Q2 2023 Adaptimmune Therapeutics PLC Earnings Call
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By your conference is ready to begin good morning, ladies and gentlemen.
Welcome.
Q2 financial and business update conference call I would now like to.
Meaning over to MS. Jody Miller. Please go ahead Mr. Miller.
Good morning, and welcome to adapt them in this conference call to discuss our second 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 sell.
All factors, including those outlined in our latest filings with the SEC.
Adrian <unk>, our Chief Executive Officer is here with me for the prepared portion of the call and other members of our management team will be available for Q&A with that I'll turn the call over to Adrian Blocker ad.
Thank you Julie and thanks, everyone for joining us.
In this morning's press release, we can pump patron catalysts, but we anticipate over the next 18 months.
For the next few minutes I want to highlight the achievements from this past quarter with a particular focus on our top priority you find myself be ally.
Over the course of this year, but that to me has made substantial progress towards filing a BLA for our fan myself, but people with synovial sarcoma.
When approved this will be the first commercially available engineered T cell therapy for solid tumor indications.
We've already completed submission of the preclinical and clinical modules and we'd be working towards submission of the final C. M. C portion of this rolling BLA submission.
We've made significant progress with the CMC module.
Candice requirements and we've taken full advantage of the opportunities for interaction with the FDA afforded by Oh, Matt designation.
In recent months, we've had two type b interactions with the agency to Derisk key areas of the file.
The first was to gain alignment with the agency the confirmatory evidence requirements to convert this file for accelerated approval to full approval would be met with data from cohort two of the spearhead one trial.
Cohort two is fully enrolled and will complete dosing shortly.
Well truth, two is trending similarly to cohort one and we believe we will have a mature dataset from this cohort next year, which will support conversion to full approval.
The second type of interaction with the FDA was to discuss our plans to sell release, including the parameters for our commercial potency assay.
Again, we received very constructive feedback from the FDA with confirmation of the adequacy about data required for the BLA.
Recently, several other critical milestones have been completed with demonstrated comparability of our fan myself drug batches manufactured clinical trial supply backdrop and commercial supply backed up.
In collaboration with excellent a companion diagnostic partner with completed submission to the FDA of the pre market application for the companion diagnostic.
We've completed method validation, but lot release assays, including the potency assay.
And we've completed vector process performance qualification or P. P kit.
Looking forward, we have the following elements to complete to enable submission of the final CMC portion of the BLA.
We are close to completing T cell P. P Q and we'll shortly complete all remaining Westwood. The last few experiment set to finish in coming weeks.
We will submit the better comparability package to the FDA for review process submission of module three which we've previously agreed with the agency that will not delay overall submission.
And finally, we will complete the write up and review of all of the sections for module three of the submission.
We have updated our guidance to reflect that we now anticipate the submission will complete in Q4 2023.
We feel confident that we have substantially derisked. The submission timeline, we have alignment with the agency on key judgment areas.
Completed the vast majority of the wet work associated with module three.
We are set for a submission in 2023 and a potential approval in 'twenty and Q4 next year or the first engineered T cell therapy for a solid tumor.
We also have the opportunity to treat even more people with sarcoma with the return of let yourself from GSK later this year.
As a reminder, let yourself is being evaluated in a pivotal trial ignite east side, and so I know, you'll sarcoma and Myxoid round salt life, a socket and.
And we anticipate data later this year this could be another near term commercial opportunity for adopt me in as well as an additional treatment for people with sarcoma.
Behind the pharma southern let yourself all pipeline continues to progress with the aim of delivering commercial cell therapies for people with cancer.
We have initiated the phase two registration directed supposed trial in platinum resistant ovarian cancer.
Trial is recruiting patients into a monotherapy and combination therapy with devote about with enrollment on going through 2023 and 2024.
We have received all that designation for the treatment of platinum resistant ovarian cancer on the basis of the excellent clinical response data from the phase one is the POS trial with ATP I too am for C. D eight in that setting.
