Iovance Biotherapeutics Inc (IOVA) 2023 Q4 法說會逐字稿

Welcome to the Iovance Biotherapeutics conference call to discuss the full-year 2023 results and recent corporate updates. My name is Kevin, and I'll be your operator for today's call. (Operator Instructions). Please note that this conference is being recorded.

I will now turn the call over to Sara Pellegrino, Senior Vice President, Investor Relations and Corporate Communications, Iovance. Sara, you may begin.

Thank you, operator. Good afternoon and thank you for joining our conference call and webcast to discuss full-year 2023 results and recent corporate updates. Dr. Fred Vogt, our Interim President and Chief Executive Officer, will provide a brief introduction.

Jim Ziegler, EVP Commercial, will highlight our initial insights for the US commercial launch of AMTAGVI following the recent Food and Drug Administration or FDA approval in advanced melanoma. Igor Bilinsky, Chief Operating Officer, will highlight commercial manufacturing and capacity expansion plans. Friedrich Finckenstein, our Chief Medical Officer, will summarize key clinical pipeline highlights. And Jean-Marc Bellemin, Chief Financial Officer; will review our financial results. Dr. Brian Gastman, EVP, Medical Affairs; and Raj Puri, EVP, Regulatory Strategy and Translational Medicine are also on the call and available for the Q&A session.

Before we start, I would like to remind everyone that statements made during this call will include forward-looking statements regarding Iovance's goals, business focus, business plans and trends revenue, commercial activity, clinical trials and results, regulatory approvals and interactions, plans and strategies, research and preclinical activities, potential future applications of our technologies, manufacturing capabilities, regulatory feedback and guidance, payer interactions, licenses and collaboration, cash position, and expense guidance and future updates.

Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond our control, including the risks and uncertainties described from time to time in our SEC filings. Our results may differ materially from those projected during today's call. We undertake no obligation to publicly update any forward-looking statements.

With that, I will turn the call over to Fred.

Thank you, Sara, and good afternoon, everyone. I'm pleased to host our 2023 full-year results conference call.

Throughout last year, we executed toward our first approval of commercial launch while advancing our pipeline. On today's call, we have a variety of exciting topics to cover on the heels of the US FDA's recent approval of AMTAGVI, the first onetime T cell therapy for solid tumor. AMTAGVI's label allows us to become the first treatment option for advanced melanoma patients after anti-PD-1 and targeted therapy. The strength of this label also reflects a best-case scenario with strong efficacy data from pivotal cohort four as well as pool cohorts two and four.

In the first few days of US launch, we are seeing strong demand and momentum for AMTAGVI. Consequently, we also expect increased demand for Proleukin. 30 authorized treatment centers, or ATCs were ready for approval and nearly all identified the patient. Jim will provide more detail later in the call.

The first tumor resection occurred in the first business day after approval and commercial manufacturing began the following data at our Iovance Cell Therapy Center, or iCTC. This is a testament to the high unmet medical need and the greater excitement around this new therapy, as well as our commercial manufacturing readiness. Igor will talk today about our capacity to serve our near-term commercial launch of clinical trials and all going expansion plans.

In addition to the US launch, our near-term expansion plans for AMTAGVI are focused on addressing many thousands of additional patients by entering new geographies and broaden the label to include frontline advanced melanoma as well as other indications. For example, our plan global expansion has the potential with more than double the total number of addressable patients for AMTAGVI imposed the anti-PD-1 melanoma. We remain on track to submit regulatory dossiers this year in the European Union in the first half of the year, followed by the United Kingdom and Canada in the second half.

In addition, our Phase 3 TILVANCE-301 trial continues with a strong momentum in several countries to support regulatory submissions in frontline advanced melanoma. We are also pleased with the progress with our robust development pipeline across solid tumor cancers. Friedrich will speak later about some key highlights in our ongoing clinical trial programs.

