Q2 2024 Adaptimmune Therapeutics PLC Earnings Call

August 12, 2024

Operator: Good day, and welcome to the Adaptimmune second quarter 2024 conference call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then 1 on a touch-tone phone. To withdraw your question, please press star, then 2. Please note this event is being recorded. I would now like to turn the conference over to Dan Od Cohen, Investor Relations. Please go ahead.

Operator: Good day, and welcome to the Adaptimmune second quarter 2024 conference call. All participants will be in a listen-only mode.

Operator: Good day and welcome to the Adaptimmune Lacking Quarter 2024 conference call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero.

Good day and welcome to the adapt them in second quarter 'twenty 'twenty four conference call.

All participants will be in a listen only mode.

Operator: Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press the star key, then 1 on a touch-tone phone.

Should you need assistance. Please signal a conference specialist by pressing the star key followed by zero.

Operator: After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then one on a touch-tone phone. To withdraw your question, please press star, then two. Please note this event is being recorded.

After todays presentation, there will be an opportunity to ask questions.

To ask a question you May press Star then one on a touchtone phone.

Operator: To withdraw your questions, please press star then 2. Please note, this event is being recorded. I would now like to turn the conference over to Dan Od Cohen, Investor Relations. Please go ahead.

To withdraw your question. Please press Star then two.

Please note this event is being recorded.

Dan Odd Cohen: I would now like to turn the conference over to Dan Odd Cohen, Investor Relations. Please go ahead.

I would now like to turn the conference over to Dan at Cowen Investor Relations. Please go ahead.

Dan Odd Cohen: Thank you, operator.

Dan Od Cohen: Thank you, operator. Good morning, and welcome to Adaptimmune's conference call to discuss our second quarter 2024 financial results and business update. I would ask you to review the full text or forward-looking statements from this morning's press release. We anticipate making projections during this call, and actual results could differ materially due to several factors, including those outlined in our latest filings with the SEC. Adrian Rawcliffe, our Chief Executive Officer, is here with me for the prepared portion of the call, and other members of our leadership team will be available for Q&A. With that, I'll turn the call over to Adrian. Add.

Dan Od Cohen: Thank you, operator. Good morning, and welcome to Adaptimmune's conference call to discuss our second quarter 2024 financial results and business updates. I would ask you to review the full text or forward-looking statements from this morning's press release. We anticipate making projections during this call, and actual results could differ materially due to several factors, including those outlined in our latest filings with the SEC. Adrian Rawcliffe, our Chief Executive Officer, is here with me for the prepared portion of the call, and other members of our leadership team will be available for Q&A. With that, I'll turn the call over to Adrian. Ed?

Dan: Thank you operator, good morning, and welcome to <unk> conference call to discuss our second quarter 2024 financial results and business updates.

Dan Odd Cohen: Good morning and welcome to Adaptune's conference call to discuss our second quarter 2024 financial results and business updates. I would ask you to review the full text or forward-looking statements from this morning's press release. We anticipate making projections during this call, and actual results could differ materially due to several factors, including those outlined in our latest filings with the SEC.

Speaker Change: Ask you to review the full text or forward looking statements from this morning's press release, we anticipate making projections during this call and actual results could differ materially due to several factors, including those outlined in our latest filings with the SEC.

Dan Odd Cohen: Adrian Rockliffe, our Chief Executive Officer, is here with me for the prepared portion of the call, and other members of our leadership team will be available for Q&A.

Speaker Change: Adrian Raw Cliff, our Chief Executive Officer is here with me for the prepared portion of the call and other members of our leadership team will be available for Q&A.

Adrian Rockliffe: With that, I'll turn the call over to Adrian Rockliffe. Add.

Speaker Change: With that I'll turn the call over to Adrian Raw Cliff add.

Speaker Change: Okay.

Adrian Rockliffe: Thanks, Dan, and thanks everyone for joining us.

Adrian Rawcliffe: Thanks Dan and thanks everyone for joining us. We are incredibly proud that Adaptimmune is now in the commercial stage self-therapy, following US FDA approval and the launch of our first product in our sarcoma franchise, T-Cellar. This is a fantastic achievement for the company, for the cell therapy field, and for people with synovial sarcoma. T-CELLAR is the first engineered cell therapy for a solid tumor, the first medicine in its class.

Adrian Rawcliffe: Thanks Dan and thanks everyone for joining us. We are incredibly proud that Adaptimmune is now in the commercial stage self-therapy, following USFDA approval and the launch of our first product in our sarcoma franchise, T-Cellar. This is a fantastic achievement for the company, for the cell therapy field, and for people with synovial sarcoma. T-CELLAR is the first engineered cell therapy for a solid tumor, the first medicine in its class.

Speaker Change: Thanks, Todd and thanks, everyone for joining us we are incredibly proud that adapt to me and is now a commercial stage cell therapy company.

Adrian Rockliffe: We are incredibly proud that Adaptune is now a commercial-stage self-therapy company. Following the US FDA approval and the launch of our first product in our sarcoma franchise, T-Cellar. This is a fantastic achievement for the company, for the self-therapy field, and for people with synovial sarcoma. T-Cellar is the first engineered cell therapy for a solid tumor, the first medicine in its class, and it's also the first new treatment option for synovial sarcoma in over a decade. The culmination of groundbreaking R&D, our investment in manufacturing, the demonstrable clinical benefit exhibited throughout development, and incredible execution of the regulatory process.

Speaker Change: Following the U S FDA approval and the launch of our first product in all sarcoma franchise T cell.

Speaker Change: This is a fantastic achievement for the company.

Speaker Change: The cell therapy field and for people with synovial sarcoma piece of it is the first engineered cell therapy for a solid chamber the first medicine in its class.

Adrian Rawcliffe: And it's also the first new treatment option for synovial sarcoma in over a decade. And the culmination of groundbreaking R&D, our investment in manufacturing, the demonstrable clinical benefit exhibited throughout development, and incredible execution of the regulatory process. T-Cellula is a vindication of autologous cell therapy for solid tumor cancer.

Speaker Change: It's also the first new treatment option for synovial sarcoma.

For a decade and the culmination of groundbreaking R&D our investments in manufacturing.

Speaker Change: Both struggled clinical benefit exhibited throughout development and incredible execution of the regulatory process.

Adrian Rockliffe: T-Cellar is a vindication of autologous cell therapy for solid tumor cancers, and together with the synovial sarcoma community, we're going to redefine how synovial sarcoma is treated. Launch activities for T-Cellar started; the instantly received approval, and we hit the ground running. I want to provide some updates on how T-Cellar's launch is going, bearing in mind that we're only 10 days in. As synovial sarcoma is a rare disease, treatment is concentrated in sarcoma centers of excellence. We've already recruited, trained, and deployed a commercial footprint to deliver T-Cellar after people with sarcoma. Our commercial, meta-fares, manufacturing and supply teams are all in place, and engaging patients, physicians, players, and treatment centers.

Speaker Change: T cell is a vindication autologous cell therapy for solid tumor cancers.

Adrian Rawcliffe: And together with the synovial sarcoma community, we're gonna redefine how synovial sarcoma is treated. Launch activities for Ticella started the instant we received approval, and we hit the ground running. I want to provide some updates on how Ticella's launch is going, bearing in mind that we are only 10 days in.

Speaker Change: Together with the synovial sarcoma community, we're going to redefine how synovial sarcoma is treated.

Speaker Change: Launch activities for T cell restarted the instantly received approval and we hit the ground running.

Speaker Change: But some updates on how you saw was launches going bearing in mind that we're only 10 days it.

Speaker Change: Yeah.

Speaker Change: So I know, there's all kind of as a rare disease treatment is concentrated in sarcoma centers of excellence, we've already recruited trained and deployed our commercial footprint to deliver T cell up to people who saw cut.

Adrian Rawcliffe: We've already recruited, trained, and deployed a commercial footprint to deliver TSOAR to people with sarcoma. Our Commercial, Medifares, Manufacturing, and Supply teams are all in place, engaging patients, physicians, payers, and treatments. The companion diagnostics for HLA and MAJ-A4 testing were approved concurrently with TESOA so healthcare providers can arrange for patients to get tested to establish their biomarker eligibility. Incidentally, we believe this is the first time that a therapy has been proven together with two new diagnostics at the same time.

Adrian Rawcliffe: We've already recruited, trained, and deployed a commercial footprint to deliver TSOAR to people with sarcoma. Our Commercial, Medifares, Manufacturing, and Supply teams are all in place, engaging patients, physicians, payers, and treatments. The companion diagnostics for HLA and MAJ-4 testing were approved concurrently with TESOL, so healthcare providers can arrange for patients to get tested to establish their biomarker eligibility. Incidentally, we believe this is the first time that a therapy has been proven together with two new diagnostics at the same time.

Speaker Change: Our commercial Med affairs manufacturing and supply teams are all in place and engaging patients physicians payers and treatment centers.

Adrian Rockliffe: The companion diagnostics of HLA and major A4 testing were approved concurrently with T-Cellar, so healthcare providers can arrange for patients to get tested to establish their biomarker eligibility. Incidentally, we believe this is the first time that a therapy has been approved together with two new diagnostics at the same time. Adaptimmune Assist, our Patient Support Program, is up and running to ensure a personalized experience throughout the treatment journey. And we've previously discussed our plan to activate 6-10 Authorised Treatment Centers during Tisella's launch periods. We're on track to do this. We have 5 ATCs available in our locator school on Tisella.com website, and all of our internal systems are in place to accept orders and to manufacture and deliver Tisella.

Speaker Change: The companion diagnostics HLA and BJ for testing were approved concurrently with T cell. So health care providers can arrange for patients to get tested to establish that biomarker eligibility.

Speaker Change: Instead, we believe this is the first time the therapy has been proved together with two new diagnostics at the same time.

Speaker Change: Okay.

Adrian Rawcliffe: Adaptimmune Assist, our patient support program, is up and running to ensure a personalized experience throughout the treatment journey. And we've previously discussed our plans to activate 6 to 10 authorised treatment centers during TSELRA's launch period, and we're on track to do this.

Adrian Rawcliffe: Adaptimmune Assist, our patient support program, is up and running to ensure a personalized experience throughout the treatment journey. And we've previously discussed our plans to activate 6-10 authorised treatment centers during TESOLA's launch period, and we're on track to do this.

Speaker Change: That's up to me and assess the patient support program is up and running to ensure a personalized experience throughout their treatment journey.

Speaker Change: We've previously discussed our plans to activate six to 10 authorized treatment centers during T cells launch periods. We're on track to do this we have five atc's available in case of tool on T cell with Dot Com website.

Adrian Rawcliffe: We have 5 ATCs available in our locator tool on the tselra.com website, and all of our internal systems are in place to accept orders and to manufacture and deliver T-cells. Over the next few quarters, and prior to having trends for patients treated and for sales, we will be updating you on two key performance indicators for launch execution as we go forward. Firstly, the number of ATCs opened, and secondly, the number of patients AFA reached.

Adrian Rawcliffe: We have 5 ATCs available in our locator tool on the TESOLA.com website, and all of our internal systems are in place to accept orders and to manufacture and deliver T-cells. Over the next few quarters, and prior to having trends for patients treated and for sales, we will be updating you on two key performance indicators for launch execution as we go forward. Firstly, the number of ATCs opened.

Speaker Change: And all of our internal systems are in place to accept orders at the manufacture and deliver T cell.

Adrian Rockliffe: Over the next few quarters and pride having trends for patients treated and for sales, we will be updating you on two key performance indicators for launch execution as we go forward. Firstly, the number of ATCs opened, and secondly, the number of patients acreaged. As we move through the first half of next year, we will transition to patients treated and obviously to sales as the keymex metrics.

Speaker Change: Over the next few quarters.

Having trends for patients treated at the sales we will be updating you on two key performance indicators for launch execution as we go forward.

Speaker Change: Firstly, the number of Atc's opened and secondly, the number of patients <unk>.

Adrian Rawcliffe: As we move through the first half of next year, we will transition to patient treatment and, obviously, to sales as the key method. Moving on to the positioning of adaptamine beyond the launch of T-SERA, I want to touch a little on our balance sheet and our pipeline. At the end of Q1 this year, we had approximately $144 million in total liquidity and runway guidance into late 2025.

Adrian Rawcliffe: Secondly, the number of patients per week. As we move through the first half of next year, we will transition to patient treatment and, obviously, to sales as the key method. Moving on to the positioning of adaptamine beyond the launch of T-CELLAR, I want to touch a little on our balance sheet and our pipeline. At the end of Q1 this year, we had approximately $144 million in total liquidity and runway guidance into late 2025. During Q2, we signed a collaboration agreement with Galapagos and entered into a debt facility with Hercules, and at the end of the course, we have total liquidity of $215 million.

As we move through the first half of next year, we will transition to patients treated and obviously to sales as the key metrics.

Adrian Rockliffe: Moving on to the positioning of adaptive and beyond the launch of Tisella. I want to touch a little on our balance sheet and our pipeline. At the end of Q1 this year, we had approximately 144 million in total liquidity and runway guidance into late 2025. During Q2, we signed a collaboration agreement with Galapagos and entered into a debt facility with Hercules. And at the end of the course, we have total liquidity of 215. We believe we are well-capitalised to deliver the successful launch of Tisella and also develop the rest of the pipeline. As we transition into a commercial therapy company, we will move away from extending cash runway guidance, given the complexities of estimating future revenues in the near term as we establish our Sarkaima franchise.

Speaker Change: Moving onto the positioning of adapt to be able to launch a T cell.

Speaker Change: Let's touch a little on our balance sheet and our pipeline.

At the end of Q1. This year, we had approximately $144 million in total liquidity and runway guidance into late 2025.

Adrian Rawcliffe: During Q2, we signed a collaboration agreement with Galapagos and entered into a debt facility with Hercules, and at the end of the course, we have total liquidity of $215 million. We believe we are well capitalized to deliver the successful launch of T-Cell RUF and also develop the rest of the pipeline. As we transition into a commercial cell therapy company, we will move away from extending cash wrong way guidance given the complexities of estimating future revenues in the near term as we establish our sarcoma franchise, and instead, we'll provide high-level forward cost guidance alongside regular updates on the commercialization program. For example, in the first half of this year, our total expenditure was approximately $114 million.

During Q2, we signed a collaboration agreement with Galapagos and entered into a debt facility with Hercules and at the end of the call. So we have total liquidity of $215 million.

Adrian Rawcliffe: We believe we are well capitalized to deliver the successful launch of T-SAURA and also develop the rest of the pipeline. As we transition into a commercial cell therapy company, we will move away from extending cash runway guidance given the complexities of estimating future revenues in the near term as we establish our sarcoma franchise, and instead, we'll provide high-level Ford cost guidance alongside regular updates on commercialization. So in the first half of this year, our total expenditure was approximately $114 million.

Speaker Change: We believe we are well capitalized to deliver the successful launch of T cell and also develop the rest of the pipeline.

Speaker Change: As we transition into a commercial cell therapy company, we will move away from extending cash runway guidance given the complexities of estimating future revenues in the near term as we establish our soft kind of a franchise.

