Okay, good afternoon, everyone. Tyler Van Buren here, Senior Biotech Analyst at TD Cowen. Thank you very much for joining TD Cowen's fifth Annual Oncology Innovation Summit. For our next session, we have a fireside chat with Iovance. From Iovance, it's my pleasure to introduce Igor Bilinsky, Chief Operating Officer. Igor, it's a privilege to have you here. Thank you very much for joining me. Tyler, good to be here. Thanks for having us. Before I get started, for those in the audience, if you have any questions, feel free to submit them via the webpage, or you can email them to me at tyler.vanburen or first.last@cowen.com. With that, we'll go ahead and get right into it with the AMTAGVI, formerly lifileucel, melanoma launch. So Igor, during first quarter earnings, you announced that 100+ patients were enrolled and 60 patients are in the screening process. So forgive me, but I have to ask, and if I don't, investors are gonna bug me about it. So do you care to provide an update on the number of patients today? Of course. In the past couple of weeks since the May 9th Q1 earnings call, the number of patients enrolled and in screening continued to increase steadily. We see that as a reflection of the strong demand and the strong launch momentum that we're seeing. I won't provide an update on the specific numbers, but the positive trends that we talked about on the Q1 call. These positive trends continue. Okay. And we got a client question here by the portal before we even started, but the question was: Has the pace of patient tissue collection increased, decreased, or stayed the same since April? It's similar to, as we mentioned on the Q1 call, we're seeing steady month-over-month increase, and that trend continues. Okay, fair enough. So, for the 100 AMTAGVI patients that have been enrolled as of Q1 earnings, potentially more now, can you define exactly what enrolled means and help provide a breakdown of what the distribution of patients is throughout the process, from opting in to tumor resection, manufacturing, and eventually dosing or infusion? Right. So, it is more now. Enrollment begins when an authorized treatment center, or ATC, registers a patient who's treatment-eligible. So when they register the patient for AMTAGVI treatment, that's enrollment. Again, I will not be providing specific breakdown of the numbers. They change every day. But as we mentioned on the Q1 call, the patients who were enrolled at the time, we expect most of them to receive AMTAGVI infusion within Q2 or early Q3. That's the expected timeframe. Okay. Upon approval, I recall that you guys stated it can take up to two months from opting in to the actual infusion of the product, and therefore, revenue recognition or recognition of sales. So is that still the case, or could it be longer for some patients than two months from opting in to infusion? So that's the rough timeline. There are several components to the timeline. The manufacturing process itself is on target. We're tracking to 34 days from the time we receive the sample for manufacturing to AMTAGVI being ready for shipment back to the patient. On the front end, the financial component, again, is proceeding. While it's accelerating, we see it accelerating nicely. The first single case agreements between the treatment center and the payer sometimes take time. It's an important negotiation. But then each subsequent patient goes through the process much, much quicker. And then on the back end, typically, patients, when the AMTAGVI shipment is received at the treatment center, patients then undergo a non-myeloablative lymph depletion and then receive AMTAGVI. That takes about a week. That is somewhat different from the clinical experience, but sometimes that was done early at risk. In the commercial setting, the ATCs typically wait to receive AMTAGVI, but they also have an opportunity to provide bridging therapy for the patient if the patient needs that. In general, the timeline that you outlined, that still stands. Okay. Can you talk about how much attrition there has been with patients, maybe for patients who are being screened to enrollment? Not sure if you could comment on attrition in that group. And then for those that are enrolled to infusion, what attrition looks like there. Tyler, it's too early to disclose the trends. I expect we'll do so perhaps in time with the revenue in the next quarter. But for now, the trends we see are very similar to what we're expecting, so nothing unexpected is happening so far, and we're quite pleased with the progress. Okay. The reasons for a patient not getting an infusion after enrollment, I guess, are kind of spread out. I think on the call, you guys mentioned that some patients, unfortunately, just don't make it. That's rare. That is rare. Okay. But there's a range. Again, as one would expect, some patients don't receive because of patient issues and all the other things that you expect as part of the patient journey, they still happen. But again, the frequency of them happening is what we've been expecting in advance of launch. So again, I cannot share specific numbers today, expect we'll do so in the next couple of months on the next earnings call. Okay. I believe the goal was to expand the number of activated ATCs to 50 by the end of May. Can you confirm that that has happened or? That is on track. That is on track. We're on track to reach 50 by the end of this week, in the next couple of days. And as you recall, we launched with the 30 ATCs at the time of approval, about 30, which is, as far as when I was unprecedented for a