We plan on taking full advantage of the opportunities offered by a robot designation to engage with the agency to evolve this product to approval as quickly as possible.
Lastly, we have completed our strategic combination with Tcl squid to form what we believe is the preeminent cell therapy company for solid tumors.
Through this strategic combination without these three programs to our pipeline along with platform technologies and truck TCR T cells on Nextgen and husband.
We have retained almost 40 colleagues with critical capabilities and added $85 million to our total liquidity confirming our cash runway into 2026.
Okay.
In summary.
Top priority is to launch our first commercial product by myself next year.
The Paducah clock was based on successful filing of the BLA and we've taken significant steps to derisk critical elements.
Behind the fan myself, we have let yourself, which is in the process of transitioning back from GSK and could offer another near term commercial opportunity for the treatment of synovial sarcoma and MLC or less.
We have progressed on nexgen by J P will talk the product with the initiation of the registration directed so past three trial in platinum resistant ovarian cancer, which we also have all of that designation.
We have a deep pipeline as outlined in this morning's press release with numerous states catalysts over the next 18 months, we look forward to updating across our pipeline on the basis of clinical data later this year.
Lastly, with funded into 2026 and with that I'd like to turn it back to Mod for questions operator.
Thank you.
We'll now take questions from the telephone lines.
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Star one on your telephone keypad.
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All participants.
Question.
For your patients.
My first question is from Nick Earl Smith.
Guggenheim Securities. Please go ahead.
Oh, Hey, good morning. This is kelsey on for Michael Thanks for taking our questions I just had a few mainly on ovarian cancer I guess, maybe first surpassed three I guess, what kind of efficacy profile do you think would ultimately be required to make a to enforce deviate a standard of care treatment option, there and then maybe building.
All of that from the T. C. R squared program could you maybe set expectations for the Doe.
Data in.
They're in cancer later, this year and maybe how we should think about responses compared to the adapting and program.
And maybe could you speak to the rate of co expression for me Jay Thank you.
Okay.
So I'm going to ask Dennis.
Dennis to talk about surpassed three and the data that we have and our expectations for a profile oh not that they will come back to the questions on the TCR square off the bat that Dennis Yeah. Thanks, Ed.
Hum in general for accelerated approval for platinum resistant ovarian cancer, one would do.
Desire to have response rates in the 30% to 40% range and those responses to be durable.
What is durable mean somewhere in the six months range or longer would be the ideal durability.
We clearly want to have a population where we have the opportunity to.
Followed patients for durable responses not dissimilar to what we've done previously for find myself.
Yes.
And with respect to our TCR T C R square and the Gaba cell data Elliot do you want to update on.
What we're going to have at the tail end of this year yeah sure. Thanks, So with respect to our treatment of ovarian cancer with Gaba cell.
In combination with <unk> in the phase two trial.
We have at this point enrolled all the patients that we would need in order to make an interim.
Assessment of the data that.
That would be anticipated later this year and at this point, we have paused further enrollment in that program until we have the opportunity to access that data.
And I think that on the expectations for what would be required to advance that product or similar to what Dennis had outlined four mm for surpass three.
With respect to MAGE, a four and these are ceiling co expression I don't have a formal analysis analysis of that but major <unk>. Four is expressed in approximately 25% of patients with ovarian cancer, while meso ceiling.
Is expressed and considerably more.
Closer to the 60% to 70% of <unk>.
<unk> with platinum resistant ovarian cancer.
So I expected that there would be some overlap biologically I don't think that they're related so it's probably just close to a mathematical equivalents, but we haven't specifically studied that.
Okay.
Thank goodness.
Thank you.
Our following question is from Tony.
The Butler E F Hudson.
Please go ahead.
Okay.
Hey, Adrian this is more big picture.
You outlined U S submissions and very much appreciate that.
What's adaptive immune cells.
View on opportunities ex U S. If any importantly.
