Greetings and welcome to the Delcath Systems’ Third Quarter 2024 Earnings Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce Mr. David Hoffman, Delcath General Counsel. Thank you. You may begin.

Thank you. And once again, welcome to Delcath Systems third quarter 2024 earnings and business highlights call. With me on the call are Gerard Michel, Chief Executive Officer; Sandra Pennell, Senior Vice President of Finance; Kevin Muir, General Manager, Interventional Oncology; Vojislav 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 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 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 third quarter 2024 results is available on our website under the Investors 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 everyone for joining us. This past quarter's results continued the strong growth we have seen since the launch of HEPZATO KIT this past January. I am very encouraged by our progress with both center activations and treatment rates. In the third quarter we reported $11.2 million in total revenue, including $10 million in US revenue from HEPZATO and $1.2 million in European revenue from CHEMOSAT. As we have previously reported, the $10 million in quarterly HEPZATO revenue was a critical milestone, triggering an approximately $25 million financing from warrant exercises. The key drivers of our revenue ramp in the US are center activation and the average number of treatments per center. In terms of center activation, we finished the quarter with 11 active centers, with an additional center becoming active in October and as of today we have 12 active centers. In the third quarter we activated Massachusetts General Hospital, Ohio State, Honor Health and University California San Diego. In early October we activated Duke and we have another center scheduled to treat their first patient in the next two weeks. There are a further five centers which recently complete fully completed preceptorships and have started screening for their first patient. We should exit the year with at least 15 treating centers and sometime in the first quarter have 20 treating centers. Our 2025 goal is 30 centers by the end of the year. Importantly, and to reiterate for prior calls, we haven't seen any center in the activation process halt the process. I'm very proud of our progress with center activations and I appreciate our investors patience and understanding regarding the complexity of the process and the inherent variability in the time required to activate a center. Now I'd like to delve into a second important metric.…

Thank you, Gerard. Revenue from our sales of HEPZATO was $10 million and CHEMOSAT was $1.2 million for the three months ended September 30, 2024, compared to $0.4 million for CHEMOSAT during the same period in 2023. Revenue grew 44% over the second quarter of 2024. Gross margins were 85% in the third quarter. For the three months ended September 30, 2024, research and development expenses were $3.9 million compared to $4.6 million for the three months ended September 30, 2023. The change in research and development expenses is primarily due to lower costs associated with the expanded access program incurred in previous periods, offset by an increase in medical affairs and regulatory costs associated with an improved product. For the three months ended September 30, 2024, compared to the same period in 2023, selling general and administrative expenses increased to $7 million from $6.2 million. The increase is due to activities for commercial launch, including marketing related expenses and additional personnel in the commercial team. We ended Q3 with $14 million in cash investments and cash used in operations was approximately $3.6 million in the third quarter compared to $4.5 million in the previous quarter. On August 1, the loan with Avenue fully matured and on October 30 the loan with Roslyn fully matured and final payment was made on both. As of today, we have no outstanding debt obligations. All Tranche B warrants from the March 29, 2023 pipe were exercised by the November 6, 2024 expiration date, resulting in approximately $25 million in proceeds. We do expect our cash from operations and the cash received from the recent warrant exercises to sustain operations through profitability and begin to fund trials into additional indications. That concludes our prepared remarks. And I'd ask the operator to open the phone lines for Q&A. Can you please check for questions.

Thank you. At this time, we will conduct a question-and-answer session. [Operator Instructions] Our first question comes from Marie Thibault with BTIG. Please proceed. Marie, your line is live.

Hello, can you hear me?

Yes, we can hear you.

Hey, this is Alex on for Marie. I just wanted to ask a question of clarification since you mentioned that Q4 this coming quarter, due to the dynamics of the holiday season, we expect to see some fewer treatment days. So, is this like a cadence that we can expect moving forward? Like, is this going to be a seasonality? Do you expect this to be the case as we move forward with the launch in like 2025 and beyond?

Yeah. So, we've, you know, starting several weeks back, we started querying both the interventional radiologists, the medical oncologists about what they thought the pace would be over the holidays for typical infused chemotherapy. You probably don't see much seasonality. This is a procedure. In the clinical trial, there was a certain amount of flexibility of timing between treatments. Remember, the max of six. And I think what patients are doing, not all, but some patients are choosing to spend the holidays with their families and push a treatment off into January, perhaps. So, we don't think we're going to lose any business. So, one and a half to two weeks is our best guess for the fewer number of treatment phase in the fourth quarter. It is at this time an estimate. I do think there will be seasonality, the degree of seasonality, you've got my best guess right now what it will be. But I want to emphasize that these are not, this is not lost business. This is business that gets stretched out into the following year.

