Q1 2023 Adaptimmune Therapeutics plc Earnings Call

Speaker 1: I I.

Speaker 1: Co I.

Speaker 2: Good morning and welcome to Adapt Immune's conference call to discuss our first quarter 2023 financial results and business updates. I would ask you to review the full text of our forward-looking statements from this morning's press release. We anticipate making projections during this call.

Speaker 2: and actual results could differ materially due to several factors, including those outlined in our latest filings with the SEC. Adrienne Rawcliffe, our Chief Executive Officer, is here with me for the prepared portion of the call. Other members of our management team will be available for Q&A. With that, I'll turn it over to Adrienne Rawcliffe. Ad?

Speaker 3: Thank you, Julie. And thanks to everyone for joining the call. My comment today will be brief and we can go directly to questions.

Speaker 3: We've started 2023 at pace and it promises to be a year of change for adapting.

Speaker 3: We completed the prioritisation and restructuring in Q1, cutting costs whilst remaining focused on our priorities.

Speaker 3: the epamicell BLA, the CD8 program in ovarian, bladder and head and neck cancers.

Speaker 3: and our allogeneic platform.

Speaker 3: a strong pipeline of cell therapies for a wide range of solid tumors.

Speaker 3: Adding to that strength, we announced that we entered into a strategic combination with TCR2. Through a talent of complex components we stand at a stage where needlessly greater

Speaker 3: We are two companies that have spent our entire histories focused on Soviet tumors.

Speaker 3: with experienced teams who advance strong clinical pipelines with significant value-creating near-term catalysts.

Speaker 3: Add to that the compatibility of our technology platforms, including an innovative next generation toolbox, and a cash runway into 2026, and taken together it's clear that this combination will create a preeminent cell therapy company to treat solid tumors.

Speaker 3: We expect the transaction to close in Q2 2023, subject of course to shareholder approval at the end of this month.

Speaker 3: Both companies are very actively planning for integration and we will update further once the transaction is closed.

Speaker 3: We are also on track to have a commercial product, a Famicel, which would be the first engineered T-cell product on the market for a treatment to a solid tube.

Speaker 3: We announced that we completed part two of the BLA submission in Q1, and part three is in progress for completion in mid-2023.

Speaker 3: Afantasel is an incredibly exciting drug and the need for the new, marketed treatments for synovial sarcoma. Compelling.

Speaker 3: Recently we had the privilege of hosting a young woman with surviving synovial sarcoma at an internal meeting.

Speaker 3: Hearing her personal account of misdiagnosis, harsh treatments and are pleased for new and innovative therapies.

Speaker 3: an inspiration for all of us here, and highlight further how important a Thamiselle is to this patient population.

Speaker 3: She also described the loss of young lives to this cancer and the experiences of her peers in the sarcoma community.

Speaker 3: We hope to share stories like hers in the future and continue to raise awareness for synovial sarcoma and the high unmet need in this cancer.

Speaker 3: Continuing with the Famicile News, we will present updated overall survival analysis for a Famicile in June at ASCO.

Speaker 3: It's clear that this is a powerful treatment for this rare and deadly cancer.

Speaker 3: Beyond the Famicile, we remain focused on developing our May J4 franchise with our next-gen CD8 therapy and progressing more products to market.

Speaker 3: To that end, we are initiating the Phase II-SURPAS-III trial in combination with the Volumab for platinum-resistant ovarian cancer. This trial has the potential to become registrational and is supported by RMAT designation with the FDA.

Speaker 3: We are also initiating additional cohorts in the Phase 1 surpass trial in combination with pembrolizumab. This is a very important part of the research that we have been doing. We are also initiating additional cohorts in the Phase 1 surpass trial in combination

Speaker 3: to treat patients in early aligned settings, head and neck in your othilio cancer.

Speaker 3: Last year we announced we have PRAIN back from GSK. We believe this is another powerful target for solid tubers with increasing validation across the industry.

Speaker 3: We are progressing praying to be IND ready by the end of this year and plan to initiate trials next year.

Speaker 3: We also announced in Q1 that we are in the process of transitioning LettaCell back and we will receive approximately $37 million from GSK in relation to the transition of the ongoing clinical trial.

Speaker 3: We anticipate Lettice-Ole data in Sinovial Sarcoma and MRCLS later this year and will evaluate this opportunity accordingly.

Speaker 3: In closing, this has been a significant first quarter for us and will undoubtedly prove to be a year of change as we move towards our first BLA and Marksti product.

