Q1 2024 Adaptimmune Therapeutics plc Earnings Call
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Operator: This conference is being recorded. All participants, please stand by. Your conference is ready to begin. Good morning, ladies and gentlemen, and welcome to the Adaptimmune Q1 2024 Financial and Business Update Conference Call. I would now like to turn the meeting over to Ms. Juli Miller. Please go ahead, Ms. Miller.
This conference is being recorded so it's closer to home that don't go as you see.
Speaker Change: All participants please standby your conference is ready to begin.
Speaker Change: Good morning, ladies and gentlemen, and welcome to the adapting your Q1 2020 financial and business update conference call I would now like to turn the meeting over to MS. Jody Miller. Please go ahead Mr. Miller.
Speaker Change: Good morning, and welcome to our conference call to discuss our first quarter 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.
Juli P. Miller: Good morning and welcome to our conference call to discuss our first quarter 2024 financial results and business updates. I would ask you to review the full text of our forward-looking statements in 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 Rawcliffe, our Chief Executive Officer, is here with me for the prepared portion of the call, and other members of our management team will be available for Q&A. With that, I'll turn the call over to Adrian.
Speaker Change: Several factors, including those outlined in our latest filings with the SEC Adrian rock with our Chief Executive Officer is here with me for the prepared portion of the call and other members of our management team will be available for Q&A.
Speaker Change: I'll turn the call over to Adrian add.
Adrian G. Rawcliffe: Thanks, Jamie and thanks, everyone for joining us for our Q1 cool trends.
Adrian G. Rawcliffe: Thanks, Julie. And thanks, everyone, for joining us for our Q1 call. I plan to provide some brief comments before we go into Q&A. The comments are going to be brief because, a couple of weeks ago, we held an Investor Day, and we provided a fairly comprehensive update on the regulatory status of Opamacar as we move towards the PDUPA date of the 4th of August. And we also talked about how important this is for the field as the first approved engineered TCR T-cell therapy for a solid tumor indication.
Adrian G. Rawcliffe: To provide.
Adrian G. Rawcliffe: Some brief comments before we go into Q&A. The comments are going to be brief because a couple of weeks ago, we held an investor day.
Adrian G. Rawcliffe: We provided a fairly comprehensive update on the regulatory status of our pharma so as we move towards the <unk> date.
And we also talked about how important they say it's for the field as the first approved engineered TCR T cell therapy for solid tumor indications.
Adrian G. Rawcliffe: We also discussed our preparations for the commercial launch of assignments out in some detail.
Adrian G. Rawcliffe: We also discussed our preparations for the commercial launch of Ofamacel in some detail. We said that we'd be ready to do this on approval of Ofamacel and that this would be the beginning of a commercial sarcoma franchise that we feel has significant and underappreciated value. In this morning's press release, we provided a further update on the BLA progress, and our head of late-stage development, Dennis Williams, is here for the Q&A portion of this call.
Adrian G. Rawcliffe: Said that we'd be ready to do this on approval of beside myself and this would be the beginning of a commercial sarcoma franchise that we feel has significant.
Adrian G. Rawcliffe: Underappreciated value.
Speaker Change: In this morning's press release, we provided a further update on the BLA progress and head of late stage development that is Williams is here for the Q&A portion of this cool.
Adrian G. Rawcliffe: In short, our interactions with the FDA are progressing as planned, and we're looking forward to our late cycle review meeting in the second half of this month. Thus far, the FDA has not requested an Adcom or a rems.
Speaker Change: In short <unk>.
Speaker Change: Our interactions with the FDA are progressing as planned and we're looking forward to a late cycle review meeting in the second half of this month.
Speaker Change: Thus far the FDA has not requested the last call.
Speaker Change: A rems program.
Speaker Change: We look forward to the labeling discussions and also to commercialization in due course and I'm happy to confirm that.
Adrian G. Rawcliffe: We look forward to the labeling discussions and also to commercialization in due course. And I'm happy to confirm that our customer-facing commercial and MedAffairs team is now fully in place. Cintia Piccina, our Chief Commercial Officer, is here for the Q&A as well.
Speaker Change: Customer facing commercial and Med affairs team now fully in place.
Speaker Change: Cynthia Ciena, our chief commercial officer is here for Q&A as well.
Speaker Change: As I said, we are on track to be ready to launch on approval. We have a focused team starting at 6% to 10 treatment centers and ramping up to approximately 30 in vehicles and if you revisit the investor day presentation by Dr. <unk>, which is available on our website you will see that.
Adrian G. Rawcliffe: As I said, we are on track to be ready to launch on approval. We have a focused team, starting at six to 10 treatment centers and ramping up to approximately 30 in due course. And if you revisit the Investor Day presentation by Dr. Mihaela Druta, which is available on our website, you will see that the expectations and anticipation for FAMICEL within the sarcoma community are very high. I think that sense of anticipation was reinforced by Philip Leider, a patient advocate and president of the Sarcoma Alliance, who lost his sister to sarcoma. He, I think, very eloquently highlighted the demand for novel therapies in this space.
The expectations in anticipation for a panel so within the sarcoma community.
Speaker Change: Very high.
Speaker Change: I see.
Speaker Change: That sense of anticipation was reinforced by our affiliate.
