AUTL - Earnings call transcript Q1 2021 | Autolus Therapeutics plc

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Operator

Hello, ladies and gentlemen, and welcome to the Autolus Therapeutics First Quarter 2021 Financial Results Conference Call.

As a reminder, this conference call is being recorded. I would now like to turn the conference over to your host, Mr. Andrew Oakley, the company's Chief Financial Officer. Please go ahead.

Andrew Oakley

for Good taking good on part results operational and thank everyone the Rebecca, of and for quarter you in highlights you, morning afternoon, or and financial XXXX. Thank first the today's call I'm Andrew Oakley, Financial Chief the Officer. is me today And Dr. with our Itin, Officer. Chief Executive Christian

the Before we this time indicated statements XXXX, those than of we Commission forward-looking company's filed company's from remind Actual annual materially time. as on these of and today, including facts forward-looking discussed result on like representing of differ Securities relied on may would be are you accessed call, at Form forward-looking this should X, section speakers today's events from results EDGAR other with our during begin, All will discussion statements I call a statements. as views be our filings subsequent contain by Factors date. various statements those XX-F in statements of any XXXX, as report call subsequent on SEC can the May to or to regarding on March the upon in the the that which not forward-looking database factors, important titled statements. historical in www.sec.gov the The as and future views the reflect with Exchange make X, and Risk

upon will being at today. will and company's concluding we advised discuss questions forward-looking statements quarter any to company webcast. today forward-looking for company's financial remarks. to today's and point, Please the the XXXX. be follows, I change. results, Slide of and our followed do introduction, the and a provide X, comments. While brief will for Christian the if next views On conclude and date statements our will call of see highlights company other that not some the milestones even And as views is specifically first should you'll representing of elect upcoming your will these update is then be be following any subsequent Christian relied it that so, recorded to the as welcome by disclaims obligation agenda may the operational as company's with course, These

So turn call with to Christian? I'd that, like to the now over Christian.

Christian Itin

to Thank the all for I'm thank morning of for And XXXX. of you, first you and Andrew joining to you. good review our quarter pleased us. progress

see to as progress the decline XXXX. before and update UK the and and on the our and bodes conduct we of This very the through the move clinical US we trials in EU the the well numbers. the pleased XXXX case seeing First get programs, with of into for gradual to we're vaccinations COVID

Europe, vaccinated people also will the operations travel for logistics. opening expect expected the the pressure US normalize, With which start to flight of we relax and between to on gradually

in timely of work We well order supply deliveries products continue and to analysis samples and our as with to integrity. ensure hard and timely clinical chain our teams transatlantic and final and ensure data centers to leukapheresis logistics trials for support clinical availability our continental as

data or fourth obecabtagene While them a study we and patient Phase referred monitor on year, to autoleucel, provided with can developments, particular QX, I updates we XXXX. about quarter carefully the In focus track we ALLCAR progressing with in from optimistic have feel is very for safety. and as FELIIX the on we the continue data expected at well to now obe-cel. received AUTOX, INN last the In ASH. be The remains study

and the European received also have for have of non-Hodgkin treatment highlighting exploring the of first recently obe-cel. prime announced in at June. Medicines Lymphoma, designation again the potential EHA also We're nature obe-cel date will from Agency, the we of We we T-cell that innovative

next the received Health Phase we of expected the which at UK for generation pediatric Products potentially of Medicines ASH designation for continues in Regulatory with evaluated and the the development and an data year. ILAP review from is importantly, AutoX/XX I MHRA this recently being accelerate enrollment AUTOX end patients regulatory program Our of AUTOX candidate. Agency may

Moving under on study. sheet February, approximately FELIX of offering quarter, conduct for billion highlighted the public highlights facility the our to we to net also our January in sale of and In ATM number discuss balance Slide X the net focus ADSs program million XX of the our on raising and strengthened January for and in proceeds. with XXX the approximately corporate AUTOX proceeds of ADSs we the

program of part DLBCL this intention to our AUTOX. partner their outlook, As we announced are

that We release of also facility in operations, terminated manufacturing process, and fully decided more resulting risk. the our able leverage UK, setup manufacturing operational In our in to the our in reviewed have manufacturing while platform current strategy experience manufacturing Rockwell. minimizing skill, a US we commercial in being to build manufacturing and economical our

