NASDAQ:ADAP Adaptimmune Therapeutics Q2 2024 Earnings Report $0.29 0.00 (-1.37%) As of 05/20/2025 04:00 PM Eastern Earnings HistoryForecast Adaptimmune Therapeutics EPS ResultsActual EPS$0.27Consensus EPS N/ABeat/MissN/AOne Year Ago EPSN/AAdaptimmune Therapeutics Revenue ResultsActual Revenue$128.23 millionExpected Revenue$58.00 millionBeat/MissBeat by +$70.23 millionYoY Revenue GrowthN/AAdaptimmune Therapeutics Announcement DetailsQuarterQ2 2024Date8/12/2024TimeN/AConference Call DateMonday, August 12, 2024Conference Call Time8:00AM ETConference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by Adaptimmune Therapeutics Q2 2024 Earnings Call TranscriptProvided by QuartrAugust 12, 2024 ShareLink copied to clipboard.There are 15 speakers on the call. Operator00:00:00Good day, and welcome to the Adaptimmune Second Quarter 20 24 Conference Call. All participants will be in a listen only mode. After today's presentation, there will be an opportunity to ask Please note this event is being recorded. I would now like to turn the conference over to Dan Odd Cohen, Investor Relations. Please go ahead. Speaker 100:00:38Thank you, operator. Good morning, and welcome to Adaptimmune's conference call to discuss our Q2 2024 financial results and business updates. I would ask you to review the full text of our forward looking statements from this morning's press release. We anticipate making projections during this call and actual results could differ materially due to several factors, including those outlined in our latest filings with the SEC. Adrian Rockliffe, our Chief Executive Officer, is here with me for the prepared portion of the call and other members of our leadership team will be available for Q and A. Speaker 100:01:15With that, I'll turn the call over to Adrian Rockliff. Speaker 200:01:22Ad? Thanks, Dan, and thanks everyone for joining us. We are incredibly proud that Adaptimmune is now a commercial stage cell therapy company, following the U. S. FDA approval and the launch of our first product in our sarcoma franchise, TCELLRA. Speaker 200:01:40This is a fantastic achievement for the company, for the cell therapy field and for people with synovial sarcoma. TCEWA is the 1st engineered cell therapy for a solid tumor, the first medicine in its class, and it's also the first new treatment option for synovial sarcoma in over a decade and the culmination of groundbreaking R and D, our investment in manufacturing, the demonstrable clinical benefit exhibited throughout development, and incredible execution of the regulatory process. TCELLRA is a vindication of autologous cell therapy for solid tumor cancers. And together with the synovial sarcoma community, we're going to redefine how synovial sarcoma is treated. Launch activities for TCELLA started the instant we received approval, and we hit the ground running. Speaker 200:02:34I want to provide some updates on how TCELLA's launch is going, bearing in mind that we are only 10 days in. As sinovial sarcoma is a rare disease, treatment is concentrated in sarcoma centers of excellence. We've already recruited, trained and deployed a commercial footprint to deliver Tsoa to people with sarcoma. Our commercial, MediFares, manufacturing and supply teams are all in place and engaging patients, physicians, payers and treatment centers. The companion diagnostics HLA and MAGE A four testing were approved concurrently with T Cella, so healthcare providers can arrange for patients to get tested to establish their biomarker eligibility. Speaker 200:03:19Instead, we believe this the first time that a therapy has been approved together with 2 new diagnostics at the same time. Adaptimmune Assist, our patient support program is up and running to ensure a personalized experience throughout the treatment journey. And we previously discussed our plans to activate 6 to 10 authorized treatment centers during TCELLA's launch periods. We are on track to do this. We have 5 ATCs available in our locator tool on tcela.com website, and all of our internal systems are in place to accept orders and to manufacture and deliver Tcellra. Speaker 200:04:00Over the next few quarters and prior to having trends for patients treated and for sales, we will be updating you on 2 key performance indicators for launch execution as we go forward. Firstly, the number of ATCs opened and secondly, the number of patients April East. As we move through the first half of next year, we will transition to patients treated and obviously to sales as the key metrics. Moving on to the positioning of Adaptimmune beyond the launch of TCEARO. I want to touch a little on our balance sheet and our pipeline. Speaker 200:04:38At the end of Q1 this year, we had approximately $144,000,000 in total liquidity and runway guidance into late 2025. During Q2, we signed a collaboration agreement with Galapagos and entered into a debt facility with Hercules and at the end of the quarter, we have total liquidity of 215,000,000 dollars We believe we are well capitalized to deliver the successful launch of TCELLRA and also develop the rest of the pipeline. As we transition into a commercial cell therapy company, we will move away from extending cash runway guidance given complexities of estimating future revenues in the near term as we establish our sarcoma franchise. And instead, we'll provide high level forward cost guidance alongside regular updates on the commercialization progress. During the first half of this year, our total expenditure was approximately $114,000,000 This included investments preparing for the launch of TECERRA as well as hiring and onboarding the commercial team. Speaker 200:05:42For the next 18 months, we expect our run rate operating expenses to be broadly consistent with that of the first half of twenty twenty four. We'll update this cost guidance as we progress, together with the launch metrics that I previously articulated, namely the number of ATCs and the number of patients they've released. Moving on to our pipeline. We are progressing our clinical pipeline with the second product in our sarcoma franchise, Letiselle, expanding the number of sarcoma patients we can treat with our cell therapies. Letiselle is clinically derisked as a pivotal trial Ignadiso has already met the primary endpoint efficacy at the interim analysis. Speaker 200:06:21And this was presented earlier this year at ASCO by Doctor. Sandra D'Angelo. Letticell's regulatory pathway will build on our experience with T Cellurus' regulatory submission. And as LetyCell also targets soft tissue sarcomas, the commercial footprint is essentially identical to Tcellular's, and we expect significant channel synergies once we launch Letisal. We're also progressing Usercell, our next generation cell therapy in the SURPASS-three trial in ovarian cancer, which is currently enrolling and we'll be moving forward in partnership with Galapagos in a head and neck cancer Phase I trial with Usacell on Galapagos' distributed manufacturing platform. Speaker 200:07:04We are an integrated cell therapy company, built from the ground up to design, develop and deliver cell therapy products to redefine the treatment of solid tumor cancers. And we are now realizing this vision in real time. And with that, myself and members of the leadership team are happy to take any questions. Operator? Operator00:07:24We will now begin the question and answer The first question today comes from Mark Frahm with TD Cowen. Please go ahead. Speaker 300:08:06Hey, thanks for taking my questions. Maybe just start out, I mean, you mentioned that you've got a few ATCs already loaded on the website. Are you already seeing patients kind of flow through that website? And maybe characterize maybe any new sources of patients that you're seeing in terms of referrals and things like that? I know it's very early days, but just anything you're seeing there. Speaker 200:08:33Thanks, Mark. I'll ask Cynthia Pucina to give us give you an update on early patient flows, etcetera. Speaker 400:08:40Yes. Thank you for the question. It is really very exciting to