All right, thank you guys. Good morning, everyone, and thank you for joining us on our next session. Up here on the front, we have a few members of the management team from Iovance. Peter Peteros, Senior Vice President of Medical Affairs, as well as Jim Ziegler, Executive Vice President of Commercial. Iovance, a commercial company, on the early stages of the launch of their new melanoma drug, Amtagvi. We just came away from ASCO, where physicians were obviously talking about the early experience. We also may have Fred Vogt, the interim CEO, join us as well up on the stage. He's running just a couple minutes behind. Maybe I would just start off with an easy question around talking about the early progress of the launch. Again, that was the theme coming away from ASCO. You've given some metrics around the launch on the earnings call. So I would love for you just to talk about some of those metrics, put a little bit more light and meat on the bone on some of those, and the confidence around the launch of Amtagvi. Mike, good morning. Thank you everyone for having us. My name is Jim Ziegler, and I lead the commercial team. We're very excited about where we are with the commercial launch. As you know, we had approval on February 16th. Our last Earnings Call was on May 9th. What we said upon approval is that we had 30 ATCs ready to go. On the last Earnings Call, we announced that we had 50, and our goal is to have more than 70 by the end of the year. I think the number of ATCs that we're launching with is unprecedented and reflects the unmet need and the sense of urgency that our providers have in treating these patients. As Mike said, we came out of ASCO. There was many KOL engagements with existing and new centers, and quite frankly, other centers that want to become an ATC. But I think the most important thing is the patients. We had an opportunity to listen to a couple of patient forums, and that's what it's all about for autologous cell therapy. In terms of the number of patients, on the last Earnings Call, we announced that we had more than 100 enrolled patients. So an enrolled patient basically means that the ATC has done the clinical workup for that patient. Generally, what happens right after that is the financial clearance between the ATC and the payer. But I think that really reflects how the patients are moving through the patient journey. What we also said is that many of these patients that we talked about on the last Earnings Call would become revenue patients in the second or third quarter, given the patient journey. Fantastic. Okay, so can you talk a little bit about the journey? You know, you have 100 patients that have enrolled. Enrolled means fill out the forms. The physician has presumably, you know, written a script, but they filled out the forms, and they're trying to get access to the drug. How long does it take to get reimbursement? There's commercial, there's CMS. How long does it take? When would that be? How far can that get down to? How fast does that happen, so that could shorten the time to get this access to the drug, so you could book revenues faster? Thanks, Mike, And get the drug sooner, but yeah. Thanks, Mike. So in our corporate deck, we do have the patient journey, so I'll just summarize some of the information there. After a multidisciplinary Tumor Board, which is often comprised of surgeon, med onc, and cell therapy, they're making the clinical decision. Either in parallel or right after that, they start working on the financial clearance. For any of you with experience with previous CAR T-cell therapies, what you'll understand is that reimbursement definitely improves over time for inpatient-delivered cell therapies. We expect the same. In fact, most of my team comes in with prior cell therapy experience, and we're very pleased with the progress that we're making. In general, prior auth will take a couple of days. We say three days in the corporate slide deck. In terms of the financial clearance overall, including single case agreements, could take anywhere between 2-6 weeks, with the idea that as a center and a payer gets more experienced, that timeframe becomes shorter and shorter. So 2-6 weeks, and then, without summarizing this part, 21-45 days from vein-to-vein to manufacture the drug, schedule the Cy/Flu, and then induce, infuse the patient. Yeah. Thanks, Mike. Okay. What we're saying is, 37 days turnaround time. 37 turnaround, yeah. Yep, followed by non-myeloablative lymphodepletion, which is 7 days, followed by Amtagvi infusion. Right. Okay. And what are the milestones to accelerate the reimbursement? Could you announce commercial contracts, which would then not have to be single case agreements- that are going through? In which case, okay, boom, he's got Cigna. Boom- yeah, he should be able to plan the resection next week. Yeah, that's a terrific question, Mike. Other CAR Ts have not necessarily entered into contracts with the payers. We don't anticipate doing the same. But what happens is, you know, when the ATC negotiates a single case agreement with a certain payer, they basically establish the foundation and the baseline, so the next one becomes faster and easier, right? The great news for us is, even on the last earnings call, what we announced was that payers responsible for more than 200 million covered lives have already approved Amtagvi for their patients. So that's reflective of the strong reimbursement, which is guided candidly by our clinical data, our broad label, and NCCN guidelines. As you may recall, back in April, just 60 days after approval- Sure NCCN, listed Amtagvi as the only FDA-approved second-line treatment. Right. Yeah. Do you believe that the time for reimbursement could shrink from 2 to 6 weeks and come down, so that as we go through each quarter or month, it's actually getting faster, so that you should be able to book revenues and get those patients, those 100 