AUTOX profile to would be treatment the Slide it as primary for is patients may option we X, the on while clinical of Moving care. how used compares to inotuzumab of The blinatumomab, and you bridging remind to typically number a like standard therapy. of

syndrome the which and at AUTOX AUTOX, strong, entering to looking and free a activity the realize our data, very patients to clinical This are study. for we is an event free program XX for standard blinatumomab AUTOX active or AUTOX neurotoxicity current had XX% compared comparable very the - move least level substantially important safety we're blinatumomab before and into care either months, six registrational months release the event has as that XX%. be simply, foundation the trial. is terms cytokine XX% blinatumomab, and at at of blinatumomab, elevated to looked very of look believe also that Put AUTOX We six to prior at twice we're value we're excellent survival, therapies the as which we months a survival, that data the approximately the received comparable. the you When is at in at at are even might If of most inotuzumab - it of looking twice profile. activity at failed exceeds product with with blinatumomab

another Blincyto number key to on and Moving products commercial X, two in view perspective. of Slide that the quick just or but at approved Besponsa programs a from space, and We're the looking inotuzumab. or blinatumomab, are

was which expect experience to hospital product in. we was community - ALL initially of Typically, for reached XXXX centers. in adults. see with patients year-over-year with who in sales which can that you key launch understand product non-academic sales is translates XXX this for Blincyto the our two the driver launched well the Blincyto to the was segment an in in Note developments patients to globally. approximately As majority of received those centers, the beyond of the Breyanzi patients US treated properties of establish expansion million. cycles Both XXXX where into also the the product product are fourth commercial the CAR annual of bode of centers XX% average while accelerating the T the We moving received received approximately have these DLBCL to XXXX, transplant the in academic AUTOX. quarter, product,

number now to turn Slide Let's X.

study XXX study. in First in motion with point approximately It response Ib/X is off, would single the overall relapsed pivotal arm a the say program two The FELIX disease. is with refractory I AUTOX at is primary patients Phase complete endpoint this rate.

recruit Secondary as will year. program into the to molecular event duration this is This of ongoing of and endpoints responses response. year and next as include well and free survival course early

also we're chronic includes lymphoma lymphocytic Lymphoma the ALL as additional leukemia. conducting mentioned, some AUTOX beyond well the B-cell other to explore the indolent and activity of I've As population. studies adult non-Hodgkin That as

version called minimizing Chimeric we're started the As indication. novel That of at loss. relapse December, CNS primary and a mentioned in a in its CDXX unique antigen pediatric looks also CDXX The exploring properties builds AUTOX earlier, which active adds ALL highly driven next typically is program by Receptor. a with the Antigen AUTOX program in AUTOX/XX lymphoma, rate also activity AUTOX/XX. In we the neglected generation

We are around ALL an B-cell AUTOX with program believe further AUTOX franchise pediatric into summary, opportunity both and fourth to commercial on and planning In the significant to the we trial a non-Hodgkin's in present adult this and have to an a this patients build year. data expand anchored quarter indications. of in there's opportunity

after year Moving is frontline clinical The and clinic limited understanding is options to have this XX, sister the product. of prepared a clinical expect The our high treatment the the point AUTOX need end towards program active Slide AUTOX number T-cell profile very program IND once medical for the for of patients in relapsed good an to of that lymphoma by available and 'XX. T-cell of lymphoma update end by in is with expect therapy. currently a the we

looking remind Moving XXXX progressing. will we're into of generation several you programs of clinic toolkit relates the AACR particularly the to to the programs, to which have We're excited we suite last recall very and tumor list, first it year. Slide our to move at developed we of be in all some as to you including showcased next our through XX, always into which good XXXX, technology solid programs

fend to hostile cancer are the with of provide environment while the off attack. T-cell activity strengthening to against cells program degree cell cancer T-cells modules and specificity Our Slide high a designed XX. number resilience create cells, to T-cell's withstand

can I to programs. see, two I the you next Phase here generation of would the programs we've start briefly As highlight alongside dates. expected tabulated like our at

AUTOX/XX last at year, of discussed, we this for planning end note will data as the You December a pediatric clinical year. and in the ALL trial are started update for

with Of year end trial we Science clinical This neuroblastoma AUTOX with program the start on the positive mentioned in course Translational which in published children to last end a programs explored clinically of first builds Phase yet haven't for partners XXXX and beyond. expect I experience XXXX. towards and will to financial AUTOXNG news collaboration of in Medicine. Andrew the that, turn over initially XXXX academic will update. clinical drive in With call I All our our with Andrew? quarter flow will be We

Andrew Oakley

to we of XX, first move it's my XXXX. pleasure If for our review financial Christian. quarter the to Thanks results Slide

yielding of the X.X of March costs of support proceeds compensation with three follow-on the an severance offering, public in months our as In Development XXXX. Cash net the cash capital XX, 'XX, the sales $X $XXX.X well our starting including February $X.X to clinical three open to per quarter. of at of of combination offering in public $XX.X X.X purchase to period to of XX, million ADSs net company additional This to that ADSs year, sold So of the same ended compensation representing net as compared share-based price operating in resulting $XX.X March proceeds under million, the ending related by million research shares of informed exclude in ADSs during market company for for the of development, from grant $X.X months is million employee an for costs ADS million million XX, the in auction in XXXX to take increase underwriters of amortization March $XX.X increase costs, income XXXX. and at XX, that of primarily was employment expenses million XXXX. of one, as XXXX, decreased total candidates in Research million $XXX.X million ordinary depreciation development XXXX which December which totaled began headcount for the the payments grant and their and net at its January workforce of increase million related $XX.X to million months reduction lower cash exercise And costs $XX.X a this sold to XX.X place position, three this income advancement net in due million in product cash million. and And March XX.X agreement, million. ending a to million increased XX, expenses Net of an of a of $X.X million consisted and expenses from the million. operating net $XX.X $XX.X compares $X.X that's million. $XXX