Speaker Change: Filipe Leite, our patient advocacy and president of the Sarcoma Alliance, who lost assistant to South Carolina, and he I think very eloquently highlighted the demand for novel therapies in this space.
Adrian G. Rawcliffe: So we are scaling our manufacturing to be able to meet what we anticipate to be the launch volumes for Afamacel in the second half of 2024. And, in summary, all is on track for the launch of FAMAS L1. And that's expected around our PDUFA date in August, and it's highly anticipated by the sarcoma community. And obviously, we are very eager to get this product into the hands of this community that has worked so hard with us over the last decade to develop medicines for sarcoma.
Speaker Change: So we are scaling up manufacturing to be able to meet what we anticipate to be the launch volumes for a farmer selling in the second half of 2024.
Speaker Change: And in summary, all is on track for famous for the launch of Amazon on the approval.
Speaker Change: And that's expected to round off a <unk> date in August and is highly anticipated by the soft guide of the community and obviously, we are very eager to get this product into the hands of this community that has worked so hard with us over the last decade to develop medicines to soft guidance.
Speaker Change: Behind the found itself. We are also progressing the development of let yourself at a point you towards a presentation of the interim data analysis from the pivotal.
Adrian G. Rawcliffe: Behind the famocelle, we are also progressing the development of leticelle, and I'll point you towards a presentation of the interim data analysis from the pivotal IGNITE-ESO trial in cyanobial sarcoma and MRCLS that we previewed at a high level last year. These data look very similar to a FAMISL, other than, of course, they are in both synovial sarcoma and myxoid round sunlitis sarcoma, and will be presented at a platform presentation at ASCO by Dr. Sandra D'Angelo, will be an important milestone for people's understanding and the de-risking of this cell therapy as we continue to move towards having a BLA in place in 2025 with anticipated approval for letucel in sinovial sarcoma and MRCLS in 2026.
Speaker Change: E site trial inside now Youll start, Thailand, MRC or less that we previewed at a high level last year.
Speaker Change: These data look very similar to our Fi myself other than of course, they are in both synovial sarcoma and Myxoid round, so lots to talk high level.
Speaker Change: And that will be presented at a platform presentation at ash.
Speaker Change: Thank you Angela.
Speaker Change: This.
Speaker Change: There will be an important milestone for peoples understanding and the derisking of the cell therapy as we continue to move towards having a BLA in place in 2025 with anticipated approval for let yourself in synovial sarcoma, and MLC or less in 2026.
Speaker Change: You have to stay at a level of press releases. This morning announcing that we've secured up to 125 million in debt financing with Hercules capital with the first tranche of $25 million available on closing.
Adrian G. Rawcliffe: You'll have seen another press release from us this morning announcing that we've secured up to $125 million in debt financing with Hercules Capital, with the first tranche of $25 million available on closing and an additional $25 million available on FAMASL approval. In addition, you will have seen that in Q1, we raised approximately $30 million off the ATM based on significant inbound inquiries. We've taken these steps to secure our financial position and have a cash runway into late 2025.
Speaker Change: And.
Speaker Change: An additional $25 million available on our by myself approval.
Speaker Change: In addition, you will have seen that in Q1, we raised approximately $30 million off the ATM based on significant inbound inquiries.
Speaker Change: We've taken the steps to secure our financial position and have cash runway into late 2025 and with this one way.
Adrian G. Rawcliffe: And with this runway, we have the funds necessary to execute on our priorities. The Lord shall not fail us all, followed by Letucel, and also executing on the other pipeline projects, such as the phase 2 trial with Usacel for platinum-resistant ovarian cancer, and Gavin Wood, our Chief Financial Officer, is here for the Q&A as well. So with that, I'd like to turn it over to the operator for questions. Operator? Thank
Speaker Change: We have the funds necessary to execute on our priorities the launch of a fan myself.
Speaker Change: I'll note by let yourself and also executing the other pipeline projects such as the Phase II trial would you use yourself for platinum resistant ovarian cancer.
Speaker Change: Gavin Wood, our Chief Financial Officer is here for Q&A as well.
Speaker Change: So with that I'd like to turn it over to the operator for questions operator.
Operator: Thank you. We will now take questions from the telephone lines. If you have a question, please press Star 1 on your device's keypad. You may cancel your question at any time by pressing Star 2. Please press star 1 at this time if you have a question. There will be a brief pause while participants register their questions. Thank you for your patience. Our first question is from Jonathan Chang from Leering Partners. Please go ahead.
Speaker Change: Thank you, we'll now take questions from the telephone lines.
Speaker Change: Do you have a question. Please press star one on your devices keypad you.
Speaker Change: <unk> sold your question at any time by pressing star two.
Please press star one at this time, if you have a question.
Speaker Change: That will there be follow small participants, but just a quick question.
Speaker Change: Thank you for your patience.
Speaker Change: Our first question is from Jonathan Chang from Leerink Partners. Please go ahead.
Speaker Change: Okay.
Speaker Change: Hi, guys. Thanks for taking my questions.
Jonathan Chang: Hi guys, thanks for taking my questions. First question, can you talk about the impact of the debt agreement announced today on your cash runway guidance? I'm just trying to better understand what's assumed in the current.
Jonathan Chang: First question can you talk about the impact of the agreement announced today on your cash runway guidance I'm, just trying to better understand what's assumed in the current guidance.
