Hello, and welcome to the Adaptimmune Therapeutics conference call to review its recent approval of Tecelra. As a reminder, all participants are in listen-only mode, and the conference is being recorded. After the presentation, there will be an opportunity to ask questions. To join the question queue, you may press star, then one on your telephone keypad. Should you need assistance during the conference call, you may signal an operator by pressing star, then zero. I would now like to turn the conference over to Dan O'Connor, Investor Relations for Adaptimmune. Dan, please go ahead.
Thank you, Operator. Hello and welcome to our conference call to discuss the recent announcement regarding approval of Tecelra by U.S. FDA. I would ask you to review the full text or forward-looking statements from our 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 Rawcliffe, 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&A. With that, I'll turn the call over to Adrian. Ad.
Thanks, Dan. And thank you, everyone, for joining us. Yesterday, we received notification that afami-cel, now Tecelra, has received accelerated approval from the FDA. This is a watershed day for Adaptimmune, for the cell therapy field, but most importantly, for the sarcoma community, and in particular, for people with synovial sarcoma. Tecelra is Adaptimmune's first commercial cell therapy product. It's also the first engineered cell therapy product approved by the FDA for a solid tumor cancer, and it's the first new treatment option for synovial sarcoma in well over a decade. We're honored to be joined on this journey by the patients, the caregivers, the clinical investigators, and their teams who participated in the SPEARHEAD-1 trial, and also by our partners and the ultra-dedicated colleagues here at Adaptimmune who have worked tirelessly with endless determination to bring Tecelra through a decade of groundbreaking R&D to this point of approval.
People with synovial sarcoma are frequently afflicted with the disease as young adults. They suddenly face a diagnosis for a rare, devastating cancer before they turn 30. Adaptimmune has developed a novel, cutting-edge, clinically impactful, one-time infusion treatment option, Tecelra. Today is the day we redefine how this cancer can be treated, and we are extraordinarily proud of this achievement. Tecelra is positioned to make a significant impact in the lives of people with synovial sarcoma. We are already in the process of onboarding sarcoma centers of excellence at authorized Tecelra treatment centers. We aim to onboard 30 ATCs over time, and we believe this will allow us to supply Tecelra to every eligible U.S. patient. Following market access research and discussion with payers, Tecelra will launch at a list price of $727,000.
We've stood up a patient support program we call Adaptimmune Assist, which aims to provide end-to-end support, ensuring a seamless, personalized experience throughout the treatment journey. And you know we've built Adaptimmune from the ground up as a fully integrated cell therapy company, complete with our in-house manufacturing. We manufactured every single dose of afami-cel for the SPEARHEAD-1 clinical trial in our manufacturing facility here at Philadelphia Navy Yard over the five years of the trial. And we've recently bolstered our manufacturing capabilities, and we stand ready to deliver all ordered doses of commercial Tecelra. Beyond Tecelra, we are dedicated to advance our clinical pipeline to bring cell therapies to more people who need them. We're planning to progress lete-cel, the next product in our sarcoma franchise, with a rolling BLA submission to the FDA next year.
We're also developing our next-generation cell therapy, uza-cel in ovarian cancer, in a potentially registration-enabling SPEARHEAD-3 trial. Adaptimmune was founded on the conviction that cell therapy would revolutionize the treatment of cancer. This has been demonstrated in the hematological cancer space, and Tecelra's approval is a significant milestone in our journey to expand cell therapy into solid tumors. With that, I and members of the leadership team here are happy to take any questions.
Thank you. We'll now begin the question and answer session. To join the question queue, you may press star, then one on your telephone keypad. You'll hear a tone acknowledging your request. If you're using a speakerphone, please pick up your handset before pressing any keys. To withdraw your question, please press star, then two. Our first question is from Marc Frahm with TD Cowen. Please go ahead.