for Other longer Non-cash White to rates XX. three that's reduction options increased related based of the $X.X from to on million the by held by the Loss million. period of recognized in million. relates million $X.X of three That increase Non-cash of XX, related for which costs primarily share-based General as leasehold three million, interest increase XXXX. to general headcount relative the year. relating months to payments year. million. pound months, $X.X reduction XX, million $X.X disposal due months year. a of That's by million There last for firstly options in and ending as purchase was utilized of months improvements that year. the in and the $X.X million a decrease in workforce fair secondly, related $X.X XX, decreased affected of costs costs decreased decreases cash ending the severance to ending decreased earlier. attributed employment $X.X commercial for related increased Cash to million This terminations X.X related offset value workforce. months, Secondly, in and related employees last the is weakening for of increased by of compares of and depreciation the XXXX, $XX,XXX US logistics, in for facility lower that materials $X.X an the of project expense $X $X.X March an on months the million million research stock to during well for of three million in by for the the lastly, The of That's increase rising the the million XX, period improvements and $X.X of the fees Tax last administrative cell expense, March $X.X corresponding for ending compensation again the decreased XX, for corresponding income the gains period ending is to which costs and of manufacturing of operations expenses. London. due no stage compensation to result ending million deposit. in to for in And in administrative quarter. is up million and months. And share-based million primarily to share offset well $X.X facilities March of last million. related $X.X corresponding R&D million decreased three an expenses offset compensation which three Income by to an lease forfeitures an fees of to And related mentioned to the increase leasehold in March $X.X company. being income increase period. March share for increase in expenses of the any costs million And Benefit $X.X which net to related other $X.X the the as a continued corresponding XXXX, was an is in the development this as facilities to expenses of I to million costs; period from The incentives corresponding $X.X $X.X amount to in during this on as as compensation million, City result is decrease compares increase last legal lower million three, scaling increase credits. million XXXX to Interest million year. million and increased an three is income becoming an And $X.X depreciation audit $X.X from $X.X due increase, preparations exclude to thirdly, of to $X.X period $X.X dollar of by $X.X from decrease March of from a

to led Research effective obtained As the are at months development loss $X.XX. $X.XX a faster at Development March for before months and a ordinary that XX, diluted rate loss income ordinary XXXX. net primarily maximum per period share net qualifying And ordinary and tax. three share basic the to research in than This and to per expenses. net $XX.X compares XX And tax the million research ending grew higher that loss rate. March XXXX. same for eligible our $XX.X million and those of for to increase was the three XXXX. attributable increase a credits loss in XX, was due of months development March and loss ending net for credit credits compares the Net three diluted basic shareholders XX.X% was our in And The to an expenses. of ending

you Our call obviously Christian the give back the that to current runway extend will half cash February, financings and will a includes of now cash January brief on the unexpected hand, recent And which XXXX. the Christian? milestones. company's cash the hand first outlook, I in with to - into

Christian Itin

in messages report and Slide to We major the The program in enroll and patients product the Thanks data poised this on for management a started out very ALL Andrew. this with of we call. our the I and position the company AUTOX today's expect in cash We're with and the end hand success. first data part conclude combined AUTOX/XX patients of continue XX the And FELIX at of about excited XXXX. with pediatric of good on for adult ALL well into QqX to from let recap read to a discussion study is year year. expect the me last program in in Phase feel

CNS ALLCAR start Additionally, is expand non-Hodgkin's lymphoma actually program on give also we lymphoma. CAR us planning patients expected with a We're first EHA extensions with study, first data the to data at AUTOX imminently. expect to cell from to to which primary

partner treatment business announced patients. a program in January focus As this intending DLBCL indicated have AUTOX while outlook the we AUTOX the to of in renewed our on year, for

to multiple expect from XXXX. Phase and AUTOX for patients in over T-cell Additionally, peripheral candidates of treatment the expect with of clinical development XXXX data the later next I in course generation program and the enter we our development year lymphoma

cash first We're to the in take into are race, Finally, of Operator? with questions. the our recent half to strength successful runway now happy position a we XXXX.