patients that have enrolled faster? Generally speaking, that's exactly right, Mike, and you've covered other CAR T, so you know that- Initially there's a lot of talk about reimbursement. Over time, it tends to dissipate because- Okay You have more established reimbursement out there. Now, another interesting metric that people are focused on, but I think it is important, is that those 100 patients that have enrolled, you are actually getting more sites up, and then more of those existing sites, as we heard at ASCO, they're getting more comfortable so that they should be writing more scripts more per month or planning more as they get more comfortable. So would you expect that to accelerate or- So 100. And by the way, I think you've sort of implied 160 or another 60 are coming, so maybe talk about that. Right, right. That those sites, this is not just a bolus per se, or at least we're early in the bolus, so these numbers should continue to remain strong and get bigger every quarter. Thanks, Mike. That's a terrific question. So, on the last earnings call, we said 100 patients enrolled- and another 60 that were in the workup phase that we were actually tracking, with the centers. So yes, what I would underscore is that we've had strong month-over-month growth, with more patients being treated at the existing centers, and then as you pointed out, as we onboard the new centers, they will start to ramp up over time as well. Okay. Our goal is to make sure that, you know, every patient that's enrolled gets treated and has successful outcomes. So, you know, we wanna do it in a deliberate, thoughtful manner. How has that been as well? You have 100 - 160, you know, that have enrolled. Can you talk about the success rate of the process, implying the number of patients who are able to go from getting enrolled to actually getting the drug? Because in many cases, these are pretty sick patients. This was a comment on the call. I think people are sort of nervous that maybe not all those people are gonna come. There's gonna be some dropout because they're pretty sick and are going to hospices, and then there's also a proportion of patients that may not get it, so you shouldn't be putting all 100 specifically in the numbers, because some of the manufacturing may be, quote, unquote, "out of spec." So can you just talk about how to adjust for those, and is that a factor that you feel okay about? Or maybe the patients will get healthier because these are the most sick patients early on, so don't worry about that metric. That's actually gonna get better. I don't know Thanks, Mike. Another great question. I can't provide specific guidance, but let me try to at least give some characterization of the patients and the journey- and what's taken place. So like other cell therapies, at launch, there's an unmet need. Many patients are calling our centers about this therapy and trying to get on. Some of the patients may not qualify, they may not have performance status to be eligible for treatment. So like other cell therapies, there is a dropout rate, and while I can't characterize the number, I think you can discern similar trends as with the early CAR Ts, our launches and our cells, but over time, patient selection gets much better. It is tough, you know this, especially with some of the multiple myeloma- products. The need is so much greater, and you wanna be able to offer this to as many patients as possible, but not all patients necessarily qualify. Can you give a ballpark percent that you would think is reasonable, or what was from the trials that we should know from an expectation standpoint? What I probably can't in the commercial setting. I think it would be offering more details than what we've shared publicly. Okay. But I would say, Mike, you're very astute in this area. You know, look at the other cell therapies, and you can- Okay make a generalization in, for your models. It's not much different or wildly different than what the other CAR Ts are seeing and from your clinical trials? Exactly. Now, in terms of as we get through the year, as you progress on this, can you talk a little bit about. While there's no formal financial guidance, the company has said that they expect that the first-year launch could be at least as good as the first generation CD19 CAR Ts. So people have tracked this, and since I've covered Gilead for a long time- I have the Gilead Yescarta numbers. That was around $150 million-$160 million for the first four quarters. You actually have easier reimbursement, and there is no specific financial guidance, but you have at least used that metric, so people think that that's a range. That's sort of where consensus is. Do you have a number you think you can get to, or at what point you'd help Wall Street think about financial guidance? We're—we haven't provided guidance. Our intent, today is not to provide guidance, but maybe I can again try to help characterize some of the details. Okay. So unlike other markets, where an epi-based model is very simple, you take patients, market share, time, all, this is a different kind of market, right? And you have to think about all the patients nationwide, and the reason why we were so focused on getting, you know, appropriate centers nationwide available is to make sure that there's access, distributed across the country. Even with 50, if you did simple math, that's like one per state, right? Of course, we are concentrated- in the, you know, metropolitan service areas where the patients are, but that was one of the major drivers, to make sure that patients had appropriate access, you know, going forward. So that, you know, if you think about all the different treatment centers and how many patients they would treat, that's probably an appropriate analog, as you know, Mike. The one thing I would say is, you know, the diffuse large B-cell lymphoma and multiple myeloma markets are bigger than our