Delcath Systems, Inc. Q2 FY2022 Earnings Call

Good morning, and welcome to the Delcath Systems Second Quarter Fiscal 2022 Financial Results Conference Call. All participants will be in listen-only mode. After today’s presentation, there will be an opportunity to ask questions. Please note this event is being recorded. I’d now like to turn the conference over to David Hoffman, General Counsel of Delcath Systems. Please go ahead.

Thank you. And once again welcome to Delcath Systems second quarter 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 statement 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 27(a) of the Securities Act of 1933 and Section 21(e) 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. Delcath has had a very productive second quarter of 2022 and year-to-date, for both the HEPZATO KIT, the company's investigational product candidate in the United States; and CHEMOSAT, the company's marketed product in Europe. In the U.S., we continue to move forward towards the resubmission of a new drug application for the HEPZATO KIT late this quarter. As previously reported, in late April, we completed a pre-NDA meeting with the FDA, and based on that interaction and subsequent meeting minutes provided by the FDA, which incorporated feedback and recommendations, we see no barriers to a resubmission of the NDA with the current data in hand. For purposes of the NDA submission, all queries have been resolved and are considered complete, and the FOCUS Trial database has been locked. While the database is locked for purposes of the submission, I want to remind listeners that certain times and event endpoints such as overall survival will continue to mature through mid-2023. Delcath expects to provide the FDA with routine periodic updates of these additional data and future submissions. Within 30 days after the resubmission, we expect the FDA to confirm receipt of the submission, and if they agree the submission is sufficiently complete to warrant review, which we fully expect they will, establish a PDUFA date six months from the submission date. While we do not know whether the FDA will convene an Advisory Committee, we are preparing for one and look forward to the opportunity to highlight HEPZATO’s efficacy and safety. The foundation of the NDA resubmission is the FOCUS Trial results, for which Dr. Jonathan Zeiger, Global Lead Investigator, provided an update during ASCO's Annual Meeting in June. I will take the time to review those data here since I have covered that many times in various forms and the updated data was largely consistent with the early data release. I will simply reiterate that we believe the totality of the efficacy data demonstrates that HEPZATO produces clinically meaningful benefits to patients suffering from liver-dominant metastatic ocular melanoma and that its safety profile is in line with other traditional cytotoxics. Taken together, we believe the data supports a very positive benefit-risk profile for patients. In an effort to ensure suitable patients have access to the HEPZATO KIT during the NDA preparation and FDA review, we have started opening expanded access program or EAP sites. The first site opened has completed three treatments to date and has another three treatments scheduled this month. The pace of treatments will increase as more patients refer to the treating sites. The second site has started to screen patients, but may not start treating until October due to clinical trial coordinator staffing issues. We will be judicious in our pace of opening EAP sites to ensure the treating sites are well qualified and prepared. Although investigators of clinical trial sites are interested in participating, clinical staffing turnover and shortages that have occurred over the last year at many of the clinical sites make it imperative that we are certain that a well-trained team is in place before we elaborate to go forward. To this end, we have recently hired a dedicated medical device procedural trainer, who will work with potential EAP site treatments. The procedural trainer will also complete the development of Rollic's training program needed for commercial launch and lead our overall training effort. Based on the ongoing usage of CHEMOSAT in Europe, during the second quarter, additional European audit publications supporting CHEMOSAT and by extension, HEPZATO KIT were published. I'll cover just two of them now. At ASCO, researchers from the Leiden University of Medical Center in the Netherlands presented additional data on the ongoing CHOPIN trial. The goal of this investigator-initiated Phase 1b randomized Phase 2 trial is to study the safety and potential synergistic effects of systemic immunotherapy, ipilimumab plus nivolumab, or IPI+NIVO, when combined with Delcath's proprietary liver-targeted treatment in metastatic uveal melanoma patients. The primary objective of Phase 1b was determining the safety and toxicity of the combined products. And last summer at the 2021 Cardiovascular Interventional Radiological Society of Europe Conference, the investigators reported that there were no dose-limiting toxicities and that the Phase 2 randomized trial comparing PHP alone to PHP with IPI+NIVO was successful. In total, 79 to 88 patients will be treated in Phase 1b and 2 combined, and we understand that to date, 28 patients have been enrolled. While the primary purpose of the first phase to file was safety, efficacy results on seven patients treated with combination PHP with IPI+NIVO were reported this past quarter at ASCO, and the results were noteworthy. The poster reported an objective response rate of 85.7% and a disease control rate of 100%. At a median follow-up time of 20.2 months, four patients have an ongoing response according to RECIST criteria. The presentation reported a median progression-free survival of 22.4 months, and all patients were still alive. If similar results are seen in the current larger randomized Phase 2 portion of the trial and the combination continues to be well tolerated, it could represent a significant improvement over the current standard-of-care, including PHP alone. It is important to take a moment to explain why this investigator-initiated trial is of great interest to Delcath. Combination therapy is a radical approach since while liver failure due to hepatic medicine is the leading direct cost of death for metastatic ocular melanoma patients, extrahepatic metastases do occur, and treatment with PHP alone cannot effectively address these cases, while systemic immunotherapy has very limited efficacy on liver metastases. Logically, combining therapies may lead to better control of both hepatic and extrahepatic disease. Beyond these additive effects, there are compelling reasons to believe the combination could have synergistic effects. First, tumor lysis induced by PHP treatment could provoke antigen release that may lead to enhanced antigen presentation and increased efficacy of immunotherapy. Secondly, a related but distinct possible synergistic effect is based on the unique role of the liver in the systemic immune system. The liver, continuously exposed to food and microbial antigens in the intestine, avoids