see the enthusiasm from not only our treatment centers and future treatment centers as well, but also beyond across other sarcoma centers of excellence now with the approval that are very excited to be able to treat patients. So we are aware of patients that started the testing journey there in that process of identifying their eligibility for TECELRA. And the majority of the new sources that we're seeing in terms of questions and interest and having potential patients to refer to the ATCs are coming from other circle and centers of excellence across the country. Operator00:09:30The next question comes from Jonathan Chang with B. R. Inc. Partners. Please go ahead. Speaker 500:09:37Hey, guys. This is Matt Kalper on for Jonathan Chang. Thanks for taking my question. Could you comment on how the first version thanks. Could you comment on how the first version of ADP-six hundred stands out within the PRAME targeting space? Speaker 500:09:49And additionally, will the initial clinical version incorporate next generation enhancements like CD8 or will those be reserved for future iteration? And if so, would introducing enhancements be stepwise and similar to the MAGE experience? Thanks. Speaker 200:10:03Sure. So I'm going to ask Joe Brewer, our Chief Scientific Officer, to talk to that. Jo? Speaker 600:10:13Hi. Thanks. Yes, so we are looking at next gen approaches with our ADP-six 100 program. We are evaluating several in research, and we're looking at how we can bring those forward to the clinic. And we will update on more firm plans with the ADP-six hundred program Operator00:10:30in the future. Speaker 700:10:34Thank you. Operator00:10:39The next question comes from Michael Schmidt with Guggenheim. Please go ahead. Speaker 800:10:45Hi, this is Paul on Speaker 900:10:46for Michael. Thanks for taking our questions. Just on the ATCs for TECELRA, it looks like the 5 active sites you've put on the website overlap with those that have a AMSEL clinical trial experience. Can you speak to roughly what proportion of synovial sarcoma patients are seen in those particular centers? And then how long until the remaining 6 to 10 that you're targeting for initial sites are onboarded? Speaker 900:11:09And can you also comment on expectations for patient capacity in terms of perhaps treated patients per center, I guess, on a monthly basis? Thank you. Speaker 400:11:21Cynthia? Thank you for your questions. So we are planning to onboard about over time about getting to 30 ATCs. These ATCs in total represent about 80% of the patients that are in the sarcoma centers of excellence today, which we believe to be about 50% to 70% of all the patients with some of the sarcoma that are across the country. The ones that we have in our locator to already and the ones that are next in line in the process of being finalizing their onboarding are most of them clinical trial sites for Afamicel and they are the ones that we are planning to be the first ones that will be up and running. Speaker 400:12:08They already have experience. We started engaging with them several months ago. And then beyond that, some of the other ATCs will be Ladysytes and then some others beyond just based on the volume of patients that they see. And site it is. Speaker 200:12:24And we expect also that referral based site it is. Speaker 400:12:32And we expect also that referral base to grow and change significantly now that there is a treatment available for synovial sarcoma in the specific site. So as we see that volume coming in, we will see that being reflected in our numbers. Speaker 900:12:53Got it. Great. Thank you. And then perhaps just a quick follow-up. So you mentioned that patients don't necessarily have to be tested at a treatment center. Speaker 900:13:01So do you have full visibility into sort of real time testing metrics? How many patients are ID ed that might be appropriate for treatments? And is it possible to provide, I guess, qualitative updates on that metric? Thank you. Speaker 400:13:15So we don't have so the testing is approved and it's available commercially and they are run by labs that are independent labs that we don't really manage or control. We are going to have visibility to part of the testing metrics, but we don't have visibility to the full number of patients that are being tested. And so for that reason, we're not going to be providing accurate testing numbers because we don't know what they are. We don't have a way to know what they are specifically. We hear anecdotal information. Speaker 400:13:50That's why I shared that we are aware of patients that are in the testing process, but we're not aware of all of them. But some of them when the treatment sites or the centers of excellence share with us, then we are aware of what's happening. The testing can happen from anywhere. We did provide in our cetera.com website the path to testing for both MAGE A 4 and HLA as well. And then at the moment that that testing is initiated, then the labs will take over, it just sends it to the labs. Operator00:14:34The next question comes from Toni Butler with Rodman and Renja. Please go ahead. Tony, your line is open. You may ask your question. Speaker 1000:14:52Yes, I'm sorry. Thank you very much. Adrian, I wanted to move to SURPASS III for a moment. Clinicaltrials dot gov suggests that 28 sites have been identified. What's interesting though is roughly maybe even slightly less than a third are in the U. Speaker 1000:15:12S, the majority ex U. S. I assume that's somewhat strategic, but I guess the question is will more U. S. Sites be opened? Speaker 1000:15:22Any thoughts around that? It may not necessarily matter, but the rate of enrollment is kind of important. And then the part 2 of this question is, I would assume and this is just an assumption that given the ramp in that trial costs, if in fact more sites were to be open then in fact the $114,000,000 or let's call it $230,000,000 a year roughly and costs would actually ramp maybe not appreciably, but certainly ramp higher than the guidance you've given. So any color would be helpful. Thanks. Speaker 200:16:02Thanks. 1 night, I'll take a stab at that and if you have follow-up questions, we can do that too. So the majority of the sites that are going to be open for the past 3 are already open. And you're right, there are a significant number of sites ex U. S. Speaker 200:16:23And that mirrors the pattern that we've had quite a lot of success recruiting both in the U. S. And in the and ex U. S. And just a reminder, we're working with the gynecology oncology group, GOG, to recruit the SURPASS-three trial. Speaker 200:16:39Recruitment is going enrollment is going well at the moment and we look forward to being able to complete enrollment next year and provide data subsequent to that. So that's going well. In terms of the cost, the overall cost profile that I gave is a mix of what you've got to think about is also the costs of SURPASS-three which is up and running and ongoing and a significant trial. But also there's been the historic costs over the 2023 and 24 of, for example, the SPEARHEAD set of trials associated with the approval of TCELLRA. And then also, of course, the ongoing we've got to factor in the ongoing IGNITE ESO trial and the cost associated with that. Speaker 200:17:31Now we've taken that over from GSK. And so that's why we're comfortable with the position that our overall run rate will remain relatively consistent. And that includes the fact that we've already recruited and made the investments in the commercial team in the first half of this year. And that's why we believe that that will be the cost will be broadly consistent going forward for the next 18 months. Speaker 1000:18:00Thanks, Adrian. Appreciate it. Speaker 200:18:02Cheers, Teddy. Operator00:18:06The next question comes from Greg Suvannave with Mizuho. Please go ahead. Greg, your line is open. You may now ask your question. Speaker 300:18:30Hey, good morning. Sorry about that. Thanks for taking my questions. And let me congratulate Adi and team on the approval. That's great