Adrian Rockliffe: And instead, we will provide high-level forward cost guidance alongside regular updates on the commercialization progress. So in the first half of this year, our total expenditure was approximately $114 million. This included investments preparing for the launch of Tisella as well as hiring and onboarding the commercial team. For the next 18 months, we expect our run rate operating expenses to be broadly consistent with that are the first half of 2024. We will update this cost guidance as we progress together with the launch metrics that are previously articulated, namely the number of ATCs and the number of patients they've reached.

Speaker Change: And instead, we will provide high level food cost guidance alongside regular updates on the commercialization progress.

Speaker Change: So in the first half of this year, our total expenditure was approximately $114 million.

Adrian Rawcliffe: This included investments in preparation for the launch of T-Sera, as well as hiring and onboarding the commercial team. For the next 18 months, we expect our run rate operating expenses to be broadly consistent with that of the first half of 2024. We'll update this cost guidance as we progress, together with the launch metrics that I've previously articulated, namely the number of ATCs and the number of patients they've bereaved. Moving on to our pipeline.

Adrian Rawcliffe: This included investments in preparation for the launch of T-Sera, as well as hiring and onboarding the commercial team. For the next 18 months, we expect our run rate operating expenses to be broadly consistent with that of the first half of 2024. We'll update this cost guidance as we progress, together with the launch metrics that I previously articulated, namely the number of ATCs and the number of patients they've bereaved. Moving on to our pipeline.

Speaker Change: This included investments preparing for the launch of T. Sara as well as hiring and on boarding the commercial team.

For the next 18 months, we expect our run rate operating expenses to be broadly consistent with that of the first half of 2024.

Speaker Change: We will update this cost guidance as we progress together with the launch metrics that I previously articulated, namely the number of Atc's and the number of patients safer east.

Adrian Rockliffe: Moving on to our pipeline, we are progressing our clinical pipeline with the second product in our Sarkaima franchise, Letticell, expanding the number of Sarkaima patients we can treat with our cell therapies. Letticell is clinically de-risked as the pivotal trial Ignidicell has already met the primary end point of efficacy at the interim analysis, and this was presented earlier this year at ASCO by Dr. Sandra DiAngelo. Letticell's regulatory pathway will build on our experience with Tisella's regulatory submission. And as Letticell also targets soft tissue Sarkaima's, the commercial footprint is essentially identical to Tisella, and we expect the significant channel synergies once we launch Letticell.

Speaker Change: Moving on to our pipeline, we are progressing our clinical pipeline with the second product and I'll start Cai with franchise, let yourself expanding the number of soft kind of a patients we can treat with our cell therapies.

Adrian Rawcliffe: We're progressing our clinical pipeline with the second product in our sarcoma franchise, Leticell, expanding the number of sarcoma patients we can treat with our cell therapy. Lenticella is clinically de-risked as the pivotal trial, IGNARDISO, has already met the primary endpoint for efficacy at the interim analysis, and this was presented earlier this year at ASCO by Dr. Sandra D'Ang Ledesel's regulatory pathway will build on our experience with Tissot's regulatory submission. And as Leticell also targets soft tissue sarcomas, the commercial footprint is essentially identical to Tessera's.

Adrian Rawcliffe: We're progressing our clinical pipeline with the second product in our sarcoma franchise, Leticell, expanding the number of sarcoma patients we can treat with our cell therapy. Lenticella is clinically de-risked, as the pivotal trial, IGNARDISO, has already met the primary endpoint for efficacy at the interim analysis. And this was presented earlier this year at ASCO by Dr. Sandra D'Angelo. LeaderCell's regulatory pathway will build on our experience with T. cellular's regulatory pathway, and as Leticell also targets soft tissue sarcomas, the commercial footprint is essentially identical to Tessera's.

Speaker Change: Let's just all these clinically derisked as the pivotal trial ignite Isa has already met the primary endpoint efficacy at <unk>.

Speaker Change: Trim analysis and this was presented earlier this year as Scott by Dr. Sandra D'angelo.

Let yourself regulatory pathway will build on our experience with T cells Louis regulatory submission.

Speaker Change: And as let's say sell also targeted soft tissue sarcomas that commercial footprint is essentially identical to sellers and we expect a significant channel synergies once we launch let yourself.

Adrian Rawcliffe: And we expect significant channel synergies once we launch Leticell. We're also progressing UserCell, our next-generation cell therapy, in the Surpass 3 trial in ovarian cancer, which is currently enrolling patients. And we'll be moving forward in partnership with Galapagos in a head and neck cancer phase 1 trial with UserCell at Galapagos' distributed manufacturing. We are an integrated cell therapy company built from the ground up to design, develop, and deliver cell therapy products to redefine the treatment of solid tumor cancer.

Adrian Rawcliffe: And we expect significant channel synergies once we launch Leticell. We're also progressing UserCell, our next generation cell therapy, in the Surpass 3 trial in ovarian cancer, which is currently enrolling and will be moving forward in partnership with Galapagos in a head and neck cancer phase 1 trial with UserCell on Galapagos' distributed manufacturing. We are an integrated cell therapy company built from the ground up to design, develop, and deliver cell therapy products to redefine the treatment of solid tumor cancer. And we are now realizing this vision in real time. And with that, myself and members of the leadership team are happy to take any questions. Operator? We will now begin the question and answer session.

Adrian Rockliffe: We're also progressing user cell, our next generation cell therapy, in the surpassed three trial in ovarian cancer, which is currently enrolling, and we'll be moving forward in parts with Galapagos in a head and neck cancer phase 1 trial with user cell on Galapagos's distributed manufacturing. We are an integrated cell therapy company built from the ground up to design, develop, and deliver cell therapy products to redefine the treatments of solid tumor cancers. And we are now realizing this vision in real time.

Speaker Change: We're also progressing use or sell our next generation cell therapy in the <unk> III trial in ovarian cancer, which is currently enrolling and we will.

Speaker Change: We will be moving forward in partnership with Galapagos in the head and neck cancer Phase one trial with used to sell on Galapagos is distributed manufacturing platform.

Speaker Change: We are an integrated cell therapy company built from the ground up to design develop and deliver cell therapy products to redefine the treatment of solid tumor cancers.

Adrian Rawcliffe: And we are now realizing this vision in real time. And with that, myself and members of the leadership team are happy to take any questions. Operator? We will now begin the question and answer session. To ask a question, you may press star then 1 on your touchtone phone.

Speaker Change: We are now realizing this vision in real time, and with that myself and members of the leadership team are happy to take any questions operator.

Adrian Rockliffe: And with that, myself and members of the leadership team are happy to take any questions, operating.

Operator: We will now begin the question and answer session. To ask a question, you may press star, then one on your touchtone phone. If you are using a speaker phone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then two.

Speaker Change: We will now begin the question and answer session.

Operator: To ask a question, you may press star then 1 on your touchtone phone. If you are using a speakerphone, please pick up your handset before pressing the key. If at any time your question has been addressed and you would like to withdraw your question, please press star then 2. At this time, we will pause momentarily to assemble our roster. The first question today comes from Marc Frahm with T.D. Cowan. Please go ahead.

Speaker Change: To ask a question you May Press Star then one on your Touchtone phone.

Operator: If you are using a speakerphone, please pick up your handset before pressing the. If at any time your question has been addressed and you would like to withdraw your question, please press star then 2. At this time, we will pause momentarily to assemble our roster. The first question today comes from Marc Frahm with T.D. Cowan.

Speaker Change: If you were using a speakerphone please pick up your handset before pressing the keys.

Speaker Change: If at any time. Your question has been addressed and you would like to withdraw your question. Please press Star then two.

At this time, we will pause momentarily to assemble our roster.

Speaker Change: Yeah.

Speaker Change: Okay.

Mark Fram: At this time, the first question today comes from Mark Fram with TD Cowan. Please go ahead.

Speaker Change: The first question today.

Speaker Change: It comes from Marc Frahm with TD Cowen. Please go ahead.

Marc Frahm: Thanks for taking my questions. Maybe just to start out, you mentioned that you've got a few ATCs already loaded on the website. You know, are you seeing patients kind of flow through that website and maybe characterize maybe any new sources of patients that you're seeing in terms of referrals and things like that. I know it's very early days, but just anything you're seeing there.

Mark Fram: Thanks for taking my questions.

Marc Frahm: Please go ahead. Thanks for taking my questions. Maybe just to start out, you mentioned that you've got a few.

Hey, Thanks for taking my questions.

Cintia Piccina: Maybe just start out. I mean, mention that you've got a few ATCs already loaded on the website. Are you seeing patients kind of flow through that website? And maybe characterize any new sources of patients that you're seeing in terms of referrals and things like that. I know it's very early days, but just anything you're seeing there.

Speaker Change: Maybe just start out and you mentioned the <unk> got a few.

Marc Frahm: ATCs already loaded on the website. You know, are you seeing patients kind of flow through that website and maybe characterize maybe any new sources of patients that you're seeing in terms of referrals and things like that. I know it's very early days, but just anything you're seeing.

Speaker Change: A T fees already loaded on the website.

Speaker Change: You are you are you already seeing patients kind of flow through that website.

Speaker Change: Can you characterize maybe the any.

Speaker Change: New sources of patients that you're seeing in terms of referrals and things like that I know, it's very early days, but just anything you're seeing there.

Adrian Rawcliffe: Thanks Mark. I'll ask Cintia Piccina to give us an update on early early patient flows, etc. Thank you for the question. It is really very exciting to see the

Cintia Piccina: Thanks, Mark.

Cintia Piccina: Thanks Mark, I'll ask Cintia Piccina to give you an update on early patient flows, etc. Yeah, thank you for the question. It is really very exciting to see the enthusiasm from not only our treatment centers and future treatment centers as well, but also beyond across other sarcoma centers of excellence now with approval that are very excited to be able to treat patients. So we are aware of patients that started the testing journey there and are in that process of identifying their eligibility for Telsera.

Speaker Change: Thanks, Mark I'll ask <unk> to give us give you an update on <unk>.

Cintia Piccina: I'll ask Cindy Puccina to give you an update on early patient flows, etc. Yeah, thank you for the question. It is really very exciting to see the enthusiasm from not only our treatment centers and future treatment centers as well, but also beyond across other circumstances of excellence. Now, with the approval, that are very excited to be able to treat patients. So we are aware of patients that started the tech journey there in that process of identifying their eligibility for the cell. And the majority of the new sources that we're seeing in terms of questions and interests and having vocational patients to refer to the ATCs are coming from other government centers of excellence across the country.

Speaker Change: The early patient flows et cetera.

Cintia Piccina: Yeah, thank you for the question. It is really very exciting to see the enthusiasm from not only our treatment centers and future treatment centers as well, but also beyond across other sarcoma centers of excellence now with approval who are very excited to be able to treat patients. So we are aware of patients that have started the testing journey. They're in that process of identifying their eligibility for Tessera. And the majority of the new sources that we're seeing in terms of questions and interest and potential patients to refer to the ATCs are coming from other sarcoma centers of excellence across the country.

Speaker Change: Thank you.

Speaker Change: It is really very exciting to see them from not only our treatment centers.

Speaker Change: The treatment centers as well, but also beyond across all their sarcoma centers of excellence now with the approval.

Speaker Change: Very excited.

Speaker Change: So we are aware of patients.

Speaker Change: Johnny Theyre in that process.

Speaker Change: I think you signed up for.

Sure.

Cintia Piccina: And the majority of the new sources that we're seeing in terms of questions and interest and potential patients to refer to the ATCs are coming from other sarcoma centers of excellence across the country. Okay, thank you. Cheers, Matt. The next question comes from Jonathan Chang with Lee Rink Partners. Hey guys, this is Matt Calperon on behalf of Jonathan Chang.

Speaker Change: Alright.

Speaker Change: Daniel.

Speaker Change: In terms of questions and interest in having potential patients should refer to the agency.

Speaker Change: I mean come on the second one that centers of excellence across the country.

Mark Fram: Okay, thank you. Cheers, Mark.

Speaker Change: Okay. Thank you.

Speaker Change: Yes.

Matt Calperon: The next question comes from Jonathan Chang with LiRink Partners. Please go ahead.

Operator: The next question comes from Jonathan Chang with Lerink Partners. Please go ahead.

Speaker Change: The next question comes from Jonathan Chang with Leerink Partners. Please go ahead.

Matt Calperon: Hey guys, this is Matt Calperon for Jonathan Chang. Thank you for taking my question. Could you comment on how the first version affects? Could you comment on how the first version of ADP 600 stands out within the trained targeting space, and additionally, will the initial clinical version incorporate next-generation enhancements like CD8 or those we reserve for future iterations? And if so, with introducing enhancements, be step wise and similar to the major experience. Thanks.

Matt Calperon: Hey guys, this is Matt Calperon on behalf of Jonathan Chang. Thanks for taking my question. Could you comment on how the first version of ADP600 stands out within the PRAME targeting space? And additionally, will the initial clinical version incorporate next generation enhancements like CD8, or will those be reserved for future iterations? And if so, would introducing enhancements be step-wise and similar to the MAGE experience?

Mac helper: Hey, guys. This is Mac helper on for Jonathan Thanks for taking my question could you comment on how the first version.

Matt Calperon: Thanks for taking my question. Could you comment on how the first version of ADP600 stands out within the PRAME targeting space? And additionally, will the initial clinical version incorporate next generation enhancements like CD8, or will those be reserved for future iterations? And if so, would introducing enhancements be stepwise and similar to the MAGE experience?

Adrian Rawcliffe: Thanks. I'm going to ask Joe Brewer, our Chief Scientific Officer, to talk to that Joe. Hi, thanks.

Mac helper: Could you comment on how the first person of ADP six understands out within the crane targeting space and Additionally will the initial clinical version incorporate next generation enhancements like TD eight or those be reserved for future iteration and if so with introducing enhancements be step wise and similar to the major experience. Thanks.

Joe Brewer: So I'm going to ask Joe Brewer, our Chief Scientific Officer, to talk to that Joe. Hi, thanks. So we are looking at next-gen approaches with our ADP 600 program. We are evaluating several in research, and we're looking at how we can bring this forward to the clinic, and we will update on more firm plans with the ADP 600 program in the future.

Joe Brewer: Thanks. I'm going to ask Joe Brewer, our Chief Scientific Officer, to talk to that Joe. Hi, thanks. So we are looking at next-gen approaches with our ADP600 program.

Adrian Rawcliffe: So I'm going to ask Joe Brewer, our Chief Scientific Officer, to talk to that Joe.

Mac helper: Sure So I'm going to ask Jo Brewer, our chief scientific officer to.

Jud: Two two that Jud.

Jo Brewer: Hi, yes.

So we are looking at next Gen approaches with our ADP 600 program and we are evaluating separately and resets and we're looking at how we can bring that forward to the clinic and we will update on in a more fine plans with the ADP 600 program.

Joe Brewer: We are evaluating several in research, and we're looking at how we can bring those forward to the clinic, and we will update you on more firm plans with the ADP600 program in the future. The next question comes from Michael Schmidt with Guggenheim. Please go ahead. Hi, this is Paul.

Speaker Change: Uh huh.

Speaker Change: Thank you.

Paul Schmidt: The next question comes from Michael Schmidt with Guggenheim. Please go ahead.

Operator: The next question comes from Michael Schmidt with Guggenheim. Please go ahead. Hi, this is Paul.

Speaker Change: The next question comes from Michael Schmidt with Guggenheim. Please go ahead.

