Iovance Biotherapeutics, Inc. (IOVA) Earnings Call Transcript & Summary

Hello, everyone, and thank you for joining us today at the Goldman Sachs Global Healthcare Conference. We are so pleased to be joined by Jean-Marc Bellemin and Friedrich Finckenstein from Iovance Biotherapeutics to give us an update on where things are and where things are headed through the rest of 2021.

So to begin, let's start with the discussion of Iovance's core technology, which is a cell therapy technology called tumor-infiltrating lymphocytes or TILs. So at kind of first pass, can we start at a big picture level describing what TILs are and how they're employed as a therapeutic by Iovance?

Sure. Thank you, Madhu. I would like to give an introduction of Iovance, and again, thank you for hosting us at the conference. So TIL technology is designed to enable a patient to fight their cancer with their own cells. TIL are immune cells naturally found in the body regularly attacking cancer causing cells. When a person gets cancer, the disease prevails over the TIL cells, and they are not able to do their normal job. The basis of TIL therapy originally started by Dr. Steve Rosenberg at NCI is to expand and rejuvenate the TIL outside the body and deliver back a much higher quantity of rejuvenated cells to the patient. We do have a proprietary TIL processes and production. So what do we do? We resect the tumor sample so that we can grow and enrich the T cell -- the TIL cells in the tumor to at least 1 billion cells. This happened during our 22 day Gen 2 manufacturing process. After we have grown the TIL, we cryopreserve the cells and send them back to the treatment center. So it is ready when the patient is ready. Before we infuse the TIL cells, patient undergo a lymphodepletion regimen to knock down the hostile microenvironment of the tumor. Then we infuse the TIL followed by a short course IL-2 dosing regimen to help the TIL expand inside the body. So today, we have seen a deep and durable responses following onetime administration of our lead TIL therapy, lifileucel in metastatic melanoma patients who have progressed in their disease following anti-PD-1 therapy with medium duration of response not yet reached at 33 months of medium study follow-up as we just reported at ASCO last week. We have also seen compelling initial clinical data for cervical cancer following progression after chemotherapy, which is our second pivotal program. We have also begun a registration supporting study of TIL in non-small cell lung cancer, which is a very important indication for TIL alone and in combination with pembrolizumab. We are also very excited about moving TIL into earlier lines of therapy, and we are pleased with the overall response rate seen so far in initial patients using TIL plus pembrolizumab in both melanoma and head and neck cancer patients who are naive to anti-PD-1 therapy. To finish our development strategies to broaden the use of TIL in new indications and [ earlier ] treatment settings for more and more patients, beyond that, we are investigating next-generation approaches to use a selected TIL designed to be more specific to the tumor and to genetically modify TIL using the TALEN technology we licensed from Cellectis, designed to be more resistant to evasion mechanisms used by cancer. We also have a third-generation manufacturing process or Gen 3 in the clinic now to see if we can further optimize and shorten the manufacturing process to 16 days. So here is a quick overview and introduction of what we're doing.

That's a great broad introduction to the company and the technology. So let's start by kind of clearing the deck around some recent news that came out about the resignation of CEO Maria Fardis. So as much as you can, which obviously might be limited, can you provide us with some context around her leaving and willing more importantly, how her leaving impacts Iovance's operations?

Yes. Thank you, Madhu. Obviously, Maria has been instrumental in advancing TIL to where it is today, and we are sorry to see her go and wish her a well. Her decision to resign is personal, and we cannot comment on employee matters. A search for new CEO has already begun, and we have a strong C-suite in place as well as a broad and experienced senior management team and development and regulatory functions to execute our plans, finish preparing our BLA, prepare to launch lifileucel and expand our pipeline.

Okay, great. So in addition to that news, there's also recent news you guys had about ongoing FDA interactions related to cell potency assays for TIL technology, particularly, you mentioned for lifileucel in checkpoint refractory melanoma. So could you please update us on where things are with that situation?

Yes, sure. So I will start by saying that we think we have a good understanding of what FDA wants based on the recent feedback we received. With additional assay work to be done in a reasonably short time frame, we are confident in the new guidance for meeting with FDA second half of 2021 and potential BLA submission in the first half of 2022. FDA obviously can always ask for more information at any time, but we have set guidance based on our understanding of the FDA feedback and our plan to address it so that we can submit the melanoma BLA.

