Iovance Biotherapeutics Inc (IOVA) 2023 Q1 法說會逐字稿

Hello, and thank you for standing by. My name is Andrew and I will be your conference operator today. At this time, I would like to welcome everyone to the Iovance Biotherapeutics First Quarter 2023 Financial Results Conference Call. (Operator Instructions)

It is now my pleasure to introduce Senior Vice President, Investor Relations and Corporate Communications, Sara Pellegrino.

Thank you, operator. Good afternoon and thank you for joining us. Speaking on today's call, we have Dr. Fred Vogt, our Interim President and Chief Executive Officer; Dr. Igor Bilinsky, our Chief Operating Officer; Jim Ziegler, our Executive Vice President, Commercial; Dr. Friedrich Finckenstein, our Chief Medical Officer; and Jean-Marc Bellemin, our Chief Financial Officer; Dr. Raj Puri, our Executive Vice President, Regulatory Strategy and Translational Medicine is available for Q&A session.

This afternoon, we issued a press release that can be found on our corporate website at iovance.com which includes the financial results for the 3 months ended on March 31, 2023, as well as recent corporate updates. 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, pre-commercial activities, clinical trials and results, regulatory interaction, plans and strategies, research and preclinical activities, potential future applications of our technologies, manufacturing capabilities, regulatory feedback and guidance, payer interaction, 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 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 introduction, I will turn the call over to Fred.

Thank you, Sara. Good afternoon, everyone. I'm pleased to update you on a productive start to the year at Iovance in 2023. We successfully completed our biologics license application, or BLA, for our lead TIL therapy, lifileucel in advanced melanoma at the end of the first quarter. This represents a critical step forward in our journey to deliver the first individualized onetime T cell therapy for solid tumor.

I would like to acknowledge the patients and physicians who participated in the C-144-01 clinical trial and the FDA review team for their commitment and support as well as our internal team for their tremendous effort in completing the first BLA submission for Iovance. We look forward to continued collaboration with the FDA as they review this nuclease treatment for advanced melanoma patients with limited options. In terms of next steps, the FDA has 60 days from when we completed the submission to determine the acceptability of the BLA for review, which is approximately May 26. We will provide an update as soon as we can, accepted for a 6-month priority review that would result in a decision on approval by late November.

We feel confident going into the BLA review process given the unmet medical need and strength of our clinical data as well as several positive interactions with and feedback from the FDA. As we prepare for potential commercialization, we are also developing our robust immuno-oncology pipeline and plan to execute an integration plan for Proleukin.

Earlier this year, we entered into a strategic transaction with Clinigen to acquire the worldwide rights to Proleukin, an IL-2 product with currently approved indications that is importantly also used to promote T cell activity following TIL infusion.

We expect Proleukin to provide revenue and full control of the IL-2 supply chain and logistics surrounding TIL therapy as well as a reduction in both clinical trial expenses and future cost of goods for lifileucel. We expect to close this transaction imminently. And we will file our Form 10-Q tomorrow afternoon with more information.

In addition, our robust TIL therapy pipeline includes 7 active clinical trials in multiple solid tumor types with the potential to create significant value for cancer patients and shareholders. As we grow our organization to transition to a commercial company, we currently have more than 500 Iovance employees experience in developing and commercializing oncology and cell and gene therapy products.

I look forward to addressing your questions later during this call. And we'll now ask Igor to present our manufacturing updates.

Thank you, Fred. Manufacturing is essential for us to successfully launch and deliver lifileucel to patients. We are committed to operational excellence and have provided TIL therapy to more than 600 patients to date with a consistent manufacturing success rate of more than 90%.

Right now, our top priority is to support the FDA BLA review process, prepare for the pre-approval site inspections and scale up our internal capabilities in staffing to meet patient needs for commercial supply at launch. We have done significant work to thoroughly prepare the ICTC and our contract manufacturers' facility for commercial launch as well as for ongoing clinical supply in our trials. The ICTC, which is expected to supply most of the commercial TIL therapies upon approval, has been supplying clinical studies since the third quarter of 2021, while supporting expanded access and preparing for commercial readiness.

In addition, our contract manufacturers provide further flexibility to optimally balance capacity and patient demand. We are also planning for future commercial and clinical capacity needs as we look to establish TIL as the next paradigm shifting class of cancer therapy. The ICTC is built to supply TIL products for more than 2,000 patients annually. We are on track with our hiring plan to support our forecasted demand at launch. Ultimately, by building out the additional existing shelf space, the ICTC is designed to supply TIL products for more than 5,000 patients annually. Longer term, our vision is to build capacity for more than 10,000 patients annually through the addition of new facilities as well as streamlining and automating manufacturing processes.

