Q4 2023 Adaptimmune Therapeutics plc Earnings Call

Operator: Hello, and welcome to Adaptimmune's fourth quarter and year-end conference call and business update. I will now turn the call over to Juli Miller. Juli, please go ahead.

Hello, and welcome to adapt them in fourth quarter and year end conference call and business update I will now turn the call over to Juli Miller Julie. Please go ahead.

Juli P. Miller: Good morning, Thank you for joining US welcome to our Q4 and full year 2023 update and I refer you to our disclaimer here as well as our forward looking statements in this mornings press release for the prepared portion of the call Adrian Walker our CEO.

Juli P. Miller: Morning, thank you for joining us. Welcome to our Q4 and full year 2023 update. I refer you to our disclaimer here, as well as our forward-looking statement in this morning's press release. For the prepared portion of the call, Adrian Rawcliffe, our CEO, is with us, and other members of our management team are available for Q&A. With that, I'll turn the call over to Adrian.

Adrian G. Rawcliffe: With us and other members of our management team are available for Q&A with that I'll turn the call over to Adrian.

Adrian G. Rawcliffe: Thanks, Juli. Thanks, everyone, for joining us today. So I plan today to recap the progress we made in 2023 and share a little bit about our plans for 2024. I'll be focused primarily on Afamacel, which will be our first commercial product in our sarcoma franchise. 2023 was a year of transformation for Adaptimmune. We completed a corporate restructuring and a merger with TCR Squared. Following that, we undertook a clinical pipeline review focusing on the highest priority and value assets. We recovered Leticell and Crane from GSK.

Adrian G. Rawcliffe: Thanks, Jamie and thanks, everyone for joining today.

Adrian G. Rawcliffe: I plan to recap the progress we made in 2023 and share a little bit about our plans for 2020 cool.

Adrian G. Rawcliffe: Primarily by myself.

Adrian G. Rawcliffe: Will be our first commercial product in a soft kind of a franchise.

Adrian G. Rawcliffe: 2023, it was a year of transformation for adopting <unk>, we completed a corporate restructuring to the merger with PCR square.

Adrian G. Rawcliffe: And following that we undertook clinical pipeline would be focusing on the highest priority in value value assets.

Adrian G. Rawcliffe: We were covered let yourself and praying from GSK.

Adrian G. Rawcliffe: I want to remind you that Leticell comes with a fully enrolled pivotal trial that has already met its primary endpoint for efficacy at the interim analysis, which was disclosed late last year. We also submitted the BLA for a FAMICEL. This is a significant milestone for Adaptimmune, obviously, but it's also a significant milestone for the sector as the first ever BLA for an engineered cell therapy for a solid tumor indication. As well as the submission, we took the opportunity, working with the RMAC designation, to understand the FDA's requirements in a number of areas and de-risk that file, and also sought the FDA's agreement on the opportunity for the second cohort of that Spearhead 1 trial to provide the confirmatory evidence for full approval.

Adrian G. Rawcliffe: To remind you that let yourself came with a fully enrolled pivotal trial.

Adrian G. Rawcliffe: Already met its primary endpoint for efficacy at the interim analysis, which was disclosed late last year.

Adrian G. Rawcliffe: We also submitted the BLA for <unk>.

Adrian G. Rawcliffe: He is a significant milestone for adapting it obviously.

Adrian G. Rawcliffe: But it's also a significant milestone for the sector is the first ever BLA useful and engineered cell therapy for a solid tumor indication.

Adrian G. Rawcliffe: Uh huh.

Adrian G. Rawcliffe: As well as the submission we took the opportunity working with the AMA designation to understand the fda's requirements on a number of areas and Derisked our file and also so the Fda's agreement on.

Adrian G. Rawcliffe: The opportunity for the second cohort.

Adrian G. Rawcliffe: One trial to provide the confirmatory evidence for full approval.

Adrian G. Rawcliffe: Yeah.

Adrian G. Rawcliffe: Famasol is the first product in our sarcoma franchise, a franchise that we estimate has peak year sales of up to 400 million. And as such, it's a beachhead for innovative cell therapy products in the solid tumor space. It's the first product of our wholly owned pipeline of cell therapy products, with the most significant of those in clinical development being a product that was previously known as ADPA2 and 4CB8, but has now been granted the USAM name of Usatresgene Autolucel or Usacel. UserCell has been developed in ovarian, bladder, and head and neck cancer, and all of this is enabled by our long-term investment in the capabilities needed to be a cell therapy company.

Adrian G. Rawcliffe: <unk> is the first product in sarcoma franchise, a franchise, but we estimate as Pts sales of about 400 million.

Adrian G. Rawcliffe: And as such it's a beachhead for innovative cell therapy products in the solid tumor space.

Adrian G. Rawcliffe: It's the first product.

Adrian G. Rawcliffe: Our wholly owned pipeline of cell therapy products.