Operator

[Operator Instructions] from And Maura the Goldstein. of line your first comes question

Mara Goldstein

- data the FELIX both Great, in XXXX. thanks wondering so this ALL we're if program and then year, programs, on quarter much. of starting the I'm obviously expecting since the fourth in

should what could on into treatment. then you're of and just of maybe some curious around I'm CAR going the terms to to number sort we as you AUTOX be AUTOX how program, and about direct what in the the you And just of color perspective, secondarily, If duration patients' in given BCMA wrap whether of your or in prioritization degree of some are suffer think competitive a terms that may, that? space fate landscape thoughts your and developing anticipating as from development not AUTOX same

Christian Itin

I Mara. question. the appreciate Thanks

first, non-Hodgkin's So the of work patients with studies. lymphoma. the to the we're with regards ALLCAR sort study indications as CNS in the explore doing study are exploratory as well the primary cell in CAR Those activities for to

So that extension. We're end the at part having of we're the we're of patients ALLCAR XX having And each is sub each of the on basically of cohorts report actually to expecting the indications. what a in approximately year.

a us of good think the us I set gives overall patients seeing and for additional feel that performance a will nice the we're it will - indications. product of give a So those us give various across

On expect data study those this by end patients. Phase well. and of by with of as available for I And the a all the we study, be to that's pediatric for classical year enrolled obviously, program, - - AUTOX/XX the the study the

this of year. because the say the enrolled these being course of treat and of I'll most limited are will follow-up be In terms patients follow-up into

at few at months up follow a looking average. we're on for these typically patients of So

the and question AUTOX you myeloma environment the competitive program multiple space. in The or basically the is on that area were touching third

with actually J&J of well. as also hydrocele, close the to market but obviously, approval the program Now getting

again, for on of that actually responses running, a product. opportunity in degree think high Phase are we're are persistence this we to whether we to product this to a a level deep Indeed, exploratory actually evaluate with academic is we a an Both what provide actually patients So we're first the study the characteristics important and whether program is do good has see differentiated I and I side, believe can doing that an program, of profile. induce of

but is. what the a of question, hurdle challenge modality true actually about do and the myeloma any a few moving asking years Has need these we that induce long-term is. this obviously, you actually need which set given meet. the over of frankly, where to clearly in Not to for care, to point a profile with just program, clearly, in last been standard care CAR from inducing we significantly good time. of correct would the still absolutely is the probability overall, T quite patients, high at perspective, a see remissions You're standard very And the in multiple being

Mara Goldstein

can program, that I Okay, could Andrew, the on ATM if outstanding thank And you remind just is you. us on less ask, what program?

Andrew Oakley

$XX around I Mara Yes, million. can. It's

Mara Goldstein

very you Thank Great. Okay. much.

Christian Itin

Thanks.

Operator

question Matt comes the next Your from Phipps. of line

Matt Phipps

four week. guys, just would questions. Hi, expect three the ASH? some I for EHA, trail or that indolent coming first beyond be patients guess from cohorts my taking we that which ALLCAR be I Christian, at abstracts Should all assays next mainly thanks going on across to data

Christian Itin

Thanks Matt. indolent focused be will cohort. for The update the on joining

Matt Phipps

And BCMA that's thanks. myeloma. of like about if following CDXX we CDXX shown you're to on I some the guess, as And kind CAR decision - here or UCL talk wondering use when [ph]. can the have multiple then Okay, of targets just a such newer bispecifics posted up DDRC for maybe trial the Xd AUTOX, for versus BCA dual of

Christian Itin

actual different in of in we're has design to - the as designed a properties the that - with receptor. way the binder that The the of –on what about in design the - - thinking is quite been CAR. for we different we're there So has using so structural - program in use is very that BCMA worked program the a of well and terms far space, anchored through AUTOX also CAR terms actually to the

moved seeing initially that a what forward. across current certainly we've have in the it's to So what change our we're also been AUTOX have programs significant but product,

address looking really and sort get which to that questions as be that take program needs first to responses, we So to we're hurdle to forward. in quite actually indicated, of the where that of do what that's is data actually reported the has moved extended an which need - that's - level common next space get challenging is to think this The a programs multiple be look the basically in the at layer been anchor reported is, persistence, has long of been so to I you myeloma you level far. the

So looking us challenging is to to reason an in as element myeloma. well what this we're but will we persistence actually that study that actually as extended multiple area gives the with basically hard heterogeneous actually still cure. buy an have is microenvironment be add getting time, can we the a program. find The disease And why quite we a third the address is time a to

get currently still approach we any were illogical, there's to sort anyone other clearly frankly, of remnants there's for of So situations to crack. and very can't tumors that that and to actually challenging

we're the on. are that basically three layers working those So

driving some actually we to get BCMA carry may maybe aspect we're multiple part cells And to in in actually those, in the that - which able using, actually, myeloma there up negative. persistence, see drive BCMA also an it, is is there a to and target part but key so a of the actually terms is potentially which support that be antigen in of of importance

Matt Phipps

product, J&J CR are meaningfully you mean, can Do think mean, I touched extremely I the of with you mean, - rates on but kind Okay. you the high. I especially this,

Christian Itin

Correct.

Matt Phipps

to to for their it meet the opposed beyond the real beat guess year I PFS - that or want beyond persistence is ability that is to meaningful here get is better thing PFS. to drive Or as just improved

Christian Itin

high. CR interesting more depth you part is CRS. CR that the pointing the outcome. that towards is that think are very right actually hydrocele drive need area of is of the the that correlated program. need differences, stringent that I is And what with per obviously, is rate responses, length deep And the the and of data actually out And You're J&J the rate very in very start really se But actually also where differences you to see between to drive. you to molecular the

over third in high then look have the right, an early it's and clearly that readout. time. the to overall an you're extended the aspect And that you And at. period profile a level persistence actually regards with CRS level keep very active you're with the as molecular for So - that certainly we're to related proceeding is an safety gives that next stringency need at to of well. ability to to actually actually And as space product the of is actually you very drive the the seeing also looking

Matt Phipps

of Great Do and on the different of and kind as so going how you mind manage as of given of far system seen forward backbone, level just using a persistence expansion programs in speak with AUTOX to lentiviral with in we've this and that last you the broader question, construct, kind what programs? kind maybe of with and scFvs keep different or safety.

Christian Itin

that's you multiple lentiviral the pro benefits. of to indications what be see lentiviral think we're as actually using context of a long-term myeloma where important the I persistence as obviously, obviously And in well sort using the backbones. We're get do of lentiviral - in you'd to backbone. is - a be clearly also benefit looking leukemia at

Matt Phipps

Christian. Thanks Okay.

Christian Itin

a Matt. Thanks lot

Operator

Your from comes line of Gil next question Blum.

Gil Blum

thanks for taking morning, good our questions. Everyone

does issues US. UK, patients it focus some manufacturing the in logistical offer in the within of in treating So

Christian Itin

only to out the US, lot UK, for out a site geographies as we London fresh do currently required all leukapheresis. the it within trials manufacture actually the timeframe in the very north that's Stevenage. Obviously, of actually of we across And we've thanks Gil also obviously, located question. clinical for well to been and actually - within our but leukapheresis, manufacturing various Well, frozen good the a Europe, serve as shape joining able of not

and the able actually most patterns can we're do during year. of course during the to we the manage - well. logistics So Even even flight that had we last very limited that

perspective. logistics of here don't significant that a adds or actually a think time we in So component either from terms that risk

Gil Blum

And Okay, AUTOXNG thank bit maybe you. about here. a little

small might in children tumor a a us remind solid you have that market. you those of could and study small specialized platform of How relatively the neuroblastoma your AUTOX kind from Could what So features across learnings engine? is in relatively indication. translate

Christian Itin

Right.

matter most T next an and the is then we're The cells from the the have to that ability is we amount that Translational microenvironment quite Was we in actually last program targeting of can low So asked generate And in had targeting also started year question, is doing program for Medicine. target actually in that are that was and through with understanding significant the challenges the address pain derived with that a antigen out resilience frankly GDX, once What actually to is the neuroblastoma receptor level CAR window of building present AUTOX first Science do we is however, the of you an tumors. adequate was AUTOX basically, there solid ways. therapeutic answered that GDX first question, GDX. that the that chimeric into publication That trial. present three in fibers. question cells, the different in at end a into the

cells to signal actually T to of available basically STAT insensitive version with and SIPX, receptors. the one or of checkpoint the insensitive actually abolish intracellular receptor coming a signals and the checkpoint receptor, that the checkpoint using transduction have dominant transmits an version checkpoints, renders antigen by is protein hand, cells normally a the to a dominant shaped set that signal that it a of the chimeric signals On which we're negative that, negative onto to negatively from cell rendering

other cells which ways actually and with off is immune have The over fend and cells of cell certainly T second this the element and tumor distance. TGFBeta, is defend one

interior rendering actually, we're actually is T from the to keep same an negative to cells signal at induced receptor. receptor going, We're Here, as the the a TGFBeta a that like cells if phimostretch they we're part as cold it's T is up using of manage. point. from the what TGFBeta very the constitutive keep them sort conditioning to actually having also, with when adding even the into - receptor the we active And is if element actually that CAR engineered IL-X a reason transmit regimen, helps this environment, is, is tendocel IL-X, into of of of cells pay again, dominant actually actually help any the actually signal using, reference CAR does we're And IL-X T to IL-X basis. and And of inducing that IL-XX. insensitive the constitutively And that you the actually overcoming the the those. cell. that therapies, version chain CAR receive signal a do what actually even a third the the it actually negative sub actually actually activated. on signals gives CAR difficult obviously, T the just case actually cells in to environment the signal keep the And of

the tumor And been be data talked setting. be three working are will components in programs we've through, hence also, that we're neuroblastoma just other across tumor that on neuroblastoma, not generating we entities that well. various the but just actually solid any to obviously, are are components these our important Now for in believe going program, as for towards relevant