Paul: Thanks for taking our questions. Just on the ATCs for testosterone, it looks like the five active sites you've put on the website overlap with those that have FAMSL clinical trial experience. Can you speak to roughly what proportion of synovial sarcoma patients are seen in those particular centers? And then how long until the remaining, you know, six to ten that you're targeting for initial sites are onboarded? And can you also comment on expectations for patient capacity in terms of perhaps three to four patients per center, I guess, on a monthly basis? Thank you.

Paul Schmidt: Hi, this is Paul. I'm from Michael. Thanks for taking our questions. Just on the ATC's for Tostel, it looks like there's five active sites you put on the website overlap with those that have a thamousal clinical drug experience. Can you speak to roughly what proportion of synovoscope patients are seen in those particular centers? And then how long until the remaining, you know, six to 10 that you're targeting for initial sites are onboarded? And can you also comment on expectations for patients past three in terms of perhaps three patients per center? Yeah, I guess on a monthly basis.

Paul Jeng: I'm from Michael. Thanks for taking our questions. Just on the ATCs for testosterone, it looks like the five active sites you've put on the website overlap with those that have a fam cell clinical trial experience. Can you speak to roughly what proportion of synovial sarcoma patients are seen in those particular centers?

Paul: Hi, this is Paul. I'm from Michael.

Speaker Change: Hi, This is Paul on for Michael Thanks for taking my questions.

Paul: Just on the ATC for T cell it looks like the five active sites you put on the web site overlap with those that have with Enzo clinical trial experience can you speak roughly what proportion of snowball sarcoma patients are seen in those particular centers and then how long until the remaining six to 10 that you're targeting.

Cintia Piccina: And then how long until the remaining, you know, six to ten that you're targeting for initial sites are onboarded? And can you also comment on expectations for patient capacity in terms of perhaps treated patients per center, I guess, on a monthly basis? Thank you. Cintia.

Speaker Change: Our initial thoughts are on boarded and can you also comment on expectations for patient capacity in terms of perhaps three patients per center.

Speaker Change: I guess on a monthly basis.

Paul Schmidt: Thank you.

Speaker Change: Cynthia.

Paul Schmidt: Thank you for your questions. So, we are planning to board about over time, about getting to 30 ATCs. These ATCs in total represent about 80% of the patients that are in the Tacoma Centers of Excellence today, which we believe to be about 50 to 70% of all the patients, with some of those being common across the country.

Cintia Piccina: Thank you for your questions. So we are planning to onboard about over time to get to 30 ATCs. These ATCs in total represent about 80% of the patients that are in the sarcoma centers of excellence today, which we believe to be about 50 to 70% of all the patients with some sarcoma that are across the country. The ones that we have in our locator tool already, and the ones that are next in line in the process of being finalizing their onboarding are most of them, clinical trial sites for AFAMICEL.

Cintia Piccina: Thank you for your questions. So, we are planning to onboard about, over time, about getting to 30, 80. These ATCs in total represent about 80% of the patients that are in the sarcoma centers of excellence today, which we believe to be about 50 to 70% of all the patients with some sarcoma that are across the country. The ones that we have in our locator tool already and the ones that are next in line in the process of being finalizing their onboarding are most of them.

Speaker Change: Thank you for your question. So we do we are planning some word about overtime about getting to 38.

Speaker Change: Total represent about 80% of the patients that are in the sarcoma centers of excellence, which we believe to be about.

Speaker Change: 7% of all the patients with some of us are coming on that are across the country.

Paul Schmidt: The ones that we have in our locator to already and the ones that are next in line in the process of being finalizing their own boarding are most of them clinical trial sites for a thamousal. And they are the ones that we are planning to be the first ones that will be up and running. They already have experience. We started engaging in them several months ago.

Speaker Change: The ones that we have in our market are two already.

Speaker Change: On Wednesday of next in line in the process.

Finalizing their onboarding.

Most of them clean.

Cintia Piccina: Clinical Trial Sites for AFAMICELL, and they are the ones that we are planning to be the first ones that will be up and running; they already have experience, we started engaging with them several months ago, and then beyond that, some of the other ATCs will be LATICELL sites, and then some others beyond, just based on the volume of patients that they have. And we've not given guidance as to how many patients go through each site on a monthly basis, and it does vary somewhat depending on which site.

Speaker Change: Clinical trial sites for our families now and they are the ones that we are planning should be.

Cintia Piccina: And they are the ones that we are planning to be the first ones that will be up and running. They already have experience. We started engaging with them several months ago. And then beyond that, some of the other ATCs will be LATICEL sites, and then some others beyond, just based on the volume of patients that they see.

Speaker Change: The first one is that it will be up and running do you already have experience started engaging with them.

Several months ago.

Paul Schmidt: And, and then beyond that, some of the other ATCs will be lightest out at the site, and then some others beyond just based on the volume of patients that they see. And we've not given guidance to how many patients go through each site on a monthly basis, and it does vary somewhat depending on which site this.

Speaker Change: And then beyond that some of the other agencies would be lifestyle sites and then some others beyond just based on the volume of patients.

Cintia Piccina: And we've not given guidance as to how many patients go through each site on a monthly basis, and it does vary somewhat depending on which site and Luke Felser.

Speaker Change: And we've not given guidance as to how many patients go through each site on a monthly basis that it does vary somewhat depending on which sizes.

Paul Schmidt: And we expect also that referral base to grow and change significantly now that there is a treatment available for the Novice Tacoma in the specific site. So, you know, as we see that volume coming in, we will see that being reflected in our numbers. Got it.

Cintia Piccina: And we expect that referral base to grow and change significantly now that there is a treatment available for synovial sarcoma at this specific site. So, you know, as we see that volume coming in, we'll see that being reflected in our numbers.

Speaker Change: Also.

Speaker Change: Zero base to grow and change significantly.

Speaker Change: Yes.

Speaker Change: Available for Synovus sarcoma.

Speaker Change: So you know as we see that volume.

Speaker Change: You'll see that being a factor.

Speaker Change:

Speaker Change: Understood.

Operator: Got it. Great. Thank you. And then, perhaps, just a quick follow-up.

Cintia Piccina: Great, thank you. And then perhaps just a quick follow-up. You mentioned that patients don't necessarily have to be tested at a treatment center. So do you have full visibility into sort of real-time testing metrics?

Speaker Change: Yes.

Speaker Change: Got it great. Thank you and then perhaps just a quick follow up you mentioned that patients don't necessarily have to be tested.

Paul Schmidt: Great. Thank you.

Paul Schmidt: And then perhaps just a quick follow-up. So you mentioned that patients don't necessarily have to be tested at the treatment center. So do you have full visibility into sort of real-time testing metrics, you know, how many patients or ID that might be appropriate for treatments and is a possible provide, I guess qualitative updates on that metrics. Thank you.

Speaker Change: So do you have full visibility into sort of real time tracking metrics. How many patients are I need that might be appropriate for treatment and is it possible to provide qualitative updates on that metric. Thank you.

Cintia Piccina: You know, how many patients are ID'd that might be appropriate for treatment? And is it possible to provide, I guess, qualitative updates on that metric? Thank you. So we don't have it, but the testing is approved, and it's available commercially. And they are run by labs that are independent labs that we don't really manage or control. We are going to have visibility into part of the testing metrics, but we don't have visibility into the full number of patients that are being tested. And so for that reason, we're not gonna be providing accurate testing numbers because we don't know what they are; we don't have a way to know what they are specifically.

Paul Schmidt: So we don't have, so the testing is approved and it's available commercially, and they run by labs that are independent labs that we don't really manage or control. We are going to have visibility to part of the testing metrics, but we don't have visibility to the full number of patients that are being tested. And so, for that reason, we're not going to be providing accurate testing numbers because we don't know what they are. We don't have a way to know what they are specifically. We hear anecdotal information; that's why I share that we are aware of patients that are in their testing process, but we're not aware of all of them.

Paul: You mentioned that patients don't necessarily have to be tested at a treatment center. So do you have full visibility into sort of real-time testing metrics? You know, how many patients are ID'd that might be appropriate for treatment? And is it possible to provide, I guess, qualitative updates on that metric? Thank you.

Cintia Piccina: So we don't have them, so the testing is approved, and it's available commercially, and it is run by labs that are independent labs that we don't really manage or control. We are gonna have visibility to part of the testing metrics, but we don't have visibility to the full number of patients that are being tested. And so for that reason, we're not gonna be providing accurate testing numbers because we don't know what they are; we don't have a way to know what they are specifically.

Speaker Change: So.

Speaker Change: We don't have the task of leading the pillows and he is available commercially and they are run by <unk>.

Speaker Change: That our independent labs that we don't really manage or control, we're going to have this ability to part of the testing metrics, but we don't have visibility to the full number of patients that are being tested and so for that reason, we're not going to be providing accurate testing because.

Speaker Change: Don't know.

I don't have a right to know what they are specifically.

Cintia Piccina: We hear anecdotal information, that's why I shared that we are aware of patients that are in the testing process, but we're not aware of all of them. But some of them, when the treatment sites or the centers of excellence share with us, then we are aware of what's happening. The testing can happen anywhere. We did provide on our teraweb.com website the path to testing for both MAJ-4 and HLA as well

Cintia Piccina: We hear anecdotal information, that's why I share that we are aware of patients that are in the testing process, but we're not aware of all of them. But some of them, when the treatment sites or the centers of excellence share with us, then we are aware of what's happening. The testing can happen from anywhere. We did provide on our teraweb.com website the path to testing for both MAJ-4 and HLA as well. And then at the moment that that testing is initiated, then the labs will take over; it just sends it to the lab.

Speaker Change: We hear anecdotal information Thats why I assure that we are aware of patients that are in that testing process, but they're not all that all of that but some of them when their treatment sites or centers of excellence shared with US then we are aware of what's happening.

Paul Schmidt: But some of them, when the treatment sites or the centers of accidents share with us, then we are aware of what's happening. The testing can happen from anywhere.

Speaker Change: The testing can happen from anywhere we did provide in our.

Paul Schmidt: We did provide in our federal.com website the past two testing for both major four and HLA as well. And then, at the moment that that testing is initiated, then, you know, the labs would take over.

Speaker Change: Dot com website.

Speaker Change: The path to testing for both <unk> and HLA as well.

Tony Butler: And then at the moment that that testing is initiated, then the labs will take over; it just sends it to the lab. The next question comes from Tony Butler with Rodman and Renshaw. Please go ahead. Tony, your line is open, you may ask your question. Yes, I'm sorry. Thank you very much. Adrian, I wanted to move to surpass three for a moment.

Speaker Change: And then the moment that that type of initiative.

Speaker Change: The labs at equal or are you just send it to their labs.

Paul Schmidt: We just send it to the labs.

Tony Butler: The next question comes from Tony Butler with Rodman and Rencha. Please go ahead. Tony, your line is open; you may ask your question.

Operator: The next question comes from Tony Butler, with Rodman and Renshaw. Please go ahead. Tony, your line is open. You may ask your question.

The next question comes from Tony Butler, with Rodman and Renshaw. Please go ahead.

Speaker Change: Tony Your line is open you may ask your question.

Tony Butler: Yes, I'm sorry.

Tony Butler: Yes, I'm sorry. Thank you very much. Adrian, I wanted to move to surpass three for a moment.

Speaker Change: Yes, I'm sorry.

Adrian Rockliffe: Adrian, thank you very much. Adrian, I wanted to move to surpass three for a moment. Clinicaltravel.gov to just the 28 sites have been identified. What's interesting, though, is roughly maybe even slightly less than a third in the US, the majority XUS. I assume that's so much strategic, but I guess the question is, will more US sites be open in any thoughts around that? It may not necessarily matter, but the rate of enrollment is kind of important. And then the part two of this question is I would assume, and this is just an assumption that given the ramp and that the trial trial costs, if in fact more sites were to be open, then in fact the 114 million or what's called 230 million a year roughly, in costs would actually ramp, maybe not appreciably but certainly ramp higher than the guides you'd given.

Tony: Thank you very much Adrian I wanted to move to surpass three for a moment.

Adrian Rawcliffe: Fund. ClinicalTrials.gov suggests that 28 sites have been identified. What's interesting, though, is that roughly, maybe even slightly less than a third are in the U.S., the majority being ex-U.S.

Tony:

Adrian Rawcliffe: ClinicalTrials.gov suggests that 28 sites have been identified. What's interesting, though, is that roughly, maybe even slightly less than a third are in the US, the majority are from outside the US. I assume that's somewhat strategic. But I guess the question is, will more U.S. sites be opened? Any thoughts around that? It may not necessarily matter, but the rate of enrollment is kind of important. And then the part two of this question is, I would assume, and this is just an assumption, that given the ramp in that trial trial cost, If, in fact, more sites were to be opened, then, in fact, the $114 million, or let's call it, you know, $230 million a year, roughly, and costs would actually ramp, maybe not appreciably, but certainly higher than the guidance you've given. So, any caller Thanks.

Speaker Change: Clinical trials Gov suggests the 28 sites have been identified what's interesting though is.

Roughly maybe even though slightly less than a third are in the U S. The majority of your ex U S.

Tony Butler: I assume that's somewhat strategic, but I guess the question is... Will more U.S. sites be opened? Any thoughts around that? It may not necessarily matter, but the rate of enrollment is kind of important.

Speaker Change: I assume that's somewhat strategic but I guess the question is.

Operator: All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero.

Speaker Change: It will more U S sites to be opened.

Speaker Change: And any thoughts around that would be not necessarily matter, but the rate of enrollment it's kind of important.

Operator: After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on a touch to an phone. To withdraw your question, please press star then two.

Adrian Rawcliffe: And then the part two of this question is, I would assume, and this is just an assumption, that given the ramp in that trial cost, if in fact, more sites were to be open than in fact the 114 million or let's call it you know 230 million a year roughly, costs would actually ramp, maybe not appreciably but certainly ramp higher than the guidance you've given, so any caller would be helpful. Thanks.

Speaker Change: And then the part two of this question is.

Speaker Change: Would assume this is just an assumption that given the ramp in that.

Speaker Change: While trial costs.

Operator: Please note this event is being recorded.

Speaker Change: If in fact more sites would it be opened and in fact, the 114 million or let's call it $230 million a year roughly.

Dan Odd Cohen: I would now like to turn the conference over to Dan Odd Cohen, investor relations. Please go ahead. Thank you operator.

Dan Odd Cohen: Good morning and welcome to Adaptune's conference call to discuss our second quarter 2024 financial results and business updates. I would ask you to review the full text or forward-looking statements from this morning's press release. We anticipate making projections during this call and actual results could differ materially due to several factors, including those outlines in our latest filings with the SEC.

Speaker Change: And costs would actually ramp.

Speaker Change: Maybe not appreciably, but certainly ramp higher than the guidance you've given so any color would be helpful. Thanks.

Adrian Rockliffe: And so, any column would be helpful. Thanks. Thanks, one night.

Adrian Rawcliffe: Thanks, one night, I'll take a stab at that, and if you have follow-up questions, we can do that too. The majority of the sites that are going to be open for CERPAS3 are already open, and you're right.

