Q4 2023 Iovance Biotherapeutics Inc Earnings Call
Participants
Sara Pellegrino; Senior Vice President, Investor Relations and Corporate Communications; Iovance Biotherapeutics Inc
Frederick Vogt; Interim President and Chief Executive Officer; Iovance Biotherapeutics Inc
James Ziegler; Executive Vice President, Commercial; Iovance Biotherapeutics Inc
Igor Bilinsky; Chief Operating Officer; Iovance Biotherapeutics Inc
Friedrich Finckenstein; Chief Medical Officer; Iovance Biotherapeutics Inc
Jean-Marc Bellemin; Chief Financial Officer; Iovance Biotherapeutics Inc
Yanan Zhu; Analyst; Wells Fargo
Tyler Van Buren; Analyst; TD Cowen
Peter Lawson; Analyst; Barclays
Colleen Hanley; Analyst; Baird
Dina Elmonshed; Analyst; Jefferies
Joseph Catanzaro; Analyst; Piper Sandler
Asthika Goonewardene; Analyst; Truist Securities
Reni Benjamin; Analyst; Citizens JMP
Andrea Tan; Analyst; Goldman Sachs
Kelsey Goodwin; Analyst; Guggenheim
Benjamin Burnett; Analyst; Stifel
Presentation
Operator
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.
Sara Pellegrino
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.
Frederick Vogt
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 4 as well as pool Cohorts 2 and 4.
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 III 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.
James Ziegler
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 2 weeks following approval, the majority of our activated ATCs have at least 1 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.
Igor Bilinsky
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.
Friedrich Finckenstein
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 III 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 II 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 II 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?
Jean-Marc Bellemin
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 III 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.
Question and Answer Session
Operator
(Operator Instructions) Yanan Zhu, Wells Fargo.
Yanan Zhu
Great.
Thanks for taking our questions and congrats on this initial momentum. I'm just curious about the 10 patients sounds like you have 10 patients that are already at this stage of scheduling manufacturing slots. I was 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 as for manufacturing slots. Just wondering what does that mean and what's behind the word pending?
Frederick Vogt
Thank you.
Yeah, hi, John. It's Fred. So they obviously move very quickly for the centers that we're able to schedule these patients are the patients that are there that are either scheduled for a slot or some of the scheduled for a slot for all move into the process. Much more quickly. Some centers move fast on center has been slow. What we're seeing here, I think is some pent-up demand and real excitement for the impact of the launch. I'll let Jim add. Jim, do you want to add any comments to that?
James Ziegler
I think spread, I think it's still too early to tell what we've guided before based upon our experience in cell therapy approvals is takes a couple of days for prior authorization and a couple of weeks were single case agreement. As Fred pointed out, there has been some quick movement because of the sense of urgency at these ADCs 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 up. I pulled the trigger on that slot.
Yes.
Frederick Vogt
All right.
If I have to 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 might if you wouldn't mind commenting on the margin for the CDMO? Thank you very much.
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 in advance and we constantly look at internal manufacturing versus external that keeps everything in play competition. And we think that's the way the best way to run a business that answer your question, right.
How would you distributed the flow to IC. two C. versus CDMO?
Yes, we have we have internal numbers and you're doing that. I can't give you the full detail, but we will distribute the flow somewhat evenly across the two sites. And as we expand as we grow. I think we'll be able to manage it even more tightly as we learn a little bit more right now, but how the sites perform and who's who's doing the best here, but we run the business internally competitive process. And I think, again, just big picture is really clear. There is no real issue with all of the capacity between the two, we have tons of capacity right now for this launch.
James Ziegler
Great.
Thanks for all the color, and congrats on the progress.
Tyler Van Buren
One moment for our next question. Our next question comes from Tyler Van Buren with TD Cowen. Your line is open.
Great.
Frederick Vogt
Hey, guys.
Thanks for taking the question of the patients and process for integrity is very encouraging update given that we're just a week and a half. And but as we think about the 20 Immtech, the patients and process does this constitute the majority of the initial bolus in the 38 DCs 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 U.S. emissions, will I events be launching life loose or broader? 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 M&A front, we intend to do that ourselves. We are 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.
Peter Lawson
We thank you for taking the questions and congrats on the progress. Just wondering if you could kind of talk through how you're thinking about how revenue gets booked and the impact of the patients on the events care program and kind of how you see patients coming in on that program versus not on that program?
It, Peter, in the press release, we talk about IBS cares. We're talking about the system that we used to register patient savings cares also includes patient assistance services. Right now, we're seeing commercial patients come through that are financially able to pay the full amount for literally for MTB for them, but don't don't confuse the two advanced care is when we say the registered in the system, that's our system, that all of the structure of that of what the of advances that help got you perfect.