Today, Iovance is the fully integrated company and is now the first company to commercialize the T cell therapy for solid tumor indication. We are well positioned to execute on our regulatory pipeline, manufacturing and commercial launch activities to remain the global leader in TIL cell therapy.

Jim will now describe the ongoing activities related to our US launch.

Thank you, Fred.

Each year, approximately 8,000 people in the US die for melanoma. Until now, there have been no FDA-approved treatment options for patients with advanced melanoma whose disease progressed following an immune checkpoint inhibitor and if appropriate, a targeted therapy. For these patients, AMTAGVI ushers in a new era for the melanoma treatment landscape as a onetime cell therapy that is manufactured specifically for each patient to address a significant unmet need. Today, I will highlight our launch activities, ATC onboarding as well as access and reimbursement.

There is strong level of ATC commitment with 30 onboard today. These onboarded ATCs are engaged in various stages of the process, including patient identification, reimbursement authorization, scheduling and tumor tissue procurement and manufacturing. In the less than two weeks following approval, the majority of our activated ATCs have at least one identified patient and are in the process of establishing financial clearance for reimbursement, including prior authorizations and single-case agreements.

There are at least 20 patients in the process, which includes 10 patients with schedule or pending manufacturing slots. The number of ATCs engaged in this process reflects the high unmet need and a sense of urgency to offer AMTAGVI for their advanced melanoma patients. In addition, we continue to onboard and remain on track to have approximately 50 active ATCs in total by the end of May.

We are also pleased with the initial market access and in-patient reimbursement trends for AMTAGVI. These are consistent with approved CAR-T products with the benefit of increased speed resulting from both our preparation and the ATC's experience.

We continue to anticipate prior authorizations to include coverage consistent with label, medical coverage policies within about 90 to 180 days and single-case agreements for commercially insured patients. I want to acknowledge our strong cross-functional teams who have worked tirelessly to ensure our launch readiness and execution. We are confident in our ability to deliver a successful commercial launch.

I will now turn the call over to Igor, who will highlight our manufacturing readiness and capabilities.

Thank you, Jim. AMTAGVI as well as our investigational TIL cell therapies are manufactured using our proprietary process to collect the patient's TIL cells from a portion of their tumor, multiply them into billions and return them back to the patient to fight cancer. The US FDA has approved commercial manufacturing at our internal facility, the Iovance Cell Therapy Center, or iCTC as well as at a nearby contract manufacturer. These facilities are built to support up to several thousand patients annually.

As Fred mentioned, the first tumor resection occurred on the first business day after approval, and commercial manufacturing of AMTAGVI is officially underway. We are currently staffed to meet the anticipated needs of our US launch as well as our ongoing and planned clinical trials.

In the BLA submission for AMTAGVI, we have included the capacity demonstration study higher than our immediate needs. This means that we can increase near-term capacity through increased staffing without requiring additional capacity authorizations.

In addition, we are building further capacity to align with our near-term and long-term manufacturing needs, as we prepare to expand AMTAGVI into new markets and indications and advance our solid tumor pipeline, expansion within the iCTC facility is already starting, build-out of additional clean rooms within the existing shelf space at iCTC, can significantly increase capacity to over 5,000 patients annually over the next few years. Longer term, our future expansion plans may bring our manufacturing capacity above 10,000 patients annually.

In summary, our team is excited to provide AMTAGVI to patients in need. We're laser-focused on the quality of the manufacturing process in the spirit of doing everything right first time at every step from incoming receipt of the tumor sample through the manufacturing and product release process to outbound shipment of the final AMTAGVI product to the ATCs and to patients.

I'm available to answer additional questions during the Q&A, and I will now hand the call over to Friedrich.

Thank you, Igor. I'm pleased to speak today about the key highlights within our clinical pipeline in solid tumors, which, as you know, represent more than 90% of all diagnosed cancers in the US. I'll begin with TILVANCE-301, our registrational Phase 3 trial in frontline advanced melanoma.

