I'm Andrew Tsai, Senior Biotech Analyst at Jefferies, and it's my pleasure to have the Iovance team with me. To my direct left is Corleen Roche, CFO, and to her left is Fred Vogt, Interim CEO, President, and General Counsel. Welcome, both of you. Thanks. Thanks for having us. For investors, briefly, who are less familiar with the story or revisiting the story, can you please give us an overview about Iovance, what you're doing at the company, what programs you have, and then milestones over the next 6- 12 months would be very helpful. Sure. Iovance, we believe, is the largest independent cell therapy company in the world right now. We're fast becoming a juggernaut across all aspects of cell therapy, from the earliest stage next generation assets, all the way through to the commercial assets right now. We manufacture and produce TIL therapies, tumor-infiltrating lymphocyte therapies. We've got a very large commercial launch underway right now with our product called AMTAGVI. It's one of the key pillars of our organization right now. That launch is going really well, accelerating very rapidly, including in the community with treatment centers that are coming on board frequently this year. As you go back in our pipeline, we have all sorts of interesting catalysts and additional indications ranging from non-small cell lung cancer. Andrew asked about stuff in the next six months. I think you'll see more from us in the next six months on non-small cell, which we can talk about more as we go here. Sure. All the way through to early phase assets, including the first IL-12 tethered TIL therapy now that we just announced recently was cleared by the FDA to enter the clinic. We've got registrational programs underway now in two sarcomas based on data we announced this year. We've got what could be a registrational program going in serous endometrial carcinoma based on data we announced just a few weeks ago at earnings. I'm sure we'll get into all the details as we go here, but we're the big leader in this space across all aspects of it. Great. Thank you. To start high level, AMTAGVI, it's growing nicely. Sounds like Q2 will rebound nicely. Big picture, second-line melanoma, remind us the total addressable market to help us frame what kind of peak sales this drug could have ultimately. Globally, in melanoma, we should be able to reach more than 30,000 patients in the markets that we think are the ideal markets for cell therapy. In the U.S. alone, we expect peak sales to reach over $1 billion from AMTAGVI and Proleukin combined at some point over the next couple of years as we develop and grow. It's a relatively large market. We have the non-small cell lung cancer market, which is about 7x that and many other markets besides that. Okay. There's plenty of penetration or room for peak sales to grow. Plenty of room for us to go. Obviously, this year we guided to $350 million-$370 million right now. We're aiming to beat that. We'll talk more about that, I'm sure, today. Yep. You're talking about two years into the launch right now. Great. Thanks for setting that framework. As for the launch itself, big picture also is just conceptually, as we think about 2026, 2027, the key drivers behind the launch to get it to accelerate even faster. Maybe talk about your key priorities for increased adoption? Yeah. Right now we have some really key drivers, and I know we'll touch on real world data at some point here. The evidence that we have out there, both from our original clinical trial that got us approved as well as real world evidence, paints a very compelling picture for AMTAGVI as the product of choice in the second-line setting. Response rates as high as 52%. Sure. Ask about this. At ASCO we showed some data. We've been showing a lot of data that strongly suggests that about half of those patients are functionally cured of their cancer. It's a very successful therapy. It works really well. It's a driver for growth and commercialization because we can communicate all that with prescribers and with payers and with patients. We are driving very hard right now towards 110 or more than 110 ATCs, or what we call authorized treatment centers, in the U.S. and a few outside the U.S. right now. A lot of those, and we'll probably talk more about this at second quarter earnings, are community centers, meaning large community oncology practices in the U.S. where the bulk of patients right now are being seen. That part of our launch is really accelerating. The academic medical centers, which are the backbone of the initial part of the launch, are doing very well, too. Quite a few of them are continuing to grow and we're still onboarding some of the large academic medical centers. Okay. Great to hear. Those are really the drivers of the launch. Yep. You mentioned ASCO. Yeah, it'd be nice to dig in a little bit more. Long-term