Adrian G. Rawcliffe: With the most significant of those in clinical development being a product that was previously known as ADP to enforce CBA.

Adrian G. Rawcliffe: It's now been granted to use that name.

The <unk> gene or <unk> or use yourself.

Adrian G. Rawcliffe: Use of <unk> is being developed in ovarian bladder and head and neck cancer and all of this is enabled by our long term investments in the capabilities needed to be a cell therapy company.

Adrian G. Rawcliffe: That means that at this point.

Adrian G. Rawcliffe: That means that at this point, we have the opportunity to transition into a fully integrated commercial-stage company, discovering, developing, and now, importantly, delivering self-therapy products to patients. I want to touch a bit on our launch preparedness, as Afamacel is currently undergoing its priority review at the FDA. We've been informed that the FDA does not currently anticipate an adcom for a famicom, but we're clearly on the FDA's clock now.

Adrian G. Rawcliffe: We have the opportunity to transition into a fully integrated commercial stage company.

Adrian G. Rawcliffe: Discovery, developing and now importantly, delivering cell therapy products to patients.

Speaker Change: I wanted to touch a bit on.

Speaker Change: Launch preparedness.

Speaker Change: As a farmer is currently undergoing its priority review at the FDA.

Speaker Change: We've been informed that the FDA does not currently anticipate that come to life by myself.

Speaker Change: We are clearly on the FDA use blocks out and everything is proceeding as you would anticipate for a product with priority review and a particular date in August.

Adrian G. Rawcliffe: Everything is proceeding as you would anticipate for a product with priority review and a PDUFA date in August. Afamacel is a highly anticipated product, and we intend to be in the position to commercialize Afamacel on approval in August. To that end, I'm delighted to welcome back Cynthia Pacino as our Chief Commercial Officer.

Speaker Change: <unk> is a highly anticipated caught up and we intend to be in the position to commercialize with Thomas L. On approval in August.

Speaker Change: To that end I'm delighted to welcome back since you could ciena as our Chief commercial officer. She will lead our commercial efforts for a famous shell BG costs for let yourself and the rest of the pipeline that I talked about.

Adrian G. Rawcliffe: She will lead our commercial efforts for Afamacel, and, in due course, for Letacel and the rest of the pipeline that I talked about. We are in the final stages of recruiting the commercial team, with the majority of that headcount secured, and the remaining few roles will be in place by the middle of the second quarter. Same goes for the medical affairs team, with the majority of that team recruited and the remaining... members of that team due to join us over the next few weeks. We've also bolstered the manufacturing team, and we'll be scaling that up to meet the commercial demand for FAMICEL. I want to put on notice and remind everybody that we have manufactured a FAMICEL in-house at the Navy Yard facility in Philadelphia.

Speaker Change: We are in the final stages of recruiting a commercial team with the majority of that head count secured and the remaining few roles will be in place by the middle of the second quarter.

Speaker Change: Same goes for the medical affairs team with the majority of that team recruited.

Speaker Change: And the remaining.

Speaker Change: Members of that team join us over the next few weeks.

Speaker Change: We've also bolstered the manufacturing team and will be scaling that up to meet the commercial demand for myself I want to remind everybody that we manufacture a famous sell in house at the Navy yard facility in Philadelphia.

Adrian G. Rawcliffe: We believe this is a key differentiator, giving us not only control and the ability to scale demand according to our needs but also the opportunity to produce FAMICEL at a margin that will be very attractive, and we've referred previously to a 70% margin for our sarcoma franchise at PQSL. As you see from this slide, we have a clear plan to stand up the necessary infrastructure, and we are on track to do so for that launch, including a sponsored testing plan for the May J4 diagnostic and the patient support infrastructure necessary to help patients and their end providers navigate through treating patients with a pharmacist. Subject to FDA approval around that PDUFA date, we anticipate actually infusing our first patients with famacel in Q4 2024.

Speaker Change: Believes this is a key differentiator, giving your estimate of any control and the ability to scale demand. According to our needs, but also the opportunity to produce a fiber cell at a margin that will be very attractive referred previously to a 70% margin for soft kind of a franchise of PSS.

Speaker Change: As you see from this slide we have a clear plan to stand up the necessary infrastructure and we are on track to do so for that launch, including a sponsored testing plan for <unk> for diagnostic and the patient.

Speaker Change: Support infrastructure unnecessarily to help patients and providers navigate through.

Treating patients with a pharmacy.

Speaker Change: Subject to FDA approval around that particular date, we anticipate actually infusing the patients with the fiber so in Q4 2024.

Speaker Change: Okay.

Speaker Change: We will be updating as we go through this process to register and launch by myself and I want to.