Speaker 3: Behind that, we have an unparalleled pipeline of cell therapies for solid tumors, and will continue to prioritise development in a thoughtful, data-driven fashion.

Speaker 3: I look forward to reporting out of future progress. And with that, I'll turn the call over to Q&A. Operator.

Speaker 2: Thank you. We will now begin the question and answer session. To join the question queue, you may press star then 1 on your telephone keypad. You will hear a tone acknowledging your request. If you are using a speakerphone, please pick up your handset before pressing any keys.

Speaker 2: To withdraw your question, please press star then 2. We'll pause for a moment as callers join the queue. Our first question comes from Mark Fram of TD Cowan. Please go ahead. We'll pause for a moment as callers join the queue.

Speaker 3: Yes, thanks for taking my questions and congrats on the progress. You made the update of Part 2 being in the VLA on the Part 3 there. Do you now have everything you need in-house and it's a question of packaging and all of appropriately and submitting it or there's still a lot of data points that you need to gather for that portion?

Speaker 4: It was still a lot of work going on to complete the BLA on time. So I'll ask Dennis, who's leading that programme, to comment a bit further.

Speaker 5: Yeah, hi. As Adrian said, I mean, we're in the final stages of method validation and some of the other activities related to the dossier preparation, but we continue to look forward towards our goal and we're excited to have two-thirds of the application already down at the FDA. Okay, that's helpful.

Speaker 3: And then maybe just on the pipeline, the May J4 CD8 program, just any data presentations we should be looking forward to maybe in the second half of the year. We said that we will provide an update on the

Speaker 4: the monotherapy cohort in late line patients and the patients that we've dosed in combination with nivolumab at an appropriate Congress later on this year.

Speaker 3: Okay, great. Thanks.

Speaker 6: Thanks. Cheers. Our next question comes from Tony Butler of E.S. Hutton. Please go ahead.

Speaker 7: Thanks very much, Adrian. I just wanted to.

Speaker 7: discuss some of the trials with checkpoint inhibitors. I want to make sure that

Speaker 7: Is adapt-immune paying for the checkpoint inhibitor? That's point one and number two is...

Speaker 7: for the checkpoint inhibitor, that's point one. And number two is, um,

Speaker 7: Is the notion here that the combinations, let's be clear, the combinations may evolve greater activity, but I guess in the absence of a total control arm, how do you actually separate the two when you're simply, if you will, doing a face to study or at least a study that's exploring the combination.

Speaker 7: How do you think through that if you were to move to a regulatory trial? Thank you.

Speaker 4: So the short answer on the question of who's paying for the checkpoint inhibitors, the answer is that the adaptor in the current pain for the checkpoint inhibitors. And then on the question of the trial design, I think we focus on the surpassed three trials since that's the one that we are.

Speaker 4: that is a phase 2 trial progressing, particularly towards registration. I'll ask Dennis to comment on that trial design and how we consider that in Platinum and the Assistant Havarian Council.

Speaker 5: Yep, sure. So in surpass three, it's a randomized trial in that there's a monotherapy arm and then there's another combination arm with nevolumab. Both arms are compared against historical response rates for non-platinum-based chemotherapy in platin-resistant disease.

Speaker 5: You know, your point's well taken, but in the checkpoint inhibitor space, both as monotherapy and in combination with chemotherapy and platyptom resistance disease, the efficacy is very well described. So for us, it will be very obvious that if the combination of arms shows something...

Speaker 5: It will allow us to compare that against the monotherapy arm to make some inferences if we see perhaps greater depth and durability. But we certainly will be able to determine that that's not solely due to the checkpoint alone because as we know, checkpoint alone don't have appreciable activity in that disease.

Speaker 5: So we feel very confident that we'll be able, the results of that trial be quite interpretable.

Speaker 7: And if I could just ask one followup, Dennis, on this topic. Thank you very much for the commentary. But the other is, do you limit the number of previous therapies that a patient may undergo?

Speaker 7: in part because it seems that at least the response rates in a number of tumors were better when it was, I think, to or less, at least for monotherapy. So I'm just curious how you may balance that in combination also with the checkpoint in Hempfer. Thank you.

Speaker 5: Yep. For surpass three, we do limit the number of prior lines of treatment. You know, the data we presented about...

baseline characteristics and how they relate to response among them being the number of lines of prior therapy. That's across the basket experience we have in the phase 1s or past trial. And of course, some of those prior lines of therapies differs notably depending on which cancer that patient has.

a number of prior pletum treatments. We would expect patients to receive a Vesizomab if...

unless the brother wise, unable to receive that, and we would also expect patients to have received.

