Q3 2023 Adaptimmune Therapeutics PLC Earnings Call

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Good morning, ladies and gentlemen, and welcome to the adaptive immune SKU, Chief financial and business update conference call.

I'd now like to turn the meeting over to MS. Jody Miller. Please go ahead Mr. Miller.

Good morning, and welcome to adapt to me on this conference call to discuss our third quarter 2023 financial results and business update I would ask you to review the full text of our forward looking statements from this morning's press release.

We anticipate making projections during this call and actual results could differ materially due to several factors, including those outlined in our latest filings with the SEC Adrian Ross is our Chief Executive Officer, and Dennis Williams, Our senior Vice President of late stage development are 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 the call over to Adrian Rockland and.

Good morning, Thanks, Julie and thanks, everyone for joining us.

In the first part of 2023, we set out to transform adapt to me.

Specifically, we set out to accomplish five key goals.

One create complete a large organizational restructuring to significantly reduce our cost base.

To submit up here like rough by myself, putting us on the path to being a commercial cell therapy company.

Three we're covered let yourself I'm praying from GSK.

We'll complete the strategic combination and subsequent integration of TCR squared.

And five prioritize our clinical portfolio on the basis of data throughout the year.

Midway through Q4 of 2023, we've made significant progress in each of these.

In relation to the reorganization.

Once these things are always difficult, we achieved it with limited disruption to the company and to its momentum.

On the second go I found myself.

We showed data last week at sea to us demonstrating clear lasting benefit for people with synovial sarcoma, who respond swift by myself.

We will complete the submission of the BLA this quarter.

I want to ask Dr. Dennis Williams Who's been responsible for the development of the affair myself program to comment on this current status Dennis.

Okay.

Thank you Ed.

I want to echo adds excitement for our firm sell data.

10 of the annual meeting of the connective tissue oncology society or seats us.

Where Dr. Brian Valentine presented updated data and they are transformational for people with Sanofi Youll sarcoma.

One of the primary goals of see task is to advance the care of people with sarcoma and.

The doctors, who treat people with synovial sarcoma are eager to have a fan myself as a therapeutic option.

We shared this eagerness and completion of the BLA has been our top priority.

As part of the Rolling submission, we submitted the first of three modules the preclinical module at the end of last year.

In quarter, one we completed submission of the clinical module since that time, we have been focused on completing submission of the CMC module.

All BLA CMC validation work is complete.

Clothing assay method validation and process performance qualification.

Completion of the final section of the BLA is imminent.

We are in the final stages of dossier preparation. This includes activities such as the comprehensive review of the dossier.

Labeling in summary document finalized.

Finalization.

The regulatory submission publishing.

We have <unk> designation and have been and we have taken advantage of frequent interactions with the FDA meetings have been positive and we have taken significant steps to derisk our file.

Last year at the pre BLA meeting adapt immune and FDA agreed on the planned content of the BLA.

We have also received what we believe is favorable FDA feedback in July on the commercial T cell potency assay, including agreement on the potency dataset for inclusion in the submission.

The agency also agreed that data from cohort two of the spearhead one trial can serve as confirmatory evidence for full approval. This cohort is fully enrolled with mature data readouts expected late next year.

We know that if I'm a cell has the potential to transform the way Pseudoallele sarcoma is treated and bringing this product to market is very important to us in the sarcoma community.

With that I will turn it back over to add Ed.

Thanks Dennis.

We're turning to the other accomplishments in 2023.

The third one relates to the recovery of let yourself I'm praying from GSK.

The rights to frame a fully recovered and then let yourself transfer isn't an advanced stage with the IMT sits transition shortly.

We recently reported data from a planned interim analysis of the pivotal ignite E. So trial with let yourself showing 18 responses by independent review out of 45 people with synovial sarcoma MLC L. S. A.

Therefore, the trial will meet its primary endpoint efficacy, which required any 16 responders after 60 patients in this cohort.

I would note that all 60 patients have been treated and we will have further data readouts next year.

We're excited about how let you sell them to find myself complement one another.

Initial assessment is but let yourself could increase the addressable market by two to three times and could be delivered with essentially the same commercial organization.