TILVANCE-301 is well underway to support accelerated and full approvals of AMTAGVI in combination with pembrolizumab in frontline advanced melanoma. Global site activation and patient enrollment continue with strong momentum in the US, Europe, Australia, Canada and additional countries. TILVANCE-301 is also the confirmatory trial to support full approval of AMTAGVI post anti-PD-1 advanced melanoma.

Shifting to our program in non-small cell lung cancer and our single-arm registrational Phase 2 trial IOV-LUN-202 and post anti-PD-1 non-small cell lung cancer, enrollment in the registrational cohort is estimated to complete in 2025. Following the partial clinical hold for new patients, we are working collaboratively with the US FDA and believe we have provided all the necessary information to resume new patient enrollment in the near future.

We are also preparing to start up a new Phase 2 trial in post anti-PD-1 endometrial cancer, which is expected to include patient populations who are efficient and proficient in mismatch repair. TIL cell therapy based on its mechanism of action may benefit both of these patient populations. We look forward to providing more details in advancing this trial this year.

Iovance is the leader in TIL cell therapy, including next-generation approaches that have the potential to optimize outcomes for patients. We continue to investigate our genetically modified PD-1 inactivated TIL therapy IOV-4001 and the GM1-201 trial. This is the first-in-human trial in previously treated advanced melanoma or non-small cell lung cancer patients.

This was just a snapshot of the many activities and progress across our solid tumor pipeline, and I'm happy to address questions about these programs and additional trials during the Q&A session.

I will now hand the call to Jean-Marc. Jean-Marc?

Thank you, Friedrich. Today, I will review our current cash position as well as our full year results for the year ended on December 31, 2023. I will also highlight our 2024 outlook.

As of February 22, 2024, our unaudited cash position is approximately $485.2 million, which includes net proceeds of approximately $197.1 million, net of underwriting and other offering expenses from the follow-on equity financing in February of 2024. The current cash position and anticipated revenue from both AMTAGVI and Proleukin are expected to be sufficient to fund current and planned operations well into the second half of 2025.

Shifting to our full year financial results. Net loss for the fourth quarter ended December 31, 2023, was $116.4 million, or $0.45 per share, compared to a net loss of $105.3 million, or $0.64 per share, for the fourth quarter ended December 31, 2022. Net loss for the year ended December 31, 2023, was $444 million, or $1.89 per share, compared to a net loss of $395.9 million, or $2.49 per share, for the year ended December 31, 2022. The net loss for the year ended December 31, 2023, includes amortization of intangible assets acquired as part of the Proleukin transaction.

Revenue from the fourth quarter and year ended December 31, 2023, was $482,000 and $1 million, respectively, and comprised of product sales of Proleukin following the acquisition in May 2023. There were no revenue for the fourth quarter and year ended December 31, 2022.

Cost of sales for the fourth quarter and year-end December 31, 2023, was $4.4 million and $10.8 million, respectively, and comprised of cost of inventory associated with sales of Proleukin as well as $3.9 million and $9.7 million, respectively, of noncash amortization expenses for the acquired intangible assets for developed technology. There was no cost of revenue for the fourth quarter and ended December 31, 2022.

Research and development expenses were $87.5 million for the fourth quarter ended December 31, 2023, an increase of $6.9 million compared to $80.6 million for the same period ended December 31, 2022. Research and development expenses were $344.1 million for the year ended December 31, 2023, an increase of $49.3 million compared to $294.8 million for the same period ended December 31, 2022.

The increases in research and development expenses in the fourth quarter and the year ended December 31, 2023, over the prior year periods were primarily attributable to increases in headcount and related costs to support the increased production capacity and commercial manufacturing readiness and clinical trial costs driven primarily by the initiation of our Phase 3 TILVANCE-301 clinical trial.

Selling, general and administrative expenses were $29.9 million for the fourth quarter ended December 31, 2023, an increase of $3.4 million compared to $26.5 million for the same period in the December 31, 2022. Selling, general and administrative expenses were $106.9 million for the year ended December 31, 2023, an increase of $2.8 million compared to $104.1 million for the same period ended December 31, 2022.

