Iovance Biotherapeutics - Earnings Call - Q3 2025

Executive Summary

• Q3 2025 total product revenue was $67.455M, up ~13% sequentially as reported, with gross margin improving to 43% on cost optimization and better manufacturing execution.
• Revenue mix: ~$58M Amtagvi (U.S.) and ~$10M Proleukin; cash and equivalents totaled ~$307M, with runway expected into Q2 2027.
• Management reaffirmed FY2025 total product revenue guidance of $250–$300M; centralization of manufacturing at ICTC in early 2026 is expected to further reduce cost of sales and lift margins.
• Lifileucel in NSCLC showed a 26% ORR and median duration of response not reached at >25 months; IOV-LUN-202 is expected to complete enrollment in 2026, targeting accelerated approval and potential launch in 2H 2027.

What Went Well and What Went Wrong

• What Went Well

  • Gross margin improved to 43% (cost of sales ~$39M) with lower out-of-spec write-offs and restructuring benefits; CFO noted continued margin improvement expected with manufacturing centralization.
  • Commercial execution: >80 ATCs active across ~40 states; community centers began treating patients; specialty pharmacy channel added to broaden access.
  • NSCLC data: Lifileucel monotherapy achieved 26% ORR with median DOR not reached after >25 months; FDA provided positive feedback on trial design/potency matrix.
  • Quote: “We continued to see revenue growth with significant gross margin improvement… Amtagvi demand is increasing as we integrate our community treatment centers…” — Frederick Vogt (Interim CEO).

• What Went Wrong

  • Q3 revenue was below consensus ($67.455M actual vs $72.809M estimate*) and EPS only modestly better than consensus (-$0.25 actual vs -$0.257*), reflecting a near-term shortfall vs Street models.*
  • Operating losses remain sizable: Loss from operations -$94.901M; net loss -$91.253M for Q3 2025.
  • Strategic transition risk: Near-term complexity managing ICTC expansion/maintenance and shift away from external manufacturing ahead of early 2026 centralization.

Transcript

Operator (participant)

Welcome to the Lovance Biotherapeutics Third Quarter and Year-to-Date 2025 Conference Call. My name is Daniel, and I will 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 call is being recorded. I will now turn the call over to Sara Pellegrino, Senior Vice President of Business Relations and Corporate Communications at Iovance. Sara, you may begin.

Sara Pellegrino (SVP of Business Relations and Corporate Communications)

Thank you, Operator. Good morning and welcome to the Iovance webcast to discuss our business achievements, pipeline milestones, and third quarter 2025 results. Members of our executive leadership team speaking on today's call include Dr. Fred Vogt, Interim CEO and President, Corleen Roche, Chief Financial Officer, Dan Kirby, Chief Commercial Officer, Dr. Igor Bilinsky, Chief Operating Officer, and Dr. Friedrich Finkenstein, Chief Medical Officer.

During the question-and-answer session, we will also welcome Doctors Raj Puri and Marc Ferré from our Regulatory Affairs Executive Leadership Team and Dr. Brian Gastman, Executive Vice President of Translational Medicine and Research. This morning, we issued a press release that is available on our corporate website at iovance.com.

I would like to remind everyone that this conference call will include forward-looking statements regarding Iovance's goals, business focus, business plans and transactions, revenue and revenue guidance, 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, restructuring, licenses and collaborations, 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 filing. Our results may differ materially from those projected during today's call. We undertake no obligation to publicly update any forward-looking statements. I will now like to turn the call over to Fred.

Fred Vogt (Interim CEO and General Counsel)

Thank you, Sara. I will start by sharing our continued progress to increase revenue and margins, advance our pipeline, reduce expenses, and improve operational execution. Third quarter revenue grew 13% over the prior quarter, and notably, gross margin improved and was 43%. Following the initial results of our strategic restructuring and cost optimization. More improvements are coming, including today's announcement of our centralization of manufacturing at our internal manufacturing facility.

Our highest priority is to accelerate revenue growth to increase the Amtagvi adoption. Across our network of academic and community authorized treatment centers, or ATCs. We have expanded to include new academic ATCs and multiple community ATCs. Initial patients are being treated in the community and are generally earlier in their melanoma treatment journey. As we educate community oncologists across our ATCs. Including the major academic centers, we are seeing earlier and more frequent patient referrals that drive growth.