achievement for the company and for patients as well. Speaker 300:18:42A couple of questions, if I could. Just on maybe the first question on your sales and projection of $400,000,000 I realize that's for the sarcoma franchise and I realize that's for the U. S. Any color on how we should think about between the two products that you have realizing that Lidicell is not yet approved, but how you think about potentially the split of revenue between those two products? My second question, maybe it is one that you might be reticent to comment on, but just your level of comfort with how the Street is currently modeling the launch and revenue over the next, let's call it, 6 quarters as we look at the back half of this year and 2025. Speaker 300:19:38I realize that you've been trying to guide us to be relatively gradual and how we think that's going to be. But just wondering if you had an opportunity just to see kind of where street is and whether you think we are doing a good job with that kind of more gradual approach? Speaker 200:19:59Thanks, Greg. So with respect to the breakdown of the peak U. S. Sales estimate for the launch indications for our sarcoma franchise of €400,000,000 the best way of thinking about that is that the patient split is roughly 40% of Famicel, 60% let's say, 40% TCELLRA, 60% let's say, and so the split of that peak year sales estimate is broadly speaking follows that. So on your second point, I think the key thing that we've been keen to ensure is that whatever you think the ramp up of the sales for TCELLRA is. Speaker 200:20:44And I think you'll appreciate I'm not going to comment specifically on the analyst expectations, although I am pleased to see that people have sort of been paying attention over the last 6 months or so to the opportunity here. Whatever you think that ramp up is, I think it's important to recognize that it is frame shifted by 2 to 3 months from the launch date. And that's the most important thing to get right in the short term is. And I think by and large people have done with first sales recognized in Q4 this year and those being relatively modest representing the very front end of the patients as they flow through the manufacturing, through the identification of manufacturing and then get treated in the quarter after launch. So that's the biggest thing that I think has changed. Speaker 200:21:40And I do think the analyst community has picked up on that frame shift into Q4 this year. Speaker 300:21:49Okay. Thank you. And then if I could ask one more just on Letticell. You might have mentioned this in your prepared comments, I might have missed it, but what are the gating steps for that BLA submission? And maybe just a follow-up, are you anticipating that we will see additional data on Lettucell before you file? Speaker 300:22:08Or is the data from your perspective already out there and pretty much we have what we or we have basically a view of the data that are available for the product? Thanks. Speaker 200:22:22Thanks, Greg. I'll ask Dennis Williams to comment on those questions. Dennis? Speaker 1100:22:29Yes, sure. So I would say that for Letticell, it follows the exact same regulatory pathway that we did for TESOLREP. So we need a companion diagnostic. We need to supply the clinical data from Ignite EASO, CMC information. And so basically, it will follow the exact same paradigm that we did for TCELLRA. Speaker 1100:22:54I will say that we are looking forward to presenting primary data from the IGNITE ESO trial later this calendar year. Speaker 300:23:04Okay. Thank you very much. Congratulations again on all of the achievements and progress. Speaker 700:23:09Thanks, Greg. Operator00:23:12The next question comes from George Farman with Scotiabank. Please go ahead. Speaker 1200:23:19Hi, great. Thanks for taking my questions. Just wanted to ask about the absence of MRCLS on the label for TCELLRA. Wondering what sort of conversations went on with FDA and does that really matter? Certainly, you have Letticell coming up. Speaker 1200:23:41And then also with Lettucell, I understand I believe that the product is manufactured in the U. K. Is that where commercial material will ultimately be originating from? And are there efforts underway to bring manufacturing over to the U. S? Speaker 200:24:02So I'm going to ask Dennis to talk about the label for and the data for TCELLRA from the SPEARHEAD-one trial and the MRCLS portion of that. And then I'm going to ask John Lunger to talk about the manufacturing for Lettecel for the approval and launch? Dennis? Speaker 1100:24:30Yes, sure. So I mean, we made the decision to not pursue mixed with brownfield liposarcoma as a labeled indication some time ago and it really came down to the fact that the trial, spherohead bone was overwhelmingly synovial sarcoma. So it would be challenging, I think, for a regulatory review to have such limited patient numbers. There were only 8 patients with exoat around cell liposarcoma treated in a trial. And we just thought that it would add a lot of regulatory burden to an application where we really wanted to get the approval in synovial sarcoma. Speaker 1100:25:08As you mentioned, right now that we have Letticell, this is less of a concern for us. Letticell is the MOUsO1 expression in myxoid round cell liposarcoma is much higher than MAGE A 4 expression in myxoid round cell liposarcoma. So from a target perspective, Letticell is where expression is north of 80% of that population is a much more appropriate target to pursue for that indication. And John? Speaker 1300:25:44Yes. Hi. So as far as the manufacturing of Letticel, the actual manufacturing that was primarily done for the Ignite trial was in a contract manufacturer in Germany, not the UK. So as you can imagine, our primary objective is speed to market for lettuce sell. And so making changes to the supply chain related to that particular filing is probably a risk that we don't necessarily want to take. Speaker 1300:26:08However, we are looking at adding a U. S. Site, whether that's our own or another CDMO, for the future to the Lettucell supply chain to better enable the supply into Speaker 1200:26:21the states. Great. Thanks for that and congratulations on all the progress. Speaker 300:26:26Thanks, Josh. Operator00:26:29The next question comes from Arthur He with H. C. Wainwright. Please go ahead. Speaker 800:26:37Hey, good morning team. Thanks for taking my question. So I had two questions. So first, thanks for the update on the onboarding for the ATC. But on the at the same time, just curious, could you guys give us the onboarding progress for those center of excellence for as a referral network? Speaker 800:26:59How should we think about dosing to support the launch? Speaker 200:27:05Cynthia? Speaker 400:27:07Sure. So yes, we do have a lot of activity going on with the sites that we will eventually become authorized the treatment centers and also to the sarcoma centers of excellence that will be referring patients to the future ATCs. So our field teams across both medical affairs and commercial target both the future ATCs and current ATCs and beyond. So that already that work already started in terms of educating the broader sarcoma centers of excellence into the new biomarkers, the importance of testing patients as early as possible, and then into referring the patients that are positive to both biomarkers to the treatment sites. So that work started with our field teams and we'll see these referrals already started to come in through the ATCs. Speaker 800:28:09Awesome. Thanks, Cynthia. And my second question is regarding the letter cell. So could you so is there before you guys submit the rolling submission of the BLA, do you still need to meet with the FDA? And if so, when or at what circumstance you can request the meeting? Speaker 200:28:37Dennis? Speaker 1100:28:39Yes, sure. I mean, we've already had meetings with the FDA and we will continue to have meetings with the FDA. This is really the advantage of having, in this case, Lettucell has breakthrough therapy designation. And one of the