Excellent. So I'm going to start to dig in this a little bit further. I'm going to start with the kind of seemingly simple-minded question. How does one define cell potency for a cell therapy like TILs?

Yes. Very good question, Madhu. Thank you for asking. So first, not that -- this is not about clinical review, but it is instead about characterizing the product for potency after it is produced in the manufacturing process. This is about biological characterization of the TIL product itself. In essence, FDA wants sponsors such as Iovance to use potency testing as a means to discriminate between potent and subpotent loads of autologous products, for example, to detect the manufacturing failures.

Okay. So with that in mind, what would you consider to be a reasonable comparable out there in terms of potency assays for cell therapies, either in oncology or outside of oncology?

Yes. Again, a very good question. So there are no true comps. TIL is first-in-class polyclonal T cell therapy. So the closest comparator is probably CAR-T. And there are multiple assays used to characterize potency with certain CAR-Ts. But even with CAR-T, there is still the ability to target CD19, which is not the same as polyclonal product. Maybe gene therapies also provide some useful comps there.

Okay. Great. So from that, would -- so how would you define -- kind of pressing on something you mentioned earlier, would you describe the state of discussions with the FDA to be more along the lines of addressing questions with a kind of specifically defined path? Or do you feel the path for potency for TILs is still being defined right now?

Look, we believe we have a path for regulatory interactions for lifileucel, so -- and we continue to address questions and present additional assays in response to FDA feedback, so we can move forward on the time line that we disclosed with regard to reinteraction in the second half of '21 and BLA filing targeted for first half of 2022. So yes, we believe we have a path.

Okay. So as you all have previously mentioned, you provided 2 assays to the FDA to evaluate kind of in this process of assessing cell potency. So again, realizing this is all in flux, as much as you can tell us, are the questions around these existing assays, around the adequacy of the assays per stage defined potency or around the variability of activity of individual TIL preparations using these individual assays?

Very good question. Thank you, Madhu. I would say that there are 2 major aspects to the potency assay process with FDA. First, an assay or a set of assays needs to be agreed. After that, specification can be proposed and agreed. We are working on gaining agreement on the assay or set of assays with FDA now. As with other autologous cell therapy products, viability between patients is relevant to the selection of assays but I would say, typically plays more a role in the specification setting process.

Okay. Cool. So following from this discussion, you're agreeing that you plan to provide additional assays to the FDA. So kind of put simply, why do you believe that additional assays are necessary or useful? And what do you think they could provide that the first 2 assays so far have not provided?

Yes. These additional assays allow us to put an alternative in front of the FDA that we think will solve the technological challenges associated with developing potency assays for polyclonal T cell product. Since these assays can have a variety of stimulation mechanisms and modes of detection, our plan is to show the FDA assays that take advance of that flexibility, and that we think will be responsive to the feedback that we have gotten from the FDA.

Okay. So addressing some concerns we've had regarding the potency assay issue, just to clarify, have you been asked to demonstrate antigen-specific stimulation of TILs or some kind of cell killing activity for TILs in your potency assay interactions with the regulator?

Yes, again, another very good question, Madhu. So clearly, we have not been asked to demonstrate antigen-specific stimulation of TILs. Based on the decades of work done by academics and Iovance, each patient's cancer has a unique antigen fingerprint, and there is very minimal overlap between patients. So yes. No, we have not been asked to demonstrate antigen-specific stimulation.

Okay. So we'll wrap up the discussion of potency assays with I think 2 kind of straightforward questions. The first one is, all things considered, how confident are you that the issue of TIL potency assays will reach a reasonable resolution. Kind of what gives you that confidence?

Yes. I have 3 words for you, Madhu. We are confident. I mean I understand that the Street was disappointed. There was a delay in time lines, so do we. But we think we can reach resolution in a reasonable amount of time. I mean the time line that we set for regulatory interaction and BLA filing reflect that confidence. So again, we are confident.

Okay. And so following from that, to your point around reasonable time frame, kind of what gives you confidence you can reach this resolution quickly? Or kind of to put in another kind of more blunt way, what stops us from having the same conversation 6 months from now, a year from now, 2 years from now?

Yes. I mean I will be short answering your question and will repeat what I said previously to you. I mean we are confident in resolution based on everything we know today. We got the feedback from the FDA. We know what we have to do to move the path forward and deliver on the BLA filing first half of 2022. So really, I want to repeat we are very confident.