The increase in selling, general and administrative expenses in the fourth quarter and the year ended December 31, 2023, compared to the prior year period was primarily attributable to increase in headcount and related costs to support the growth in the overall business and related corporate infrastructure, professional fees and travel costs as well as costs associated with Proleukin integration activities. This increase was partially offset by a decrease in stock-based compensation expenses, legal and other costs.

For additional information, please see this afternoon's press release and our annual report on Form 10-K to be filed later today.

Regarding our outlook for this year, we continue to guide towards full-year 2024 cash burn in the range of $320 million to $340 million, excluding onetime expenses, and we will continue to leverage opportunities to optimize spending. The US launch of AMTAGVI as well as the sales of Proleukin used in conjunction with the AMTAGVI treatment regimen are expected to drive significant revenue in the second half of 2024 and into 2025 and beyond. Revenue recognition for our AMTAGVI occurs upon infusion like other cell therapies. So we expect to begin recognizing and reporting significant revenue in the second quarter of this year.

I will now turn the call over to the operator to begin the question-and-answer session.

(Operator Instructions) Yanan Zhu, Wells Fargo.

Great. Congrats on this initial momentum. Just curious about the 10 patients. Sounds like you have 10 patients that are already at the stage of scheduling manufacturing slot. Wondering how long did these patients reimbursement process took. Does that give you any updated thinking, a way of thinking of the average time from patient identification to tumor resection? And also we see the word -- some of these 10 patients are pending for manufacturing slots. Just wondering what does that mean? And what's behind the word pending?

Yes, Yanan. It's Fred. So they obviously moved very quickly for the centers that we're able to schedule these patients, 10 patients there that are either scheduled for a slot or soon to schedule for a slot are all moving through the process much more quickly. Some centers move fast. Some centers move slow. What we're seeing here, I think, is a pent-up demand and real excitement for the AMTAGVI launch. I'll let Jim add -- Jim, do you want to add any comments to that?

Thanks, Fred. I think, Yanan, it's still too early to tell what we've guided before based upon our experience in cell therapy approvals, it takes a couple of days for prior authorization and a couple of weeks per single case agreement. As Fred pointed out, there has been some quick movement because of the sense of urgency at these ATCs. To further define what pending means, ATC basically will schedule a slot once they know they have successful reimbursement. So pending is that they're registered, they're ready to go, but they're not quite ready to pull the trigger on that slot yet.

Great. If I can have a very quick follow-up, namely, you mentioned manufacturing could be conducted at iCTC or the CDMO, just wondering how are you distributing the flow to these two facilities? And if you would mind commenting on the margin for the CDMO.

Yes. We can't really say what their margin is. They know that. Obviously, that's their business. We think it's competitive with what we do. So we employ a make versus buy strategy at Iovance, and we constantly look internal manufacturer versus external that keeps everything in tight competition, and we think that's the way, the best way to run a business. Does that answer your question?

Right. How would you distribute the flow to iCTC versus CDMO?

Yes. So we have internal algorithms for doing that, and I can't share the full details, but we distribute the flow somewhat evenly across the two sites. And as we expand and as we grow, I think we'll be able to manage that even more tightly as we learn a little bit more right now about how the sites perform and who's doing the best here. But we run them as an internally competitive process. Again, just to make sure it's really clear. There is no real issue at all of the capacity between the two. We have tons of capacity right now for this launch.

Tyler Van Buren, TD Cowen.

Hey, guys. Thanks for taking the question. The patients in process for AMTAGVI is a very encouraging update given that we're just 1.5 weeks in. But as we think about the 20 AMTAGVI patients in process, does this constitute the majority of the initial bolus in the 30 ATCs with the majority of sites having at least one patient, as you noted? Or would you be more likely to characterize it as a fraction? And just as a quick second question, with the MAA to be submitted in the first half in other ex-US submissions, will Iovance be launching lifileucel broad? Or do you expect to partner.

