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. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. 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 at Iovance. Sarah, 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 update. 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 U.S. commercial launch of AMTAGVI, following the recent U.S. 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 conference call will include forward-looking statements regarding Iovance's goals, business focus, business plans and transactions, revenue, commercial activities, 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 U.S. FDA's recent approval of AMTAGVI, the first one-time T cell therapy for solid tumor. The AMTAGVI 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 4 as well as pull Cohorts 2 and 4. In the first few days of U.S. launch, we are seeing strong demand and momentum for AMTAGVI. Consequently, we also expect increased demand for Proleukin. 32 authorized treatment centers or ATCs were ready for approval and nearly all identified a patient. Jim will provide more detail later in the call. The first tumor resection occurred on the first business day after approval and commercial manufacturing began the following day at our Iovance Cell Therapy Center, or ICTC. This is a testament to the high unmet medical need and the great 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 ongoing expansion plans. In addition to the U.S. launch, our near-term expansion plans for AMTAGVI are focused on addressing many thousands of additional patients by entering new geographies and broadening the label to include frontline advanced melanoma, as well as other indications. For example, our planned global expansion has the potential to roughly double the total number of addressable patients for AMTAGVI post 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 strong momentum in several countries to support regulatory submissions in frontline advanced melanoma. We are also pleased with the progress in our robust development pipeline across solid tumor cancers. Friedrich will speak later about some key highlights of our ongoing clinical trial programs. Today, Iovance is a fully integrated company and is now the first company to commercialize a T cell therapy for solid tumor indications. We are well positioned to execute on our regulatory pipeline and manufacturing commercial launch activities to remain the global leader in TIL cell therapy. Jim will now describe the ongoing activities related to our U.S. launch.

Thank you, Fred. Each year, approximately 8,000 people in the U.S. die from 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 one-time 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 a 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, 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 scheduled 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 inpatient reimbursement trends for AMTAGVI. These trends are consistent with approved CAR T products and benefit from increased speed resulting from both our preparation and the ATC's experience. We continue to anticipate prior authorizations to include coverage consistent with the 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 TIL cells from a portion of their tumor, multiply them into billions and return them back to the patient to fight cancer. The U.S. 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 of the approval and commercial manufacturing of AMTAGVI is officially underway. We are currently staffed to meet the anticipated needs of our U.S. launch, as well as our ongoing and planned clinical trials. In the BLA submission for AMTAGVI, we 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, extensions within the iCTC facility are 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 and are committed to doing everything right the 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 U.S. I'll begin with TILVANCE-301, our registrational Phase 3 trial in frontline advanced melanoma. TILVANCE-301 is well underway, it’s both accelerated and full approval of AMTAGVI in combination with pembrolizumab in the frontline advanced melanoma. Global site activation and patient enrollment continue with strong momentum in the U.S., 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-COM-202 in 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 U.S. 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 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. T cell therapy, based on its mechanism of action, may benefit both of these patient populations. We look forward to providing more details as we advance this trial this year. Iovance is the leader in T 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 in the GM1-201 trial. 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.

Thank you, Fred. 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 was 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 non-cash amortization expenses for the acquired intangible assets for developed technology. There was no cost of revenue for the fourth quarter and year 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 for the year ended December 31, 2023, over the prior year periods were primarily attributable to increases in headcount and related costs to support increased production capacity and commercial manufacturing readiness, as well as 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 ended 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 prior year periods was primarily attributable to increases 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 in the afternoon 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 a full year 2024 cash burn in the range of $320 million to $340 million, excluding one-time expenses, and we will continue to leverage opportunities to optimize spending. The U.S. 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 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.

Thank you. Our first question comes from Yanan Zhu with Wells Fargo. Your line is open.

Thank you for taking our questions and congratulations on the initial momentum. I'm curious about the 10 patients. It seems you have 10 patients who are already at the stage of scheduling manufacturing slots. How long did the reimbursement process take for these patients, and has that given you any updated perspective on the average time from patient identification to tumor resection? Additionally, some of these 10 patients are listed as pending for manufacturing slots. What does that mean and what is behind the term pending? Thank you.

Yes, it's Fred. We've been able to move quickly for the centers that are scheduling these patients. The 10 patients either scheduled or about to be scheduled are progressing through the process much faster. While some centers operate quickly, others are slower. What we're observing is a strong demand and real enthusiasm for the AMTAGVI launch. Jim, would you like to share any thoughts on this?