HERX So of the one actually you the homogeneously which tumor we're sort of reason case I why important in neuroblastoma, GDX, think modules of target are And that interpret which try have you antigens, with to results if elements a of a the highly in wide is takes example, that fact, The you of in cells challenges, obviously tumor an in think generate. a first, out given EGFR expression, and creates within as sample. neuroblastoma actually often across range of a because associated we actually lot part. or about are expressed variable variability these which often exploring that expression have is have - antigen, their

and have indications. we a perspective a setting, here center well. it us and a pediatric establish tumor background. So good medical the additional it's also need in gives There's ALL as a to obviously in background very commercial But the we're with setting. doing a solid from those clean high background It's fit pediatric their a good perspective, from a homogeneous modules utility very actually work

Gil Blum

in helpful. product Thank competitive us important the lymphoma is one you CRS indolent you. this remind here? was very Could on program. CAR population, how safer last maybe T It a lower look having programs a at And patient with

Christian Itin

centers mantle very we programs look also, approvals in the a It's large with that that. Gil. perspective, proportion of to in - T transplant fundamental from experience have of cost should has is Ts haven't be obviously, initial is now then therapy because to And cell it's And follicular perspective, important do although through their so that that go really is why to indications, where question patients. when of the T we highly but infrastructure specialized at a we difficult managing we the a actually from able difficult. handling been DLBCL we we stage, reach lot commercial the CAR expected reality Thanks from been able brought happen that the the far CAR perspective. first, CAR centers outside reason an that didn't a in The reached we a that

the adverse logical in in so actually the of disease has and have commercial use, majority profile ability fact actually of the their event limited to event reach frankly, profiles those and patients the the limited And settings. product adverse significantly their and

needed reach be of indications. And of And therapeutic treated even that setting, for highly is excellent mantle a often into therapy periphery, also DLBCL a respective academic need is Now, very in an for actually approach and centers. in specialized what go we're follicular or core those if this the the CLL outside seeing an significant creates you can the to what in example. that's disease managed range so a is these or terms indeed, lymphoma, translation that commercial in matter, what the that into patients cell of so are of more than as profile much the of patients really like more safety lymphoma, very broader that the

Operator

of Joseph. the comes Eric question from next mind Your

Unidentified Analyst

Rahul morning. is on the good This Hi, taking questions. for Eric and for thanks

followed would Just the durability line firstly, meaningful and clinically as of its a I do adult and how relative us, you on be what mean couple assess in then to that settings by earlier in say the safe the on treatment the PSP potential the be setting, it based expansion And likely to approval study? initial is landscape? third seen a would from ALL? label response continuity existing kind line AUTOX, potential

Christian Itin

we're of lot at that thanks level amount agents a setting. So ALL but highly both where that poor for an is joining. to. The is because And cytotoxic toxicity development cumulative the experienced consequence already exposed have been for the enormous patients in of of that overall point questions. for challenge that suppressed, and line thanks as the AUTOX rather they've also in the they've starting with condition last are a the high are of immune Obviously, a

and are So at with obviously obviously but a deal to particular but safety perspective, line difficult in obviously, that to more a keep actually obviously, through, because very that line source that actually population the of sense, both withstand, that with point, treat. from it's you perspective, also every break from a difficult disease therapy, selecting

setting by very the remission showing blinatumomab or product starting line well nicely the XX%. showing data patients where third the rate earlier the Blincyto, bodes in at level This extremely an a potential also of in approximately line the so exemplified actually was experience line of of line. setting with or activity was of last adult complete And in ALL a line this last in terms significant last and

line However, front have In rate. point in residual at population, Blincyto cycle chemotherapy showed still actually complete constipation minimal XX% gone through was who was one, patient actually that consolidation frontline obviously disease, and in chemo. have that which induction to resistant remission patients

this you patients said one seeing transplant that T that about to more you that are activity, obviously in would similar the expect and to setting early as is therapy. we second go. the to up, move Those So what in settings patients and practical And actually what mediated with and think product you patients is in of also is just seeing frontline to that can go setting want consolidation move that into the that would in expect for is we're an could into substantially are eligible you cell you the ALL of patients as high-risk Or we're a might improve we're basic choose either line induced actually other as ineligible of contemplate I that transplant. that words, seeing move also therapy. what is line are third of activity the to up terms to - clearly, or see line we benefit settings the you can for regards earlier line we

Unidentified Analyst

useful and the AUTOX, clarify I/II for the of on can Phase as study then a outpatient color. in follow survival Thanks. the XXXX is such cohort? Thanks readouts for ALEXANDER store from additional up And maybe safety you data data and

Christian Itin

Right, the in so in on we're of writing the the on a up data program, publication. process the AUTOX actually

full hence moving four we limited a in show picture we course XX-minute we're it's feel And which we're publish last that of the only had a the presentations obviously in that of the presentations. publication, to actually to now to time possible year. right the Given year, hoping this way oral which of data, is during

Unidentified Analyst

the Great, thanks taking for questions.