main advantages of that is to have frequent interactions with regulatory agencies. So we'll be talking about a lot of things related to the rolling submission, how the application should be organized. Speaker 1100:29:06I mean, some of this to be fair, like an earlier comment, I mean, some of what we'll do with Letticell is a bit of excuse the expression, rinse and repeat of what we did with TESOLRA. But there are definitely some things that are unique, right? There's 2 different populations in this data set. And so there and as John mentioned about the supply chain aspect, so there are some differences. But in general, I would expect to have many meetings between now and the submission of the rolling BLA next year. Speaker 800:29:41Great. Thanks, Dennis. And talk to you guys soon. Speaker 200:29:46Thanks. Operator00:29:48The next question comes from Yanan Xu with Wells Fargo. Please go ahead. Speaker 700:29:56Hi, thanks for taking our question. Congrats on the progress. This is Quan on for Yanan. So can you share with us the overall timeline from patients screening to the infusion? Like roughly how long does it take? Speaker 700:30:09And which part of the process can be accelerated? Thank you. Speaker 400:30:17Cynthia? Sure. So the timelines between patient screening and infusion over time, the testing can take a few weeks if you do both tests in parallel. And then from the time in which the a freeze take place all the way into the infusion can be received back into the site to the patient, it takes about 30 days. At the beginning of this process, because the testing just got approved and we have to go also through reimbursement journey and the referral pattern from the beginning, we believe that the first patient is going to take a little bit longer until the whole process can get more on a faster pace. Speaker 400:31:06And so that's why we are anticipating to be able to treat our first patients in the Q4 of the year. Speaker 700:31:14Got it. Thank you so much for that. And when do you expect to have broad payer coverage? Thank you. Speaker 400:31:23So right now, in terms of Medicare, we already have it's already available. It's covered for commercial patients. We expect similar coverage than what we see for CAR Ts. At the beginning, it usually is through a single case negotiation with the payers until a policy is established, but it doesn't mean that we book have coverage, only that it can take a little bit longer because it will be through single case agreements and fewer is established moving forward. So we expect to have good coverage at the beginning. Speaker 400:31:58It may take just a little longer. Speaker 700:32:02Scott, thank you so much for all the colors. Thanks. Operator00:32:08The next question comes from Michael Kim with SAC Small Cap Research. Please go ahead. Speaker 1400:32:15Hey, everyone. Good morning and thanks for taking my questions. First, just assuming similar pricing and penetration rates for GCELLREN and Letacell, My math suggests peak sales of $400,000,000 translates into roughly about a 50% to 55% market penetration rate. So just wondering if you could maybe provide some color on sort of the underlying drivers behind your thinking? Operator00:32:48Cynthia? So a couple of thoughts. So first, Speaker 400:32:51I think that the penetration rate for Ladicell is hopefully going to be faster. So the uptake faster because a lot of the treatment sites will be opened and have experience with the testing and with having the patients being referred to and treated. So I would expect that to be greater. The assumption in terms of potential number of patients is given more so by the eligibility based on HLAH2 and then the MAGE A 4 and the NY ESO expression in both tumor types. And then the assumptions beyond that are really mostly assuming similar access rates than other products in the space and similar manufacturing success rates as we've seen in our clinical trials. Speaker 1400:33:50Got it. Okay, that's helpful. And then maybe just second question, Appreciate your updated guidance on expenses over the next 18 months. And I know you guys have done a good job in terms of scaling up your sales infrastructure ahead of TCELLRA approval. But just curious if your guidance Speaker 1100:34:18So Speaker 200:34:21So maybe I'll cover that briefly. So we've not included in that expense guidance the things that the revenue sources that offset expenses in that context. And you'll look back on our filings and you'll see that there are elements for both partnership income and R and D tax credits and things like that that offset those expenses. So that's not included. In terms of the timing, we've not updated beyond what we said at the time of the partnership with Galapagos, which is that we anticipate going into the clinic in head and neck just soon as humanly possible and that we're working with Galapagos to enable that. Speaker 1400:35:25Understood. Thanks for taking my questions. Speaker 200:35:28Thanks. Operator00:35:30The next question comes from Peter Lawson with Barclays. Please go ahead. Speaker 700:35:37Hey, good morning. This is Alex on for Peter. Thank you for taking our questions. You previously talked about the possibility to do an interim analysis in the SURPASS-three study. Just wondering if you could remind us kind of the timing for that and the gating factors for that in the study? Speaker 200:35:59Elliot, do you want to talk about interim reads on Sarsapar? Speaker 1400:36:05Yes, just very briefly. I mean, we do anticipate interim analyses that are built into the trial at certain junctures, the first one being after 13 patients are dosed in each arm. We have not provided specific guidance as to the timeline for that. But I also want to just advise that when we see that interim analysis, it will not lead us to disclose clinical data until the entire study has been enrolled in that it has the potential to be registration enabling and we wouldn't want to put out clinical data that could bias the trial. Speaker 200:36:47That enrollment, full enrollment we anticipate happening next year. Speaker 700:36:53Great. Thank you. Thanks. Operator00:36:58This concludes our question and answer session. I would like to turn the conference back over for any closing remarks. Speaker 200:37:05Thank you everyone for your time today and your questions. We look forward to updating you as we progress the launch of TESARRA and of course the development of the rest of the pipeline to redefine how cancer is treated with cell therapies. Please don't hesitate to follow-up if you would like to discuss anything further and have a great day. Cheers. Operator00:37:28The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.Read morePowered by Key Takeaways Adaptimmune is now a commercial stage cell therapy company after the FDA approved TCELLRA, the first engineered cell therapy for a solid tumor and first new synovial sarcoma treatment in over a decade. In just 10 days post-approval, the company has activated 5 authorized treatment centers (ATCs) and aims for 6–10 ATCs during launch, tracking ATC openings and patients prepped as key performance indicators. As of Q2, Adaptimmune held $215 million in liquidity with runway into late 2025, and expects a stable operating expense run rate of about $114 million per half-year over the next 18 months. The pipeline is advancing Leticell, whose pivotal trial met its interim efficacy endpoint and will follow TCELLRA’s regulatory blueprint, alongside Usacell enrolling in the SURPASS-3 ovarian cancer trial and a Galapagos-partnered head and neck study. Launch infrastructure includes simultaneous approval of HLA and MAGE-A4 diagnostics, a personalized patient support program, and full commercial, medical affairs, manufacturing, and supply teams. A.I. generated. May contain errors.Conference Call Audio Live Call not available Earnings Conference CallAdaptimmune Therapeutics Q2 202400:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) Adaptimmune Therapeutics Earnings HeadlinesHC Wainwright Brokers Boost Earnings Estimates for ADAPMay 18 at 2:11 AM | americanbankingnews.comStockNews.com Initiates Coverage on Adaptimmune Therapeutics (NASDAQ:ADAP)May 18 at 1:23 AM | americanbankingnews.comMusk’s Project Colossus could mint millionairesI predict this single breakthrough could make Elon the world’s first trillionaire — and mint more new millionaires than any tech advance in history. And for a limited time, you have the chance to claim a stake in this project, even though it’s housed inside Elon’s private company, xAI.May 21, 2025 | Brownstone Research (Ad)Leerink Partnrs Has Bullish Estimate for ADAP Q2 EarningsMay 17, 2025 | americanbankingnews.comWells Fargo & Company Cuts Adaptimmune Therapeutics (NASDAQ:ADAP) Price Target to $1.00May 17, 2025 | americanbankingnews.comBarclays Cuts Adaptimmune Therapeutics (NASDAQ:ADAP) Price Target to $0.46May 17, 2025 | americanbankingnews.comSee More Adaptimmune Therapeutics Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Adaptimmune Therapeutics? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Adaptimmune Therapeutics and other key companies, straight to your email. Email Address About Adaptimmune TherapeuticsAdaptimmune Therapeutics (NASDAQ:ADAP), a clinical-stage biopharmaceutical company, provides novel cell therapies primarily to cancer patients in the United States and the United Kingdom. It develops SPEARHEAD-1 that is in phase II clinical trials with ADP-A2M4 for synovial sarcoma; SURPASS-3 that is in phase II clinical trial with ADP-A2M4CD8 for people with platinum resistant ovarian cancer; and SURPASS that is in phase I clinical trials in patients with head and neck, and urothelial cancers. The company has strategic collaboration and license agreement with Genentech, Inc. and F. Hoffman-La Roche Ltd to develop personalized allogeneic and allogeneic T-cell therapies; research, collaboration, and license agreement with Universal Cells, Inc.; third-party collaborations with Noile-Immune and Alpine Immune Sciences; and strategic alliance agreement with the MD Anderson Cancer Center. 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There are 15 speakers on the call. Operator00:00:00Good day, and welcome to the Adaptimmune Second Quarter 20 24 Conference Call. All participants will be in a listen only mode. After today's presentation, there will be an opportunity to ask Please note this event is being recorded. I would now like to turn the conference over to Dan Odd Cohen, Investor Relations. Please go ahead. Speaker 100:00:38Thank you, operator. Good morning, and welcome to Adaptimmune's conference call to discuss our Q2 2024 financial results and business updates. I would ask you to review the full text of our forward looking statements from this morning's press release. We anticipate making projections during this call and actual results could differ materially due to several factors, including those outlined in our latest filings with the SEC. Adrian Rockliffe, our Chief Executive Officer, is here with me for the prepared portion of the call and other members of our leadership team will be available for Q and A. Speaker 100:01:15With that, I'll turn the call over to Adrian Rockliff. Speaker 200:01:22Ad? Thanks, Dan, and thanks everyone for joining us. We are incredibly proud that Adaptimmune is now a commercial stage cell therapy company, following the U. S. FDA approval and the launch of our first product in our sarcoma franchise, TCELLRA. Speaker 200:01:40This is a fantastic achievement for the company, for the cell therapy field and for people with synovial sarcoma. TCEWA is the 1st engineered cell therapy for a solid tumor, the first medicine in its class, and it's also the first new treatment option for synovial sarcoma in over a decade and the culmination of groundbreaking R and D, our investment in manufacturing, the demonstrable clinical benefit exhibited throughout development, and incredible execution of the regulatory process. TCELLRA is a vindication of autologous cell therapy for solid tumor cancers. And together with the synovial sarcoma community, we're going to redefine how synovial sarcoma is treated. Launch activities for TCELLA started the instant we received approval, and we hit the ground running. Speaker 200:02:34I want to provide some updates on how TCELLA's launch is going, bearing in mind that we are only 10 days in. As sinovial sarcoma is a rare disease, treatment is concentrated in sarcoma centers of excellence. We've already recruited, trained and deployed a commercial footprint to deliver Tsoa to people with sarcoma. Our commercial, MediFares, manufacturing and supply teams are all in place and engaging patients, physicians, payers and treatment centers. The companion diagnostics HLA and MAGE A four testing were approved concurrently with T Cella, so healthcare providers can arrange for patients to get tested to establish their biomarker eligibility. Speaker 200:03:19Instead, we believe this the first time that a therapy has been approved together with 2 new diagnostics at the same time. Adaptimmune Assist, our patient support program is up and running to ensure a personalized experience throughout the treatment journey. And we previously discussed our plans to activate 6 to 10 authorized treatment centers during TCELLA's launch periods. We are on track to do this. We have 5 ATCs available in our locator tool on tcela.com website, and all of our internal systems are in place to accept orders and to manufacture and deliver Tcellra. Speaker 200:04:00Over the next few quarters and prior to having trends for patients treated and for sales, we will be updating you on 2 key performance indicators for launch execution as we go forward. Firstly, the number of ATCs opened and secondly, the number of patients April East. As we move through the first half of next year, we will transition to patients treated and obviously to sales as the key metrics. Moving on to the positioning of Adaptimmune beyond the launch of TCEARO. I want to touch a little on our balance sheet and our pipeline. Speaker 200:04:38At the end of Q1 this year, we had approximately $144,000,000 in total liquidity and runway guidance into late 2025. During Q2, we signed a collaboration agreement with Galapagos and entered into a debt facility with Hercules and at the end of the quarter, we have total liquidity of 215,000,000 dollars We believe we are well capitalized to deliver the successful launch of TCELLRA and also develop the rest of the pipeline. As we transition into a commercial cell therapy company, we will move away from extending cash runway guidance given complexities of estimating future revenues in the near term as we establish our sarcoma franchise. And instead, we'll provide high level forward cost guidance alongside regular updates on the commercialization progress. During the first half of this year, our total expenditure was approximately $114,000,000 This included investments preparing for the launch of TECERRA as well as hiring and onboarding the commercial team. Speaker 200:05:42For the next 18 months, we expect our run rate operating expenses to be broadly consistent with that of the first half of twenty twenty four. We'll update this cost guidance as we progress, together with the launch metrics that I previously articulated, namely the number of ATCs and the number of patients they've released. Moving on to our pipeline. We are progressing our clinical pipeline with the second product in our sarcoma franchise, Letiselle, expanding the number of sarcoma patients we can treat with our cell therapies. Letiselle is clinically derisked as a pivotal trial Ignadiso has already met the primary endpoint efficacy at the interim analysis. Speaker 200:06:21And this was presented earlier this year at ASCO by Doctor. Sandra D'Angelo. Letticell's regulatory pathway will build on our experience with T Cellurus' regulatory submission. And as LetyCell also targets soft tissue sarcomas, the commercial footprint is essentially identical to Tcellular's, and we expect significant channel synergies once we launch Letisal. We're also progressing