survivorship, it sounded as if 50% of the patients from the clinical studies are functionally cured after 10 years, and it sounds as if their mortality rate is in line with a normal patient. Is that one of the takeaways? Yeah. Share more details about that? Yeah. Yeah. The poster at ASCO, and there's other data we've put out before, including the five-year overall survival data from 144-01, our main registrational study, all suggests that when you get a deep response to AMTAGVI, you're not going to relapse. This is actually consistent with the original data from the National Institutes of Health, Steve Rosenberg's data, where he saw the same thing. He had a number that sticks in my head. If the patient was in response, there was a 96% chance that patient would not recur 10 years later in one of his papers that he published a few years ago. We're seeing the same results with our TIL therapy, and that's what we showed at ASCO in that poster you mentioned. I see. You're taking this data as well as the clinical data to educate the community to treat earlier, because treating earlier does matter. Yeah. Absolutely. The real-world data that we put out at ASTCT, a conference in February of this year, shows that when you treat in the second line, you get a 52% response rate. When you treat in the third line, it falls to 33%. Second line is on label. We can treat at second line. That's what we show them, and that data's been very useful with prescribers and with patients. Okay. As we think about the launch so far, in Q1, most recently, typically or historically, you've had this kind of manufacturing period. It's fairly short, but it does impact your sales and perhaps margins, and I think that's somewhat of what we saw in Q1. The question is, going forward though, can we expect anything like that, or have you kind of fixed this kind of dynamic? The short answer is no, don't expect that going forward because we now have all of our manufacturing in-house with the ability to have continuous supply. We achieved that through the upgrades in Q1. Let me take it in two parts. Little bit of impact to AMTAGVI revenue, about $5 million. It was down $5 million- $60 million in Q1. The revenue did absorb the period of time that we needed for the upgrades, that is the last time we need to do that. Great. Looking ahead, I think during the Q1 earnings call, you mentioned how coming out of that maintenance period, maybe April, the patient uptake was looking the strongest ever for that month. I'm curious, May, June, how's that looking? Is the momentum sustaining as we think about Q2? Just to remind you, we did guide product revenue for Q2. AMTAGVI was $79 million-$81 million, so a big move from Q1 of $60 million. Why are we so sure about that? Couple things. The demand signal is really strong, and we had our strongest revenue month in March. I know you can't see that because you're just looking at Q1. However, that gives us, I guess, a good ability to forecast Q2. Also, we have visibility into the quarter, so when we gave that guidance, think about we know what patients are enrolled, what patients had resections, and when they're planned for manufacturing for those batches. Visibility, to be clear, because it takes a little bit of time for payer access and then the manufacturing turnaround time, maybe a month. That's how you have the visibility? Exactly. That's how we have the visibility. Okay. As we think about your full-year guidance, looks like $350 million-$370 million. If I added your Q1, Q2 sales with your Q2 guidance together, it's about $158 million. That means maybe $200 million implied for second half of this year at the midpoint. Do you have line of sight into that ramp, that second half ramp by chance? Yes. Based on what we know, we feel very comfortable with that guidance, and that's why we guided the range that we did, and I think we're also pushing wherever we can to do more. Is there room then to potentially beat and raise through as the quarters come by? Is this kind of fairly accurate type of guide? I don't know how to use the right word. Potentially. I'll keep you posted. Okay. Sounds good. As we think about revenues, then margins as well, and they've been steadily improving on a quarterly basis. Of course, Q1 is kind of an exception this time, but again, it won't happen again. Come Q2, I'm curious, Q2 AMTAGVI sales should be the strongest ever it feels like. Compare that to Q4 margin. I forget, maybe your Q4 gross margin was 50%. Should we expect Q2 gross margins to look even better compared to Q4 is the question. I'm not guiding the margin, but I will tell you too that the Q1 margin had a one-time non-recurring impact, so expect to think about it in terms of Q4. Okay. In terms conceptually though, as sales grow on a quarterly basis, by year-end, we should get better margins. Outer years, we should