Jonathan Chang: So.
Jonathan Chang: Gavin.
unknown: Thank you.
Gavin Hilary James Wood: Yeah, Hi, Jonathan so.
Gavin Hilary James Wood: Yeah, hi Jonathan. So a number of things have changed since we last gave guidance at the start of the year. Clearly, we have the termination of the Genentech agreement, and we're still working through the terms of that termination agreement. We've made significant progress on Famicel and the broader development of the broader sarcoma franchise. As Ad just mentioned, we've raised money under the ATM, and we've also executed a new debt facility at Hercules. Putting all those moving pieces together, we thought it prudent to bring in our cash runway by about a quarter to late 2025.
Speaker Change: Number of things have changed since we last gave guidance starts as of yet clearly at the termination of the Genentech agreement and we're still working through the terms of that termination agreements.
Speaker Change: We've made significant progress on that.
Speaker Change: Myself and the broader development of the broader sell kind of a franchise.
Gavin Hilary James Wood: Got it. And what assumptions are there for how much of the debt is being drawn down?
Speaker Change: That's just mentioned besides money under the ATM and we've also excuse me debt facility with Hercules, putting all those moving pieces together are we.
Speaker Change: We felt it prudent bringing.
Speaker Change: That's why I'm like well I pass the call to like 2025.
Speaker Change: Got it.
Speaker Change: What what assumptions are there for how much of the debt.
Speaker Change: Being drawn down.
Gavin Hilary James Wood: We drew down 25 close, 25 million close, and there will be 25 million available at the PDUFA date.
Speaker Change: We drew down 25 cloud is 25 million plus and $25 million available at that particular date.
Speaker Change: Got it.
Adrian G. Rawcliffe: Got it. And then, second question, can you help set expectations for the upcoming ASCO IGNITE event presentation? Thank you.
Speaker Change: And then second question just can you help set expectations for the upcoming <unk> ignite.
Speaker Change: Ignite presentation. Thank you.
Speaker Change: Yeah.
Speaker Change: Dennis do you want take that.
Adrian G. Rawcliffe: Yes, sure. For the ASCO presentation, we're going to be presenting results from the intramenalysis of the Pivotal Ignite ESO trial. So this is 45 patients in that trial, followed for at least six months. It's evenly comprised of patients with synovial sarcoma and mixed root brown cell, lapar sarcoma, and will present the efficacy data and safety data that were available at that interim analysis.
Dennis: Yes, sure so for the <unk> presentation, we're going to be presenting results on the interim analysis.
Jonathan Chang: Got it. Thanks for taking my questions.
Dennis: The pivotal ignite ESO trial. So this is a 45 patients in that trial followed for at least six months.
Dennis: Only comprised of patients with synovial sarcoma, and Myxoid round, so labor sarcoma. So.
Dennis: We will present, the efficacy data and safety data that were available at that interim analysis.
Speaker Change: Got it thanks for taking my questions.
Speaker Change: Uh huh.
Operator: Thank you. The following question is from Marc Frahm from TD Cohen. Please go ahead. And thanks for asking the questions.
Speaker Change: Thank you.
Speaker Change: Following question is from Marc Frahm from TD Cowen. Please go ahead.
Marc Alan Frahm: Hi, Thanks for taking my questions, maybe just first.
Marc Alan Frahm: Thanks for giving the questions. Maybe just first, you know, like what you're giving these details along the way of the FDA review and, you know, the late cycle review meeting coming up. Can you kind of review what your closure strategy is going to be around some of the information that may be conveyed or gleaned by you guys at that meeting?
Speaker Change: Like did you give any details along the way.
Speaker Change: The FDA review.
Speaker Change: The late cycle review meeting coming up.
Speaker Change: You can review what your goals your strategy, it's gonna be around some of the information that may be.
Speaker Change: Conveyed or green, but you guys are at that meeting.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Yeah.
Speaker Change: So what why did I take a stab at that.
Adrian G. Rawcliffe: So, why don't I take a stab at that? We're actually running pretty hard towards the late cycle review meeting and the discussions on labeling that we anticipate and on post-marketing commitments. You know, we're going to be focused on that in the run-up to the PDUFA date, and I think if there's anything material that comes out from that, we will be disclosing it; otherwise, we're pushing hard for the discussions with the agency and getting to PDUFA and then being able to launch.
Speaker Change: So we are actually running pretty hard towards the late cycle review meeting and the <unk>.
Speaker Change: Discussions with our labeling that we anticipate kind of post marketing commitments.
Speaker Change: We are going to be focused on what's in the run up to the due date.
Speaker Change: And I think there is anything material that comes out from that we will be disclosing otherwise.
Speaker Change: <unk> hard for.
Speaker Change: The discussions with the agency and getting to do for them and being able to launch.
Speaker Change: Okay, and then as you get into the Woodlands, which is I mean, what do you what.
Dennis Williams: Okay, as you get into the labeling sections, I mean, what do you view as the major questions that need to be answered about, you know, indications and things like that, and things to include or not include in the labeling?
Speaker Change: What do you view at that time.
Speaker Change: Hum.
Speaker Change: Questions I need to be answered about education.
Speaker Change: And thanks to include or not including illegal.