Adrian Rawcliffe: Thanks. One night, I'll take it, a stab at that, and if you have follow-up questions, we can do that too. So the majority of the sites that are going to be open for the past three are already open, and you're right, there are a significant number of sites ex-US, and that mirrors the pattern that we've had quite a lot of success recruiting both in the US and ex-US, and just a reminder, we're working with the Gynecological Oncology Group, GOG, to recruit the surpassed three trial, recruitment is going, enrolment is going well at the moment, and we look forward to being able to complete enrolment next year and provide data subsequent to that.

Speaker Change: Okay.

Rod: Thanks Rod.

Adrian Rockliffe: I'll take a stab at that, and if you have follow-up questions, we can do that too. So the majority of the sites that are going to be open for Surpass three are already open. And you're right, there are a significant number of sites XUS and that we're as the pattern that we've had quite a lot of success recruiting both in the US and in the XUS. And just a reminder, we're working with the gynecological oncology group. Go to recruit the Surpass three trial. Recruitment is going well at the moment, and we look forward to being able to complete enrollment next year and provide data subsequent to that.

I'll take it.

Speaker Change: To establish that.

Speaker Change: If you have follow up questions. If we can do that too.

Speaker Change: So the majority of the sites.

Speaker Change: There's going to be open for <unk> three are already open.

Dan Odd Cohen: Adrian Rockliffe, our chief executive officer, is here with me for the prepared portion of the call and other members of our leadership team will be available for Q&A.

Speaker Change: <unk>.

Speaker Change: And Youre right. There are a significant number of sites ex U S and that mirrors the pattern that we've had quite a lot of success recruiting both in the U S side.

Adrian Rawcliffe: There are a significant number of sites outside the U.S., and that mirrors the pattern that we've had quite a lot of success recruiting both in the U.S. and in the ex-U.S. And just a reminder, we're working with the gynecological oncology group, GOG, to recruit the CERPAS3 trial. Recruitment is going well, enrollment is going well at the moment, and we look forward to being able to complete enrollment next year and provide data subsequent to that.

Adrian Rockliffe: With that, I'll turn the call over to Adrian Rockliffe. Add. Thanks Dan, and thanks everyone for joining us. We are incredibly proud that Adaptune is now a commercial stage self therapy company. Following the US FDA approval and the launch of our first product in our sarcoma franchise, T-Cellar. This is a fantastic achievement for the company, for the self therapy field, and for people with synovial sarcoma. T-Cellar is the first engineered cell therapy for a solid tumor, the first medicine in its class, and it's also the first new treatment option for synovial sarcoma in over a decade.

<unk> just a reminder, we are working with the.

Speaker Change: The gynecological oncology group the GOG to recruit the surpassed III trial recruitment is Gary enrollment is going well at the moment and we look forward to being able to complete enrollment next year and provide data subsequent to that.

Adrian Rawcliffe: So that's going well. In terms of the cost, the overall cost profile that I gave is a mix of what you've got to think about is there's also the costs of CERPAS3, which is up and running and ongoing and a significant trial, but also there's been the historic costs over 2023 and 4 of, for example, the spearhead set of trials associated with the approval of T-Cellar. And then also, of course, the ongoing we've got to factor in the ongoing 89 ESO trial and the costs associated with that.

Adrian Rawcliffe: So that's going well. In terms of the cost, the overall cost profile that I gave is a mix of what you've got to think about is there's also the costs of surpassed three, which is up and running and ongoing, and a significant trial, but also there's been the historic costs over the 2020 three and four of, for example, the spearhead set of trials associated with the approval of T-Cellera, and then also, of course, the ongoing, we've got to factor in the ongoing 89 ESO trial and the costs associated with that, now we've taken that over from GSK, and so that's why we're comfortable with the position that our overall run rate will remain relatively consistent, and that includes the fact that we've already recruited and made the investments in the commercial team in the first half of this year, and that's why we believe that the costs will be broadly consistent going forward for the next 18 months. Thanks, Adrian. Appreciate it.

Adrian Rockliffe: So that's going well in terms of the cost. The overall cost profile that I gave is a mix of what you've got to think about. Is also the costs of Surpass Three, which is up and running and ongoing and a significant trial. But also there's been the historic costs over the 2023 and four of, for example, the spearhead set of trials associated with the approval of Ticelra and then also, of course, the ongoing. We've got to factor in the ongoing Ignite Eso trial and the cost associated with that. Now we're taking that over from GSK, and so that's why we're comfortable with the position that our overall run rate will remain relatively consistent. That includes the fact that we've already recruited and made the investments in the commercial team in the first half of this year.

Speaker Change: So that's.

Speaker Change: Well in terms of the cost the overall cost profile that I gave is a mix of what you've got to think about is that all the costs.

Speaker Change: <unk>, three which is up and running and ongoing.

Speaker Change: And a significant trial, but also this has been the historic costs over the 2023 and four.

Adrian Rockliffe: The culmination of groundbreaking R&D, our investment in manufacturing, the demonstrable clinical benefit exhibited throughout development, and incredible execution of the regulatory process. T-Cellar is a vindication of autologous cell therapy for solid tumor cancers, and together with the synovial sarcoma community, we're going to redefine how synovial sarcoma is treated. Launch activities for T-Cellar started the instantly received approval, and we hit the ground running. I want to provide some updates on how T-Cellar's launch is going, bearing in mind that we're only 10 days in.

Speaker Change: For example, the spearhead set of trials associated with the approval of of T cell raw.

Speaker Change: And then also of course the ongoing.

Speaker Change: We've got to factor in the ongoing <unk> trial, and the cost associated with that that would take that over for them.

Adrian Rawcliffe: Now we're taking that over from GSK. And so that's why we're comfortable with the position that our overall run rate will remain relatively consistent. And that includes the fact that we've already recruited and made the investments in the commercial team in the first half of this year. And that's why we believe that that cost will be broadly consistent going forward for the next 18 months.

Speaker Change: From GSK and so that's why we're comfortable with the position that our overall run rate will remain relatively consistent.

Speaker Change: That includes the fact that we've already recruited and made the investments in the in the.

Speaker Change: Commercial team in the first half of this year and that's why we believe that that will be the cost will be broadly consistent going forward for the next 18 months.

Adrian Rockliffe: As synovial sarcoma is a rare disease, treatment is concentrated in sarcoma centers of excellence. We've already recruited, trained and deployed a commercial footprint to deliver T-Cellar after people with sarcoma. Our commercial, meta-fares, manufacturing and supply teams are all in place, and engaging patients, physicians, players and treatment centers. The companion diagnostics of HLA and major A4 testing were approved concurrently with T-Cellar, so healthcare providers can arrange for patients to get tested to establish their biomarker eligibility.

Adrian Rockliffe: And that's why we believe that the cost will be broadly consistent going forward for the next 80 months.

Adrian Rockliffe: Thanks, Adrian; appreciate it. Thanks.

Adrian Rawcliffe: Thanks, Adrian. I appreciate it. Cheers, buddy. The next question is,

Speaker Change: Thanks I appreciate it.

Speaker Change: Got it.

Graig Suvannavejh: The next question comes from Graig Suvannavejh, with Muzouho. Please go ahead. Greg, your line is open. You may now ask your question. Good morning. Sorry about that. Thanks for taking my questions. Let me congratulate you and the team on the approval. It's a great achievement for the customer and for patients as well.

Operator: The next question comes from Graig Suvannavejh with Mizuho. Please go ahead. Craig, your line is open. You may now ask your question.

Adrian Rawcliffe: Cheers, buddy. The next question comes from Graig Suvannavejh with Mizzouho. Please go ahead. Craig, your line is open. You may now ask your question. Hey, good morning, sorry about that.

Speaker Change: The next question comes from Greg Susan off with Mizuho. Please go ahead. Please go ahead.

Speaker Change: Okay.

Speaker Change: Yeah.

Graig Suvannavejh: Hey, good morning. Sorry. Sorry about that.

Speaker Change: Greg Your line is open you may now ask your question.

Adrian Rockliffe: Incidentally, we believe this is the first time that a therapy has been approved together with two new diagnostics at the same time. Adaptimmune Assist, our Patient Support Program is up and running to ensure a personalized experience throughout the treatment journey. And we've previously discussed our plan to activate 6-10 Authorised Treatment Centers during Tisella's launch periods. We're on track to do this. We have 5 ATCs available in our locator school on Tisella.com website and all of our internal systems are in place to accept orders and to manufacture and deliver Tisella.

Adrian Rawcliffe: Thanks for taking my questions. And let me congratulate you and the team on the approval. That's a great achievement for the company and for patients as well. A couple of questions, if I could, just on Maybe a first question on your sales and projection of $400 million. I realize that's for the Sarcoma franchise, and I realize that's for the US. Any color on how we should think about the two products that you have, realizing that Let Us Sell is not yet approved, but how do you think about potentially the split of revenue between those two products?

Speaker Change: Hey, good morning, sorry, sorry about that thanks for taking my questions and let me congratulate you and the team on the approval that's great too.

Graig Suvannavejh: Thanks for taking my questions, and let me congratulate Adieu and the team on the approval. That's a great achievement for the company and for patients as well. A couple of questions if I could, just on... Maybe the first question on your sales and projection of $400 million. I realize that's for the Sarcoma franchise, and I realize that's for the U.S. Any color on how we should think about the two products that you have, realizing that Lettuce Cell is not yet approved, but how do you think about potentially the split of revenue between those two products?

Speaker Change: Treatment for <unk> and for patients as well.

Graig Suvannavejh: A couple of questions I could just on, maybe a first question on your sales and projection of 400 million. I realized that's for the U.S. Any color on how we should think about between the two products that you have, realizing that let us sell is not yet approved, but how you think about potentially the split of revenue between those two products.

Speaker Change: A couple of questions if I could.

Speaker Change: Just on.

Speaker Change: Maybe a first question on your.

Speaker Change: Sales and projection of 400 million I realize that's for the sarcoma franchise and I realize that's for the U S. Any color on how we should think about between the two products that you have realizing that sellers might get approved with how you.

Adrian Rockliffe: Over the next few quarters and pride having trends for patients treated and for sales, we will be updating you on two key performance indicators for launch execution as we go forward. Firstly, the number of ATCs opened and secondly, the number of patients acreaged. As we move through the first half of next year, we will transition to patients treated and obviously to sales as the keymex metrics.

Speaker Change: How you think about potentially the splits are.

Speaker Change: Revenue between those two products.

Graig Suvannavejh: My second question, maybe it is one that you might be reticent to comment on, but just your level of comfort with how the street is currently modeling the launch and revenue over the next, let's call it six quarters as we look at the back half of this year and 2025. I realize that you've been trying to guide us to be relatively gradual and how we think that's going to be, but just wondering if you had an opportunity just to see kind of where the street is and whether you think we are doing a good job with that kind of more gradual approach.

Adrian Rawcliffe: My second question, maybe it is one that you might be reticent to comment on, but just your level of comfort with how the street is currently modeling the launch and revenue over the next, let's call it six quarters as we look at the back half of this year and 2025. I realize that you've been trying to guide us to be relatively gradual and how we think that's going to be, but I was just wondering if you had an opportunity to just see kind of where the street is and whether you think we are doing a good job with that kind of more gradual approach.

Speaker Change: My second question, maybe it is one that.

Speaker Change: Be reticent to comment on but just your level of comfort with how the street is currently modeling the launch and revenue over the next.

Adrian Rawcliffe: I realize that you've been trying to guide us to be relatively gradual and how we think that's going to be, but just wondering if you had an opportunity just to see kind of where the street is and whether we are doing a good job with that. Thanks Greg. So, with respect to the breakdown of the peak US sales estimate for the launch indications for our sarcoma franchise of 400 million, the best way of thinking about that is that the patient split is roughly 40% of famacel, 60% letacel, so 40% t-cellular, 60% letacel, and so the split of that peak year sales estimate, broadly speaking, follows that.

Speaker Change: Let's call it six quarters as we look at the back half of this year and 2025 I realize that you've been trying to guide us to be.

Speaker Change: A relatively gradual and how we think that's going to be but I'm. Just wondering if you've had an opportunity just to see kind of where the street is and where whether you think.

Speaker Change: We are doing a good job with that kind of.

Speaker Change: More gradual.

Adrian Rockliffe: During Q2, we signed a collaboration agreement with Galapagos and entered into a debt facility with Hercules. And at the end of the course, so we have total liquidity of 215. We believe we are well-capitalised to deliver the successful launch of Tisella and also develop the rest of the pipeline.

Speaker Change: Approach.

Adrian Rawcliffe: Thanks Greg. So with respect to the breakdown of the peak US sales estimate for the launch indications for our sarcoma franchise of 400 million, the best way of thinking about that is that the patient split is roughly 40% ephamacel, 60% leticel, so 40% chiselra, 60% leticel, and so the split of that peak year sales estimate broadly speaking follows that. So on your second point, I think the key thing that we've been keen to ensure is that whatever you think the ramp-up of the sales for t-cellera is, and I think you'll appreciate I'm not going to comment specifically on analyst expectations, although I am pleased to see that people have sort of been paying attention over the last six months or so to the opportunity here.

Graig Suvannavejh: Thanks, Greg. So, with respect to the breakdown of the peak U.S. Sales estimate for the launch indications for our sarcoma franchise of 400 million; the best way of thinking about that is that the patient's split is roughly 40% to that peak U.S. Sales estimate, broadly speaking, follows that.

Greg Susan: Thanks, Greg so.

Speaker Change: With respect to the breakdown of the peak U S sales estimate for the launch indications for all saw kind of a franchise.

Speaker Change: A $400 million that the best way of thinking about that is that the patient split is roughly 40% to <unk>, 60%.

Adrian Rockliffe: As we transition into a commercial therapy company, we will move away from extending cash runway guidance given the complexities of estimating future revenues in the near-term as we establish our Sarkaima franchise. And instead, we will provide high-level forward cost guidance alongside regular updates on the commercialisation progress. So in the first half of this year, our total expenditure was approximately $114 million. This included investments preparing for the launch of Tisella as well as hiring and onboarding the commercial team.

Speaker Change: 60% lets say, 40% T cell.

Speaker Change: 60% left to sell and so the split of that peak sales estimate to broadly speaking follows that.

Adrian Rockliffe: So, on your second point, I think the key thing that we've been keen to ensure is that whatever you think the ramp up of the sales for two-cellera is, and I think you all appreciate I'm not going to comment specifically on the analytic expectations, although I am pleased to see that people have sort of been paying attention over the last six months or so to the opportunity here. Whatever you think that ramp up is, I think it's important to recognize that it's frame shifted by two to three months from the launch date. And that's the most important thing to get right in the short term is, and I think by and large people have done, you know, with first sales recognized in the Q4 this year and those being relatively modest, representing the very front end of the patients as they flow through the manufacturing, through the identification and manufacturing, and then get treated in the quarter after launch.

Speaker Change: So on your second point I think I think the key thing that we've been keen to ensure that whatever you think the ramp up of the of the sales.

Adrian Rawcliffe: So, on your second point, I think the key thing that we've been keen to ensure is that whatever you think the ramp-up of the sales for t-cellular is, and I think you'll appreciate I'm not going to comment specifically on analyst expectations, although I am pleased to see that people have sort of been paying attention over the last six months or so to the opportunity here. Whatever you think that ramp-up is, I think it's important to recognize that it's frame-shifted by two to three months from the launch date, and that's the most important thing to get right in the short term.