James Ziegler
Thank you.
Frederick Vogt
And then how should we think about how long it would take to kind of stop booking revenues? Is that a kind of a 30, 40 days period before we can think about that?
Friedrich Finckenstein
Or is it longer or is it kind of beginning of 2Q versus 2Q?
Frederick Vogt
So we recognize revenue at the time of infusion. Jean-marc was talking about that earlier. And we talked about that last year to just like the other cell therapies. We recognize revenue when we actually infuse the intake into the arm of the patient. So obviously, we just commenced manufacturing, get some type of 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 there is a time lag and that's what we've been talking about first quarter versus second quarter versus third quarter revenues here, which I know Martin, anything to them?
Jean-Marc Bellemin
No, I think you characterized it properly, so we will have the first infusion coming out. You know, some sometimes after all the manufacturing process that really will and then we'll move the revenue.
Frederick Vogt
Now it's a question of several weeks till, but anything you can say about the patients that have already been migrated to that kind of thing later line earlier line. Any any details around that upgrade?
Yes, Jim, can you get this from?
James Ziegler
Yes, it's probably not appropriate to comment too much other than in this patient has had been identified and was ready to go on. The center that we're talking about had work them up. And as soon as we got approval moved literally on within our.
Great.
Frederick Vogt
Thanks much.
One number for next question.
Our next question comes from Kevin Cassidy with Baird. Your line is open.
Colleen Hanley
Okay, great. Thanks, good afternoon. Congrats on the progress and thanks for taking our questions. On the example of the reduction that happened the next business day, does 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?
Frederick Vogt
So far your Colorado partially cut off the reverse question, but the first patient had as their financial clearance already worked up that we were saying.
Sara Pellegrino
Yes, exactly.
Yes.
Frederick Vogt
So that data center Jim, Jim can comment more, but that center basically wanted to get ahead so fast that they are doing it in parallel such and it gives you want to comment on selling second question about the health financial grids is going overall.
James Ziegler
Yes, Colin, 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 MTACB. and to date we haven't had any issues, but I would I'll provide the disclaimer that we are very, very early on just going back to that first patient and having a very competent and experienced team. And when this particular 80 C 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.
Sara Pellegrino
That's really helpful. Thank you. And one quick follow-up, if I can. On Europe. Can you just remind us of your regulators has historically approached this review similar to U.S. regulators? And is there anything unique about this filing versus the US filing? And just remind us what time line would be in Europe, please?
Frederick Vogt
And Raj, you want to take that one?
Rogers and Bell white vans are calling that video accelerated approval. Anything in Europe as well, we won't know that until we actually get further in the M&A process and it can be available on First a 40 month review period. We will obviously aim for the fences reviews as we can possibly get with the EMA EMA. It's a very cooperative and very interested in getting this drug to European patients.
Great.
Sara Pellegrino
Thanks for taking the questions and congrats again.
One moment for next question.
Our next question comes from Michael Yee with Jefferies. Your line is open.
Dina Elmonshed
Hi, this is on for Mike. Just wanted to say congrats again, on the approval and thanks for the update today. Just a quick question on on how we should think about the cadence, how patients would be treated and in the coming months I know you mentioned that you had the 20 patients sort of in process and you know, those could be infused weekly. How can we sort of think about the bolus and the cadence of how many new patients will be identified and per site in the next coming months.
And just quickly on slots and capacity on how much 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?
Yes.
Frederick Vogt
So on the cadence of treatment. We expect to essentially a large bolus to go through just as you can see from all the banks and the analysts getting KOL calls, stuff like that. There's a lot of patients waiting for some tanks that we think we're going to be a 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, both the sites have several patients a month. And when you average it all out across 30 moving the 50 cc's. 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 state states that That's helpful.
On sites and capacity, we haven't actually publicly disclosed the total amount of slots that we've got, but we envision for ICTC. facility creates enormous. And I think we'll be able to handle any load that comes in with what we got. And we're very happy with the fact that the FDA gave us a lot of space to beyond main factor and the regarding the success rate, we don't really we can't really disclose at this point with 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. We will be successful manufacturing and the vast majority cases. But again, we're only 12 literally 12 days in the launch right now. So we still have some commentary that out kind of thinking One moment for our next question.
Our next question comes from Joel Simkins are with Piper Sandler. Your line is open.
Joseph Catanzaro
I appreciate you taking my questions here.
I wanted to maybe follow up on manufacturing capacity, but at the business slightly differently on so as we think about the dynamic of a bolus and the early indicators of demand you just mentioned today.