Real-world data showed response rates of 60% in the second-line treatment setting, which has provided a strong foundation to amplify our compelling story to the melanoma community for the power of TIL therapy in melanoma. We are on track to achieve our revenue guidance range of $250 to 300 million for the full year of 2025. With robust current demand, we expect a strong fourth quarter of for Amtagvi alongside increasing Proleukin sales as we saw in late 2024.

We continue to project Amtagvi peak sales of more than $1 billion in the US and melanoma, with larger additional opportunities in international markets and in future indications. For example, our interim clinical data in previously treated non-squamous, non-small cell lung cancer showed a best in class. Excuse me. Apologies for technical difficulty here. One second.

For example, our interim clinical data in previously treated non-squamous, non-small cell lung cancer showed a best in class profile and unprecedented durability compared to standard of care in this population, including an objective response rate of 26% and a median duration of response not reached at more than 25 months of follow-up. There is a significant market opportunity in this lung cancer indication, which is about seven times greater than our current advanced melanoma indication.

We expect to quickly complete enrollment in our LUN- 202 registration trial in 2026 with approximately 80 patients. This sample size will support an accelerated approval given the unmet need in non-small cell lung cancer, precedent of the Amtagvi approval in 73 melanoma patients, and recent accelerated approvals based on 70-80 patients from the defined non-small cell lung cancer population. The US FDA previously provided positive feedback on our trial design.

Which aligns with FDA guidance for single-arm trials to support accelerated approvals for single agents in conditions with unmet medical need. We look forward to advancing toward a supplemental biologics license application in non-squamous, non-small cell lung cancer and a potential launch in the second half of 2027. As we increase revenue and advance our pipeline, we are laser-focused on expense management profitability.

Following our third quarter reorganization, we are refining our operating plan to ensure we are appropriately investing in our commercial launch and high-value programs. Again, cost of sales and gross margin will improve significantly as we transition manufacturing to our internal facility in early 2026. During this call and our future quarterly updates, we will highlight our ongoing efforts toward further expense reductions and resource allocation. Corleen will now highlight our third quarter financials in further detail.

Corleen Roche (CFO)

Thanks, Fred. Good morning, everyone. During my first quarter as Chief Financial Officer, I want to emphasize our focus on driving the company toward sustained profitability. Our strategy includes prioritizing top-line growth, significantly improving margin, and controlling costs with a disciplined approach. In the third quarter, our top-line revenue remained strong. Total product revenue increased approximately 13% over the prior quarter to about $68 million.

This included Amtagvi sales of approximately $58 million. Global Proleukin revenue was nearly $10 million. As expected and consistent with prior quarters, overall gross to net was less than 2% and is expected to remain minimal. As Fred mentioned, we are on track to achieve our revenue guidance in the first full calendar year of Amtagvi sales. Next, I am pleased to highlight initial improvements in expenses and gross margin from the corporate restructuring and continued cost optimization initiatives implemented in the third quarter.

We reduced total costs and expenses by approximately 10% over the prior quarter, excluding restructuring charges of approximately $5 million. We lowered cost of sales by approximately 21% over the prior quarter, resulting in improved gross margin of approximately 43%. Importantly, costs associated with patient drop-off and manufacturing results continue to decline as our revenue continues to grow.

Gross margin will improve over time as we accrue benefits from our recent restructuring, implement additional cost savings initiatives, and centralize manufacturing at our internal facility. Our cash position of approximately $307 million as of September 30th was bolstered by expense reductions and is expected to fund operations into the second quarter of 2027. I will now turn the call to Dan Kirby, our Chief Commercial Officer.

Dan Kirby (Chief Commercial Officer)

Thanks, Corleen. Our ultimate goal is to establish Amtagvi as the preferred option for all eligible patients. Patients deserve a one-time cell therapy with curative intent, and we are steadfast in delivering on that promise. My conversations with patients and caregivers remind us of the commitment to the Iovance mission, pioneering a new treatment paradigm for patients with solid tumor cancers. At the recent Melanoma Research Foundation Gala in Denver, Iovance received the Corporate Leadership Award in recognition of our efforts to advance care for melanoma patients.

In my first eight months at Iovance, we have made notable progress to lay the foundation for revenue growth by driving adoption across our ATCs. I'll highlight three key areas of focus. First. New ATCs are driving growth. In the third quarter, we added community ATCs alongside new high-volume academic ATCs. These new ATCs contributed to the highest number of patient starts with better capture in the third quarter. Our first community ATCs are beginning to treat patients with Amtagvi in this setting. New ATCs continue to come online and will drive further growth in the fourth quarter and beyond.

