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spk13: Hello, and thank you for standing by. My name is Andrew, and I'll 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. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star then one on your telephone keypad. If you'd like to withdraw your question, press star one again. It is now my pleasure to introduce Senior Vice President, Investor Relations and Corporate Communications, Sarah Pellegrino.
spk01: Thank you, Operator. Good afternoon, and thank you for joining us. Speaking on today's call, we have Dr. Fred Vose, our Interim President and Chief Executive Officer, Dr. Igor Belinsky, our Chief Operating Officer, Jim Ziegler, our Executive Vice President, Commercial, Dr. Frederick Finkenstein, our Chief Medical Officer, and John Mark Bellamine, our Chief Financial Officer. Dr. Raj Puri, our Executive Vice President, Regulatory Strategy and Translational Medicine, is available for the 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 three months ended on March 31st, 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 interactions, plans and strategies, research and preclinical activities, potential future applications of our technologies, manufacturing capabilities, regulatory feedback and guidance, payer interactions, 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.
spk11: Thank you, Sarah. Good afternoon, everyone. I'm pleased to update you on a productive start to the year at I-Advance in 2023. We successfully completed our biologics license application, or BLA, for our lead TIL therapy, lifelucel, and advanced melanoma at the end of the first quarter. This represents a critical step forward in our journey to deliver the first individualized one-time T cell therapy for a solid tumor. I would like to acknowledge the patients and physicians who participated in the C14401 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 IVANS. We look forward to continued collaboration with the FDA as they review this new class of 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. If accepted for a six-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 Prolucan. Earlier this year, we entered into a strategic transaction with Clinigen to acquire the worldwide rights to Prolucan, an IL-2 product with currently approved indications that is importantly also used to promote T-cell activity following TIL infusion. We expect Perlucan 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 Lifolucel. 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 seven 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 iAdvance employees experienced in developing and commercializing oncology and cell and gene therapy products. I look forward to addressing your questions later during this call, and will now ask Igor to present our manufacturing updates.
spk10: Thank you, Fred. Manufacturing is essential for us to successfully launch and deliver life elusive 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 and 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 ICDC 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 II patent rights that we expect to provide exclusivity into 2038. Extensive detail on our event'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?
spk02: 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 Lipoleucel, 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 cell therapies, including Lipoleucel, and we believe our ATCs can accommodate our expected demand for Lipoleucel at launch. Our payer engagement also remains strong following our completed BLA submission. Reimbursement and access expectations for Lifolucil 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 Lifolucil, 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.
spk07: Thank you. Bye-bye.
spk02: Including operational readiness for Prolucan. 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.
spk07: 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 life-elusive and 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 C14401 trial, which is the largest single clinical study ever conducted for cell therapy in post-ICI melanoma, and FDA agreement for the Phase III TILVANS301 trial. TILVANS301, which we expect to be well underway at the time of potential approval, is designed to serve as our registrational trial for accelerated and full approvals of Life Elucil in combination with Pembrolizumab in frontline advanced melanoma, as well as a confirmatory trial to support full approval of Life Elucil in post-anti-PD-1 advanced melanoma. We recently activated TILBANS3A1. 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 lifelucidin 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 and 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 IOVAN with six cohorts across three IOVAN 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 LM145 in combination with Pembrolizumab from cohort 3A of the IOV COM202 trial in patients with advanced NSELC 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 Liferucelin frontline advanced and SELC patients. Enrollment to cohort 3A 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, IOIOV LUN202 trial is investigating LN145 monotherapy after prior anti-PD-1 and chemotherapy. This trial, which includes an option for pre-progression tumor harvest, as well as till product manufactured from starting core biopsy tumor material, is expected to continue enrollment throughout this year. Moving to cervical cancer, our expanded cohort two in the ongoing T14504 trial is investigating life elusal following progression on or after chemotherapy and anti-PD-1 therapy. Based on our dialogue and feedback from FDA, Core 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 TILT therapies, particularly IOB4001 and other genetically modified TILT therapies that utilize the gene-editing TALEN technology licensed from Selectus. to optimize TIL therapy by inactivating immune checkpoint proteins that inhibit anti-tumor response. We are investigating IOV4001, a PD-1 inactivated TIL therapy candidate in our first in human IOVGM1-201 trial in patients with previously treated advanced melanoma or NSCLC. Additional programs using the TALEN 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, IOV3001, and approaches to increase TIL potency, including the selection of CD3969 double-negative TILs and enhancements such as Tevet cytokines. 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.
