Q3 2020 Adaptimmune Therapeutics PLC Earnings Call
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Ladies and gentlemen, todays conference is scheduled to begin shortly please continue to standby. Thank you for your patience.
Operator: Ladies and gentlemen, today's conference is scheduled to begin shortly. Please continue to stand by. Thank you for your patience. [inaudible] Ladies and gentlemen, thank you for standing by and welcome to Adaptimmune's third quarter 2020 financial results and business update. At this time, all participants are in a listen-only mode.
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Ladies and gentlemen, thank you for standing by and welcome to adapt Immunes third quarter to 2020 financial results and business update.
At this time, all participants Arnie listen only mode.
Operator: After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. Please be advised that today's conference may be recorded. If you require any further assistance, please press star 0. I would now like to hand the conference over to your host, Adapt Immune's Investor Relations, Juli Miller. Madam, please go ahead.
The speaker presentation, there will be a question and answer session to ask a question. During the session you will need to press star one on your telephone.
Please be advised that todays conference maybe recorded if you require any further assistance. Please press star zero I would now like to hand, the conference over to your host Adaptimmune as Investor Relations Julie Miller.
Please go ahead.
Juli P. Miller: Good morning, and welcome to Adapt Immune's conference call to discuss our third quarter 2020 financial results and business updates. I would ask you to please review the full text of our forward-looking statements from this morning's press release. We anticipate making projections during this call, and actual results could differ materially due to a number of factors, including those outlined in our latest filings with the FCC.
Good morning, and welcome to adapt and use conference call to discuss our third quarter 2020 financial results and business update I would ask you to please review the full text of our forward looking statements from this mornings press release.
We anticipate making projections during this call and actual results could differ materially between number of factors, including those outlined in our latest filings with the FTC Adrian Rawcliffe, Our Chief Executive Officer, and Eleonore, Our Chief Medical Officer are with me for the prepared portion of this call other members of our management team.
Juli P. Miller: Adrian Rawcliffe, our Chief Executive Officer, and Elliot Norry, our Chief Medical Officer, are with me for the prepared portion of this call. Other members of our management team will be available for Q&A. With that, I'll turn the call over to Adrian.
We will be available for acuity with that I'll turn the call over to Adrian Ballclub ad.
Adrian G. Rawcliffe: Thank you, Juli, and thank you, everyone, for joining us. Before Elliot talks about the clinical updates we'll be providing later this month at CITSE and CITOS, I want to share a few reflections. This time last year, I hosted my first quarterly call as CEO.
Thank you Julie and thank you everyone for joining us.
Before Andy it talks about the clinical updates food with rising later this month <unk> see in sequels I want to share a few reflections.
It's done last year I see my first quarterly call to see Ya.
Adrian G. Rawcliffe: And I said then that I was committed to our focus on execution, and this remains our focus, while the management of the pandemic continues to evolve at our clinical site. I'm happy to report that we've seen an increase in enrollment across our early phase clinical trials over the course of the third quarter. We are enrolling and treating patients in the ADPA2 AFP trial in HCC and our ADPA2 M4 CD8 Next Generation Surpass trial in a range of solid tumors. The numbers of patients that we see coming in for apheresis and cell manufacturing prior to being treated continue to provide us with confidence that we will be able to evaluate the initial safety and efficacy of these products in the coming months. As I reported last call, Recruitment continues to go very well, and we're on track to complete enrollment in the first half of 2021, further strengthening our ambition to launch ADPA2M4 in the US in 2022.
And I said that I was committed to all focused on execution. This.
This remains our focus.
Well the management of the pandemic continues to evolve with our clinical sites I'm happy to report that we've seen an increase in enrollment across all early phase clinical trials over the course of the cool.
We are enrolling and treating patients in the 80, P. I too I P trial in HCC.
80, P. I too am for CB eight next generation suppose trial in a range of solid tumors. The numbers of patients that we see coming if I read this and so manufacturing process being treated continue to provide us with confidence that we will be able to evaluate the initial safety and efficacy of these products is becoming mums.
As I reported loss cool.