first cell therapy launch. And we're tracking very well with the number of ATCs, and we're planning to grow that number to about 70 by the year- end because of the high demand that we've seen from ATCs who want to provide the AMTAGVI as a treatment option for their patients, rather than referring patients elsewhere to the ATCs that are already active. That's great to hear. So of the ATCs that have been activated, what percent has enrolled patients, and what percent has treated or infused patients already? Again, we'll, I'll stay away from the specific numbers for today. But patients have been treated across multiple ATCs today, and in general, the ATCs are doing well in navigating the AMTAGVI journey, particularly the ones who are relatively new. They're doing well, and they also have commented positively back to us on the availability of manufacturing slots and the just overall generally positive experience with the scheduling process, and also the level of support that they are receiving from the Iovance team that's working closely with the ATCs to, first of all, onboard them, but also work with them very closely through the patient treatment journey, and especially through some of the first patients treated. Each ATC, the Iovance team provides very close, close support. Okay, that's good to hear. You mentioned that you guys have had engagement with payers covering, I guess, up to about 90% of covered lives. So when can we expect coverage to get close to that 90% level, and how should it progress through the end of the year? So as of today, AMTAGVI treatment has already been authorized by payers who, in total, cover more than 200 million lives. And, about 13 payers have established published medical coverage policies that are consistent with label and clinical trials and consistent with the recently published updated NCCN guidelines that, of course, now include AMTAGVI. And so far, more than 75% of enrolled patients are covered by private insurance, which is, again, a positive trend and, and attractive for the ATCs. So overall, I would say the reimbursement, financial process is going well on target and, and very much as expected, based on our pre-launch discussions with payers. Okay. Just following up on the launch, what do you expect the launch curve. I mean, well, you clearly stated that you've seen month-over-month increases, since April, as you guys stated on the Q1 call over the last few months. So what should we expect the launch curve to look like through the remainder of the year? So on the reimbursement side, as I mentioned, we're seeing the shortening timelines for the reimbursement review by the payers. That's real, and we're pleased to see that. And the demand, we're seeing so far, steadily increasing demand, and we expect that to continue through the end of the year and beyond, driven both by ATCs that are already onboarded. They may start with one or two patients, and then they ramp up, as well as the additional number of ATCs that are coming online. So the steady ramp we expect to continue for the coming quarters. Just curious, so are these ATCs primarily clinical trial sites, or is it a mix of sites that were involved in clinical trials but not involved? It is a mix. It is a mix. Some, some we've worked with closely in the clinical trials of lifileucel, AMTAGVI, and some are ATCs that are relatively new to lifileucel, but they have, many of them have a lot of cell therapy experience, and many of them are large, large ATCs. Yeah. Can you speak to the capacity for each center and how many patients each center might be able to treat each month? It varies. It varies, and, I think there have been a lot of analyst reports published in the past few months, you know, interviewing AOLs at various ATCs, and the range of numbers came out. That's generally very much the case. So some are small ATCs, and they're seeing a fewer number of patients. Some we're already seeing ramp up quite rapidly, and, so there'll be quite a distribution, which is reflecting the size of these ATCs and their geographic location, the coverage of melanoma patients with melanoma in that area. Okay. And, with respect to the iCTC manufacturing facility, when do you expect expansion of the facility to supply 5,000 patients to occur or be completed? So we started the process. We started the expansion of the manufacturing capacity at iCTC. It's within the existing building, within the existing shell space. As built, iCTC has capacity of over 2,000 patients annually, and we're now building out the shell space to bring it to 5,000 patients annually. The process, construction, and then qualification of the facility is expected to take a couple of years. And that essentially, and if we're matching that closely to the demand forecast that we see from the U.S. market in melanoma, from the expansion to ex-U.S. markets, Europe, Canada, Australia, and beyond, as well as moving to first-line melanoma, the lung cancer demand. So all of that we're taking into account as we're building out our capacity and expanding iCTC. Okay. And a related question, but how big of an opportunity do you believe second-line melanoma is for AMTAGVI in the U.S.? AMTAGVI is the only therapy that's approved for patients with second-line melanoma, those who have progressed on after PD-1 inhibitors. And the market opportunity is significant, citing more than 8,000 patients with melanoma die in the U.S. annually, and that number is increasing year-over-year, and AMTAGVI is really the only product that's approved in the U.S. today that can satisfy that