Second, penetrating the community market is key to unlocking Amtagvi's tremendous potential as we increase the frequency, speed, and efficiency of community referrals to ATCs. Healthcare professional and patient-focused campaigns are having a positive impact. Under our specialty pharmacy agreement with Biologics by McKesson, patients have broader access to Amtagvi. Hospitals now have flexibility to obtain Amtagvi directly or through a specialty pharmacy, giving their finance teams confidence to place more orders. Our third focus area is to drive earlier treatment with Amtagvi. This will increase penetration in our academic centers. We are educating medical oncologists on the advantages of cell treatment.

With Amtagvi when it has the greatest benefit. Earlier shifts in referral patterns are supported by our first real-world data that shows 60% of patients respond in the second-line setting. In addition, new initiatives in academic ATCs will address earlier tissue procurement for patient types, such as BRAF mutations, so they can be treated before their health status declines. Proleukin revenue also grew in the third quarter. Our main revenue channel for Proleukin is used with Amtagvi. Two US wholesalers ordered in the third quarter, and all three wholesalers are expected to order significant volume in the fourth quarter.

Proleukin will continue to grow through this main revenue channel in addition to the two other revenue channels for clinical and manufacturing use. Like other companies, we are evaluating our Proleukin pricing strategy outside of the United States based on the current environment, which may help drive future revenue growth. Amtagvi has the potential to reach more than 30,000 patients with advanced melanoma globally. Canada became the first new market to approve Amtagvi, and approvals are pending in three additional markets: the UK and Australia in the first half of 2026, and Switzerland in early 2027.

In the European Union, we are confident in our planned strategy. We are seeking scientific advice from the European Medicines Agency and intend to resubmit for regulatory approval shortly thereafter. Looking at the broader potential of lung cancer, our interim data demonstrates that one-time treatment with lifileucel represents a true game changer and potential cure for patients with non-squamous advanced non-small cell lung cancer.

With approximately 50,000 addressable patients in the US alone, the market opportunity is about seven times larger than our current melanoma opportunity and represents potential US peak sales of $10 billion. US academic and community practices are enthusiastic about our lung cancer program.

All of our current and future ATCs are expected to launch in non-small cell lung cancer. A significant portion of them already treat patients in our IOV-LUN-202 trial. The ATC footprint for lung cancer is essentially the same as our melanoma treatment network. ATCs are eager to leverage their current TIL infrastructure to quickly adopt lifileucel in lung cancer upon approval. I will now pass the call to Igor.

Igor Bilinsky (COO)

Thank you, Dan. I will provide a brief manufacturing update. We have streamlined our manufacturing organization while reducing costs and improving our manufacturing success rate, as reflected in our third quarter gross margin. Importantly, we are finalizing an expansion at our internal facility, the Iovance Cell Therapy Center, or ICTC, that will enable us to support anticipated demand without the need for a contract manufacturer. All Amtagvi and clinical manufacturing will transition to ICTC in early 2026 to maximize capacity utilization, lower cost of sales, and drive future gross margin growth.

We will complete a key step in this facility expansion during routine annual maintenance around the end of this year. During this time, our contract manufacturer will provide continued access for patients to meet demand before we transition full manufacturing to ICTC. We will also boost capacity immediately prior and following the maintenance period to provide additional manufacturing slots for patients, allowing smooth supply through the next two quarters. Bringing full manufacturing internally will be an important milestone for us as a company.

In addition to the cost benefits, we will maintain uninterrupted supply during routine maintenance in the future using internal capabilities. We can also scale up within the existing facility to support future markets globally and indications, including lung cancer. I will now pass the call to Friedrich.

Friedrich Graf Finckenstein (CMO)

Earlier this week, we reported interim data from our registrational IOV-LUN-202 clinical trial of lifileucel. The data demonstrated a potentially best-in-class clinical profile. A meaningful improvement over current standard of care in previously treated patients with non-squamous non-small cell lung cancer. Following one-time treatment with lifileucel monotherapy, the objective response rate was an impressive 26%. An objective response was observed in 10 out of 39 patients, which included two complete responses.

The disease control rate was 72%, showing a meaningful benefit for many patients with stable disease. Importantly, median duration of response was not reached at more than 25 months of follow-up, which is unprecedented durability for non-small cell lung cancer therapy in the post-chemo and immune checkpoint inhibitor setting. Standard of care docetaxel on monotherapy recently showed an objective response rate of only 13% and a median duration of response of only 5.6 months without any complete responses in the same patient population.