Okay. So I know that was a lot, but I really thank you for helping dig in there on that issue because, obviously, it's very important for you all as kind of like fundamental question. So let's move over to recent clinical data. So last week and over the weekend, you all provided some early data for studies of your TIL drug, lifileucel, in melanoma, both in the PD-1 refractory and PD-1 naive setting. So you mentioned this earlier. Could you please walk through that data and kind of hit the highlights for us?

Yes, I'll take that question on the clinical data. So we were super pleased to share our latest clinical data with the physician community at ASCO, and we also held an update call on Sunday afternoon that I encourage everyone to listen to if they didn't already. It's available on our website, and we dig a little deeper in the data there. There was a lot of excitement about our initial data in 7 patients with metastatic melanoma who were anti-PD-1 naive. These patients were treated with lifileucel in combination with pembrolizumab, and we observed a very, very encouraging overall response rate of 86% with 2 complete responses, 1 unconfirmed complete response, 3 partial responders and 1 best response of stable disease. We were impressed to see, again, conversion of partial to complete responses over time. And while these are early results, we believe that the overall response rate is impressive compared to available single agent and combination options in that setting. In addition, lifileucel may be additive to pembrolizumab when used in combination, and the combination is feasible and safe with a safety profile that was as expected for, number one, the stage of the underlying disease and the use of nonmyeloablative lymphodepletion chemotherapy, IL-2 and pembrolizumab therapies. Added and together with the initial clinical data for TIL in combination with pembro in head and neck cancer for which we reported a 44% ORR at SITC last year, we think that TIL has great potential in combination with pembrolizumab and earlier treatment [ set mix ] across indications. And we are excited about the additional combination cohorts in our basket study, and we also know there's keen interest in the non-small cell lung cancer cohorts.

Okay. So let's spend a little time -- I want to talk both about the PD-1 refractory data and the PD-1 naive data. Let's talk about the PD-1 refractory data. So one thing we found interesting out of the data was that, as you mentioned, the responses seemed to keep deepening. And so for example, there are 2 stable disease patients for whom responses seem to be continuing to -- or where kind of tumor growth appears to be declining over time or partial response patients for whom the response seems to be deepening over time. So to what extent do you think that as you track this Cohort 2 over time, you could see a bump up in the objective response rate or an increase in the complete response rate in these kind of late responders or kind of late convert -- complete response conversion patients?

Yes. I think in the melanoma Cohort 2 data that Dr. Larkin presented on Sunday, we had clear evidence for exactly that. We showed the waterfall plot in which we indicated that 11% of the patients had deepening responses. We indicated them in the waterfall plot with downward facing arrows, and one of these was a conversion of a patient with a previous partial response to complete response. This was in comparison to the data as we had shown at last year's ASCO. There's clear evidence for continuing deepening of responses, which, for me, suggests continuing anti-tumor activity of persist T cell clones that are continuing to do their job, which is what we infused them into these patients for.

And so I want to also follow up on kind of just a simple-minded description of the drug. It's like to get everyone on the same page that, for this drug, you're taking 5 to 7 days of cy/flu, receiving a TIL infusion, receiving 6 doses of IL-2 and treatment ends then, right? So these responses that are occurring now over years are in people who are receiving no additional therapy, just walking around, doing their thing. They're still able to see these kind of responses that persist out for 2-plus years.

That's correct. I think that is one of the big points and one of the big differentiations of this type of therapy. It's the onetime treatment. It's also reflected in the safety profiles. We showed the safety profile as part of our presentation on the Cohort 2 data, the melanoma data as well as the combination data. The majority of events really is occurring early on during the first 10 to 14 days after TIL therapy, and the profile of the adverse events that we are observing is consistent with the lymphodepletion chemotherapy and IL-2. And then there's a rapid decline with adverse event rates that are consistent with the underlying disease, the age of the patients and really is in background, right? So that is exactly it. It's very supportive of the benefit of the onetime treatment.

No, that's great. It's very helpful. So moving over to the PD-1 naive melanoma data so far. So given what you've seen so far, this 86% response rate, this 43% complete response rate, how would you frame this data given the kind of evolving landscape in PD-1 naive melanoma, both the existing standard of care PD-1 monotherapy but also now PD-1 plus CTLA-4, which is recently approved as a combination and also PD-1 plus LAG-3, the early data from Bristol from the RELATIVITY trial?

