Ladies and gentlemen, good morning and welcome to the Delcath Systems Q3 2025 earnings conference call. At this time, all participants are in listen-only mode. A brief question-and-answer session will follow the formal presentation. If anyone requires operator assistance during the conference, please signal the operator by pressing Star and Zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mr. David Hoffman, Delcath's General Counsel. Please go ahead. Thank you, and welcome to Delcath Systems Q3 2025 earnings call. With me on the call are Gerard Michel, Chief Executive Officer; Sandra Pennell, Chief Financial Officer; Kevin Muir, General Manager, Interventional Oncology; Boya Vukovic, Chief Medical Officer; and Martha Rook, Chief Operating Officer. I'd like to begin the call by reading the Safe Harbor Statement. This statement is made pursuant to the safe harbor for forward-looking statements described in the Private Securities Litigation Reform Act of 1995. All statements made on this call, with the exception of historical facts, may be considered forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Although the company believes that expectations and assumptions reflected in these forward-looking statements are reasonable, it makes no assurance that such expectations will prove to have been correct. Actual results may differ in a material manner 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 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. Our press release with our Q3 2025 results is available on our website under the Investor section and includes additional details about our financial results. Our website also has our latest SEC filings, which we encourage you to review. A recording of today's call will be available on our website. Now, I would like to turn the call over to Gerard Michel. Gerard, please proceed. Thank you for joining us today to review our Q3 financial results and business updates. Many of you joined our October 20 business update call, where we reported the compelling results from the investigator-sponsored Chopin trial, and you may have also seen our announcement about the first patient dosed in our CRC trial. I'm immensely proud of our clinical and medical affairs team as they work to bring our technology to an ever-growing set of patients with unresectable liver metastases. On the commercial front, the Q3 was impacted by a number of factors, including the 340B pricing related to NDRA participation, which resulted in an approximate 13% reduction in average revenue per kit sold versus the prior quarter. We expect a similar average price level in the Q4. While there was a slowdown in the pace of site activation from June to August, we have returned to a steadier pace, activating four new sites the past two months. There are currently 25 REMS-certified treatment sites. Major cancer centers continue to show interest in joining, and based on our current conversations, we are planning to begin the 26-28 active treating centers by the end of 2025 and 40 centers by the end of next year. It is important to note that the 40-center target excludes clinical sites, which will appear on our website as required by REMS-related regulations. We aim to build referral networks to these locations, as many of our targeted clinical sites have few metastatic uveal melanoma patients. On our quarterly calls, we will distinguish sites with minimal commercial activity that are clinical sites to give investors a clear understanding of our site activation progress. Currently, one site, City of Hope, is active in the colorectal trial and has not yet treated any metastatic uveal melanoma patients, although they anticipate doing so. To support both the expansion of sites and actively treating sites, as we outlined in previous calls, we grew our U.S. sales force in 2025 from four to six regions, each staffed with a liver-directed therapy manager, oncology manager, and clinical specialist. By the Q2 of 2026, we plan to expand even further to nine regions, enabling the commercial team to both prioritize building referral networks and maintain a steady pace of site activation. As previously reported, in late summer, we experienced a slowdown in new patient starts, partially due to summer seasonality. Each episodic treatment necessitates the collaboration of a trained perfusionist, anesthesiologist, and interventional radiologist after the assessment period. During holiday periods, scheduling capacity challenges are difficult to overcome, and new patients may start alternative therapies. Fortunately, patients currently under treatment continue to return at expected rates, averaging four treatments per patient, and the feedback from oncologists consistently indicates HEPZATO Kit continues to address a significant unmet need for patients with liver metastasis resulting from uveal melanoma. Importantly, we believe the Chopin protocol, which starts with systemic therapy, may provide increased schedule flexibility in clinical practice since some physicians may just decide to extend systemic therapy duration while waiting for HEPZATO treatment team availability. Aside from seasonality, we believe that competition for