You know, a prior PARP if that was indicated. But we do intend to have a more homogenous phase to population and among that to limit the number of prior lines.

if that was indicated. But we do intend to have a more homogenous phase to population and among that, to the limit number of prior lines in this trial.

Thank you very much.

Thanks, Dedy. Our next question comes from Mara Goldstein of MISU. Please go ahead. I thank you for taking all questions. You support from Mara. Two small ones first. When are you?

are going to get the $37 million payment from GSK. And it says on the release that there'll be the vote on the 30th. Is that TCR or is that that the moon's vote?

So I will comment on the vote and I will ask Helen to comment on the payments received from GSK. The votes on the 30th are both the TCR squared and the adaptive mean votes happen on the same day. So I will comment on the payment.

and subject of course to that both we planted close to the transaction very shortly thereafter. Helen?

Yes, thanks for the question. This is Helen Tason Martin. In relation to the money, the income from the GFK transition, the majority of that will be in line with the transition of the programmes which is anticipated, the Lettahel programme which is anticipated during the course of 2023. There was...

some very small amount which will come in 2024, but we haven't disclosed that it'll come in stages basically, but the majority of it will be during this year and hence it being built in to our runway and protection.

Got it. And then just to follow up on the app and e-sales launch, I was wondering if you can, it doesn't even share regarding the pay-your-discussion, how's that going, and I only kind of want to try some strategy would be helpful. Thank you.

I think the discussions with payers are going well at this point in time. We are obviously...

a year or so away from launch and we will have more to say on pricing strategy as we approach approval.

Got it. Thank you so much. Our next question comes from Michael Schmidt of Guggenheim. Please go ahead.

This is Paul on for Michael. Thanks for taking your questions. I have my first one on frame as you look towards a future phase one. How are you currently thinking about expression thresholds for frame and potentially enriching for certain tumors of thrones versus sort of a broader signal finding approach? And then maybe just a redo from the recent frame updates across the landscape seems like some of the responses that have mostly been in.

particular tumor types, and a melanoma, ovarian. So as you're moving towards the IND, what gives you confidence in the broader opportunity and are there any particular indications and focus for you?

So I will ask Joe Brewer to comment on that and our thinking as regards, Prem expression, RTCR and what indications we are considering.

So you're right, we'll likely look at more than one indication. We are making, you know, informed decisions about our clinical strategy at the moment. We're still deciding exactly where we will go. There are obviously synergies in ovarian with our other trials as we're looking, you know, working with the right people in that area. But there are great expression profiles in other tumor types as well. And PRAME is..

a large opportunity for us. So I think we will use some of our learnings from Mayday for most definitely. We'll look at working with sites that we know well. And we will see, we're still in the pre-clinical phase here, getting ready for R&D. And obviously we're discussing those right now.

But I think in terms of PRAME out there, it's obviously a well-validated target. There's been some great data recently from Amatics and we're very mindful of that. Our TCR is engineered as you would expect. So we have a higher affinity engineered TCR where we've been optimizing the TCR for binding and function. So we're quite confident that this is going to give.

and edge with our brain products. We're also looking at our next-gen opportunities with frame as well based on work that we've done with the Mayday 4th. We're transferring that across to frame. And so we will be looking to make the most of frame as a target with product coming forward. And I think it's still early days for the frame space and we intend to be in there.

doing the best that we can and hopefully bring you forward some great products.

Great. And then maybe just a follow up on Let us Sell. Just wanted to get your updated views on that program and how you might expect that program transfer in the recorder to perhaps impact your op-X. And then for that data later this year, is there a particular response rate threshold you're hoping to speed?

let ourselves return as essentially a pre-option on what has the potential to be quite a late stage product given that the Ignite ESA trial was designed to support at least in part registration. So we look forward to getting those data back in-house.

and it will be very much tail end of this year. And we will make rigorous data driven decisions. And I think the standard for activity in this space has been set by a pharmaceutical.

with a response rate approaching 40%, but I think if we look...

Historically, at what we've said about the required response rates in the space, I think, if we're not at 30% in the space, I think it's the key challenging to think about development. So that's been our historic benchmark. It probably ends up being our future benchmark at this point in time for this for that particular asset.

Great. Thanks so much. Thank you. Our next question comes from Jonathan Chang of SVB Securities. Please go ahead. Thank you.