Speaker Change: For T cell is.

Speaker Change: I think youll appreciate I'm not going to comment specifically on the on the analyst expectations, Although I am pleased to say that people have.

Adrian Rockliffe: For the next 18 months, we expect our run rate operating expenses to be broadly consistent with that are the first half of 2024. We will update this cost guidance as we progress together with the launch metrics that are previously articulated, namely the number of ATCs and the number of patients they've reached.

Speaker Change: So <unk>.

Speaker Change: Been paying attention over the last six months or so too.

Speaker Change: Two the opportunity here.

Speaker Change: Whatever you think that ramp up is I think it's important to recognize that the H frame shifted by by two to three months.

Adrian Rawcliffe: Whatever you think that ramp-up is, I think it's important to recognize that it's frame shifted by two to three months from the launch date, and that's the most important thing to get right in the short term, and I think by and large people have done, you know, with first sales recognized in Q4 this year and those being relatively modest, representing the very front end of the patients as they flow through the through the manufacturing through the identification and manufacturing and So that's the biggest thing that I think has changed, and I do think the analyst community has picked up on that frame shift into Q4 this year.

Graig Suvannavejh: Okay, thank you. And if I could ask one more question, just on Let us Sell.

Speaker Change: From the launch date and that's the most important thing to get right in the short time is and I think by and large people have them with.

Adrian Rawcliffe: And I think, by and large, people have done so, with first sales recognized in Q4 this year, and those being relatively modest, representing the very front end of the patients as they flow through the manufacturing, through the identification and manufacturing, and then get treated in the quarter after launch. So, that's the biggest thing that I think has changed, and I do think the analyst community has picked up on that frame-shift into Q4 this year.

Speaker Change: With us sales recognized in Q4, this year and those being relatively modest representing the very front end of the of the patients as they flow through the <unk>.

Through the manufacturing through the identification of manufacturing and then get treated and they.

Speaker Change: At quarter after launch.

Graig Suvannavejh: So that's the biggest thing that I think has changed, and I do think the analyst community has picked up on that frame shift into Q4 this year. Okay, thank you.

Speaker Change: Yes.

Speaker Change: The biggest thing that I think has changed and I do think the analyst community.

Speaker Change: That has picked up on that frame shifted to Q4 this year.

Adrian Rockliffe: And as Letticell also targets soft tissue Sarkaima's, the commercial footprint is essentially identical to Tisella, and we expect the significant channel synergies once we launch Letticell. We're also progressing user cell, our next generation cell therapy, in the surpassed three trial in Ovarian cancer, which is currently enrolling, and we'll be moving forward in parts with Galapagos in a head and neck cancer phase 1 trial with user cell on Galapagos's distributed manufacturing.

Graig Suvannavejh: You might have mentioned this in your prepared comments; I might have missed it. But what are the gating steps for that BLA submission? And maybe just to follow up, are you anticipating that we will have the additional data on Let us Sell before you file? Or is the data, from your perspective, already out there? And pretty much, we have what we, or the, you know, we have basically a view of the data that are available for the product. Thanks. Thanks, Graig.

Speaker Change: Okay. Thank you and then if I could ask one more just on the plate.

Graig Suvannavejh: Thank you. And if I could ask one more, just on the subject of let us, let us sell. You might have mentioned this in your prepared comments, but I might have missed it.

Graig Suvannavejh: And then if I got to ask one more, just on let us let us out, you might have mentioned this in your prepared comments; I might have missed it. But what are the gating steps for that BLA submission and maybe just a follow-up? Are you anticipating that we will the additional data on let us out before you file, or is the data from your perspectives already out there and, and pretty much we have what we, you know, we have basically a view of the data that are available for the product.

Speaker Change: Let us let us know.

Speaker Change: You might have mentioned this in your prepared comments I might've missed it but what are the gating steps for that BLA submission and maybe just a follow up are you anticipating that we will need.

Speaker Change: The additional data on let us sell before you file or is that data from your perspective 40 out there and then pretty much we have with us.

Adrian Rockliffe: We are an integrated cell therapy company built from the ground up to design, develop and deliver cell therapy products to redefine the treatments of solid tumor cancers. And we are now realising this vision in real time.

Dennis Williams: But what are the gating steps for that BLA submission? And maybe just a follow-up? Are you anticipating that we will receive the additional data on let us sell before you file? Or is the data, from your perspective, already out there, and pretty much we, or the, you know, we have basically a view of the data that are available.

Speaker Change: We have basically a view of the data that are available for that product. Thanks.

Dennis Williams: Thanks. Thanks, Greg.

Adrian Rawcliffe: Thanks Greg. I'll ask Dennis Williams to comment on those questions.

Dennis Williams: Thanks Greg. I'll ask Dennis Williams to comment on those questions. Yeah, sure. So I would say that, you know, for lettuce salad, it follows the exact same regulatory pathway that we did for cell rep, so we need a companion diagnostic.

Greg Susan: Thanks, Greg.

Dennis Williams: All of Dennis Williams to comment on those questions. Yeah, sure. So I would say that, you know, for Let Us Out, it follows the exact same regulatory pathway that we did for To Solve. So we need a companion diagnostic. We need to supply the clinical data from Ignite Ezo. Sam's the information. And so basically all the exact same paradigm that we did for to sell.

Greg Susan: Dennis Williams to comment on those questions.

Speaker Change: Got it.

Dennis Williams: Yes, sure. So, I would say that, you know, for letacell, it follows the exact same regulatory pathway that we did for cell rep. So we need a companion diagnostic. We need to supply the clinical data from IGNITE-ESO, CMC information, and So basically, it will follow the exact same paradigm that we did for Tesla. I will say that we are looking forward to presenting primary data from the IGNITE-ESO trial later this calendar year.

Dan Odd Cohen: And with that, myself and members of the leadership team are happy to take any questions, operating. We will now begin the question and answer session. To ask a question, you may press star than one on your touchtone phone. If you are using a speaker phone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star than two.

Dennis Williams: Yeah sure so I would say that.

Dennis Williams: You know for let us sell it follows the exact same regulatory pathway that we did for to sell rep.

Speaker Change: So we need a companion diagnostic we.

Dennis Williams: We need to supply the clinical data from IGNITE-ESO, CMC information, and So basically, it will follow the exact same paradigm that we did for Tesselra. I will say that we are looking forward to presenting primary data from the IGNITE ESO trial later this year. Leader of this calendar year.

Speaker Change: We need to supply the clinical data from ignite Zoe.

Speaker Change: CMC information.

Speaker Change: And.

Speaker Change: So basically with all the exact same paradigm that we did for silver up I will say that we are looking forward to presenting primary data from the ignite <unk> trial later this year.

Graig Suvannavejh: I will say that we are looking forward to presenting primary data from the Ignite Ezo trial later this calendar year. Okay, thank you very much. Congratulations again on all of the achievements and progress.

Speaker Change: Later this calendar year.

Graig Suvannavejh: Okay, thank you very much. Congratulations again on all of your achievements and progress.

Speaker Change: Okay. Thank you very much congratulations again on all of them.

Mark Fram: At this time, the first question today comes from Mark Fram with TD Cowan.

Speaker Change: The achievements and progress.

George Farmer: Thank you, Greg.

Greg Susan: Thanks, Greg.

George Farmer: The next question comes from George Farman with Scotia Bank. Please go ahead. Hi, great. Thanks for taking my questions.

Operator: The next question comes from George Farman with Gosia Bank. Please go ahead.

Graig Suvannavejh: Okay, thank you very much. Congratulations again on all of the achievements. Thank you. The next question comes from George Farman with Gosia Bank. Please go ahead. Hi.

Greg Susan: The next question comes from George Farmer with Scotiabank. Please go ahead.

Cintia Piccina: Please go ahead. Thanks for taking my questions. Maybe just start out. I mean, mention that you've got a few ATCs already loaded on the website. Are you seeing patients kind of flow through that website? And maybe characterize any new sources of patients that you're seeing in terms of referrals and things like that. I know it's very early days, but just anything you're seeing there. Thanks, Mark.

George Farmer: Hi. Great.

George Farmer: Hi, great. Thanks for taking my questions.

George Farmer: Thanks for taking my questions. I just want to ask about the absence of MRCLS on the label for Telsera. I'm wondering what sort of conversations went on with FDA and whether that really matters. Certainly, you have LetaCell coming up, and then also with LetaCell, I understand, I believe the product is manufactured in the UK. Is that where commercial material will ultimately be originating from, and are there efforts underway to bring manufacturing over to the U.S.?

Dennis Williams: I just want to ask about the absence of MRCLS on the label for Tulsa, for to sell. I'm wondering, you know, what sort of conversations went on with FDA. And does that really matter? Certainly, you have let us sell coming up. And then also with let us sell, I understand I believe the product is manufactured in the UK.

George Farmer: Great. Thanks for taking my questions. I'm going to ask about... MRCLS. Sourat Fort, Sourat.

George Farmer: Wanted to ask.

George Farmer: Ask about.

Speaker Change: The absence of MRC L. S on the label for <unk>. So it for it to sell I'm wondering you know what sort of conversations that went on with FDA and does that really matter I certainly you have let yourself coming up.

George Farmer: I was wondering, you know, what sort of conversations went on with FDA and does that really matter? Certainly you have blood cell coming, and then also..., with Leticel. As far as I know, I believe the product is manufactured in the UK.

Speaker Change: And then also.

Speaker Change: With let us sell I understand I believe the product is manufactured in the U K.

John Lunger: Is that where commercial material will ultimately be originally originating from, and are there efforts underway to bring manufacturing over to the US?

Cintia Piccina: And the majority of the new sources that we're seeing in terms of questions and interests and having vocational patients to refer to the ATCs are coming from other government centers of excellence across the country. Okay, thank you. Cheers, Mark.

Speaker Change: Is that where the commercial material will ultimately be originally originating from and are there efforts underway to bring manufacturing over to the U S.

Speaker Change: Yeah.

Dennis Williams: So I'm going to ask Dennis to talk about the label for the data for T-celler from the Spare Head One trial and the MRCLS portion of that.

John Lunger: Is that where commercial material will ultimately be originating from and are there efforts underway to bring manufacturing? So I'm going to ask Dennis to talk about the label for, and the data for T-Cellra from the Spearhead 1 trial and the MRCLS portion of that. And then I'm going to ask John Lunger to talk about the manufacturing for LeteCell for approval and launch.

Adrian Rawcliffe: So I'm going to ask Dennis to talk about the label for, and the data for T-Cellera from the Spearhead 1 trial and the MRCLS portion of that. And then I'm going to ask John Lunger to talk about the manufacturing of LeteCell for approval and launch. Thank you. Thank you.

Okay.

Speaker Change: So I'm going to ask.

Dennis Tito: Dennis Tito.

Speaker Change: About the label for the data for T cell raw.

Speaker Change #100: From the spearhead one trial in the MLR CLS portion of that and then I'm going to ask John loan got to talk about the manufacturing for let's say sell.

Dennis Williams: And then I'm going to ask John Longer to talk about the manufacturing for let us sell for the approval of George Dennis. Yeah, sure. So, I mean, we made the decision to not pursue mixed with rounds of liposarcoma as a labeled indication sometime ago, and it really came down to the fact that the trial spirit bomb was overwhelming with synovial sarcoma. So it would be challenging, I think, you know, for regulatory review to have such limited patient numbers that there were only eight patients with except around cell liposarcoma treated in a trial. And we just thought that it would add a lot of regulatory burden to an application where we really wanted to get the approval in Synovial sarcoma.

Speaker Change #100: For the approval and launch Dennis.

Dennis Williams: Yeah, sure. But we made the decision to not pursue mixed with brown cell liposarcoma as a labeled indication some time ago, and it really came down to the fact that the trial spearhead one was overwhelmingly synovial sarcoma. So, it would be challenging, I think, you know, for a regulatory review to have such limited patient numbers. There were only eight patients with myxoid around cell liposarcoma treated in a trial, and we just thought that it would add a lot of regulatory burden to an application where we really wanted to get the approval for synovial sarcoma. As you mentioned, right now that we have lettuce cell, this is less Lettuce cell is... The only use of one expression in mixed or round cell liposarcoma is much higher than MeGa4 expression and Mixed Red Round Cell Liposarcoma.

Dennis Williams: Yeah, sure. But we made the decision to not pursue mixed with brown cell liposarcoma as a labeled indication some time ago, and it really came down to the fact that the trial spearheaded one was overwhelmingly synovial sarcoma. So, it would be challenging, I think, for a regulatory review to have such limited patient numbers. There were only eight patients with myocardial infarct, so I left the sarcoma treated in a trial, and we just thought that it would add a lot of regulatory burden to an application where we really wanted to get the approval for synovial sarcoma.

Dennis: Yeah sure. So I mean, we made the decision to not pursue it makes it a brownfield LAPIS arkoma as a.

Speaker Change #102: Labeled indication sometime ago and it really came down to the fact that the trial.

Matt Calperon: The next question comes from Jonathan Chang with LiRink Partners. Please go ahead. Hey guys, this is Matt Calperon for Jonathan Chang. Thank you for taking my question. Could you comment on how the first version affects?

John: So you heard bump was overwhelmingly so it'll be all sarcoma.

John: So.

John: It would be challenging I think for a regulatory review times, such limited patient numbers, there were only eight patients with et cetera, and so I'll, let the sarcoma.

Matt Calperon: Could you comment on how the first version of ADP 600 stands out within the trained targeting space and additionally will the initial clinical version incorporate next-generation enhancements like CD8 or those we reserve for future iterations. And if so, with introducing enhancements be step wise and similar to the major experience. Thanks.

John: Treated in our trial and we just thought that.

John: It would without a lot of regulatory burden to an application, where we really wanted to get the approval and snowmobile sarcoma.

Dennis Williams: As you mentioned, right now that we have Letacel, this is less of a concern for us. Letacel is, The NYESA-1 expression in mixed red round cell liposarcoma is much higher than the MAGIE-4 expression in mixed red round cell liposarcoma. From a target perspective, let us sell it is, you know, where expression is north of 80% of that population is a much more appropriate target to pursue for that indication.

Dennis Williams: As you mentioned, right now that we have, let us sell. This is less of a concern for us on let us sell is. The only use of one expression in Mixed Red Round Cell liposarcoma is much higher than magicore expression in Mixed Red Round Cell liposarcoma. So, from a target perspective, let us know where expression is in north of 80% of that population is much more appropriate target to pursue for that indication. And John.

Speaker Change #104: As you mentioned right now that we have let us sell I'm. This is less of a concern for us and let us sell is.

Joe Brewer: So I'm going to ask Joe Brewer, our Chief Scientific Officer, to talk to that Joe. Hi, thanks. So we are looking at next-gen approaches with our ADP 600 program. We are evaluating several in research and we're looking at how we can bring this forward to the clinic and we will update on more firm plans with the ADP 600 program in the future.

Speaker Change #104: Then we used to one expression and myxoid round. So lipid sarcoma is much higher the major core expression.

Speaker Change #104: It makes it round cell type of sarcoma so.

John Lunger: From a target perspective, let us sell it is, you know, where expression is north of 80% of that population is a much more appropriate target to pursue for that indication, and John. Yeah, hi. So, as far as the manufacturing of Ledacel is concerned, the actual manufacturing that was primarily done for the IGNITE trial was done by a contract manufacturer in Germany, not the UK.