We will continue to evaluate how let yourself fits into our pipeline and I'll update you on our plans for our expanded sarcoma franchise early next year. After the transition from GSK is complete and after we have submitted the BLA for our by myself.

For the full scope related to the combination with T. C. All squared we completed the transaction in Q2 and the business integration is now also complete.

And on the Cisco the prioritization of the clinical pipeline based on data.

Today, we announced we are stopping further development of the two Mr. Seely indirect truck programs Gaba cell and T C five Ted.

We have reviewed the data from the phase two trial of Gaba. So in the phase one trial of TC five Ted and the Max issues of the clinical benefit and I like the program does not justify further development.

Although it's difficult to stop a program when it is evidenced some patients are getting benefit.

We do not see a rapid route to market with all these sort of these assets and we are committed to focus our resources on cell therapies with this path is clear.

With respect to other pipeline priorities, we are narrowing our nextgen a D. P. A to enforce C. D. Eight surpass trials to focus on ovarian and head and neck and bladder cancer and we showed data supporting this prioritization of Tesla.

You know focus indications.

There was a 50% response rate, which improved to 75% in patients who received three or fewer prior lines of therapy.

Based on this encouraging data for <unk> phase, one trial will only enroll patients with head and neck and euro failure cancer in earlier lines of treatment and in combination with checkpoint inhibitors.

The enrollment of patients with other indications in this trial is being discontinued.

And we have also initiated the phase II <unk> III trial in platinum resistant ovarian cancer, which we intend to be registrational.

This has been a transformational year for the company and we will achieve each of the goals we set out in 2023.

Data readouts demonstrate that our engineered cell therapies work across multiple solid tumors and we continue to prioritize our resources on those products that have the greatest chance of commercial success.

In closing I want to focus attention on three events in the short term.

One the completion of the submission of the affair myself BLA this year.

To transfer our let yourself I N D from GSK this year and.

And three updating you in the new year on the path to deliver our expanded sarcoma franchise.

With that I'd like to turn it over to the operator for questions operator.

Thank you we will now take questions from the telephone lines.

And you are using a speaker phone please lift your handset before making Euthenics Jin.

If you have a question. Please press star one on your devices keypad you.

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We thank you for your patience.

Our first question is from the Maha Goldstein from Mizuho Securities. Please go ahead.

Hi, This is Jerry Dongguan for Marigold screen starts taking our questions and congrats on a quarter.

I guess starting off with.

Surpass.

That trial are there wasn't bad activities seen in earlier line patients and you can can we expect that to be an increased focus.

And surpass it surpassed three enrolling patients earlier in their disease course, and I guess secondly, with ADP 600, which is that prime TCR I know, it's early but has a starting dose and planned yet and how quickly. If so do you think you can progress to a therapeutically active dose. Thanks.

So I'm going to ask Elliot to talk about the implications of the earlier line observation on our development plan, a head and neck bladder and what we're doing in ovarian cancer, then we'll come back to prime.

Yeah. Thanks, very much. So I think you know you you stated it correctly are the focus of the treatment of patients in the surpass phase one trial will be solely on patients who have either head and neck cancer or euro filial cancer with particular attention.

And two patients who have had fewer prior lines of therapy.

In addition to that we plan to dose the patients that we can with that with checkpoint inhibitors in combination.

And that it's our intent to really optimize them. The data that we have coming out of that study in the next six to 12 months to demonstrate.

How the product works, particularly in in that patient set.

As it relates to surpass three.

That study is being conducted in patients with platinum resistant ovarian cancer, which is a fairly well defined patient entity.

That being said, we do restrict the number of prior lines and that study.

And I am pleased to say that that study is open and enrolling.

And we really do expect to see a robust enrollment of the trial in 2024.

Yeah.

And then with respect to Prime I think it's a little early to say, we're very excited about the opportunity with the Prime program boasts ADP 600, the TCR itself and the second Gen approaches that we have in the hopper, but it's a little too early to say what the dose escalation in the starting dose is going to be.

Yeah.

Thank you.

Our following question is from Mark from from TD Cowen. Please go ahead.

Thanks for taking my questions, even though that's the durability data continues to evolve and sarcoma just.