Cool.
I used to spearhead one trial with 80 P.A. two important sarcoma has been less affected by code bids on TV.
Recruitment continues to go very well and were on track to complete enrollment in the first half of Twentytwenty one further.
Further strengthening our ambition to launch 80, P. I too am pool in the U.S. in Twentytwenty two.
I want to thank the investigators study coordinators and other healthcare professionals at the centers, where we conduct of clinical trials and everyone working in our clinical CMC and supply team for their work and commitment.
Adrian G. Rawcliffe: I want to thank the investigators, study coordinators, and other healthcare professionals at the centers where we conduct our clinical trials and everyone working in our clinical, CMC, and supply teams for their work and commitment. Later this month, we will have our Virtual Investor Day, where I will lay out the strategy and value drivers for the company over the next five years, and present our perspective on the blockbuster market opportunity that May J4 targeted products represent, our near-term plans for bringing ADPA2M4 to market in 2022, and the cell therapy products we are developing beyond our current clinical autologous pipeline. You will also hear from senior leaders who will provide more details about how we will deliver our vision for the future of the company. There will be no new data updates.
Later this month, we will have a bunch of Investor day, I will lay out the strategy and value drivers for the company over the next five years.
We will present, our perspective on the blockbuster market opportunity that may take a little tougher to products represent our.
Our near term plans for bring 80, P.I. two important marketing 2022.
And the cell therapy products, we are developing beyond our current clinical autologous pipeline.
You will also hear from senior leaders, who bought more details about how we will deliver our vision for the future of the company.
There will be no new data updates as we've said previously we will provide new clinical data. When we believe we have ample information to determine next steps in these communications would be at medical Congresses.
I will now turn it over to Elliot to provide more perspective on the upcoming presentations at 60 and Cecos Elliott over to you.
Thanks, Chad.
In Q3, Dr. Bruno San grow presented data at the international liver Congress from our ATP eight to a F.P. trial.
These data confirmed the safety profile of this product.
Reported a complete response in one patient with a pair of sounding like carcinoma.
This patient had disease progression with new lesions at week 32.
As Ed said earlier, we are continuing to treat patients in the expansion phase of this trial at doses up to 10 billion cells and I remain very encouraged about the potential of this product.
We have a few presentations coming up in Q4, it feels to US we will present duration of response data from the 16 patients with synovial sarcoma from the 80 P. a two m. for phase one trial.
These data further validate the potential of this product to meet the significant unmet medical need for patients with synovial sarcoma and our updated data from what we presented at ASCO earlier this year.
Elliot Norry: As we've said previously, we will provide new clinical data when we believe we have ample information to determine next steps, and these communications will be at medical. I will now turn it over to Elliot to provide more perspective on our upcoming presentations at CITSI and CITOS. Elliot, over to you.
[laughter] City, we will present the data update for the first six patients treated in the dose escalation cohorts of the surpass trial with 80 P.H.U.M. four C.D.A.R. first next generation products.
In every dose escalation stage, there was a staggered between patients and cohorts for safety evaluation.
I want to provide some additional context for the surpass data, particularly following the abstract being made available ahead of the schedule date.
In late May we reported very early data with three out of four responses.
At that time to have these responses were unconfirmed.
The city abstract with a later data cut off in July reported that one of the unconfirmed responses, which was in a patient with a softer go gastric junction cancer did not confirm and one in a patient with head and neck cancer did.
Elliot Norry: Thanks, Ed. In Q3, Dr. Bruno Sangro presented data at the International Liver Congress from our ADP A2-AFP trial. These data confirm the safety profile of this product. Additionally, we reported a complete response in one patient with hepatocellular carcinoma. This patient had disease progression with new lesions at week 32. As Ed said earlier, we are continuing to treat patients in the expansion phase of this trial at doses up to 10 billion cells, and I remain very encouraged about the potential of this product. We have a few presentations coming up in Q4.
One additional patient with M.R.C.L.S. was treated and pretty abstract.
For a total of five patients.
[laughter] city.
We will report updated and more in depth data from these five patients and one additional patient.