clinical trials increased in the middle of the year. Specifically, the Replimune sponsor trial for RP2 expanded the number of clinical sites to 24, and Thomas Jefferson continues to initiate their own single-center trials. This competitive dynamic ebbs and flows as new trials start and others end. We're confident that the compelling results from the Chopin trial should lessen the competitive impact from trials as the Chopin data is disseminated and physicians experience firsthand durable patient responses using the Chopin protocol. As you know, as a result of the changes in the rate of new patient starts, last month we adjusted our 2025 annual guidance to $83-$85 million. On our Q2 business update call, we discussed in detail the positive results of the trial that was presented at ESMO by Professor Ellen Capitan from Leiden University. In summary, the primary endpoint was met with one-year PFS significantly higher, at 54.7% in the combination group versus 15.8% in the perfusion group. The combination also significantly improved median overall survival, 23.1 months versus 19.6 months, and best overall response rate, 76.3% versus 39.5%. All results were statistically significant. During the update call, Dr. Vojislav Vukovic discussed the significance of these findings with Dr. Vincent Ma, Assistant Professor and Medical Oncologist at the University of Wisconsin–Madison. Dr. Ma, an experienced user of HEPZATO, expressed that he was impressed by the high objective response rate observed in the Chopin trial. He noted that the Chopin trial results are potentially practice-changing and are consistent with the scientific rationale underlying this combination therapy. The presentation at ESMO and a replay of our call with Dr. Ma is linked on our website. The combination treatment evaluated in Chopin achieved extraordinary efficacy and acceptable safety despite the treatment duration being limited to just 10 weeks with no maintenance therapy. Importantly, no other prospective trial of metastatic uveal melanoma has shown a higher response rate, longer PFS, or OS. In clinical practice, after completing the 10-week Chopin induction period, physicians may choose to add maintenance therapies with the potential to extend the benefits achieved by combining PHP and Ipilnivo as an induction strategy. The option of this combination liver-directed systemic therapy regimen may accelerate uptake, given some oncologists are uncomfortable postponing systemic treatment, and we do know this has caused some patients to consider it appropriate for HEPZATO therapy to be put on other treatments. In addition to addressing barriers related to physicians not wanting to postpone systemic therapy and the episodic scheduling constraints, the Chopin trial should also alleviate the concerns of the subset of physicians who are reluctant to use HEPZATO to treat patients with extrahepatic disease. Despite the fact that the FOCUS trial included patients with extrahepatic metastasis and that hepatic failure is usually the ultimate cause of death, some physicians are reluctant to use liver-directed therapy in patients with extrahepatic disease. Since the CHOPIN protocol obviously includes systemic therapy, which can treat extrahepatic disease, we believe this specific objection will diminish as the CHOPIN results are broadly disseminated. Delcath is actively engaging with healthcare professionals currently using HEPZATO, as well as those planning to utilize it. Our team remains committed to meeting regularly with key opinion leaders to foster transition towards establishing this approach as a first-line option for appropriate patients. With the favorable results from CHOPIN and ongoing positive patient outcomes, our field teams will work with clinicians to better understand how combination therapy might be used to improve patient outcomes. Beyond our current focus on uveal melanoma, we are committed to advancing research and development for HEPZATO. We are confident that HEPZATO and its proprietary hepatic delivery system platform offer substantial potential to improve outcomes for a broad spectrum of patients with liver metastases. As mentioned in earlier calls, we are conducting two company-sponsored trials in liver-dominant metastatic colorectal cancer and liver-dominant metastatic breast cancer. These studies target large patient populations with unmet clinical needs. Both trials have a primary endpoint of hepatic progression-free survival. Patient dosing for the metastatic CRC trial began in August of this year, with enrollment for metastatic breast cancer likely to follow in the Q1 of 2026. For metastatic CRC, we expect the release of interim data as early as the Q2 of 2027, with an anticipated release of primary endpoint results in mid-2028, and overall survival data expected to follow in 2029. For our metastatic breast cancer trial, we anticipate interim data release as early as the Q4 of 2027, with anticipated release of primary endpoint results in mid-2029, and overall survival data expected to follow in 2030. In collaboration with experts and key opinion leaders, we continue to evaluate a number of other tumor types and indications for HEPZATO. There is