We are on track to quickly complete enrollment of approximately 80 patients in 2026. We have seen a strong increase in enrollment this year, driven by the positive reception of the efficacy data among trial investigators. In addition to the 39 patients in the data set, a double-digit number of patients are awaiting or have recently received TIL infusions, and more patients have entered the trial as of today. We plan to share more data from LUN-202 at a medical meeting next year, including a meaningful number of additional patients and longer follow-up.

We also look forward to advancing towards a supplemental biologics license application for lifileucel in non-squamous non-small cell lung cancer and a potential launch in the second half of 2027. We also continue to make progress across the rest of our pipeline, which I am happy to discuss during the Q&A session. Thank you.

Operator (participant)

Thank you. To ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. In the interest of time, we ask that you please limit yourself to one question. Please stand by while we compile the Q&A roster. Our first question comes from Andrew Tsai with Jefferies. Your line is open.

Andrew Tsai (SVP)

Hey, good morning. Nice execution this quarter. Great to see various dynamics improving. Good job. My question this quarter is on the lung cancer data update that you had. It's interesting that the signal did not necessarily degrade compared to the prior data cut. In fact, maybe the efficacy on DOR seemed to get better. For the remaining batch of patients, would you expect the third data cut to be also similar or even better than what we're seeing in this interim that you just had? Would you expect some kind of efficacy degradation on a larger sample size? Thank you.

Fred Vogt (Interim CEO and General Counsel)

Thanks, Andrew. I can start, and then maybe Friedrich can chime in here. We do not expect any degradation in the efficacy signal. We are getting very good within the LUN 202 trial at making sure our investigators identify the right patients for the trial. We are obviously going to be cutting the data with longer and longer follow-ups. With ongoing responders, as you can see in the swimmers plot from that data cut, we would expect to see that durability improve even beyond what we have today. I will let Friedrich comment a little bit on the details of how we think that study is going to play out, but that is the big picture view.

Friedrich Graf Finckenstein (CMO)

Yeah, I agree with Fred. Not much to add there. I think the study now has reached that phase where folks know what they're doing. They're familiar with the therapy. They know how to identify patients. We are able to communicate best practices. I think this is all in a very stable place. What is noticeable is that we saw a true uptick in enrollment, which is really driven by the positive data that we were able to share with the investigators lately. That's also fairly typical. It's kind of an inflection point where then things just take off because folks see and believe in the therapy and things are working really well.

Andrew Tsai (SVP)

Thank you.

Operator (participant)

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

Yanan Zhu (Senior Analyst of Biotechnology Equity Research)

Great. Thanks for taking our questions and congrats on the quarter. Just a quick one on the lung cancer. Can you talk about when did you touch base with FDA regarding the path and the regulatory path? And you did mention 80 patients. I wanted to hear your confidence that 80 patients is enough for the lung cancer filing. Then on Amtagvi in melanoma. Can you talk about infusion growth into fourth quarter and into 2026?

Your confidence for inflection points in the patient infused. And lastly, sorry, if I may, on the improved gross margin, great to see that result. Can you comment on how much of it is coming from patient dropout and manufacturing success rate improvements versus how much is coming from cost reduction measures? Thank you.

Fred Vogt (Interim CEO and General Counsel)

All right, thanks, Yanan. Why don't I start on the FDA point, and then Raj Puri will jump in and I'll ask Dan and Corleen to help out with the Amtagvi inflection point as well as the gross margin questions here. We've engaged heavily with FDA on the LUN 202 trial. I've gotten guidance from them, feedback on the trial design, patient population, CMC, things like the potency assay. We feel very comfortable that we're on the right track here. Obviously, engagement with FDA is a continuous process during the trial. As I'm sure investors know, we have to engage frequently, and we do engage frequently.

A lot of it doesn't get talked about. We'll continue to do that on this trial, but we're very comfortable with where we stand right now in the trial design and on what we need to do to get a supplemental BLA submitted on time.

On the sample size for the patient, for the 80 patients, we pointed out during a lot of our calls earlier this week, as well as during our prepared remarks here, that we think 80 patients will be sufficient based on the precedent of Amtagvi with 73 patients, which led to the approvals on label in melanoma, as well as a lot of recent FDA, meaning the last couple of months, FDA approvals in non-small cell lung. I'll let Raj and maybe Marc comment on that, on what they've seen at the FDA and why they think that's reasonable.