Has there been discussions about some.
Any partnering opportunities where.
A potential partner maybe may wish to.
Or help develop a product.
In the EU and the war otherwise thank you.
Yeah.
So I think I think conceptually.
We have thoughts about.
The opportunity to take our cell therapies in this space global and but we also recognize that we are.
Unlikely to be the right people to do that in all geographies and so you can imagine that we are.
Obviously interested in opportunities.
Opportunities to partner or in geographies, where we are not going to be able to be the primary commercialization agent.
I think the rock there are challenges, obviously associated with with registration and with pricing getting some of those in some of those jurisdictions, but I think those challenges are solvable, particularly when you are at some level of manufacturing volume in your cost of goods is commensurately.
And so we fully anticipate that I find myself and the other products in our pipeline will be available in due course.
On a broader basis than the United States.
I cant speak specifically to partnering opportunities at this point in time and I would anticipate that we will launch I find myself in the United States and gained significant traction with doctor in the other parts of our portfolio.
Before there as much traction ex U S.
Thank you Adrian.
Thank you.
Following question is from Mark from from T D Cohen.
Please go ahead.
Great. Thanks for taking my questions.
First on the BLA submission.
Cohort, two serving as confirmatory and being essentially enrolled as of today.
Should we think of that as being data that's likely to get provided to the FDA during the review and ultimately.
Part of the original.
You know just a regulatory decision.
Okay.
Dennis Yes, thanks, Ed.
Cohort two data is going to be in the BLA from a safety perspective, we have not discussed with the F. D. A to provide updated efficacy data, including cohort two data during the course of the review that would be a typical like during the course of a BLA review them, that's not something that's been on the table to date.
So at this point is not deemed to be needed for this initial approval I guess, it's like there's these discussions evolve with with the FDA. We can we can discuss options if that were to come up but at present, we would want to come in with cohort two data win the follow up.
<unk> is sufficiently mature.
Okay.
That's helpful.
And then maybe following up on Tony's questions you'd given some of your comments there about hogs and scale.
Do you think next year some of those partnerships and other territories.
Require.
These are data from that or just a broader deal around your second generation products or indoor other targets.
Just maybe Jay for.
Uh huh.
I think it would be inappropriate for me to comment on the specifics of our discussions.
Walk deal constructs might look like I think I think that varies depending on who the potential partner is and what their interest is.
And I think we will.
Deal with that in the coming years.
Okay. Thank you.
Thank you.
Following question is from Jonathan Chang from Leerink Partners. Please go ahead.
Hi, guys. Thanks for taking my questions. First question can you help set expectations for the upcoming surpassed update at ESMO.
Yeah.
Yeah.
Suddenly I will ask.
Elliot to update on our two.
I'll answer that so no incremental update at ESMO Elliot.
Thanks, Jonathan.
First of all we're pleased that we've been granted an oral presentation at ESMO for this update for the surpass trial.
As as you may recall last year at ESMO, we presented data from 43 evaluable heavily pre treated patients.
Shortly after updated that data demonstrating a 52% response rate across our three areas of focus ovarian cancer, urothelium cancer, and head and neck cancers.
And the overall response rate in across all indications with 37% with a <unk>.
Median duration of response around five months this year at ESMO, we will provide an incremental data update showing more mature data from from that dataset and the original monotherapy arm.
As well as a few additional patients in that in that arm.
We amended the trial previously to look at combination therapy with checkpoint inhibitors, and we will show early data from approximately 10 patients in the combination arm.
And remember that this is also in late stage patients who have been heavily pretreated.
There will also be presentation of translational data and translational insights.
And going forward.
As we've said previously as a result of these phase one results we initiated surpassed three.
Registration directed trial in platinum resistant ovarian cancer with arm that designation.
And we will also be focusing the trials going forward.
An earlier line treatment of head and neck and Euro filial cancers.
Again in a in combination with checkpoint inhibitors.
Okay.