strong interest in scientific rationale to develop HEPZATO in patients with intrahepatic cholangiocarcinoma, cutaneous metastatic melanoma, and non-small cell lung cancer. Immune checkpoint inhibitors are approved and widely used in these three cancer types, and there are clear areas of unmet need in the subset of these patients with liver metastasis that provide an opportunity to develop HEPZATO in combination with checkpoint inhibitors. It will take another three to six months to finalize development plans for future combination trials and other indications. The team is executing effectively on the clinical front, and we are prepared to pursue new opportunities in various cancer indications. I will now ask Sandra to briefly review our financial results. Thank you, Gerard. Revenue from our sales of HEPZATO was $19.3 million, and CHEMOSAT was $1.3 million for the Q3 of 2025, compared to $10 million for HEPZATO and $1.2 million for CHEMOSAT during the same period in 2024. We recognize gross margins of 87% in the Q3, compared to 85% for the same period in the prior year. Research and development expenses for the quarter were $8.0 million compared to $3.9 million for the same period in the prior year. Selling, general, and administrative expenses for the Q3 were $10.3 million, compared to $7.0 million for the same period in the prior year. Our Q3 2025 net income was $0.8 million, compared to $1.9 million net income in the Q3 of last year. Non-GAAP positive adjusted EBITDA for the Q2 was $5.3 million, compared to positive adjusted EBITDA of $1.0 million for the same period in 2024. We ended the quarter with approximately $89 million in cash and investments, and quarterly positive operating cash flow of $4.8 million, compared to $7.3 million operating cash flow in the Q2. As of today, we have no outstanding debt obligations and no outstanding warrants. Forecast for 2025 gross margins are expected to be between 85%-87%, with continued positive non-GAAP adjusted EBITDA and positive cash flow for the rest of the year. The total HEPZATO treatment volume in 2025 is projected to increase by nearly 150% versus 2024. We thank you all for participating today, and this does conclude our prepared remarks, and I'd ask the operator to open the phone lines for Q&A. Thank you. Ladies and gentlemen, we will now begin the question and answer session. If you would like to ask a question, please press Star and 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press Star and 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the Star keys. Ladies and gentlemen, we will wait for a moment while we poll for questions. The first question comes from the line of Marie Thibault from BTIG. Please go ahead. Good morning. Thanks for taking the questions. I'll keep my questions to just one here. I wanted to understand, I'm glad to see that the pace of center activation has picked up again. I wanted to understand what's built into your Q4 expectations in terms of some of that competitive clinical trial activity you called out in Q3, some of the seasonality. It sounds like it's recovered, but are you expecting any seasonality from the winter holidays? Just a little more granularity on what we should expect for Q4. Thanks for taking the question. Yeah. When we put together that guidance, we did assume there'd be a modest amount of seasonality in the Q4. Keeping in mind that we haven't been through too many seasons to date, it's hard to really know. We were surprised by the summer seasonality, as you know. We assumed it's prudent to put some expectation there. In terms of clinical trial competition, we kind of assumed the same level that we started seeing mid-year. The short answer is we factored both in. Thank you. We take the next question from the line of John Newman from Canaccord Genuity. Please go ahead. Hi there. Thanks for taking my question. I just wondered if you could comment on how you expect the site additions to roll out going forward into 2026 and whether you think the current pace of additions through the balance of 2025 is a good indicator there. Thank you. Yeah. I mean, right now. I think it's probably prudent to assume that the site additions will accelerate in the back half of the year because we're going to have nine regions at that point. I think if you want to do a 40/60 split in terms of them coming on board, that might be reasonable. Okay. Great. Thank you. Thank you. We take the next question from the line of Chase Knickerbocke from Craig Hallum Capital Group. Please go ahead. Good morning. Thanks for taking the questions. This is Jake on for Chase. As you get up to those nine sales territories, are there any steps that the team is taking to improve utilization on some of the lower volume accounts? Yeah. Without a doubt. I mean, I think probably the biggest lever to pull for us in terms of lower utilization sites, or two biggest levers are, one, for sites that aren't getting that many patients. Because some of the sites we initiated were big liver centers that didn't have that many patients but were very interested in the product, us building referral networks to those sites. Again, that's part of the reason for the expansion