autoimmune damage due to specialized mechanisms of immune tolerance. Extensive published literature supports the idea that the liver functions as an immune-modulating organ, possibly enhancing tolerance to tumor antigens outside of the liver. It is well documented that patients with liver metastases derive limited benefit from immunotherapy, possibly due to these effects. In preclinical models, the elimination of immune cells resident in the liver has been shown to reverse the immunosuppressive effect of hepatic metastases. This may be relevant to HEPZATO and CHEMOSAT, given that high doses of melphalan in the liver may be reducing the local and systemic immunosuppressive effects of hepatic metastases by depleting the various immune cells in the liver responsible for these effects. We look forward to further data coming out of Leiden, both in terms of patient outcomes, as well as other analyses which may help elucidate whether CHEMOSAT is actually improving the efficacy of immunotherapy by the elimination or reduction of the immunosuppressive effect of hepatic metastases. While the results will be important in terms of treatment for metastatic ocular melanoma patients, they could also have relevance across multiple tumor types where hepatic metastases are present and immunotherapy is an accepted treatment. Last week, a retrospective analysis of patients treated with PHP at three European centers was published in the Journal of Cardiovascular Interventional Radiology. The study included 101 patients, who were treated with a total of 212 PHP procedures between 2014 and 2019. After a median follow-up time of 15 months, a complete response was reported in five patients, partial responses in 55 patients, and stable disease in a third, resulting in an overall response rate of 59.4% and a disease control rate of 89.1%. The median progression-free survival was nine months, and overall survival was 20 months. The study also found statistically significant differences in overall survival between patients who had complete response, partial response, stable disease, or progressive disease. For example, patients with complete response or partial response had a median overall survival of 27 months. For patients with stable disease, the median overall survival was 21 months, and for patients with progressive disease, the median overall survival was six months. This correlation between response status and overall survival is critical since response rates do not always correlate with survival. As overall response rate is the primary endpoint of the FOCUS trial, any supportive data that shows a correlation between overall response rate and survival is helpful. As we have previously reported, we did see the same correlation in the FOCUS trial, and we intend to share the details of that specific analysis at an upcoming medical conference. Further safety analysis in this publication showed that the most common adverse events for hematological toxicities were Grade 1 and 2 and were self-limiting in the majority of patients, consistent with previous reports on PHP. Other adverse events were thromboembolic in nature. The adverse events reported in this retrospective study are consistent with other publications and the FOCUS trial results. Turning to the commercial progress of CHEMOSAT in Europe. The second quarter was the first full quarter since we resumed direct responsibility on March 1 for sales, marketing, and distribution activities. Q2 unit volumes were down approximately 10% from Q2 of 2021, but essentially flat if one considers that almost all patients being treated with CHEMOSAT in the Netherlands are being enrolled and treated in the CHOPIN trial. In terms of unit performance over Q1 2022, growth was over 75%, but the first quarter and second quarter unit volumes may have been impacted due to the business transition from Medac back to Delcath on March 1. While we expect meaningful growth going forward, I would not expect that level of quarter-on-quarter growth regularly. We are satisfied with this performance since we have a very limited team in place at the moment with only a single account manager in all of Europe. Clearly, the current business is primarily being driven by investigator word of mouth, and we are confident we can drive uptake as we build our commercial infrastructure. Revenue comparisons at this time are not relevant, given the prior quarter's revenue comprised of product sales to Medac and a share of gross profits. Our primary focus in Europe at the moment is hiring an account representative in Germany to increase referrals, utilizing our medical affairs personnel to foster increased support in larger markets such as Italy and France, where we do not yet have much active commercial business, and developing the submission packages for national coverage in major markets. We anticipate submitting for national coverage in the United Kingdom, Austria, and the Netherlands by the end of this year. In 2023, we'll submit for national coverage in France, Italy, the Scandinavian markets, and other select smaller markets in the EU. We already have reimbursement in Germany under the ZE scheme, but we need to increase awareness and subsequent referrals to the treating centers. While it will likely take several years to obtain national coverage in the majority of major markets, we are confident that Europe will become a meaningful revenue contributor to the business, with EU revenues likely growing alongside the U.S. commercial launch of HEPZATO, if approved next year. I want to note that given the difficult capital market situation, we have decided to manage the European business on a cash flow neutral basis to maintain adequate capital for the U.S. submission and launch. At the moment, the European business is self-sustaining, and we continue to be so as revenues grow and are reinvested in the European business. While we continue to plan on expanding the PHP platform to other indications, like many companies in this difficult capital markets environment, we need to prioritize the shorter-term, higher-return activities, which is clearly submission of the NDA and preparations for a potential U.S. launch. We continue to hold advisory boards to obtain feedback on and review the post-clinical trial protocols, including intrahepatic cholangiocarcinoma and colorectal as well as discussing IPs in various areas, including other combination immunotherapy trials. Although we believe, based on feedback and protocol proposals, that there is real interest from the investigators to expand the usage of HEPZATO and CHEMOSAT, the timing of the trials may be delayed to ensure the activities most critical to the success of the business are adequately funded. We are confident we can access the capital necessary to fund the business and want to do so in a manner that minimizes dilution to our existing shareholders. Hence, our decision last month to raise $5 million was to do what was effectively a straight common deal priced at market, which is a larger raise, which may have involved much less favorable terms. I look forward to taking questions. But first, we'll turn the call over to Tony to review the financials. Tony?

