy seen in the earlier pivotal trial conducted with a different version of our medical device procedure, while dramatically improving the safety profile. We have clearly demonstrated that goal. We are excited that the FOCUS trial results will be presented as an oral presentation at the American Society of Clinical Oncology annual meeting, which will be held virtually from June 4 to 8. We will hold a Q&A webinar on Monday, June 7 at 8:30 AM Eastern Time to answer any questions which the broader investment community may have regarding the results. We are currently projecting final data by the end of the summer, whether or not we release that at a medical meeting, such as the European Society of Medical Oncology, or ESMO in September or sooner has not yet been determined. It is important to keep in mind that this is the second large multi-center trial to demonstrate efficacy for our PHP system. And that the Complete Response Letter or CRL that we received from the FDA in September 2013 was largely due to safety-related issues. While at the time of the CRL, the company had developed an improved version of the PHP system procedure, the FDA required that we clinically demonstrate that this modified system procedure did indeed improve the safety results associated with the prior device or procedure. Based on these results, again, we have clearly improved both efficacy and safety. We have started compiling the various modules of the NDA despite the final database log being months away; we are still targeting the first quarter of 2022, but with the caveat that all this depends on access to the clinical sites. The primary gating item to our submission is still data monitoring, which requires site access, and some sites are still restricting access due to COVID mandates, especially in Europe. As sites open, we, like most other sponsors, are trying to get additional days on-site to catch up on the last monitoring days. Timelines may shift, but we will endeavor to do all we can to avoid that. If timelines do shift, we will still be creating incremental value by increasing the number of expanded access sites, which should accelerate market uptake upon launch. Now the FOCUS Trial enrollment is complete; we anticipate formally initiating an expanded access program for metastatic ocular melanoma patients to receive HEPZATO treatments. While we strongly believe we have an approvable therapy in metastatic ocular melanoma, an orphan indication with high unmet need, we are confident there is utility in the treatment for indications well beyond metastatic melanoma. Intrahepatic cholangiocarcinoma, or ICC, and metastatic colorectal cancers are worthy of note since we already have strong evidence that PHP should have some level of efficacy in these conditions, and ICC where there are few good treatment options. We have strong signals of efficacy from commercial usage in Europe in approximately 50 patients. While we have paused the trial in ICC due to slow enrollment, we believe that we should continue to pursue this indication given the unmet need and existing data that indicates PHP may provide a meaningful clinical improvement over current options. We are now scheduling advisory boards with oncologists to both design protocols, which will enable appropriate recruitment rates, as well as increase awareness among investigators, which should enable expanded access site recruitment. In terms of a clinical signal in colorectal cancer, we can leverage existing publications reporting results from a surgical procedure referred to as isolated hepatic perfusion, or IHP. Over the past two decades or more IHP has been utilized to treat numerous cancers, with the largest metastatic colorectal and the most common chemotherapeutic agent being melphalan. IHP is an open abdominal surgery in which the circulation of the liver is isolated by placing multiple canyons in a variety of major arteries and veins in order to route the blood from these vessels into an extra corporeal circuit in which the chemotherapeutic agent is delivered at high doses. Given its very invasive and demanding surgical procedure, it is performed in relatively few centers, and it is not repeatable. Over the past two decades, eight publications have documented results in well over 400 metastatic colorectal patients with response rates ranging from 41% to 71%. Given the strong results, this technique would likely widely used, if it were not for the significant morbidity and mortality associated with surgery. HEPZATO was essentially a percutaneous and thus far less invasive, repeatable replacement for surgical isolated hepatic perfusion, and we believe the published results from these eight studies documented results from 400 patients have direct bearing on the likelihood that HEPZATO or PHP could offer a meaningful option for colorectal patients suffering from hepatic metastasis. ICC and colorectal patients with liver dominant disease alone would expand the initial metastatic ocular melanoma target addressable market more than tenfold. And there are multiple other tumor types which might warrant investigation. We are midway through a consulting engagement to assess the appropriate setting and related protocols to study ICC, colorectal, as well as other possible indications. We look forward to reporting on that later in the year. As we prepare for our FDA submission, we continue to design our commercial launch strategy. We are assessing the size of our commercial organization, the efficacy of competitive treatments, and our strategy for coding, pricing, and reimbursement. In addition to the Delcath commercial team, we are enlisting the assistance of a well-known consulting firm and KOL advisory boards in ocular melanoma to help fine-tune our commercial launch strategy with a focus on market access. Because of the rarity and prognosis of metastatic ocular melanoma, most patients seek care at one of approximately 20 medical centers across the US that specialize in the treatment of ocular melanoma. This modest number of centers will allow us to meet the needs of the ocular melanoma community with a small but specialized commercial team. Currently, most metastatic ocular melanoma treatment regimes begin with the costly combination of immunotherapy agents. Ocular melanoma has not responded as well to these treatments. If HEPZATO is approved, it will represent a well-documented clinically significant advance in the treatment of metastatic melanoma. Given that the pricing of HEPZATO should be comparable to compete with current immunotherapy treatment options. While HEPZATO will be used in both the inpatient and outpatient settings, our market access plans are being designed accordingly. Our outreach has indicated a consensus among physicians experienced with HEPZATO that this will predominantly be an outpatient procedure. Most importantly, the US investigators involved in the trial are anxious to get access to HEPZATO, which bodes well for rapid uptake upon launch. Another important commercial development has been the changing guidance of the United Kingdom's National Institute for Health and Care Excellence, better known as NICE, for CHEMOSAT in the treatment of patients with metastatic melanoma. Previously, the NICE guidance recommended CHEMOSAT can only be used in the context of formal research studies. Due to that guidance, private insurance and regional funding were generally not available, particularly for CHEMOSAT, nor was it possible to apply for national coverage. Under the revised NICE guidance, CHEMOSAT has been categorized under a special arrangement designation. Under this designation, private insurance may be more likely to fund treatment with CHEMOSAT, some regional funding may be more accessible, and a process is now available to seek national reimbursement. The past six months have marked the start of a critical transformation for Delcath. During that time, we have attracted new investors, strengthened the management team, and most importantly, released preliminary results from the FOCUS trial which as of this compilation strongly indicates HEPZATO's benefit-risk ratio is a significant improvement versus an earlier generation of Delcath's proprietary percutaneous hepatic perfusion system. We look forward to continued progress in the balance of the year as we prepare both to file an NDA in early 2022 and expand the HEPZATO into additional areas of high unmet need. I look forward to taking questions, but first we'll turn the call over to Christine to review the first quarter financial results.