get even better margins? Where should we go? That's the goal. That's for sure the goal. Yeah. Remind us what kind of margins you've guided to that peak? Well, we haven't guided specifically to margin, but we want to get to the level of about 70% long-term. Yeah. That's pretty standard in the industry for a company of this nature. We think that's doable based on what we know today about how we can improve efficiencies in manufacturing, scale, volume, this kind of thing. Owning our own facility is a huge part of that, and having it be a relatively large footprint, shutting down the CMO and getting some of the lower margin stuff out of there. Okay. Very good. As you scale, you've done a good job curving expenses along the way. I think you reduced OpEx to about $100 million a quarter now. Is there more room for improvement, more cost-cutting, or are we kind of at the floor at this juncture? I would say there's room for efficiencies. I mean, we'll have to invest here and there as we grow, but we're keeping it under control with very strong financial discipline. Okay. As we think about expansion opportunities, I actually lose track of your ex-U.S. progress, so can you please remind me where you are on the regulatory side of things, which countries are approved ex-U.S.? I think you just had approval today. We just announced something yesterday on that last day after market yesterday. Yeah, we just had an approval we announced last night after market in Australia. The Therapeutic Goods Administration approved AMTAGVI. Australia obviously has the highest incidence rate of melanoma in the Western markets. We're really excited about that market long term. We're going to have an ATC up and running there relatively soon for private pay patients, and we'll enter, and we are entered into the reimbursement process, which as I'm sure you know, outside the U.S. takes a while. It could take some time to negotiate, and we want to make sure we have consistent pricing approaches in other countries too, because we've got the U.K. pending right now. We've got Switzerland pending as well. We also have Canada already approved, same deal there. We will probably talk a little bit more about additional markets soon and some of the other things that we're planning in that area for melanoma. Other high instance markets, Western markets that we think can work, or countries where you see a lot of medical tourism or patient concentration into particular metro areas. I see. In those certain regions, it would be your intention to market independently at the structure? Yes. Are you open to a partnership? Yeah, we may partner with distributors in certain areas, but we would not partner in any kind of significant way on a JV type structure. We would be only in a distribution agreement with minimal financial impact to us. Okay. Bigger picture, again, sales are growing nicely. It is a high unmet need for this indication. There are technically competitors in the horizon potentially, maybe speak to your differentiation, first and foremost, and why you think AMTAGVI is unaffected should there be increased competition down the road. I don't think there's going to be any near-term competition for AMTAGVI in the first place, meaning in the next couple of years. There's a competitor out there that's got multiple CRLs and is attempting again to get approval based on some data that they showed at ASCO, which it's difficult for us to understand why that would alter the FDA's thinking for them. They also showed some OS data, which is not something FDA considers in an accelerated approval. They also showed that their median duration of response fell dramatically, which is something FDA does consider in an accelerated approval for single-arm studies. I just don't know exactly how that's going to work out. You've heard me many times, probably at one of these conferences before, I talked about this and you can go read the CRL and it pretty much matches what I was saying back then. There's another competitor in the TIL space that's really very far behind us, many years, doesn't have the scale, the manufacturing capacity. It's hard for people sitting in a room like this to understand, but Iovance has enormous scale and enormous moat around its intangible and tangible property to make this stuff. We are the leaders in this space. It's very hard to catch up with this level of capital investment that's in here, and now we're really looking to drive that forwards and leverage that out and make sure we get some successful returns for investors. Right. As we think about your indication expansion opportunities, out of curiosity, you have your own center. How many doses can you supply each year, out of curiosity? At least 5,000 patients a year, and I wouldn't be surprised if you hear us take that number up quite a bit. Okay As we continue to work on