Delcath Systems, Inc.

Good morning, ladies and gentlemen, and welcome to the DeKalb First Quarter 2021 Earnings Event. At this time, all participants have been placed on a listen-only mode, and the floor will be opened for questions and comments after the presentation. It is now my pleasure to turn the floor over to your host, James Carbonara of Hayden Investor Relations. Sir, the floor is yours.

Thank you. And once again, welcome to Delcat Systems' First Quarter 2021 Earnings Call. With me on the call are Gerard Michel, Chief Executive Officer, John Perpora, Chief Operating Officer, Dr. Johnny John, VP Medical Affairs, Christine Padula, Interim Principal Accounting Officer, and Kevin Moore, 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 fact, 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 the 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 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 roll are made only as of the date of this call. We do not undertake any obligation to update or supplement any core 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 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 an 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 of 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 N in the best alternative care arm. In the per-protocol population, the overall response rate was 32.9% in the Hepsado arm versus 13.8% for the best alternative care arm. Medium progression-free survival was nine months for the Hepsado arm versus 3.1 months for the Best Alternative Care arm. And the disease control rate was 70.9% for the Hepsado arm 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 Hepsado may have advantages over both the checkpoint inhibitors used in the trial and TACE in the treatment of metastatic oculomelanoma patients. TACE and checkpoint inhibitors represent the bulk of current treatments utilized for metastatic ocular melanoma, these data may result in HF-SATO becoming the standard of care for metastatic ocular 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 of multicenter 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 Endocrinology Annual Meeting, which will be held virtually June 4th to 8th. We will hold a Q&A webinar on Monday, June 7th at 8.30 a.m. 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 multicenter 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 and 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 final database lock 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 lost 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 that the focus of all enrollment is complete, we anticipate formally initiating the expanded access program for metastatic octomelanoma patients to receive hep-sado treatments. While we strongly believe we have an approvable therapy in metastatic octomelanoma, an orphan indication with high M at need, we are confident there is utility in the treatment for indications well beyond metastatic octomelanoma. Interhepatic 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. In ICC, where there are a 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 PHB may provide a meaningful clinical improvement over current options. We are now scheduling advisory boards with oncologists both to design protocols which will enable appropriate recruitment rates as well as increase awareness among investigators which should enable expanded site recruitment. In terms of a clinical signal and 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 septum colorectal and the most common chemotherapeutic agent being melphalan. IHP is an open abdomen surgery in which the circulation of the liver is isolated by placing multiple cannulas in a variety of major arteries and veins. in order to route the blood from these vessels into an extracorporeal circuit in which the chemotherapeutic agent is delivered at high doses. Given it is a 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 41% to 71%. Given the strong results, this technique would likely be widely used if it was not for the significant morbidity and mortality associated with the surgery. Hepzada 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 documenting results from 400 patients have direct bearing on the likelihood that Pepsado or PHP could offer a meaningful option for colorectal patients suffering from hepatic metastases. ICC in colorectal patients with liver-dominant disease alone would expand the initial metastatic oculomeloma target additional 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 DELCCAP 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 a costly combination of immunotherapy agents. Ocular melanoma has not responded well to these treatments. If Hepsado is approved, it will represent a well-documented, clinically significant advance in the treatment of metastatic ocular melanoma. Given that, the pricing of Hepsado should be comparable to compute current immunotherapy treatment options. While Hepsado will be used in both the inpatient and outpatient settings, and our market access plans are being designed accordingly. Our outreach has indicated a consensus among physicians experienced with Hepsado that this will predominantly be an outpatient procedure. Most importantly, the US investigators involved in the trial are anxious to get access to Hepsado, which bodes well for rapid uptake upon launch. Another important commercial development has been the change in guidance for the United Kingdom's National Institute for Health and Care Excellence better known as NICE, for chemoset in the treatment of patients with metastatic ocular melanoma. Previously, the NICE guidance recommended chemoset can only be used in the context of formal research studies. Due to that guidance, both private insurance and regional funding were generally not available for treatment with chemoset, nor was it possible to apply for national coverage. Under the revised NICE guidance, chemoset 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 DELCAP. 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 that Hepzato's benefit-risk ratio is a significant improvement versus an earlier generation of Delcat's proprietary percutaneous hepatic perfusion system. We look forward to continued progress in the balance of the year as we prepare bills to file on NDA in early 2022 and expand the development of 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 31st, 2021, was approximately $389,000 compared to the $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 31st, 2021 of $6.8 million compared to a net loss of $7.9 million in the same period in 2020. At March 31st, we had 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 poll for questions?