demand. Okay. I have a client question with respect to an update on European markets. So maybe you could describe where you guys are at in terms of filing the MAA and additional ex-U.S. submissions. The filings are on track. We plan to file in the EU, actually in the first half of this year, so within the next month. It's getting pretty close, and we're on track for that. And then in the second half of the year, we plan to file in the U.K., and also the NDS, new drug submission in Canada. And then additional markets such as Australia and beyond are planned potentially for next year. Okay. Previously, you guys have said that you're not planning to partner for ex-US at the moment, because of the potential to kind of dilute the brand, which makes sense, I suppose, as the launch is still over a year away. You know, so I guess, are you maintaining optionality for an acquisition at this point? When does that decision point occur, where you have to decide to take on a partner for an ex-US launch? So we do plan to commercialize and supply AMTAGVI ex U.S., and we have the capacity to supply Europe from... and other markets from iCTC. We've been supplying European clinical trials from iCTC for some time now and have sufficient capacity to provide commercial supply for the European market. And because of the very concentrated nature of the... There are very few ATCs, we're talking in the U.S., you know, 30, 50, 70. In Europe, again, it's a fairly small number, and that does not require a large commercial footprint, which gives us confidence that we can do this on our own. Got a client question that I probably wouldn't ask, but I'm going to ask it anyway. Has there been any acquisition interest from large pharma? Well, it's something that I wouldn't be able to comment on this call anyway, right? Fair enough. That's what I suspected you would say. So, for Proleukin, what magnitude of Proleukin sales can we expect for the year? And, you know, can you comment on how much you might make from each patient, with respect to Proleukin revenue? So we're not providing revenue guidance, not yet. But as a reference, for Proleukin, the WAC per vial is $5,551 per vial, and in the clinical trial, on average, each patient received 18 vials of Proleukin. So do the math, that's the expected gross revenue, and the gross to net is typical for a biologic product. Again, we'll share more specific numbers, but these are the in general strokes, what one would expect from Proleukin. Not bad. Okay. With respect to cash runway, do you guys believe it's possible to achieve profitability with the current cash on hand? Or what is the potential runway and financing plan? So again, because revenue is the big factor for the breakeven equation, and so we're not giving revenue guidance, so we cannot give the breakeven guidance as a consequence. But as far as the financing, if we do need to finance prior to breakeven, we'd expect it would be based on a strong launch trajectory. So we've been very, very prudent and very careful with our spend and our finances. Understood. Let's move to the frontline in melanoma. So the TILVANCE-301 phase III confirmatory trial is ongoing. When could we expect enrollment completion? And what does the AMTAGVI pembro arm need to show for that trial to be successful? So we just, the ASCO abstracts came out last week, and, there's an. We'll have an oral presentation on Friday in the melanoma oral session, on the updated results from the cohort 1A of the IOV-COM-202 trial, which is essentially the patient population that we are enrolling in the TILVANCE-301 trial. And we believe the results that will be presented in ASCO, at ASCO in more detail, are very exciting. About two-thirds of the patients had an ORR of 65%, and that's at least 30% tumor shrinkage. About a third of patients had complete response, and including six PRs that converted to CRs over time. And the tumor shrinkage was reported for all patients who were available with follow-up scans, so 22 out of 23 patients. These results, we believe, are rather unprecedented in that setting and very exciting and bode well for enrollment of the TILVANCE-301 trial and the potential success of the study. These results compare very favorably to immune checkpoint inhibitor monotherapy or combo regimens in first-line melanoma. So stay tuned for more details at ASCO. There'll be more in-depth data presented in addition to what we announced and what was in the abstract. And then we expect to plan to have an investor event in the evening on Friday following the ASCO presentation. So going back to TILVANCE-301, that study is enrolling well. We expect it will get additional boost from this updated, larger patient size release from Cohort 1A, again, similar patient population. But we're not providing the specific dates yet for the completion of enrollment. As you recall, TILVANCE-301 has dual primary endpoints, ORR and PFS. The ORR endpoint can potentially read out before all patients are even enrolled, and that could provide for accelerated approval in first line and confirmatory approval for AMTAGVI in second line. And then PFS would then convert to full approval in first line. Okay, very helpful. So, competitor Obsidian recently reported initial clinical data, and we've started getting questions from investors on the potential competitive threat. So curious to hear your guys' thoughts on that, you know, and the potential competitive impact and the competitive landscape in general for AMTAGVI. Right. So Iovance is the only TIL company to succeed in large-scale clinical