Yes, Tyler, that's a tiny fraction we think of the patients out there. It's not the initial bolus. The bolus is going to go on for quite some time, and our sales team is out there, and they've got a lot of information, and it looks like this is going to be sustainable for quite some time. On the MAA front, we intend to do that ourselves. We're not looking for a partner right now to do that. We think that could potentially dilute the value of our assets.

Peter Lawson, Barclays.

Thank you for taking the questions and congrats on the progress. Just wondering if you can kind of talk through how you're thinking about how revenue gets booked and the impact of the patients on the IovanceCares program and kind of how you see patients coming in on that program versus not on that program?

Yes. Peter, in the press release, we talked about IovanceCares, we're talking about the system that we use to register patients. IovanceCares also includes patient assistance services. Right now, we're seeing commercial patients come through that are financially able to pay the full amount for AMTAGVI. But don't confuse the two. IovanceCares when we say they're registered in the system, that's our system that all the patients track through no matter what they all within the system. Does that help?

Got you. Perfect. And then, how should we think about how long it would take to kind of start booking revenues? Is that a kind of a 30, 40-day period before we can think about that? Or is it longer? So is it kind of beginning of 2Q versus late 2Q?

So we recognize revenue at the time of infusion. Jean-Marc was talking about that earlier, and we talked about that last year too. Just like the other cell therapies, we recognize revenue when we actually infuse AMTAGVI into the arm of the patient.

So obviously, if we just commenced manufacturing, you've got to add some time for manufacturing and release of the product and then the infusions will occur, and you'll see us accrue revenue at that point. It's not very far away. We're talking weeks now until that starts to happen. But it does -- there is a timeline, and that's why we've been talking about first quarter versus second quarter versus third quarter revenues here. Jean-Marc, anything to that?

No, I think you characterized it properly. So we will have the first infusion coming sometimes after all the manufacturing process, the release will happen and then we'll book the revenue now. It's a question of several weeks still.

Got you. And anything you can say about the patients that have already been selected? Do they kind of -- are they later line, earlier line? Any details around that would be great.

Yes, Jim, could you get this?

Yes, it's probably not appropriate to comment too much other than this patient had been identified and was ready to go. The center that we're talking about had worked them up. And as soon as we got approval, moved literally within hours.

Kevin Cassidy, Baird.

Okay, great. Thanks, good afternoon. Congrats on the progress and thanks for taking our questions. On the example of the tumor section that happened in the next business day, did that patient have reimbursement lined up already? Or does that speak to the confidence of the center and eventually getting reimbursement? And add on to that, can you just speak to the early reimbursement success rate so far?

Yes, Colleen, you got partially cut off there for the first question. But I think you're asking whether the first patient had their financial clearance already worked up? Is that what you're saying?

Yes, exactly.

Yes. So that center -- Jim can comment more, but that center basically wanted to get ahead so fast that they are doing it in parallel, essentially. And then, Jim, do you want to comment on telling second question about the -- how the financial clearance is going overall?

Yes. Colleen, it's still a bit too early to tell. But what I would say is the payers appreciate the unmet need, understand the clinical value of AMTAGVI. And to date, we haven't had any issues. But I would provide the disclaimer that we are very, very early on. Just going back to that first patient and having a very competent experienced team, when this particular ATC reached out to the payer, the payer reached out to our account manager connected the dots and everything moved very smoothly and very quickly in this particular situation.

Great. That's really helpful. And one quick follow-on, if I can, on Europe. Can you just remind us, have you regulators historically approached this review similar to US regulators? Or is there anything unique about this filing versus the US filing? And just remind us what timelines would be in Europe, please?

Raj, do you want to take that one? Raj is unavailable to answer, Colleen. The accelerated approval, like in Europe as well, we won't know that until we actually get further in the MAA process, and it can be at level on first the 14-month renew period. We will obviously aim for the fastest review as we can possibly get with the EMA. EMA has been very cooperative. I'm very interested in getting this drug to European patients.