Usercell, our next generation cell therapy in the SURPASS-three trial in ovarian cancer, which is currently enrolling and we'll be moving forward in partnership with Galapagos in a head and neck cancer Phase I trial with Usacell on Galapagos' distributed manufacturing platform. Speaker 200:07:04We are an integrated cell therapy company, built from the ground up to design, develop and deliver cell therapy products to redefine the treatment of solid tumor cancers. And we are now realizing this vision in real time. And with that, myself and members of the leadership team are happy to take any questions. Operator? Operator00:07:24We will now begin the question and answer The first question today comes from Mark Frahm with TD Cowen. Please go ahead. Speaker 300:08:06Hey, thanks for taking my questions. Maybe just start out, I mean, you mentioned that you've got a few ATCs already loaded on the website. Are you already seeing patients kind of flow through that website? And maybe characterize maybe any new sources of patients that you're seeing in terms of referrals and things like that? I know it's very early days, but just anything you're seeing there. Speaker 200:08:33Thanks, Mark. I'll ask Cynthia Pucina to give us give you an update on early patient flows, etcetera. Speaker 400:08:40Yes. Thank you for the question. It is really very exciting to see the enthusiasm from not only our treatment centers and future treatment centers as well, but also beyond across other sarcoma centers of excellence now with the approval that are very excited to be able to treat patients. So we are aware of patients that started the testing journey there in that process of identifying their eligibility for TECELRA. And the majority of the new sources that we're seeing in terms of questions and interest and having potential patients to refer to the ATCs are coming from other circle and centers of excellence across the country. Operator00:09:30The next question comes from Jonathan Chang with B. R. Inc. Partners. Please go ahead. Speaker 500:09:37Hey, guys. This is Matt Kalper on for Jonathan Chang. Thanks for taking my question. Could you comment on how the first version thanks. Could you comment on how the first version of ADP-six hundred stands out within the PRAME targeting space? Speaker 500:09:49And additionally, will the initial clinical version incorporate next generation enhancements like CD8 or will those be reserved for future iteration? And if so, would introducing enhancements be stepwise and similar to the MAGE experience? Thanks. Speaker 200:10:03Sure. So I'm going to ask Joe Brewer, our Chief Scientific Officer, to talk to that. Jo? Speaker 600:10:13Hi. Thanks. Yes, so we are looking at next gen approaches with our ADP-six 100 program. We are evaluating several in research, and we're looking at how we can bring those forward to the clinic. And we will update on more firm plans with the ADP-six hundred program Operator00:10:30in the future. Speaker 700:10:34Thank you. Operator00:10:39The next question comes from Michael Schmidt with Guggenheim. Please go ahead. Speaker 800:10:45Hi, this is Paul on Speaker 900:10:46for Michael. Thanks for taking our questions. Just on the ATCs for TECELRA, it looks like the 5 active sites you've put on the website overlap with those that have a AMSEL clinical trial experience. Can you speak to roughly what proportion of synovial sarcoma patients are seen in those particular centers? And then how long until the remaining 6 to 10 that you're targeting for initial sites are onboarded? Speaker 900:11:09And can you also comment on expectations for patient capacity in terms of perhaps treated patients per center, I guess, on a monthly basis? Thank you. Speaker 400:11:21Cynthia? Thank you for your questions. So we are planning to onboard about over time about getting to 30 ATCs. These ATCs in total represent about 80% of the patients that are in the sarcoma centers of excellence today, which we believe to be about 50% to 70% of all the patients with some of the sarcoma that are across the country. The ones that we have in our locator to already and the ones that are next in line in the process of being finalizing their onboarding are most of them clinical trial sites for Afamicel and they are the ones that we are planning to be the first ones that will be up and running. Speaker 400:12:08They already have experience. We started engaging with them several months ago. And then beyond that, some of the other ATCs will be Ladysytes and then some others beyond just based on the volume of patients that they see. And site it is. Speaker 200:12:24And we expect also that referral based site it is. Speaker 400:12:32And we expect also that referral base to grow and change significantly now that there is a treatment available for synovial sarcoma in the specific site. So as we see that volume coming in, we will see that being reflected in our numbers. Speaker 900:12:53Got it. Great. Thank you. And then perhaps just a quick follow-up. So you mentioned that patients don't necessarily have to be tested at a treatment center. Speaker 900:13:01So do you have full visibility into sort of real time testing metrics? How many patients are ID ed that might be appropriate for treatments? And is it possible to provide, I guess, qualitative updates on that metric? Thank you. Speaker 400:13:15So we don't have so the testing is approved and it's available commercially and they are run by labs that are independent labs that we don't really manage or control. We are going to have visibility to part of the testing metrics, but we don't have visibility to the full number of patients that are being tested. And so for that reason, we're not going to be providing accurate testing numbers because we don't know what they are. We don't have a way to know what they are specifically. We hear anecdotal information. Speaker 400:13:50That's why I shared that we are aware of patients that are in the testing process, but we're not aware of all of them. But some of them when the treatment sites or the centers of excellence share with us, then we are aware of what's happening. The testing can happen from anywhere. We did provide in our cetera.com website the path to testing for both MAGE A 4 and HLA as well. And then at the moment that that testing is initiated, then the labs will take over, it just sends it to the labs. Operator00:14:34The next question comes from Toni Butler with Rodman and Renja. Please go ahead. Tony, your line is open. You may ask your question. Speaker 1000:14:52Yes, I'm sorry. Thank you very much. Adrian, I wanted to move to SURPASS III for a moment. Clinicaltrials dot gov suggests that 28 sites have been identified. What's interesting though is roughly maybe even slightly less than a third are in the U. Speaker 1000:15:12S, the majority ex U. S. I assume that's somewhat strategic, but I guess the question is will more U. S. Sites be opened? Speaker 1000:15:22Any thoughts around that? It may not necessarily matter, but the rate of enrollment is kind of important. And then the part 2 of this question is, I would assume and this is just an assumption that given the ramp in that trial costs, if in fact more sites were to be open then in fact the $114,000,000 or let's call it $230,000,000 a year roughly and costs would actually ramp maybe not appreciably, but certainly ramp higher than the guidance you've given. So any color would be helpful. Thanks. Speaker 200:16:02Thanks. 