Raj Puri (Chief Regulatory Officer)

In addition to what Yanan and Fred said, we, in continuous interaction with the FDA, plan to apply for many different priority designations such as fast track designation, RMAT designation, etc. As Fred mentioned, 80 patients also, based on the 73 melanoma patients that we got Amtagvi approval on. Recently, Marc will elaborate further that the FDA has approved about four non-small cell lung cancer trials based on accelerated approval of patients between 70-80 patients.

Fred Vogt (Interim CEO and General Counsel)

Yeah, I agree with what you had said, Raj. I think there's recent precedent for this number of patients, inpatients. Non-small cell lung cancer and very high unmet medical needs. With the response rate and particularly this unprecedented duration response, we feel, based on the precedent and the data thus far, an 80 patient data set would be sufficient and compelling. All right. On the inflection question and fourth quarter growth, obviously, we feel very confident in having a strong fourth quarter, but I'll let Dan talk about some of the details there.

Dan Kirby (Chief Commercial Officer)

Thank you. Thanks, Fred, and thanks, Yanan, for the question. First, the answer is yes. We expect continued growth in the fourth quarter and beyond into 2026. The reasons behind that are, I'm going to separate this from academic and community. In the academic setting, we've launched field efforts, including a disease awareness campaign in Q3 to educate medical oncologists for earlier referral into those centers. We're seeing some results from that right now that will continue moving forward.

We also are launching in the academic setting initiatives to increase penetration, which would have to do with addressing certain patient types that we haven't been able to capture, such as BRAF mutations I mentioned, where we have opportunities to get tissue earlier. We do see growth in the academic setting. Moving to community, I mentioned that we're onboarding now, and we've started to treat at the first community site. We have several large ones that are coming on in this quarter that will drive significant growth. In Q4 and beyond into 2026, and that also sets the table for launch.

Corleen Roche (CFO)

For first margin, let me just focus you on two areas, and I think you mentioned them. One, which is patient drop-off and manufacturing results. If you think about the dollars that are written off from out-of-spec since the beginning of the year, they have decreased by 40%. They're about $9 million this quarter. We are now seeing the initial benefit of the restructuring that we announced in Q3. Those are two key areas that are driving revenue improvements or margin improvements.

Yanan Zhu (Senior Analyst of Biotechnology Equity Research)

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

Fred Vogt (Interim CEO and General Counsel)

Thank you, Yanan.

Operator (participant)

Thank you. Our next question comes from Salim Syed with Mizuho. Your line is open.

Salim Syed (Managing Director of Equity Research, Head of Biotechnology Research, and Senior Biotechnology Analyst)

Great. Thanks so much, guys. Congrats on the progress. I guess one for me on the guidance here. I know you're reiterating the guidance, Corleen. I guess, is there any scenario here in your mind where you're going to actually hit the closer to the top end here? I'm just curious why at this point. Two months left in the year, why we haven't narrowed it down the top end of the range to a lower number that seems more reasonable. Thank you.

Fred Vogt (Interim CEO and General Counsel)

Yeah, Salim, we reiterated our guidance range of 250-300, which is a pretty narrow range to begin with. It's our first full calendar year on the market, as you know, and we're on track right now towards that guidance. Fourth quarter, as Dan was just mentioning a minute ago, we have a large influx of new ATCs. We've got Proleukin sales to contend with, which we think will be very strong in the quarter, especially based on fourth quarter last year.

You can go back and look at those numbers. And we have got this ATC growth both in the community and in the academic setting. I think at this point, we're just comfortable with the guide that we put out, 250-300, and we'll be in that range, and that's what we're comfortable saying right now.

Salim Syed (Managing Director of Equity Research, Head of Biotechnology Research, and Senior Biotechnology Analyst)

Okay. Thank you very much.

Operator (participant)

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

Great. Thanks very much. This is Nick on for Tyler. Just one for me. Can you let us know how many Amtagvi patients were treated this quarter? And then also, how will the ICTC maintenance this quarter impact Amtagvi infusions and sales? Thanks very much.

Fred Vogt (Interim CEO and General Counsel)

Yeah. Nick, we're not talking about infusions anymore. We're just going to use revenue going forward, as you can see from our press release. We think that's the ultimate story here, and we hope investors appreciate that we're focusing on the dollars, and that's what matters at the end of the day. On the ICTC maintenance, I'll pay it to Igor for that question. I think he covered it in his prepared remarks, so maybe you can highlight that again, Igor.