of the sales force, as well as we've recently expanded the medical affairs team. Probably the second lever to pull, quite frankly, is changing physician prescribing behavior. At some of the lower utilization sites, we've heard things such as, "The patient has extrahepatic metastasis. I'm not confident using liver-directed in this patient upfront." Clinical trials at some of the larger centers take a lot of patients. I think the Chopin data, disseminating that data, is going to be very important to try to blunt that. I think the third thing is where there are some of the higher-using sites that you haven't asked about that are capped out in terms of capacity. I think the Chopin—now, this wasn't the protocol they used—but it's not a stretch to say, "Hey. Docs might put patients on another few weeks of checkpoint inhibitors if they need to wait to get a slot for Hepzato," and still put them on Hepzato. Great. Do you expect Chopin to start impacting utilization sometime in 2026, mid-2026? Twenty-six, yes. I think it would be a stretch to expect to see a step change in the Q4. I think as the quarters roll on in 2026, there's likely to be a meaningful publication that comes out of this trial, hopefully in December. Again, that's out of our hands. It's an investigator-initiated trial. Yeah, I think increasingly as 2026 moves on, that'll be more of an impact. Thank you. That's helpful. Thank you. We take the next question from the line of Sudan Loganathan from Stephens. Please go ahead. Good morning, Delcath team. This is Keith Salvan for Sudan. Thank you for taking my question. Just got a quick one on my end. Since neutropenia is common with trifluridine and tipiracil, bevacizumab, how are investigators addressing this in the phase II HEPZATO/GAAT combo trial? Is this through GCSF usage or dosing adjustments? Thank you. Probably both, but I'm going to ask Vojislav to comment. Sure. You correctly pointed out that the standard of care regimen for colorectal patients in third line can cause some bone marrow toxicity. And we also know that PHP with melphalan can also have hematological toxicity. Patients will be managed using appropriate standard supportive care, and those adjustments and drug holidays will be also factored in. It's all defined in the protocol. GCSF as well. Yeah. Yeah. Yeah. Of course. Right. Standard of care, right? So the answer is yes to both of GCSF and, if necessary, delays in dosing. Okay. Great. Thank you. Thank you. We take the next question from the line of RK from H.C. Wainwright. Please go ahead. Thank you. This is RK from H.C. Wainwright. Good morning, folks. Quick question from me is how to think through your participation in the NDRA program and how we should think about its influence on your profitability and revenue growth not only in 2026 but beyond. What is your long-term plan in terms of trying to sustain growth against the NDRA? Sure. In terms of the NDRA and implications for revenue growth, this is a one-time step down due to the NDRA. We do not anticipate, although we do not know, we do not anticipate there being a dramatic change in average revenue per kit. We have to see, as we sign up new sites, how many of them actually participate. Ninety-some-odd percent of major academic hospitals have an NDRA legal entity. What we are finding is only about half of them end up participating because of where the site of care is for this product. Assuming we continue to have the same rate of participation, the average discount or average reduction, I think, will stay the same. In terms of what that will do in terms of revenue growth overall, does it make a difference on volume? Impossible to know, and I have said this on one-on-one calls unless we have kind of a parallel universe to run an experiment on. I expect that there are some sites that economics did play a role. For such a severe disease, you would hope that was not the case, but it might. Net-net, there is probably some volume increase, but we will never know how much. In terms of profitability, talking about gross margins, I will toss that to Sandra who is sitting right here. Yeah. Hi, RK. Overall. We've mentioned in the past, as we build up the R&D program from a profitability standpoint and a cash flow perspective, it might be a little bit bumpy over the next couple of years. However, from a gross margin perspective, we are still expecting probably 85%-80% into 2026, depending on some cost efficiencies that we can gain. Beyond 2026. Potentially high 80%. I think it's also important to note, with our healthy cash balance, I just don't see any need to raise capital just to get to the bottom line of the issue. Thank you. And one quick question, if I may, as a follow-up. I think on the October 20th call, you were stating you had like 24 active centers. Now you're saying 25 active centers, and you're giving a guidance of adding maybe three more by the end of this year. What's the chance that you can overshoot that 28 number? Any commentary there will be helpful. No. Highly unlikely we'd overshoot it. Are there seven or so on deck? Yes. Do I think four of them are going to come out? No. I think it's one to three. Okay. Thank you. Thanks for