Dennis Williams: Yeah, so hi, this is Dennis Williams. I think it's like I mentioned that Investor Day, some of this really comes down to the individual sort of wording that goes on the label. Like, for example, I'll give you, to follow up on the example I gave you on Investor Day, how we manage cytokine release syndrome, right? So we'll be talking about how that information should be structured in the label, how we give Tocilizumab, or how we would recommend that product, and for what reasons. And how the words are structured in the label.
Speaker Change: Yeah. So hi, this is Dennis Williams.
Speaker Change: I think it's like I mentioned at the Investor days. Some of this really comes down to individual sort of warning that goes into label like for example, ill give the default in the example, I gave at Investor day, how we manage cytokine release syndrome. So we will be talking about how that information should be structured in a label how we give.
Speaker Change: Just listen lab, or how we would recommend that product and for what grade Crs. So.
Speaker Change: Sometimes it's really about the finer points of.
Speaker Change: Of how the words are in the label we have had no discussions to date with the FDA around the indication statement and we feel very confident that the indication statement. We proposed is more or less a few words as what we're going to end up with at the end of this review.
Dennis Williams: We have had no discussions to date with the FDA around the indication statement, and we feel very confident that the indication statement we proposed, which is more or less a few words, is what we're gonna end up with at the end of this review.
Speaker Change: Okay. Thanks very helpful.
Marc Alan Frahm: Okay, thanks. Very helpful.
Speaker Change: Thanks, a lot.
Operator: Thank you. The following question is from Tony Butler from Rudman and Renshaw. Please go ahead.
Speaker Change: Thank you.
Speaker Change: Following question is from Tony Butler from Rodman and Renshaw. Please go ahead.
Tony Butler: Yes, good morning.
Charles Anthony Butler: Yes, good morning. I'm very respectful of the focus on the TanaCell and, to a lesser extent, on Luddy, but I wanted to ask about you, you the cell, and whether or not, at least in the calendar year, there was any anticipation of a follow-up on the past three, either in ovary or in phase one with bladder, etc. Thanks very much.
Speaker Change: Switzerland.
Tony Butler: Focus on the sand itself and to a lesser extent on later, but I wanted to ask about your use itself.
Tony Butler: Or not at least in the calendar year.
Speaker Change: Any anticipation of a follow up on surpass three.
Speaker Change: In ovarian or stage one.
Speaker Change: Bladder so thanks very much.
Speaker Change: Yeah.
Speaker Change: So why don't I wasn't I cover that.
Adrian G. Rawcliffe: So why don't I cover that with what we're thinking about for USSL. With the past three in platelet-resistant ovarian cancer, that's designed with the potential to end up as a registrational trial, and therefore, we won't be putting out any data on that until we have at least enrolled all of the patients in that trial. There are interim reads for futility analysis, but we won't be communicating the data until we've at least enrolled all of the patients in that trial, which we anticipate being a 2025 event, full enrollment in that trial.
Speaker Change: What we're thinking about the use yourself.
Speaker Change: It was the past III in platinum resistant ovarian cancer.
Speaker Change: That's that's designed with the potential to end up as a registrational trial, and therefore, we won't be putting out.
Speaker Change: Any data on that until we have at least enrolled all of the patients in that trial there are interim.
Speaker Change: Reeds full futility analysis, but we won't be communicating that data until there, but at least in most all of the patients in that trial, which we anticipate being a 2025 event.
Speaker Change: I fully enrollment of that trial.
Adrian G. Rawcliffe: So with respect to the other indications, we've now focused down on ovarian cancer in SPAS3 and the two other indications in head and neck and bladder, and the objective is to gather data in a phase one setting in a range of patients, potentially in combination with checkpoint inhibitors as well. And what we've said there is that we anticipate giving an update on the basis of the data that we've gathered at the tail end of this year about how we anticipate moving forward with those, which would include the data themselves.
Speaker Change: So with respect to the other indications so let's now focus down on to <unk>.
Speaker Change: Ovarian cancer is plus three and the two other indications in head and neck and bladder and the objective is to get that data in a phase one setting.
Speaker Change: In a range of patients potentially in combination with checkpoint inhibitors as well.
Speaker Change: And what we've said the areas, we anticipate giving an update on.
Speaker Change: So on the basis of the data that we've gathered at the tail end of this year about how we anticipate moving forward with values, which would include the data themselves.
Speaker Change: Yeah.
Speaker Change: Excellent.
Speaker Change: Yes.
Speaker Change: Thank you.
Operator: The following question is from Craig. Suvannavejh from Mizuho Securities, please go ahead.
Speaker Change: Following question is from Craig.
Jay: No Jay.
Speaker Change: J F.
Speaker Change: From Mizuho Securities. Please go ahead.
Graig C. Suvannavejh: Good morning, thanks for taking my question and congratulations on all the progress. I just wanted to go back to the FDA review process and, in particular, one of the great analysts or investors that you had, Diamond Shelley. I'm just curious if there has been any other, perhaps, progress or... Committee, any additional inspections by FDA on the manufacturing facilities? Do you expect any other visits prior to approval? Just want to get a better handle on how things are shaping up there as it related to, you know, CNC manufacturing in your facilities.
Speaker Change: Hi, Good morning, Thanks for taking my question and congrats on all the progress.
Speaker Change: Progress.
Speaker Change: Just wanted to go back to the FDA review process and in particular.