Adrian G. Rawcliffe: We will be updating as we go through this process to register and launch FAMASL, and I want to... I want to tell everybody that the first such update will occur on our Investor Day on Thursday the 18th of April. There, we will discuss not only our plans and preparation for the commercial launch of the first engineered T-cell for a solid tumor, but also how we see the opportunity in advanced sarcomas, the paucity of existing treatment options, and the opportunity to hear from patient advisory groups and providers about the opportunity represented by FAMASL for these patients. With the PAMICEL BLA filed and awaiting approval, we're executing on our plans for our As I referred to earlier, Letacell has now been recovered from GSK, the pivotal trial has finished enrollment, the primary endpoint for efficacy has been met, and it's now clear that Letacell is a product in its own right and has the opportunity to go through exactly the same commercial channels that we'll be developing for Afamacel, resulting in substantial synergies for these overlapping patient populations.

Speaker Change: Tell everybody to the first such update will occur.

Speaker Change: Investor Day.

Speaker Change: Stay the 18th of April that we will discuss not only our plans and preparation for the commercial launch of the first engineered T cell for solid tumor, but also the how we see the opportunity in advanced Sarcomas, the paucity of existing treatment options and the opportunity to hear.

Speaker Change: From patient advisory groups and provide us about the opportunity represented by pharma South forward. Despite these patients.

Speaker Change: With the <unk> BLA filed and are waiting approval, we're executing on our plans for all sarcoma franchise.

Speaker Change: As I referred to earlier, let yourself has now been recovered from GSK as a pivotal trial has finished enrollment the primary endpoint for efficacy has been met and is now clear that necessarily as a product in its own right and has the opportunity to go through exactly the same commercial channels, but we will be <unk>.

Speaker Change: Eloping fourth I myself, resulting in substantial synergies.

Speaker Change: These overlapping patient populations.

Adrian G. Rawcliffe: We have the opportunity to reach 400 million in peak sales with these cell therapies with an addressable patient population of a little north of 1,000 patients per year with synovial sarcoma and MRCLS. I just want to make the point that that is in the United States, in the launch indications, but we anticipate only. We're proud of the progress that we made in 2023.

Speaker Change: We have the opportunity to reach $400 million in peak sales with B cell therapies.

Speaker Change: The addressable patient population, a little north of a thousand patients a year with synovial sarcoma, and then I'll say I'll ask just what I'd like to point the bodies in the United States in the launch indications, but we anticipate only.

Speaker Change: We're proud of the progress that we made in 2023.

Adrian G. Rawcliffe: We view this as securing our place on the starting line to make cell therapy products available for people with solid tumors, beginning with our sarcoma franchise. This gives us the immediate opportunity to create near-term commercial value in 2024 and 2025 and set the company up for long-term success with our wholly-owned pipeline of self-therapy products. Operator?

Speaker Change: We view this as securing our place on the starting line to make cell therapy products available for people with solid achievements, beginning with our Sakai of a franchise.

Speaker Change: It gives us the immediate opportunity to create near term commercial value in 2024 and 2025.

Speaker Change: And set the company up for long term success with our wholly owned pipeline of cell therapy products.

Speaker Change: And with that I'll turn it over to the operator for Q&A operator.

Speaker Change: Thank you we will now begin the question and answer session.

Operator: Thanks. We will now begin the question and answer session. To join the question queue, you may press star and then 1 on your telephone keypad. You will hear a tone acknowledging your request. If you are using a speakerphone, please pick up your handset before pressing any. To withdraw your question, please press star, then.

Joining the question queue you May Press Star then one on your telephone keypad, you'll hear a tone acknowledging your request.

Speaker Change: If you are using a speakerphone. Please pick up your handset before pressing any teeth to withdraw. Your question. Please press Star then two we will pause for a moment as callers join the queue.

Operator: We will pause for a moment as callers join the conversation. Our first question comes from Greg Suvenevay of Mizu Security. Go ahead. Elliot Norry Transcript by www.simplified inclusion.com. Greg, your line is live. Story, very first.

Speaker Change: Our first question comes from Greg Savannah Bank of Maine.

Greg Savannah: <unk> Securities. Please go ahead.

Greg Savannah: Retinal vasculitis has remained unchanged and that rate is 0.0% to 1% so pretty low Greg. Your line is live right, Greg New disclosure of the risks of retinal vasculitis during a very first injection product, maybe we'll come back to Greg.

Operator: Maybe we'll come back to Greg. Our next question comes from Jonathan Chang of Lerink Partners. Let's go ahead. Hi guys.

Greg Savannah: Yeah.

Greg Savannah: Our next question comes from Jonathan Chang of Leerink Partners. Please go ahead.

Adrian G. Rawcliffe: Good morning, and thanks for taking my questions. First question, can you walk us through the assumptions around the $400 million US peak sales opportunity for the sarcoma franchise? And then second question, can you provide any additional color on the cash runway guidance, specifically on what's assumed on the payment front from current and past partners? Thank you.

Jonathan Chang: Hi, guys. Good morning, and thanks for taking my questions.

Jonathan Chang: First question can you walk us through the assumptions around the 400 megawatt last peak sales opportunity for the sarcoma franchise and then second question.