Thank you, Gerard. Product revenues for the three months ended June 30th, 2022, were approximately $797,000, compared to $398,000 for the prior year quarter from the sales of CHEMOSAT in Europe. Since the second quarter of 2022 was the first full quarter of direct sales, it is not comparable to the second quarter of 2021, in which we generated product revenues in Europe on a revenue share arrangement. Research and development expenses for the quarter increased to $5.5 million, compared to $3.5 million in the prior year quarter, primarily due to higher professional service costs relating to the preparation for our NDA submission by the end of the third quarter of 2022. Selling, general, and administrative expenses for the quarter were approximately $4.1 million compared to $3.3 million in the prior year quarter. The increase was primarily due to pre-launch costs related to the commercialization of HEPZATO. Interest expense increased to $665,000 from $40,000 a year ago due to the interest expense and amortization related to the debt finance that we entered into on August 6th, 2021, with Avenue. On June 30th, 2022, the company had cash, cash equivalents and restricted cash totaling $14.4 million, as compared to cash, cash equivalents and restricted cash totaling $27 million on December 31st, 2021. During the six months ended June 30th, 2022, we used $12.4 million and $11.7 million, respectively, of cash in our operating activities. On July 20th, 2022, we closed a private placement of $5 million for the issuance and sale of 690,954 shares of common stock at a price of $3.98 each, and the prefunded warrants have sold at a price of $3.97 per prefunded warrant. The prefunded warrants have an exercise price of $0.01 per share of common stock and are exercisable immediately. We received gross proceeds from the private placement of approximately $5 million before deducting offering expenses. That concludes my financial remarks. I ask the Operator to open the phone lines for Q&A. Can you please check for questions?