Hey, thanks for taking my questions, and congratulations on getting the first approval. A big accomplishment for any company, particularly in this space of cell therapies. Maybe just first, can you just kind of remind us the timeline from here to actually being able to recognize revenue? Obviously, there's a whole multi-step process to actually getting to an infusion. But then also, have you had any ability to kind of maybe warehouse some patients getting cells already harvested that you can kind of now, with the approval in hand, convert over to the commercial process? Or does everybody have to start completely from scratch for that entire process?
So actually, what I'll do is I'll ask Cintia to talk about the patient journey, and then I'll come back to what that means for revenue recognition at the end. Cintia, our Chief Commercial Officer.
Thank you for the question. That's exactly what we are doing right now. In the process of onboarding the sites, we do expect patients to be tested, to start to be tested right now, and go through their journey starting immediately. It will take some time until we get the revenue recognition. We know that there's a lot of anticipation and excitement, and as soon as the treatment sites get onboarded, we'll be able to see the orders coming through.
The impact of that is that we anticipate first commercial sales in Q4 this year. Those will obviously be modest because it's the front end of the curve, and we'll see increasing sales as we move into 2025.
Okay. Very helpful. And then just in terms of disclosures, as you kind of onboard and get towards that 30 ATCs actually active, able to administer commercial therapy, just what's kind of the disclosure strategy there? Do you plan on disclosing when the first center is fully authorized, not until you get to the next earnings? Just what's the plan there?
Yeah. So I'll ask Cintia to comment on what we're going to see in terms of as we onboard centers, starting immediately with the centers that are in process. Then I'll wrap up now with the discussion that we will have more to say about what we're going to be doing from a metrics perspective in our Q2 call in about a week's time. Cintia, do you want to talk about the immediate centers?
Yes. So we are in the process of onboarding the 6-10 treatment sites that we are planning to have fully activated in the next few months. We have a locator tool that will be available in our website, so that information will be public immediately. We already have a few sites that are going to be up and available at that locator tool. Hopefully, we're going to be able to see that even today publicly. And as more sites get in that onboarding process, they will be visible so then patients can look it up and be able to reach out to them as well. One important thing to keep in mind is that the testing was approved also at the same time that Tecelra was approved, and they are available as well. So the patients don't need to go to a treatment center to be tested.
They can get tested anywhere, and the testing is already available too. So that journey can start right away.
Great. Thank you. Congrats again.
Thanks, Mark. Cheers.
The next question is from Michael Schmidt with Guggenheim. Please go ahead.
Hey, guys. Good morning and congrats from me as well. Great accomplishment. Just a quick housekeeping question. So there are some minor differences in response rate and duration of response in the label versus the Lancet article. Could you just comment on any differences there in the analysis, perhaps?
Certainly. I'm going to ask Dennis Williams, head of our late stage, who led the development and approval of Tecelra, to comment on that. Dennis.
Yep. Sure. So during the FDA review of this application, they've requested some additional analysis, including independent review analyses. Those analyses resulted in actually a higher response rate because some additional patients were identified as having response by independent review. Additionally, that analysis identified some patients that were determined now to be complete responses when previously they were determined to be partial responses. With these additional responders, it did affect the median duration of response because some of these patients, their response durations were not greater than 6 months. The responses were very consistent to the Lancet article where the proportion of patients that have responses 12 months or longer is 39%. You can see what's in the prescribing information that these responses were quite durable with some patients ongoing in response up to year 3 at the data cut.
Okay. Great. Super helpful. Thanks for that. And then, yeah, so thinking about sort of the early launch, do you have a sense of how many patients are seen in these initial 6-10 ATCs? And related to that, generally, how would you characterize physician awareness of the therapy, perhaps outside of your clinical trial sites? And how quickly do you anticipate NCCN guideline inclusion, for example, would you expect it to be a driver for uptake next year? Thanks.
Okay. So let me address your questions. So I'll start with the last one, from an NCCN perspective. We have approval. We will wait to see and hope to have it revised as soon as possible. So we're looking forward to that. With the treatment sites that we are onboarding, the majority of them have been clinical trial sites. So they have been working with afami-cel from the beginning of the clinical program and are now in the process of getting ready to make it available in the commercial setting as well. So in terms of awareness and understanding how the patients need to be tested and treated, it's very high. We also have onboarded our commercial and medical affairs field teams.