Igor Bilinsky
To what extent if at all, will you have to stagger receipt of tumor samples, meaning, you know, the ATC is going to have to dictate the timing of their resection based on your ability to provide a slot or a TC.s able to resect and sample pretty much at their at their choosing.
And then sort of my second question, I know it's still the early days on both, but with the 50 ATC's plan to be onboarded by the end of May. Are there any plans to add agencies beyond that? And if so, to what extent and what's the timing around that? Thanks.
Frederick Vogt
Yes, you go. Do you want to take the first part maybe, Jim, you could talk a little bit about the planned pit 52?
Igor Bilinsky
Yes, it's great to Joe. 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 design no capacity. Part of it, though, was extensive research, understanding the preferences for each and every PTC., both the typical surgery days and all of that's accounted for in our plants. So we expect to accommodate basically be completely flexible just to what ATC's need to do and provide all the capacity they need to treat all the patients who are in the queue right now. And as additional agencies on board, we plan to do the same. And also, as I mentioned, the of the capacity authorization enables us to hire additional staff and increase capacity without conducting additional filings with the agency.
James Ziegler
Joe, this is Jim. On the 58 TC.s 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 up 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 Immtech.
Frederick Vogt
Okay.
James Ziegler
Got it.
Thanks. That's helpful.
Igor Bilinsky
And appreciate you taking my questions and number four.
Next question.
Our next question comes from a significant opportunity with Truist Securities.
Asthika Goonewardene
Your line is open again and just want to maybe get a little bit more about insurance coverage. Maybe could you tell us a bit about what proportion of lives in the U.S. and some degree of coverage right now? And what proportion have preferential coverage right now. I know it's three day 12 or 13 up a person's approval, but just want to get an idea of where you are right now. And then if you could also maybe look done, look down to a three year where 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 a strong coverage and reimbursement. This includes 55% commercial and in Medicare, 4% RIPPS. exempt where the centers are reimbursed at 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. That coverage seems to be appropriate and payers our insurance access at this moment.
Great.
Sara Pellegrino
Thanks for taking my questions.
One number for next question.
Our next question comes from Reni Benjamin with Citizen's GMP. Your line is open.
Reni Benjamin
A great, guys. Thanks for taking the questions on maybe just to start off, are you seeing multiple patients potentially getting treated this early in the launch from the same ATC.? Or where do you think this early on maybe it's more of a. And 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 on the cohort 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 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 4,001 or one of the other studies that's ongoing this year.
Frederick Vogt
So running, we had a technical issue because we couldn't hear most of the first question. Can you just for it, but we are the part the clinical question. I guess Apple was the first question again.
Yes.
So I'm just trying to understand from BATC.'s that are on board on, are they like?
Yes, patients going through the process is each ATC. pretty much putting one patient on and then they're kind of going to wait until an infusion takes place before they bring another patient on. Are you seeing a disease like putting two or three patients on and they've just go ahead and ramping right away, you're ramping right away.
That is your question around whether or not limited in any way by that.
And then I guess the second part of question, Fredrik, could you that we'll be able to clearly see RPU here if you take that one?
Friedrich Finckenstein
Yes, I think I heard that. So think site on the so your question was about the core IA data. As a reminder for everyone that the concordance study IoT come to two that's involving on checkpoint inhibitor naive patients with advanced melanoma to be treated with TIL plus pembro. So that's our kind of proof of concept as part of study for tool and some deep then you were asking is, is it more patients or more follow up with both farm? It's obviously great to bring out some more data here in the context of us having having a trial that's enrolling. But we haven't really said anything about additional publications at this time. So stay posted on that.
Okay. Can I just ask a follow up and for both those questions again, do you see any at any point in the process? Do you see an area where there could be potential bottlenecks and then from the clinical trial perspective, is there any color you can provide just regarding the FDA, hold you Friedrich, I think you mentioned you've 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.
Tim, do you want to go first and then I take the question about.
James Ziegler
Well, you want to actually hear from Randy, 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 ATC.s become more comfortable that you'll see demand with multiple patients from ATC.s going forward.
Friedrich Finckenstein
And on your question regarding regarding the LUN two studies. So we're confident that we that we gave them what what they needed them being the FDA in this case in order to see what our plans are. And what are we expecting as responsiveness and to start enrolling fairly soon as well.
Perfect back.
James Ziegler
I can have a question.
Sorry, if I can.
Igor Bilinsky
I can also add that add that to fluidics comment regarding the clinical hold, as Fredrik mentioned, that FDA has everything they need to lift the clinical hold. And we are actually expecting really soon the resolution of this this whole, we'll begin enrolling the patients.
Frederick Vogt
Again, thanks for taking the questions.