How is that impacting your kind of view on on pricing for that product as we get towards approval.

And then on the earlier stage with the Prime just with the increased sensitivity I guess, how would you expect that to manifest them in the clinic.

Do you think that's more likely drive a response rate benefit of duration benefit or is it just maybe somewhat broader eligibility criteria.

Yeah.

So I think I think it's a little too early to to comment on the pricing strategy that we have for a fall.

For myself, the only think I will comment on is that the the efficacy that we are clearly seeing the duration of response the clear benefit on to.

To the responders on overall survival and on time to next treatment is clearly the type of evidence that one needs to support pricing gain I rare tumor type like synovial sarcoma, and we look forward to.

Getting the product approved and be the commercialization of thought of that as al first of all first product with respect to prime I'm going to ask Joe to comment on the.

The expectations that we have a fall that are highly sensitive T C L.

It's a peptide sensitivity, we would expect it to be able to tackle tumors with lower antigen expressions that way.

To be able to treat a broader range of antigen expression and we would expect the effects.

I've seen you gave a response rate and duration of response.

It should affect based metrics in a positive way.

Yeah.

Yes.

Okay. Thank you.

Thanks, a lot Keith.

Our following question is from Michael Smith.

From Guggenheim Partners. Please go ahead.

Hi, This is Paul on for Michael Thanks for taking our questions I have.

Follow up on the Crane just on the competitive landscape given that there was some updated data this morning.

<unk> with plans to move forward in melanoma and signals in ovarian and uterine I mean, what is your view on the clinical landscape the bar for Crane and what's your confidence in potentially being able to address no cancer types beyond those listed like lung and breast cancer with the enhanced sensitivity TCR Oh, that's my first.

And second one is just just quickly on let US sell can you help with that interim data from ignite ESO in context, with what you've shown with the Bam itself and any view on how that might translate over to a survival benefit. Thank you.

Suddenly so maybe I'll just I'll just touch on the prime with the competitive landscape I think where we're quite I'm delighted to see the data.

Yeah, Batiks as Prime program to die I think that really is a very strong validation.

If anyone needed of the opportunity for TCR based therapies in the solid tumor space, particularly those targeting cancer testis antigens like like probably like for like NY ESO and I think this is just a further validation that the future or at least a significant part of the future of cell therapy in solid tumors.

Lives through these approaches I'm sorry.

Very very happy about that and I'm really in the cell therapy space. There are only really two significantly advanced our prime of programs with specific engineered TCR.

And I think therefore that there's a lot of opportunity for product development in that space to leverage what we believe from our perspective will be a best in class program and I'd just point out that the you compare the competition that to the competition against almost any other.

<unk> cell therapy target I would refer you to see Dr. Tina <unk> by way of example, and if the space is wide open and these are these are clearly the two leading programs in that space.

With respect to let yourself and.

And the data I I think I'm, just going to I'm going to take that comment and just.

And I sure summarized fashion site the data at the moment looks to be quite comparable to the data with a buy myself well that obviously its in a larger broader population because it includes MLC L S, but a 40% response rate and.

Decent but slightly immature what's your ability I think is is consistent with what we've seen with a fan myself and so we look forward to getting that program back considering gifts and I'll update everybody in the new year about our plans for that.

Okay. Thanks very much.

Thanks, Paul.

Thank you.

<unk> question is from Jonathan Chang from Leerink Partners. Please go ahead.

Hi, guys. Thanks for taking my question I, just don't trade on for Jonathan Chang. It seems you had another step up in R&D expense. This quarter I was wondering how we should think about stand going forward with the S. M. S. I'll go into a commercial stage the TCR square that stopped being discontinued in the Prime program entering the clinic.

Yeah.

So Gavin I'll see if I can tell.

Thank you that question yeah. So the step up this quarter in R&D was down for two reasons. One was the first quarter of TCR split R&D expenses included and secondly is a reduction in the R&D tax credit.

Change in the tax regime here in the U K.

The offsetting tax credits declining.

That legislation is actually under review.

In terms of going forward clearly with Scott you haven't got that myself with commercial launch with great data.

See unless you sell the movies updating all our plans yet.

Yeah.

Yeah.

Great. Thanks, so much and if I could just ask one follow up how are you guys. Currently thinking about your second Gen. Vers. Your first your first Gen product candidates and do you plan on utilizing the C D and Chloraseptic transaction with Euro 600 candidate as well.

So we are planning multiple next gen approaches with them the prime candidate with ADP takes Andreas and we do think that that is next gen approaches will be part of it.

Broadening the franchise out to multiple tumor types and may not be that Cta is optimal and all of them know that that will certainly be one of the ones that we're using and we're using some other little patches as well say, one particularly to tackle the longevity of it.

So hopefully increase the duration of response I don't say, we're looking at a switch receptor as well thinking that may be in different contexts, you will actually have greater success with different candidates.

Great. Thanks, so much I appreciate that.

Thank you.

The following question is from Yanan, Zhu from Wells Fargo Securities. Please go ahead.

Oh, great. Thanks for taking our questions Oh first off a question about the MAGE a four so you're enrolling a head and neck and you will see that all patients in earlier line setting and surpassed one I was wondering how many patients do you aim to enroll them in that.

In those indications what are would be a bar for success.

Obviously, you had a great data in your previously reported patients, but going forward. What's your bar for success for the additional patients to be enrolled and when we might be able to see data from those additional patients. Thank you.

Yeah.

Yeah. Thanks, so much so we haven't specifically guided to the exact number of patients that we would intend to enroll.

I think that we've seen.

Small to moderate datasets in head and neck and bladder cancer are with four patients having been.

Four patients in the dataset with head and neck, and seven with Euro filial and I and I'd like to see us get closer to the size datasets that we have.

Seen in phase, one with ovarian cancer to be able to make the most.

Informed decisions about how to prosecute those two indications going forward with respect to when you would see that data and it certainly wouldn't be in in the early part of next year and we haven't provided specific guidance.

But we're enrolling those patients actively now and hope to be able to provide additional information in the future.

Yes.

Got it in terms of our key metrics for success with it with the new data the Uh Huh hold are held to the same.

Kind of a level as the prior few patients reported or.

Where does the bar a start.

But positive signal.

Well I think that for the for response rate what we've seen in phase one is really quite remarkable and the number of patients that we've dosed Ah.

I would love to see with a larger dataset that that kind of response rate is maintained although for example in head and neck cancer. If it doesn't turn out to be 75% responses, but something slightly lower than that I think we'd still be thrilled.

Ruth is that we'd be ultimately from the standpoint of being able to provide meaningful benefit to patients.

I think that response rates.

In in the spaces that we would likely pursue needs to be north of 35% or so and durations of response are need to be in the at least in the in the in the five to six month range for.

For us to be able to think about later stage programs, but we're and we're incredibly enthusiastic about the data that we've seen and I think that we just need to consolidate that was additional clinical information to move forward.

Great if I may I'm, sorry, and one question on hemophilia.

Cancer here.

You know there was a recently practice changing data.

Out of the I think E D C O two trial for <unk> for the ADC plus PD one.

Frontline setting.

Does that have any impact you think to.

Positioning or how you conduct a study for the OCD patients.

So of course, I think we have to take that into consideration with respect to positioning and that data is fantastic for patients with hemophilia a cancer received a standing ovation at ESMO I'm. So we of course have to consider that I think that the idea that <unk>.

Isn't mad and and pads have are being moved clearly towards the first line space opens up a lot of opportunity in second line plus treatment. So from the standpoint of bladder cancer.

In the patients that we enroll them, we do expect that some of them will have potentially been treated with that type of treatment regimen going forward, but.

If we're able to demonstrate with a single therapy that kind of.

A onetime therapy that kind of response rate that we have in patients with <unk>.

Very advanced disease, and we think that that debt.

The movements of parallelism that into first line chemotherapy out of first line treatment likely opens up the space for more opportunity if it if nothing else.

Very helpful on the frame announcements I.

It just happens just curious a couple of curious questions how does the.

The sensitivity Oh, this TCR to praying compare with your.

And for TCR sensitivity against MAGE a four.

And then I was just curious about positioning oh potentially to a sale.

T cell therapies in melanoma.

There is toes are in late stage, a review by F. D. A and obviously it looks like the melanoma data today are from a competitor. It looks also quite encouraging them. Hopefully you would also show even you know the demonstration of our.

Differentiation either from the competitor.

But how do we think about how these cell therapies T cell therapies are positioned against each other are in the melanoma setting. Thank you.

Okay, I'll get ask Joe to take the.

Question on sensitivity relative to my Jay for all then comment briefly on the emerging field of cell therapy in solid tumors and of course, we're happy to set up a follow up call right any other questions you might have as well Joe.

Yes, it is a crane TCR T.

He is very similar to the May take full one actually slightly better.

And so we anticipate yeah. That's one of the things that makes us very confident in this TCR. Obviously every chemo vaccine is slightly different so it does depend on how the protein is expressed and how well it's process. They talk they don't read exactly one to one and that sensitivity analysis.

Say.

We're very confident that it will react case relatively low levels of antigen, which is really positive.

With respect to the competitive landscape.

I would put both the til therapy and the opportunity for prime in melanoma.

He had a much broader context.

I see.

If you think about what's happened in the last year or two AIDS.

It's become clear that cell therapies in solid tumors can demonstrate incredible response rates in very late stage patients.

And that gives us I think confidence that this is a modality of therapy is here to stay if you roll forward a year from now the high probability that you will have two therapies to cell therapies in the solid tumor space on the market find myself, our pharma side and obviously the til program come.

Behind that could be let's say south coming behind that could be see a CD eight program in ovarian cancer.

Coming behind that is head and neck and bladder cancer coming behind box is perhaps a matrix as prime program in melanoma.

Just think youre seeing I E.

I move to establish cell therapy in these spaces as a modality that can have significant benefits for patients who have very few other options.

And I'm looking forward to initially the tills and subsequently the.

Engineered cell therapies presence in spaces like melanoma, because I think unlike sarcoma, which is a relatively.

Yeah.

Focused indication these are much larger indications I think establishing them in those much larger populations will be really important for the field.

Great. Thank you for all the color.

Thank you. Thank you once again, please press star one at this time, if you have a question.

Following question is from Peter Lawson from Barclays. Please go ahead.

Great. Thanks, so much thanks for taking the question just on the varying cancer program would be.

You get interim analysis.

That in the second half of 'twenty four just if you could kind of give us any.

Timelines around the datasets and kind of how much how many patients with seafood dairy and catch it but what are some of them.

So I'm not going to give specific timelines, but the only thing I'm going to do is say that we will we will likely be in a position to disclose the interim.

Data analyses once we have completed enrollment of all of the patients in that study yeah. We as previously stated we do we do intend for this study to be Registrational and if we do not want to introduce any bias into the up.

And to the patient enrollment and so that will be the earliest point.

When we give interim analysis in interim dataset.

Perfect. Thank you so much and then on the paint mezcal and apologize if I missed this but.

There are other components, you're going to be an engineer it into the T cell.

C D eight or if you use in the TCR squibb's approach.

Joe do you want to talk about how you're thinking about that.

So we're really thinking about doing days as individual kind of test products.

Looking at the merits of each faa's nextgen individually to see how well it will perform.

Okay, So you're kind of being almost like a bake off of it.

Various components C D a.

Yeah Yeah.

And I think Joe you commented earlier that it might be that in different settings.

Different next generation approaches are more more or less useful.

So we will be taking that into account as well.

Okay. Thanks, so much.

Thanks Peter.

Thank you.

And we have a second line from Peter Lawson from Barclays.

So please go ahead.

Peter you have other questions.

Okay.

I think that wasn't repeated.

Thank you. So we have no further questions registered at this time I would now like to turn the meeting back over to you Mr. Ratliff.

Thanks, very much and thanks, everybody for your time today and the questions across the breadth of the portfolio, but we are we are we now are developing.

I am looking forward to updating you on the three key things in the course of the coming months one the submission of the BLA for a fan myself to the transfer of the let yourself I M D and in the new year, the plans for a soft kind of a franchise.

In the meantime, if you have any questions. Please do reach out thanks for your time today take care.

Thank you.

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