Thank you, Gerard and good morning to everyone. Our product revenue for the first three months ended March 31, 2021, was approximately $389,000 compared to $293,000 for the prior year period of our sales of CHEMOSAT procedures in Europe. Selling, general and administrative expenses were approximately $3.3 million compared to $2.3 million in the prior year quarter. Our research and development expenses for the quarter were $3.7 million, compared to $3 million in the prior year quarter. Total operating expenses for the quarter were $7 million compared to $5.3 million in the prior year quarter. We recorded approximately $2.2 million of stock option expense in the first quarter 2021 versus no material expense recorded in the prior year quarter. We recorded a net loss for the three months ended March 31, 2021 of $6.8 million, compared to a net loss of $7.9 million in the same period in 2020. At March 31, we had cash, cash equivalents, and restricted cash totaling $26.7 million compared to $4.7 million of total cash at March 31, 2020, and $28.8 million at December 31, 2020. During the three months ended March 31, 2021, and 2020, we used $4.6 million and $5.2 million, respectively of cash in our operating activities. That concludes my financial remarks. And I now ask the operator to open the phone lines for Q&A. Operator, can you please pull for questions?

Our first question today is coming from Scott Henry at ROTH Capital.

Thank you and good morning. I just had a couple of questions. Christine, perhaps starting with you since you just spoke. Could you talk about how you expect spending trends in the rest of the year? And as far as stock compensation, I know you there was a big chunk in Q1, how should we think about stock compensation going for the rest of the year?

Christine, you may be on mute.

Sorry about that. Yes, I did mute myself. Sorry. Yes, stock option expense will continue through the rest of this year and next year. It is only accelerated methods. So we'll see it gradually come down. But if we do new additional grants, we'll see it picked back up again. But I would see it roughly at the same level.

Okay, great. Thank you. That's helpful. And then when we think about the changes to the NICE guidelines, would you expect an impact on the revenue line? I mean obviously, it would take some time. But just curious if we should expect that revenue stream to be increasing over time as this changes?

Yes, I think there's probably a good year lead time before we have an answer as to whether or not we'll end up getting covered by the NHS. So that's obviously a binary outcome. I do believe that we'll see a modest uptake in the UK over the, maybe not immediately, but let’s say three to six months as private insurance starts, we hope starts covering this. And there's access to some regional funding. But I think it'll be a pretty gradual uptick in revenue until we see the outcome of the national reimbursement decision.