We will also show a compelling waterfall plot with initial tumor reductions in five out of the six patients.
This plot is similar to the very early data we saw with the 80 P.H. two and four synovial sarcoma.
And is indicative I believe of what is likely to be a highly active pronto.
We will also present in vitro data with analyses of the 80 P.A. to enforce CB eight manufactured products supporting the increased potency of these spear T cell.
We are committed to developing these first nexgen spear T cells and see great promise, particularly in gastroesophageal cancers with all three patients unsurpassed demonstrating reduction in tumor size.
Elliot Norry: At CTAS, we will present duration of response data from the 16 patients with synovial sarcoma from the ADP A2M4 Phase 1 trial. These data further validate the potential of this product to meet the significant unmet medical need for patients with synovial sarcoma and are updated from what we presented at ASCO earlier this year. At CITSE, we will present data update for the first six patients treated in the dose escalation cohorts of the SURPASS trial with ADP A2M4 CD8, our first next-generation product. At every dose escalation stage, there was a stagger between patients and cohorts for safety evaluation.
Therefore, we plan to initiate a phase two trial in the first half of 2021 for the treatment of these difficult to treat cancers.
It is crucial that we continue to treat more patients with these and other tumor types, focusing on gastroesophageal head and neck bladder and lung cancers to gain a more complete picture of the potential of this product.
We continue to look forward to identifying further signals in additional indications that we can take into later phase trials.
As well as test combination therapies and next generation enhancement as the data guide us.
Now I'll open the call up to questions.
Operator.
Thank you as a reminder, if you'd like to ask a question. Please press Star then one on your Touchtone telephone to withdraw your question from the queue. Please press the pound key.
Standby when we compiled acumen a roster.
Our first question comes from Tony Butler with Roth Capital. Your line is now open.
Oh, good morning, Hey.
Your your comments around so.
Phase two with you to him for.
I guess first off the jewel bladder and head and neck, so a little bit of a consortium.
Why not just pick one of the tumor and move forward or just would love to understand your rationale to continue to look at a basket. Thank you very much.
Elliot Norry: I want to provide some additional context for the surpassed data, particularly following the abstract being made available ahead of the scheduled date. In late May, we reported very early data with three out of four responses. At that time, two of these responses were unconfirmed. The CITSE abstract, with a later data cutoff in July, reported that one of the unconfirmed responses, which was in a patient with esophagogastric junction cancer, did not confirm, and one in a patient with head and neck cancer did. One additional patient with MR-CLS was treated, and, per the abstract..., for a total of five patients.
So thanks, Toni and good morning.
Let me just clarify or the the the phase two study with he 80 P. Eight two m. for CB eight.
At that plant is in gastroesophageal cancers, only we are continuing to explore other tumor types, including the ones that you mentioned so yeah.
I guess first off the journal cancer is included but also a head and neck and bladder cancer and lung cancer in particular in the phase one study.
So the basket is in phase one the phase two study is a limited family of gastroesophageal cancers, I hope that clarifies.
It does so it would be just a quick <unk>, you're going to continue you're expanding the phase one enrollment and then you're going to start a phase two and just first off to that but that's the way we should think about.
Yes, I mean phase one is continuing in the tumor types that are in that study and the phase two.
We will start in 2021 in gastroesophageal cancers, that's correct.
Thank you very much.
Thank you. Our next question comes from Michael Schmidt with Guggenheim Securities. Your line is now open.
Elliot Norry: At CITSE, we will report updated and more in-depth data from these five patients and one additional patient. We will also show a compelling waterfall plot showing initial tumor reductions in five out of these six patients. This plot is similar to the very early data we saw with the ADP A2M4 synovial sarcoma and is indicative, I believe, of what is likely to be a highly active product. We will also present in vitro data with analyses of the ADP A2M4 CD8 manufacture product, supporting the increased potency of these SPIR T cells.
Hi, Good morning, guys. This is he on for Michael Thanks for taking my questions.