We will now begin the question-and-answer session. And our first question will come from Scott Henry of Roth Capital. Please go ahead.

Thank you and good morning. I did have a couple of questions. I guess for starters, since we just went through the financials, with the top off from the private placement, do you think that gives you the runway to get to an FDA response? So I think it will be close. But I was just curious of your thoughts.

I believe we could achieve it by making some very tough decisions. It may be wise to consider taking action a bit earlier.

Okay. Thank you. That's helpful. And then staying on the financial side, I just wanted to check. So under the direct sales in Europe now, does other revenue that we've seen in prior quarters go away? And at the same time, should we think of the $797,000 as a base going forward? And as well, are the gross margins what we would expect to see under the new model?

Yes. In terms of viewing that as a base, yes. And again, the prior quarters were a mix of supply sales and gross profit split. In terms of gross margin, yes, we just look at that as a couple percentage going forward. Tony, chime in if I've got anything wrong there.

Thank you. I wanted to ask about the FDA review timeline. We have always anticipated a six-month review period. Is there any possibility that the FDA may extend this review? How confident are you in the six-month review timeframe?

I can provide you with the pros and cons related to that. Overall, we feel confident that they should be able to navigate this because it involves just one trial, and it’s not a large one requiring extensive evaluation. In many respects, this simplifies the process for them. We are all aware that the FDA has a busy schedule, and there's often pushback on usage. Therefore, I can’t speculate on whether this division is likely to proceed more quickly. However, the fact that it’s a single trial they need to assess significantly eases their workload. We are also working hard to prepare this NDA in a way that supports their review. There are specific methods we can use to present the information cohesively. I would say there is a strong likelihood that this review will be straightforward for them. However, I can’t guarantee that they will complete it in six months, though I believe we should be able to achieve that timeline.

Okay. Great. Thank you for the color. Final question, just with regards to the expanded access program, how should we think about that as a means to prepare the market such that when you do get approval, the expanded access program is in place in the real centers that you convert into revenue-producing centers? Is there a way to quantify how much of an impact that could be at least in that initial year from the expanded access centers?

Yes, I can provide the framework for a model but will avoid giving specific numbers. Ideally, I aim for at least five, maybe ten. However, there are challenges: first, the cost of the expanded access protocol is roughly equivalent to that of Phase 3 trials regarding individual sites and cost base. Given the current capital market situation, I'd like to target achieving 5%. Secondly, we’ve encountered staffing issues and turnover at many of our clinical sites. This has highlighted our commitment to ensuring that all team members are well-trained before opening these sites. We are cautious about the onboarding process to ensure that every participant has received the necessary training, and achieving the same results as other groups is less feasible than anticipated due to the dynamics I mentioned earlier. This will slow down the pace of bringing them onboard. Our aim is still to reach five; we’ll see how it unfolds, but we want to ensure that each site is properly established before proceeding.

Okay, great. Thank you for taking the questions.

The next question comes from Marie Sebalt of BTIG. Please go ahead.

Thank you. Good morning, Gerard and Tony. And congrats on the progress. I wanted to check here now that we're in the final weeks before the resubmission, what else needs to get done? Are you just in the final writing stage? Or are there any other tasks to check off the list?

It’s pretty much the final writing stages. As you go through this, you're occasionally just additional analyses that you want to run. But John, why don't you talk through kind of where you're at in terms of pulling together the critical modules like five and then clinical sections of demonstration?

Sure. Thank you, Gerard. Yes, as Gerard said, the database has been locked, and we have all the data in hand. We are putting it through all the programming that was programmed earlier to get the outputs in the analysis. In terms of documents, there's a variety of documents that go into the different modules, and they're all being worked on concurrently as we go week-by-week, and this includes a clinical summary report, the summary of clinical efficacy, some ray of clinical safety. We have a PK manual and a PK analysis, POP PK analysis that we're also conducting. We're also putting together the REMS program that's required for the submission. So a variety of different tasks are in play at the same time. And that's where we currently stand.