target first indication here. But I feel very confident that, you know, we have the team, the strategy, the structure in place to get this treatment available to as many patients as possible. You know, we're a startup company without the billion-dollar war chest, but I think we're being very competitive in how we've gone to market here, with the solid- So that was a reasonable analog, and you feel confident that you have the resources and the capabilities to have a similar launch- Yes is what you're saying? Okay. There's Fred right, coming in right here. Okay, Fred, financial guidance. No, I'm kidding. Fred, thanks for joining us. The question that Jim, he already gave the financial guidance. No. All jokes aside, Fred, before you take a breath from having just come in from the train, maybe you could also provide your perspective about the early launch and your confidence on hitting the types of numbers that Yescarta did early on, and that were the consensus numbers are early on. Because there seems to be a great discussion this year about whether Iovance can deliver on numbers this year. Yeah, we're really confident. We've got. I'm sure Jim covered this, but the main things that are giving us confidence is the existing ATCs are ramping up. Okay. New ATCs are coming on. We're at 50 now, obviously, and going up from that. And then we've got community referrals now starting too, and you heard—if you were at ASCO, you heard we had a community physician there. You were there. W as talking about the referral that's being repeated 50 times over the country, and so that's, that's driving a lot of referrals. So what we're seeing now is infusions are ramping up, and infusions are what matters. That's the, that's the revenue-generating event for the company. So to be clear, at the big ATC centers, where they may have existing melanoma patients, now they're getting referrals from community practices, sending them over to the academic center. So now we're getting actual referrals coming in, patients that were not actually being treated at that site- Correct. But they were referrals now. Yeah. So the- Now Jim's team- The queue is getting bigger. That's right, and Jim's team is going to be starting to drive that. We've got more people out there, and we're going to be adding more people to that to drive that further. We didn't want to do that right out of the gate instantly, because you don't want to overwhelm your manufacturing right away. It takes some time. So we're ramping up- manufacturing at the same time while we're doing this. Can you talk a little bit about this idea that in the first couple of quarters, that maybe some of these numbers, which are pretty strong, by the way, is more about a bolus? And so some people think that the numbers are strong, but it's just these patients that are this pool, who are out there, who direly need a drug, but overall that this bolus is going to moderate. You don't think it's a bolus or that it's early on, and these numbers are actually going to continue to accelerate. I, you know, Don Lawrence at ASCO called it... What did he call it? A surge. A surge, okay. A different, different word. Whatever you want to call it, it's, there's a lot of patients that have been waiting in this line because there has not been any option for them besides Dacarbazine or recycling checkpoints. -which is what they're doing in clinical trials. So those patients are coming through. Some of them are in bad shape, some of them are in better shape. They're being bridged right now. I think what's going to happen is that'll, that'll moderate, but the organic growth will, will be there. So we're in the midst of that right now. We're seeing a lot of those patients still today, right? Yep. They're coming through right now. I'm sure you guys talked about it before. You know, new patients that are newly diagnosed are coming too. Yes. The idea would be a couple quarters into the launch, you're seeing almost all newly diagnosed patients at that point, which are frankly the ones that are going to get the better outcomes, probably. Right, and are healthier- and are going to get through the process. They get through the process. better T-cells, et c, et c. Yeah. Okay, and then just finishing off on that comment, putting that together since Fred sat down as the interim CEO. You know, is there a point where, rather than us having to guess on quarters, that financial guidance is something you'd provide later this year or for 2025? How are you thinking about it sitting in the CEO seat at Iovance? We're considering providing guidance sooner rather than later right now. Because we want to make it really clear to the Street, you know, especially about infusions. There's also some... Iovance is a little bit more complicated than the CAR T companies. The CAR T companies recognize revenue just like we do on infusion of their cell product. But we have Proleukin too. So what's going to happen with us is you're going to see a leading indicator of Proleukin sales. Proleukin sales- The revenue is recognized when you sell to the specialty distributor or you sell directly to the ATC. So there'll be a surge of Proleukin revenue, or, or not a surge, but Proleukin revenue starts soon, and then Amtagvi revenue comes behind it. So that one's a leading and one's a lagging indicator, kind of the launch performance. So with that in mind, we may provide some guidance to help you guys understand that, because we don't want that to, to come out and people have, you know, a, a difficult- Wait, clarify that. So yes, Proleukin is the IL-2 portion that is administered after the infusion of Amtagvi. Yes. Yeah, actually- Well, yes, and, without getting into the details of, well, some analysts include the Amtagvi in the total revenue, other people sort of break it out. You know, the idea is that that is a up to 10%-20% of the total cost of the, of the therapy, and that you're