Jonathan Chang: Can provide any additional color on the cash runway guidance.

Jonathan Chang: Specifically on what's assumed in the payment Frank from current and past partners. Thank you.

Jonathan Chang: Yeah.

Speaker Change: Thanks, Jonathan So I'll take the question on the assumptions from the commercial.

Adrian G. Rawcliffe: So I will take the question on assumptions from the commercial perspective. And then I'll ask Gavin, our CFO, to talk about the cash runway and the cash receipts from our partners, etc. So, with respect to the 400 million PTSAs, I want to reiterate that's a U.S.-only number, and it also only speaks to the anticipated launch indications in second-line advanced sarcomas, but myxoid round cell and spinovial sarcoma for fama cell, spinovial sarcoma for letter cell, myxoid round cell, and spinovi Both of those indications, both of those products are characterised by HLA restriction; they're all HLA-A2, that's about 45% of the patients, and they are also targeted therapies in that they have their own, each has their own target; ephamacel is for MAJ-4, letacel is for NY-Eso.

Speaker Change: Show perspective, and then I'll ask Gavin.

CFO: CFO to talk about the cash runway and the cash receipts from partners et cetera.

Gavin: So with respect to the $400 million of peak sales I want to reiterate that.

Speaker Change: The us only number and it also speaks to the anticipated launch indications in second line advanced Sarcomas, but myxoid round cell and so no real soft <unk>.

Speaker Change: For myself.

Speaker Change: Myself synovial sarcoma for next yourself Myxoid round, so and synovial sarcoma.

Speaker Change: Both of those indications both of those products.

Speaker Change: <unk> by HLA restriction they'll HLA, a two it's about 45% of the patients.

Speaker Change: And they are also targeted therapies.

Speaker Change: They have that each has their own target if I'm a salad for MAGE, a four letter salaries for NY ESO.

Adrian G. Rawcliffe: So the starting point is the incidence of soft tissue sarcomas in about 13,500 patients per year in the United States. You can cut that for the incidence of synovial sarcoma and myxoid round sarcoma. Each of those represents 5-10% of that total, then you cut each of those for the HLA at 45%, and the target.

Speaker Change: So the starting point is.

Speaker Change: Incidents of soft tissue sarcomas of about 13, and a half thousand patients per year in the United States.

Speaker Change: You can cut to that.

Speaker Change: For the incidence of synovial sarcoma myxoid round solve each of those represents 10% of that total.

Speaker Change: Than you.

Speaker Change: Each of those for the.

Speaker Change: H L. A 45% in the targets and what you end up with is shown on this slide which is about 1000 patients a year coming through that funnel.

Adrian G. Rawcliffe: And what you end up with is shown on this slide, which is about 1,000 patients a year coming through that funnel, of which about 400 are for FAMR cells in synovial sarcoma. And the remainder, a little over 600, are the incremental patients for Letacell in synovial sarcoma and Letacell in myxoid rounds and liposarcoma. So that opportunity with both of these products adds up to a little over 1,000 patients and 400 million in PTS sales. Gavin, do you want to talk about the assumptions on the cash flow going forward? Of course, Ad. Hi Jonathan.

Speaker Change: Of which about 400 off for a farmer selling synovial sarcoma and the remainder.

Speaker Change: <unk> 600.

Speaker Change: Incremental patients four left to sell.

Speaker Change: Synovial sarcoma and less southern Myxoid round, so unlike the sarcoma.

Speaker Change: So that that opportunity with both of these products adds up to a little over for a little over 1000 patients and $400 million of Pts sales.

Speaker Change: Gavin do you want to talk about the assumptions.

Gavin: On the cash flow going forward.

Gavin: Yes of course at Hi, Jonathan.

Gavin Hilary James Wood: So if we step through this, so if we take our closing liquidity of about $147 million, and then over the course of our CASH runway period into early January 26, we've got three sources of income, a high degree of. The first of those is the smallest, balance on the payment of £30 million sterling from GSK, so expect to get that in Q2, second component R&D tax credits from the UK Government.

Gavin: So if you take her closing liquidity of about $147 million and then the.

Gavin: Cost of our cash runway.

Gavin: Too early January 'twenty six we've got three sources of income that we that we.

Gavin: High degree of certainty around the first device is the smallest which is the balance on the payment of 30 million pounds Sterling from GSK expects to get that in Q2, the second component.

Gavin: R&D tax credits from the UK government.

Gavin Hilary James Wood: We received $30 million in January pertaining... Claims for 2022, and we can anticipate smaller amounts as the regime changes, but we've got a good line of sight to those over the next couple of years, and the third and largest component are payments from Genentech in association with our collaboration with them on our allogeneic platform. Two components to that are laid out in the 10-K. The first is anniversary payments totaling $150 million over the period of five years. The exact shape of that isn't public and is confidential, but we have two of those.

Gavin: Receipts in January 30 million pertaining to the claim for 2022, and we can anticipate smaller amounts regime changes, but we've got good line of sight to that.