Okay. Great, very helpful. And then I wanted to go back to the retrospective study that was published on press release last week. Certainly, some very impressive data coming out of that. And I want to hear how you'll be using that sort of commercially in the U.S. with your direct sales team, as well as whether it will be part of any of your submissions to support reimbursement in those various countries you discussed?

Yes. If published, we will utilize it in detail as long as it aligns with the label, which it will do. We plan to leverage any available literature that is consistent with the published label. For any data that does not align with the label but piques the interest of doctors, our medical affairs teams can discuss it. All data we have will be supportive, and we will present it to the FDA. Regarding national coverage submissions, the published data will be very beneficial. A vital part of the NDA will be the quality of life study, which was published in a journal I did not mention on this call. We will also use another study focusing mainly on patients at a live event to support the U.K. and other national coverage submissions. All literature will aid in national coverage, and we will include some specialized quality of life retrospective and prospective analyses in those submissions.

Okay. Thank you so much.

The next question will come from Bill Maughan of Canaccord Genuity. Please go ahead.

Hi, good morning and thank you. As you prepare for the launch, are there any additional programs or efforts you need to undertake beyond getting the EAP sites operational? Are any of these currently on hold or being limited as you aim to manage capital effectively?

I'd say we're probably slowing down a few things. But given this is such a focus of prescribing population, it doesn't have much of an impact. But Kevin, why don't you just give a brief overview of some of the major activities that are taking place right now in terms of commercial products?

Thank you, Gerard. We are currently focused on enhancing our branding and market access. We are developing a patient access assistance program, which we plan to launch by the end of Q4, ensuring it is ready in time for approvals around April.

Thanks, Kevin. Some of the more important things you're doing as well are looking very carefully at terms of codes that will be used to make sure that the hospitals are appropriately reimbursed for actually conducting the procedure. We've mapped out codes that are similar. They may end up using miscellaneous codes, which will be helpful with the codes that are most similar to what we're doing now to reimburse well for the procedure. But that's very helpful that we can point to something that has a decent price to it in terms of the procedure even if we end up using the miscellaneous.

Okay. And I know you said you're in the final writing stages of the NDA, but just to be a little more specific. Do you have all of the data or assurances you need from any third parties, and everything is in-house? Or is there anything else that's out of your hands that you're relying on someone else for to keep to your timeline?

Yes, I believe we have nearly everything we need. The POP PK model is not fully in hand yet, but that's a positive development. I should have a handle on that, although I'm not completely sure about the timeline. We don't have any data gaps or issues; everything is mostly in order. The focus now is on completing all the necessary documentation, which involves significant contributions from external medical professionals. I cannot estimate how many are involved, but I would say it's definitely over a dozen people working on different parts to assist us. However, there won't be any delays due to data issues.

Okay. And then on the takeover of the EU commercialization, has there been any kind of qualitative learnings from you having switched to a direct sales model in terms of receptivity of doctors? Any challenges that you've identified?

Yes. We discovered that many treatment centers have not interacted with any representatives for a long time regarding our product, which confirmed our suspicions. Additionally, surveys we've conducted, such as one in Germany, showed that doctors who are aware of the treatment and using it hold very favorable views. The main issue is a lack of broad awareness about the treatment's effectiveness and the referral process at various centers, and that is something we need to improve in Germany. In the U.K., there are opportunities for regional funding while we await NICE approval, but there haven't been significant efforts to pursue that funding until now. Overall, we have not encountered any negative feedback about the product; there has been either silence or not much support since I took over. We are confident in our ability to increase adoption, though there are limits to how much can be done, especially as many patients in Europe are paying out-of-pocket and there is a lack of short-term regional funding. Our goal is to achieve national coverage in the long run to encourage uptake.

Okay. Thank you very much.

The next question comes from Yale Jen of Laidlaw & Co. Please go ahead.

Good morning and thanks for taking the questions. My first question is that what's the inventory preparation at this point, preparing for the launch? And then I have some follow-ups.

Sure. John, do you want to take that one?

Thank you for your question, Yale. Regarding inventory preparations, we are closely monitoring the expiry dates for all components involved in HEPZATO KITS since this is a sterile product. We are carefully managing this and gathering launch quantities at the right time. We do not anticipate any issues in assembling inventory for the initial launch, both for the drug and its components.