1 night, I'll take a stab at that and if you have follow-up questions, we can do that too. So the majority of the sites that are going to be open for the past 3 are already open. And you're right, there are a significant number of sites ex U. S. Speaker 200:16:23And that mirrors the pattern that we've had quite a lot of success recruiting both in the U. S. And in the and ex U. S. And just a reminder, we're working with the gynecology oncology group, GOG, to recruit the SURPASS-three trial. Speaker 200:16:39Recruitment is going enrollment is going well at the moment and we look forward to being able to complete enrollment next year and provide data subsequent to that. So that's going well. In terms of the cost, the overall cost profile that I gave is a mix of what you've got to think about is also the costs of SURPASS-three which is up and running and ongoing and a significant trial. But also there's been the historic costs over the 2023 and 24 of, for example, the SPEARHEAD set of trials associated with the approval of TCELLRA. And then also, of course, the ongoing we've got to factor in the ongoing IGNITE ESO trial and the cost associated with that. Speaker 200:17:31Now we've taken that over from GSK. And so that's why we're comfortable with the position that our overall run rate will remain relatively consistent. And that includes the fact that we've already recruited and made the investments in the commercial team in the first half of this year. And that's why we believe that that will be the cost will be broadly consistent going forward for the next 18 months. Speaker 1000:18:00Thanks, Adrian. Appreciate it. Speaker 200:18:02Cheers, Teddy. Operator00:18:06The next question comes from Greg Suvannave with Mizuho. Please go ahead. Greg, your line is open. You may now ask your question. Speaker 300:18:30Hey, good morning. Sorry about that. Thanks for taking my questions. And let me congratulate Adi and team on the approval. That's great achievement for the company and for patients as well. Speaker 300:18:42A couple of questions, if I could. Just on maybe the first question on your sales and projection of $400,000,000 I realize that's for the sarcoma franchise and I realize that's for the U. S. Any color on how we should think about between the two products that you have realizing that Lidicell is not yet approved, but how you think about potentially the split of revenue between those two products? My second question, maybe it is one that you might be reticent to comment on, but just your level of comfort with how the Street is currently modeling the launch and revenue over the next, let's call it, 6 quarters as we look at the back half of this year and 2025. Speaker 300:19:38I realize that you've been trying to guide us to be relatively gradual and how we think that's going to be. But just wondering if you had an opportunity just to see kind of where street is and whether you think we are doing a good job with that kind of more gradual approach? Speaker 200:19:59Thanks, Greg. So with respect to the breakdown of the peak U. S. Sales estimate for the launch indications for our sarcoma franchise of €400,000,000 the best way of thinking about that is that the patient split is roughly 40% of Famicel, 60% let's say, 40% TCELLRA, 60% let's say, and so the split of that peak year sales estimate is broadly speaking follows that. So on your second point, I think the key thing that we've been keen to ensure is that whatever you think the ramp up of the sales for TCELLRA is. Speaker 200:20:44And I think you'll appreciate I'm not going to comment specifically on the analyst expectations, although I am pleased to see that people have sort of been paying attention over the last 6 months or so to the opportunity here. Whatever you think that ramp up is, I think it's important to recognize that it is frame shifted by 2 to 3 months from the launch date. And that's the most important thing to get right in the short term is. And I think by and large people have done with first sales recognized in Q4 this year and those being relatively modest representing the very front end of the patients as they flow through the manufacturing, through the identification of manufacturing and then get treated in the quarter after launch. So that's the biggest thing that I think has changed. Speaker 200:21:40And I do think the analyst community has picked up on that frame shift into Q4 this year. Speaker 300:21:49Okay. Thank you. And then if I could ask one more just on Letticell. You might have mentioned this in your prepared comments, I might have missed it, but what are the gating steps for that BLA submission? And maybe just a follow-up, are you anticipating that we will see additional data on Lettucell before you file? Speaker 300:22:08Or is the data from your perspective already out there and pretty much we have what we or we have basically a view of the data that are available for the product? Thanks. Speaker 200:22:22Thanks, Greg. I'll ask Dennis Williams to comment on those questions. Dennis? Speaker 1100:22:29Yes, sure. So I would say that for Letticell, it follows the exact same regulatory pathway that we did for TESOLREP. So we need a companion diagnostic. We need to supply the clinical data from Ignite EASO, CMC information. And so basically, it will follow the exact same paradigm that we did for TCELLRA. Speaker 1100:22:54I will say that we are looking forward to presenting primary data from the IGNITE ESO trial later this calendar year. Speaker 300:23:04Okay. Thank you very much. Congratulations again on all of the achievements and progress. Speaker 700:23:09Thanks, Greg. Operator00:23:12The next question comes from George Farman with Scotiabank. Please go ahead. Speaker 1200:23:19Hi, great. Thanks for taking my questions. Just wanted to ask about the absence of MRCLS on the label for TCELLRA. Wondering what sort of conversations went on with FDA and does that really matter? Certainly, you have Letticell coming up. Speaker 1200:23:41And then also with Lettucell, I understand I believe that the product is manufactured in the U. K. Is that where commercial material will ultimately be originating from? And are there efforts underway to bring manufacturing over to the U. S? Speaker 200:24:02So I'm going to ask Dennis to talk about the label for and the data for TCELLRA from the SPEARHEAD-one trial and the MRCLS portion of that. And then I'm going to ask John Lunger to talk about the manufacturing for Lettecel for the approval and launch? Dennis? Speaker 1100:24:30Yes, sure. So I mean, we made the decision to not pursue mixed with brownfield liposarcoma as a labeled indication some time ago and it really came down to the fact that the trial, spherohead bone was overwhelmingly synovial sarcoma. So it would be challenging, I think, for a regulatory review to have such limited patient numbers. There were only 8 patients with exoat around cell liposarcoma treated in a trial. And we just thought that it would add a lot of regulatory burden to an application where we really wanted to get the approval in synovial sarcoma. Speaker 1100:25:08As you mentioned, right now that we have Letticell, this is less of a concern for us. Letticell is the MOUsO1 expression in myxoid round cell liposarcoma is much higher than MAGE A 4 expression in myxoid round cell liposarcoma. So from a target perspective, Letticell is where expression is north of 80% of that population is a much more appropriate target to pursue for that indication. And John? Speaker 1300:25:44Yes. Hi. So as far as the manufacturing of Letticel, the actual manufacturing that was primarily done for the Ignite trial was in a contract manufacturer in Germany, not the UK. So as you can imagine, our primary objective is speed to market for lettuce sell. And so making changes to the supply chain related to that particular filing is probably a risk that we don't necessarily want to take. Speaker 1300:26:08However, we are looking at adding a U. S. Site, whether that's our own or another CDMO, for the future to the Lettucell supply chain to better enable the supply into Speaker 1200:26:21the states. Great. Thanks for that and congratulations on all the progress. Speaker 300:26:26Thanks, Josh. Operator00:26:29The next question comes from Arthur He with H. C. Wainwright. Please go ahead. Speaker 800:26:37Hey, good morning team. Thanks for taking my question. So I had two questions. So first, thanks for the update on the onboarding for the ATC. But on the at the same time, just curious, could you guys give us the onboarding progress for those center of excellence for as a referral network? Speaker 800:26:59How should we think about dosing to support the