ADAP - Earnings call transcript Q1 2022 | Adaptimmune Therapeutics plc

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Operator

Good morning and thank you for standing by. Welcome to the First Quarter 2022 Adaptimmune Earnings Conference Call. At this time all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today's conference is being recorded. to Miller, conference Head like speaker to now Juli today, of would hand over the your I Investor Relations. ahead. go Please

Juli Miller

those several Good materially you anticipate during actual statements Wood, for outlined members to that, I'll from conference making Adaptimmune's filings Other the full call portion quarter projections and welcome morning's latest Q&A. With due with with the over Chief Executive our discuss could prepared factors, review SEC. our updates. Ad? available call. results in and forward-looking of business our ask Financial of first including results XXXX here Adrian and our press call Officer; would this our are I the this the Rawcliffe. to the Rawcliffe, and call turn Adrian Officer, management text our differ for Gavin team financial me morning to to of release. We to be Chief will

Adrian Rawcliffe

Juli, franchise, across the X-X-X-X discovering, towards Thank have long-term all we clear short by ambition lives scale cancer products MAGE-AX is with and the afami-cel, up strategy. well and areas: manufacturing our us. But cell a focus term, building This In And allogeneic four the medium continue our four this specifically first file of our focused are executed ambition. delivery we on the of people year, is our for the BLA clinic. progress transform our areas. Adaptimmune's in quarter, for is therapies. capabilities clearly to joining and and the you, on delivering developing you everyone thank

analysis CTOS this for afami-cel, update At submission towards progress of planned will from for with product, SPEARHEAD-X our BLA on present from month, year. we synovial ASCO with later sarcoma. patients good with pooled a sarcoma of trials the across first treatment synovial trial our making our are the for next the We afami-cel, full

Secondly, MAGE-AX. our of expanding a targeting with family our is SURPASS trials clinical MAGE-AX T-cells using SPEAR franchise next-generation

recruit we are planning the We I year. continued at in SURPASS to Phase have steadily a update this ESMO data trial and

a I to into broad these trial esophageal as responses tumors, Phase been of a and shown for convert There across range far ovarian As cancers. aim identified have progression, registrable types solid EGJ early further is this that we two products. reminder, a has well as and so signals tumor

esophageal SURPASS-X, additional in are ovarian For And EGJ this II trial, for our we and SURPASS-X Phase recruiting cancer, II year. an are initiate to cancers, trial. we Phase planning

also nivolumab I We combination a with are initiating arm in Phase SURPASS the trial.

Thirdly, progress making allogeneic manufacturing cell advanced and And nearing our programs are scaling with wholly-owned Astellas. And the for with our of begin as the new to only towards allo our we'll as commissioning facility the commercial capabilities deliver we and trials. autologous in and well the completion year construction cell MAGE-AX our targeting with in dedicated lastly, as product well product ongoing we allogeneic late QX. clinical facilities next IND space, the our first and planned are U.S. for as progressing in first filing as stage we an company therapy collaborations for are Genentech manufacturing process U.K., therapies

allogeneic been in XX in teams of has team its over Genentech Officer partners Scientific with track more Astellas and Xth. with constantly additions cell-derived most the the clinical T-cells the She's integrated us in our than stem an all building the we provide Last worked leadership years companies And T-cells are Chief of Gavin? about in therapy. that and predecessor partnerships on playing for a allogeneic financial clinical and Jo scientific years. exceptional to I'd is role TCR driving coming idea She cell receptors, with long announced with with building efforts, therapy from has effective therapies. programs, and scratch, and quality. like Gavin Adaptimmune the May external cell call, that, innovation to history company, cell towards role alpha-beta We of in an Brewer building appointed record and leader as be talked strong specifically developing with her to a team recently, week, autologous taking required allogeneic an reality our update. a T-cell from has Jo key capabilities over our with and successful to to experience, I of the a led commercial a hand our last And company. to

Gavin Wood

out. sheet balance of end robust enabling a cash With execute just us Ad. can of total this with the has laid provides extends liquidity that I $XXX focus areas a that confirm at million, Ad the Thanks, to and into XXXX, runway early against QX

integrated significantly few are the – believe therapy for this of company a an of aware by to you, end-to-end success still strongly last biotech wider years challenges of is Like we cell range long-term as acutely invested presented the over have the we critical capability, and the build We that financial full we as markets. with Adaptimmune.

the and valuation have to be that well-placed will a team, that products commercialization in believe rebalance. management achieve good the seasoned with difficult as a with platform We proven fundamentally have markets who past. weathered companies to close are We markets fair

and our the the against the long-term us to the position people success to people lives well execute capabilities cancer. to for transform of with mission have We

you. for call that to with operator Q&A. turn over So financial update, the Thank I'll the

Operator

Marc Thank from with you. a Company. question Cowen [Operator and We Frahm Instructions] have

line open. is Your

Marc Frahm

the expect and esophageal? you ovarian guiding to decision .Maybe at questions be that next to kind program start some to the the just that types gotten from the color AXMXCDX expect to no taking for tumor many go And there? reach update off, Can Thanks provide you patients kind Ad, to already to of do you how Hi. do more with ESMO. go of you're as you've

Adrian Rawcliffe

is patients. recruited we hi, Thanks answer we'll Marc. estimates of cut is steadily for the the do on Phase any in we answer question. patients data that we're the and said short providing we no, that have not for at for We've update – So I all the the ESMO. numbers trial, guidance on time Short that of

I think entire that. the answer is to your Obviously, of in I Phase the is purpose trial signals second question bit nuanced. more the to deliver a

additional as by, on indications and time anticipate will that's And that. the goes development, to all so of for that the say clearly, purpose going we that's and I'm identify we trial,

Marc Frahm

of lines on that kind still submission, your that there, you of And if meeting? be you not, helpful. process That's BLA maybe request guess, the the And – to of need part Thanks. had what get can Okay. scheduled? then what's pre-BLA I on before the and just time done kind stuff

Adrian Rawcliffe

to file. relate got right the of slide, And we got to refer the the I So cetera. have in a in the the that list that progress, haven't yet say completed, we've the of is section preclinical things things had sections which side to, the with many pre-BLA all are filing What that you we've which on pediatric items I the CMC hand of deck. that's the that of we the meeting. it's range slide et then outlined of including do, would that of We've corporate our plans, on

for filing of aspects year. progress those I we the and on on good remain all this is think track

Marc Frahm

Okay. And and major last a you're core one, the ASGCT, new product then IL-X on pivot presenting to with next-generation CCLXX.

that's Just that think tumor well particularly explain product? particular microenvironments or for? that tumor you can the types rationale you on there And are suited

Adrian Rawcliffe

I'm to going ask take Tayton-Martin So to Helen? Helen that.

Helen Tayton-Martin

Yes. question. Thanks, you. Marc. Good Thank

referring just you're is additional in IL-X, of construct there alongside is which construct next-gen to program with immune increase tumor construct same is increases TCR, well. as the the collaboration trafficking program Noile-Immune, And T-cells. molecules there the CCLXX, them proliferation from and to other a the of is So one site were a T-cells, but where broader the one the of cells two the basically to survival which not

basically CDX I tumors to mechanisms question slightly – types, view CDX which to that potency in the cells. that answer And regards of alpha, in taking different think a are which your tumor is increasing two we to So then we whether that that we're looking on to to the we will, the study. more so to closer delivered mechanisms come had as cold both they get together hot at that opening effect and two hope see these

Marc Frahm

Perfect, thank you.

Adrian Rawcliffe

Marc. Thanks,

Operator

Capital. Our Tony ROTH Butler next with question comes from

is Your open. line

Tony Butler

heavy-weighted if to Yes. as lifts, item that Slide being, What off. Thanks if to manufacturing, brief I to very use the And One, building Good a XX and – morning. you correct. you're want more, let's to also needs your I'm could you the Adrian much just Two vector if the directly continue going say, understand just much. strike Miltenyi's questions. from speak you're curious want are be own I vector, but refer Miltenyi. would there. to again nuances speak vector to the release to I'm of correct, really me checked steps that that – that's to

perhaps question MAGE-AX? around is is there very indication guess, consider agnostic Second Thanks desire tumor to SURPASS. to a is a consideration what much. And there or end, a I for for

Adrian Rawcliffe

Okay.

deliveries ask that Miltenyi question, want for own products, So I'm make answer going John, you our point around And BLA? the going which vector John afami-cel. other do out to – supplier something to comment all and the Biotec for our the on say I'd I'm first I to is ask to just for we is vector.

John Lunger

Yes, sure. Thanks, Tony. John. is This

actually. quite commercial So in not advanced the facility. [indiscernible] commissioning They're facility. early of of – early They're new days days, that

for you're So that for also we to our own QX. by that in have future from drug for right that own and material have well expect as facility PPQs we'll product, use on products. autologous SURPASS And facility we QX our

viral vector. use We for that will the

Adrian Rawcliffe

the that. Elliot indication Officer, the trial, opportunity to with comment our a John. to I'm Norry, out tumor-agnostic on Thanks, of going SURPASS ask to And respect Chief for arising Medical

Elliot Norry

Hi. Yes. Thanks.

the that think certainly from sense. approach, tumor-agnostic a makes it I standpoint of

regulatory That efficacy the Our said, conversations in and approach. being approach then the or with would target, establish needs to type. with basis that belief one the can types that tumor drug in and is not – generally initially and more tumor more experts a the tumor-agnostic for one approvable advice, be is

are move are then type an a along that Tony. indication, can looking our So what we another simultaneously. tumor a another type do would at tumor have of look eye simultaneously, can that one tumor-agnostic type pursued at But also, I be tumor-agnostic approach ability those warrant to designed we at simultaneously. this we're of how demonstrate certainly trial The They individually we paths to sort look that exclusive standpoint, tumor so specific indication. the each not think and on trials from in to

Adrian Rawcliffe

thanks Elliot, appreciate very much. I it.

Adrian Rawcliffe

Tony. Thanks,

Operator

Securities. Chang question SVB a Jonathan with from have We

is Your line open.

Faisal Khurshid

SURPASS-X, just taking for Thank steps take Jonathan. that on detail is and guys. just initiation? Hi, trial if to you need for can on to Faisal what and you plan now provide is And there? other This the ask between the on I any wanted place there trial just questions.

Adrian Rawcliffe

to take Elliot, do that? you want

Elliot Norry

Sure. Hi, Jonathan.

For really running. the different SURPASS-X trial, what get it's takes it other to trials up and than no

to that while questions with We really and we're our really have upfront. study get out worth learned time the the protocol it answering over is specifically the hammered that

seeking study really So are protocol, ongoing, this sort remaining to are to to track finalizing KOL advice, ready the on and getting initiate that of we're and that study not the protocol regulatory authorities sites, steps year. but submit ongoing,

Faisal Khurshid

if there. versus for curious the there’s monotherapy inhibitor checkpoint warranted you ask you’re think additional combination combination indications detail be approach? it’s Then for that Thank starting wanted you like as the also certain the strategy, for more CDX just to just might Great.

Elliot Norry

Yes.

can combination indications the of in trial. SURPASS used any the So with be the

T-cells T-cells We all not to indications. should the specific being that for or think bring based types. into tumor to help we the it’s across know one And action really we other be of our actually the two studies own both that’s And introduced of tumor it’s there applicable translational mechanism and the types. T-cells. on that tumor So and

types. checkpoint of across range that’s had in if the really efficacy inhibitors working tumor a types. should have chance Obviously, those a the case, So of have then checkpoint tumor inhibitors

to behaves it all pursue it reason we tumor there’s that tumor possible differently to think that from it’s them. So type, type but of in

Faisal Khurshid

Great. Thank you.

Operator

Thank you.

Our Michael from next Schmidt question Guggenheim. with comes

Your open. line is

Unidentified Analyst

taking for Hey, good Michael. question. morning. is This Thanks Paul on from our

from Just the on filing. more BLA one us

of has some therapies mentioned process, the validation during as orphan for You cell issues part previously assays for the process. which method caused other potency the

in your So similarities FDA others potency your or assays lining from confidence differences there? on maybe thoughts just on the with and

Adrian Rawcliffe

So, that John? I’ll ask one. John to cover

John Lunger

Yes.

drug on validating we in for potency potency So, assay, the the we’re same assay the product our that clinic. used

to have test what the validation. that about have companies, some companies, successfully the MAGE-AX toll the complete particularly So is which than we feel little against pretty had to able confident different Obviously, to other being face. of target we a

in from two a think for potency good we’re I reasons, perspective. those So assay shape

Unidentified Analyst

the And Thanks. secondly, data. then ASCO great. Okay, quickly on just really

for in the Thanks. So data already or analysis update for we’ve will will new patients seen in this any updated cohort one be afami-cel there primarily patients update be at ASCO? from whom

Adrian Rawcliffe

Yes.