Okay, great. Thank you for that color. And then just the final question. I really appreciated you going over the data. That was helpful. The one piece of data we're still waiting for, which isn't available yet is overall survival. Any thoughts on that endpoint as far as trends you've seen to date?

Yes, we did, we knew that would be obviously a key metric that investors would be interested in to allay any concerns that we are holding back because it was trending against us. We did say there's about a four-month advantage when we did the analysis. But roughly maybe even half the patients, we didn't have the date of death for and therefore censoring the analysis. So therefore, the data could be construed as fairly, almost meaningless at this point in time. We don't expect it to achieve statistical significance to that; that's a much harder metric to do that with such a small comparative arm of 32 patients. We expect to release that data, those data by the end of the summer, and again, probably roughly around the ESMO timeframe whether or not we release it there or beforehand; that involved but recognize the importance, it's not trending against us at the moment. But with that said, a lot of data is missing.

Our next question today is coming from Yale Jen at Laidlaw & Company.

Good morning and thanks for taking the questions. Gerard I know that you spoke before, there are the three main goals of your strategy: start with the data, clinical data, and also the pipeline development. Lastly, the personnel to build the teams. You talked a little bit about the pipeline earlier in your prepared remarks. Could you elaborate a bit more in terms of where you think things are? Is that ahead of your expectations or planning? Or what should we anticipate for the rest of the year?

Yes, our planning is on track, as we're currently focused on phone calls, desk research, and video calls. Our initial step has involved investigating various research sources, including our records and interviews, as well as looking into CHEMOSAT in Europe and published data. We’re particularly examining the use of melphalan, both systemically and in isolated hepatic perfusion, and are conducting interviews with expert oncologists to determine our areas of focus. At this point, we are planning broader tumor-specific advisory boards across different cancer types to figure out suitable protocols. I anticipate that by the end of summer, we will have mapped out some protocols. While we may not be ready to start site recruiting immediately, I'm optimistic that we will be able to specify our plans, such as pursuing ICC and possibly making protocol adjustments. We might also look into colorectal cancer for second-line treatment in metastatic disease, with a long-term strategy to expand our efforts. These examples are not definitive but represent our direction; ICC is likely to play a role, as is colorectal cancer, given the compelling existing data. There are eight studies indicating over 400 patients treated with melphalan, showcasing results from a surgical approach that may prove relevant to our CHEMOSAT or HEPZATO efforts. The research around isolated hepatic perfusion is particularly insightful, especially in advanced colorectal cancer, which has shown impressive overall response rates in published results.

Okay, great. That's very helpful. And maybe just one question here, which is that you mentioned a little earlier that an open-label extension study could start at CERN, and maybe a little bit more color in terms of the probably the timing as well as the scope as you planned it at this moment. And thanks.

Sure. So it's an expanded access protocol that's used for patients where there is the research, clinical COVID is stopped and there's no available treatment for the patients. We'll be submitting the protocol to the FDA shortly for their approval. Johnny, maybe you can comment a little bit on the sites you plan on approaching and how many you have hoped to have up and running by the end of the year.

Sure, Gerard. Thank you. So we have already started our discussions with sites to have this up and running. We have been working on the protocol. The case report forms on the database for this expanded access program. Currently, we have initiated negotiations and discussions to get it open at Moffitt Cancer Center in Tampa, Florida, Duke University in North Carolina, Emory University in Atlanta, Georgia, and The University of Tennessee. Subsequent to that, we have a number of sites that will come up in the second phase of this. But our plan is to have these sites open in the next coming months for where the ability to enroll patients into the program.

Yes, and the importance of this, I just want to comment for the importance of this is that there aren't a large number of sites that we need to cover when we commercialize to get the bulk of the patients. But we want to make sure there are a large number of sites trained and actively using the product. So we can get rapid uptake with metastatic ocular melanoma. The beauty of this first indication is that it does not require a significant salesforce or commercial expense, the thing we really need to focus on, though, is making sure there are multiple sites trained and running. So my hope is we have roughly 10 sites give or take when we launch this that are already using the product and that would enable rapid uptake. The rapid uptake, combined with a likely high price point, could allow us hopefully very quickly to become cash flow positive after launch, which can help fund these additional indications I'm talking about.

Okay, great. That's very helpful and I agreed that increased awareness in all parties. That's a very helpful thing going forward. And thanks.