Gavin: Over the next couple of years, and then third and largest component.

Gavin: Payments from Genentech in association with our collaboration with them on the old address Tonight platform two components to that and these are laid out in the 10-K, the first anniversary payments totaling $150 million over the period of five years, the exact shape of that isn't public and these confidential, but we have.

Gavin: Two of those payments and this elicit two milestone R&D milestone payments of $25 million.

Gavin Hilary James Wood: And there are also two R&D milestone payments of $25 million. We anticipate one of those for Everyone. It gives us a line of sight to capital north of 300 million. Of course, we continue to look at the market, and reinforce that. Got it.

Gavin: We anticipate one of those in 2024 and one in 2025 gives us line of sight to capsules North of 300 million of course, we continue to look at them.

Gavin: Market and continued to have easy conversations bulks.

Bulks to that financing.

Adrian G. Rawcliffe: Thanks for taking my question. Thanks so much. Our next question comes from Yanan Zhu of Wells Fargo Security. Please go ahead. Great, thanks for taking our questions. Regarding the patient number, the 400 patients for the AFAMICEL launch, I was wondering how many of those patients can be expected to be reached in the initial 6 to 10 ATCs that might be online. And also, regarding the manufacturing capacity, what is the capacity that you expect to be online at the time of launch?

Speaker Change: Got it thanks for taking my questions.

Speaker Change: Yes.

Speaker Change: Uh huh.

Speaker Change: Our next question comes from Yanan, Zhu of Wells Fargo Securities. Please go ahead.

Yanan Zhu: Great. Thanks for taking our questions.

Yanan Zhu: On the patient a number the 400.

Yanan Zhu: Patient for the Omnicell launch I was wondering.

Yanan Zhu: How many of those patients can be expected to be reached in the initial six to 10 atc's that might be online.

Yanan Zhu: And also regarding the manufacturing capacity.

Yanan Zhu: What is the capacity that you expect to be online at the time of launch and also a question on ADP <unk> CD eight.

Adrian G. Rawcliffe: And also, a question on ADP A2M4 CD8, any guidance in terms of updates on data from surpassed trials? Thank you.

Yanan Zhu: Any guidance.

Yanan Zhu: Guidance in terms of update.

Yanan Zhu: <unk> data from surpass trials. Thank you.

Speaker Change: Okay. So.

Speaker Change: I think the.

Adrian G. Rawcliffe: So I think the exact number of those patients in those centers will reflect the centers that we stand up first, which ones those actually are. The plan is to start with six to ten but grow fairly rapidly over the first two years of the launch to up to 30 centers. We've estimated that something a little, maybe a little north of 40% of the total patients are currently in those centers. However, we also anticipate, as with other therapies of this nature, that there will be an increasing concentration of patients eligible for the therapy in the centers where we have established treatment capacity in our treatment centers. So that plan, we anticipate increasing it over time substantially. And then, obviously, we'll be leveraging the existing and well-established referral networks within the sarcoma community and the Sarcoma Centers of Excellence to ensure that we make ephamacel available to as many patients as possible.

Speaker Change: The exact.

Speaker Change: Of those patients in those centers.

Speaker Change: Will.

Speaker Change: Reflect the centers that we stand up first.

Speaker Change: Each one of those actually al.

Speaker Change: The plan is to start with sixth patent, but grow fairly rapidly over the first two years of the launch to up to 30 centers.

Speaker Change: We've estimated that something a little maybe a little north of 40% of the total patients are currently in those centers. However, we also anticipate as with other therapies of this nature.

Speaker Change: There will be increasing concentration of patients eligible for the therapy in the centers, where we have established treatment capacity in our treatment centers.

Speaker Change: So that we plan on that plan, we anticipate increasing over time substantially and then obviously, we will be leveraging the existing well established referral networks within the sarcoma community Ensco with centers of excellence to ensure that we may if I'm a seller bailable to as many patients.

Speaker Change: It is possible the 30 centers.

Adrian G. Rawcliffe: The 30 centers at Maximum will be geographically quite well distributed across the United States, reducing the need for travel, but we fully anticipate that these patients will travel for this therapy. And I want to point out in that regard, as a one-off therapy, this has the opportunity of being easier for that travel to occur than if it was a constantly repeating therapy where the proximity to home would obviously be preferable, with respect to the user cell, as we are now calling the product previously known as ADPA2 and 4 CD8. That product will, that data that we've set for that, it falls into two categories. The first is the phase two trial surpassed phase three in platinum-resistant ovarian cancer.

Speaker Change: At.

Speaker Change: Maximum.

Speaker Change: We will be geographically quite a well distributed across the United States, reducing the need for travel, but we fully anticipate that these patients will travel for this therapy.

Speaker Change: And I want to point out in that regard as a one off therapy.

Speaker Change: Has the opportunity of being easier.

Speaker Change: For that traveled to occur.