From a target perspective, let us sell is a you know we're expression is north of 80% of that population is.

Speaker Change #104: As a much more appropriate target.

Speaker Change #104: A suite for that indication.

John: And then John.

John Lunger: Yeah, hi. So, as far as the manufacturing of let us sell, the actual manufacturing that was primarily done for the Ignite trial was in a contract manufacturer in Germany, not to UK. So, as you can imagine, our primary objective is speed to market for Let us sell.

John Lunger: Yeah, hi. So as far as the manufacturing of Ledacel, the actual manufacturing that was primarily done for the IGNITE trial was done by a contract manufacturer in Germany, not the UK. So, as you can imagine, our primary objective is speed to market for Ledacel, and so making changes to the supply chain related to that particular filing is probably a risk that we don't necessarily want to take. However, we are looking at adding a U.S. site, whether that's our own or another CDMO, in the future to the Ledacel supply chain to better enable supply into the system.

John: Yeah, Hi, so as far as the manufacturing of let itself. The actual manufacturing that was primarily done for the ignite trial was in the contract manufacturer in Germany. The U K.

Paul Jeng: The next question comes from Michael Schmidt with Guggenheim. Please go ahead. Hi, this is Paul, I'm from Michael. Thanks for taking our questions. Just on the ATC's for Tostel, it looks like there's five active sites you put on the website overlap with those that have a thamousal clinical drug experience. Can you speak to roughly what proportion of synovoscope patients are seen in those particular centers? And then how long until the remaining, you know, six to 10 that you're targeting for initial sites are on boarded? And can you also comment on expectations for patients past three in terms of perhaps three patients per center? Yeah, I guess on a monthly basis. Thank you.

George Farmer: So, as you can imagine, our primary objective is speed to market for Ledacel, and so making changes to the supply chain related to that particular filing is probably a risk that we don't necessarily want to take. However, we are looking at adding a U.S. site, whether that's our own or another CDMO, in the future to the Ledacel supply chain to better enable supply into the U.S. The next question comes from Arthur He with HC Wainwright. Please go ahead. Hey, good morning, team.

John: So as you can imagine.

Speaker Change #105: Our primary objective is speed to market for let us sell and so making changes to the supply chain related to that particular filing.

John Lunger: And so making changes to the supply chain related to that particular filing is probably a risk that we don't necessarily want to take. However, we are looking at adding a US site, whether that's our own or another CDMO. For the future to the let us sell supply chain to, you know, to better enable the supply into the states. Great.

There's probably a risk and we don't necessarily want to take however, we are looking at adding a U S site, whether that's our own or another C. D M O for.

Speaker Change #105: For the future to the letter cell supply chain to better enabled to supply into the states.

George Farmer: Great, thanks for that, and congratulations on all the progress.

Great. Thanks for thanks for that and congratulations on all the progress.

George Farmer: Thanks for thanks for that and congratulations on all the progress. Nice job.

Josh: Thanks, Josh.

Arthur He: The next question comes from Arthur. He with H.C. Wayne Wright.

Operator: The next question comes from Arthur He with H.C. Wainwright. Please go ahead, www.cdc.gov.au

Speaker Change #107: The next question comes from Arthur He with H C. Wainwright. Please go ahead.

Arthur He: Please go ahead. Hey, good morning, team. Thanks for taking my question. So, I had two questions. So, first, thanks for the update on the onboarding for the ATC. But at the same time, just curious, could you guys give us the onboarding progress for those Center of Excellence for as a referral network? How should we think about those things to support the launch? Did you? Sure. So, yes, we do have a lot of activity going on with the sites that we will eventually become authorized the treatment centers and also to the sarcoma centers of excellence that will be referring patients to the future ATCs.

Paul Jeng: Thank you for your questions. So we, we are planning to board about over time, about getting to 30 ATCs. These ATCs in total represent about 80% of the patients that are in the Tacoma Centers of Excellence today, which we believe to be about 50 to 70% of all the patients with some of those are common that are across the country. The ones that we have in our locator to already and the ones that are next in line in the process of being finalizing their own boarding are most of them clinical trial sites for a thamousal.

Arthur He: Hey, good morning team. Thanks for taking my question. So first, thanks for the update on the onboarding for the ATCs. But at the same time, just curious, could you guys give us the onboarding progress for those centers of excellence as a referral network? How should we think about those things to support alumni?

Arthur He: Thanks for taking my question. So first, thanks for the update on the onboarding for the ATCs. But at the same time, just curious, could you guys give us the onboarding progress for those centers of excellence as a referral network? How should we think about those things to support alumni, Silvia?

Arthur He: Hey, good morning team.

Arthur He: For taking my question, so I had two questions. So.

Arthur He: First thanks.

Speaker Change #109: Thanks for the update on the on boarding for the ATC.

Speaker Change #110: On the same time, just curious could.

Speaker Change #110: Could you guys give us the onboarding progress toward those.

Center of excellence for as the referral network.

Speaker Change #111: How should we think about dosing to support the launch.

Speaker Change #111: Cynthia.

Cintia Piccina: Sure, so yes, we do have a lot of activity going on with the sites that will eventually become authorized treatment centers and also with the sarcoma centers of excellence that will be referring patients to the future ATCs. So our field teams across both medical affairs and commercial target both the future ATCs and current ATCs and beyond. So that work has already started in terms of educating the broader sarcoma centers of excellence about the new biomarkers, the importance of testing patients as early as possible, and then referring the patients that are positive for both biomarkers to the treatment sites. So that work has started with our field teams, and we'll see these referrals have already started coming in through the ATCs. Awesome. Thanks.

Cintia Piccina: Sure, so yes, we do have a lot of activity going on with the sites that will eventually become authorized treatment centers and also with the sarcoma centers of excellence that will be referring patients to the future ATCs. So our field teams across both medical affairs and commercial target both the future ATCs and current ATCs and beyond. So work has already started in terms of educating the broader sarcoma centers of excellence about the new biomarkers, the importance of testing patients as early as possible, and then referring patients that are positive for both biomarkers to treatment sites.

Speaker Change #111: Sure. So yes, we do have a lot of activity going on.

Speaker Change #111: The sites that we would think.

Paul Jeng: And they are the ones that we are planning to be the first ones that will be up and running. They already have experience. We started engaging in them several months ago. And, and then beyond that, some of the other ATCs will be lightest out at the site and then some others beyond just based on the volume of patients that they see. And we've not given guidance to how many patients go through each site on a monthly basis, and it does vary somewhat depending on which site this.

Speaker Change #111: Should it become.

Speaker Change #112: I'll try to treatment centers and also to the sarcoma centers of excellence that we will be referring patients to the future Egypt. So our field teams across both medical affairs and <unk>.

Cintia Piccina: So, our field teams across both medical affairs and commercial target both the future ATCs and current ATCs and beyond. So, that already, that work already started in terms of educating the broader sarcoma centers of excellence into the new biomarkers, the importance of testing patients as early as possible. And then into referring the patients that are positive to both biomarkers to the treatment sites. So, that work started with our few teams, and we will see these referrals already started to coming through the ATCs.

Speaker Change #112: So target.

Speaker Change #112: The future agencies and current agencies and beyond so that already that where can I. Just started in terms of educating the broader sarcoma centers of excellence into the new biomarkers the importance of testing patients.

Paul Jeng: And we expect also that referral base to grow and change significantly now that there is a treatment available for the Novice Tacoma in the specific site. So, you know, as we see that volume coming in, we will see that being reflected in our in our numbers. Got it. Great. Thank you. And then perhaps just a quick follow up. So you mentioned that patients don't necessarily have to be tested at the treatment center.

Speaker Change #112: <unk> and then into referring to patients that are positive simple biomarkers should the treatment sites. So that work started with a few teams and.

Cintia Piccina: So that work has started with our field teams, and we'll see these referrals already starting to come in through the ATCs. Awesome, thanks Cintia. And my second question is regarding the lettuce sale. Before you guys submit the rolling submission of the DOA, do you still need to meet with the FDA? And if so, when or under what circumstances can you request the meeting?

Speaker Change #112: So we will see these referrals already starting to come into the <unk>.

Arthur He: Awesome.

Cintia Piccina: And my second question is regarding the lettuce sale. Before you guys submit the rolling or submit the DOA, do you still need to meet with the FDA? And if so, when or under what circumstances can you request the meeting?

Speaker Change #112: Awesome. Thanks.

Arthur He: Thanks. And my second question is regarding the let the sale. So, could you? So, is there before you guys submit the rolling submission with the UI, do you still need to meet with the FDA? And if so, when or under what circumstance you can request the meeting? Okay. Yeah, sure. I mean, we've already had meetings with the FDA, and we will continue to have meetings with the FDA.

Paul Jeng: So do you have full visibility into sort of real-time testing metrics, you know, how many patients or ID that might be appropriate for treatments and is a possible provide, I guess qualitative updates on that metrics. Thank you. So we don't have, so the testing is approved and it's available commercially, and they run by labs that are independent labs that we don't really manage or control. We are going to have visibility to part of the testing metrics, but we don't have visibility to the full number of patients that are being tested.

Speaker Change #113: And my second question is regarding the let the sale.

Speaker Change #113: So could you is there.

Speaker Change #114: Before you guys submit the rolling submission of a BLA.

Speaker Change #115: Do you still need to meet.

Speaker Change #115: And if so.

Speaker Change #116: And when or as the worst circumstance you can request.

Speaker Change #115: Meeting.

Speaker Change #115: Okay.

Speaker Change #115: Dennis.

Dennis Williams: Yeah, sure. I mean, we've already had meetings with the FDA, and we will continue to have meetings with the FDA. This is really the advantage of having, in this case, Letocell has breakthrough therapy designation. And one of the main advantages of that is to have frequent interactions with regulatory agencies. So we'll be talking about a lot of things related to the rolling submission, you know, how the application should be organized. I mean, some of this. To be fair, like an earlier comment, I mean, some of what we'll do at Let Us Sell is a bit of... excuse the expression, rinse and repeat of what we did with Tessera.

Dennis Williams: Yeah, sure. I mean, we've already had meetings with the FDA, and we will continue to have meetings with the FDA. This is really the advantage of having, in this case, Letocell, breakthrough therapy designations. And one of the main advantages of that is to have frequent interactions with Regulatory Agencies. So we'll be talking about a lot of things related to the rolling submission, you know, how the application should be organized. I mean, some of this... To be fair, like an earlier comment, some of what we'll do at Let Us Sell is a bit of... Excuse the expression, rinse and repeat of what we did with Tessera, but there are definitely some things that are unique, right? There are two different populations in this data set.

Dennis: Yeah sure I mean, we've already had meetings with the FDA and we will continue to have meetings with the F. D. A.

Dennis Williams: This is really the advantage of having, in this case, let us all as Breakthrough Therapy Designation. One of the main advantages of that is to have frequent interactions with regulatory agencies. So we'll be talking about a lot of things related to the rolling submission, you know, how the application should be organized. I mean, some of this, to be fair, like an earlier comment. I mean, some of what we'll do with Let Us Sell is a bit of, excuse the expression, rinse and repeat of what we did with Tissera, but there are definitely some things that are unique, right?

Dennis: Really the advantage of having in this case, a lessor has breakthrough therapy designation.

Paul Jeng: And so, for that reason, we're not going to be providing accurate testing numbers because we don't know what they are. We don't have a way to know what they are specifically. We hear anecdotal information that's why I share that we are aware of patients that are in their testing process, but we're not aware of all of them. But some of them, when the treatment sites or the centers of accidents share with us, then we are aware of what's happening.

Dennis: One of the main advantages of that is to have frequent interactions with.

Dennis: Regulatory agencies, so we will be talking about a lot of things related to that.

Speaker Change #117: The rolling submission you know how the application should be organized I mean, some of this to be fair I'm like an earlier comment I mean, some of what we will do it let us tell us a bit of.

Speaker Change #118: Excuse the expression of a rinse and repeat of what we did with the silver.

Paul Jeng: The testing can happen from anywhere. We did provide in our federal.com website the past two testing for both major four and HLA as well. And then at the moment that that testing is initiated, then, you know, the labs would take over. We just send it to the labs.

Dennis Williams: But there are definitely some things that are unique, right? There are two different populations in this data set. And, you know, so they're in, you know, and as John mentioned about the supply chain aspect, so there are some differences. But in general, I would expect to have many meetings between now and the submission of the rolling BLA next year.

Speaker Change #118: But there are definitely some things that are unique right. There's two different populations in this dataset.

Dennis Williams: There's two different populations in this data set. And, you know, so they're in, you know, and as John mentioned about the supply chain aspect. So there are some differences, but in general, I would expect to have many meetings between now and the submission of the rolling submission to be late next year. Oh, great. Thanks, Dan.

Dennis Williams: And you know, so they're in, you know, and as John mentioned about the supply chain aspect, so there are some differences, but in general, I would expect to have many meetings between now and the submission of the rolling BLA next year. Well, great. Thanks, Dennis, and talk to you guys soon. Thanks. The next question comes from Yanan Zhu with Wells Fargo. Please go ahead.

Speaker Change #119: And you know so there and you know.

Speaker Change #119: And as John mentioned about the supply chain aspects. So there are some differences but in general.

John: I would expect to have many meetings between now and then.

John: Submission of the Rolling BLA.

B a late next year.

Arthur He: Well, great. Thanks, Dennis. And I'll talk to you guys soon.

Speaker Change #120: Oh, great. Thanks, guys and talk to you guys soon.

Arthur He: And I'll talk to you guys soon. Thanks.

Tony Butler: The next question comes from Tony Butler with Rodman and Rencha. Please go ahead. Tony, your line is open, you may ask your question. Yes, I'm sorry. Adrian, thank you very much. Adrian, I wanted to move to surpass three for a moment. Clinicaltravel.gov to just the 28 sites have been identified. What's interesting though is roughly maybe even slightly less than a third in the US, the majority XUS. I assume that's so much strategic, but I guess the question is, will more US sites be open in any thoughts around that?

Speaker Change #120: Thanks.

Michael Kim: The next question comes from Jan and Shu with Wells Fargo. Please go ahead. Hi, thanks for taking our question and contrast on the progress.

Operator: The next question comes from Yanan Zhu with Wells Fargo. Please go ahead. All right.

The next question comes from Kevin <unk> with Wells Fargo. Please go ahead.

Yanan Zhu: Hi, thanks for taking our question. Congratulations on the progress. This is Kuan Ang for Yanan.

Speaker Change #120: Hi, Thanks for taking our question congrats on the progress. This is Colin on for Ya Man. So can you share with us the overall timeline from patient screening to the infusion like roughly how long does it take and and which part of the process can be sandler.

Michael Kim: This is Kuan Ang for Jan. So can you share with us the overall timeline from patient screening to the infusion, like roughly how long does it take and which part of the process can be a seller. Thank you. Sure. So the timeline is between patient screening and infusion over time. The testing can take a few weeks if you do both testing parallel. And then from the time in which the aphoristic place all the way into the infusion can be received back into the site, to the patient, it takes about 30 days. At the beginning of this process, because the testing just approved, and we have to go also through the reimbursement journey and the referral pattern from the beginning, we believe that the first patient is going to take a little bit longer into the whole process. You know, can get more on a faster pace.