Great, thank you. And I just had a follow up since you guys mentioned that you guys are going to start two phase II RCTs and colorectal and breast cancer next year. So how should we think about the increase in R&D spend with these RCTs?

Yes, you know, Q4, R&D expenses should be relatively flat from Q3, but the new indication expense is more relevant in 2025. You know, at this point, the full year R&D should probably range anywhere from $35 million to $40 million at this time. That includes base R&D as well as new indications.

Great, thank you so much.

The next question comes from John Newman with Canaccord. Please proceed. John Newman, your line is live. Next question comes from Sudan Loganathan with Stephens, please proceed.

Yes, thanks for taking my questions and congrats on the great quarter on the execution side. So my question is kind of pinging off again, the seasonality or what to expect with the fourth quarter. Does that also mean that preceptorship and kind of onboarding of sites are kind of will be done before kind of the holiday season or during some of these weeks? Will there be kind of a break in kind of completing that process for some of the ones coming on board?

Yeah, definitely. I think just as with preceptors are done at treatments; proctorships are done at treatments. So yeah, they will by definition be a slowdown there. You know, I'd highlight we have a good five plus out there actively now seeking patients. So, we do have a good pipeline of sites ready to go. I don't think it'll slow down. You know, I don't think, I don't think that would have a material effect on our overall progress in terms of projections, in terms of site activation.

Gotcha. Okay. And then my follow up is just on kind of the, on the financial side, the $3.6 million warrants at the $10 exercise price you have expiring in December 2024, I believe, and some in May 2025. Is these funds also kind of year marked or expected to kind of hit and also really help with the, you know, the launch of these trials next year or just how are you viewing, you know, the cash inflow not just from the business but also from these other from the warrants that you have.

Gonna hand this off to Sandra so she can reply.

Yeah, right now we are not including that additional $36 million in our cash forecast in terms of what we need to fund additional indications and the business. We believe that our cash on hand and the $25 million that came in from the Tranche B warrant as well as cash earned from revenue and operations should fund these syndications.

Gotcha. I appreciate it. Thanks for the answer to the questions. And congrats again on the quarters.

The next question comes from Swayampakula Ramakanth with H.C. Wainwright. Please proceed.

Thank you. Good morning, Gerard and Sandra. Just trying to understand some of the metrics around the number of treatments some of these physicians are performing. Is the interval between treatments similar to what you had seen in the FOCUS trial? And also, you know, compared to what physicians experience during the trial, how is the real world experience looking? If you have any anecdotal information that will be helpful.

Sure. So, I think most of the treatments are still occurring between six to eight weeks. Some might stretch out a little longer. And I suspect what we'll find is that patients who had a treatment sometime early, mid, early fourth quarter will likely have longer than six to eight weeks because again, they may postpone it to be with their family for the holidays. But in general, we're seeing six to eight weeks in normal course. In terms of anecdotes, let me hand it off to Kevin because he's got a wealth of anecdotes. So, want to give a few that are helpful?

Yeah. Okay. Our field sales team attends all the PHP procedures, and thus far, the treating physicians and the medical oncologists have been generally positive with the outcomes that they're achieving with HEPZATO KIT. When you go to the number of procedures, the treatment centers which opened up in Q1 and Q2, so the beginning of this year, they're just now completing their fourth and fifth treatment. So, the medical community as well as we are, we're very excited about the outcomes that we'll see, and we'll have more information when the patients complete their cycles.

Perfect.

And I would add the message we're getting back from the medical oncologist and the IRS, and it's anecdotal, but they generally believe the response rate they're seeing are far greater than what we've seen in the focus trial. Now, whether or not that's absolutely true or not is hard to say. It may have to do with patient selection. We may have gotten, unfortunately, the worst of the worst in the focus trial. I think we're getting patients earlier on now, and there's again, anecdotally, they're all claiming they see much better response rates to the point they're saying, well, what did you do differently? We haven't done anything differently. In general, they're very, very pleased with the results we're seeing.

Perfect, then. Kevin, I have a couple more questions. Maybe it's you, Gerard, on the SCANDIUM and the CHOPIN trials. So do you think these studies by themselves are enough to get in front of the FDA for indication expansion or once you get data from these two studies, you may have to do another study in the US as well to get in front of the FDA.

There's nothing that prohibits physicians now from sequencing these products. So, I don't believe indication expansion would really be necessary. And I don't think we really necessarily have to push for that at all. I think that the important thing is it opens the door for kind of theoretically, maybe even a basket trial for patients have been on IO therapy across a number of different cancer types and start failing once they have liver mets, which is a very, very common dilemma for patients. I think that opens up the opportunity for us looking across cancer types to do a trial for patients who are failing on IO. But in terms of Metastatic Uveal Melanoma, I think the data will be, the data and the doctors will have, will act appropriately. And I don't think we need to seek any type of regulatory adjustment or label expansion.