Got it. Thank you and second question I appreciate all the color around the progress toward staff Omnicell BLA submission.
Provide any more color around what specifically are the BLA submission delay can be attributed to.
Yeah.
Certainly I think I think the first important thing to understand is that isn't one specific.
Thing well item and I think the the purpose of me talking through the interactions with the F D. A.
And the wet work that we've done was to demonstrate that.
That's we have substantially derisked, the filing itself and that the.
The reason that we've taken the extension into Q4.
Is that there have been a number as we've gone through that Derisking there've been a number of elements that are just taking a little longer than we anticipated not each one not by much each one not hugely significant but obviously you need to do these things in sequence. So you need to validate the assay.
You could do the P. P. J for example, and so the effect of the sequential change.
Changes to those individual timelines means that.
Although we discharged most of the risk associated with that time line. We are now confident to submit a quality file in 2023, it will take us to Q to Q4 2023 to do that so not one specific.
Specific thing and actually a lot of lots of areas of potential risk removed, but it is going to take us to keep or to get this done.
Understood. Thanks for taking my questions. Thanks, gentlemen.
Thank you.
The following question is from Mohan Goldstein from Mizuho. Please go ahead.
Great. Thanks, so much.
Wanted to ask.
T O.
Okay.
Hum you get.
Suggest that you'll be redoing de at all not just from China.
Hum.
Just a guide.
Yeah sure.
Hum Gavin.
And like how should we think about that <expletive>. Indeed, some of those programs now progressed.
Yep.
That's all I'll ask.
Gavin to talk about the the guidance and the and how it covers a range of scenarios Gavin.
Hi, there all right yeah. So as we think about our guidance we'd go to.
Variety of programs and products that we want to bring forward and we'll be making resource allocations across that portfolio as we do each year.
Therefore, whilst.
We're excited about each of the Potline.
Products that we have we we havent actually finalized which ones will be taking forward as we exit this year and begin to move out and pension next year.
Yeah.
Okay. Thank you.
Yeah.
Thank you.
Following question is from Peter Lawson from Barclays.
Please go ahead.
Hey, Good morning, everyone. This is Alex on for Peter Thanks for taking the question just two for me a quick follow up on the ethanol update.
From surpass do we in the 10 patients the <unk> combination patients should we expect to see a ovarian cancer patients specifically.
Okay.
Eddie I don't think that we've guided specifically to the types of patients that we would present, but but those those 10 patients are across all indications.
They were not selected particularly for one tumor type versus another so are there are a range of tumor types in the trial ovarian cancer being one of them.
And.
And I think that that's all we can say at this point.
Okay. That's helpful. Thank you and then just on the BLA a follow up here if you could just.
To reiterate what you know what the confirmatory evidence will be required here in terms of your agreement with FDA and then do you expect a priority review.
Dennis Thanks, Chad I'll answer that.
Second question first the answer would be yes, we would expect a priority review and we have our math designation.
And expedited designation and certainly.
Certainly the application.
Would would justify a priority review.
As far as the compare are the confirmatory evidence of the proposal was to utilize cohort to complete cohort two data with sufficient follow up for duration of response, just as a reminder rate the durability of this of responses and if Amazon is quite long. So we have to follow patients for you know.
The appropriate amount of time to come in with mature DLR data for duration of response data.
So we will be discussing with the FDA as a full cohort two data set which is slightly larger than what we did for cohort one for Sanofi to sarcoma and spearhead one and we discuss a broad timing for when that may come in with the FDA and they agreed to this would be an appropriate plan.
Yeah.
Great. Thank you.
Thank you.
And we have no further questions.
I would now like to turn the meeting back over to Mr. Smith.
Thanks, everyone for your time today, we look forward to updating you further later on in 2023 on our BLA progress as well as on our other programs in the meantime, please don't hesitate to reach out with any questions. Thanks again.
Thank you.
The conference has now ended please.
Disconnect your lines at this time and we thank you for your participation.