Our next question today is coming from Marie Thibault at BTIG.

Hi, good morning. Thank you for taking the questions. One quick one here, I saw that you have an oral presentation slated for ASCO next month. Congrats on that just curious if we'll be seeing any additional patients added to that data, anything incremental to look for in that presentation.

There will be some modest incremental data; it won't be the number of patients that will be incremental. We'll have some additional analyses in terms of best overall response rate. So that'll be helpful. But I don't want to say too loudly because ASCO doesn't love it when you release most of what you're going to present. But that is the case here. But there'll be a few incremental analyses regarding best overall response rate.

Okay, we'll look out for that. That's great. And then maybe a two-parter here on reimbursement, nice to see the NICE guidance update. Curious if we should be looking for other European reimbursement progress in various countries now that some of the FOCUS data is out. And then here in the US, maybe you can walk us through some of the steps you need to take to work toward outpatient codes in the meantime as we wait for FDA. Thanks.

So in Europe, we'll definitely be taking advantage of the FOCUS trial data, which will really, when it's fully available, be the driver for reimbursement in many markets. The second thing we need for some European markets is quality of life data. And that relies on a registry that we've put in a reinvigorated focus into by staffing up in Europe medical teams to try to increase the number of patients in that registry. So European reimbursement will require, one, the FOCUS trial data. So by the end of this year, we should have that package up in a way that we can start bringing it in front of the various national payers in Europe. And the second thing would be quality of life data; some countries really are focused on, no pun intended, and that will primarily be driven by the registry. So that's, as you know, kind of a huge effort that takes a year-plus in Europe, but thankfully, we're going to have the data necessary to make that happen. Medac is our commercial partner. So they are really charged with working with consultants to get this done. But we do not do they are active. We have regular calls with them. And they're preparing to hire the consultants now that the data is coming close. In terms of US access and such, I'll ask Kevin Muir, our Vice President, Commercial Operations, to speak to the work that we're doing in terms of commercial access and the success he anticipates.

Yes, thank you, Gerard. So right now we have a large healthcare consulting firm that is helping us for the market access. And we have done some outreach with not only physicians, but also hospitals and payers to see what their feelings are about the procedure. So we have a comprehensive strategy to not only help the hospitals and the payers from an inpatient but also an outpatient. And our indications right now is I hesitate to use the forward consensus, but we've seen the consensus that physicians would plan to use this on an outpatient basis. So, but that doesn't mean there won't be inpatient usage as well. So we have a strategy in place to assist our hospitals and payers on both accounts.

Kevin, it might be worth explaining how this is reimbursed, more like, and a drug in terms of a pass-through with the hospitals on an outpatient basis.

Oh, yes. So, after approval, we will apply for DRG ICV10 code as well as the HCPCS code. HCPCS code is what will be used as a pass-through code for the hospitals, since this is a drug, they will have a J code. So probably about three months after submission or approval, we will get access to these codes to our hospitals, and payers can use this as a pass-through and be fully reimbursed on the cost for the HEPZATO test here in the United States.

What kind of feedback have you gotten, Kevin, in terms of, on an outpatient basis, the willingness of hospitals to use it in terms of financial stakeholders?

Yes, so as I mentioned, we've done some outreach, we've done physician interviews, hospital interviews, and payer interviews. And the kind of main concern is in our trial protocol, we have this as a two-day or an inpatient procedure; we feel, and so do the physicians that we've talked to, they feel that one of those days in which we trial protocols would not be needed in a commercial setting. So we would probably be under the 48-hour rule, which is considered an inpatient procedure in the hospital. So we would think that these patients would be in the hospital for less than 48 hours or the two-night rule, as they call it. So we would anticipate the patient showing up on the day of the procedure and being discharged the next day, which would be considered an outpatient procedure; the majority of our physicians feel as if that is how they would treat their patients.

Our next question today is coming from Arlinda Lee at Canaccord.

Hey, guys. Thanks for taking my question. Could you provide an update on how the database update is going and what else is needed to file in the US? And then maybe looking into the future can you talk about maybe how easy it is to add or swap ingredients into HEPZATO mixture or a cocktail? And then lastly, maybe can you talk about your thoughts on partnering either regionally, or by indication? Thank you.

Sure, let's start with just the process of pulling the NDA together. And starting with the database, maybe Johnny you can talk about where we are in terms of data entry and monitoring. And what you're doing to make sure we stay on track there, and then perhaps, jump before you can comment on just the whole process upon the NDA together.