efficiencies. Sticking with melanoma, second, now in the pipeline, there's a first-line melanoma study, the TILVANCE Study. You're trying to move upstream, ultimately, in that study. Can you remind us, I think the study actually has a dual purpose. Can you just remind us the latest and greatest on the regulatory side of things, what you have agreement on with the FDA? Yeah. First, let me just say that the reason we run that study is because in oncology, as a general rule, you want to put your most effective therapies first with patients. We have, I just mentioned earlier, the real-world data shows a 52% response rate in second-line patients with AMTAGVI. We have Steven Rosenberg's data in the frontline population before checkpoints were even approved that shows 56%, I think, was the response rate back then. No checkpoint alone, including pembrolizumab, gets to that level, 33% versus 50%. Really, the therapy of choice should really be frontline. That's what TILVANCE-301 is designed to do, is put it in the frontline. Now, that study is set up to both confirm the benefit of the accelerated approval, which we already have in the U.S., as well as obtain another accelerated approval in the frontline and a confirmatory full traditional approval in the frontline. It does three for the price of one. It does that through an interim analysis. I don't know how much detail you want to get into here, but basically, there's an interim analysis that will allow us to confirm the benefit in the second line and get the accelerated approval in the frontline, and then it reads out finally to confirm the frontline. Great. For the second line confirmatory, is it PFS or ORR that gets you? For the interim analysis, it's going to be ORR to get you accelerated approval in the frontline and PFS to confirm the benefit in the second line. Okay. When you read again later at the end of the study for PFS, that confirms the frontline. Thank you. There's no OS endpoint. There's a secondary OS, but OS is not a regulatory- Very clear. ...primary endpoint in the study. Very clear. Which is actually really important. And- We have crossover in the study too, which would be confounding on that endpoint. Oh, I see. Which FDA allowed us to do. Okay. That's good. You just mentioned PD-1 in first line mono. Sounds like they do 30% ORR, give or take. Yep. That's what's on the label. That's the bar to beat kind of thing. Yeah. That study, I should have mentioned, that study we're running in combination with pembrolizumab versus pembrolizumab. Yeah. Contribution of elements is sorted out by that. It also puts us in combination with the preferred single agent in the frontline setting right now. Okay. We think that study will perform better than ipi/nivo does in the frontline setting, which is the current, really the bar, if you want to think about it from commercial, regulatory bar is yes, pembro. Yeah. Ipi/nivo is the commercial bar. We have to beat that. Understood, ipi/nivo. How's enrollment go? This is a 670 patient study. How's enrollment going? Any color when we might get the interim? Not yet. It's going well. It's only 600 patients in the main analysis set. 70 patients are adjuvant patients. We're exploring them as well. It's running. It's at a lot of centers. We had a lot of excitement about it at ASCO. We had an investigators meeting in the middle of ASCO that I attended myself and was really thrilled to hear some of the stories of how fast patients were responding and how deep they were responding. It's really, in the words of one of our investigators, is an extraordinarily powerful therapy in the frontline setting for these patients. Like I said earlier, if you put a patient into a CR very quickly in a couple of weeks, the odds are 10 years from now, very good that that patient will still be like that. Okay. Exciting. Moving on to second-line lung now, in a pivotal phase II also going after the accelerated approval approach, here actually it's an open label study. I think what is the hurdle, I guess, or the regulatory pathway? What do you need to show in this upcoming update in second half 2026 to be able to file and get an approval? I think you've guided an accelerated approval maybe second half of 2027? Second half, yeah. Yeah. Yeah. We're nearly, obviously you can from those timelines estimate that we're nearly complete on enrollment right now, which is true. That's where we are. The regulatory bar for this, well, the regulatory decision for an accelerated approval is going to be based on ORR supported by median DOR and DOR. As you know, we put out data already showing the ORR was 26%, and this is just within the last six months we put this data out, and median DOR was not reached with 25 months of follow-up. It's looking good for this patient population right now, and I think we'll see in the final analysis what it looks like. We