Turning to our intellectual property, or IP, we currently own at least 60 granted or allowed U.S. and international patents, including Gen 2 patent rights that we expect to provide exclusivity into 2038. Extensive detail on Iovance's owned IP, which is a critical component to support and protect our proprietary manufacturing processes and know-how is available on our corporate website and within our annual report on Form 10-K.

Now, I'd like to hand the call over to Jim Ziegler to highlight our commercial launch preparations. Jim?

Thank you, Igor. Our commercial launch readiness activities with authorized treatment centers or ATCs and payers are on track and aligned with our regulatory milestones. Our cross-functional teams are making steady progress towards onboarding and developing TIL cell therapy service lines at our ATCs. Our leadership team has also been visiting several ATCs as part of the onboarding process. And we are hearing strong enthusiasm to offer TIL cell therapy as a new treatment option upon approval.

In conjunction with our capacity planning for lifileucel, our onboarding process also includes market research and assessment of bed capacity at each hospital. Our targeted ATCs have given consistent feedback that they have inpatient hospital beds to support TIL therapies, including lifileucel. And we believe our ATCs can accommodate our expected demand for lifileucel at launch.

Our payer engagement also remains strong following our completed BLA submission. Reimbursement and access expectations for lifileucel are consistent with other CAR T-cell therapies, which often include prior authorizations and single case agreements between hospitals and payers. Our goal is to ensure patients have timely access to lifileucel, and our Iovance Cares reimbursement and patient support programs will offer support for ATCs and patients.

In closing, we remain on track for commercial launch, including operational readiness for Proleukin. I want to thank our dedicated cross-functional teams who are working tirelessly because patients are counting on us.

I will now pass the call to Friedrich Finckenstein, our Chief Medical Officer, to highlight our clinical progress.

Thank you, Jim. Today, I would like to summarize recent updates with our TIL therapy pipeline and next-generation technologies. As Fred mentioned, we completed our BLA submission for lifileucel in post anti-PD-1 advanced melanoma in late March. We are confident in the potential for FDA accelerated approval. We have RMAT designation positive results from our C-144-01 trial, which is the largest single clinical study ever conducted for cell therapy and post-ICI melanoma and FDA agreement for the Phase 3 TILVANCE-301 trial.

TILVANCE-301, which we expect to be well underway at the time of potential approval, is designed to service our registrational trial for accelerated and full approvals of lifileucel in combination with pembrolizumab in frontline advanced melanoma as well as a confirmatory trial to support full approval of lifileucel in post-anti-PD-1 advanced melanoma.

We recently activated TILVANCE-301. The trial is now actively enrolling patients. And we will randomize the first patient soon. As a reminder, we plan to randomize 670 patients who are naive to therapy in the advanced setting to either lifileucel in combination with pembrolizumab in the experimental arm or pembrolizumab monotherapy in the control arm. The trial is expected to include an appropriate number of global sites in key geographies with a large presence of melanoma patients and the potential for strong enrollment, including the U.S., Australia, Canada and Europe.

Additional information on participating sites, trial design, outcome measures and eligibility criteria are available on clinicaltrials.gov. We also continue to execute on our non-small cell lung cancer or NSCLC pipeline at Iovance with 6 cohorts across 3 Iovance studies to investigate multiple treatment regimens in various populations at various stages of disease.

In the first quarter, we shared positive initial data for our TIL therapy LN-145 in combination with pembrolizumab from Cohort 3A of the IOV-COM-202 trial in patients with advanced NSCLC who are naive to ICI treatment. Based on these positive results, particularly within the treatment naive and post-chemotherapy subsets of patients, we plan to meet with FDA in 2023 to discuss data and a potential registration path for lifileucel in frontline advanced NSCLC patients.

Enrollment took is ongoing. And we plan to present detailed and updated results at a medical meeting in the second half of this year. For patients with non-small cell lung cancer who are more advanced in their disease, our IOV-LUN-202 trial is investigating LN-145 monotherapy after prior anti-PD-1 in chemotherapy. This trial, which includes an option for a pre-progression tumor harvest as well as TIL product manufactured from starting core biopsy tumor material, is expected to continue enrollment throughout this year.