Yes. That's an excellent question. I mean the first thing that we need to do and what we want to do is we want to see responses in the current patients continue over a longer duration. We need to understand the durability of these responses and to see responses in additional patients. So this core is continuing to enroll patients, and we're obviously following up the patients that we've presented on. I think at this time, it will be premature to comment on detail for the next study. But at the time we need to make decisions, we would need to develop a registration supporting study, and we will have to factor in the current as well as the emerging treatment landscape at that time.

Okay. So kind of then following from that point of needing additional patients, what is the data set that you think would kind of -- in your mind, what in terms of patient numbers, kind of duration of assessment, the data set that would give you a kind of fair basis for thinking about frontline or PD-1 naive melanoma trial?

Again, I think that right now, in the absence of having a specific design and the comparator in mind, I think it's premature to give you details on what we would need for that. These things go hand in hand. I think the data set, the size of the data set, the amount of follow-up and what we're trying to see as decision-driving data depends very much on that next step, which, as I just told you, we would have to look at the time when we have to make that decision.

Okay. And then following from that, when we think about that data as well, it was interesting to observe that responses persisted in patients who came off PD-1 because of adverse events. And also it seemed to follow that many patients -- several other patients who didn't discontinue PD-1 blockade had a lower dosing frequency. So first, in your understanding of the kind of melanoma landscape, how prevalent is that kind of discontinuation or reduction in dosing frequency of PD-1 in PD-1 naive melanoma patients? And how do you think that frames into the opportunity for TILs? Again, following from the PD-1 refractory data where you have a drug where you take for 2 weeks, and that's it, to what extent could that be employed even in the PD-1 combination setting where you combine this with PD-1 for a while but then eventually come off the PD-1 and you're just living your life?

Yes. That's a great question. I think right now what we're doing initially is generate data that follow the protocol as written, which is planning for continuation of pembrolizumab but follows the discontinuation rules as consistent with the pembrolizumab standards. I do think that at this time, we do need to generate more data with that types of rules in place. There are no discontinuation rules in our protocol that would be differing from standard of care. We need to generate more data on that. And then based on the emerging data set, I think we can interpret and see whether we can learn beyond that.

Okay. Great. So shifting gears from melanoma. Could you please give us an update on the lifileucel program in cervical cancer? And particularly, as we think about both melanoma and cervical cancer, whether there's potential to release data from these studies sooner than, say, the resolution of the potency assay issue?

Yes. Again, a very good question, Madhu. So now that the BLA time lines have shift, we are definitely considering when we should initiate and read the independent review committee data for both melanoma and cervical. So aside from the BLA time lines, we also have considered the implication of reading the pivotal data sets in advance of resolving our assay discussion with the FDA. So as of now, this is definitely under discussion internally, and we are not providing guidance. But again, we are definitely considering the read-out from independent review committee data.

Okay. And so could you then briefly kind of remind us where you are in those -- in the melanoma trials, I guess, for now in the kind of refractory setting, where you are in terms of recruitment and how to think about those initial studies?

Friedrich?

So you were asking about the refractory setting?

Yes, in the after frontline chemotherapy and in the after PD-1. Just remind us where you are in terms of recruitment of those studies.

Yes. We have completed enrollment and dosing in the Cohort 2 as well as that Cohort 4 that we are currently following both -- we had follow-up on both of these cohorts.

Okay. And then given, again, much like with melanoma, the evolving landscape in cervical cancer, particularly things like the LIBTAYO Phase III data and also giving your own data now in PD-1 naive head and neck cancer and PD-1 melanoma -- naive melanoma, how do you think about the kind of implementation of a combination study of TILs plus PD-1 in kind of PD-1 naive or an earlier line cervical cancer?

Yes. It's a great question. So we are already exploring that as part of our cervical cancer study. We have a cohort that enrolls patients that are in that -- in the treatment-naive metastatic setting who are receiving TIL plus pembro. Our strategies around this, well, again, you have to reflect the current emerging treatment landscape as well as the unmet need patient population in each of these indications. Overall, we've been impressed with what we've seen initially in melanoma and head and neck cancer with the combination and the potential for TIL in combination with PD-1 checkpoint inhibitors in additional indications, including cervical.