– what Phase in Phase be we’re the X the about will So ASCO the from presentation sarcoma. that study the combining data will X patients evaluation different study and with be

be it’ll which So us a at larger contributing look a to efficacy more will to data factors set allow robust in fashion.

Unidentified Analyst

numbers. point, your there – set that data – significant specifically, aren’t there aren’t new But patients patients new any to significant any in

Adrian Rawcliffe

Yes. dataset, I mean, it’s a makes larger. it Yes. pooled which

Unidentified Analyst

you. Thank it. Got

Operator

you. Thank

Abbott question have Nick from a with Fargo. Wells We

line Your open. is

Nick Abbott

is to and makes question on to are that are support T-cell the spreading, assumption these that IL-X a the follow-up. [indiscernible] to Oh, and sufficient I TIL-induced control levels good used that of you is expect morning. you. IL-X And hopeful on Thank reproduce? then have populations a the the My obviously the I question what sense. have IL-X other TIL antigen

Adrian Rawcliffe

Okay.

So IL-X and of presentation produced your levels we’ll deal with you that. I at think on will What’s the that the have ASGCT to get follow-up? back we

Nick Abbott

one another Well, kind of ASGCT. from the

Adrian Rawcliffe

Okay.

Nick Abbott

target varying able But reflective it of you quality data T-cells and level correlate tumor. be it’s in effectively think could the to of IL-X to is, a is [ph] for better interpret patients TIL you able the of TIL term – would want to do the from of measure levels you’ll

better hopefully to that products I patients. might expect if quality produce IL-X, more. you be in able don’t but to TIL So measure know

Adrian Rawcliffe

Yes.

So Tony – sorry.

Sorry, just Wanted – let try that. Nick, to sorry. me and address

T-cell in but IL-X IL-X First important actually of the way the construct made is is production the triggered is And it’s tumor. measure really the IL-X that all, can activity. is by patients, that what’s we the in

can So biopsies to the markers that actually impact And that a assess measurements itself. assess other efficacy translational will other activation post-treatment will be will the IL-X of inside and in ways we action with And it. of addition be there T-cells to the use of tumor are at systemic be tumor. of part IL-X, ways that and to there’ll look the

Nick Abbott

Fair enough. you. Thank

Adrian Rawcliffe

Thanks, Nick.

Operator

And you. a Thank have Peter from Lawson with Barclays. we question

Your line is open.

Unidentified Analyst

the is morning. on Jenny This Good Thanks taking [ph] question. for Lawson. Peter for

we what up then sense over testing? And that, for particularly believe release you for is briefly timing Or X? in it, SURPASS-X. had you. few to X, you there when And there? any the about next you're then Are just for manufacturing and the that Phase might expect briefly thinking here? are could you the bit expecting just planning And pre-BLA on update prepping of your that I when happen And this that next there? are nivo and an filing you little Just ahead steps on around talk cohort. if meeting. into SURPASS-X launch the as of how have what mentioned you set have like and third, this just Thank months incorporate date secondly, a the but well could Phase a to may the now already about you look

Adrian Rawcliffe

first So pre-BLA first question around meeting. question, the

typically happen file. So few that ahead will of months a the

that this we later So year. anticipate

with BLA. the all your we’ve We that was to will the and respect on question there? between outlined on second now update What With progress the the on what to and question of milestones that launch? respect was

Unidentified Analyst

– in expect Yes, do XXXX? correct. that, to The might when launch and that you earliest

Adrian Rawcliffe

Okay.