Speaker Change: Then if it was a constantly repeating therapy, where three proximity to Hollywood, obviously preferable.

Speaker Change: Sure.

Speaker Change: With respect to.

Speaker Change: Use a cell as we are now calling the previous United is a DPA to enforce 88.

Speaker Change: That product will that data that we've set for that it falls into two categories.

Speaker Change: First is the.

Speaker Change: Phase II trial surpassed three.

Speaker Change: Resistant di Bari in cancer.

John Lunger: That being a registrational trial, that trial is recruiting, potentially a registrational trial, that trial is recruiting as we speak, and we anticipate that recruitment going through 2024 and into 2025. And we will be able to give an understanding of what happened at the interim analysis, the futility analysis, as we go through that trial, but we won't be putting out any efficacy data until, at least, we have enrolled and treated the last patient. With respect to the earlier studies on user cell in head and neck cancer and in bladder cancer, we anticipate recruiting sufficient patients during this year to make a decision around about the end of the year, and we will communicate the basis of that decision, based on data from an increased number of Phase 1 patients, potentially with some of those in earlier lines and in combination with standard of care therapy. John, do you want to talk to Capacity at the Navy Yard?

Speaker Change: In a registrational trial that trial is recruiting potentially registrational trial that trial is recruiting as we speak.

And we anticipate that recruitment going through 2024 and into 2025.

Speaker Change: And we will we.

Speaker Change: We will be.

Speaker Change: Able to give.

Speaker Change: Understanding of what happened at the interim analysis for futility analysis as we go through those trial that trial, but we won't be putting out any efficacy data.

Speaker Change: Until at least at a minimum we have enrolled and treated the last patient.

Speaker Change: With respect to the early.

Speaker Change: Studies on use of cell and head and neck cancer in bladder cancer, we anticipate recruiting sufficient patients during that trial to make it just during this year to make a decision around about the end of the year.

Speaker Change: And we will communicate the basis of that decision being dietary an increased number of phase one patients potentially with some of those United Airlines and in combination with standard of care therapy.

Speaker Change: John do you want to talk to the.

Speaker Change: Capacity.

Speaker Change: Okay.

Speaker Change: The Navy up yeah.

John Lunger: Yeah, happy to add. So, you know, we've said that our maximum capacity for internal manufacturing in Philadelphia is around six to 700 patients per year. And while it won't be necessary to get to that range for the launch, we will have enough capacity to meet both our anticipated clinical and commercial needs for the launch. Enabling this capacity is done through the onboarding of manufacturing and quality staff, and we're executing against that to make sure we have what we need come August. Great. Thanks for all the covers.

John: Yeah happy to add so so we've said that our maximum capacity for internal manufacturing in Philadelphia is around six to 700 patients per year.

John: It won't be necessary to get to that range for the launch we will have enough capacity to meet both our anticipated clinical and commercial needs for the launch enabling this capacity is done through our onboarding of staff manufacturing and quality staff and we're executing against that to make sure. We have what we need come August.

Speaker Change: Great. Thanks for all the color.

Greg Suvenevay: Thanks. Our next question comes from Greg Savonovich of Mizu Security. Go ahead. Good morning. So sorry about that this morning.

Speaker Change: Thanks.

Speaker Change: Our next question comes from Greg Savanna fish.

Greg Savanna: Mizuho Securities. Please go ahead.

Greg Savanna: Hey, good morning, so sorry about that this morning, I do have a couple of questions and congrats on the progress in the quarter.

Adrian G. Rawcliffe: I do have a couple of questions. And congratulations on the progress in the quarter. I'm curious, following the approval of iobansis-tilled-based cell therapy, what you think the potential implications may be for you guys, whether it makes things easier, any learnings out of that process, could give some. And then also on Iovance, they were able to get an ICD-10 code as well as a DRD. You're watching. Inclusion prior to their approval. Are you expecting something like that for... Family Fell?

Greg Savanna: I'm curious following the approval of Io dances until a cell therapy I'm wondering what you think.

Greg Savanna: Potential implications.

Greg Savanna: It may be.

Greg Savanna: You know for you guys, whether it makes things easier any learnings out of that process.

Greg Savanna: That could give some.

Greg Savanna: Incremental insight into how you think the review for your project will be.

Greg Savanna: And then also on I events, they were able to get in ICD 10.

Greg Savanna: 10 code as well as the DRG I think it's they're one H inclusion prior to their approval are you expecting something like that for Ami.

Greg Savanna: Thanks.

Speaker Change: Thanks, Greg so with respect to the long anticipated approval of.

Adrian G. Rawcliffe: Thanks Greg. So, with respect to the long-anticipated approval of Lifelucel by Iovant, we're quite delighted about that. We think that that heralds the fact that 2024, I think, really will be the year where cell therapy becomes a commercial reality for solid tumors with what will be the first two cell therapy launches with FAMAS upcoming in August. Now, having said that, I think they're very, very different commercial propositions, melanoma versus synovial sarcoma.

Speaker Change: <unk> lusso by <unk>.

Speaker Change: We were quite delighted about that.

Speaker Change: We think.

Speaker Change: That that heralds the.

Speaker Change: The fact that 2024, I think really will be the yes.

Speaker Change: Cell therapy becomes a commercial reality for solid tumors.

Speaker Change: Yes.

Speaker Change: It will be the first to cell therapy launches.

Speaker Change: Where the farmers out coming in August.

Speaker Change: Having said that I think that very very different.

Speaker Change: Commercial propositions melanoma versus synovial sarcoma.

Adrian G. Rawcliffe: But we look forward to Iovant doing a great job because we look to that as indicative of how cell therapies might be adopted in larger indications. And when you look back in our pipeline, you'll see many such larger indications where we anticipate cell therapy has the opportunity to change the standard of care and be transformative for patients. And so, Iovant's experience in this large melanoma indication will be really instructive, and we believe that a rising tide lifts all boats in this regard. So, we're very excited to see what they're able to do. With respect to the DRG code, confirm you're right; we anticipate the same code for FAMAS. I could ask a follow-up question just on the PRAME opportunity; obviously, there is a lot of interest in that target. How are you guys assessing the competitive landscape? So, I'm going to ask Joe, our Chief Scientist Officer, to take a stab at that and talk about it and our differentiation in our PRAIME program. Joe?

Speaker Change: But we look forward to doing a great job, because we look to that as indicative of how cell therapies.

Speaker Change: Might be adopted in these larger indications and when you look back in our pipeline, you'll see many such larger indications, where we anticipate cell therapy has the opportunity to change the standard of care and be transformative for patients and so <unk> is experiencing this large melanoma indication I think.

Speaker Change: Be really instructive.

Speaker Change: We are we believe that rising tide lifts all boats in this regard I'm, sorry, where we're very excited to see what that theyre able to they're able to do.

Speaker Change: With respect to the DRG code.

Speaker Change: You are right. We anticipate we anticipate the same code floor if Amazon.

Speaker Change: Great and if I could ask a follow up just on the frame opportunity, obviously, a lot of interest and I argued.

Speaker Change: How are you guys assessing the competitive landscape in great right now.

Speaker Change: So I'm going to ask Joe.

Joe: Chief Scientific officer.

Joe: Take step back and talk about Boston does our differentiation of our Prime program Joe.

Joe: Thanks, Ed.

Joe: Yeah, we're very excited about Frame as a target, as the field in general is. I think there's obviously, we're well aware that there's lots of competition in this area from bi-specifics as well as cell therapies. But we're still quite bullish about our own internal program because we have a strong TCR that was previously partnered with GSK, and we're looking at ways of taking that forward. So in our own internal analysis, where we've looked at other competitors' products.

Joe: Yes, we're very excited about.

Joe: Okay.

Joe: That's the sound in general is I think what we see we are well aware that there's lots of competition in this area.

Joe: Specifics as well as cell therapy.

Joe: But we're still quite bullish about our own internal program because we have a strong TCR that was previously partnered with GSK.

Joe: And we're looking at ways of taking that flow, let's say in our own internal analysis, where we are.

Joe: Nick that other competitor.

Joe: We think our TCR.

Joe: We think our TCR does have a different safety-efficacy profile, which we are very happy with. And we're also looking at ways of bringing next-generation additions to PRAME to actually make it competitive. So we want to look at our TCR for PRAME in multiple different constructs so that we can choose the best one in the clinic and take that forward. So we will start with a TCR that we believe has a good safety profile and we're looking at ways of improving the efficacy for next gen, up to next-gen opportunities, PREMA is a really complementary target to our other programs, both in ovarian cancer and other indications. So we're hoping to leverage our clinical experience in those indications to really push the frame. Thank you for taking my question. Thanks, Greg. Once again, if you have a question, please press star, then 1. Our next question comes from Peter Lawson of Barclays. Good morning. This is Tracy Neon on behalf of Peter Lawson.

Joe: Have a different safety efficacy profile, which we are very happy with.

Joe: And we're also looking at ways of bringing next generation additions to train you actually make a competitive said we won't look.

Joe: Look at our TCR for frame and multiple different construct to say that we can keep the best one.

Joe: In the clinic and take that fluid.

Joe: We will be we start with the TCR, which we believe has a good safety profile and monitoring that ways of increasing the efficacy for nexgen.

Joe: Nextgen opportunities and prime is really complementary to our other programs.

Joe: And I Varian with Asia, now and I know there are indications that we're helping to leverage our clinical experience in those indications.

Joe: Painful it.

Speaker Change: Thank you for taking my question.

Speaker Change: Yeah.

Speaker Change: Thanks, Greg.

Speaker Change: Once again, if you have a question. Please press Star then one are.

Speaker Change: Our next question comes from Peter Lawson of Barclays. Please go ahead.