Okay. And then kind of following from that, one question we kind of think about a little bit following from these discussions about combinations and discontinuation is the potential to combine TILs with other novel assets. Like I would -- certainly, we would think about it in cervical cancer. To what extent is there potential to combine TILs with, say, antibody drug conjugates like tisotumab vedotin? And how do you think about where combinations with TILs makes sense versus that, and particularly around the question of finding agents where you get kind of combinatorial activity but you don't get anti-TIL kind of drug activity. So it brings everyone to think a chemotherapy might not make sense because the chemotherapy is going to go after your TILs just as much as it goes after kind of the tumor tissue. So how do you balance how you think about potential combinations with other novel agents?

I can take this question. So I do think that the most rational combination for TIL therapy is combinations with immunomodulators. I think the current data with checkpoint inhibitors is supporting that. Again, these are nonmodified autologous T cells, which are subject to immune regulation, so exploring combinations with drugs that are modifying immune regulation makes a lot of sense. I think other mechanisms become more complex because you would have to think not about -- not only about what you combine with but also how you combine in regards to sequence and timing.

Yes. That sounds -- that's fair enough. So shifting gears from both melanoma and cervical cancer, let's briefly discuss kind of the updated program in head and neck cancer. How should we think about the PD-1 combo study in head and neck? And kind of when will we get the kind of next update from that study?

Sure. For head and neck cancer, we have expanded the cohort in the basket study that was initially sized with 12 patients, and then we saw the encouraging data that we presented at SITC. And we expanded that cohort size to 19. Again, as a reminder, response rate was 44%, 11% CR and 33% PR rate, had a median of [ 8.1 ] of study follow-up. So obviously, we want to follow up with longer duration, and we want to see how the patients are faring that we are -- that we have added. We are looking at appropriate venues, time lines and opportunities for publications for the next data update, but that would be something that we certainly consider.

Okay. So thinking about that head and neck cancer data for a second, and just as a kind of reminder for people for frame of reference, how many patients of your initial 9 had experienced prior therapy before the PD-1-TIL combo? And kind of in that context, how do existing immunomodulatory agents do in terms of response rate?

So what we know here is there are, obviously, the different settings that we are talking about here. There is the setting of treatment naive head and neck cancer patients treated with checkpoint inhibitor monotherapy, and what we are usually considering the benchmark here for that is about 16% response rate. You can bump that up with combinations of checkpoint inhibitor chemotherapy in that setting, and you bump up the response rate to about above 30%. And then in the second-line setting, again, in patients who have had prior systemic chemotherapy with or without EGFR antibody, again PD-1 checkpoint inhibitor monotherapy gets you about 16%. So the 16% is about the benchmark that you would be expecting in both of these settings with PD-1 inhibitor monotherapy, and that is what we're comparing the 44% response rate of the combination with.

Okay. Cool. So one question, which we get all the time, which I'm sure you all get all the time as well is how should we think about the TIL opportunity in non-small cell lung cancer. And so first, can you kind of walk through the extent data that exists for -- not necessarily TILs from Iovance but TILs generally in non-small cell lung cancer? And then how should we look at the path for Iovance-specific TIL programs in this non-small cell lung cancer space?

Sure. I'll try to keep this short. I can talk a long time about this. I have a passion for non-small cell lung cancer development. But I think what we probably should point at first is the existing data with TIL therapy for non-small cell lung cancer, and that is the data set that was presented by Dr. Creelan from the Moffitt in the AACR conference last -- early last year. These 4 patients treated on a single institution study. Patients that were checkpoint inhibitor naive were treated with nivolumab monotherapy. And then if they did not respond to nivolumab monotherapy, they moved on to receive TIL and then continue with nivolumab maintenance therapy. So that is a little different from each of the currently open cohorts and studies that we are doing within the Iovance portfolio. Here, there were 12 -- or all 12 evaluable patients that have received TIL, 3 of which experienced response, 2 of which experienced a complete response that was durable at the time of the data cut of that study. So that's very encouraging. That makes for a 25% response rate in non-small cell lung cancer patients who had not benefited from checkpoint inhibitor. Interestingly, that data set included one of the complete responders who had a driver mutation-positive tumor and had failed TKI, which indicates the differentiation of TIL immunotherapy from checkpoint inhibitor immunotherapy because you would not necessarily expect a response of a driver mutation-positive tumor to checkpoint inhibitor therapy. Now moving to the Iovance portfolio, we are exploring lung cancer in cohorts in our basket study both in the checkpoint inhibitor naive setting, where we are treating patients with TIL plus pembro combo and in the checkpoint inhibitor pretreated setting with TIL monotherapy or with the combination of TIL and nivo/ipi and a recently added cohort in the basket study. And then also, we opened a dedicated lung cancer study, LUN-202, which enrolls patients who have failed prior treatment with checkpoint inhibitor chemotherapy combination to be treated with TIL monotherapy.