One moment for our next question.
Our next question comes from Andrew Tan with Goldman Sachs.
Andrea Tan
Your line is open quoting and quoting.
Sara Pellegrino
A question feedback, maybe a follow up on the last question there, but just wanted to confirm if you could share any more details on the basis of the partial clinical hold? And if it was any different from your initial thoughts on back in December, that would be helpful. Thank you.
Friedrich Finckenstein
You know, it's like no, there's nothing there's there's no information on it, no new aspects. And we would have learned in the meantime from our interactions with the FDA. And so the basis and we discussed it quite a bit of detail in December. We've been working on addressing that. And as we said, we have addressed and are expecting a response about the enrollment of new patients from again, just to the just as a reminder, this was a partial hold rate. So we are we are in agreement with the FDA to be able to offer us the therapy to patients who were already enrolled and who had available product. So that also hasn't changed. So again, no, no new information, no, nothing unexpected or knew that.
Frederick Vogt
And we did not buy them and we'll do one more before next question.
Yes.
Our next question comes from Kelsey Goodwin with Guggenheim. Your line is open.
Kelsey Goodwin
Have a good afternoon, particularly, but I guess just to build a bit on some prior questions.
Frederick Vogt
First for the app were overdue dosing.
Sara Pellegrino
Okay.
Frederick Vogt
Can Can can you hear me better now, operator, we're unable to hear Chelsea's question from euros one moment.
And we'll move on to the next question and come back to Kelcy one moment.
Yes.
Can you guys hear me now offer with your you're just having a difficult time hearing the Alice moment, right.
Our next question comes from Ben Burnett with Stifel. Your line is open.
Benjamin Burnett
Great.
Thank you very much.
James Ziegler
I just had a question on the help of the model.
Frederick Vogt
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 handled the same regardless of if it's if the patient has commercial insurance versus GOVERNMENT insurance.
Igor Bilinsky
And this is a really, really simple question, please. The first part of the question was cut off.
Frederick Vogt
Apologies. I wanted to ask about Proleukin and how much incremental revenue per patient you might expect. And I'll top of the Tag and Tag the price tag sort of the follow-up to that was, would that be handled the same regardless of commercial insurances involved versus government insurance?
Sure.
James Ziegler
Why don't I take the first part and then Jean-Marc, you can jump in. So as you know, for the and TAG, the regimen in China to 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 commercial or government at this point with the exception of mandatory discounts for government sector say.
Frederick Vogt
Okay, that's helpful.
James Ziegler
Thank you. And just maybe one question for Jean-Marc. To what extent is the cash rent runway assumption that you mentioned earlier incorporate a revenue estimate from TAG?
Igor Bilinsky
No.
Okay.
So Jean-Marc, where you are you there?
Could you repeat that question one more time.
Frederick Vogt
And certainly I was just curious to what extent is the cash runway assumption that was mentioned earlier, the prepared remarks, I guess, incorporate a revenue estimate for integrity. And curious, can you maybe that estimate Can you hear me now?
Jean-Marc Bellemin
Yes, we can hear you now focus our zone. We are having some technical difficulties. So thank you for the question, Ben. So yes, we think we'll have to take into account some revenue from that and tag Canadians are looking into our cash runway. But of course, obviously we have been very conservative in the way we have taken those revenue. So I'm not disclosing more that's again, conservatively on the revenue side, and we have enough cash well into second half of 2025.
Frederick Vogt
Understood. Thanks so much.
Ladies and gentlemen, this does conclude today's presentation. I will now turn the call back over to Fred for any closing remark remarks.
And operator, can you confirm you can hear me just because of the technical difficulties.
Second, here, you can hear that. 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 cell therapies, and we have now planted a firm stake in the ground as the pioneers. The first commercial TIL therapy is also a momentous occasion for the oncology community has been advancing research cell therapy for solid tumors for decades for Thanks for all the scientists, researchers, health care 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 patients. And this achievement is a testament to the unwavering commitment expertise and collaborative efforts of many Thank you to those. And then healthcare advocacy and patient communities as well as the regulators are partners in the local communities in Philadelphia, San Carlos and Tampa that made this US approval possible possible. I'd also like to thank our shareholders and covering analysts for the support. And lastly, I want to thank our exceptional events team. We could not be here without their cross-functional efforts and our collective steadfast commitment to find sites. We look forward to providing further updates on the integrity launch in our pipeline on the First Quarter 2020 Conference Call. And please feel free to reach out to our Investor Relations team for follow-up, and apologies for the technical difficulties today. Thank you.
Sara Pellegrino
This concludes today's conference call, and thank you for participating. You may now disconnect.