Speaker Change: Good morning. This is Jason <unk> on for Peter Lawson. Thank you for taking our question.

Operator: Thank you for taking our question. I'm just going to touch on a little bit more on the FomuCell launch in 3Q. I believe you've highlighted that you'll be focusing on six to 10 treatment centers in the beginning. Can you maybe add a little color for how you're expecting to scale up to the 30 additional treatment centers and how long that might take? And if you're expecting any kind of bolus of patients onboarding in 3Q. Thank you so much.

Jason: Just you touched a little bit more on the <unk> launch and take you.

Jason: And I believe you've highlighted that you'll be focusing on sept attend treatment centers in the beginning you maybe add a little color for how you're expecting to scale up to the 30 additional treatment centers and how long that might take and if you're expecting any kind of bolus of onboarding of patients and take care. Thank you so much.

Adrian G. Rawcliffe: Thanks. So yes, we anticipate that the first wave of treatment centers will be up and running within that launch window, six to ten within that launch window, and then expanding quite rapidly. We anticipate that we will be at up to 30 centers within the first two years following launch. Those treatment centers, the initial ones are almost exclusively major sarcoma centers; well, they are all major sarcoma centers. They are obviously major treatment centers, and they have deep experience in cell therapy. They almost all also have a lot of experience working with a FAMR cell. And as we roll out to the 30 top centers, since we have been conducting our clinical trials and GSK was conducting the clinical trials for Letucell in major sarcoma centers, there's obviously going to be a large overlap between the clinical trial footprint for those two products and these centers. That has the advantage that the physicians know and understand FAMR cells well, having utilized them in clinical trials, that they're well used to cell therapy, and that they are indeed the major treatment centers, the top tier of the sarcoma centers of excellence.

Jason: Thanks.

Speaker Change: So yes, we anticipate that the first wave of treatment centers.

Speaker Change: <unk> will be up and running within that launch windows six to 10 within that launch window.

Speaker Change: And then expanding quite rapidly we anticipate that we will be at up to 30 centers within the first two years following launch.

Speaker Change: Those treatment centers the initial ones are almost exclusively.

Speaker Change: Major soft cognizant that while they are all major sarcoma centers there.

Obviously, therefore major treatment centers when they have deep experience of cell therapy.

Speaker Change: Most also have a lot of experience of working with a fan myself.

Speaker Change: And as we rollout to the.

Speaker Change: The top centers.

Speaker Change: Since we have been conducting.

Speaker Change: Clinical trials on GSK was conducting the clinical trials to let yourself in that made yourself kind of centers, there's obviously going to be a large overlap between the clinical trial footprint for those two products and these are the centers that have.

Speaker Change: The advantage that the physicians know and understand I found myself well having used utilized in clinical trials.

Speaker Change: Well use to cell therapy, and they are indeed, the major treatment centers the top tier of the soft guide in our centers of excellence.

Operator: That answers the question, I think. Any further questions? This concludes the question and answer session. I would like to turn the conference back over to Adrian Rawcliffe for any closing remarks.

Speaker Change: So the question I think.

Speaker Change: Yeah.

Speaker Change: Any further questions.

Speaker Change: This concludes the question and answer session I would like to turn the conference back over to Adrian <unk> for any closing remarks.

Adrian G. Rawcliffe: Thank you. And thanks, everybody, for being on the call. And thanks for your questions. We're excited to have come this far in 2023. We look forward to 2024 to our first commercial approval and launch. And we'll be updating you as we go through the year, starting, I think, with our Investor Day on the 18th of April at our Navy Yard facility in Philadelphia. And we look forward to seeing as many of you there as possible. Take care. This concludes today's conference call. You may disconnect your lines. Thank you for participating, and have a pleasant day. www.apmt.us

Speaker Change: Yeah.

Adrian G. Rawcliffe: Thank you and thanks, everybody for being on the call and thanks for your questions. We're excited to have come this far in 2023, we look forward in 2024.

Adrian G. Rawcliffe: First commercial approval and launch.

Adrian G. Rawcliffe: And we'll be updating you as we go through the year, starting I think with our Investor day on the 18th of April at our Navy yard facility in Philadelphia, and we look forward to seeing as many of you there as possible.

This concludes today's conference call you may disconnect your lines.

Adrian G. Rawcliffe: For participating and have a pleasant day.

Adrian G. Rawcliffe: Okay.

Adrian G. Rawcliffe: [music].

Okay.

Adrian G. Rawcliffe: [music].

Adrian G. Rawcliffe: Yeah.

Adrian G. Rawcliffe: Yeah.

Adrian G. Rawcliffe: Okay.

Adrian G. Rawcliffe:

Adrian G. Rawcliffe: Yeah.

Adrian G. Rawcliffe: Okay.

Adrian G. Rawcliffe: Okay.

Adrian G. Rawcliffe: Yeah.

Adrian G. Rawcliffe: Okay.

Adrian G. Rawcliffe: Okay.