spk00: Thank you, Frédéric. My comments will summarize our planned acquisition of Proloquium, 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 ICC filings. At the end of January, we announced that we have entered into an agreement to require polluting from Plunigen. Terms of the agreement include an upfront payment of 167.7 million British pounds, a 41.7 million British pounds milestone payment upon first approval of lipolucel in advanced melanoma, and double-digit Prolokin global sales royalties from Iovance to Clinichem. The transaction will be financed with existing cash and is expected to close imminently. As Fred mentioned, we expect Prolokin to provide revenue and full control of the IL-2 supply chain and logistics surrounding TLT-API. We anticipate significant revenue for Prolokin to begin after the launch of Lycolosoft. 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 through an at-the-market, or ATM, financing facility during the first quarter of 2023. This cash position is expected to found our operating plan into the second half of 2024, including the polluting 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 31st, 2023, our net loss was $107.4 million, or 50 cents per shares, compared to a net loss of $91.6 million, or 58 cents per share, for the first quarter of 2022. Research and development expenses were $82.7 million for the first quarter of 2023, and an increase of $14.4 million compared to $68.3 million for the first quarter of 2022. This year, over a 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 composition 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 of 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 prologue in 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 31st, 2023, There were approximately 224.4 million common share outstanding. I will now hand the call back to the operator to kick off the Q&A session.
spk13: Thank you. As a reminder, to ask a question, you will need to press star 1 on your telephone. If your question has been answered or you wish to remove yourself from the queue, press star 1 again. Once again, to ask a question, press star 1. Our first question comes from the line of Michael Yee with Jefferies.
spk16: Hey guys, thanks for the questions and congrats on the progress. We had two 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
spk15: your expectations for an FDA inspection for the factory and how that process would go about during the regulatory timelines 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 sort of codes before. And if you go back to CAR T, that was a real gaining 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. Thank you.
spk11: Yeah, Mike, regarding an AGCOM, right now, as we've said before, we don't expect an AGCOM. 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 could talk more about that at that time. Typically, that comes after acceptance of the BLA. Regarding inspection and timing for inspections, what we call PLI, or pre-licensing inspections, those are things that occur typically towards the end of the review cycle. They will occur around late third quarter, something like that, this year. Potentially, we don't know. FDA might tell us, give us more detail, and give us more insight into that at some point. But we are preparing today heavily at all of our sites, including our manufacturing site at ICTC, as well as at WUSHI, and everywhere else in our organization for the PLI, as well as for what's called the BiMo, or Bioresearch Monitoring GCP audit. So we intend to be in very good shape when that happens. And for the ATCs that 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 JCOs. JCOs don't apply in our space. We're more interested in what's called MS-DRG 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 add anything to that.
spk02: 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 engage in payers. We engage payers responsible for 90% of covered lives for commercial and Medicare patients. We're competent in our approach in that payers understand the unmet need and the clinical data that we've shared thus far. Thanks, Fred.
spk13: Thank you. And our next question comes from the line of Peter Lawson with Barclays.
spk12: Great. Thank you so much. The TILD-VAN 3-in-1 trial, just kind of how we should be thinking about that. as regards to the balance of U.S. versus ex-U.S. sites?
spk11: Yeah, we're going to be international fully there, Peter. Maybe I can say a few words and then Frederick can add. But we are intending to have European sites. We're 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. Frederick, do you want to add anything?
spk07: Yeah, I totally agree. We have interactions with sites and investigators across all of the regions that we were commenting on there 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.
spk12: Gotcha. For long, just the data you'll be sharing this year, how much data should we expect for, I guess, Cohort 3A?
spk11: 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.
spk12: 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?
spk11: As an end of May kind of event? No, I think we're in May right now. We've got a BLA acceptance that we just mentioned around May 26th. 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, or 3 a.m. for some of the other data releases. You're looking at the second half of this year.
spk12: Okay, perfect. Thank you so much.
spk13: Thank you. And our next question comes from the line of Colleen Cousy with Baird.
spk14: Good afternoon. Thanks for taking our questions. So for the confirmatory study till advance, has 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?
spk11: No, they've never said anything about percentage enrollment. They used the term well underway with us, and 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. They're quite aggressive, but we can't, at this point, we're not gonna be disclosing those right now.
spk14: Understood, thank you. I guess another question on enrollment, just this one on the cervical cancer study, any update on how that enrollment's going and how quickly you could expect to file using that data?
spk11: Right now, the study is enrolling quite well. Maybe, Frederick, 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. bullish about this. We're very focused, obviously, on the melanoma BLA first, though, so I think after we pass the melanoma BLA, you'll hear more from us about cervical. Fredrik, do you want to give Colleen an idea of how the investigators feel about cervical right now and how it's going?
spk07: Yeah, maybe just as an additional color, 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 going well.
spk14: Great. Thanks for taking our questions.
spk13: Thank you. And our next question comes from the line of Rennie Benjamin with JMP Securities.
spk04: Hey, good afternoon, guys. Thanks for taking the questions and congratulations on the filing and all the progress. Fred, can you talk a little bit to any and all, you know, 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, you know, give you the thumbs up that, you know, it's ready for review?
spk11: Yeah, 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.
spk05: Okay.
spk04: And then, you know, I've 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.
spk11: I think the best label for us would be to include both cohort two and cohort four. I think we've talked about that before. 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. Right now, we don't anticipate that. We're preparing to have a nice Label includes 153 patients from 2 plus 4, the full data set that we talked about at CITI 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 it's 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. Great. Thanks for taking the questions, and good luck.
spk13: Thank you. And our next question comes from the line of Mark Bradenbach with Oppenheimer.