Moving to cervical cancer. Our expanded Cohort 2 in the ongoing C-145-04 trial is investigating lifileucel following progression on or after chemotherapy and anti-PD-1 therapy. Based on our dialogue and feedback from FDA, Cohort 2 is intended to be pivotal to support regulatory submissions and we look forward to continuing enrollment this year. We are also excited about our next-generation TIL therapies, particularly IOV-4001 and other genetically modified TIL therapies that utilize the gene editing talent technology licensed from Cellectis to optimize TIL therapy by inactivating immune checkpoint proteins that inhibit anti-tumor response.

We are investigating IOV-4001, a PD-1 inactivated TIL therapy candidate in our first-in-human IOV-GM1-201 trial in patients with previously treated advanced melanoma or NSCLC. Additional programs using the talent technology are expected to enter clinical development in 2024, including genetically modified TIL therapy with multiple inactivated immune checkpoint targets. Our research and preclinical studies also include IND-enabling studies for our novel interleukin 2 analog, IOV-3001, and approaches to increase TIL potency, including the selection of CD39/69 double-negative TILs and enhancements such as Teva's cytokine.

I am available for questions during the question-and-answer session. For now, I will hand the call over to Jean-Marc to discuss our first quarter 2023 financial results.

Thank you, Friedrich. My comments will summarize our planned acquisition of Proleukin as well as the high-level financial results for our first quarter ended on March 31, 2023. More details can be found in this afternoon's press release as well as in our SEC filings. At the end of January, we announced that we have entered into an agreement to acquire Proleukin from Clinigen. Terms of the agreement include an upfront payment of GBP 167.7 million, the GBP 41.7 million milestone payments upon first approval of lifileucel in advanced melanoma and double-digit Proleukin Global sales royalties for Iovance to Clinigen.

The transaction will be financed with existing cash and is expected to close imminently. As Fred mentioned, we expect Proleukin to provide revenue and full control of the IL-2 supply chain and logistics surrounding TIL therapy. We anticipate significant revenue for Proleukin to begin after the launch of lifileucel. We continue to invest in launch preparations, internal manufacturing and pipeline activities. As of March 31, 2023, we held $632.7 million in cash, cash equivalents, investments and restricted cash compared to $478.3 million as of December 31, 2022.

Our current cash position includes approximately $260 million of net proceeds raised to an at the market or ATM financing facility during the first quarter of 2023. This cash position is expected to fund our operating plan into the second half of 2024, including the Proleukin acquisition, manufacturing activities, launch readiness and execution, ongoing and planned clinical trials and pipeline advancement.

Transitioning to the financial results for the first quarter ended on March 31, 2023. Our net loss was $107.4 million or $0.50 per share compared to a net loss of $91.6 million or $0.58 per share for the first quarter of 2022. Research and development expenses were $82.7 million for the first quarter '23 and an increase of $14.4 million compared to $68.3 million for the first quarter of 2022. This year-over-year increase in research and development expenses was primarily attributable to growth of the internal research and development team as well as clinical trial costs, cost to support commercial manufacturing readiness and facility-related costs, which were partially offset by lower stock-based compensation expense.

General and administrative expenses were $28.1 million for the first quarter of 2023, an increase of $4.7 million compared to $23.4 million for the first quarter of 2022. The increase in general and administrative expenses in the first quarter 2023 compared to the prior year period was primarily attributable to growth of the internal general and administrative and commercial teams in preparation for launch. Fees to support the Proleukin acquisition as well as costs associated with pre-commercial activities, which were partially offset by lower stock-based compensation and marketing expenses. As of March 31, 2023, there were approximately 224.4 million common shares outstanding.

I will now hand the call back to the operator to kick off the Q&A session.

(Operator Instructions) And our first question comes from the line of Michael Yee with Jefferies.

And congrats on the progress. We had 2 areas of questions. One was, as you go about the regulatory process, can you just shed some light on your expectations for an AdCom and what discussions you may have had about that as well as your expectations for an FDA inspection for the factory and how that process would go about during the regulatory time lines that you laid out?

And the second question is about preparation for launch. Can you just remind me how many ATC centers you expect at the start and whether you feel comfortable about reimbursement? I know you've mentioned you have J-codes and all of those sorts of code before. And if you go back to CAR-T, that was a real gating factor for the launch. So could you just talk about whether you expect that to be an issue or not, and you would expect it to be pretty straightforward due to the codes?

Yes, Mike, regarding an AdCom, right now, as we've said before, we don't expect an AdCom. We think FDA has seen enough T cell therapies at this point. However, if we get one, we'll get word of that fairly soon and we would -- I could talk more about that at that time. Typically, that comes after acceptance of the BLA.

Regarding inspection and timing for inspection is what we call PLI or pre-licensing inspections. Those are things that occur typically towards the end of the review cycle. That will occur around late third quarter or something like that this year.

Potentially, we don't know. FDA might tell us, give us more detail and give us more insight on that at some point. But we are preparing today heavily at all of our sites, including our manufacturing site at ICTC as well as WuXi and everywhere else in our organization for the PLI as well as for what called the bio mode bio research monitoring GCP audit. So we intend to be in very good shape when that happens.

And for the ATCs, it start, we said, as we said publicly, we're aiming for 40 ATCs to start. That's something we'll launch with either 40 at the time of launch or shortly thereafter. You mentioned J-code, that take us on apply in our space. We're more interested in what's called MSDRG for Medicare as well as getting ourselves in line with single case agreements with the private payers before they issue their coverage policies, all that is going very well.

Maybe, Jim, if you want to -- particularly want to add anything to that?

No, I think you covered most of it. Just a reminder, our goal is to launch with top 40 ATCs within the first 90 days of approval.

And on the reimbursement front, over the past couple of years, we've had a team out there engaging payers. We engage payers responsible for 90% of covered lives for our commercial and Medicare patients. And we're confident in our approach in that payers understand the unmet need and the clinical data that we've shared thus far.

And our next question comes from the line of Peter Lawson with Barclays.

The TILVANCE-301 trial, just kind of how we should be thinking about that as regards to the balance of U.S. versus ex U.S. sites?

Yes. We're going to be international fully there, Peter. Maybe I can say a few words and then Friedrich can add.

But we are intending to have European sites. We are intending to have Australian sites and beyond. This is some stuff we talked about. You can see this in the script and elsewhere from today's call. But we are intending it to be a very international trial. And we're well underway in those respects. Friedrich, do you want to add anything?

Yes. I totally agree. We have interactions with sites and investigators across all of those regions that we were commenting on in our presentation. So we are not intending to intentionally go for one region over another one. We are working with all of these regions in the same way and the activities are ongoing in all of them.

And then on the lung, just the data you're sharing this year, how much data should we expect for, I guess, Cohort 3?

I think, Peter, you'll see something similar, a little bit incremental to what we put out previously, because we've had some more time. But it's not going to be a huge increase in what we put out in January. But it should be significant data, obviously, since that data was, of course, very important. And I think when you see the additional data; you'll understand why we're so excited about it.

Is there anything else we should be thinking about as regards to the BLA acceptance. Is that kind of an end of May kind of event or anything else we should be contemplating?

As an end of May kind of event, no, I think we're in May right now. We've got a BLA that we just mentioned around May 26. That's kind of the big event for May. We put out some of the information about what we'll be doing at ASCO. So you can see that in the press release today. But really for 3A and for some of the other data releases as you're looking at the second half of this year.

And our next question comes from the line of Colleen Kusy with Baird.

So for the confirmatory study, Teva, FDA suggested to you that a certain proportion of the study should be enrolled before they would grant accelerated approval? And if there hasn't been any communication, do you have an internal goal for enrollment at the time of approval?

No. They've never said anything about percentage enrollment. They use the term well underway with us. And they -- in fact, they told us they were pretty happy when we presented the trial to them about our timing last year. So they have not given us anything like that. We do have internal targets for enrollment, of course and they're quite aggressive, but we can't. At this point, we're not going to be disclosing those right now.

And I guess another question on enrollment, just this one on the cervical cancer study. Any update on how that enrollment is going and how quickly you could expect to file using that data?

Right now, the study is enrolling quite well. Maybe Friedrich, you can take a little bit of this after I finish here. But it's enrolling well. We don't have really an update for you just yet. We just restarted the trial not too long ago. We are bullish about this. We're very focused, obviously, on non-BLA first, though. So I think after we pass non-BLA, you'll hear more from us about cervical. Friedrich, do you want to give any -- give Colleen idea of how the investigators feel about cervical right now and how it's going?

Yes. Maybe just as additional color. I mean, given that we had to restart this cohort, because we had initially communicated that we were holding enrollment and then we restarted it, as we have shared before. I'm actually pretty pleased with where we are with the level of engagement by sites and investigators and the enrollment at this time. So it's doing well.

And our next question comes from the line of Reni Benjamin with JMP Securities.

Congratulations on the filing and all the progress. Fred, can you talk a little bit, to any and all interactions that might be occurring between you and the regulatory agency kind of between now and the acceptance of review. Do you get a sense as to maybe how things are going? Or is there any back and forth that takes place before they kind of give Visa thumbs up that it's ready for review?

Yes. There's been -- on FDA's end, they seem to be very, very interested in BLA. There's been a lot of good engagement. It's really -- it doesn't enter the review process until after acceptance. But at this stage, I can say -- what I can tell you at least at the color level is they're engaged, they're interested. They're asking about things that we think are important. They seem to be very interested in the clinical data and those are all things that we take as good signs.

Okay. And then maybe it's a little bit too early to talk about it. But as we think about potential acceptance and then there's the manufacturing site visits and things like that. I'd love to get some sort of commentary on what you think would be the most ideal label for you guys to negotiate versus maybe what might be a base case label that you're thinking about?

I think the best label for us would be to include both Cohort 2 and Cohort 4. I think we've talked about that before. We've -- we're seeking that. We think that there's a good possibility for that. As we go through the review process as well as the inspection process because we have multiple manufacturing facilities involved. There could be questions and things that we have to do to adjust to FDA's comments. I don't -- right now, we don't anticipate that. We're preparing to have a nice label that includes 153 patients from 2 plus 4, the full data set that we talked about at SITC last year.

That's the ideal case and I think that's also the base case. I mean that's really where we're at. It's possible, as I said, many earnings calls now, we've said possible they may put 4, give us 4 on the label, followed by a Section on 2. They did imply more recently that they would consider the pooled cohort on there as well. So that's a third option to be part of that.

And our next question comes from the line of Mark Breidenbach with Oppenheimer.

Just a couple of quick ones for me on the pending Proleukin acquisition. Can you remind us if that deal comes with any sales personnel, specifically with experience in promoting Proleukin? And maybe it would be helpful if you kind of spell out for us how the upfront payment to Clinigen will be recognized on your P&L as well as the potential milestone that would come with lifileucel approval? Are these going to be kind of like lump sum payments or they can be spread out a bit.

Well, I'll take the first one and then Jean-Marc can talk to you about the P&L. Yes, we are getting Proleukin people, Clinigen people as part of the deal. And we've also gone out. And we've hired some people that have experience in this area as well. So we think we're going to have a fully staffed team in commercial medical affairs and beyond for Proleukin, including on the manufacturing side. We intend to have the expertise to keep the product rolling and also support the expansion of the product as lifileucel launches in the U.S. Jean-Marc, do you want to talk a little bit about P&L and how we're going to recognize the expenses?

Yes. So thank you for the question, Mark. So under the term of the agreement, we have 2 things that we will consider. But this will be our cash-related activities. Meaning, we'll have an upfront payment of -- roughly, we talk about $200 million. It's exactly GBP 167.7 million. That will be eating right away our cash at the time of the deal close. And then we will have a milestone that will be paid, which will be roughly $50 million or GBP 41.7 million at the time of the first approval of lifileucel in advanced melanoma. But those 2 events have to be considered as cash flow-related activities not hitting our P&L, if you think accounting-wise.

And our next question comes from the line of Mara Goldstein with Mizuho.

With respect to the ATCs, when you -- in your commercial plan, how quickly or what is like the time of the lag for ATCs to begin to treat patients once product is approved? What does the commercial sale look like -- sorry?

Yes. So it's very, very rapid, Mara. It's something that they can do very quickly. We have the ATC stood up. In fact, I visited one last week and saw how ready they were for this. We have a great team, Jim's team as well as our medical affairs team and our ATC operations teams are out there making sure that the sites are ready to go as soon as the product is approved. So it's something that the structure will be in place. The financial side will be in place. The operational side will be in place. Everything will be ready for the launch as if it was a traditional like a launch of the CAR-Ts.

And if I could just ask another question. Given there are trials running also in melanoma, although obviously different. I mean are you -- are the ATCs competing also for clinical trial patients?

No. We don't really see that as a major limitation right now for us. That's really not.

And our next question comes from the line of Asthika Goonewardene with Truist.

This is Karina for Asthika. I had a question on the TILVANCE-301 study. Has the first patient been dosed yet? And how many sites do you guys plan to activate?

We'll announce when we randomize the first patient hasn't occurred yet. But it's hopefully quite imminent now and we'll talk about that as soon as we can. We haven't disclosed the number of sites yet. But it's going to be a large international trial. So you can assume it's going to be very significant numbers of sites.

Okay. And you said it's going to be outside of the U.S. primarily? Or what's the percentage are you looking at?

We'll have a lot of U.S. centers and we'll have European centers, Australian centers. We intend to go elsewhere beyond that. It's going to be a true international intercontinental study. I don't know the percentages yet. That's something that we'll establish as we go through the course of starting up a large international trial like this.

And our next question comes from the line of Michael Schmidt with Guggenheim.

This is Ed on for Michael. Quick one from us for second and third line non-small cell lung cancer. Can you talk about your current thinking on the bar in this setting given the multiple upcoming Phase 3 readout of ATCs and small molecule TKIs in this setting?

Yes. Friedrich, do you want to talk about that?

Yes. So I think for bars in this space, I think you would have to look at available on approved therapies at this point. Things to look at our docetaxel monotherapy or docetaxel just bevacizumab, that's usually an accepted benchmark for settings. Obviously, as a evolves, we're going to have to look because we know that FDA as they are looking at particularly single-arm data set is looking at available therapy at the time of bringing this forward. But right now, docetaxel, docetaxel bevacizumab is probably the most appropriate benchmark to look at.

(Operator Instructions) And our next question comes from the line of Madhu Kumar with Goldman Sachs.

So I guess kind of can we expect any more updates from Cohort 4 from the ongoing Cohort 2, Cohort 4 trials in terms of things like overall survival and kind of longer-term follow-up on therapy from that study?

At some point, we might do. But we put out overall survival data next year that was pretty mature. So I would -- I could continue a link to that. But there's really not a whole lot of reason for us to go back and do that again. You can see that the -- in those curves have been kind of reached from the Capital Myers. And there's a probation as well that came with that. We remember we did a companion publication last year, too, so you could check them both out.

Yes, absolutely. So maybe kind of following up on the bed capacity commentary you said earlier about ATCs. What do you think that launch is going to be kind of the effective number of beds that will be available? And what do think can be a steady-state flow? I'm thinking about the Sinti event last year, where they talked about kind of maybe 4 beds on average per site per way. Do you think that's a reasonable number? How are you thinking about kind of where the steady state is going to lie in terms of kind of available hospital use capacity?

No, I think you're going to see much higher capacities. And I visited the site last week where they showed me capacities that far, far, far exceed that in their BMT allo TIL CAR-T units. So I do think maybe that's something that people should understand better about the sites that they really -- or they're building for cell therapies. This is an economic opportunity for hospitals, too. And they're expanding and expanding and trying to get ahead of this. And the sites that we're working with don't seem to have that limitation as a general matter. Yes, it came up at SITC. It was a comment made at SITC, but it's not something we've seen very often. And by the way, Madhu, I got -- I pulled the slide up. The OS curve from SITC goes out to 6 months. So it's pretty good.

Okay. And then one last one on that point. So I guess as you think with the launch of lifileucel in post-PD-1 melanoma, where do you think the bottleneck potentially would be? Would it be on kind of the ability to manufacture? Would it be on bed capacity? Like where do you think you're going to be so if you look at kind of the test case, right, from BCMA CAR-T drugs, there's a bottleneck on manufacturing, like where do you think the kind of rate limiting step to effectively be?

Well, they had manufacturing as their rate limiter. We're trying to make sure that doesn't happen by building big there. We've talked about that. Beds we just discussed. I don't think that's going to be a real limiter. I don't know exactly where it will occur at this point. We're going to have to test it and see at this point. But we're building big and we're preparing for a very large successful launch. So hopefully, whatever happens will not appear to be a drag from one of those things. And we'll be able to achieve numbers that are appropriate for the patient demand that's out there.

Now, I'm showing no further questions at this time. So with that, I'll hand the call back over to Interim CEO, Fred Vogt, for closing remarks.

Thank you again for joining the Iovance Biotherapeutics first quarter 2023 financial results and corporate update conference call. We've had an exciting start to 2023 upon completing the BLA, entering the Proleukin agreement and delivering on our key regulatory commercial manufacturing and pipeline activities. I'm grateful for the patients, physicians, regulators as well as our employees and cross-functional teams who have collaborated on our BLA submission, while advancing our mission to be a global leader in TIL therapy. I would also like to thank our shareholders and covering analysts for their support. Please feel free to reach out to our Investor Relations team for follow-up. Thank you.

Ladies and gentlemen, this concludes today's conference call.