So let's think about that last trial, you just described the 202 trial. So currently, as we understand it, you can correct me if I'm wrong, that once you fail PD-1 plus chemotherapy in a frontline non-small cell, unless you have a mutation, like kind of standard course then is kind of taxane chemotherapy, some form of taxane. So what would you say is kind of what standard of care looks like practically in terms of things like response rate, duration of response and so on?

Yes. So you're talking me right into my comfort zone. I was the clinical lead for the CheckMate 057 trial, which compared nivolumab monotherapy with standard of care in exactly that setting, and the comparator there was docetaxel monotherapy. And that's exactly the setting in which you would now have these patients. These patients have received and failed platinum doublet plus checkpoint inhibitor. And there, really the therapeutic choice in that setting is again chemotherapy monotherapy. Response rate is probably about 10% in that setting, and we have a lot of data on that because that was the comparator arm for a number of studies in that setting as we were bringing checkpoint inhibitors into that line of therapy.

Okay. Great. So kind of bigger picture, Jean-Marc mentioned in the beginning, the idea of next-generation TILs either by selection or by gene editing. So kind of focusing in on the gene editing aspect of it. How would you think to employ gene editing? What are kind of -- kind of asking as much as I can. You could tell me to buzz off. Kind of what are the -- what are some targets that make intuitive sense to pursue for gene editing in TILs? And I guess kind of practically, how do you get around the concern around kind of genetic bottlenecking that when you add it and expand, you'll create a selection bias for -- you'll maintain the kind of heterogeneity that, as you mentioned at the beginning, is kind of one of TIL's main edges?

Jean-Marc, I think that was a question for you or -- Madhu?

No, I think this is more towards you.

I see. So I think, yes. So as we're talking about gene editing, I'm happy to take this question talking about gene editing. I think one of the directions that makes sense to think about is to think about alternative ways of both -- of disrupting inhibitory mechanisms, and makes a lot of sense to think about the inhibitory mechanisms that are best validated clinically, which is really going into the direction of inhibiting targets or switching off targets that are currently the targets of antibody therapy. So I'm talking about checkpoint inhibitors here. The beauty of doing this with a genetic modification approach is that you do that only at the place of action of where the T cell is, and you circumvent the potential of tumor-directed T cell toxicity or activity that would come with systemic administration of checkpoint inhibitors.

Excellent. So shifting over to kind of the balance sheet. Can you remind us of your current cash position and how you think about runway and what kind of clinical development and regulatory development that runway assumes?

Yes. So this one is really for me, Friedrich.

Great. I'm glad.

Although I'm sure you can answer, but no, let's be fact based. So what we have is disclosed, we have $610 million in cash at the end of March. And we have said it's sufficient to fund our pipeline expansion, our commercial launch readiness to 2023. What I can add is we have an active ATM offering, which was in place early Q1, and we want to maintain at least 2 years of cash. And we do have a strength in our current balance sheet, and we have no immediate need to raise capital at or near current stock price, obviously, which is no concern. So definitely, strong balance sheet for the moment.

Excellent. Well, I'll close this with a question we ask every company we have these conversations with to very simply, why should someone own Iovance stock in the next 12 months?

Yes. No, I think that's a very good question. Thank you, Madhu. I mean, clearly, there are many potential inflection points for Iovance and our clinical data in the coming months. And hopefully, resolution of the potency assay question will allow us to submit the first BLA for melanoma plus other indication. And we clearly have for the TIL a significant potential, so this is definitely right time to invest at Iovance.

Excellent. Well, this is an excellent session. I want to thank Friedrich and Jean-Marc for joining us today and walking us through the Iovance story and what I think is definitely kind of really exciting and kind of critical time for the company. So it's great to catch up with you guys at this point.

Thank you, Madhu.

Thank you. Thank you very much.

Thanks, everyone, and thank you very much for joining us today. Have a good night, everyone.