Michael Yee, Jefferies.

Hi, this is Dina on for Mike. Just wanted to say congrats again, on the approval and thanks for the update today. Just a quick question on how we should think about the cadence of how patients would be treated in the coming months? I know you mentioned that you have the 20 patients, sort of in process, and those could be infused weekly. But how can we sort of think about the bolus and the cadence of how many new patients would be identified per site in the next coming months?

And just quickly on the slots and capacity, how many slots were actually approved by the FDA? And is the manufacturing success rate likely to be in spec of at least 80%? Or how should we model and assume that?

Yes. So on the cadence of treatment, we expect essentially a large bolus to go through this. As you can see from all the banks and the analysts getting KOL calls and stuff like that, there's a lot of patients waiting for AMTAGVI, so we think we're going to be really busy here for the next couple of months.

And then after that, we think we're going to continue to be busy, as you can see from the same KOL interactions, most of the sites have several patients a month. And when you average that all out, across 30, moving to 50 ATCs, that's a very large number of patients every month for us to contend with. So we expect the cadence to essentially be a bolus and then move to a steady state. That's helpful.

On slots and capacity, we haven't actually publicly disclosed the total amount of slots that we've got between WuXi and our iCTC facility creates enormous and I think we'll be able to handle any load that comes in what we got, and we're very happy with the fact that the FDA gave us a lot of space to be on manufacture.

And then regarding the success rate, we don't really -- we can't really disclose at this point what the percentages and what's happening. We don't really know yet. We're still working on that, still testing. We think it's going to be quite high, and we will be successful in manufacturing in vast majority of cases. But again, we're only 12 -- literally 12 days in the launch right now. So we still need a bit of time to figure that out.

Joseph Catanzaro, Piper Sandler.

I appreciate you taking my questions here. I wanted to maybe follow up on manufacturing capacity, but as it in a slightly different way. So as we think about the dynamic of a bolus and the early indicators of demand you just mentioned today, to what extent, if at all, will you have to stagger receipt of tumor samples, meaning, the ATC is going to have to dictate the timing of their resection based on your ability to provide a slot or ATC is able to resect and send sample pretty much at their choosing?

And then sort of my second question, I know it's still the early days, but with the 50 ATCs planned to be onboarded by the end of May, are there any plans to add ATCs beyond that? And if so, to what extent? And what's the timing around that? Thanks.

Yes, Igor, do you want to take the first part? Maybe Jim, we can talk a little bit about the plan for 50...

Yes. Great. Joe, thanks for the question. So we have -- as I mentioned, we have ample capacity to support launch as well as the clinical trials. And the way we designed our capacity, part of that was extensive research, understanding the preferences of each and every ATC about the typical surgery dates and all of that accounted for in our plan.

So we expect to accommodate basically be completely flexible as to what ATCs need to do and provide all the capacity they need to treat all the patients who are in the queue rate now and as additional ATCs on board, we plan to do the same.

And also, as I mentioned, the capacity authorization enables us to hire additional staff and increase capacity without conducting additional filings with the agency.

Joe, this is Jim. The 50 ATCs that we identified by the end of May is going to pick up the significant portion of the treated patients in the country. We will continue to monitor the need to expand from that point. But what we want to do is make sure that with these top centers, we've reinforced success. We build their service line and make sure that they're successful in the treatment.

And just a reminder, what I had mentioned before, like the CAR T market, there's a concentration of care at the top centers. We expect the top 40 to do about 80% of all the treatments for AMTAGVI.

Asthika Goonewardene, Truist Securities.

I just want to maybe ask a little bit more about insurance coverage. Maybe could you tell us a bit about what proportion of lives in the US have some degree of coverage right now? And what proportion has preferential coverage right now? I know it's only day 12 or 13 since approval. But just want to get light of where you are right now. And then if you can also maybe look down into the year, where do you plan on getting that two in the next six months?