Sure. Thank you, Gerard. So in terms of the database, as in any trial, we had sites that were large enrolling sites and sites that enrolled a fewer number of patients across globally across the trial sites. The sites that enrolled a fewer number of patients were very much caught up both in data entry and data monitoring. Currently, we are still working on the sites that tended to be the larger enrolling sites both in Europe and the US. And the COVID pandemic and the restrictions caused by having less access to these sites for not only the site staff that do the data entry for our trial data patients, but also the access to our monitors has created some issues for us in terms of getting this done. So what remains now for completing the work on the database is to have those remaining larger sites that enrolled patients of the trial complete their data entry and then have access for our monitors to go in and monitor it. As you can imagine, we still have some patient data entry that were still in follow up, we have one patient that is still expected to have their last treatment later on this week of next week, I should say on May 18, so that patient's data has also to be entered. So at these remaining sites that enrolled the last remaining patients on the trial, we have some data entry that has to take place. And then, of course, the monitoring. So the answer is the larger sites, larger enrolling sites have data monitoring that has to take place. And we're, of course, writing the restrictions, especially in Europe, with the lockdown and the restricted access; we have been able to use other methods to continue with monitoring and establish remote monitoring at certain sites. And we have also done remote monitoring phone calls with sites and done Zoom calls in order to facilitate and expedite the process of monitoring. But once we complete the larger sites, then the database would be complete.

And John, just briefly go through the overall process, the resources we have placed, et cetera, to get the NDA pulled together.

Sure, Gerard. Thank you. And thank you, Johnny for the detailed description of the clinical data compilation. So the clinical data compilation for the NDA is typically what's known as Module 5 of the NDA compilation. So there's an enormous quantity of non-clinical data, animal studies, toxicology studies, and medical device engineering studies that go into Module 3 and 4 of the NDA. So there's a lot of work that we're parallel passing to construct the NDA resubmission, all while the data gathering on the clinical side for Module 5 is ongoing. So these things aren't happening sequentially; they are happening concurrently. Does that answer your question?

Yes, I believe that addresses your inquiry. Arlinda also asked about other chemotherapeutic regimes that could be utilized with percutaneous hepatic perfusion. In essence, can we incorporate additional agents besides melphalan and what combinations are possible? The answer is affirmative; we anticipate that it won't require significant adjustments to use other small molecules with the device. In fact, there have been studies conducted years ago using doxorubicin with a similar device. We are confident that platinum compounds and the FOLFOX regimen, among others, could be effectively employed with this. We view this as step two in our development process. Step one focuses on other indications utilizing melphalan. Step two will involve exploring additional chemotherapeutic regimes for this device. As part of the ongoing advisory boards, we are consulting oncologists about which chemotherapy regimes they believe would be suitable with PHP. We are currently gathering that data, and I expect that next year, we will formalize a development program to investigate other agents, but that won’t happen this year. Next year, we plan to initiate something along those lines. Arlinda, your third question was about our partnering strategy. Currently, we have a partnership in Europe with Medac, which has not progressed as well as we had anticipated, but we are collaborating with them to enhance the situation. It requires a concentrated effort. The positive aspect of this product, especially with the initial indication, is that there are a limited number of centers that need to be approached and supported. Thus, a large presence is unnecessary, but we require highly specialized sales representatives and clinical support specialists, as well as a Medical Science Liaison team, to effectively commercialize this. A large presence in the US, Europe, and eventually Asia will not be required. It makes more sense for us to consider this product as a significant asset for other strategic players already engaged in the interventional oncology space. Therefore, it may be prudent to avoid excessive regional partnerships, as I'd prefer to keep this asset relatively unencumbered for a potential strategic partner who might appreciate an asset without many entanglements. For now, we are not actively pursuing major partnerships, but we will certainly evaluate any opportunities that arise.

Thank you. We have reached the end of the question-and-answer session. Mr. Michel, I would now like to turn the floor back over to you for closing comments.

Thank you. So in closing, we are excited about the prospects for Delcath as we start to continue to analyze the FOCUS trial data, prepare the NDA for metastatic ocular melanoma, and start outlining the development plans for the next indications for HEPZATO. As the year moves on, we look forward to updating you on these developments. Thank you all for taking the time today to join the call.

Thank you, ladies and gentlemen. This does conclude today's event. You may disconnect at this time. And have a wonderful day. Thank you for your participation.