spk03: Hey, good afternoon. Thanks for taking our questions. 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 Perlucan? 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 that. are these going to be kind of like lump sum payments, or are they going to be spread out a bit? Thanks for taking your questions.
spk11: I'll take the first one, then John Mark can talk to you about the P&L. Yes, we are getting Prolucan people, Clinagen people as part of the deal. 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 Prolucan, 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 Lefulusa 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 expenses?
spk00: Yeah, so thank you for the question, Marc. So under the term of the agreement, we have two things that we will consider, but this will be cash-related activities, meaning we'll have an upfront payment of roughly, we talk about $200 million. It's exactly 167.7 million British pounds. that will be, you know, 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 41.7 million British pounds at the time of the first approval of life or loss in advanced melanoma. But those two events have to be considered as, you know, cash flow related activities, not eating our PNL, if you think accounting-wise.
spk03: Got it. Okay. Thanks for taking the questions.
spk13: Thank you. And our next question comes from the line of Mara Goldstein with Mizuho.
spk08: Great. Thanks so much for taking the question. With respect to the ATCs, in your commercial plan, how quickly or what is like the time or the lag for ATCs to begin to treat patients once product is approved?
spk11: What does that commercial sale look like?
spk08: Sorry.
spk11: Yeah, so it's very, very rapid, Mara. It's something that they can do very quickly. We have the ATCs 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 team are out there making sure that the sites are ready to go as soon as the product's 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-T's.
spk08: Okay, and if I could just ask another question. Given there are trials running, you know, also in melanoma, although obviously different, I mean, are the ATCs competing also for clinical trial patients?
spk11: No, we don't really see that as a major... limitation right now for us. Okay. That's really nice.
spk08: Thank you. I appreciate it.
spk13: Thank you. And our next question comes from the line of Astika Gunwarden with Truist.
spk17: Hi, this is Karina for Astika. I had a question on the Tillens 301 study. Has the first station been dosed yet, and how many sites do you guys plan to activate? Thank you.
spk11: We'll announce when we randomize the first patient. It 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 a very significant number of sites.
spk17: Okay. And you said it's going to be outside of the U.S. primarily, or what's the percentage are you looking at?
spk11: 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.
spk17: Okay. Thank you.
spk13: Thank you. And our next question comes from the line of Michael Schmidt with Guggenheim.
spk06: Hi, good afternoon. This is for Michael. Thanks for taking our questions. 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 that multiple upcoming phase three readouts of ADCs and small molecule TKIs in this setting? Thank you.
spk11: Yeah, Frederick, do you want to talk about that?
spk07: Yeah, so I think... For bars in this space, I think you would have to look at available and approved therapies at this point. Things to look at there are docetaxel monotherapy or docetaxel plus ramiocerumab. That's usually an accepted benchmark for settings. Obviously, as the space evolves, we're going to have to look, because we know that FDA as they are looking at particularly single-arm data sets, is looking at available therapy at the time you bring this forward. But right now, docetaxel, docetaxel, Ramu is probably the most appropriate benchmark to look at.
spk13: Thank you. And as a reminder, to ask a question, please press star 1 on your telephone. Once again, to ask a question, please press star one. And our next question comes from the line of Madhu Kumar with Goldman Sachs.
spk05: Great. Yeah, thanks for taking our question. So I guess kind of can we expect any more updates from cohort four or from the ongoing cohort two, cohort four trials in terms of things like overall survival and kind of longer-term follow-up on therapy from that study? Okay.
spk11: At some point we might do, but we put out overall survival data this year, and it was pretty mature. So I could continue to 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 plateau in those curves has been kind of reached on the Kaplan-Myers. And there's a publication as well that came with that. Remember we did a companion publication last year too, so you can check them both out.
spk05: Yeah, absolutely. So maybe kind of following up on the bed capacity commentary that you had earlier about ATCs, what do you think at launch is going to be kind of the effective number of beds that will be available? And what do you think is going to be the steady state flow? I'm thinking about the CISI event last year where they talked about kind of maybe four beds on average per site per week. 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?
spk11: I think you're going to see much higher capacities. I visited a site last week where they showed me capacities that far, far, far exceed that in their BMT, allo, till, CAR T units. So I do think maybe that's something that people should understand better about the sites that they really are 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 CITSE. It was a comment made at CITSE, but it's not something we've seen very often. Oh, and by the way, Madhu, I pulled this slide up. The OS curve from CITSE goes out to 60 months. Okay.
spk05: Okay, and then one last one on that point. So, again, as you think with the launch of Mifilucil and 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 sold? 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 will effectively be?
spk11: 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.
spk05: Great. Thank you very much, everybody.
spk13: Thank you. Now I'm sure no further questions at this time. So with that, I'll hand the call back over to interim CEO, Fred Vogt, for closing remarks.
spk11: Thank you again for joining the I-Advanced Biotherapeutics first quarter 2023 financial results and corporate updates conference call. We've had an exciting start to 2023 upon completing the BLA, entering the Prolucan agreement, and delivering on our key regulatory commercial manufacturing and pipeline activities. I am 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 till 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.
spk13: Ladies and gentlemen, this concludes today's conference call.
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