saying that you're going to see sales of Amtagvi, what, through third-party channels like IMS go up, and that that's a leading indicator? Or you're just- Yeah, you want to see- Yeah, I want to focus on sales of Amtagvi. Yeah, so what you're going to see... Let me explain it again- Right Maybe a little more clearly. Yeah. You're going to see sales of Proleukin- Yeah -to specialty distributors. Now, you can't pick that up in IMS Health or Symphony type data, 'cause they're specialty distributors deal. We use an SD model primarily- Got it -for the distribution of this product, for good reason. It has a lot of benefits to us. The revenue from those sales gets recognized, potentially many weeks in advance- Got it -of the revenue from a linked Amtagvi- Yes -uh, sale. Yep. So imagine a single patient. Yep. That patient's 18 vials of Proleukin could be two months ahead of their Amtagvi infusion. Yep. Yep. Okay. They typically hold, what, 30-60 days- Mm-hmm -inventory. So the 3 PLs are willing to buy the product ahead of time and then sell it to the ATC. Oh, in other words, the sales of Amtagvi are a good leading indicator for the future quarter, month, et cetera, et cetera. So that should also give you some early signals to the demand- Exactly for the next quarter for Amtagvi. Think about it like economic leading and lagging- Yeah -lagging indicators, right? That's, that's what it will show. So one will surge first, and the other one will come behind it. Okay. So would you, since Wall Street's not always so smart, can you-- are you going to give some financial guidance for the Amtagvi part too? That's what we're thinking. Okay. We're thinking we'd probably break it down- Okay. - So people can see how it will fit together. Okay, good. So it's 'cause just because the CAR T launches will not be like for like on this. Yeah. Okay. So again, to summarize that part, you feel confident on the early demand. Jim commented on the numbers that have already been enrolled. Reimbursement is shortening, getting better- More sites are coming on, and there's community referrals now coming in. So overall, you feel very good about it, and you're in fact thinking about giving some financial guidance that would help people put that all together. Yeah, I think that's a good summary. Okay. Yeah. Quick question. Yeah, okay. the $0.7 million of Proleukin- In 1Q, was that ex-U.S. sales only, or does that include some U.S.? I think it was primarily, ex-US sales, right, Jim? Yes. Yeah, so we do some. They can be quite significant. That was a small number. We can do significant ex-US sales of that product. I think that was largely ex-US. Thank you. So in the second quarter, when you report the second quarter later in July, August, you would be reporting revenues in Amtagvi and Proleukin or just one revenue line, basically? Yeah. There'll be one revenue line, but we'll probably provide some detail as to how- Okay. and Amtagvi Okay. and Proleukin contribute to that. All right. And then- Let's pull this together in the last few minutes that we have with the idea that, on one hand, there's a first-line melanoma study ongoing. Can you maybe just summarize that and your confidence about being able to enroll that study and deliver and when those results would come? Because getting to first line would be pretty important- Yeah, so- to expanding this market. Thanks, Mike. So, at ASCO, we presented our cohort 1A results- Yeah - which were very exciting. We saw an objective response rate of nearly 2/3 of patients, and 30% of patients had a complete response by strict RECIST criteria. That's really unprecedented, the rate, durability, and in patients who are checkpoint naive. So we really feel that there's a role here for lifileucel in the first line for a variety of factors. One, if you look at patients who are treated with first-line combination immune checkpoint, at least half of those have no benefit. Furthermore, you need a effective, durable, end therapy that has really a limited long-term side effect profile. So we really feel lifileucel is set for that. Our ongoing phase 3 confirmatory trial, TILVANCE, is global in scope, so includes countries that have a high incidence of melanoma and those that use anti-PD-1 monotherapy. That continues to enroll, and we expect that to- to continue to enroll pretty successfully. Okay. And remember, you just saw an ORR 65%- Yep and our primary endpoint in TILVANCE's ORR, the first primary endpoint. We have dual primary endpoints, so we can get approval on one. We don't need both. Right. Well, I, I'd even go one step further is since PFS and survival are pretty important, that your CR rate was so high. I totally agree. that presumably those patients are not going to progress very quickly. So that is gonna drive 30% of the PFS curve, and should provide a longer tail or a higher tail, because a lot of melanoma patients, it's really all in the first, the progressions are all in the first part of the curve. Right. And then presumably with IO, you should be able to drive a better tail. So if you think about the PFS and the OS, if you can be patient, that those would be a much stronger results than Keytruda alone. And remember, six of those CRs were actually PRs, so they deepened over time. Interesting. Now, with respect to PFS- Yeah we're going to read ORR- Yeah like 2-3 years from now. Yeah. PFS might be like 4, 4 years from now. Okay, okay. You can get approval just on ORR. Yeah. Got it. So I agree with you completely, but we're very focused on- Yep getting the earliest possible approval. Yep. First look should be positive on ORR. Obviously, that should beat Key, Keytruda alone. We follow that out from a more fundamental perspective, that the quality of the data is clearly going to support a stronger result on PFS as well. Yeah, but the supplemental BLA will go off of ORR. Yes. Right? Yeah. We'll turn right around and file that BLA. Fantastic.