Christian Itin

it. Appreciate lot. a Thanks

Operator

Shi. comes question of Your Kelly from next the mind

Kelly Shi

taking you T lymphoma. Thank in Good I have for regarding morning. question my AUTOX a questions. cell

competitive to what should meaningful So what the out? patients year, of of you. look his laid does kind we like? enroll for update you the expect landscape as do on Also And advocacy trial? ASH see Thank this

Christian Itin

Thanks. a for joining. Kelly, Thanks lot

they therapy, get typically three So therapy Phase not trial. have the that patients enrolling we're onto obviously, in failed, with our peripheral frontline the just trial lymphoma but of patients I cell actually before the lines AUTOX are T

the that are these the expecting to enrolling assume dose we end three the we're of but through point dose that, than trial. and see advanced bit with escalation What we're would towards is patients potentially So at. sort going into levels we're the that very we're the obviously, year we of expect from more a looking that data from data time, that's ballpark the but currently, in program

to we're and escalation looking that. obviously, readout dose the So at the related

the patients of those assessments safety pharmacological expect us in data give that as setting. of pharmacodynamic product which In see obviously well data the From the performance as that tumor a would and in data, terms understanding limited. as good the of at to of is unfortunately we PTCL for population. in perspective, environment say brentuximab, this subset patient setting is only There's the the positive I point, which patients small competitive obviously are of portion a rather CDXX which eligible of competitive are a would late-stage type that

actually For participate are in to brentuximab not the current predominantly are clinical opportunities eligible obviously, for patients trials. that the

perspective printout. set the that not that of chemotherapy, CD your to perspective potential very related there positive sense, on transplant are if and or There small a therapy market. dose currently agents XX of commercial from a in predominantly available, high So sort there is is

Kelly Shi

would Thank for very far, AUTOX. the physician much. trigger Also safeties the safety have CAR. up follow a I'm what incorporated At switch? allowed juncture you so a which be just wondering in to

Christian Itin

did activity we designed we neurological had major an safety be the we the original design question get would that of eliminated, pain out, not really predict and couldn't to obviously, significant was syndrome. access without case we toxicity, in indeed, when to into could inducing the product this So obviously, hypotheses product, the switch would allow the put whether clinical should around a program, the whether AUTOX the that off a working around become product very be our question we necessity. actually which or because And

the it. of in would switch that without that actually exploration to expect having that I to toxicity, Phase inducing want a neuroblastoma gone patients it's we didn't actually use have in certainly the the unlikely type initial actually physician need product would through a With I and use quite

actually, really I it's call whether not which think abort product, the literally abort In at physicians your frankly, physicians the built in into right. switches it of in to end therapy. is, you And CAR a when dose you'd therapy, what the or decision. which it's take the out providing general, them offer actually this would would T case, which cells, point you be is rituximab, the the

So have where a have significant this that to - physician the - decision a And - toxicity of indication the you clearly controlling. has is ultimately that if that decide. you do of level that heart station you but of treating that frankly

Kelly Shi

much. very you Thank

Christian Itin

Thank you.

Operator

Your next Asthika from question the of Goonewardene. comes line

Asthika Goonewardene

or I got talk you my of the AUTOX help And more could CRS into I couple I toolkit - the factors patients you AUTOX are of on then incorporating then suppressive that taking up in microenvironment? what a MRD you your Hi, question. the CAR more design Christian, of stringent features if And in those may. tumor could help overcome the AUTOX. negativity? items about you of get can guys, some Can that have thanks for a follow

Christian Itin

Okay, is amounts earlier BCMA. towards the patients. we're in cell, what that of is of range receptors can that can well, of of magnitude XX, be. expression to actually per we thanks get low would below activity magnitude, example per level design these general, published in two X, Tier a - joining. work a cytotoxic bit four of receptors an had of in it's against below order to orders But quite cell. of working what very were as XX receptors vary low very What really and the express that as cells for up an we've XX BCMA high Asthika was be to What done I multiple product as with myeloma the

exactly to driving that very BCMA that to activity levels low that very be multiple give cells. level you designs optimization features that sort real those work active of the very, for the get express test ability that give outcome. is, express exactly well choose a we there. against the the that actually and did pagers, cetera was low So of myeloma still of those as that types actually cells of will cells receptors to very those we That's range you at of a these challenge applied. still is very different design, as - and to us on test high on that do how And amounts, really for to the has it selection really et And be on that really

of question needs series is actually heart with at done. to And - using, the that to that at that but of the key terms particular we're went improvement of setting. With exact believe think of - we those a that the regards be elements further believe this I the to is sort The addressed believe be would modules an activity we I think drive was we it would So disclosed well through fundamental elements toolkit, haven't activity of designs actually how the we composition we that outcome. these actually just for in in that multiple as the what tested the how supportive that I regards and all and ATOXNG program, context any example point, as then of actually, myeloma. relevant in be for