Great. John, you are keeping a careful eye on lead times.

Yes. Given the supply chain issues that we've sort of been working through during the conduct of the FOCUS Trial, we have certainly monitored all of the supply chain issues that could become a rate-limiting factor and have built that into our inventory builds and calculations. So as of this moment, we don't see that to be any rate-limiting issues on any components.

Okay. Great. That's very helpful. In terms of the potential AdCom meeting, if that occurs, do you have any comments on the preparations you might have at this stage? This could happen very quickly in the first quarter of next year.

Sure. John, do you want to talk a little bit about the prep we're planning on and the third party we might bring in, you don't want to name of the name, but our efforts there?

Yes, thank you, Gerard. We are currently preparing for the potential of appearing before an Advisory Committee, although we do not have a definitive indication of that happening. We have engaged a third-party vendor that specializes in preparing sponsors for such events. Internally, we are creating various slide presentations that focus on our data and efficacy while also addressing any concerns we anticipate may arise during the FDA review. We will be emphasizing the safety and efficacy observed in our analysis, which will be included in our submission. This preparation involves a significant amount of work on the slide decks along with contingency plans for potential questions during the event, if it occurs. This process will extend over several months, starting as soon as possible and continuing into early next year.

I’m sorry. Can we anticipate feedback from the FDA on 30 days after you filed for the resubmission of the NDA? They will give you a hint as to whether that could happen?

I don't think they're really going to give us much of a hint until the end of the year at the earliest, January is more likely. But do you have any other thoughts on that?

Yes. Sure, Gerard. The first 30 days is simply a review to determine if the filing warrants a substantive review. But once the FDA starts the substantive review, we could potentially be in receipt of any information request that they so desire from that point forward.

Right. So saying that you're going to have an advisory panel meeting. I generally you don't know until they give you a notification, I believe.

That's correct. They will tell you that we plan to take your product to an Advisory Committee. But again, they have to cut through certain amounts of data and a certain amount of time has to pass while it's not actually defined. If we do have an Advisory Committee, it will probably be in the fifth month of the review.

Okay. Great and maybe the last question here is that you mentioned the checkpoint combo study and you will have the third data readout. Do we have any sense of what time that data readout might be?

John, what is the latest you're hearing out of Leiden that you can share?

Yes. So the next readout they have scheduled is approximately after 40 patients, as we have mentioned during our remarks that we're currently at around 28 patients treated. So we have been discussing the next potential readout because we also would like very much to see some additional analysis. But currently, they are looking at around the 40th patient. With the 40th patient just treated, we need about 12 additional patients that have to be treated.

Okay, great. That’s very helpful. Again congrats on the other progress so far.

Thank you.

And our next question will come from Swayampakula Ramakanth of HC Wainwright. Please go ahead.

Thank you. I hope you can hear me clearly because the call has been quite uneven for me.

Yes, I think we can hear you okay.

Most of my questions have been addressed, but I have one inquiry regarding the EAP program. You mentioned that the program may not have patients enrolled until October. If that's the case, will there be sufficient data from the program to support the commercialization of HEPZATO in the U.S. when that time comes?

I believe that at this moment from that specific study, it might not yield much, but any data that gets published is beneficial. However, if you consider the consistent flow of information coming from Europe, particularly with CHEMOSAT, which is essentially the same product, I think that will be very advantageous for the U.S. as well.

Okay, perfect. I will stop here and then I talk to you folks later. Thank you very much.

All right. Thanks.

This concludes our question-and-answer session. I would like to turn the conference back over to Gerard Michel for any closing remarks.

Yes. I just want to thank everyone for their continued support. This is really an exciting time for the company after a very long journey of preparing, submitting, and resubmitting the NDA, confirming a PDUFA date 30 days after that, participating in a possible Drug Advisory Committee, and if the NDA is approved, commencing a U.S. launch. In parallel, we're building a commercial team in Europe while submitting for national coverage in major markets. Importantly, more clinical data will likely be generated by the Japan trial, the relevance of which could extend well beyond the metastatic ocular melanoma. So I look forward to continuing to update all of you on future calls and have a great day.

The conference has now concluded. Thank you for attending today's presentation, and you may now disconnect.