Speaker Change: Also in light of the great analyst event.
Speaker Change: First of all you have done in Philly just curious if theres been any other perhaps.
Speaker Change: Perhaps.
Speaker Change: Or.
Speaker Change: Hum.
Speaker Change: Maybe any additional inspections by yesterday on the manufacturing facilities do you expect any.
Speaker Change: Other visits prior to approval just wanted to get a better handle on how things were shaping up there as it related to.
Speaker Change: CMC manufacturing in your facilities.
Dennis Williams: Yep, hi, this is Dennis Williams again. So yes, I think at this point, all the inspections are expected to be completed, right? So we both have manufacturing facilities that we utilize, so our own manufacturing for a familial drug product. The Lentiviral Manufacturing Facility for the vector that supplies the drug products has been inspected at, and had a good outcome. And all the clinical trial sites that were inspected have also been completed, and they all had a very good outcome.
Speaker Change: Yeah, Hi, this is Dennis Williams again.
Speaker Change: So yes, I think at this point all the inspections.
Speaker Change: Our expected to be completed right. So we both manufacturing facility that we utilize our own manufacturing for our pharma cell drug product.
Speaker Change: Lindsay viral manufacturing facility that we for the vector that supplies for drug product has been inspected.
Speaker Change: <unk> had a good outcome.
Speaker Change: And all of the clinical trial.
Speaker Change: Trial sites that were inspected also are completed they will.
Had a very good outcome and as I mentioned during Investor day that the AVR facility here from a <unk> standpoint was also inspected so at this point we.
Dennis Williams: And as I mentioned during Investor Day, the AVR facility here from a GCP standpoint was also inspected. So at this point, we think all the inspections are complete. I guess there's always a scenario where another clinical site could be inspected. But at this point, I think at this stage in the review, all the inspections are complete.
Speaker Change: We think all the inspections are complete.
Speaker Change: I guess, there's always a scenario where another clinical site.
Speaker Change: But could be inspected but at this point I think at this stage in the rearview mirror.
Speaker Change: Sections are completed.
Speaker Change: Okay. Thank you for that clarity.
Dennis Williams: Okay, thank you for that clarification. And just with regard to earlier comments that have been coming in late about not anticipating or not expecting perhaps an ADCOM or a REMS program, maybe just on the latter with regard to a REMS, just from a calendar perspective, is this something that a discussion would naturally have happened by now? Or is it still part of a potential discussion between now and PDUFA? Thank you. Yep, sure. So
Speaker Change: And just with regards to earlier comments.
Speaker Change: Coming to made about not anticipating.
Speaker Change: We're not expecting perhaps.
Speaker Change: AD com or a Rems program, maybe just on the matter with regards to our revenues.
Speaker Change: Just from a calendar perspective is this something that.
Speaker Change: <unk> would naturally have happened by now or is it still a part of a potential discussions between now and the particular thank you.
Dennis Williams: Yep, sure. So we did not submit a REMS in this BLA application, and we've had discussions with the FDA during the review, and I think at the time I had this discussion at Investor Day, the FDA review was ongoing, and there was no decision about a REMS at that time, and they certainly had not asked for one at that time. You're correct that had a REMS been requested, that time would have elapsed already. It would have occurred within the few weeks of that mid-cycle meeting. I can just say, in general, from the conversations we've had with the FDA, we don't anticipate a REMS for this product.
Speaker Change: Yeah sure. So we did not submit a rems in this BLA application.
Speaker Change: And we've had discussions with the FDA during the review.
Speaker Change: And I think at the time I had this discussion at Investor day.
Speaker Change: The FDA review is ongoing and.
There was no decision about a rems at that time and they certainly have not asked for one at that time.
Speaker Change: Youre correct that had a rems been requested that that time would have elapsed already that would've occurred within a few weeks of that mid cycle meeting.
Speaker Change: I can just say in general the conversations we've had with the FDA, we don't anticipate a rems for this product.
Speaker Change: Yeah.
Speaker Change: Okay. Thank you and maybe just the last question if I could just you could remind us all.
Adrian G. Rawcliffe: Okay, thank you. And maybe it's the last question if I could just, if you could remind us all, assuming an on time approval, what we should be thinking about the shape of the uptake curve, particularly from the revenue perspective. Thank you.
Speaker Change: And on time approval.
Speaker Change: How we should be thinking about the shape of the uptick curve, particularly from a revenue perspective.
Speaker Change: Yeah.
Speaker Change:
Speaker Change: So why don't I wasn't I touched on that.
Adrian G. Rawcliffe: So why did I touch on that? What we're basically guided to is that we haven't given guidance on the specific numbers of patients that we anticipate coming through in the early part of the launch. What we have said is that it's important to understand that because this is an autologous product that's manufactured, it needs to be screened for targets and then manufactured and then returned to patients. Whatever you think that uptake curve looks like, it's essentially shifted by, and we're guiding to, about a quarter.
Speaker Change: What we basically guided to is that.
We.
Speaker Change: We've not given guidance on the on the specific numbers of patients that we anticipate coming through in the early part of the.
Speaker Change: Of the of the launch.
Speaker Change: And what we have said is that it was important to understand that because this is an autologous product that's manufactured needs to be screening for targets and then manufactured and then with the patients.
Speaker Change: Whatever you think that uptake looks like it's essentially frame shifted by a great guiding to about a quarter from the first revenues from our pharma.
Adrian G. Rawcliffe: So the first revenues from Famacel, the first patients would not be dosed, treated, and the first revenues recognized until Q4 this year, even though we anticipate approval, and we anticipate starting to enroll patients from the Vodafone data organization.
Speaker Change: Myself wood prices would not be dosed treated and diverse revenues recognized until Q4 this year.
Speaker Change:
Speaker Change: Even though.
Speaker Change: We anticipate approval and we anticipate starting to enroll patients.
Speaker Change: Adam.
Speaker Change: They have to do protect in August.
Speaker Change: Okay. Thank you.
Speaker Change: Okay.
Speaker Change: Thank you.
Operator: Thank you. The following question is from Michael Schmidt from Guggenheim. Please go ahead.
Speaker Change: Following question is from Michael Schmidt from Guggenheim. Please go ahead.
Paul: Hi, This is Paul on for Michael Thanks for taking our question.
Paul Jeng: Hi, this is Paul. I'm from Michael. Thanks for taking our question. So for the Afanasel launch, you talked about targeting about 6 to 10 sites for that early launch, but looking beyond this year, what's your current thinking on strategy for scaling up to all 30 ATCs across the country and how many of those centers have had experience with Afanasel in the clinical trial setting?
Paul: So on the fan to sell launch that you talked about targeting about six to 10 sites for that early launch, but looking beyond this year whats your current thinking on strategy for scaling up to all 30 agencies across the country and how many of those centers have had experience with the van is felt in the clinical trial setting.
Speaker Change: But since it all off since yesterday talked to that.
Cintia Piccina: I'll ask Cintia to talk to him about that. Thank you.
Cintia Piccina: Thank you. Yes, so we are, as Adrian said, targeting about 6 to 10 sites during the launch period, meaning the first quarter after launch, and we are already starting to engage beyond those, with the expectation to have up to 30 sites available about 18 months after launch. Out of these 30 sites in total, 16 of them, which would be the priority sites, have clinical experience with Afamicel, and some additional sites that are part of the 30 also have experience with Letucel.
Speaker Change: Thank you, yes so.
Adrian G. Rawcliffe: Adrian said, we are targeting about 610 sites.
Speaker Change: During the last periods, meaning.
Speaker Change: First quarter after launch.
We are already starting to engage beyond the dose with the expectation that you have up to the 30 sites available about 18 months after launch.
All of these.
Speaker Change: Is there any sites totaled 16 of them, which would be the priority sites have clinical experience with the funnel. So.
Speaker Change: And some additional sites that are part of it. They also have experienced it let us know.
Cintia Piccina: So all of our 30 ATCs in the future, all of our clinical sites from Letucel and Afamicel will be part of those 30. And again, we know that those sites see the majority of synovial sarcoma patients in the country.
Speaker Change: So all of our 38.
Speaker Change: In the future.
Speaker Change: All of our clinical sites from <unk> will be part of those 30 and again.
Speaker Change: We know that those sites the majority of this and I'll just circle foundations in the country.
Speaker Change: Yeah.
Cintia Piccina: Great, thanks for that. And maybe just a follow-up, as you look ahead to the launch, can you give a sense of what kind of metrics you're planning to sort of disclose in the early months to give a sense of how that launch is progressing? This has been an area of focus for the Academy launch for Ioban, so just curious if we can expect updates on, you know, the number of patients identified versus infused or if you're likely to provide more qualitative updates in the early months. Thank you. So we plan on updating that at our next...
Speaker Change: Great. Thanks for that and maybe just a follow up as you look ahead to the launch can you give a sense of what kind of metrics youre planning to sort of disclose in the early months to get a sense of how that launch is progressing as it has been in there.
Speaker Change: Area of focus for the entire B launch for I've answered just curious if you can expect updates on a number of patients identified versus infused or if you're likely to provide more positive updates in the early months. Thank you.
Cintia Piccina: So we plan on updating that at our next Q call.
Speaker Change #100: We plan on updating that.
Speaker Change: <unk> keep cool.
Speaker Change #101: Got you. Thanks, so much.
Speaker Change #102: Thank you.
Speaker Change #102: Thank you.
Operator: Our following question is from Archer He from HC Rainwright. Please go ahead.
Speaker Change #103: A following question is from Archer from H C. Wainwright. Please go ahead.
Archer He: Hi Yan and team, this is Arthur from HCN Era, and thanks for taking my questions. I guess I just had a broad picture question. So, as we see the self-help industry moving to the autoimmune disease area, could you help educate us on the potential of your platform aiming for autoimmune diseases? I know you guys are later focusing on lunch, but I'm just curious about the potential there.
Angie: Hey, Angie this is honestly, probably sitting here right and thanks for taking my questions.
Speaker Change #103: Yes.
Speaker Change #105: Just had a broad picture question.
Speaker Change #106: So as we see the industry moving to different autoimmune disease area.
Speaker Change #107: Could you help educate us the potential for on your platform.
Speaker Change #107: Aiming for.
I mean, I know you guys, Linda Philippines launched but just curious on the HD X.
Speaker Change #107: Yeah.
Speaker Change #107: Sure.