Perfect. Perfect. Great. Thanks for taking my questions and talk to you folks soon.

The next question comes from John Newman with Canaccord. Please proceed.

Hi, guys. Good morning. Thanks for taking my questions. You know, I'm curious what types of data we might expect to see from the CHOPIN trial next year. And then also just timing on the PRC and breast cancer trials that you're expected to start next year. Just curious as to how you're thinking about enrollment there? Thanks.

Sure. I'm going to ask Vojo to answer those questions.

Hey, John. This is Vojo Vukovic. Thanks for your questions. I think your first one was regarding the CHOPIN trial data. As Gerard mentioned earlier during the prepared remarks, the enrollment of this 76-patient large randomized phase II trial is complete. That's not standing. The patients are undergoing treatment. And based on the information that we have, the investigators are expecting the data readouts mid next year, which would put them in a position to present the data in the second half of next year. It's a randomized trial. It's a blinded trial. We do not have data insight, so we cannot share any information beyond what we just said. And the second question was really, I think, regarding recruitment of patients into the upcoming colorectal and breast cancer trials. Is that correct?

Yes.

Okay, so we plan to start operational activities, including patient enrollment on both trials in the course of next year. We've initiated activities on both trials and we expect recruitment to start mid '25 for colorectal and towards the end of '25 for the breast cancer trials. These trials are randomized trials, 90 patients each, and we expect that the enrollment will take approximately two years.

Great. Thank you.

[Operator Instructions] Our next question comes from Yale Jen with Laidlaw. Please proceed.

Good morning and thanks for taking the question. My first one is that giving the ramp up is very well. It's doing very well. Are you guys already started approaching the medical oncologist and getting more referral and getting a greater awareness of them or that some something that you would do maybe starting next year?

Yeah. Kevin's team is definitely approaching medical oncologists at centers where we're not treating. It happens. We're getting a fair number of referrals right now to active sites. And now admittedly, most of those referrals, not all of them, many of those referrals are coming from centers that are going through the preceptorship and training program. They want to treat patients. They're not up and running yet, either because of training or sometimes it's just committee reviews, and sometimes they're just structurally every six months or something. So, we're getting referrals from those. We have gotten referrals from centers we're not targeting. One of our sites is all referrals. They had essentially no uveal melanoma business to speak of. So, they're all referrals. And what we have to do is partner with the oncologist. The way Kevin has set this up is we talk to the oncologists and we say, hey, are you interested in getting referrals? We tell them. They generally say yes. We ask them, where are your patients coming from now? In our teams, you know, I'll remind you that every one of our four regions has a clinical support specialist who's in every procedure and make sure things go smoothly. We have a liver directed manager who their job is to open the centers and kind of manage them. And then the third component is an oncology manager in each region we have. And their job is to develop those referral networks. It's still early days for us to be successful. You know, we're going to have to, I think, you know, we're going to have to really lean heavily into referrals next year and the year thereafter to be successful. But, yeah, we're well on our way. We're learning how to do it. It's a very fragmented market, but, you know, we'll get there. And yes, we're having success with referrals, but we, you know, we got to do better and we will do better.

Okay, great. That's very helpful. Maybe another question here is that you anticipate to start a CRC, the trial in CRC mid later in breast. Just curious what sort of clinical data or clinical information you had so far to support these two indications to pursue.

Yeah, sure. So, the first set of data we're going to have is from colorectal is primarily from a surgical procedure called intrahepatic perfusion. This, the concept of the hepatic delivery system, CHEMOSAT HEPZATO, really came from a surgical procedure that is rarely done nowadays, if ever, because of very high levels of morbidity and mortality. But essentially, doctors at a number of sites, Leiden University, unsurprisingly, a site in Sweden, and then I think the other one was Pittsburgh, would basically take the liver, put it on a heart lung machine, for lack of a better way to explain it, and put very high doses of chemo, usually melting into the liver. Two of the places that was most commonly done were uveal melanoma as well as colorectal. So, there's very strong data. And I could take a look at our investor day deck. We've summarized some of that data in colorectal. So, whether or not surgically you're putting high doses of Methylene in or whether or not you're doing it with our HDS, we would expect to see the same results. And I think that the ORR in those studies were about in the high 50s or low 60s, if I remember correctly. So that's the data there for breast cancer. It's thinner. It's based on about a dozen or so patients across a number of different centers in Europe over the years. We've seen some profound responses, in fact, some complete responses in breast cancer patients. So, we've seen some pretty good response rates. And breast cancer carcinoma, breast cancer is generally more susceptible to chemo as well. So, I think there's a very good rationale for use it here. So, about a dozen patients across centers, we've seen some response rates, and just the general type of tumor that it is gives us some hope that this will be a good thing for patients.