Officer Piccina, Cintia our just Cintia? that. to ask on Commercial I’ll touch So Chief

Cintia Piccina

Adrian. you, Thank

end So we’re the the of planning year. to submit by

by able preparation launch of And is the year. end great. next so be going The launch to hopefully

expertise a cell very have centers sites that of the the ultra be together the from opportunity launch also lot on we extremely clinical and very have perspective as and customer the focused focused It clinical from an we a already are really the rare centered perspective, have we on a excellence. is to leveraging of alone. that be putting a operations We’re therapies disease, team to will

and for So really our launch. the expertise very focused agile leveraging in

Adrian Rawcliffe

and Phase ask that. potential trial comment the to use Phase trial, to outside its out of respect on X that I’ll with Elliot nivolumab X And in

Elliot Norry

Yes.

there the And given of this that well important the it’s certainly trial think other signals. So advance are plan it, important the advantages we is to arm X. an nivolumab this, to test of the that current with we But which is on every see look then use that is that fact If we fits four in I Phase the explore. this trial. just very we way combination stage really the mean, into that a weeks based we could for organized. think that’s really it I of trial, later like to efficacy nature

Unidentified Analyst

you. Thank Great.

Operator

Thank you.

We have Mara Mizuho. a with question Goldstein from

Your line is open.

Mara Goldstein

taking so for the question. much Thanks Okay.

you us you terms First SURPASS-X XXXX. of should on would we and XXXX of we program in can what about and sort for where is for just And I’m maybe how target second think that the programs, about wondering for the and SURPASS-X outline if programs? and bar the signal those sort of for the identification is are of think Genentech with be considered, in what terms should

Adrian Rawcliffe

talk to and back Tayton-Martin bar [indiscernible] and Helen touch I’ll on about ask program, then I’ll the the status Helen? come Genentech the of So

Helen Tayton-Martin

Hi, Mara.

term. initial deals, and and targets in of of were in they’re So, collaboration, disclosed time terms to be the near at disclosed already not the unlikely Genentech the selected the the

is pleased plan. moving nominated forward per targets The collaboration and the So expected with we’re that.

cell here have a with. that system gene-edited start think we that – I autologous it's different stem you the to you line because

drop then focus obviously the that. So is and there constructs into

really are we collaboration. think, pleased I plan, the to according forward, with moving is work the So

update to also research that payments course. really those in come the due due will and be will payments I around probably and become we think, on milestones more anniversary

Mara Goldstein

Thanks. Okay.

Adrian Rawcliffe

of to with three think individual answer and out thinking anticipate at tumor types of answer, general consideration level we’re bars patient i.e., the respect studying. exist given be across will the response general and treatment taking there that in that vary that’s the specific things efficacy least we with types efficacy as that’s of of that XX the a answer. in is XX Obviously which maybe specific that that SURPASS-X. paradigms – are inherently about to lot But reasonable with patients SURPASS-X show population. populations is with out are the to responses order as in significant signal, late within terms signal and sufficient of very Elliot into the And for specific efficacy to stage one three identify in that a for referred Helen. we tumor there’s you I we’ve SURPASS-X earlier, forward. The patient Thanks, go durability a taking what into end quite And

Mara Goldstein

you. thank Okay,

Sorry.

Adrian Rawcliffe

Thank to closing it. like I’m That’s in queue. to And Rawcliffe no back turn for Adrian the showing you. questions other call I’d the any remarks.

Adrian Rawcliffe

Thanks.

I refer we the short-term want designing not As call, cell our and delivering do just cancer people is back that. therapies, ambition I a to conclude lives which ambition, by I have with opened but deliverables the to transform of as to against with short-term

you to about broadly, forward significant ESMO. we submit to product. we across product. And we that that we’ll for and Overall, against believe shown both gen position strong our clinical commercial manufacturing trial. at to have are cancer are close we And are in responses our indications are developing context, go tumors next deliver facility. and call. in listening. with to ambition, the to I I product products look a investors. updating we’re We our BLA And the for the And solid that, for the chosen we first capabilities and have for for for finalize treat to our multiple difficult manufacturing the with More construction with well allogeneic after to underway about first first people Thank deliver

Operator

you concludes call. for This Thank today’s conference participating.

disconnect. You now may

Adaptimmune Therapeutics (ADAP) 9 May 222022 Q1 Earnings call transcript