Hey guys, Dylan Drake from For Jonathan, thanks for taking my question. First of all, I just want to ask how you guys are thinking about strategic priorities for your pipeline programs, following the merger, particularly when you think about your approach to a variant cancer and how you plan to address any overlapping major or mesocelan patient populations.

that we're focused on our priorities for adaptive users of the company, which I went through, a Famousel, DLA, CD8.

and our Alachnac platform. However, clearly, as we bring this pipeline together, we will need to address two angles. One is how do you develop these programs in a synergistic fashion, a synergistic and efficient fashion?

And there's pros to the benefits to the fact that we have both both assets in a variant in terms of execution, clinical execution, and experience in the a variant space. And there's also considerations like overlap between the antigen that we need.

we need to think about how on the deal. With all of that is driven by data. I think we are looking forward to the data that has been accumulated by TCR squared of Gavisal in combination with the Volumab and we look forward to making data driven decisions on the entire portfolio.

as we go through this year and into next year. So we are very clear that we will need to be thoughtful and rigorous about the prioritization across the portfolio in order to develop the best meds and out of what is the best pipeline.

with the broader range of targets and the deepest place of assets in the South European industry at this point in time.

I'll call up on that. I suppose how do you see the halogenate pipeline progressing and how do you guys think about prioritizing both the halogenate and autologous programs in the future?

So I'm going to touch on that just very briefly and then I'm going to invite Joe to comment as she leading the allergenic platform work. I think one of the things has become clear in the industry. In fact, I think this is why the very resurgence of interest in the autologous space is that...

It's been clear to us for a long time that the allogeneic promise is definitely there. The idea of an off-the-shelf cell therapy product.

clear to us for a long time that the allergenic promise is definitely there. The idea of an off-the-shelf cell therapy product is incredibly attractive.

It's also quite a long way away and I think the next decade is in particularly in the solid tumour space is the decade of autologous solid self-eurobiz. And I think you can see in the investments that people are making in the CAR-2 space.

that I think this is becoming an industry perspective. Now, it's unfortunate that some of that is because of the inevitable challenges that have arisen as you try to develop a new modality of allogeneic details. What I mean is now I think going to be quite a gap. Autologous is not simply a bridge to allogeneic. They will be different products.

and the allogeneic products will be, I think, quite a way behind the autologous products, particularly in the solid tunelessness. And as such, our focus is on developing our autologous pipeline of products which have near-term potential, near- and medium-term potential to benefit.

thousands of patients who have deadly cancers and then I think the evolution of the allogeneic platform will then determine two things. One, the extent to which there is direct overlap or the extent to which there is complementarity between these platforms.

autologous space in solid tumours before there's any allogeneic players out there including our own. Joe anything that you'd like to add to that?

I think you covered that pretty well as as I said, we're still really committed to the other genetic platform and we are making progress there.

It's one of those working through unknown unknowns, you know, what comes up in these programs, they're new challenges that need to be solved. And the team's been working very hard on this for a long time now and we've made a huge amount of progress. But we have to react to whatever changing landscape around us as well.

So the regulatory bar for alginate programs is very different to autologous and the way that the autologous programs are progressing in terms of, you know, business model and ability to supply patients is also making that bar harder for alginate products as well. You know, it's becoming, getting better at supplying and treating patients with autologous products, which means that the alginate

in a similar way to ourselves in that this is a long-term play for good games at the end of it.

We've not been talking about it much recently because we're just carrying on and it's great, but

Right now, the transformative data is in the autologous space and we're committed to that as well. We're making a valid business with strong data and treating patients. All they will come in time, but for now, there's important work to be done in autologous as well and important products that we can bring forward.

Great, thank you. I appreciate that. Our next question comes from Peter Lawson of Barclays. Please go ahead.

Hey, good morning. This is Alex on for Peter. Thank you for taking our questions. Just another question on the PRAIM program. I was wondering if you could clarify just the timing of the IND if that's mid-23, and then when would you be in position to start a phase 1 study here?

and then kind of related, you know, in terms of manufacturing for the PRAME program, are there any synergies in terms of, you know, being able to leverage your current manufacturing footprint or know-how processes for manufacturing for that program? Thank you.

This concludes the question and answer session. I would like to turn the conference back over to Adrian, Rocklif, for any closing remarks. Thanks everyone for your time today. We've been very pleased to share our progress with you and we look forward to updating later on in 2023 after we have concluded our transaction with PCR squared. In the meantime, please feel free to reach out with any questions. Thank you again for your time. Bye.

Thank you for participating and have a pleasant day.

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