Kuan Ang: So can you share with us the overall timeline from patient screening to the infusion, like roughly how long it takes and which part of the process can be accelerated? Thank you. Cintia.

Kuan Ang: So can you share with us the overall timeline from patient screening to the infusion? Like roughly how long does it take? And which part of the process can be accelerated?

Kuan Ang: Thank you.

Speaker Change #121: Thank you.

Speaker Change #121: Cynthia.

Cintia Piccina: Sure, so the timelines between patient screening and infusion, over time, the testing can take a few weeks if you do both tests in parallel, and then from the time in which the apheresis takes place all the way until the infusion can be received back into the site for the patient, it takes about 30 days. At the beginning of this process, because the testing just got approved, and we have to go through the reimbursement journey and the referral pattern from the beginning, we believe that the first patient is going to take a little bit longer until the whole process can get going more on a faster pace, and so that's why we're anticipating being able to treat our first patients in the first quarter of the year.

Cintia Piccina: Sure, so the timelines between patient screening and infusion over time, the testing can take a few weeks if you do both tests in parallel. And then from the time in which the apheresis takes place all the way until the infusion can be received back into the site for the patient, it takes about 30 days. At the beginning of this process, because the testing just got approved, and we have to go through the reimbursement journey and the referral pattern from the beginning, we believe that the first patient is gonna take a little bit longer until the whole process can get going more on a faster pace. And so that's why we're anticipating being able to treat our first patients in the first quarter of the year. I got it. Thank you so much for that.

Speaker Change #122: Sure so the timeline between patient screening and infusion overtime.

Speaker Change #123: The testing can take.

Cynthia: A few weeks distributable tests in parallel and then from the time in which the a freeze take place all the way into the infusion can be received back into the site to the patient.

Tony Butler: It may not necessarily matter, but the rate of enrollment is kind of important. And then the part two of this question is I would assume, and this is just an assumption that given the ramp and that the trial trial costs, if in fact more sites were to be open, then in fact the 114 million or what's called 230 million a year roughly, in costs would actually ramp, maybe not appreciably but certainly ramp higher than the guides you'd given. And so any column would be helpful. Thanks. Thanks, one night.

Speaker Change #125: Takes about 30 days.

Speaker Change #125: At the beginning of the process because the testing just got approved and we have to go also to reimbursement.

Speaker Change #125: Journey and the referral pattern.

Speaker Change #125: From the beginning we believe that the first patient is going to take a little bit longer into the whole process.

Speaker Change #126: Can get more on a faster.

Speaker Change #126: Faster piece and so that's why we are anticipating to be able to treat our first patient in the first quarter of the year.

Adrian Rockliffe: And so that's why we are anticipating to be able to treat our first patients in the first quarter of the year.

Adrian Rockliffe: Thank you so much for that. And when do you expect to have broad payer coverage? Thank you. So right now, in terms of Medicare, we already have it's already available. It's covered for commercial patients. We expect similar coverage than what we see for parties at the beginning. It usually is through a single case negotiation with the payers and to policies established, but it doesn't mean that we do have coverage; only that it can take a little bit longer because it will be through single case. So we expect that you have a good coverage at the beginning; it may take just a little longer.

Cintia Piccina: And when do you expect to have a broad Peer Coverage? Thank you. So right now, in terms of Medicare, we already have, it's already available, it's covered for commercial patients. We expect similar coverage than what we see for CAR T's. In the beginning, it usually is through a single case negotiation with the payers until a policy is established, but that doesn't mean that we do have coverage, only that it can take a little bit longer because it will be through single case agreements until a rate is established moving forward.

Kuan Ang: Got it. Thank you so much for that. And when do you expect to have broad payer coverage? Thank you.

Adrian Rockliffe: I'll take a stab at that and if you have follow up questions, we can do that too. So the majority of the sites that are going to be open for surpass three are already open. And you're right, there are a significant number of sites XUS and that we're as the pattern that we've had quite a lot of success recruiting both in the US and in the XUS. And just a reminder, we're working with the gynecological oncology group, go to recruit the surpass three trial recruitment is going well at the moment and we look forward to being able to complete enrollment next year and provide data subsequent to that.

Speaker Change #127: Got it. Thank you so much for that and when do you expect to have a broad.

Speaker Change #128: Pair coffee thank you.

Cintia Piccina: So right now, in terms of Medicare, we already have it; it's already available, and it's covered. For commercial patients, we expect similar coverage than what we see for CAR T's. In the beginning, it usually is through single case negotiation with the payers until a policy is established, but that doesn't mean that we do have coverage, only that it can take a little bit longer because it will be through single case agreements until a sanctuary is established moving forward. So we expect to have good coverage. In the beginning, it may take just a little longer.

Speaker Change #129: So right now in terms of Medicare we already have already available.

Speaker Change #130: Available Crawford for commercialization, we expect similar coverage than what we see for car Ts.

Speaker Change #130: Beginning.

Speaker Change #131: Usually the east through a single case negotiation with the payers and QE policies established but it doesn't mean that.

Speaker Change #131: We do have coverage.

Speaker Change #131: Take a little bit longer because it will be two single case agreements in jewelry is established moving forward.

Michael Kim: So we expect to have good coverage. In the beginning, it may take just a little longer. Thank you so much for all the callers. The next question comes from Michael Kim with SACS Small Cap Research. Please go ahead. Hey, everyone.

Speaker Change #131: So we expect it to have good coverage at the beginning of May take just a little longer.

Adrian Rockliffe: So that's going well in terms of the cost, the overall cost profile that I gave is a mix of what you've got to think about is also the costs of surpass three which is up and running and ongoing and a significant trial. But also there's been the historic costs over the 2023 and four of, for example, the spearhead set of trials associated with the approval of of of of Ticelra and then also, of course, the ongoing.

Adrian Rockliffe: Thank you so much for all the colors.

Kuan Ang: Thank you so much for all the college help.

Speaker Change #131: Scott. Thank you so much for all the counters.

Michael Kim: Thanks. The next question comes from Michael Kim with Zach Small Cap Research. Please go ahead. Hey everyone, good morning, and thanks for taking my questions. First, just assuming similar pricing and penetration rates for G cell run, let us out. My math suggests peak sales of 400 million translates into roughly about a 50 to 55% market penetration rate.

Speaker Change #131: Thanks.

Operator: The next question comes from Michael Kim with SACS Small Cap Research. Please go ahead.

Speaker Change #131: The next question comes from Michael Kim with Zacks small cap research. Please go ahead.

Cintia Piccina: Good morning. And thanks for taking my questions. First, just assuming similar pricing and penetration rates for G-Cell Run and LetaCell, my math suggests peak sales of $400 million translates into roughly about a 50 to 55% market penetration rate. So just wondering if you could, Maybe provide some color on sort of the underlying drivers behind your thinking. Cintia?

Michael Kim: Hey, everyone. Good morning, and thanks for taking my questions. First, just assuming similar pricing and penetration rates for G-Cell Run and LetaCell, my math suggests peak sales of $400 million translates into roughly about a 50 to 55% market penetration rate. So just wondering if you could maybe provide some color on sort of the underlying drivers behind your thinking.

Michael Kim: Hey, everyone. Good morning, and thanks for taking my question.

Speaker Change #133: First just assuming similar pricing and penetration rates for.

Speaker Change #134: T cell right and let us sell.

Speaker Change #135: My My math suggests peak sales of 400 million translates into roughly about a 50% to 55% market penetration rates. So just wondering if you could.

Adrian Rockliffe: We've got to factor in the ongoing Ignite Eso trial and the cost associated with that now we're taking that over from from GSK and so that's why we're we're comfortable with the position that are overall run rate will remain relatively consistent and that that includes the fact that we've already recruited and made the investments in the in the commercial team in the first half of this year. And that's why we believe that that will be the cost will be broadly consistent going forward for the next 80 months. Thanks Adrian, appreciate it. Thanks.

Adrian Rockliffe: So just wondering if you could maybe provide some color on sort of the underlying drivers behind your thinking. Thank you.

Speaker Change #136: Maybe provide some color on sort of the underlying drivers are behind your thinking.

Speaker Change #136: Okay.

Cintia Piccina: Cintia? So, a couple of thoughts.

Cynthia: Cynthia So a couple of thoughts so first I think that the penetration rate for latest salaries, hopefully going to be faster still gift faster because a lot of the treatment sites to be opened and have experienced it the testing and having the patience.

Cintia Piccina: So, a couple of thoughts. First, I think that the penetration rate for Ladislau is hopefully going to be faster, so the uptake is faster, because a lot of treatment sites will be opened and have experience with the testing and with having patients being referred to and treated. So I would expect that to be greater. The assumption in terms of the potential number of patients is given more so by the eligibility based on HLA-H2 and then the MAJ-4 and the NY-ESO expression in both tumor types. And then the assumptions beyond that are really mostly assuming similar access rates to other products in the space and similar manufacturing success rates as we've seen in our clinical trials.

Cintia Piccina: So, a couple of thoughts. First, I think that the penetration rate for Ladislau is hopefully going to be faster, so the uptake is faster, because a lot of treatment sites will be opened and have experience with the testing and with having patients being referred to and treated. So, I would expect that to be greater. The assumption in terms of the potential number of patients is given more so by the eligibility based on HLA-H2 and then the MAJ-4 and the NY-ESO expression in both tumor types.

Michael Kim: Got it. Okay, that's helpful. And then maybe just a second question.

Adrian Rockliffe: So a couple of thoughts. So do you have to take faster because a lot of the treatment sites will be open and have experience with the testing and with having the patients being referred to and treated. So I would expect that to be a greater. The assumption in terms of potential number of patients is given more so by the eligibility based on HLA H2 and then the major for and the NYESO expression in both tumor types, and then the assumptions beyond that are really mostly assuming a similar access rates than other products in the space and similar manufacturing success rates as we've seen in our clinical trials.

Speaker Change #137: Sure and treat it so I would expect that it should be.

Speaker Change #137: The assumption in terms of cost.

Speaker Change #138: The number of patients even more so by the eligibility based on <unk> and then to me Jay for and the NY ESO expression.

Graig Suvannavejh: The next question comes from Graig Suvannavejh, with Muzouho. Please go ahead. Greg, your line is open. You may now ask your question. Good morning. Sorry about that. Thanks for taking my questions. Let me congratulate you and the team on the approval. It's great achievement for the customer and for patients as well.

Speaker Change #139: And then did the assumptions beyond that really mostly assuming huh.

Adrian Rawcliffe: And then the assumptions beyond that are really mostly assuming similar access rates to other products in this space and similar manufacturing success rates as we've seen in our clinical trials. Okay, that's helpful. And then maybe just a second question, I appreciate your updated guidance on expenses over the next 18 months. And I know you guys have done a good job in terms of scaling up your sales and infrastructure ahead of Piscella approval, but I was just curious.

Speaker Change #140: <unk> accessory then are there product space and similar manufacturing success rates as we've seen in our clinical trials.

Michael Kim: Got it. Okay, that's helpful.

Adrian Rawcliffe: Appreciate your updated guidance on expenses over the next 18 months. And I know you guys have done a good job in terms of scaling up your sales and infrastructure ahead of Picellar approval. But just curious as to whether your guidance includes the R&D funding from Galapagos and then any updates on sort of the anticipated timeline for starting the proof-of-concept trial?

Speaker Change #141: Got it Okay. That's helpful. And then maybe just second question I. Appreciate your updated guidance on expenses over the next 18 months and I know you guys have done a good job in terms of scaling up yourself in.

Adrian Rockliffe: And then maybe just second question. Appreciate your updated guidance on expenses over the next 18 months. And I know you guys have done a good job in terms of scaling up your sales infrastructure ahead of the cell approval, but just curious if your guidance includes the R&D funding from Galapagos and then any updates on sort of the anticipated timeline for starting the proof of concept trial. So maybe I'll cover that briefly. So we've not included in that expense guidance. The things that the revenue sources that offset expenses and that context and you'll look back on our filings and you'll see that there are elements for both partnership income and R&D tax credits and things like that that offset those expenses.

Speaker Change #142: Infrastructure are ahead of the seller approval, but just curious if.

Adrian Rawcliffe: Your guidance includes the R&D funding from Galapagos and then any updates on the anticipated timeline for starting the proof-of-concept trial? So maybe I'll cover that briefly, so we've not included in that expense guidance the things that the revenue sources that offset expenses in that context, and you'll look back on our filings, and you'll see that there are elements for both partnership income and R&D tax credits and things like that that offset those expenses so, so that's not included. In terms of the timing, we haven't updated beyond what we said at the time of the understood. Thanks for taking my questions. Thanks. The next question comes from Peter Lawson with Barclays; please go ahead. Hey, good morning. This is Alex on for Peter.

Speaker Change #142: Your guidance.

Speaker Change #143: Includes the R&D funding from Galapagos, and then any updates on sort of the anticipated timeline for.

Speaker Change #143: Starting the proof of concept trial.

Speaker Change #143: Okay.

Adrian Rawcliffe: So maybe I'll cover that briefly. So we've We've not included in that expense guidance, the things that the revenue sources that offset expenses in that context and you'll look back on our on our filings and you'll see that we're there's there are elements for both partnership income and R&D tax credits and things like that that offset those expenses so so that that's not included um the uh in terms of the timing uh we've not we've not updated beyond uh what we said at the time of the uh partnership with Galapagos which is that we anticipate uh going into the clinic in head and neck just soon as humanly possible and that we're working with Galapagos to to enable that

Speaker Change #143: So maybe I'll.

Speaker Change #143: Cover briefly so.

Speaker Change #143: We've.

Speaker Change #143: We've not included in that.

Adrian Rockliffe: My second question, maybe it is one that you might be reticent to comment on, but just your level of comfort with how the street is currently modeling the launch and revenue over the next, let's call it six quarters as we look at the back half of this year and 2025. I realize that you've been trying to guide us to be relatively gradual and how we think that's going to be, but just wondering if you had an opportunity just to see kind of where the street is and whether you think we are doing a good job with that kind of more gradual approach.

Speaker Change #143: Expense guidance.

Speaker Change #143: The things that the revenue sources that offset to expenses.

Speaker Change #143: Context, and you look back at all.

Speaker Change #144: Oh God.

Speaker Change #144: Filings and you'll see that where there are elements for both partnership income and.

Speaker Change #144: R&D tax credits and things like that that offset those expenses.

Adrian Rockliffe: So, so that's not included. The in terms of the timing, we've not we've not updated beyond what we said at the time of the partnership with Galapagos, which is that we anticipate going into the clinic and had a net just soon as humanly possible and that we're working with Galapagos to enable that. Understood. Thanks for taking my questions.

Speaker Change #144: So.

Speaker Change #144: That's all included.

Speaker Change #144: <unk>.

Speaker Change #144: In terms of the timing, we've not we've not updated beyond what we said at the time of the.

Adrian Rockliffe: Thanks, Greg. So with respect to the breakdown of the peak U.S, sales estimate for the launch indications for our sarcoma franchise of 400 million, the best way of thinking about that is that the patient's split is roughly 40% to that peak U.S, sales estimate, broadly speaking, follows that. So on your second point, I think the key thing that we've been keen to ensure is that whatever you think the ramp up of the sales for two-cellera is, and I think you all appreciate I'm not going to comment specifically on the analytic expectations, although I am pleased to see that people have sort of been paying attention over the last six months or so to the opportunity here.