Igor Bilinsky (COO)

Yeah, of course. Thanks for the question, Nick. As I mentioned, as part of the routine maintenance this year, we'll complete the extension part of the facility. That's important for centralizing manufacturing at ICTC and also kind of continue providing uninterrupted capacity from ICTC during future maintenance periods. This year, we've learned from our experience in Q1 2025, so we made several improvements. We will boost manufacturing capacity immediately and prior to the ICTC maintenance. That will provide additional manufacturing slots for patients, and that will allow essentially smooth supply through the next two quarters.

Thank you very much.

Operator (participant)

Thank you. Our next question comes from David Dye with UBS. Your line is open.

David Dye (SVP of Wealth Management)

Great. Thanks for taking my questions. A couple of questions for me. Just on the ATC ramp, you're seeing early community initiatives in there. I'm just curious in terms of what are the timeline for the community activation to actually see patients treated. That's the first question. The second question just around the margin improvement. You said you're planning to have more margin improvement over the next few quarters. I'm just curious, what is sort of the of the margin we should be expecting over the next quarters? Essentially, when should we be expecting the plateauing of the margin over time?

Fred Vogt (Interim CEO and General Counsel)

I'll take the ATC one first and look at the ramp for that. You mentioned specifically community. Our first community centers are starting to treat now. Typically, with centers, they treat a few patients. They make sure the insurance goes through. They get comfortable with it, and they start ramping patients after that. That is expected to continue with our community ones that are just starting to treat now. The newer ones coming on with the volume will start slow with a few patients in there for it, but then will start to ramp up.

The key with the community is that the referral patterns are already there to get those patients in earlier. As we discuss with those larger entities opening them, we also have robust discussions regarding referral patterns and patients lining up. We will see a ramp there a little faster than you'll see with the academics, but it should be coming over in the next quarter or two, and then we'll get to full peak probably by mid next year.

Corleen Roche (CFO)

David, on the gross margin, yes, we mentioned they will continue to improve. That will be further benefit from the restructuring, but also a number of initiatives across operational efficiency in the manufacturing plant, as well as cost-saving initiatives to run the organization as efficiently as possible.

Fred Vogt (Interim CEO and General Counsel)

Just to finish off, we did announce one of those things today, David, by transitioning all manufacturing to internal, as Igor and Corleen and others discussed. We expect this to have additional margin improvements on the back of that. That's not something that's reflected in the 43% that we reported today.

David Dye (SVP of Wealth Management)

All right. Thank you so much for the color.

Operator (participant)

Thank you. Our next question comes from Colleen Kusi with Baird. Your line is open.

Great. Good morning. Thanks for taking our questions and congrats on the progress. On the community ATCs that you're seeing come online, can you just speak to the capacity that you see at those centers versus what the capacity is that you're seeing at the academic centers?

Fred Vogt (Interim CEO and General Counsel)

Sure. Thank you very much, Colleen, for the question. The capacity with the community centers, they are hospitals. They do have the bed space comparable to the academics. What we do see with them, though, is less of a clinical trial allocation and other competing priorities for those beds and more of a priority in the solid tumor space than we see in the academics for it because they do split beds in the academics with the hematology space where the CAR-Ts are, etc. We do see an opportunity to have a larger % of their capacity in the community setting.

That's helpful. Thank you.

Operator (participant)

Thank you. Our final question comes from Reni Benjamin with Citizens. Your line is open.

Reni Benjamin (Managing Director)

Hey, guys. Thanks for taking the questions. I'm sorry I jumped on the call a little late. You may have answered this already, so just indulge me. I'd like to understand a little bit more about the global expansion that you highlighted. How do you envision this program or the expansion without a partner?

Should we really be thinking about any sort of a meaningful contribution in terms of revenues going forward, or at least in 2026, or is this something that goes out much further? Just a follow-up question regarding both TILVANCE and the LUN 202 study. It seems like enrollment was slow, at least from the 202 study. Can you just give us a better sense as to how enrollment is progressing in each of those studies? That would be great. Thank you.

Fred Vogt (Interim CEO and General Counsel)

Yeah, Reni. First, on the global expansion, we're not thinking right now really about partnership. TIL technology and the science of delivering patients and medicine behind it is complicated. We're not really sure there's a partner out there that would give us any kind of advantage. We're always really cautious about asset dilution and giving anybody rights to anything that we do because we think that TILs are going to be extremely powerful in the future, and we would like to own all of that. That said, we may work with distributors in certain markets.

We may work with people that can help enter markets for us. We tend to stay fairly light and lean in those markets while we wait for revenue to appear. In 2026, I don't expect a significant amount of revenue from those markets. However, we'll start to see that business grow. Over time, I think it will become a major component of our business in the future.

Since Dan heads those teams, I'll let him give us some color and maybe just highlight the markets that we're going to go back into, including the UK and we're going to be entering for the first time in the UK and Australia and other places where there's a significant number of patients in need.

Dan Kirby (Chief Commercial Officer)

Sure. Reni, one of the things we've always said about our global expansion, if you look at the history of cell therapies globally, this has been more of a long-term strategy to produce revenue in 2027 and beyond. You needed to get the filing and approvals in place because reimbursement does take a while in those regions, and you want to make sure you do it in the proper sequence. Where we are right now with it, we are ramping up in Canada with our first ATC. We have pending approvals in the UK as well as Australia.

We're in discussion right now in the UK about getting NHS support on which ATCs will go up and running there. We're getting the process in place as well as within Switzerland and then refiling in the EU. This has been a long-term strategy with it and something that we will see if you look at Kite, who did a great job with Yescarta globally. It took them several years from the approvals to get revenue in there. We followed that model, knowing it would take 2027, would be our first year to have any appreciable revenues. Not saying we won't get any next year, but really appreciable revenues in 2027 from XUS.

Fred Vogt (Interim CEO and General Counsel)

On the enrollment question, I'll focus on Lung 202, Reni, because TILVANCE, we really haven't said anything publicly about the enrollment there beyond that it's going well. We think that that's on track right now. On LUN 202, enrollment has really picked up lately. If you heard on the calls earlier this week, we have double-digit patients right now waiting for infusions, and we have a lot of activity there.

I'll let Friedrich comment in a second here, but we think we can easily hit the timeline that we gave for the launch of lifileucel in non-small cell lung in the second half of 2027 based on our current enrollment timings in the LUN 202 trial. Frederick, do you want to add to that?

Friedrich Graf Finckenstein (CMO)

Yeah, just really quick, Reni, since I don't know when you joined, I described that before. Earlier in the call, I think in the lung study, we've now reached this point where, number one, we have stability and familiarity of the investigators and the sites with the therapy. They know how to pick patients. And important, we have a data set that has the size and the quality and the data that are driving investigator engagement.

They see the potential for this therapy. They see the benefit in the patients. They now are enrolling at the speed of what is typical for a trial that has shown data like this. I share Fred's confidence in us being on track here with our goals.

Reni Benjamin (Managing Director)

Got it. And just as a quick follow-up, maybe, Fred, to your comments about TILVANCE, that enrollment's going well and things are on schedule. Can you just remind me, when do you think ultimately enrollment would be complete or when you might be filing the BLA? Have you provided any of that guidance before?

Fred Vogt (Interim CEO and General Counsel)

Not yet. We're still pretty early in this trial here. This is a longer-term study. We do have the ability to read at an interim time point for ORR and seek an accelerated approval in first-line melanoma in this study. That's not too far off. We have not guided anything publicly, and there's obviously, for a 670-patient trial, at least 600 patients in the main population. That's tough to predict accurately right now, but we should be in touch pretty soon with some more updates on that as that starts to crystallize for us.

Reni Benjamin (Managing Director)

Excellent. Thanks very much for taking the questions.

Operator (participant)

Thank you. This concludes the question-and-answer session. I would now like to turn it back to Fred Vogt for closing remarks.

Fred Vogt (Interim CEO and General Counsel)

Thank you again for joining the Iovance Biotherapeutics third quarter of 2025 conference call. We look forward to providing future updates on our commercial launch and pipeline, as well as our cost optimization initiatives to drive towards profitability. We are motivated by the stories we continue to hear about the patients who benefit from Iovance TIL Cell Therapies.

I'm confident that Iovance will remain the global leader in innovating, developing, and delivering current and future generations of TIL Cell Therapies for patients with cancer. As always, we are thankful to our patients, the healthcare and advocacy communities, our partners, and our exceptional Iovance team. I would also like to thank our dedicated shareholders and covering analysts for their support. Thank you.

Operator (participant)

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