Adrian G. Rawcliffe: Sure. So, as you've said, we are laser focused on the launch. We have, if you dig into the history of the company long enough, we have explored the opportunity to develop TCR-targeted therapies for autoimmune disease, mostly focused on Treg programs. But I think in the short term, our focus is obviously on the launch of FAMSL and the sarcoma franchise, but also between that and the very long-term future in autoimmune and maybe other indications, just the massive unmet need that can be addressed with TCR-T cell therapies in the oncology space.
Speaker Change #108: As you've said.
Speaker Change #108: We are laser focused on the launch.
Speaker Change #108: We have if you dig into the history of the company long enough.
Speaker Change #108: Have explored.
Speaker Change #108: Explored the opportunity to develop.
Speaker Change #108: TCR targeted.
Speaker Change #108: <unk> auto immune disease, mostly focused on.
Speaker Change #108: T Reg programs, but I think in the short in the short term.
Speaker Change #108: Focus is on obviously the launch of our find myself in the soft kind of a franchise, but also in <unk>.
Speaker Change #108: Tween, Boston, the very long term future in autoimmune and maybe other indications just the massive unmet need that can be addressed with TCR T cell therapies in the oncology space. So if you look at the rest of our pipeline, you'll see that as we over the coming years, we will very quickly moved from a.
Adrian G. Rawcliffe: And if you look at the rest of our pipeline, you'll see that over the coming years, we will very quickly move from a sarcoma-only franchise with two products and 400 million in sales into much larger patient populations. And there's an opportunity with user cell in obviously ovarian, bladder, and head and neck. And then beyond that with PRANE, given the recent interesting data with that target and with CD70, both of which are in the late preclinical pipeline, and the opportunity there to address over 100,000 patients that are currently dying from their indications with the right target and the right HLA type.
Speaker Change #108: Sarcoma only.
I'm charged with two products in $400 million of sales into much larger patient populations and there's an opportunity with the use of cell and obviously ovarian bladder and head and neck I think beyond that with praying.
Speaker Change #108: Given the recent interesting data with that target.
Speaker Change #108: And with CD 70, both of which are in the late preclinical pipeline and the opportunity there to address.
Speaker Change #108: <unk> hundred over 100000 patients that are currently dying from their indications with the right target and the right HLA type and so.
Adrian G. Rawcliffe: And so when we see this in terms of horizons, short-term sarcoma, longer term, broaden that out, making cell therapies potentially curative and mainstream across a broad range of tumors, and then taking cell therapies into other spaces where patients can benefit from them in other non-oncology indications in the long term.
Speaker Change #109: Yeah, we see we see this in terms of Horizons short term.
Speaker Change #109: Sarcoma.
Speaker Change #109: Longer term broadened that out making cell therapies.
Speaker Change #109: Hence the curative and mainstream across a broad range of tumors, and then taking cell therapies into other spaces, where patients can benefit and other non oncology indications in the long term.
Archer He: Oh, thank you. Thanks for the call.
Speaker Change #110: Thanks, Thanks for the color.
Speaker Change #111: Thank you.
Speaker Change #112: Our last question is from Peter Lawson from Barclays. Please go ahead.
Operator: Our last question is from Peter Lawson from Barclays. Please go ahead. Mr. Lawson, your line is open, and you may proceed with your question.
Speaker Change #113: Mr. Nelson. Your line is open you May proceed with your question.
Peter Richard Lawson: Great. Thank you so much. Thanks for taking my question, and thanks for the update. I wonder if you could talk about the turnaround time, the time between approval, and booking the initial revenues. If we could just think about the turnaround time from your end, also the turnaround time, with the hospitals and the patients, any variables that we should be thinking about.
Peter Richard Lawson: Great. Thank you so much thanks for taking my question.
Peter Richard Lawson: Thanks for the update.
Peter Richard Lawson: I Wonder if you could talk around the <unk>.
Speaker Change #115: Turnaround time.
Peter Richard Lawson: Right.
Speaker Change #116: Tape between connects approval booking initial revenues is just think about the turnaround time your endo said the turnaround time with.
Is it because the hospitals locations.
Speaker Change #116: Any variables that we should be thinking about.
Cintia Piccina: Cintia, do you want to talk to him about that?
Speaker Change #117: Cynthia do you want to talk to that.
Cintia Piccina: Yes, absolutely, yes, so when we think about the turnaround time from the patient journey perspective, we need to consider that patients, when they are identified, the first step is that they need to be tested for HLA and MAJ-4, which is a process that can take a few days. Then we go through the apheresis process, scheduling apheresis, and then when we receive the apheresis material from the manufacturing turnaround time, which would be about 30 days, and then we ship it back to the site.
Speaker Change #116: Yes.
Cynthia Ciena: Yes, so when we think about a good turnaround time from the patient journey perspective.
Speaker Change #119: We need the chipmunks, either that's a patient.
Speaker Change #120: When they are identified the first step is that they need that should be tested for Italy and meeting for which is a process that can take a few days.
Speaker Change #120: And then we go through the a freezing process scheduling efrain.
Speaker Change #120: And then when we receive the excuses mature from a manufacturing turnaround time, and then that would be of about 30 days and then shifting back to ship.
Speaker Change #120: To the site so that's why at launch.
Cintia Piccina: So that's why at launch, the Companion diagnostic test will be approved at the same time, that's our expectation, at the same time that a pharmacy is approved, so we would expect to see, as Adrian mentioned before, the first patients dosed during the fourth quarter of the year. Okay, thank you again. After the patient's identified and their atheresis, what's the general timeline you expect?
Speaker Change #121: Uh huh.
Speaker Change #121: Companion diagnostic test to be approved at the same time, that's our expectation at the same time that finance that is approved so.
Speaker Change #122: We expect to see as Adrian mentioned before first patients dosed.
Speaker Change #122: During the fourth quarter of the year.
Speaker Change #123: Okay. Okay. Thank you and then.
Peter Richard Lawson: Okay, thank you again. After the patient's identified and their atheresis, what's the general timeline you expect around that? Imagine there's a fair amount of variability. Yeah, hi, this is John, leading manufacturing. So the turnaround time from the typical time from the collection of the apheresis material until the release of the product is sended back to the site tends to range between four and six weeks. Okay, are there things we should be thinking about on the front end and the back end that are outside your control and the sense you get? how long it takes patients to kind of get through that funnel from being identified by the diagnostic test page and then the other end once they get to the hospital and actually get the infusion.
Speaker Change #123: The patients identified.
Speaker Change #125: What's the general timeline, you expect around that.
Speaker Change #124: I imagine, there's a fair amount of variability.
John: Yeah, Hi, this is John leading manufacturing so the turnaround time from typical time from the collection of the April research material until the release of their product to send it back to the site tends to range between four and six weeks.
John: Okay.
Okay.
Speaker Change #127: I think we should be thinking about the front end and the backend or outside your control.
Speaker Change #128: Since you get.
Speaker Change #129: How long it takes for patients to kind of get through that funnel from being.
Speaker Change #129: 75.
Speaker Change #129: By diagnostic test.
Speaker Change #129: And then the other end.
Speaker Change #129: To get to the hospital that you could get.
Speaker Change #129: Okay.
Speaker Change #129: Okay.
Cintia Piccina: Yes, so a couple of things to consider before will be patient identification, the testing, then, depending on where these patients are, they will have to be referred to a treatment center, which can take a few days. Reimbursement is also something that will be checked at that very early part of the journey. Then from a freeze all the way back to infusion, it's mostly straightforward. We could potentially have the patient's condition getting worse or other things that are out of control, but then it's mostly a little bit more straightforward.
Speaker Change #130: Yes so.
Speaker Change #131: A couple of things to consider before we will be patient identification. The testing then depending on the legislation sorry, do you have to be referred to a treatment center.
Can take a few days.
Speaker Change #131: Hmm.
Speaker Change #131: Horseman is also something that it would be checked that that very early part of the journey then from a freezes all the way back to infusion.
Mostly straightforward we could have potentially.
Speaker Change #131: One condition getting worse or all these things are out of control, but then it's mostly a little bit more straightforward.
Peter Richard Lawson: Okay, just a final question just around the surpass data. I guess it's later this year we get EDNIC and BLADO. Just the expectations around the number of patients we should see and kind of what you regard as positive coming out of those data sets. Elliot. Yeah, thanks. We haven't
Okay.
Speaker Change #132: Just I guess a final question just around the surpass data.
Speaker Change #133: I guess you can answer this year, if you get it make them just.
Speaker Change #134: Just the expectations around number of patients we should see in China.
Speaker Change #135: What do you regard as a positive came out with that.
Speaker Change #136: Thank you Sir.
Speaker Change #135: Eddie.
Elliot Norry: Yeah, thanks. We haven't gotten to specific numbers that we would anticipate as it relates to patient dosing, but we have said that we anticipate having sufficient data to make directional decisions regarding both of those indications by the end of the year.
Speaker Change #137: Yeah. Thanks.
Speaker Change #138: Yeah, we havent guided to specific numbers that we would anticipate as it relates to.
Speaker Change #138: Patient dosing.
Speaker Change #138: We have said that we have.
Speaker Change #138: We anticipate having sufficient data to make.
Speaker Change #138: Directional decisions regarding both of those indications by the end of the year.
Speaker Change #138: Yeah.
Speaker Change #139: Great. Thanks, so much.
Speaker Change #139: Okay.
Thank you.
Speaker Change #140: We have no of course.
Operator: We have no further questions registered at this time. I would now like to turn the meeting over to Mr. Rawcliffe.
Speaker Change #141: I have no further questions registered at this time.
Speaker Change #142: I would now like to turn the meeting over to Mr. Rochester.
Adrian G. Rawcliffe: So, thank you everybody for your time today. Thank you for your questions. I look forward to seeing those of you at ASCO who are attending and look forward to updating you as we move towards approval and launch of FMSL later this year. Thanks a lot. Take care.
Unknown Attendee: So thank you everybody for your time today. Thank you for your questions.
Unknown Attendee: Look forward to seeing those of you ask those who are attending and look forward to updating you as we move towards approval and launch of our pharma satellite this year. Thanks a lot.
Adrian G. Rawcliffe: Take care.
Unknown Attendee: Thank you.
Operator: The conference has now ended. Please disconnect your lines at this time, and we thank you for your participation.
Speaker Change #144: The conference has now ended please disconnect your lines at this time.
Speaker Change #145: Thank you for your participation.