So they have been already engaging with sites beyond the clinical sites to communicate all the information that they need to know about testing and also about Tecelra. So the awareness is very good on the treatment sites and will increase over time now with the approval.
Great. Thanks. Maybe just one more, just following up on a prior question. I know the manufacturing time itself is very short for afami-cel, but yep, how long would you estimate it would take from a patient initially receiving the test, the antigen test, to actually being able to recognize sales for that patient? Is it a few weeks, a few months? How would you estimate that?
We're basically encouraging people to think about a 3-month from approval to first registration or first recognition of revenue. That will put it into Q4 this year.
Super helpful. Thanks so much, and congrats again.
Thanks, Michael.
The next question is from Tony Butler with Rodman & Renshaw. Please go ahead.
Good morning. Thank you. First of all, again, much like the others, congratulations, Adrian, to you and the team. Two questions for Cintia. One is, how roughly, how long does it take to onboard a site? And the second question is, with the commercial team available today, what do they actually do today given that the 6-10 sites are currently being onboarded? Thank you.
So the field teams are very engaged in not only helping to onboard the sites because this is part of what they work closely with the sites that will become treatment sites, but also engaging with other centers of excellence in sarcoma to make them aware of the availability of biomarkers that are now actionable in synovial sarcoma and also educating them on the clinical profile of afami-cel so then we can identify patients beyond the treatment sites, have these patients tested, and then referred to the treatment sites. The onboarding process that we put together is fairly simple. We started this onboarding already a few months ago. There are activities that are on our side and some activities that are on the site side. It depends a little bit on each site.
We are very close to have sites fully activated, and we will already have a few sites that are in the final stages of just now that we got approval being receiving the final activation. Their names will be already up in the locator tool very soon. So then patients will know where to go if they want to go directly to a treatment site. As we have more ATCs that are going to be getting closer to that point, their names will also be available there.
Thank you.
Thanks, Tony.
The next question is from Jonathan Chang with Leerink Partners. Please go ahead.
Hi guys. Congrats on the approval, and thanks for taking my questions. First question, how should we be thinking about the Tecelra early launch? What could that look like? I know you guys have given your thoughts on peak sales. How should we be thinking about the early ramp? And then second question, do you guys have updated cash runway guidance post the announcement today and the recent Galapagos deal? Thank you.
So on the launch dynamics, I think we've sort of talked about the number of centers we have up and running. When we talk in Q2, we'll talk a little at the Q2 call about a week's time. We'll talk a little bit more about how we're thinking about some of the metrics that we're going to be tracking. And so I'd encourage you to wait for that. With respect to earnings guidance, runway guidance, etc., we'll also cover that in the Q2 call. Obviously, since the last Q, we've not only taken on board the debt deal with Hercules Capital, we've also done the deal with Galapagos, and we will update appropriately at the Q2 call.
Got it. Thanks for taking my questions.
Thanks, John.
The next question is from Graig Suvannavejh with Mizuho. Please go ahead.
Hi, this is Sam Slutsky for Graig Suvannavejh. Congrats again on the approval, and thank you for taking our questions. Maybe just some quick ones on my end. How should we be thinking, I guess, about gross-to-net and price increases if you had any guidance there? And then also maybe any updates on timelines for Europe for afami-cel as well?
So I'll take the European one, and then I'll ask Cintia to comment on thinking on gross-to-net , etc. So with respect to Europe, I think over time we are committed to bring the benefits of cell therapy, Tecelra, and the rest of our pipeline to as many patients as possible. But for the moment, our focus is on the U.S. commercialization and launch and will be for some time. So that's the singular focus of this organization at this point in time and in the coming months. And Cintia, do you want to comment on growth in that?
Yeah. From gross-to- , we expect that it will be similar to other cell therapies. We're not contracting at this point in time. So just regular and traditional discounts, and so probably about between 8%-10%.
Got it. Thank you so much. And congrats again.
Thanks, Sam.
The next question is from George Farmer with Scotiabank. Please go ahead.
Hi, good morning. My congratulations as well. I was wondering.
Thanks for coming.
Is it possible to prospectively identify patients prior to being eligible for therapy? Does MAGE-A4 expression change over time and the like, just to get them ready for treatment when they ultimately will need it?
Thank you.
So we don't know for sure if the MAGE-A4 expression changes over time. We don't have any data to support that, but we do support and emphasize the ability to treat patients early in their journey, and so they can plan for a treatment plan that is the most appropriate for the patient. We have the companion diagnostic from Agilent that just got approved today. So from a commercial test that is going to be available that is IHC-based, it got approved today, and it will be broadly available as we speak so that journey can start.
Do you want to say anything about HLA testing as well?
HLA testing is more broadly available. We do have a companion diagnostic that also got approved yesterday, last night, in fact. But the HLA typing then, that doesn't change over time. That's something that is a characteristic of the patients.
Okay. Great. And with regard to price, what went into the thinking about the appropriate price for this therapy?
So we determined the price of Tecelra based on the clinical value that it brings to patients that have a rare type of tumor and with a very high unmet need. We provide the very strong clinical efficacy with a single dose, and that's also very different than traditional therapies, in particular in the synovial space where there has been no innovation in the past several years.
Okay. Great. Thanks again, and congratulations.
Thanks, George.
The next question is from Arthur He with H.C. Wainwright. Please go ahead.
Hey, Adam. Thank you. Congrats. And I have two questions. So, regarding the FDA's requirement for the confirmatory evidence to convert these to a full approval, is there additional information you can provide to us? Is that a Cohort 2 data or a successful requirement?
Thaddeus, do you want to talk to that?
Yeah, sure. So like we have previously communicated, the confirmatory evidence plan really is around the ongoing SPEARHEAD-1 trial. So we have both Cohort 2 data, and we actually have a Cohort 3 as well. Essentially, those cohorts are nearly identical, and they're both treating the synovial sarcoma patient population. And essentially, those two groups pooled comprise the confirmatory evidence, which we will submit to the FDA next year to complete that obligation and convert this application to regular approval.
Oh, great. Thanks, Sam. And my second question is regarding the label expansion for afami-cel. Could you give us some status update on the SPEARHEAD-3 study, and when can we expect the data?
SPEARHEAD-3 is early in its development, the pediatric trial. So that trial is currently recruiting, and we do not expect full data for that for some time. We certainly could give further updates on that. Ultimately, if that data shows that we see the very similar efficacy in the pediatric population of synovial sarcoma, we would look to extend the indication statement down to that age range.
Very helpful. Thanks again for taking my question, and congrats.
Cheers, Arthur.
The next question is from Ted Tenthoff with Piper Sandler. Please go ahead.
Great. Thank you very much, and congratulations. Great day for patients. A lot of the questions have been answered, but yeah, absolutely. So I wanted to ask about CMC and manufacturing. I know this has been an intense focus for the company. Was there anything in there in terms of release specs or anything like that that we should be aware of or that came as a surprise? What do you guys envision as potential out-of-spec? Thank you.
I'm going to ask John Lunger, our Chief Patient Supply Officer, to take you through that. John?
Yeah. Thanks for asking. So on the specifications, no surprises there. The specifications for the drug product are consistent with what we measured against in the Spearhead trial. And really, there's nothing that we have at the moment that tells us that our out-of-spec rate should be markedly different, if at all, from what we saw in Spearhead, which was about 90%.
Great. Thank you.
Cheers, Ted.
The next question is from Yanan Zhu with Wells Fargo Securities. Please go ahead.
Hi. Congrats on the approval. This is Quan Wan for Yanan Zhu. Two quick questions from us. First is on the box warning of CRS. When you engage with physicians, is this a concern of physicians and any colors you got from the physicians? And second is on the enrollment in Cohort 2 and 3 of SPEARHEAD-1. Can you share with us the enrollment status and when we may see the data? Thank you.
Certainly. So I will ask Elliot Norry, our Chief Medical Officer, to comment on physicians' reactions to the black box warnings. And then Dennis to comment on the status of the other cohorts in SPEARHEAD. Elliot.
Yeah. Hi. As it relates to cytokine release syndrome in the black box warning, the physicians that are going to be treating patients with Tecelra are very well versed in identifying and managing cytokine release syndrome. The means by which to treat it are good, particularly with IL-6 inhibitors. I don't think that it represents any hesitation from the standpoint of a treating physician as it relates to using this product.
Yeah. Hi, this is Dennis Williams again. So for Cohorts 2 and 3, so Cohort 2 has been completely recruited, and all the patients have been treated, and they're currently in follow-up. Similarly, for Cohort 3, we expect recruitment to close. The last patient treated this summer. But essentially, that cohort is also nearly finalized in its treatment journey. Since the responses to afami-cel can be the duration of response can be quite long, what we have agreed with the FDA is to take a data cut 15 months after the last patient is treated in Cohort 3. So we expect that data cut to occur mid-next year, at which point we would present the data, and then we would subsequently file with the FDA, as I mentioned earlier, to convert the application from accelerated to regular approval.
Got it. Thank you so much for the comments.
Thanks, Quan.
The next question is from Peter Lawson with Barclays. Please go ahead.
Hey, good morning. This is Alex for Peter at Barclays. Thank you for taking the question, and congrats on the approval. I was curious if there was any updated or new thinking around potential expansion opportunities into earlier lines, other HLA types, or other sarcomas for afami-cel or a next-gen product.
Certainly. So I think the short answer is that I think there's a lot of potential over time to expand the use of our sarcoma franchise products. So that's Tecelra and potentially lete-cel in a couple of years' time into geographically, as we've talked about already on this call, in terms of line of therapy, potentially in terms of other MAGE-A4 expressing sarcomas. The opportunities are significant. However, what I do want to say is that our focus at this point in time is very much on delivering Tecelra for patients with synovial sarcoma who really need it, and that's going to be the focus over the short period of time.
And furthermore, the sales projections that we've made for our sarcoma franchise, I want to be really clear, all of the expansion opportunities is in addition to the sarcoma franchise opportunity that we see at about $400 million peak sales in the United States in the launch indications only. So I think whilst there are lots of opportunities to go forward, our focus in the short term, as I'm sure you would expect, is on let's deliver Tecelra to patients who need it.
Yep. Makes sense. Thank you. And then maybe just another quick one on lete-cel on the BLA. Anything you can say in terms of timing here of when you could initiate that rolling BLA and if there are any other sort of complexities or differences from an afami-cel that we should keep in mind with respect to the BLA? Thank you.
So I think at a very high level, the differences are that lete-cel has a different supply chain. It's a third-party supply chain and will require a companion diagnostic specific for its target NY-ESO-1, so as opposed to the target for Tecelra and MAGE-A4. And so those two things are likely to be amongst the gating items for us initiating a rolling BLA, which we're working on, as you can imagine, at full speed. And we anticipate that rolling BLA starting in 2025. And that's what we've said. Okay.
This concludes the question and answer session. I'd like to turn the conference back over to Adrian Rawcliffe for any closing remarks.
Thank you, everyone, for joining us on the call today. Thank you for your questions. But I think most of all, thank you for your support. There's a lot of familiar faces on this call. I think thank you for your support over the years to deliver this groundbreaking cell therapy. Now, as I said in response to repeated questions over the past half an hour, we turn our attention to making Tecelra the first engineered cell therapy approved for a solid tumor available to people with synovial sarcoma. Thank you very much. Have a good day.
This brings to a close today's conference call. You may disconnect your lines. Thank you for participating, and have a pleasant day.