Okay, great. That's very helpful. And congrats again on the great quarter.

The next question comes from Chase Knickerbocker with Craig Hallum. Please proceed.

Good morning. Thanks for taking the questions. Maybe just to start, are we learning more kind of about how long it takes to fully activate a center? I know we kind of asked this question last quarter as well, but kind of any new thinking there? And then speak to kind of how those learnings kind of inform your confidence that you'll get eight of these kind of 10 centers that are in the works activated at some point in Q1, and then any of those centers that look you know, like a similar profile to your three largest customers. Thanks.

Yeah. What we're learning is it's very, very, very hard to predict. You could be flying through it and then hit, I don't want to say a roadblock, but hit, you know, something that takes a bit of time. Someone in a billing finance group might say, look, I need to talk to somebody who want to see the EOBs. How much did they get paid? And then the hospitals are very, very protective of that. We got to find someone to talk to somebody. It could be all of a sudden the profusionist leaves and we better train somebody else. It's a long list of n equals one, issues that usually slows this down. So, it's very hard to predict. This is a very, very complex activation process. With that said, we are getting it done. And once we're done, we're done. I'm guessing the mean timeframe now, and I'm looking across to Kevin and see what kind of face he makes at me. But I'm guessing the mean activation time now is north of six months. Six to nine months. You know, when we started, guess what, it was a couple months, because those are the first ones that came on board. But in terms of competence of getting to the 20. Yeah, we'll get there. I think we'll get there in the first quarter. I've been surprised by how long some take, and I've also been surprised by how productive some centers are. So, we've, you know, net, we're doing just fine compared to our projections. In terms anybody else going to pop up and be like the top three centers? Yeah, I think at least one of those in that mix that we're activating should be, you know, a top four performer. So, yeah, we've got some strong, some players with some strong book of business in terms of uveal melanoma patients in that list.

Great. And then, yeah, I think many agree that CHOPIN data, if you kind of show anything similar to what we saw in earlier stages, could be transformative for the company. Can you kind of help us decode kind of what it means for you commercially if that does occur? Kind of walk us through how you see, you know, reasonable usage, expanding with a data set that kind of recreates what we've seen to a degree.

Yeah, if it recreates what we've seen, I would argue that this becomes standard of care. And, you know, I would say it increases the ramp of uptake, obviously, increases the peak penetration obviously. It may change the dynamic of when patients get treatments, if it replicates CHOPIN, I suspect what we'll see is patients will get too. And then they will pause while they're on maintenance therapy with Ipi/Nivo. But unfortunately, these patients all do eventually progress and then they will come back and get additional HEPZATO treatments. I think you won't notice that in any increased ramp because you're going to get a lot more patients coming in, even though some patients, some of the treatments get stretched out, later treatments. But yeah, I think the simple answer is bigger peak revenue, faster ramp.

And then just last from me, any thoughts and sorry if I missed this earlier, any thoughts on kind of the amount of R&D investments incrementally that will be required for these two studies? Gerard or Sandra? Thanks.

Sure. And I could add one more thing to the prior question and Vojo was scribbling on a piece of paper because it's a big issue with him. You know, one of the dynamics we had early on and it's decreasing is, you know, people look at this product, the Medox, and go, it's old school chemo, not terribly exciting. You know, if there's something unique going on with the liver as an immune regulating organ and combining it with checkpoint inhibitors with HEPZATO, there'll be a strong surge of interest in medical oncologists both within uveal melanoma and outside uveal melanoma. So that's an important point to mention as well. But Sandra, could you answer questions about R&D?

Yes. Hi, Chase. You know, Q4, R&D expenses should be relatively flat from Q3, but as we move into new indications in these trials and potentially IITs in 2025, we can expect R&D ranging anywhere from $35 million to $40 million, depending on the timing. That's including the base R&D as well as new indications.

Great. Thanks, guys. Congrats on progress.

Thank you. At this time, I would like to turn the call back to management for closing comments.

Okay. I want to thank everybody for joining today and I look forward to giving future updates on both our commercial uptake and importantly, our future efforts in both colorectal cancer and breast cancer. Thanks so much everybody for paying attention and joining today. Goodbye.

Thank you. This does conclude today's teleconference. You may disconnect your lines at this time. Thank you for your participation and have a great day.