launch? Speaker 200:27:05Cynthia? Speaker 400:27:07Sure. So yes, we do have a lot of activity going on with the sites that we will eventually become authorized the treatment centers and also to the sarcoma centers of excellence that will be referring patients to the future ATCs. So our field teams across both medical affairs and commercial target both the future ATCs and current ATCs and beyond. So that already that work already started in terms of educating the broader sarcoma centers of excellence into the new biomarkers, the importance of testing patients as early as possible, and then into referring the patients that are positive to both biomarkers to the treatment sites. So that work started with our field teams and we'll see these referrals already started to come in through the ATCs. Speaker 800:28:09Awesome. Thanks, Cynthia. And my second question is regarding the letter cell. So could you so is there before you guys submit the rolling submission of the BLA, do you still need to meet with the FDA? And if so, when or at what circumstance you can request the meeting? Speaker 200:28:37Dennis? Speaker 1100:28:39Yes, sure. I mean, we've already had meetings with the FDA and we will continue to have meetings with the FDA. This is really the advantage of having, in this case, Lettucell has breakthrough therapy designation. And one of the main advantages of that is to have frequent interactions with regulatory agencies. So we'll be talking about a lot of things related to the rolling submission, how the application should be organized. Speaker 1100:29:06I mean, some of this to be fair, like an earlier comment, I mean, some of what we'll do with Letticell is a bit of excuse the expression, rinse and repeat of what we did with TESOLRA. But there are definitely some things that are unique, right? There's 2 different populations in this data set. And so there and as John mentioned about the supply chain aspect, so there are some differences. But in general, I would expect to have many meetings between now and the submission of the rolling BLA next year. Speaker 800:29:41Great. Thanks, Dennis. And talk to you guys soon. Speaker 200:29:46Thanks. Operator00:29:48The next question comes from Yanan Xu with Wells Fargo. Please go ahead. Speaker 700:29:56Hi, thanks for taking our question. Congrats on the progress. This is Quan on for Yanan. So can you share with us the overall timeline from patients screening to the infusion? Like roughly how long does it take? Speaker 700:30:09And which part of the process can be accelerated? Thank you. Speaker 400:30:17Cynthia? Sure. So the timelines between patient screening and infusion over time, the testing can take a few weeks if you do both tests in parallel. And then from the time in which the a freeze take place all the way into the infusion can be received back into the site to the patient, it takes about 30 days. At the beginning of this process, because the testing just got approved and we have to go also through reimbursement journey and the referral pattern from the beginning, we believe that the first patient is going to take a little bit longer until the whole process can get more on a faster pace. Speaker 400:31:06And so that's why we are anticipating to be able to treat our first patients in the Q4 of the year. Speaker 700:31:14Got it. Thank you so much for that. And when do you expect to have broad payer coverage? Thank you. Speaker 400:31:23So right now, in terms of Medicare, we already have it's already available. It's covered for commercial patients. We expect similar coverage than what we see for CAR Ts. At the beginning, it usually is through a single case negotiation with the payers until a policy is established, but it doesn't mean that we book have coverage, only that it can take a little bit longer because it will be through single case agreements and fewer is established moving forward. So we expect to have good coverage at the beginning. Speaker 400:31:58It may take just a little longer. Speaker 700:32:02Scott, thank you so much for all the colors. Thanks. Operator00:32:08The next question comes from Michael Kim with SAC Small Cap Research. Please go ahead. Speaker 1400:32:15Hey, everyone. Good morning and thanks for taking my questions. First, just assuming similar pricing and penetration rates for GCELLREN and Letacell, My math suggests peak sales of $400,000,000 translates into roughly about a 50% to 55% market penetration rate. So just wondering if you could maybe provide some color on sort of the underlying drivers behind your thinking? Operator00:32:48Cynthia? So a couple of thoughts. So first, Speaker 400:32:51I think that the penetration rate for Ladicell is hopefully going to be faster. So the uptake faster because a lot of the treatment sites will be opened and have experience with the testing and with having the patients being referred to and treated. So I would expect that to be greater. The assumption in terms of potential number of patients is given more so by the eligibility based on HLAH2 and then the MAGE A 4 and the NY ESO expression in both tumor types. And then the assumptions beyond that are really mostly assuming similar access rates than other products in the space and similar manufacturing success rates as we've seen in our clinical trials. Speaker 1400:33:50Got it. Okay, that's helpful. And then maybe just second question, Appreciate your updated guidance on expenses over the next 18 months. And I know you guys have done a good job in terms of scaling up your sales infrastructure ahead of TCELLRA approval. But just curious if your guidance Speaker 1100:34:18So Speaker 200:34:21So maybe I'll cover that briefly. So we've not included in that expense guidance the things that the revenue sources that offset expenses in that context. And you'll look back on our filings and you'll see that there are elements for both partnership income and R and D tax credits and things like that that offset those expenses. So that's not included. In terms of the timing, we've not updated beyond what we said at the time of the partnership with Galapagos, which is that we anticipate going into the clinic in head and neck just soon as humanly possible and that we're working with Galapagos to enable that. Speaker 1400:35:25Understood. Thanks for taking my questions. Speaker 200:35:28Thanks. Operator00:35:30The next question comes from Peter Lawson with Barclays. Please go ahead. Speaker 700:35:37Hey, good morning. This is Alex on for Peter. Thank you for taking our questions. You previously talked about the possibility to do an interim analysis in the SURPASS-three study. Just wondering if you could remind us kind of the timing for that and the gating factors for that in the study? Speaker 200:35:59Elliot, do you want to talk about interim reads on Sarsapar? Speaker 1400:36:05Yes, just very briefly. I mean, we do anticipate interim analyses that are built into the trial at certain junctures, the first one being after 13 patients are dosed in each arm. We have not provided specific guidance as to the timeline for that. But I also want to just advise that when we see that interim analysis, it will not lead us to disclose clinical data until the entire study has been enrolled in that it has the potential to be registration enabling and we wouldn't want to put out clinical data that could bias the trial. Speaker 200:36:47That enrollment, full enrollment we anticipate happening next year. Speaker 700:36:53Great. Thank you. Thanks. Operator00:36:58This concludes our question and answer session. I would like to turn the conference back over for any closing remarks. Speaker 200:37:05Thank you everyone for your time today and your questions. We look forward to updating you as we progress the launch of TESARRA and of course the development of the rest of the pipeline to redefine how cancer is treated with cell therapies. Please don't hesitate to follow-up if you would like to discuss anything further and have a great day. Cheers. Operator00:37:28The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.Read morePowered by