that. Thank you. We take the next question from the line of Yale Jen from Laidlaw & Company. Please go ahead. Good morning, and thanks for taking the questions. We understand there's another European investor group that sponsored the study ongoing as a combo with the checkpoint inhibitors. Could you guys give us a little bit of color on the status as well as when they reported data? Was there any impact in terms of the sort of practice of the sequels of the two treatments or any comments on that? Yeah. Yeah. You're referencing the Scandium III trial, I believe. Similar to Chopin, except they've flipped the first drug that's used. They use your CHEMOSAT first, and then they move on to epinephrine. That's recruiting rather slowly. I don't have a timeline at all as to when. I'd love to have a timeline, but I don't have a timeline right now for when that might read out. I think it's kind of in the too distant future right now for projection purposes to think about. Okay. Great. That's helpful. Maybe just one more here. Given that you will have a constant growth in the top line, but at the same time, you will have increased expenses on the R&D side, especially when you start the second breast cancer trials. Could you give us a little bit of color in terms of how the capital allocation between those two events, those things you are planning? Yeah. In terms of that capital allocation, I think we're really taking this on a program-by-program basis. It's actually how I work with the board. We have a fixed R&D budget every year for either ongoing trials, in this case, CRC and breast, as well as a fixed budget for IITs. We do our homework on, I'll pick one, non-small cell lung cancer we're digging into now in combination with checkpoint inhibitors. We're going to look at the protocol, the subset of patients. I suspect it will make a lot of sense to do it, but we have a lot of homework yet to do. If it looks like a positive NPV project, not to sound like an MBA student here, but basically, if it looks like it makes sense, stands in its merits, we've got plenty of capital on the balance sheet, I think we can fund it off of our own top line. As I've said before, if something looks really compelling and the cost of capital is adequate, we fund it in other means. We'll pick up the programs one at a time. I'm not sitting here with a fixed R&D budget in mind. Instead, again, we look at it on a program-by-program basis. Okay. Great. That's very helpful. Just congrats on continuing to chugging along. Thank you. Thank you. We take the next question from the line of Bill Mahon from Clearstream. Please go ahead. Good morning and thanks, Bill, from Clearstream. After Chopin kind of broadly validated systemic treatment with HEPZATO, trying to read that through to breast and colorectal. Given that it's not a combination with IO, but it is a combination between HEPZATO and systemic, how much read-through do you see from the success of Chopin into these new combinations? Do you see the potential or attraction for adding in maybe a checkpoint inhibitor to that treatment paradigm in those specific indications? Yeah. In terms of right now, those trials are both sequenced with systemic chemo, which has factoring toxicities. That's one of the hassles we've had with, or obstacles we've had with, trying to integrate this therapy into existing treatment protocols. That's one of the beauties of working with checkpoint inhibitors, is that you don't fundamentally have stacking toxicities. You mentioned colorectal. That is, as well as some subsets of breast, don't use checkpoint inhibitors. In colorectal, liver mets are the most common thing. The portal vein, which goes right into the liver, is exposed almost immediately with either antigens from the tumor or tumor cells themselves. There is a theory out there that the reason checkpoint inhibitors don't work in much of CRC is because of the exposure to the liver, which increases systemic immune tolerance. Maybe we could make cold tumors hot, to use an old phrase. And Vojislav, who's sitting here with me, has talked to a variety of KOLs about that. We're still kind of thinking through that one. Our first areas to go after are places where IOs are firmly established, have good efficacy, and there are high rates of liver mets, for example, non-small cell lung cancer, cutaneous melanoma, ICC. Just maybe a little more granular one. You specifically called out Thomas Jefferson as a hospital that's running its own trials and potentially competing with you for patient enrollment. Can you quantify that at all? Let me see. Vojislav, do you know how many patients Thomas Jefferson has in their single-center trials? That's why I pulled them. They probably, more than anybody else, have their own single-center trial. Lots of centers do single-center trials, but Thomas Jefferson and uveal melanoma is probably top of the list. How many? 109 patients. 109 patients for their single-center trials. Yeah. That's the most current one. Other centers run trials of 20, 30 patients, and Thomas Jefferson's the one that we are referencing. The combination of liver-directed and immunotherapy is 109 patients. Yeah. Thanks. Thank you. Thank you.