development, regulatory approval, manufacturing, scale up, commercialization, and those, each of those are significant steps, and we expect to remain the leader in this space for many years to come, as competition and second line advanced melanoma is likely at least four or five years behind. In parallel, we have a leading portfolio actually of next-generation treatments for better TIL efficacy, and some of them we talked about. Well, one is in the clinic, PD-1 inactivated TIL, that actually just advanced from the safety-leading phase to multicenter phase II. Another one we announced just recently, it's the IL-12 tethered TIL, that's in preclinical development, and we expect to be the next generation of TIL therapy and should be in the clinic, we expect, next year. All of that, the leadership in the commercial space and then the strong pipeline, that next-generation technologies that we don't talk about very much. The focus is very much on the pivotal and late-stage programs and commercial, but we have been investing very significantly to ensure that we remain the leader in this space with next-gen TIL technologies and increase our leadership going forward. Okay. No, that's, that's great. Let's move to lung cancer. Last time I checked, you guys have 6 cohorts across 3 trials, if I'm not mistaken. So maybe you could start by just providing kind of a brief overview and hopefully simplifying it for folks and kind of where people should focus when it comes to lung cancer. So the IOV-LUN-202 trial, it is a potentially registrational trial and includes cohorts one and two, depending on PD-L1 level, TPS less than 1% or unknown in cohort one, and then TPS more than 1% in cohort two. And so that's probably the most important study we have in lung cancer because it's likely to be registrational, and it's enrolling. We recently came off partial clinical hold in fairly record time, less than three months. Working very closely with the FDA, it took us to remove the clinical hold. And that study is expected to enroll fully by next year, by the end of next year. And we're seeing responses in both PD-L1 high and PD-L1 low patients, which is consistent with the mechanism of action of TIL, and that's the trial we're very excited about. The additional cohorts, there's an, we're enrolling frontline, a combination of lifileucel TIL and pembro in frontline non-small cell lung cancer patients. That's an important study as well, but that could be the next step in clinical development, similar to the model we've taken up in melanoma, where we've pursued approval initially in second-line setting and then potentially moving to first-line setting. Okay. For the LUN-202 trial, do you guys believe that cohort 1 TPS less than 1% or cohort 2 TPS greater than 1%, that one is more likely to succeed than the other? We've seen responses in both, and, and, the unmet need on the market may be different depending on the TPS score. But as far as TIL responses, we expect, them to be equally, equally positioned because we, we don't see the, TIL response rates as significantly dependent on the TPS score. Okay. I mean, I guess, for LUN-202 to be successful in those two different cohorts, I guess these are second-line plus patients, right? So the alternatives, especially if your TPS less than 1% is quite limited, are. Have you guys been able to comment on what you need to show from, like, a response rate or duration of response perspective to achieve approval? Right. So I mean, the FDA will be looking at, we expect will be looking at ORR, duration of response, and safety. In terms of the ORR, we expect that the response rate in the 20% range with appropriate median duration of response should be registration enabling. So that's the anchor we have for that target product profile and that indication. Okay. Can we expect an update from the LUN studies sometime soon? It's a registrational trial, so we need to be very judicious about how much data we disclose and when. But we do understand that this trial is an important for investors. The market potential is very significant, and we shared some of the results recently in terms of the durability of response, which is important, and so far has been very promising. Understood. Before we wrap, just a quick client question, maybe you could answer this briefly, is just the BIOSECURE Act and replacement for WuXi, what level of risk do you have related to that? So we believe that if the BIOSECURE Act or its variation becomes law, we do not expect any significant impact on Iovance's ability to supply AMTAGVI commercially or supply TIL for our clinical trials, in part because we built our own iCTC facility to have full control over our capacity, and to date, actually, iCTC has provided most of the commercial supply of AMTAGVI, as well as supplying our clinical trials. So we're not concerned about the legislation going forward. Okay. With that, we'll go ahead and wrap up, but maybe in closing, briefly, Igor, what aspect of the Iovance story do you believe is most underappreciated by investors at the moment? Probably the broad potential of our TIL therapy, TIL cell therapy technology platform to ultimately benefit tens of thousands of patients with solid tumors across numerous indications, across numerous lines of therapy, and being in the commercial setting now provides us data volumes that are multiple times larger than clinical data volumes, which allows us to further accelerate technology development in this space. Okay, tremendous. Igor, thank you very much for your time. Thank you, Tyler. Thanks, team.