Delcath Systems, Inc. (NASDAQ:DCTH) Q3 2023 Earnings Call Transcript

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Gerard Michel: Yeah. So we are having the conversations with sites or had the conversation with sites. It varies by site. That — we plan — we’d like to transition EAP patients over to commercial patients once commercial supply is available. With the exception, of course, if a patient doesn’t have coverage, we wouldn’t stop treating them. That the way we set up the protocol is it’s not an automatic. We can’t force that, and there are some important reasons why we chose not to set it up so that we could force it. But I don’t know whether or not it will be a third or half but there’ll be some meaningful percentage of the patients that we’ll treat in the first quarter will be patients who switch over from EAP.

Yale Jen: Okay. That’s very helpful and thanks a lot for the details and congrats — again, congrats on the progress.

Gerard Michel: Thanks so much, Yale.

Operator: The next question comes from Swayampakula Ramakanth with H.C. Wainwright. Please go ahead.

Unidentified Participant: Thank you. This is RK from H.C. Wainwright. In terms of getting centers ready in your — when you start launching the drug — the kit in January, as you’re preparing some of these hospitals, are you getting a feel for like how long it’s taking for some of these doctor teams or the surgery teams in terms of training and — so that they can start doing their surgeries? And do you see that — and also, how do you think that, that training time is going to evolve as you launch in more of the physician teams start training.

Gerard Michel: Yeah. So in terms of how long, it really varies. We have one site that immediately jumped on it and got their preceptorship done within a month or so of having a discussion, maybe a month or two, having a discussion with them. We have other sites that, again, I’ve used in term on multiple calls or one-on-ones herding (ph) cats where it’s been very difficult to get an interventional radiologists and anesthesiologists and prefusionist all attending the case at the same time, which requires an airplane flight, et cetera. So I think that’s the reason why — one of the reasons why I’m saying, look, we’ll probably have 11 sites — well, we’re planning on having 11 sites receptor, hopefully, within about two months plus.

But of those, I think five will end up getting proctored, is that then we have to look at a team of experienced Docs. And right now, that’s just Moffit because we have a requirement that they need to have done a certain number in the recent past that Moffit’s the only one that checks off that box as well as some European sites. We expect there’ll be some issues with experienced sites. We’re getting an experience site to preceptive site. So that will be the second gating item. Again, it’s going to be — it’s tough to predict. That’s where we’re saying out of the 11 that we think we’ll have 10 prececeptor ships, maybe five will get on board. And we can’t really decide which — we don’t know exactly which five it will be. Thereafter, as more sites do more cases and more sites get beyond the — I think it’s 10 cases they have to do before they can be a proctor.

Once they get beyond the 10 cases, all of a sudden, we’ll have multiple experienced sites that can proctor. And I think towards the back end of next year, that’s when it will really accelerate. And it will be a lot simpler to get sites up and running. So varied, hard to predict. It will take much longer in the beginning of this year than it will towards the end — the beginning of next year, then it will take towards the end of next year as more and more sites are available to be proctors. So hopefully, that answers the question, RK, which is basically, it depends.

Unidentified Participant: No, I got that. And then in terms of, how do you see hospitals and even Docs (ph) trying to get on treatment — treating with HEPZATO KIT versus KIMMTRAK. And when you go in to have some of these conversations, what sort of conversations that you end up having. And do you think you will be able to get any of the things to move from KIMMTRAK to the kit.

Gerard Michel: Yeah, I think — well, Kevin, why don’t you give an example from a commercial rep perspective, what will the conversation be?

Kevin Muir: Yeah. I don’t think that we will replace KIMMTRAK with HEPZATO KIT. The conversations that we’ve had in the field right now have been — have revolved around potential to use these two therapies in sequence. What’s the best sequence? How can they complement each other? Ultimately, these patients are probably going to go at least on two lines of treatment, if not three. So what is the order that is going to provide these patients with the best options and ultimately, the longest overall survival. So that’s where the conversations have been really focusing around, not so much on the either/or between HEPZATO KIT or KIMMTRAK.

Unidentified Participant: Very good. That’s good to hear. Thank you.

Gerard Michel: And I think it’s also important to remember, and I think everyone on this call does remember this, but the KIMMTRAK has indicated for about 40% to 45% of the overall population. So this is a subset of the patients that we – this conversation is pertinent to – but I think everybody knows that, but worth highlighting.

Unidentified Participant: Thanks, Gerard. Thanks for taking my questions.

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

Gerard Michel: Okay. Well, I want to thank everyone for taking the time this afternoon. I look forward to providing future updates regarding the launch and subsequent to that commercial uptake. Thank you, everyone, and have a good evening.

Operator: The conference has now concluded. Thank you for attending today’s presentation. You may now disconnect

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