Speaker Change #144: Partnership with Galapagos switches that we anticipate.

Going into the clinic in head and neck as soon as humanly possible and that we're working with Galapagos two to enable that.

Speaker Change #145: Understood. Thanks for taking my questions.

Peter Lawson: Thanks. The next question comes from Peter Lawson with Barclays. Please go ahead. Hey, good morning.

Speaker Change #145: Thanks.

Michael Kim: Understood. Thanks for taking my questions. Thanks. The next question comes from Peter Lawson with Barclays; please go ahead. Hey, good morning. This is Alex on behalf of Peter.

Operator: The next question comes from Peter Lawson with Barclays. Please go ahead.

Speaker Change #145: The next question comes from Peter Lawson with Barclays. Please go ahead.

Alex: Thank you for taking our questions. You previously talked about the possibility to do an interim analysis in the Surpass 3 study. I'm just wondering if you could remind us, you know, kind of the timing for that and the gating factors for that in the study. Thank you. Elliot, do you want to talk about interim reads on Spastic? Yeah, just very briefly.

Speaker Change #145: Hey, Good morning, this is Alex on for Peter.

Alex: This is Alex on for Peter. Thank you for taking our questions. You previously talked about the possibility to do an interim analysis in the Surpass Three study. Just wondering if you could remind us, you know, kind of the timing for that and the getting factors for that in the study. Thank you.

Alex: Thank you for taking our questions you previously talked about the possibility to do an interim analysis in the surpassed three study.

Speaker Change #147: Just wondering if you could remind us kind of the timing for that and the gating factors for that study. Thank you.

Speaker Change #147: Okay.

Elliot Norry: Elliot, do you want to talk about the interim reeds on Spasfoot? Yeah, just very briefly. I mean, we do anticipate interim analyses that are built into the trial at certain junctures. The first one being after 13 patients are dosed in each arm. We have not provided specific guidance to the timeline for that.

Elliot Norry: Elliot, do you want to talk about interim reasons on Spastic?

Speaker Change #147: Elliot do you want to talk about.

Elliot: Interim rates of phosphate.

Elliot Norry: Yeah, just very briefly, we do anticipate interim analyses that are built into the trial at certain junctures, the first one being after 13 patients are dosed in each arm. We have not provided specific guidance as to the timeline for that, but I also want to just advise that when we see that interim analysis, it will not lead us to disclose clinical data until the entire study has been enrolled in because it has the potential to be registration-enabling, and we wouldn't want to put out clinical data that could buy us the trial, that enrollment.

Elliot Norry: I mean, we do anticipate interim analyses that are built into the trial at certain junctures, the first one being after 13 patients are dosed in each arm. We have not provided specific guidance as to the timeline for that, but I also want to just advise that when we see that interim analysis, it will not lead us to disclose clinical data until the entire study has been enrolled in because it has the potential to be registration-enabling, and we wouldn't want to put out clinical data that could bias the trial.

Elliot: Yes, just very briefly I mean, we do anticipate.

Elliot: Interim analyses that are built into the trial.

Adrian Rockliffe: Whatever you think that ramp up is, I think it's important to recognize that it's frame shifted by two to three months from the launch date. And that's the most important thing to get right in the short term is, and I think by and large people have done, you know, with first sales recognized in the Q4 this year and those being relatively modest, representing the very front end of the patients as they flow through the manufacturing, through the identification and manufacturing, and then get treated in the quarter after launch. So that's the biggest thing that I think has changed, and I do think the analyst community has picked up on that frame shift into Q4 this year.

Elliot: At certain junctures, the first one being after a 13 patients are dosed in each arm, we have not provided specific guidance as to the timeline for that but I also want to.

Graig Suvannavejh: Okay, thank you.

Elliot Norry: But I also want to want to just advise that when we see that interim analysis, it will not leave us to disclose clinical data until the entire study has been enrolled in that it has the potential to be registration enabling, and we wouldn't want to put out clinical data that could bias the trial. That enrollment, that enrollment, full enrollment, we anticipate happening next year. Great.

Wanted to just advise that when we see that interim analysis. It will not lead us to disclose clinical data until the entire study has been enrolled in that it has the potential to be registration, enabling and we wouldn't want to put out clinical data that could bias the trial.

Elliot Norry: That enrolment, that enrolment, full enrolment, we anticipate happening next year.

Elliot: That enrollment that enrollment fully involved what we anticipate happening next year.

Elliot Norry: That enrolment, that enrolment, full enrolment we anticipate happening next year. Great, thank you. This concludes our question and answer session. I would like to turn the conference back over to the speaker for any closing remarks. So, thank you everyone for your time today and your questions. We look forward to updating you as we progress with the launch of TSARA and, of course, the development of the rest of the pipeline to redefine how cancer is treated with cell therapies. Please don't hesitate to follow up if you would like to discuss anything further, and have a great day. Cheers. The conference is now concluded. Thank you for attending today's presentation. You may now disconnect. [music]

Great. Thank you.

Operator: Thank you. Thanks.

Elliot: Thanks.

Dan Odd Cohen: This concludes our question and answer session.

Adrian Rawcliffe: This concludes our question and answer session. I would like to turn the conference back over to the speaker for any closing remarks.

Speaker Change #149: This concludes our question and answer session I would like to turn the conference back over for any closing remarks.

Graig Suvannavejh: And then if I got to ask one more just on let us let us out, you might have mentioned this in your prepared comments, I might have missed it. But what are the gating steps for that BLA submission and maybe just a follow up? Are you anticipating that we will the additional data on let us out before you file or is the data from your perspectives, already out there and and pretty much we have what we, you know, we have basically a view of the data that are available for the product.

Dan Odd Cohen: I would like to turn the conference back over for any closing remarks. Thank you, everyone, for your time today and your questions. We look forward to updating you as we progress the launch of Tisala and, of course, the development of the rest of the pipeline to redefine how cancer is treated with cell therapies.

Adrian Rawcliffe: So, thank you everyone for your time today and your questions. We look forward to updating you as we progress the launch of TSARA and, of course, the development of the rest of the pipeline to redefine how cancer is treated with cell therapies. Please don't hesitate to follow up if you would like to discuss anything further, and have a great day. Cheers.

Speaker Change #149: Okay. Thank you everyone for your time today and your questions.

Operator: The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.

Dennis Williams: Thanks. Thanks, Greg.

Speaker Change #149: We look forward to updating you as we progress.

Speaker Change #149: Launch of T cell up and of course, the development for the rest of the pipeline to redefine how cancer is treated with cell therapies. Please don't hesitate to follow up if you would like to discuss anything further and have a great day.

Operator: Please don't hesitate to follow up if you would like to discuss anything further, and have a great day.

Operator: Cheers.

Operator: The conference has now concluded. Thank you for.

Speaker Change #150: The conference has now concluded. Thank you for attending today's presentation you may now disconnect.

Dennis Williams: All of Dennis Williams to comment on those questions. Yeah, sure. So I would say that, you know, for let us out, it follows the exact same regulatory pathway that we did for to solve. So we need a companion diagnostic. We need to supply the clinical data from Ignite Ezo. Sam's the information. And so basically all the exact same paradigm that we did for to sell.

unknown: [music]

Speaker Change #150: Okay.

Speaker Change #150: [music].

George Farmer: I will say that we are looking forward to presenting primary data from the Ignite Ezo trial later this later this calendar year. Okay, thank you very much. Congratulations again on all of the achievements and progress. Thank you, Greg.

Speaker Change #151: Uh huh.

Speaker Change #151: [music].

George Farmer: The next question comes from George Farman with Scotia Bank.

Dennis Williams: Please go ahead. Hi, great. Thanks for taking my questions. I just want to ask about the absence of MRCLS on the label for Tulsa, for to sell. I'm wondering, you know, what sort of conversations went on with FDA. And does that really matter? Certainly you have let us sell coming up. And then also with let us sell, I understand I believe the product is manufactured in the UK. Is that where commercial material will ultimately be originally originating from and are there efforts underway to bring manufacturing over to the US?

Dennis Williams: So I'm going to ask Dennis to talk about the label for the data for T-celler from the spare head one trial and the MRCLS portion of that. And then I'm going to ask John Longer to talk about the manufacturing for let us sell for the approval of George Dennis. Yeah, sure. So, I mean, we made the decision to not pursue mixed with rounds of liposarcoma as a labeled indication sometime ago and it really came down to the fact that the trial spirit bomb was overwhelming with synovial sarcoma.

Dennis Williams: So it would be challenging, I think, you know, for regulatory review to have such limited patient numbers that there were only eight patients with except around cell liposarcoma treated in a trial. And we just thought that it would add a lot of regulatory burden to an application where we really wanted to get the approval in synovial sarcoma. As you mentioned, right now that we have let us sell this is less of a concern for us on let us sell is. The only use of one expression in Mixed Red Round Cell liposircoma is much higher than magicore expression in Mixed Red Round Cell liposircoma.

John Lunger: So, from a target perspective, let us know where expression is in north of 80% of that population is much more appropriate target to pursue for that indication.

John Lunger: And John. Yeah, hi. So, as far as the manufacturing of let us sell, the actual manufacturing that was primarily done for the ignite trial was in a contract manufacturer in Germany, not to UK. So, as you can imagine, our primary objective is speed to market for let us sell. And so making changes to the supply chain related to that particular filing is probably a risk that we don't necessarily want to take. However, we are looking at adding a US site, whether that's our own or another CDMO. For the future to the let us sell supply chain to, you know, to better enable the supply into the states.

George Farmer: Great. Thanks for thanks for that and congratulations on all the progress. Nice job.

Arthur He: The next question comes from Arthur. He with H.C. Wayne Wright.

Cintia Piccina: Please go ahead. Hey, good morning, team. Thanks for taking my question. So, I had two questions. So, first, thanks for the update on the onboarding for the ATC. But on the same time, just curious, could you guys give us the onboarding progress for those center of excellence for as a referral network? How should we think about those things to support the launch? Did you?

Cintia Piccina: Sure. So, yes, we do have a lot of activity going on with the sites that we will eventually become authorized the treatment centers and also to the sarcoma centers of excellence that will be referring patients to the future ATCs. So, our field teams across both medical affairs and commercial target both the future ATCs and current ATCs and beyond. So, that already, that work already started in terms of educating the broader sarcoma centers of excellence into the new biomarkers, the importance of testing patients as early as possible. And then into referring the patients that are positive to both biomarkers to the treatment sites. So, that work started with our few teams and we will see these referrals already started to coming through the ATCs.

Cintia Piccina: Awesome. Thanks.

Dennis Williams: And my second question is regarding the let the sale. So, could you? So, is there before you guys submit the rolling submission with the UI, do you still need to meet with the FDA? And if so, when or as the what circumstance you can request the meeting? Okay. Yeah, sure. I mean, we've already had meetings with the FDA, and we will continue to meetings with the FDA. This is really the advantage of having, in this case, let us all as Breakthrough Therapy Designation.

Dennis Williams: One of the main advantages of that is to have frequent interactions with regulatory agencies. So we'll be talking about a lot of things related to the rolling submission, you know, how the application should be organized. I mean, some of this to be fair, like an earlier comment. I mean, some of what we'll do with let us sell is a bit of excuse the expression of rinse and repeat of what we did with Tissera, but there are definitely some things that are unique, right?

Dennis Williams: And I'll talk to you guys soon. Thanks.

Kuan Ang: The next question comes from Jan and Shu with Wells Fargo. Please go ahead. Hi, thanks for taking our question and contrast on the progress. This is Kuan Ang for Jan.

Kuan Ang: So can you share with us the overall timeline from patient screening to the infusion, like roughly how long does it take and the and which part of the process can be a seller. Thank you. Sure. So the timeline is between patient screening and infusion over time. The testing can take a few weeks if you do both testing parallel. And then from the time in which the aphoristic place all the way into the infusion can be received back into the site, to the patient, it takes about 30 days.

Kuan Ang: At the beginning of this process because the testing just what approved and we have to go also through reimbursement journey and the referral pattern from the beginning, we believe that the first patient is going to take a little bit longer into the whole process, you know, can get more on a faster pace.

Cintia Piccina: And so that's why we are anticipating to be able to treat our first patients in the first quarter of the year. Thank you so much for that.

Cintia Piccina: And when do you expect to have broad payer coverage? Thank you. So right now in terms of Medicare, we already have it's already available. It's covered for commercial patients. We expect similar coverage than what we see for parties at the beginning. It usually is through a single case negotiation with the payers and to policies established, but it doesn't mean that we do have coverage only that it can take a little bit longer because it will be through single case. So we expect that you have a good coverage at the beginning, it may take just a little longer. Thank you so much for all the colors.

Michael Kim: Thanks.

Michael Kim: The next question comes from Michael Kim with Zach Small Cap Research. Please go ahead. Hey everyone, good morning and thanks for taking my questions. First, just assuming similar pricing and penetration rates for G cell run, let us out. My math suggests peak sales of 400 million translates into roughly about a 50 to 55% market penetration rate. So just wondering if you could maybe provide some color on sort of the underlying drivers behind your thinking. Thank you.

Adrian Rockliffe: So a couple of thoughts. So do you have to take faster because a lot of the treatment sites will be open and have experience with the testing and with having the patients being referred to and treated. So I would expect that to be a greater. The assumption in terms of potential number of patients is given more so by the eligibility based on HLA H2 and then the major for and the NYESO expression in both tumor types and then the the assumptions beyond that are really mostly assuming a similar access rates than other products in the space and similar manufacturing success rates as we've seen in our clinical trials. Got it. Okay, that's helpful.

Adrian Rockliffe: So we've we've not included in that expense guidance. The things that the revenue sources that offset expenses and that context and you'll look back on our on our filings and you'll see that there are elements for both partnership income and R&D tax credits and things like that that offset those expenses. So so that's not included. The in terms of the timing, we've not we've not updated beyond what we said at the time of the partnership with Galapagos, which is that we anticipate going into the clinic and had a net just soon as humanly possible and that we're working with Galapagos to to enable that. Understood. Thanks for taking my questions. Thanks.

Peter Lawson: The next question comes from Peter Lawson with Barclays. Please go ahead. Hey, good morning.

Alex: This is Alex on for Peter. Thank you for taking our questions. You previously talked about the possibility to do an interim analysis in the surpass three study. Just wondering if you could remind us, you know, kind of the timing for that and the getting factors for that in the study. Thank you.

Elliot Norry: But I also want to want to just advise that when we see that interim analysis, it will not leave us to disclose clinical data until the entire study has been enrolled in that it has the potential to be registration enabling and we wouldn't want to put out clinical data that could bias the trial. That enrollment, that enrollment, full enrollment, we anticipate happening next year. Great. Thank you. Thanks.

Dan Odd Cohen: This concludes our question and answer session. I would like to turn the conference back over for any closing remarks. Thank you everyone for your time today and your questions. We look forward to updating you as we progress the launch of Tisala and of course the development of the rest of the pipeline to redefine how cancer is treated with cell therapies. Please don't hesitate to follow up if you would like to discuss anything further and have a great day. Cheers.

Operator: The conference has now concluded.

Operator: Thank you for

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