Asthika Goonewardene

AUTOX case also indolent generates this that to which to there's then that I'm that AUTOX of Christian. the response the also deep way, durable may more persistence question interval? And is Great, important data in is put let's this with does in the that's another data say some out, trying so does yeah, or be just think here, figure data in durability Axi-cel, - Kind suggests maybe a Or something driver over upfront in lymphoma? you so than DLBCL. of Do how better public domain suggest do setting? to this

Christian Itin

depths response. of actually, Right, so in terms question, it's an interesting of

and modality. to excellent responses actually response impact a or to across of in sets look data outcome where long-term who getting is to also reaching cell malignancies of with molecular of context, have data the receive correlative critical at that obviously, that other you outcome. show B a subsequent I molecular transplants, the looking ALL, chance think Whether and whether have have data we But for you're in a importance actually the best patients molecular we the actually do outcomes. responses, therapeutic is the

don't to about I way, us disease myeloma point and very seeing the very similar multiple gives achieve will think that picture. come starts quickly. that set we're as If quite back before, very, sort you similar The in talked data we is a

response quite more yet responses that remission obviously with is generated. as that I I the disease three that guide settings. think will I in in molecular But as field those to data getting way, long-term the are the durability terms not data a significant very start With I much outcome the as or we're sets answers as the data yet. in there expect data get to deep general, still the But guess to settings in quite a in more use molecular there's regards more strong gain a lymphoma I generating lymphoma, years, sets well. looking remissions information enough more of correlation broadly. don't between well two substantive as probably starting into this being that will actually much we're would and it think matters, correlation conclusive the sense next follicular to around around of the think But that is of non-Hodgkin's

Asthika Goonewardene

thanks, Great, Christian.

Christian Itin

Thank you.

Operator

from of comes question the next line Your Burns. Robert

Unidentified Analyst

Rob. [ph] on Hey, is My everyone. on This AUTOX. question is Jay first for

and words provide of target? on can study in question that when going the pretty potentially would help other study? think update do And are to Phase and you even has for evolved CRS like maybe lower in the I to rates than thanks a eliciting a you the So color toxicities? some adoption? the design. an of field barrier these manage Thanks patients these you're potentially on allogeneic J&Js quick And a asset, neutropenia initiate high do showed to In AUTOX type you something and major program, which on And optimized think like

Christian Itin

that that - marrow to cytopenias on we're is on of a joining and myeloma the I an has of safety the has marrow, drive myeloma Thanks the having prolonged cytopenias, course, The and sort Jay. it for of multiple of think onset - bone significant is et multiple in present seeing, the that what can its segments and as related lot health the obviously of question obviously, the ALL bone disease present well. cetera actually we're of impact And impact patients. to similar a type that ultimately

we - on is that's it think active with the levels these can that approaches we to an actually here intrinsic the to are drive element therapeutic have be of I obviously, to active actually the in which have significant highly highly bone marrow's cytokines then disease, a regenerate. and working have So in can marrow the impact and marrow as negative in well, patients ability

I that and lead sure need to more think have types that at actually and these on there's I to bit and does its just on the think to in will of actually function. is point design something to the regard ability around actually more cetera, a properly of which with need in that sense It we'll is the look marrow what basically a a I'm that see to give you what sort at start compensate at outcome improve we probably rebuild we point need we not et general you to data toxicities. to data field good recuperate that start - is premises this -

doing we'll that Second Obviously, of the is related where - partners. with of give we're the that kind having point with side you're time that question one. get activity on program program academic going and that referring allogeneic And and that you is that at raised to the actually year the also our expect going collaboration report in in to that update the middle to towards the program. was we're we an

to going clinical track course the about side. of talking down we're this during initiated obviously, to time is So and we'll before in on But bit actually here still year a start program it more be detail. that of to need the

Unidentified Analyst

Thanks.

Christian Itin

Thank you

Operator

closing time, remarks? there questions. you any Do are this further no have At

Christian Itin

And and much. updates first Have Obviously, continued will updated. few you very interest thanks lot your for at to next Well, keeping off, day. right, EHA. be you a appreciate thank us Really forward support. great All a we're looking joining. for

Operator

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

You may now disconnect.

Autolus Therapeutics (AUTL) 10 May 212021 Q1 Earnings call transcript