Great. This is Jim. I'll just remind you that in the corporate deck, we have our payer mix. About [three-fourths] of our payer mix has strong coverage in reimbursement. This includes 55% in commercial, and in Medicare, 4% or IPPS exempt where these centers are reimbursed their cost and 70% are Medicare Advantage. So I would say that we have a lot of tailwinds in terms of coverage. And right now, initial indications, granted, we're very, very early on in launch, is that coverage seems to be appropriate and payers our insurance access at this moment.

Reni Benjamin, Citizens JMP.

Great, guys. Thanks for taking the questions. Maybe just to start off, are you seeing multiple patients potentially getting treated this early in the launch from the same ATC? Or do you think this early on, maybe it's more of a -- once the reimbursement and infusion takes place, the next patient will get online. Just trying to understand how you see that developing?

And then maybe one for Friedrich. You have the Cohort 1A data expected at a medical meeting. Would love to know, should we just be expecting longer follow-up? Will we have more patients and for that update. And related to that, you guys have other trials that are ongoing, could we be -- could we get additional clinical data from either 4001 or one of the other studies that's ongoing this year?

So Reni, we had a technical issue here. We couldn't hear most of the first question. Can you just -- we heard the part, the clinical question you ask. But what's the first question again?

Yes. So I'm just trying to understand from the ATCs that are on board, are they, like you have the patients going through the process. Is each ATC pretty much putting one patient on and then they're kind of to wait until an infusion takes place before they bring another patient on? Or are you seeing ATCs putting two or three patients on and they've just go ahead and ramping right away?

They're ramping right away. That's the easy question. They're ramping right away. They're not limited in any way by that. And then I guess the second part of the question, Friedrich, could you -- that will keep -- if you clearly at least hear, did you hear? Can you take that one.

Yes. I heard that. So thanks, Reni. So your question was about the cohort 1A data. So as a reminder, for everyone, that's the cohort in study IOV-COM-202, that's evolving checkpoint for naive patients with advanced melanoma to be treated with TIL plus pembro, so that's our kind of proof-of-concept to other study for TILVANCE, and you were asking is it more patients or more follow-up, it's both. And it's obviously great to bring out some more data here in the context of us having TILVANCE enrolling. We haven't really said anything about additional publications at this time. So I'll stay posted on that.

Okay. Can I just ask a follow-up for both those questions again? Do you see any -- at any point in the process, do you see an area where there could be a potential bottleneck? And then from the clinical trial perspective, is there any color you can provide just regarding the FDA hold? Friedrich, I think you mentioned you've already replied to the FDA. Correct me if I'm wrong. Do you expect there to be back and forth? Or do you feel like it was pretty straightforward and you should be -- the hold should be lifted pretty soon?

Jim, do you want to go first and then I take the question about -- you want to talk to?

Sure. Reni, just to circle back on your question about multiple patients. It's still very early on, but we are seeing multiple patients from centers even multiple patients on a given day in the scheduling calendar. So I think you should expect that as we ramp up and ATCs become more comfortable that you'll see demand with multiple patients from ATCs going forward.

And on your question regarding the LUN-202 study. So we are confident that we gave them what they needed them being the FDA in this case in order to see what our plans are, and we're going to -- we're expecting us to respond and to start enrolling fairly soon as well.

Yes. This is Raj Puri. Can I also add that to Friedrich's comments regarding the clinical hold. As Friedrich mentioned that FDA has everything they need to live the clinical hold, and we are actually expecting really soon the resolution of this hold to begin enrolling the patients again.

Andrea Tan, Goldman Sachs.

Friedrich, maybe a follow-up to the last question there, but I just wanted to confirm if you could share any more details on the basis of the partial clinical hold if it was any different from your initial thoughts back in December? That would be helpful.

No. So -- there's nothing. There's no information or no new aspects that we would have learned in the meantime from our interactions with the FDA. So the basis we discussed in quite a bit of detail in December, we've been working on addressing that. And as we said, we have addressed and are expecting response about the enrollment of new patients.