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, ATCs basically will schedule a slot once they know they have successful reimbursement. So, pending means 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 CTC or the CDMO. Just wondering how are you distributing the flow to these two facilities? And if you wouldn’t mind commenting on the margin for the CDMO? Thank you very much.

Yes, Yanan, 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 at internal manufacturing or external that keeps everything in tight competition, and we think that's 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. And again, just to make sure it's really clear, there is no real issue at all of capacity between the two. We have tons of capacity right now for this launch.

Great. Thanks for all the color and congrats on the progress.

Thank you.

Our next question comes from Tyler Van Buren with TD Cowen. Your line is open.

Great. Hey guys. Thanks for taking the question. The patients in process for AMTAGVI is a very encouraging update given that we're just a week and a half 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 and 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. 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.

Thank you.

One moment for our next question. Our next question comes from Peter Lawson with Barclays. Your line is open.

Great. Thank you. Thanks 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 Iovance care 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 Iovance cares; we're talking about the system that we use to register patients. Iovance care 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. Iovance care, when we say they're registered in the system, that's our system that all the patients track no matter what the status.

Got you. Perfect. Thank you. And then how should we think about how long it would take to kind of start booking revenues? Is that a kind of 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 ratio, 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 there is a timeline, and that's what we've been talking about first quarter versus second quarter versus third quarter revenues here. Jean-Marc, do you have anything to add 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 move the revenue. Now it's a question of several weeks.

Got you. Can you provide any information about the patients who have already been selected? Are they in later lines or early lines? Any details around that would be appreciated. Thank you.

Yes. Jim, could you address this?

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

One moment for our next question. Our next question comes from Colleen Kusy with Baird. Your line is open.

Great. Thanks. Good afternoon. Congrats on the progress, and thanks for taking our question. On the example of the tumor resection that happened 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 as an add-on to that, can you just speak to the early reimbursement success rate so far?

Yeah, 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?

Yeah, exactly.

Yeah. So that center, Jim can comment more, but that center basically wanted to get ahead so fast that they were doing it in parallel, essentially. And then, Jim, do you want to comment on Colleen’s second question about the health financial clearances overall?

Yeah. Colleen, it's still a bit too early to tell. But what I would say is the payers appreciate the unmet need and 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. Thank you. And one quick follow-on, if I can, on Europe. Can you just remind us how regulators have historically approached this review similar to U.S. regulators? Is there anything unique about this filing versus the U.S. filing? And just remind us what time lines would be in Europe, please?

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

Great. Thanks for taking our questions and congrats again.

One moment for our next question. Our next question comes from Michael Yee with Jefferies. Your line is open.

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 in process, and those could be infused weekly, but how can we 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? Thank you.

Yes. We anticipate a significant influx of treatments in the coming months, as there are many patients awaiting AMTAGVI, indicated by the interest from banks and analysts. We expect to be quite busy for the next few months, and thereafter, we believe that the demand will remain steady since interactions indicate that most sites have multiple patients each month. When you calculate that across 30 to 50 ATCs, it results in a substantial number of patients for us to manage monthly. We foresee initial high demand followed by a steady rate of treatment. Regarding our capacity, we have not disclosed the total number of slots available between our WuXi and iCTC facilities, but we are confident in our ability to manage incoming demand. We're pleased that the FDA has granted us ample capacity for manufacturing. As for the manufacturing success rate, we expect it to be quite high, with a vast majority of cases being successful. However, since we are only 12 days into the launch, we still have some time to evaluate this further.

Got it. Thank you.

One moment for our next question. Our next question comes from Joseph Catanzaro with Piper Stanley. Your line is open.

Hey, guys. Appreciate you taking my questions here. I wanted to maybe follow-up on manufacturing capacity, but asset 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 ATCs are going to have to dictate the timing of their resection based on your ability to provide a slot or ATCs able to resect and 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.

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

Thank you for the question, Joe. We have sufficient capacity to support the launch and the clinical trials. Our capacity planning involved extensive research to understand the preferences of each ATC regarding typical surgery dates, which has been incorporated into our strategy. We anticipate being flexible in accommodating the needs of ATCs to provide the necessary capacity for treating all patients currently in the queue, as well as for additional ATCs that will come on board. We intend to maintain this approach. Additionally, the capacity authorization allows us to hire more staff and expand capacity without needing to file any further requests 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 reinforce 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.

Okay. Got it. Thanks. That's helpful. I appreciate you taking my question.