Certainly. Ladies and gentlemen, the floor is now open for questions. If you have any questions or comments, please press star 1 on your phone at this time. We do ask if you are listening via speakerphone to please pick up your handset for optimum sound quality. Once again, if you have any questions or comments, please press star 1 on your phone now. Our first question today is coming from Scott Henry at Roth Capital. Your line is live.

Thank you, and good morning. I did just have a couple 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 comp, I know there was a big chunk in Q1. How should we think about stock comp going for the rest of the year?

Christine, you may be on mute.

Sorry about that. Yep, I did mute myself. Sorry. Yes, stock option expense will continue through the rest of this year and next year. It is on an accelerated method, so we'll see it gradually come down. But if we do new additional grants, we'll see it pick back up again. But I would see roughly about 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.

Yeah, 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 obviously is a binary outcome. I do believe that we'll see a modest uptake in the UK over the, you know, maybe not immediately, but within, 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 uptake and increase 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 end point as far as trends you've seen to date?

Yeah, well, we knew that would be obviously a key metric that investors would be interested in. To allay any concerns that we're 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 roughly about half the patients we didn't have the date of death for and therefore censored in the analysis. So therefore, the data could be construed as fairly almost meaningless at this point in time. We don't expect to achieve statistical significance to that. That's a much harder metric to do that with such as 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. But recognize the importance, you know, it's not trending against us at the moment, but with that said, a lot of data missing.

Okay. Thank you for the caller, and thank you for taking the questions.

Thank you. Our next question today is coming from Yale Jen at Laidlaw & Company. Your line is live.

Good morning, and thanks for taking the questions. Tara, I know that you spoke before. There's three main goals of your program. As CEO, you start with the 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 little bit more in terms of where you think the things are? Is that ahead of your expectation or planning, or what should we anticipate for the rest of the year?

Yeah, so the planning there really, you know, the activities right now are, you know, phone calls and desk research and video calls with being the new age. I think we're right on track as to what we wanted to do. You know, the first step of that was to try to dig into the available desk, you know, paper research or electronic research, ranging from looking at our own records and interviews. Docs have used PHB, known as Chemosat, in Europe. and trying to get their sense of what they've seen, as well as looking at published data, whether it's with melphalan systemically or melphalan used in isolated hepatic perfusion that I mentioned before, and then a set of interviews with expert oncologists to get a sense of where we should focus, and right now where we're at. Right now is planning broader tumor-specific advisory boards with the number of types of cancers that we're looking at, focused at, and trying to understand what setting would make sense of what protocol would make sense i believe by the end of the summer we'll have protocols mapped out um maybe not yet to the point where we'll start site recruitment but i'm hopeful by the end of the summer we'll be able to say hey look as an example you know we're going to continue to go after icc here are the protocol changes we're going to make here the number of sites we want to enroll and perhaps again as an example We're going to go after colorectal in second line for metastatic disease. And over time, we have to move up the chain, et cetera, et cetera. Again, those are kind of more illustrative examples. I'm not saying that's exactly what's going to happen in terms of the setting and the disease state. But if I were a betting man, I'd say ICC is probably going to be one of them in some form. And the same with colorectal, given the existing data in IHB. And that data really is fascinating. I don't think we've made enough of it in the past. But there are eight studies out there that have well over 400 patients treated with melphalan, where they've essentially done what we do, but done it with a surgical procedure. Keep in mind that the two docs that came up with this idea, I think over two decades ago, or roughly two decades ago, what they were trying to do was replace that IHP surgical procedure with a percutaneous method. So the data out there for IHP really has direct bearing on the likelihood of efficacy for chemostat or Hepsado in the patients. And again, the largest body of data is in colorectal cancer, advanced colorectal cancer, where they've published some really compelling results in terms of overall response rate.

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

Sure, sure. So it's an expanded access protocol, and that's used for patients, you know, where The clinical development has 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 hope to have up and going 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, and 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 the ability to enroll patients into the program.

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. uh when we commercialize this to get the book with the patients um but we want to make sure is that there are large number of sites trained and actively using the product so we can get rapid uptake with metastatic doctor melanoma the beauty of this first indication is that it does not require a significant sales force or commercial expense 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 will help fund these additional indications I'm talking about.

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

Thank you. Our next question today is coming from Marie Tybalt at BTIG. Your line is live.