Again, just as a reminder, this was a partial hold, right? So we are in agreement with FDA to be able to offer the therapy to patients who were already enrolled and who had available product. So that also hasn't changed. So again, no new information, no -- nothing unexpected or new that we didn't know back then.

Kelsey Goodwin, Guggenheim.

Good afternoon. I guess just to build a bit on some of the prior questions. First, for the (technical difficulty)

One moment. We'll move on to the next question and come back to Kelsey. One moment. Can you guys still hear me?

Yes. Operator, we can you hear you but just having a difficult time hearing the analyst.

Ben Burnett, Stifel.

Thank you very much. I just had just a question to help with the model. Can you talk about the price of Proleukin, and just how much incremental revenue per patient this will be? And I guess as sort of a follow-up to that, is this handled the same regardless of if it's -- if the patient has commercial insurance versus government insurance?

Ben, can you repeat the question, please. The first part of the question was cut off.

Apologies. I wanted to ask about Proleukin and how much incremental revenue per patient you might expect on top of the AMTAGVI price tag? And then sort of the follow-up to that was, would that be handled the same regardless of commercial insurance is involved versus government insurance?

Sure. Why don't I take the first part and then, Jean-Marc, you can jump in. So as you know. For the AMTAGVI regimen, Proleukin would be used six doses on average 18 vials per dose at a whack of 5,551. What I would share is that the cost would be the same. The reimbursement would be the same, whether you are a commercial or government at this point, with the exception of mandatory discounts for government sectors.

I see. Okay. That's helpful. And just maybe one question for Jean-Marc. To what extent does the cash runway assumption that you mentioned earlier incorporate revenue estimate for AMTAGVI (technical difficulty)

Jean-Marc, are you there? Could you repeat that question one more time, Ben?

Certainly. I was just curious, to what extent is the cash runway assumption that was mentioned earlier in the prepared remarks? I guess, incorporate revenue estimate for AMTAGVI. I'm curious if you could maybe speak to that estimate.

Can you hear me now?

Yes, we can hear you now.

Okay. Sorry. We are having some technical difficulties there. So thank you for the question, Ben. So yes, we do have taken into account some revenue from AMTAGVI, and we're looking into our cash runway. But of course, obviously, we have been very conservative in the way we have taken those revenues. I'm not disclosing more. But again, conservatively on the revenue side. We have enough cash well into second half of 2025.

Ladies and gentlemen, this does conclude today's presentation. I would now like to turn the call back over to Fred for any closing remarks. Fred?

And operator, can you confirm that you can hear me just because of the technical difficulties.

Yes, I can hear you.

Thank you again for joining the Iovance Biotherapeutics fourth quarter and full-year 2023 financial results and corporate update conference call.

2024 is already off to an incredible start for Iovance. Our mission is to remain the global leader in innovating, developing and delivering TIL therapies, and we've now planned a firm stake in the ground as the pioneers of the first commercial TIL therapy. This is also a momentous occasion for the oncology community has been advancing research cell therapy for solid tumors for decades.

We're thankful to all the scientists, researchers, health care providers and institutions who have contributed to the field, to the patients, and their love who have participated in TIL therapy clinical trials. It takes a large, coordinated effort to deliver this type of first-in-class category therapy to patients, and this achievement is a testament to the unwavering commitment expertise and collaborative efforts of many.

Thank you to those and the health care advocacy and patient communities as well as the regulators, our partners and the local communities in Philadelphia, San Carlos, and Tampa that made this US approval possible. I would also like to thank our shareholders and covering analysts for their support.

And lastly, I want to thank our exceptional Iovance team. We could not be here without their cross-functional efforts and our collective steadfast commitment to following the science.

We look forward to providing further updates on the AMTAGVI launch and our pipeline on the second quarter 2024 conference call in May. Please feel free to reach out to our Investor Relations team for a follow-up and apologies for the technical difficulties today. Thank you.

This concludes today's conference call. Thank you for participating. You may now disconnect.