One moment for our next question. Our next question comes from Asthika Goonewardene with Truist Securities. Your line is open.

Hi, guys. I just want to maybe ask a little bit more about insurance coverage. Could you tell us a bit about what proportion of lives in the U.S. 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 I just want to get an idea 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 to 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 quarters of our payer mix has strong coverage in reimbursement. This includes 55% 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 are ensuring access at this moment.

Great. Thanks for taking my questions.

One moment for our next question. Our next question comes from Reni Benjamin with Citizens JMP. Your line is open.

Thank you for taking my questions. To start, are you seeing multiple patients being treated this early in the launch from the same treatment center? Or do you think it’s more likely that once reimbursement and infusion occur, the next patient will start treatment? I'm trying to understand how you see this evolving. Also, Friedrich, you have the Cohort 1A data expected at a medical meeting. Should we anticipate longer follow-up, and will there be more patients included in that update? Additionally, since you have other ongoing trials, can we expect to see more clinical data from either 4001 or one of the other studies this year?

So Rene, we experienced a technical issue and couldn't hear most of the first question. Can you please repeat the first question? We did catch part of the clinical inquiry when you asked it.

Yes. So I'm just trying to understand from the ATCs that are on board, are they putting multiple patients through the process, or does each ATC mainly put one patient on and then kind of waiting until an infusion happens before they bring another patient on? Or are you seeing ATCs putting two or three patients on 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 take that one?

Yes. I've heard that. So thanks, Reni. So your question was about the Cohort 1A data. So as a reminder for everyone, that's Cohort 1A IOV-COM-202 that's evolving checkpoint inhibitor-naive patients with advanced melanoma to be treated with TIL plus pembro, so that's our kind of proof-of-concept to out-of-study. And you were asking a bit 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 having show that's enrolling. We haven't really said anything about additional publications at this time, so stay close for that.

Can I ask a follow-up to both those questions? Do you see any potential bottleneck at any point in the process? From the clinical trial perspective, can you provide any information regarding the FDA hold? Friedrich, I believe you mentioned that you've already replied to the FDA. Am I correct? Do you expect there will be back and forth, or do you think it was straightforward and the hold will be lifted soon?

Jim, do you want to go first and then I take the question about LUN-202?

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, we're confident that we gave the FDA everything they need to lift the clinical hold. We expect to respond and to start enrolling very soon as well.

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

Thanks for taking the questions.

One moment for our next question. Our next question comes from Andrea Tan with Goldman Sachs. Your line is open.

Good afternoon. Thanks for taking our question. 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? Thank you.

No, there’s nothing new we have learned from our interactions with the FDA. We have been working on addressing the basis we discussed in detail in December, and we expect a response regarding the enrollment of new patients. This is a partial hold, and we are in agreement with the FDA to offer therapy to patients who are already enrolled and who have available products. That situation has not changed. Again, there is no new information or anything unexpected that we didn’t know back then.

One moment for our next question. Our next question comes from Kelsey Goodwin with Guggenheim. Your line is open.

Hey, good afternoon. Thank you for taking my question. I guess just to build a bit on some prior questions.

Your voice is breaking, Kelsey.

Operator, we are unable to hear Kelsey’s question. One moment for our next question. Our next question comes from Ben Burnett with Stifel. Your line is open.

Great. 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 the patient has commercial insurance versus government insurance?

Could 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 you might expect from AMTAGVI 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 whether the patient has commercial insurance 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 cost of $5,551. What I would share is that the cost would be the same. The reimbursement would be the same, whether you are commercial or government at this point with the exception of mandatory discounts for government sectors.

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

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

Certainly. I was just curious to what extent the cash runway assumption that was mentioned earlier incorporates a 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're having some technical difficulties there. So thank you for the question, Ben. So yes, we do take into account some revenue from AMTAGVI and Proleukin 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 the second half of 2025.

Understand. Thanks so much.

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.

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 health therapies, and we have now planned a firm stake in the ground as the pioneers of the first commercial TIL therapy. It's also a momentous occasion for the oncology community that has been advancing research and cell therapy for solid tumors for decades. We're thankful to all the scientists, researchers, healthcare providers, and institutions who have contributed to the field, to the patients and their loved ones who have participated in TIL therapy clinical trials. It takes a large and 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 in the healthcare advocacy and patient communities, as well as the regulators, our partners, and the local communities in Philadelphia, San Carlos, and Tampa that made this U.S. 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 first 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.