Maybe I'll just start with a quick follow up on the surface trial, even the small patient numbers up or tumor type I mean to surpass maybe can you help us understand you know what kind of efficacy signal.
EGI that keeps you guys you know companies to Walgreens initiation of a phase two trial.
So Elliot do you want to take that.
Sure so.
I want to just be clear that you know we've we've now well you will see some updated information in in the 60 presentation regarding all of the the six patients that we've treated but.
But as was mentioned in the call and even before that the the most recent patient we've seen compelling anti tumor activity.
Elliot Norry: We are committed to developing these first next-gen SPIRT T-cells and see great promise, particularly in gastroesophageal cancers, with all three patients in surpass demonstrating reduction in tumor size. Therefore, we plan to initiate a Phase II trial in the first half of 2021 for the treatment of these difficult-to-treat cancers. It is crucial that we continue to treat more patients with these and other tumor types focusing on gastroesophageal, head and neck, bladder, and lung cancers to gain a more complete picture of the potential of this product. We continue to look forward to identifying further signals and additional indications that we can take into later phase trials, as well as pest combination therapies and next generation enhancements as the data guide us. Now, I will open the call up to questions. Operator?
In the first two patients treated with the south ago gastric juncture in cancer.
And in addition to that both of those patients were treated at a lower cell dose.
And as we said this is really a reminiscent or similar to the type of efficacy that we saw early on with the.
Sarcoma population with the first generation program.
And.
We've also now said that there's that all three patients and surpass them showing evidence of anti tumor activity.
Which we think is really sufficient to to to guide us towards a later stage program.
Got it that's that's super helpful. Thank you very much.
Thank you. Our next question comes from Jonathan Chang with SBB Leerink. Your line is now open.
Hey, guys. Good morning. This is Bruce on for Jonathan Thanks for taking our questions.
First question around the city data, so I'm, giving the heterogeneity of tumor types and the surpass study in the range of age scores that you noted in the abstract major sports fashion could.
Could you provide any color on the biomarker data, we might start to see it and any color on how we're thinking about about moving forward.
So sorry, one but yeah.
Sure and thanks, very much so I think that what I'm really going to say is you know please wait for the city poster and rather than providing the information now you know in advance and it'll be very clear what the range and specifics of H. score are.
And the translational data that were that were you know, making public <unk> that it helped guide us in this study or will.
It will be present as well so I don't think it will be appropriate to you know given the conference rules to to provide any.
Operator: Thank you. As a reminder, if you'd like to ask a question, please press star then 1 on your touchtone telephone. To withdraw your question from the queue, please press the pound key.
Any specific additional color around.
Anything beyond what's in the abstract.
Got it understood.
Second question just to go back to the last question for a second around you didn't do patient for the patients who achieved the unconfirmed PR. A is there any color you can provide on that patient duration of treatment and can you confirm whether they're still on study and ER or is this something we're going to have to wait for this.
Operator: Please stand by while we compile the Q&A roster. Our first question comes from Tony Butler with Roth Capital. Your line is now open. Good morning, Elliot. Your comments around phase 2 with phase 2 and 4 in gastroesophageal bladder and head and neck, so a little bit of a consortia. Why not just pick one tumor and move forward? I just would love to understand your rationale for continuing to look at a
The data for as well.
I'm.
Unfortunately, I'm gonna have to say that you're going to have to wait for the safety data again, it's not that far away, it's not that far away going to only a couple of weeks.
Understood understood I'll tell them more than could you talk about the odd the H.L.A. independent TTR program at the salad and a and give us any update on that program and if not when do we expect to maybe find lots more detail on this program and the target you selected thank you.
So I'm going to ask Helen or.
Ah tighten Martino Chief business officer is that talked about.
Sure. So I'm afraid I'm going to tell you see much more other than to say that the program is continuing to make good progress moving forward will be without pergo minimal the more confident we all its.
Elliot Norry: Thank you very much. So thanks, Tony, and good morning. Let me just clarify, the phase two study with ADP A2M4 CD8 that's planned is in gastroesophageal cancers only. We are continuing to explore other tumor types, including the ones that you mentioned, gastroesophageal cancers included, but also head and neck and bladder cancer, and lung cancer, in particular, in the Phase 1 study. So the basket is in phase one. The phase two study is a limited family of gastroesophageal cancers.