have to do an IRC read, if it continues to hold up at that level, that should be enough for us to get approval on the second line non-small cell lung setting. I see. When you share the data later this year, do you intend to press release first and then share it at a medical conference? What is the kind of disclosure strategy? Got to figure that out, but it's probably going to be a press release followed by a medical, because just the timing of these things, the medical conferences don't line up well with some of the things we want to do as a company. We're very devoted to getting stuff out at medical conferences so you can see the full data set. Yeah. We always play that game. Stay tuned and we'll see what happens. Sure. The bottom line is you're close to completing the enrollment target of around, is it 80 patients? Yeah, roughly 80 patients. Okay. It'll be a sizable readout because off of memory the last cut was about 39 patients. Yeah, it'll be about double that. Okay. That's right. Yep. Okay. Is there a strategy for now to go first line also in lung? There could be. We will have to have a confirmatory study, and so we'll talk about that probably around the same time that we put the data out to tell you what our strategy is, because that's obviously something we must be talking with the FDA around the same time. It's possible it'll be in frontline, it's possible it'll be in second line. It's possible to do both. Obviously, we think that TILs work best in the frontline setting, but with an indication as large as lung, you can really enroll very quickly into a second line study. If you're going to go head to head with docetaxel with something that has a higher ORR and clearly a much better mDOR, you think you probably would win on PFS. You may run that study. It might be faster and easier. Right. We'll figure out. We're working on that hard right now. Great. I guess relatively recently there have been FDA changes at CBER with a B, by chance, have you spoken to the FDA recently to reconfirm you have an accelerated approval pathway for second line, for instance? We have, and we think we do, and we're in constant contact with the FDA. The management changes there are really not affecting the day-to-day review team and the teams we meet with when we have our Type B/C/D meetings and those kind of exchanges. We just recently got fast track for lung, and I think that helped confirm a lot of the analysis that we were doing, and you can just assume it's true. We are in constant contact with them. We're constantly having meetings on one thing or another. Yes, we feel pretty comfortable that nothing's changed on that front. Okay, good to hear. Shifting to some of your other programs, cancer programs, I think endometrial, you had some initial phase II data, was it earlier this year? Can you share? It's just a few weeks ago in May we put out. Okay. It's all a blur. We have a 40% response rate in a small initial number of patients in serous endometrial, which is the most deadly histological subtype of endometrial cancer. We also have data we put out three months prior to that in two sarcomas, UPS, which is undifferentiated pleomorphic sarcoma and dedifferentiated liposarcoma, or DDLPS. Both of those showed very high response rates, 50% response rates. That's an indication that doesn't have checkpoint approved in the front line, and we can really go post-chemo and really do some good there because you're not selecting off the patients that are the good IO responders by giving them checkpoint. We'll get them all coming through. Those are both, all three of them are both. All three of them are good shots at getting additional approvals in the very near future on single arm trials. I see. This, like for instance, the endometrial program where you showed data, the current study, is it designed as a pivotal type study? It is. You just need to accrue more patients kind of thing? Correct. Okay. Yeah. Any color how many patients you need? Is 30% enough and satisfactory for FDA approval? It's 40%, but yeah. 40%. Yeah, I think that would be more than enough for FDA with some good durability, which we'll have to generate. Typically, for these single arm trials for accelerated approvals in oncology, you're seeing about 80 patients. 80 patients you said. 80 patients. Yeah, we have a lot of approvals, especially for biomarker or smaller populations like UPS and DDLPS, as well as serous endometrial. There's been a number of approvals over the last two years coming up through the summer where people have gotten on about 80 patients. We anticipate probably something similar. In each one of those cases, we're talking to FDA, getting that feedback, making sure we make those adjustments right away. Okay. The two rare sarcoma studies where you saw a 50%-55% OR. You mentioned there's no PD-1, just chemo, it feels like the bar was a bit lower. Is that fair to say? The bar is low on all of them. There's nothing available for any of these lines. Yes, when you're dealing with UPS and DDLPS, you're looking at chemo most of the time, anthracycline in the frontline setting, which has lower response rates and very poor durability in many cases. Okay. We'll be coming in behind that for the accelerated approval. We could always try to move up into the frontline setting. Okay. Any color when we might get more data cuts for these? Not yet. There's a lot of conferences at the end of the year where sarcoma is a good option to present. Just stay tuned on that front. Okay. Clearly, we want to get the data out soon so you can see the full scope of it. Sure. How big are these indications? They're a substantial size. If you put all three of them together, you're larger than melanoma. You put UPS and DDLPS together, it's about 70%-some of melanoma, we think. Okay. A couple thousand patients a year in each one of them. Sizable. Okay. Maybe finally then, unless you have more in the pipeline that you wanted to mention, but I did want to ask about this new, I think it was like an IL-12 tethered program. Yeah. We just announced that a couple weeks ago. Can you maybe describe what that is or the differentiation? I'd be keen to understand more. IL-12 is a cytokine that's been in everybody's mind for the last 40 years as one of the most powerful cytokines to potentially achieve an anticancer response. It's a very pro-inflammatory cytokine. The problem with it has been how to control it. When given systemically, it causes toxicities. When given through different injection approaches or through devices and stuff like that, there's been all sorts of complications. At the NCI in 2015, Steven Rosenberg published his work on an IL-12-secreting TIL, and he had, with very low cell doses, about 100 to tenfold lower than what we give today, he had a 63% objective response rate in those patients. In particular, we saw patients, he had a patient who we personally know, actually. who received regular TIL therapy, like AMTAGVI, relapsed, and then was given IL-12 tethered TIL or IL-12 secreting TIL therapy at a dose that was about 100-fold less than what she got in the front line, the initial thing, and she went into a 10-year response. When we have a longitudinal patient like that, you know there's something hot there. Both Steve Rosenberg and I, and the teams have been looking at this for years. Steve had developed the tethered technology. We licensed all this at NCI a few years ago, and now we're taking this concept with some additional bells and whistles on it that we've added to it into the clinic. We think it has the potential to turn immunologically cold tumors hot, and that's why you see us targeting things like colorectal, triple-negative, HER2-low breast, and more. I see. It really could expand the platform to hundreds of thousands of patients, and this is something you can't do with a bispecific, you can't do it with a T-cell engager. There's nothing else out there for these patients that works like this. If this works, it could truly be the game changer. That's why we're so excited about it. I see. That's starting phase I or II? Phase I safety, but it will roll directly into phase II. Okay. Very good. In a basket that's got a modular IND, so we've got the ability to add indications, but we've already got a whole number of them in there. Okay. Anything else you wanted to mention from the pipeline? I know you're working on a lot. Yeah, we have two other good assets, IOV-4001, which is our PD-1 knockout, and we could be putting data on that out soon, too. That's another one that's, I think, up for discussion with investors so they can see what we're cooking there. We've got IOV-3001, which is our IL-2 analog that abrogates some of the side effects of IL-2, of Proleukin, which we own, the product that we use today, but without giving up some of the efficacy and the T-cell growth factor performance that we want to have. That's also in safety right now and is in dose escalation, and we could have an update on that, too. Great. We can talk about some of that data. Maybe finally, Corleen, cash position, and then how should we think about From here, do you have enough cash to see everything through as you're scaling, for instance, and potentially turn profitable? Maybe talk about the cash. Our last disclosure regarding cash was about $320 million at the end of Q1. We've said that we're expecting that to fund operations into 2028. However, how are we going to go further than that? I am obviously doing this every day. I'm looking at when we can be profitable. Increase revenue, increase margins, and control spend. That's the main goal, and I think we can get there. Thank you very much for the update. I appreciate it, and thank you everyone for listening.