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 it 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 U.S., 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 really, when it's fully available, because that really will 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 reinvigorated focus into. In fact, we're staffing up in Europe medical teams 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 packaged 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, is kind of an effort that takes a year plus in Europe, but thankfully we're going to have the data necessary to make that happen. Now, MEDEC is our commercial partner, so they are really charged with working with the consultants to get this done, but we do know they're 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 U.S., access and such, you know, I'll ask Kevin Muir, our vice president of 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 full word consensus, but we've seen the consensus that physicians would plan to use this on an outpatient basis. But that doesn't mean there won't be inpatient usage as well. So we have a strategy in place to assist our hospital repairs on both accounts.

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

Yes, so after approval, we will apply for DRG and ICD-10 code as well as the HCPCS code. HCPCS code is what will be used as a pass-through code for these hospitals. Since this is a drug, they will have a J code. So, probably about three months after approval, We will get the access to these codes so our hospitals and payers can use this as a pass-through and be fully reimbursed on the cost for the Hepsado kit here in the United States.

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

Yes. So, as I mentioned, we've done some outreach. We've done physician interviews, hospital interviews, 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 that one of those days, which were trial protocols, would not be needed in a commercial setting, so that 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 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.

All right. That's very helpful. Thank you, and good luck with it.

You're welcome.

Thank you. Our next question today is coming from our Linda Lee at Canaccord. Your line is live.

Hi, guys. Thanks for taking my questions. Could you provide us an update on how the database update is going and what else is needed to file in the U.S.? And then maybe looking into the future, can you talk about maybe how easy it is to add or swap ingredients and or warm the Hepsado mixture or 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, you know, 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, you know, what you're doing to make sure we stay on track there. And then perhaps, John, before you can comment on just the whole process of pulling 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. 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 U.S., 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, you know, created some issues for us in terms of getting this done. So what remains now for, you know, in completing the work on the database is to have those remaining larger sites that enrolled patients on 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 patients that we're still in follow-up. We have one patient that is still expected to have their last treatment later on this week, next week, I should say, on May 18th. 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, fighting the restrictions, especially in Europe with the lockdowns 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, maybe just briefly, go through the overall process, resources we have in place, 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 the Module 5 of the NDA compilation. So there's an enormous quantity of non-clinical data, animal studies, toxicology studies, medical device engineering studies that go into a module three and four 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 five is ongoing. So these things aren't happening sequentially. They're happening concurrently. Does that answer your question?

Yeah, I think that, that, that does it now. I think, um, Arlinda also asked about various other chemotherapeutic regimes that could be used with percutaneous hepatic perfusion. In other words, can we put something else in besides melphalan and what combinations? The answer is yes. I think it won't take a lot of tweaking to use other small molecules with the device. And there are actually studies that have used doxorubicin years ago. with a similar device. So we're confident platinum compounds, Folfax, et cetera, a number of different regimes could be used with this. I think that is kind of step two for us in terms of development. Step one is other indications using melphalan. Step two is other chemotherapeutic regimes put through this device. As part of the advisory boards that we're currently running, we are asking these oncologists You know, what other types of chemo regimes do you think makes sense to use with PHP? You know, we're gathering that data. Sometime next year, I think we will formalize a development program to look at other agents, but not this year, but sometime next year, I think we'll kick something off along those lines. Arlinda, your third question, and I'm proud of myself for remembering all three, was, what our partnering strategy is. So right now, we have a partnership in Europe with MEDAC. And that has not, frankly, gone quite as well as we'd hoped, but we're working with them to try to improve it. It really does require a very focused effort. The good part of this product is that, especially with the first indication, is that really are a finite number of centers that one needs to call on and support. So a large footprint is not required, but it needs to be a very specialized type of sales rep, very specialized type of clinical support specialist, and MSL team to appropriately commercialize this. So we don't need a large footprint in the US, in Europe, and in Asia, eventually when we get there, it wouldn't require a very large footprint. What probably makes the most sense is for us to think of this product as a very valuable asset for other strategic players who are already in the interventional oncology space. And I think because of that, it probably makes sense to try to not do too many regional partnerships, because I think I'd like to keep this asset somewhat clean for perhaps an eventual strategic partner who might value an asset without a lot of entanglements. So for now, we're not driving for major partnerships. If something comes along that makes sense, we will certainly consider it.

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 DILCAP as we start to continue to analyze the focused trial data, prepare the NDA for metastatic octa-melanoma, and start outlining the development plans for the next indications for HPSADO. 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.