Yeah, Hey jointly.
Programming, so we wouldn't be able to reveal the likes of the target.
Today, we have some point that we maybe able to reveal that would obviously have to agree.
We what it sounds like one of them on the appropriate timing for that but so you can probably imagine it is somewhat related to the progress we made but we have got to the point is that plan and it's not fully on track sales at this point I mean, you know that we remain maintains what offences for that we might say, yes, that's what we're about.
Hey, programmable with me.
Coming into play as well one of the areas, but each of the company, which we want to anything and so that's a one.
Got it thank you and look forward to the Investor day, Thanks, a lot.
Hi.
Thank you. Our next question comes from Gabriel Gabriel phone with Mizuho. Your line is now open.
I know guys on isn't Gabriel on for Matt Goldstein.
And for taking the questions. Just the first question here I'm, just I'm trying to get a friend trial for any p. to enforce CD eight and it's off to a gas or kind of John Deford Duncan cancer have any clinical trials.
Elliot Norry: I hope that clarifies things. It does, so let me just be clear that you're going to continue, you're expanding the Phase 1 enrollment, and then you're going to start a Phase 2 in gastroesophageal. That's the way we should think about it.
Clinical sites been identified and perhaps on order for potential enrollment yet or in 2011, I said 2021, and just one other question. If you can provide an update on the allogeneic program. Thank you.
So I'm going to Dallas, I, I mean, I'm actually I'm going to cover I'm going to cover the first one myself I cover but the myself actually to the first one the short answer is that trial will initiate next year I mean, clearly we have sites ongoing in Austin Pos phase one trial that would be eligible.
For the gastroesophageal cancers trial next year, but that that trial will initiate which means slides will get recruited to initiate next year in the first half of next year.
Elliot Norry: Yes, I mean phase one is continuing in the tumor types that are in that study, and phase two will start in 2021 in gastroesophageal cancers. That's correct. Thank you very much, Elliot. Thank you. Our next question comes from Michael Schmidt with Guggenheim Securities. Your line is now open. Hi, good morning, guys. This is Iggy Yang for Myco.
Okay. Secondly on the question on Allogeneic, we I would refer you to our Investor day on the 20 for an update on but <unk>.
Cool foundational platform for our strategy over the next few years.
Hi, Thanks for that.
Thank you.
Thank you and I'm showing no further questions in the queue. At this time I want to turn the call back to CEO Adrian Rawcliffe for any closing remarks.
Great. Thank you everybody for your time today on this relatively short cool Oh, we look forward to data updates at 60, and the Cetone I'm to hosting you for our Investor Day on November Twentyth for a deep dive into the long term strategies and value drivers for the company.
Operator: Thanks for taking our questions. Maybe to start with a quick follow-up on the CERBUS trial, given the small patient number per tumor type in the CERBUS trial, maybe can you help us understand what kind of efficacy signal in EGJ gives you guys confidence to warrant initiation of a phase two trial? Elliot, do you want to take that?
With that have a great day.
Ladies and gentlemen, thank you for your participation on today's conference. This does conclude your program you may now disconnect.
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Elliot Norry: Sure. So, I want to just be clear that, you know, we've now, well, you'll see some updated information in the CITSE presentation regarding all of the six patients that we've treated. But as mentioned in the call, and even before the most recent patient, we've seen compelling anti-tumor activity in the first two patients treated with esophagogastric junction cancer. And in addition to that, both of those patients were treated at a lower cell dose.
Elliot Norry: And as we said, this is really reminiscent or similar to the type of efficacy that we saw early on with the sarcoma population with the first-generation program. And, um... We've also now said that all three patients in SURPASS have shown evidence of anti-tumor activity, which we think is really sufficient to guide us toward a later stage program. Got it. That's super helpful.
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Operator: Thank you very much. Thank you. Our next question comes from Jonathan Chang with SVB Learig. Your line is now open. Hey guys, good morning. This is David Roush. I'm on behalf of Jonathan Chang.
Operator: Thanks for taking our question. First question around the CITSI data. So given the heterogeneity of tumor types in the SURPASS study and the range of age scores that you noted in the abstract of the NAEJFOR expression, could you provide any color on the biomarker data we might expect to see at 50 and any color on how you're thinking about that moving forward? Elliot, do you want to take it?
Elliot Norry: Yeah. Sure. Thanks very much. So I think that what I'm really going to say is, you know, please wait for the CITSI poster. And, you know, rather than providing the information now, you know, in advance, it'll be very clear what the range and specifics of the age score are, and the translational data that we're, you know, making public that helped guide us in this study will be present as well. So I don't think it would be appropriate, given the conference rules, to provide any specific additional color around, anything beyond what's in the abstract.
Elliot Norry: Got it, understood. Second question, just go back to the last question for a second about EJG patients. For the patient who achieved the unconfirmed PR, is there any color you can provide on that patient's duration of treatment? And can you confirm whether they're still on study? And, or is this something we're gonna have to wait for the safety data for us? I... Unfortunately, I'm going to have to say that you're going to have to wait for the SIT-T data again. It's not that far away. It's not that far away.
Elliot Norry: It's only been a couple of weeks. Understand, understood. I'll try one more then. Could you talk about the HLA independent TCR program with Astellas and give us any update on that program? And if not, when can we expect to maybe find out some more details on this program and the target you selected? Thank you. So I'm going to ask Helen Tayton-Martin, our Chief Business Officer, to talk to us. Sure, so I'm not going to be able to tell you too much more other than to say that the program is continuing to make good progress, and the constructs are moving forward. The more we do with that program, the more confident we are.
Helen Katrina Tayton: It's obviously a jointly sponsored program, and so we won't be able to reveal the focus of the target today. We hope at some point that we may be able to reveal that, but obviously, we have to agree with Estella on the appropriate timing for that, which you can probably imagine is somewhat related to the progress that we have made. But we have got a defined research plan, and it's moving forward on track. So at this point, we remain really pleased with our sponsors for it. We may also be able to talk more about, and we hope to talk more about the HITS program more broadly at our forthcoming investor day as well. It's one of the areas of the future of the company that we want to bring to investor awareness.
Operator: Got it, thank you, and look forward to Investor Day. Thanks a lot. Thanks. Thank you. Our next question comes from Gabriel Fung with Mizzou Health. Your line is now open. Hi there, guys. This is Gabriel Allen from Mara Goldstein.
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Operator: Thanks for taking the questions. Just the first question here. Surrounding the planned trial for ADP A2M4CD8 in esophageal gastric junction cancer, have any clinical sites been identified and perhaps on order for potential enrollment yet in 2011, sorry, 2021? And just one other question; could you provide an update on the allogeneic program? Thank you. I'm going to ask, I'm actually going to cover, I'm going to cover that first one myself. I've covered both of them myself actually. The first one, the short answer is that the trial will start next year. I mean, clearly, we have sites ongoing in our Surpass Phase 1 trial that would be eligible for the gastroesophageal cancers trial next year, but that trial will start, which means sites will get recruited and initiated next year, in the first half of next year.
Adrian G. Rawcliffe: Secondly, on the question about allogeneic, we would refer you to our Investor Day on the 20th for an update on that as a core foundational platform for our strategy over the next few years. Thanks for that. Thank you. Thank you. Thank you, and I'm showing no further questions in the queue at this time. I'd like to turn the call back to CEO Adrian Rawcliffe for any closing remarks. So, thank you, everybody, for your time today on this relatively short call. We look forward to data updates at CITSI and at CITOS and to hosting you for our Investor Day on November 20th for a deep dive into the long-term strategies and value drivers for the company. With that said, have a great day.
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Adrian G. Rawcliffe: Ladies and gentlemen, thank you for your participation on today's conference. This does conclude your program and you may now disconnect. ??? ??? ??? ??? ??? ??? ??? ??? ??? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ??